Title 42 — The Public Health and Welfare

Part A · Chapter 6A — Public Health Service

§ 282. Director of National Institutes of Health

Statutory text

Appointment

The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) and as the Secretary may otherwise prescribe.

Duties and authority

In carrying out the purposes of section 241 of this title, the Secretary, acting through the Director of NIH—

shall carry out this subchapter, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;

shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities within the National Institutes of Health;

shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;

shall assemble accurate data to be used to assess research priorities, including—

information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and

data on study populations of clinical research, funded by or conducted at each national research institute and national center, which—

specifies the inclusion of—

women;

members of minority groups;

relevant age categories, including pediatric subgroups; and

other demographic variables as the Director of the National Institutes of Health determines appropriate;

is disaggregated by research area, condition, and disease categories; and

is to be made publicly available on the Internet website of the National Institutes of Health;

shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, and through the development, implementation, and updating of the strategic plan developed under subsection (m);

shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans;

shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—

identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning;

include information on such research in reports under section 283 of this title; and

in the case of such research supported with funds referred to in subparagraph (B)—

require as appropriate that proposals include milestones and goals for the research;

require that the proposals include timeframes for funding of the research; and

ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health;

may, with respect to funds reserved under section 282a(c)(1) of this title for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and

shall, with respect to funds appropriated to the Division of Program Coordination, Planning, and Strategic Initiatives pursuant to section 282a(a)(2) of this title, allocate such funds to the national research institutes and national centers for making grants for pediatric research that is identified under subparagraph (A) and shall prioritize, as appropriate, such pediatric research that does not duplicate existing research activities of the National Institutes of Health; and

may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director;

shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers—

preserve an emphasis on investigator-initiated research project grants, including with respect to research involving collaboration between 2 or more such institutes or centers;

when appropriate, maximize investigator-initiated research project grants in their annual research portfolios;

foster collaboration between clinical research projects funded by the respective national research institutes and national centers that—

conduct research involving human subjects; and

collect similar data; and

encourage the collaboration described in subparagraph (C) to—

allow for an increase in the number of subjects studied; and

utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;

shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title and that, after such review, the research is reviewed in accordance with section 289a–1(a)(2) of this title by the appropriate advisory council under section 284a of this title before the research proposals are approved for funding;

shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes;

shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section 288 of this title; and

may conduct and support research training—

for which fellowship support is not provided under section 288 of this title; and

that does not consist of residency training of physicians or other health professionals;

may, from funds appropriated under section 282a(b) of this title, reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority;

may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;

for the national research institutes and administrative entities within the National Institutes of Health—

may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal property, and

may acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed ten years;

may secure resources for research conducted by or through the National Institutes of Health;

may, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups and scientific program advisory committees as are needed to carry out the requirements of this subchapter and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups;

may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad;

may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;

may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment;

may accept voluntary and uncompensated services;

may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter;

may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of chapter 74 of title 38;

shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development;

implement the Cures Acceleration Network described in section 287a of this title;

may require recipients of National Institutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—

human research participants, including with respect to privacy, security, informed consent, and protected health information; and

proprietary interests, confidential commercial information, and the intellectual property rights of the funding recipient;

shall consult with the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal agencies and offices, as appropriate, regarding research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging infectious diseases, chemical, radiological, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats;

shall consult with the Director of the Office of National Security within the Department of Health and Human Services, the Assistant Secretary for Preparedness and Response, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other appropriate agencies on a regular basis, regarding biomedical research conducted or supported by the National Institutes of Health that may affect or be affected by matters of national security;

shall ensure that recipients of awards from the National Institutes of Health, and, as appropriate and practicable, entities collaborating with such recipients, have in place and are adhering to appropriate technology practices and policies for the security of identifiable, sensitive information, including information collected, stored, managed, or analyzed by domestic and non-domestic entities; and

shall ensure that recipients of awards from the National Institutes of Health are in compliance with the terms and conditions of such award, which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipients of the award.

Chapter 10 of title 5 shall not apply to the duration of a peer review group appointed under paragraph (16). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States.

Availability of substances and organisms for research

The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.

Services of experts or consultants; number; payment of expenses, conditions, recovery

The Director of NIH may obtain (in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of service) the services of not more than 220 experts or consultants, with scientific or other professional qualifications, for the National Institutes of Health.

Except as provided in subparagraph (B), experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment.

Expenses specified in subparagraph (A) shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph.

Dissemination of research information

The Director of NIH shall—

advise the agencies of the National Institutes of Health on medical applications of research;

coordinate, review, and facilitate the systematic identification and evaluation of, clinically relevant information from research conducted by or through the national research institutes;

promote the effective transfer of the information described in paragraph (2) to the health care community and to entities that require such information;

monitor the effectiveness of the activities described in paragraph (3); and

ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded by the National Institutes of Health and intended for the general public are in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (Public Law 102–73).

Associate Director for Prevention; functions

There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—

annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs; and

recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemination, using advanced technologies to the maximum extent practicable, of research results to such entities.

Transferred

Increased participation of women and disadvantaged individuals in biomedical and behavioral research

The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.

Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions

The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the “data bank”). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information.

The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.

In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers.

The data bank shall include the following:

A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to section 355(i) of title 21, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, a point of contact for those wanting to enroll in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol.

Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available—

under a treatment investigational new drug application that has been submitted to the Secretary under section 360bbb(c) of title 21; or

as a Group C cancer drug (as defined by the National Cancer Institute).

The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments.

The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment.

Fees collected under section 379h of title 21 shall not be used in carrying out this subsection.

Expanded clinical trial registry data bank

Definitions; requirement

Definitions

In this subsection:

Applicable clinical trial

The term “applicable clinical trial” means an applicable device clinical trial or an applicable drug clinical trial.

Applicable device clinical trial

The term “applicable device clinical trial” means—

a prospective clinical study of health outcomes comparing an intervention with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and

a pediatric postmarket surveillance as required under section 360l of title 21.

Applicable drug clinical trial

In general

The term “applicable drug clinical trial” means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 355 of title 21 or to section 262 of this title.

Clinical investigation

For purposes of subclause (I), the term “clinical investigation” has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation).

Phase I

For purposes of subclause (I), the term “phase I” has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation).

Clinical trial information

The term “clinical trial information” means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3).

Completion date

The term “completion date” means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.

Device

The term “device” means a device as defined in section 321(h) of title 21.

Drug

The term “drug” means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of this title.

Ongoing

The term “ongoing” means, with respect to a clinical trial of a drug or a device and to a date, that—

1 or more patients is enrolled in the clinical trial; and

the date is before the completion date of the clinical trial.

Responsible party

The term “responsible party”, with respect to a clinical trial of a drug or device, means—

the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or

the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.

Requirement

The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2).

Expansion of clinical trial registry data bank with respect to clinical trial information

In general

Expansion of data bank

To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the “registry data bank”). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.

Content

The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include—

descriptive information, including—

a brief title, intended for the lay public;

a brief summary, intended for the lay public;

the primary purpose;

the study design;

for an applicable drug clinical trial, the study phase;

study type;

the primary disease or condition being studied, or the focus of the study;

the intervention name and intervention type;

the study start date;

the expected completion date;

the target number of subjects; and

outcomes, including primary and secondary outcome measures;

recruitment information, including—

eligibility criteria;

gender;

age limits;

whether the trial accepts healthy volunteers;

overall recruitment status;

individual site status; and

in the case of an applicable drug clinical trial, if the drug is not approved under section 355 of title 21 or licensed under section 262 of this title, specify whether or not there is expanded access to the drug under section 360bbb of title 21 for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;

location and contact information, including—

the name of the sponsor;

the responsible party, by official title; and

the facility name and facility contact information (including the city, State, and zip code for each clinical trial location, or a toll-free number through which such location information may be accessed); and

administrative data (which the Secretary may make publicly available as necessary), including—

the unique protocol identification number;

other protocol identification numbers, if any; and

the Food and Drug Administration IND/IDE protocol number and the record verification date.

Modifications

The Secretary may by regulation modify the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not reduce such clinical trial information.

Format and structure

Searchable categories

The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:

The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.

The name of the intervention, including any drug or device being studied in the clinical trial.

The location of the clinical trial.

The age group studied in the clinical trial, including pediatric subpopulations.

The study phase of the clinical trial.

The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization.

The recruitment status of the clinical trial.

The National Clinical Trial number or other study identification for the clinical trial.

Additional searchable category

Not later than 18 months after September 27, 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.

Other elements

The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis.

Format

The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared.

Data submission

The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, September 27, 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of 1 subparagraph (A)(ii) not later than the later of—

90 days after September 27, 2007;

21 days after the first patient is enrolled in such clinical trial; or

in the case of a clinical trial that is not for a serious or life-threatening disease or condition and that is ongoing on September 27, 2007, 1 year after September 27, 2007.

Posting of data

Applicable drug clinical trial

The Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in accordance with this paragraph is posted in the registry data bank not later than 30 days after such submission.

Applicable device clinical trial

The Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in the registry data bank—

not earlier than the date of clearance under section 360(k) of title 21, or approval under section 360e or 360j(m) of title 21, as applicable, for a device that was not previously cleared or approved, and not later than 30 days after such date, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval; or

for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary.

Option to make certain clinical trial information available earlier

The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I).

Combination products

An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered—

an applicable drug clinical trial, if the Secretary determines under section 353(g) of title 21 that the primary mode of action of such product is that of a drug or biological product; or

an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.

Expansion of registry data bank to include results of clinical trials

Linking registry data bank to existing results

In general

Beginning not later than 90 days after September 27, 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial—

not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or

not later than 30 days after the results information described in clause (ii) becomes publicly available.

Required information

FDA information

The Secretary shall ensure that the registry data bank includes links to the following information:

If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug Administration summary document regarding such applicable clinical trial.

If an applicable drug clinical trial was conducted under section 355a or 355c of title 21, a link to the posted Food and Drug Administration assessment of the results of such trial.

Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any.

For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under section 355(l)(2) of title 21.

For an applicable device clinical trial, in the case of a premarket application under section 360e of title 21, the detailed summary of information respecting the safety and effectiveness of the device required under section 360j(h)(1) of title 21, or, in the case of a report under section 360(k) of title 21, the section 360(k) summary of the safety and effectiveness data required under section 807.95(d) of title 21, Code of Federal Regulations (or any successor regulation).

NIH information

The Secretary shall ensure that the registry data bank includes links to the following information:

Medline citations to any publications focused on the results of an applicable clinical trial.

The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available.

Results for existing data bank entries

The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to September 27, 2007, as available.

Inclusion of results

The Secretary, acting through the Director of NIH, shall—

expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the “registry and results data bank”);

ensure that such results are made publicly available through the Internet;

post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and

in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public.

Basic results

Not later than 1 year after September 27, 2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:

Demographic and baseline characteristics of patient sample

A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.

Primary and secondary outcomes

The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.

Point of contact

A point of contact for scientific information about the clinical trial results.

Certain agreements

Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.

Expanded registry and results data bank

Expansion by rulemaking

To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after September 27, 2007, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph.

Clinical trials

Approved products

The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for—

each applicable drug clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title; and

each applicable device clinical trial for a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21.

Unapproved products

The regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for—

an applicable drug clinical trial for a drug that is not approved under section 355 of title 21 and not licensed under section 262 of this title (whether approval or licensure was sought or not); and

an applicable device clinical trial for a device that is not cleared under section 360(k) of title 21 and not approved under section 360e or section 360j(m) of title 21 (whether clearance or approval was sought or not).

Required elements

The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories:

A summary of the clinical trial and its results that is written in non-technical, understandable language for patients, if the Secretary determines that such types of summary can be included without being misleading or promotional.

A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included without being misleading or promotional.

The full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial.

Such other categories as the Secretary determines appropriate.

Results submission

The results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine—

whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months;

whether the clinical trial information described in clause (iii) should be required to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and results data bank before the effective date of the regulations issued under this subparagraph; and

in the case when the clinical trial information described in clause (iii) is required to be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account—

the certification process under subparagraph (E)(iii) when approval, licensure, or clearance is sought; and

whether there should be a delay of submission when approval, licensure, or clearance will not be sought.

Additional provisions

The regulations under this subparagraph shall also establish—

a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank;

additional information on clinical trials and results that is written in nontechnical, understandable language for patients;

considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional;

the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked;

a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and

additions or modifications to the manner of reporting of the data elements established under subparagraph (C).

Consideration of World Health Organization data set

The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph.

Public meeting

The Secretary shall hold a public meeting no later than 18 months after September 27, 2007, to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph.

Submission of results information

In general

Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of—

the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); 2 or

the actual date of completion.

Clinical trials described

An applicable clinical trial described in this clause is an applicable clinical trial subject to—

paragraph (2)(C); and

subparagraph (C); or

the regulations issued under subparagraph (D).

Delayed submission of results with certification

If the responsible party for an applicable clinical trial submits a certification that clause (iv) or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as required under the applicable clause.

Seeking initial approval of a drug or device

With respect to an applicable clinical trial that is completed before the drug is initially approved under section 355 of title 21 or initially licensed under section 262 of this title, or the device is initially cleared under section 360(k) or initially approved under section 360e or 360j(m) of title 21, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m), as applicable.

Seeking approval of a new use for the drug or device

In general

With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under section 355 of title 21, licensing under section 262 of this title, or clearance under section 360(k), or approval under section 360e or 360j(m) of title 21 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date—

the new use of the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m);

the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 355, 262, 360(k), 360e, or 360j(m); or

except as provided in subclause (III), the application or premarket notification under such section 355, 262, 360(k), 360e, or 360j(m) is withdrawn without resubmission for no less than 210 days.

Requirement that each clinical trial in application be treated the same

If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under section 262 of this title or section 355, 360(k), 360e, or 360j(m) of title 21, as applicable) of the use studied in the clinical trial.

Two-year limitation

The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years after the date a certification under clause (iii) was made to the Director of NIH, if an action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.

Extensions

The Director of NIH may provide an extension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted. The Director of NIH may grant more than one such extension for a clinical trial.

Notice to Director of NIH

The Commissioner of Food and Drugs shall notify the Director of NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph (5)(B) of such action not later than 30 days after such action.

Posting of data

The Director of NIH shall ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission.

Waivers regarding certain clinical trial results

The Secretary may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted.

Adverse events

Regulations

Not later than 18 months after September 27, 2007, the Secretary shall by regulation determine the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for applicable clinical trials described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists.

Default

If the Secretary fails to issue the regulation required by clause (i) by the date that is 24 months after September 27, 2007, clause (iii) shall take effect.

Additional elements

Upon the application of clause (ii), the Secretary shall include in the registry and results data bank for applicable clinical trials described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements:

Serious adverse events

A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

Frequent adverse events

A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

Posting of other information

In carrying out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the tables information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public.

Relation to subparagraph (C)

Clinical trial information included in the registry and results data bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank pursuant to subparagraph (C).

Additional submissions of clinical trial information

Voluntary submissions

A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial information for each applicable clinical trial that is required to be submitted under section 262 of this title or under section 355, 360(k), 360e, or 360j(m) of title 21 in an application or report for licensure, approval, or clearance of the drug or device for the use studied in the clinical trial.

Required submissions

In general

Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry and results data bank of clinical trial information for such clinical trial is necessary to protect the public health—

the Secretary may require by notification that such information be submitted to the Secretary in accordance with paragraphs (2) and (3) except with regard to timing of submission;

unless the responsible party submits a certification under paragraph (3)(E)(iii), such information shall be submitted not later than 30 days after the date specified by the Secretary in the notification; and

failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of the corresponding requirement of such paragraphs.

Clinical trials described

A clinical trial described in this clause is—

an applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or for a device that is cleared under section 360(k) of title 21 or approved under section 360e or section 360j(m) of title 21, whose completion date is on or after the date 10 years before September 27, 2007; or

an applicable clinical trial that is described by both by 3 paragraph (2)(C) and paragraph (3)(D)(ii)(II)).4

Updates to clinical trial data bank

Submission of updates

The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates—

shall be provided not less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period;

shall include identification of the dates of any such changes;

not later than 30 days after the recruitment status of such clinical trial changes, shall include an update of the recruitment status; and

not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete.

Public availability of updates

The Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual site status, location, and contact information, the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding updates, and information in such databases is presented in a manner that enables users to readily access each original element submission and to track the changes made by the updates. The Director of NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).

Coordination and compliance

Clinical trials supported by grants from Federal agencies

Grants from certain Federal agencies

If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, including the Food and Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3).

Verification by Federal agencies

The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee.

Notice and opportunity to remedy

If the head of an agency referred to in clause (i), as applicable, verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to correct such non-compliance and submit the required clinical trial information.

Consultation with other Federal agencies

The Secretary shall—

consult with other agencies that conduct research involving human subjects in accordance with any section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such research is an applicable clinical trial; and

develop with such agencies procedures comparable to those described in clauses (i), (ii), and (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under paragraphs (2) and (3).

Certification to accompany drug, biological product, and device submissions

At the time of submission of an application under section 355 of title 21, section 360e of title 21, section 360j(m) of title 21, or section 262 of this title, or submission of a report under section 360(k) of title 21, such application or submission shall be accompanied by a certification that all applicable requirements of this subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial control numbers.

Quality control

Pilot quality control project

Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the publicly available information described in paragraph (3)(A) and any other information available to the Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under paragraph (3)(C).

Notice of compliance

If the Secretary determines that any clinical trial information was not submitted as required under this subsection, or was submitted but is false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such noncompliance by submitting the required revised clinical trial information not later than 30 days after such notification.

Truthful clinical trial information

In general

The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading in any particular.

Effect

Clause (i) shall not have the effect of—

requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial involved; or

requiring clinical trial information described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C).

Public notices

Notice of violations

If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice—

that the responsible party is not in compliance with this chapter by—

failing to submit required clinical trial information; or

submitting false or misleading clinical trial information;

of the penalties imposed for the violation, if any; and

whether the responsible party has corrected the clinical trial information in the registry and results data bank.

Notice of failure to submit primary and secondary outcomes

If the responsible party for an applicable clinical trial fails to submit the primary and secondary outcomes as required under section 2(A)(ii)(I)(ll),5 the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice that the responsible party is not in compliance by failing to register the primary and secondary outcomes in accordance with this chapter, and that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial.

Failure to submit statement

The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: “The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.”.

Submission of false information statement

The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: “The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.”.

Non-submission of statement

The notice under clause (ii) for a violation described in clause (ii) shall include the following statement: “The entry for this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.”.

Compliance searches

The Director of NIH shall provide that the public may easily search the registry and results data bank for entries that include notices required under this subparagraph.

Limitation on disclosure of clinical trial information

In general

Nothing in this subsection (or under section 552 of title 5) shall require the Secretary to publicly disclose, by any means other than the registry and results data bank, information described in subparagraph (B).

Information described

Information described in this subparagraph is—

information submitted to the Director of NIH under this subsection, or information of the same general nature as (or integrally associated with) the information so submitted; and

information not otherwise publicly available, including because it is protected from disclosure under section 552 of title 5.

Authorization of appropriations

There are authorized to be appropriated to carry out this subsection $10,000,000 for each fiscal year.

Day care for children of employees

The Director of NIH may establish a program to provide day care services for the employees of the National Institutes of Health similar to those services provided by other Federal agencies (including the availability of day care service on a 24-hour-a-day basis).

Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee.

For purposes regarding the provision of day care services, the Director of NIH may enter into rental or lease purchase agreements.

Council of Councils

Establishment

Not later than 90 days after January 15, 2007, the Director of NIH shall establish within the Office of the Director an advisory council to be known as the “Council of Councils” (referred to in this subsection as the “Council”) for the purpose of advising the Director on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives, including making recommendations with respect to the conduct and support of research described in subsection (b)(7).

Membership

In general

The Council shall be composed of 27 members selected by the Director of NIH with approval from the Secretary from among the list of nominees under subparagraph (C).

Certain requirements

In selecting the members of the Council, the Director of NIH shall ensure—

the representation of a broad range of disciplines and perspectives; and

the ongoing inclusion of at least 1 representative from each national research institute whose budget is substantial relative to a majority of the other institutes.

Nomination

The Director of NIH shall maintain an updated list of individuals who have been nominated to serve on the Council, which list shall consist of the following:

For each national research institute and national center, 3 individuals nominated by the head of such institute or center from among the members of the advisory council of the institute or center, of which—

two shall be scientists; and

one shall be from the general public or shall be a leader in the field of public policy, law, health policy, economics, or management.

For each office within the Division of Program Coordination, Planning, and Strategic Initiatives, 1 individual nominated by the head of such office.

Members of the Council of Public Representatives.

Terms

In general

The term of service for a member of the Council shall be 6 years, except as provided in subparagraphs (B) and (C).

Terms of initial appointees

Of the initial members selected for the Council, the Director of NIH shall designate—

nine for a term of 6 years;

nine for a term of 4 years; and

nine for a term of 2 years.

Vacancies

Any member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member’s term until a successor has taken office.

National Institutes of Health Strategic Plan

In general

Not later than 2 years after December 13, 2016, and at least every 6 years thereafter, the Director of the National Institutes of Health shall develop and submit to the appropriate committees of Congress and post on the Internet website of the National Institutes of Health, a coordinated strategy (to be known as the “National Institutes of Health Strategic Plan”) to provide direction to the biomedical research investments made by the National Institutes of Health, to facilitate collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine.

Requirements

The strategy under paragraph (1) shall—

identify strategic research priorities and objectives across biomedical research, including—

an assessment of the state of biomedical and behavioral research, including areas of opportunity with respect to basic, clinical, and translational research;

priorities and objectives to advance the treatment, cure, and prevention of health conditions;

emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps; and

the identification of near-, mid-, and long-term scientific needs;

consider, in carrying out subparagraph (A)—

disease burden in the United States and the potential for return on investment to the United States;

rare diseases and conditions;

biological, social, and other determinants of health that contribute to health disparities; and

other factors the Director of National Institutes of Health determines appropriate;

include multi-institute priorities, including coordination of research among institutes and centers;

include strategic priorities for funding research through the Common Fund, in accordance with section 282a(c)(1)(C) of this title;

address the National Institutes of Health’s proposed and ongoing activities related to training and the biomedical workforce; and

describe opportunities for collaboration with other agencies and departments, as appropriate.

Use of plans

Strategic plans developed and updated by the national research institutes and national centers of the National Institutes of Health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national research institutes and national centers shall have a common template.

Consultation

The Director of National Institutes of Health shall develop the strategic plan under paragraph (1) in consultation with the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.

Unique research initiatives

In general

The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out—

the Precision Medicine Initiative under section 289g–5 of this title;

subsection (b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under section 282a(c)(1) of this title for purposes of carrying out such subsection (b)(7) may be used to engage in such other transactions; or

high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat.

Requirements

The authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office—

submits a proposal to the Director of NIH for the use of such authority before conducting or supporting the research, including why the use of such authority is essential to promoting the success of the project;

receives approval for the use of such authority from the Director of NIH; and

for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activities of the institute, center, or office relating to such research.

Regenerative medicine

The Director of NIH shall, as appropriate, continue to consult with the directors of relevant institutes and centers of the National Institutes of Health, other relevant experts from such institutes and centers, and relevant experts within the Food and Drug Administration, to further the field of regenerative medicine using adult stem cells, including autologous stem cells, therapeutic tissue engineering products, human cell and tissue products, human gene therapies, and genetically modified cells.

Footnotes

1 So in original. The word “of” probably should not appear.
2 So in original. The second closing parenthesis probably should not appear.
3 So in original.
4 So in original. The second closing parenthesis probably should not appear.
5 So in original. Probably should be “paragraph (2)(A)(ii)(I)(ll),”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1944
Health Research Extension Act of 1985
Pub. L. 99–158 § 2 · 99 Stat. 820
Enacted · 42 U.S.C. § 282
July 1, 1944, ch. 373, title IV, § 402, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 823
Source evidence
Code source credit
July 1, 1944, ch. 373, title IV, § 402, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 823
Enacted provision · exact public law section
SEC. 2. REVISION OF TITLE IV OF THE PUBLIC HEALTH SERVICE ACT. Title IV of the Public Health Service Act is amended to read as follows: “TITLE IV— NATIONAL RESEARCH INSTITUTES “Part A— National Institutes of Health “Sec. 401. “organization of the national institutes of health (a) The National Institutes of Health is an agency of the Service. “(b) (1) The following national research institutes are agencies of the National Institutes of Health: “(A) The National Cancer Institute. “(B) The National Heart, Lung, and Blood Institute. “(C) The National Institute of Diabetes and Digestive and Kidney Diseases. “(D) The National Institute of Arthritis and Musculoskeletal and Skin Diseases. “(E) The National Institute on Aging. “(F) The National Institute of Allergy and Infectious Diseases. “(G) The National Institute of Child Health and Human Development. “(H) The National Institute of Dental Research. “(I) The National Eye Institute. “(J) The National Institute of Neurological and Communicative Disorders and Stroke. “(K) The National Institute of General Medical Sciences. “(L) The National Institute of Environmental Health Sciences. “(2) The following entities are agencies of the National Institutes of Health: “(A) The National Library of Medicine. “(B) The Division of Research Resources. “(C) The John E. Fogarty International Center for Advanced Study in the Health Sciences. “(D) The National Center for Nursing Research. “(c) (1) The Secretary may establish in the National Institutes of Health one or more additional national research institutes to conduct and support research, training, health information, and other programs with respect to any particular disease or groups of diseases or any other aspect of human health if— “(A) the Secretary determines that an additional institute is necessary to carry out such activities; and “(B) the additional institute is not established before the expiration of 180 days after the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate written notice of the determination made under subparagraph (A) with respect to the institute. “(2) The Secretary may reorganize the functions of any national research institute and may abolish any national research institute if the Secretary determines that the institute is no longer required. A reorganization or abolition may not take effect under this paragraph before the expiration of 180 days after the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate written notice of the reorganization or abolition. “(d) For purposes of this title, the term ‘national research institute’ means a national research institute listed in subsection (b) or established under subsection (c). A reference to the National Institutes of Health includes its agencies. “Sec. 402. “appointment and authority of director of nih (a) The National Institutes of Health shall be headed by 42 USC 282. the Director of the National Institutes of Health (hereafter in this title referred to as the ‘Director of NIH’) who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) and as the Secretary may otherwise prescribe. “(b) In carrying out the purposes of section 301, the Secretary, acting through the Director of NIH— “(1) shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health; “(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health; “(3) shall assure that research at or supported by the National Institutes of Health is subject to review in accordance with Post, p. 874. section 492; “(4) for the national research institutes and administrative entities within the National Institutes of Health— “(A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal property, and “(B) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed ten years; “(5) may secure resources for research conducted by or through the National Institutes of Health; “(6) may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, 5 USC 5101. 5 USC 5331. and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups as are needed to carry out the requirements of this title and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups; “(7) may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad; “(8) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor; “(9) may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment; “(10) may accept voluntary and uncompensated services; and “(11) may perform such other administrative functions as the Secretary determines are needed to effectively carry out this title. Prohibition. 5 USC app. The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (6). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review func-tions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States. “(c) The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate. “(d) (1) The Director of NIH may obtain (in accordance with section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of service) the services of not more than two hundred experts or consultants, with scientific or other professional qualifications, for the National Institutes of Health. “(2) (A) Except as provided in subparagraph (B), experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place of service and for other expenses associated with their assignment. “(B) Expenses specified in subparagraph (A) shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph. “(e) The Director of NIH shall— “(1) advise the agencies of the National Institutes of Health on medical applications of research; “(2) coordinate, review, and facilitate the systematic identification and evaluation of, clinically relevant information from research conducted by or through the national research institutes; “(3) promote the effective transfer of the information described in paragraph (2) to the health care community and to entities that require such information; and “(4) monitor the effectiveness of the activities described in paragraph (3). “(f) There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities. The Associate Director shall annually report to the Director of Report. NIH on the prevention activities undertaken by the Associate Director. The report shall include a detailed statement of the expenditures made for the activities reported on and the personnel used in connection with such activities. “Sec. 403. “report of director of nih The Secretary shall transmit to the President and to the Congress a biennial report which shall be prepared by the Director of NIH and which shall consist of— “(1) a description of the activities carried out by and through the National Institutes of Health and the policies respecting the programs of the National Institutes of Health and such recommendations respecting such policies as the Secretary considers appropriate; “(2) a description of the activities undertaken to improve grants and contracting accountability and technical and scientific peer review procedures of the National Institutes of Health and the national research institutes; “(3) the reports made by the Associate Director for Prevention Ante, p. 823. under section 402(f) during the period for which the biennial report is prepared; and “(4) the biennial reports of the Directors of each of the national research institutes, the Director of the Division of Research Resources, and the Director of the National Center for Nursing Research. The first report under this section shall be submitted not later than July 1, 1986, and shall relate to the fiscal year ending September 30, 1985. The next report shall be submitted not later than December 30, 1988, and shall relate to the two-fiscal-year period ending on the preceding September 30. Each subsequent report shall be submitted not later than 90 days after the end of the two-fiscal-year period for which the report is to be submitted. “Part B— General Provisions Respecting National Research Institutes “Sec. 405. “appointment and authority of the directors of the national research institutes (a) The Director of the National Cancer Institute shall be appointed by the President and the Directors of the other national research institutes shall be appointed by the Secretary. Each Director of a national research institute shall report directly to the Director of NIH. “(b) (1) In carrying out the purposes of section 301 with respect to the human diseases or disorders or other aspects of human health for which the national research institutes were established, the Secretary, acting through the Director of each national research institute— “(A) shall encourage and support research, investigations, experiments, demonstrations, and studies in the health sciences related to— “(i) the maintenance of health, “(ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders, “(iii) the rehabilitation of individuals with human diseases, disorders, and disabilities, and “(iv) the expansion of knowledge of the processes underlying human diseases, disorders, and disabilities, the processes underlying the normal and pathological functioning of the body and its organ systems, and the processes underly-ing the interactions between the human organism and the environment; “(B) may, subject to the peer review prescribed under section 492(b) and any advisory council review under section Post, p. 874. Post, p. 828. 406(a)(3)(A)(i), conduct the research, investigations, experiments, demonstrations, and studies referred to in subparagraph (A); “(C) may conduct and support research training (i) for which fellowship support is not provided under section 487, and (ii) Post, p. 869. which is not residency training of physicians or other health professionals; “(D) may develop, implement, and support demonstrations and programs for the application of the results of the activities of the institute to clinical practice and disease prevention activities; “(E) may develop, conduct, and support public and professional Education. education and information programs; “(F) may secure, develop and maintain, distribute, and support the development and maintenance of resources needed for research; “(G) may make available the facilities of the institute to appropriate entities and individuals engaged in research activities and cooperate with and assist Federal and State agencies charged with protecting the public health; “(H) may accept unconditional gifts made to the institute for Gifts and property. its activities, and, in the case of gifts of a value in excess of $50,000, establish suitable memorials to the donor; “(I) may secure for the institute consultation services and advice of persons from the United States or abroad; “(J) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor; “(K) may accept voluntary and uncompensated services; and Voluntarism. “(L) may perform such other functions as the Secretary determines are needed to carry out effectively the purposes of the institute. The indemnification provisions of section 2354, title 10, United Contracts. States Code, shall apply with respect to contracts entered into under this subsection and section 402(b). Ante, p. 823. Grants. Contracts. “(2) Support for an activity or program under this subsection may be provided through grants, contracts, and cooperative agreements. The Secretary, acting through the Director of each national research institute— “(A) may enter into a contract for research, training, or demonstrations only if the contract has been recommended after technical and scientific peer review required by regulations under section 492; and Post, p. 874. “(B) may make grants and cooperative agreements under paragraph (1) for research, training, or demonstrations, except that— “(i) if the direct cost of the grant or cooperative agreement to be made does not exceed $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under section 492, and “(ii) if the direct cost of the grant or cooperative agreement to be made exceeds $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under section Post, p. 874; infra. 492 and is recommended under section 406(a)(3)(A)(ii) by the advisory council for the national research institute involved. “(c) In carrying out subsection (b), each Director of a national research institute— “(1) shall coordinate, as appropriate, the activities of the institute with similar programs of other public and private entities; “(2) shall cooperate with the Directors of the other national research institutes in the development and support of multi-disciplinary research and research that involves more than one institute; and “(3) may, with the approval of the advisory council for the institute and the Director of NIH, appoint technical and scientific peer review groups in addition to those appointed under Ante, p. 823. section 402(b)(6). “Sec. 406. “advisory councils (a) (1) Except as provided in subsection (h), the Secretary shall appoint an advisory council for each national research institute which (A) shall advise, assist, consult with, and make recommendations to the Secretary and the Director of such institute on matters related to the activities carried out by and through the institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C. “(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with section 42 USC 300aa. 2101, of conditional gifts for study, investigation, or research respecting the diseases, disorders, or other aspect of human health with respect to which the institute was established, for the acquisition of grounds, or for the construction, equipping, or maintenance of facilities for the institute. “(3) Each advisory council for a national research institute— “(A) (i) may on the basis of the materials provided under Post, p. 874. section 492(b)(2) respecting research conducted at the institute, make recommendations to the Director of the institute respecting such research, “(ii) may review applications for grants and cooperative agreements for research or training and for which advisory Ante, p. 826. council approval is required under section 405(b)(2) and recommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and “(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the institute; “(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspect of human health with respect to which the institute was established and with the approval of the Director of the institute make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and “(C) may appoint subcommittees and convene workshops and conferences. “(b) (1) Each advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. “(2) The ex officio members of an advisory council shall consist of— “(A) the Secretary, the Director of NIH, the Director of the national research institute for which the council is established, the Chief Medical Director of the Veterans’ Administration or the Chief Dental Director of the Veterans’ Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and “(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions. “(3) The members of an advisory council who are not ex officio members shall be appointed as follows: “(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behavioral or social sciences) relevant to the activities of the national research institute for which the advisory council is established. “(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management. “(4) Members of an advisory council who are officers or employees Government organization and employees. Prohibition. of the United States shall not receive any compensation for service on the advisory council. The other members of an advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule. 5 USC 5332 note. “(c) The term of office of an appointed member of an advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member’s term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs. “(d) The chairman of an advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the national research institute for which the advisory council is established to be the chairman of the advisory council. The term of office of the chairman shall be two years. “(e) The advisory council shall meet at the call of the chairman or upon the request of the Director of the national research institute for which it was established, but at least three times each fiscal year. The location of the meetings of each advisory council is subject to the approval of the Director of the national research institute for which the advisory council was established. “(f) The Director of the national research institute for which an advisory council is established shall designate a member of the staff of the institute to serve as the executive secretary of the advisory council. The Director of such institute shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of such institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council. “(g) Each advisory council may prepare, for inclusion in the biennial report made under section 407, (1) comments respecting the activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the national research institute for which it was established in meeting its objectives, and (3) recommendations respecting the future directions and Report. program and policy emphasis of the institute. Each advisory council may prepare such additional reports as it may determine appropriate. “(h) (1) Except as provided in paragraph (2), this section does not terminate the membership of any advisory council for a national research institute which was in existence on the date of enactment Ante, p. 820. of the Health Research Extension Act of 1985. After such date— “(A) the Secretary shall make appointments to each such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section; “(B) each advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and “(C) the Director of each national research institute shall perform for such advisory council the functions prescribed by this section. “(2) (A) The National Cancer Advisory Board shall be the advisory council for the National Cancer Institute. This section applies to the National Cancer Advisory Board, except that— “(i) appointments to such Board shall be made by the President; “(ii) the term of office of an appointed member shall be 6 years; “(iii) of the members appointed to the Board not less than five members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors); “(iv) the chairman of the Board shall be selected by the President from the appointed members and shall serve as chairman for a term of two years; “(v) the ex officio members of the Board shall be the Secretary, the Director of the Office of Science and Technology Policy, the Director of NIH, the Chief Medical Director of the Veterans’ Administration, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers); and “(vi) the Board shall meet at least four times each fiscal year. “(B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that the advisory council shall meet at least four times each fiscal year. “Sec. 407. “biennial report The Director of each national research institute, after 42 USC 284b. consultation with the advisory council for the institute, shall prepare for inclusion in the biennial report made under section 403 a Ante, p. 826. biennial report which shall consist of a description of the activities of the institute and program policies of the Director of the institute in the fiscal years respecting which the report is prepared. The Director of each national research institute may prepare such additional reports as the Director determines appropriate. The Director of each national research institute shall provide the advisory council for the institute an opportunity for the submission of the written comments referred to in section 406(g). Ante, p. 828. “Sec. 408. “authorizations of appropriations (a) In addition to amounts otherwise authorized to be 42 USC 284c. appropriated under this title for the National Institutes of Health, the following amounts are authorized to be appropriated: “(1) (A) For the National Cancer Institute (other than its programs under section 412), there are authorized to be appropriated Post, p. 832. $1, 194,000,000 for fiscal year 1986, $1,270,000,000 for fiscal year 1987, and $1,344,000,000 for fiscal year 1988. “(B) For the programs under section 412, there are authorized to be appropriated $68,000,000 for fiscal year 1986, $74,000,000 for fiscal year 1987, and $80,000,000 for fiscal year 1988. “(2) (A) For the National Heart, Lung, and Blood Institute (other than its programs under section 419), there are authorized Post, p. 836. to be appropriated $809,000,000 for fiscal year 1986, $871,000,000 for fiscal year 1987, and $927,000,000 for fiscal year 1988. Of the amount appropriated under this subsection for such fiscal year, not less than 15 percent of such amount shall be reserved for programs respecting diseases of the lung and not less than 15 percent of such amount shall be reserved for programs respecting blood diseases and blood resources. “(B) For the programs under section 419, there are authorized to be appropriated $82,000,000 for fiscal year 1986, $90,000,000 for fiscal year 1987, and $98,000,000 for fiscal year 1988. “(b) (1) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal year for administrative expenses of the National Institutes of Health may not exceed an amount which is 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health. “(2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing Research, the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G. Magnuson Clinical Center, and the Office of Medical Applications of Research. “(3) For purposes of paragraph (1), the term ‘administrative expenses’ means expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health. In identifying expenses incurred for such support and administration the Secretary shall consult with the Comptroller General of the United States. “(4) Not later than December 31, 1987, and December 31 of each succeeding year, the Secretary shall report to the Congress the amount obligated in the fiscal year preceding such date for administrative expenses of the National Institutes of Health and the total amount appropriated for the National Institutes of Health for such fiscal year. The Secretary shall consult with the Comptroller General of the United States in preparing each report. “Part C— Specific Provisions Respecting National Research Institutes “Subpart 1— National Cancer Institute “Sec. 410. “purpose of institute The general purpose of the National Cancer Institute (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer and the continuing care of cancer patients and the families of cancer patients. “Sec. 411. “national cancer program The National Cancer Program shall consist of (1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other national research institutes, including an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute. “Sec. 412. “cancer control programs The Director of the Institute shall establish and support demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this section shall include— “(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting— “(A) the detection, diagnosis, prevention, and treatment of cancer, “(B) the continuing care of cancer patients and the families of cancer patients, and “(C) rehabilitation and counseling respecting cancer, Physicians. to physicians and other health professionals who provide care to individuals who have cancer; “(2) the demonstration of and the education of students of the health professions and health professionals in— “(A) effective methods for the prevention and early detection of cancer and the identification of individuals with a high risk of developing cancer, and “(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and “(3) the demonstration of new methods for the dissemination Public information. of information to the general public concerning the prevention, early detection, diagnosis, and treatment and control of cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer. “Sec. 413. “special authorities of the director (a) The Director of the Institute shall establish an Education. Physicians. Public information. 42 USC 285a–2. information and education center to collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to cancer patients and their families, physicians and other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer). The Director of the Institute may take such action as may be necessary to insure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and other scientific, medical, and biomedical disciplines and organizations nationally and internationally. “(b) The Director of the Institute in carrying out the National Cancer Program— “(1) shall establish or support the large-scale production or distribution of specialized biological materials and other therapeutic substances for cancer research and set standards of safety and care for persons using such materials; “(2) shall, in consultation with the advisory council for the Institute, support (A) research in the cancer field outside the United States by highly qualified foreign nationals which can be expected to benefit the American people, (B) collaborative research involving American and foreign participants, and (C) the training of American scientists abroad and foreign scientists in the United States; “(3) shall, in consultation with the advisory council for the Institute, support appropriate programs of education and training (including continuing education and laboratory and clinical research training); “(4) shall encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research; “(5) may obtain (with the approval of the advisory council for the Institute and in accordance with section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of service) the services of not more than one hundred and fifty-one experts or consultants who have scientific or professional qualifications; “(6) (A) may, in consultation with the advisory council for the Real property. Institute, acquire, construct, improve, repair, operate, and maintain laboratories, other research facilities, equipment, and such other real or personal property as the Director determines necessary; “(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and “(C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years; “(7) may, in consultation with the advisory council for the Institute, appoint one or more advisory committees composed of such private citizens and officials of Federal, State, and local governments to advise the Director with respect to the Director’s functions; “(8) may, subject to section 405(b)(2) and without regard to section 3324 of title 31, United States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5), enter into such contracts, leases, cooperative agreements, as may be necessary in the conduct of functions of the Director, with any public agency, or with any person, firm, association, corporation, or educational institution; “(9) shall maintain and operate the International Cancer Research Data Bank, which shall collect, catalog, store, and disseminate insofar as feasible through the use of information systems accessible to the public, general practitioners, and oncologic investigators, the results of cancer research and treatment undertaken in any country for the use of any person involved in cancer research and treatment in any country; and “(10) (A) shall, notwithstanding section 405(a), prepare and submit, directly to the President for review and transmittal to Congress, an annual budget estimate (including an estimate of the number and type of personnel needs for the Institute) for the National Cancer Program, after reasonable opportunity for comment (but without change) by the Secretary, the Director of NIH, and the Institute’s advisory council; and (B) may receive from the President and the Office of Management and Budget directly all funds appropriated by Congress for obligation and expenditure by the Institute. Except as otherwise provided, experts and consultants whose services are obtained under paragraph (5) shall be paid or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place of service and for other expenses associated with Prohibition. their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (5) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence. “Sec. 414. “national cancer research and demonstration centers (a) (1) The Director of the Institute may enter into Contracts. Grants. 42 USC 285a–3. cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of advanced diagnostic, prevention, and treatment methods for cancer. “(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute’s advisory council. “(b) Federal payments made under a cooperative agreement or grant under subsection (a) may be used for— “(1) construction (notwithstanding any limitation under section Post, p. 877. 496); “(2) staffing and other basic operating costs, including such patient care costs as are required for research; “(3) clinical training, including training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer; and “(4) demonstration purposes. As used in this paragraph, the term ‘construction’ does not include the acquisition of land, and the term ‘training’ does not include research training for which National Research Service Awards may be provided under section 487. Post, p. 869. “(c) Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. “Sec. 415. “president’s cancer panel (a) (1) The President’s Cancer Panel (hereafter in this 42 USC 285a–4. section referred to as the ‘Panel’) shall be composed of three persons appointed by the President who by virtue of their training, experience, and background are exceptionally qualified to appraise the National Cancer Program. At least two members of the Panel shall be distinguished scientists or physicians. “(2) (A) Members of the Panel shall be appointed for three-year terms, except that (i) any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member’s predecessor was appointed shall be appointed only for the remainder of such term, and (ii) a member may serve until the member’s successor has taken office. If a vacancy occurs in the Panel, the President shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred. “(B) The President shall designate one of the members to serve as the chairman of the Panel for a term of one year. “(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade 5 USC 5332. GS–18 of the General Schedule for each day (including traveltime) during which they are engaged in the actual performance of duties as members of the Panel and shall be paid or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place of service and for other expenses associated with their assignment. “(3) The Panel shall meet at the call of the chairman, but not less often than four times a year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the chairman shall make such transcript available to the public. “(b) The Panel shall monitor the development and execution of the activities of the National Cancer Program, and shall report directly to the President. Any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the Reports. President. The Panel shall submit to the President periodic progress reports on the National Cancer Program and shall submit to the President, the Secretary, and the Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, and shall submit such other reports as the President shall direct. “Sec. 416. “associate director for prevention (a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of cancer. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine. “(b) The Associate Director for Prevention shall prepare for inclusion Ante, p. 831. in the biennial report made under section 407 a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities. “Subpart 2— National Heart, Lung, and Blood Institute “Sec. 418. “purpose of the institute The general purpose of the National Heart, Lung, and Blood Institute (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of research, training, health information dissemination, and other programs with respect to heart, blood vessel, lung, and blood diseases and with respect to the use of blood and blood products and the management of blood resources. “Sec. 419. “heart, blood vessel, lung, and blood disease prevention and control programs The Director of the Institute, under policies established by the Director of NIH and after consultation with the advisory council for the Institute, shall establish programs as necessary for cooperation with other Federal health agencies, State, local, and regional public health agencies, and nonprofit private health agencies in the diagnosis, prevention, and treatment (including the provision of emergency medical services) of heart, blood vessel, lung, and blood diseases, appropriately emphasizing the prevention, diagnosis, and treatment of such diseases of children. “Sec. 420. “information and education The Director of the Institute shall collect, identify, 42 USC 285b–2. analyze, and disseminate on a timely basis, through publications and other appropriate means, to patients, families of patients, physicians and other health professionals, and the general public, information on research, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, the maintenance of health to reduce the incidence of such diseases, and on the use of blood and blood products and the management of blood resources. In carrying out this section the Director of the Institute shall place special emphasis upon— “(1) the dissemination of information regarding diet and nutrition, environmental pollutants, exercise, stress, hypertension, cigarette smoking, weight control, and other factors affecting the prevention of arteriosclerosis and other cardiovascular diseases and of pulmonary and blood diseases; and “(2) the dissemination of information designed to encourage children to adopt healthful habits respecting the risk factors related to the prevention of such diseases. “Sec. 421. “national heart, blood vessel, lung, and blood diseases and blood resources program (a) (1) The National Heart, Blood Vessel, Lung, and 42 USC 285b–3. Blood Diseases and Blood Resources Program (hereafter in this subpart referred to as the ‘Program’) may provide for— “(A) investigation into the epidemiology, etiology, and prevention of all forms and aspects of heart, blood vessel, lung, and blood diseases, including investigations into the social, environmental, behavioral, nutritional, biological, and genetic determinants and influences involved in the epidemiology, etiology, and prevention of such diseases; “(B) studies and research into the basic biological processes and mechanisms involved in the underlying normal and abnormal heart, blood vessel, lung, and blood phenomena; “(C) research into the development, trial, and evaluation of techniques, drugs, and devices (including computers) used in, and approaches to, the diagnosis, treatment (including the provision of emergency medical services), and prevention of heart, blood vessel, lung, and blood diseases and the rehabilitation of patients suffering from such diseases; “(D) establishment of programs that will focus and apply Science and technology. scientific and technological efforts involving the biological, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood diseases with emphasis on the refinement, development, and evaluation of technological devices that will assist, replace, or monitor vital organs and improve instrumentation for detection, diagnosis, and treatment of such diseases; “(E) establishment of programs for the conduct and direction of field studies, large-scale testing and evaluation, and demonstration of preventive, diagnostic, therapeutic, and rehabilita-tive approaches to, and emergency medical services for, such diseases; “(F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects of the management of blood resources in the United States, including the collection, preservation, fractionation, and distribution of blood and blood products; “(G) the education (including continuing education) and training of scientists, clinical investigators, and educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs respecting heart, blood vessel, lung, and blood diseases and blood resources; “(H) public and professional education relating to all aspects of such diseases, including the prevention of such diseases, and the use of blood and blood products and the management of blood resources; “(I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of children (including cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and Cooley’s anemia, and hemophilic diseases) and for the development and demonstration of diagnostic, treatment, and preventive approaches to such diseases; and “(J) establishment of programs for study, research, development, demonstrations and evaluation of emergency medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases. “(2) The Program shall be coordinated with other national research institutes to the extent that they have responsibilities respecting such diseases and shall give special emphasis to the continued development in the Institute of programs related to the causes of stroke and to effective coordination of such programs with related stroke programs in the National Institute of Neurological and Communicative Disorders and Stroke. The Director of the Institute, with the advice of the advisory council for the Institute, shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan. “(b) In carrying out the Program, the Director of the Institute, under policies established by the Director of NIH— “(1) may, after approval of the advisory council for the Institute, obtain (in accordance with section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of such service) the services of not more than one hundred experts or consultants who have scientific or professional qualifications; “(2) (A) may, in consultation with the advisory council for the Institute, acquire and construct, improve, repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood resource laboratories, research, training, and other facilities, equipment, and such other real or personal property as the Director determines necessary; “(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and “(C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years; “(3) subject to section 405(b)(2) and without regard to section Contracts. Ante, p. 826. 3324 of title 31, United States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5), may enter into such contracts, leases, cooperative agreements, or other transactions, as may be necessary in the conduct of the Director’s functions, with any public agency, or with any person, firm, association, corporation, or educational institutions; and “(4) may make grants to public and nonprofit private entities Grants. to assist in meeting the cost of the care of patients in hospitals, clinics, and related facilities who are participating in research projects. Except as otherwise provided, experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence. “Sec. 422. “national research and demonstration centers for heart, blood vessel, lung, and blood diseases, sickle cell anemia, and blood resources (a) (1) The Director of the Institute may provide, in 42 USC 285b–4. accordance with subsection (c), for the development of— “(A) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for heart and blood vessel diseases; “(B) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for lung diseases (including bronchitis, emphysema, asthma, cystic fibrosis, and other lung diseases of children); and “(C) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for blood diseases and research into blood, in the use of blood products and in the management of blood resources. “(2) The centers developed under paragraph (1) shall, in addition to being utilized for research, training, and demonstrations, be utilized for the following prevention programs for cardiovascular, pulmonary, and blood diseases: “(A) Programs to develop improved methods of detecting individuals with a high risk of developing cardiovascular, pulmonary, and blood diseases. “(B) Programs to develop improved methods of intervention against those factors which cause individuals to have a high risk of developing such diseases. “(C) Programs to develop health professions and allied health professions personnel highly skilled in the prevention of such diseases. “(D) Programs to develop improved methods of providing emergency medical services for persons with such diseases. “(E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and treatment of such diseases and the maintenance of health to reduce the incidence of such diseases and information programs for the public respecting the prevention and early diagnosis and treatment of such diseases and the maintenance of health. “(3) The research, training, and demonstration activities carried out through any such center may relate to any one or more of the diseases referred to in paragraph (1) of this subsection. “(b) The Director of the Institute shall provide, in accordance with subsection (c), for the development of ten centers for basic and clinical research into the diagnosis, treatment, and control of sickle cell anemia. “(c) (1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of the management of blood resources and advanced diagnostic, prevention, and treatment methods for heart, blood vessel, lung, or blood diseases. “(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute’s advisory council. “(3) Federal payments made under a cooperative agreement or grant under paragraph (1) may be used for— “(A) construction (notwithstanding any limitation under section Post, p. 877. 496); “(B) staffing and other basic operating costs, including such patient care costs as are required for research; “(C) training, including training for allied health professionals; and “(D) demonstration purposes. As used in this subsection, the term ‘construction’ does not include the acquisition of land, and the term ‘training’ does not include research training for which National Research Service Awards may Post, p. 869. be provided under section 487. “(4) Support of a center under paragraph (1) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Direc-tor and if such group has recommended to the Director that such period should be extended. “Sec. 423. “interagency technical committee (a) The Secretary shall establish an Interagency Technical Interagency Technical Committee on Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources, establishment. 42 USC 285b–5. Committee on Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources which shall be responsible for coordinating those aspects of all Federal health programs and activities relating to heart, blood vessel, lung, and blood diseases and blood resources to assure the adequacy and technical soundness of such programs and activities and to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities. “(b) The Director of the Institute shall serve as chairman of the Committee and the Committee shall include representation from all Federal departments and agencies whose programs involve health functions or responsibilities relevant to the functions of the Committee, as determined by the Secretary. “Sec. 424. “associate director for prevention (a) There shall be in the Institute an Associate Director 42 USC 285b–6. for Prevention to coordinate and promote the programs in the Institute concerning the prevention of heart, blood vessel, lung, and blood diseases. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine. “(b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under section 407 a description of Ante, p. 831. the prevention activities of the Institute, including a description of the staff and resources allocated to those activities. “Subpart 3— National Institute of Diabetes and Digestive and Kidney Diseases “Sec. 426. “purpose of the institute The general purpose of the National Institute of Diabetes 42 USC 285c. and Digestive and Kidney Diseases (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of research, training, health information dissemination, and other programs with respect to diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional disorders, and kidney, urologic, and hematologic diseases. “Sec. 427. “data systems and information clearinghouses (a) The Director of the Institute shall (1) establish the 42 USC 285c–1. National Diabetes Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with diabetes, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing diabetes, and (2) establish the National Diabetes Information Clearinghouse to facilitate and enhance knowledge and understanding of diabetes on the part of health professionals, pa-tients, and the public through the effective dissemination of information. “(b) The Director of the Institute shall (1) establish the National Digestive Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with digestive diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing digestive diseases, and (2) establish the National Digestive Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of digestive diseases on the part of health professionals, patients, and the public through the effective dissemination of information. “(c) The Director of the Institute shall (1) establish the National Kidney and Urologic Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with kidney and urologic diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing kidney and urologic diseases, and (2) establish the National Kidney and Urologic Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of kidney and urologic diseases on the part of health professionals, patients, and the public through the effective dissemination of information. “Sec. 428. “division directors for diabetes, endocrinology, and metabolic diseases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases (a) (1) In the Institute there shall be a Division Director for Diabetes, Endocrinology, and Metabolic Diseases, a Division Director for Digestive Diseases and Nutrition, and a Division Director for Kidney, Urologic, and Hematologic Diseases. Such Division Directors, under the supervision of the Director of the Institute, shall be responsible for— “(A) developing a coordinated plan (including recommendations for expenditures) for each of the national research institutes within the National Institutes of Health with respect to research and training concerning diabetes, endocrine and metabolic diseases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases; “(B) assessing the adequacy of management approaches for the activities within such institutes concerning such diseases and nutrition and developing improved approaches if needed; “(C) monitoring and reviewing expenditures by such institutes concerning such diseases and nutrition; and “(D) identifying research opportunities concerning such diseases and nutrition and recommending ways to utilize such opportunities. “(2) The Director of the Institute shall transmit to the Director of NIH the plans, recommendations, and reviews of the Division Directors under subparagraphs (A) through (D) of paragraph (1) together with such comments and recommendations as the Director of the Institute determines appropriate. “(b) The Director of the Institute, acting through the the Division Director for Diabetes, Endocrinology, and Metabolic Diseases, the Division Director for Digestive Diseases and Nutrition, and the Division Director for Kidney, Urologic, and Hematologic Diseases, shall— “(1) carry out programs of support for research and training (other than training for which National Research Service Awards may be made under section 487) in the diagnosis, Post, p. 869. prevention, and treatment of diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional disorders, and kidney, urologic, and hematologic diseases, including support for training in medical schools, graduate clinical training, graduate training in epidemiology, epidemiology studies, clinical trials, and interdisciplinary research programs; and “(2) establish programs of evaluation, planning, and dissemination of knowledge related to such research and training. “Sec. 429. “interagency coordinating committees (a) For the purpose of— 42 USC 285c–8. “(1) better coordination of the research activities of all the national research institutes relating to diabetes mellitus, digestive diseases, and kidney, urologic, and hematologic diseases; and “(2) coordinating those aspects of all Federal health programs and activities relating to such diseases to assure the adequacy and technical soundness of such programs and activities and to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities; the Secretary shall establish a Diabetes Mellitus Interagency Coordinating Diabetes Mellitus Interagency Coordinating Committee, establishment. Digestive Diseases Interagency Coordinating Committee, establishment. Kidney, Urologic, and Hematologic Diseases Coordinating Committee, establishment. Committee, a Digestive Diseases Interagency Coordinating Committee, and a Kidney, Urologic, and Hematologic Diseases Coordinating Committee (hereafter in this section individually referred to as a ‘Committee’). “(b) Each Committee shall be composed of the Directors of each of the national research institutes and divisions involved in research with respect to the diseases for which the Committee is established, the Division Director of the Institute for the diseases for which the Committee is established, the Chief Medical Director of the Veterans’ Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers) and shall include representation from all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, as determined by the Secretary. Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four times a year. “(c) Each Committee shall prepare an annual report for— Report. “(1) the Secretary; “(2) the Director of NIH; and “(3) the Advisory Board established under section 430 for the Post, p. 844. diseases for which the Committee was established, detailing the work of the Committee in carrying out paragraphs (1) and (2) of subsection (a) in the fiscal year for which the report was prepared. Such report shall be submitted not later than 120 days after the end of each fiscal year. “Sec. 430. “advisory boards (a) The Secretary shall establish in the Institute the National Diabetes Advisory Board, the National Digestive Diseases Advisory Board, and the National Kidney and Urologic Diseases Advisory Board (hereafter in this section individually referred to as an ‘Advisory Board’). “(b) Each Advisory Board shall be composed of eighteen appointed members and nonvoting ex officio members as follows: “(1) The Secretary shall appoint— “(A) twelve members from individuals who are scientists, physicians, and other health professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines relevant to the diseases with respect to which the Advisory Board is established; and “(B) six members from the general public who are knowledgeable with respect to such diseases, including at least one member who is a person who has such a disease and one member who is a parent of a person who has such a disease. Of the appointed members at least five shall by virtue of training or experience be knowledgeable in the fields of health education, nursing, data systems, public information, and community program development. “(2) (A) The following shall be ex officio members of each Advisory Board: “(i) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, the Director of the Centers for Disease Control, the Chief Medical Director of the Veterans’ Administration, the Assistant Secretary of Defense for Health Affairs, and the Division Director of the National Institute of Diabetes and Digestive and Kidney Diseases for the diseases for which the Board is established (or the designees of such officers). “(ii) Such other officers and employees of the United States as the Secretary determines necessary for the Advisory Board to carry out its functions. “(B) In the case of the National Diabetes Advisory Board, the following shall also be ex officio members: The Director of the National Heart, Lung, and Blood Institute, the Director of the National Eye Institute, the Director of the National Institute of Child Health and Human Development, and the Administrator of the Health Resources and Services Administration (or the designees of such officers). “(c) Members of an Advisory Board who are officers or employees of the Federal Government shall serve as members of the Advisory Board without compensation in addition to that received in their regular public employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of 5 USC 5332 note. the annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Board. “(d) The term of office of an appointed member of an Advisory Board is four years, except that no term of office may extend beyond the expiration of the Advisory Board. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member’s term until a successor has taken office. If a vacancy occurs in an Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90 days from the date the vacancy occurred. “(e) The members of each Advisory Board shall select a chairman from among the appointed members. “(f) The Secretary shall, after consultation with and consideration of the recommendations of an Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, such services of consultants, such information, and (through contracts or other arrangements) such administrative support services and facilities, as the Secretary determines are necessary for the Advisory Board to carry out its functions. “(g) Each Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year. “(h) The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board shall— “(1) review and evaluate the implementation of the plan (referred to in section 433) respecting the diseases with respect Post, p. 848. to which the Advisory Board was established and periodically update the plan to ensure its continuing relevance; “(2) for the purpose of assuring the most effective use and organization of resources respecting such diseases, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and “(3) maintain liaison with other advisory bodies related to Federal agencies involved in the implementation of such plan, the coordinating committee for such diseases, and with key non-Federal entities involved in activities affecting the control of such diseases. “(i) In carrying out its functions, each Advisory Board may establish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities. “(j) Each Advisory Board shall prepare an annual report for the Report. Secretary which— “(1) describes the Advisory Board’s activities in the fiscal year for which the report is made; “(2) describes and evaluates the progress made in such fiscal year in research, treatment, education, and training with respect to the diseases with respect to which the Advisory Board was established; “(3) summarizes and analyzes expenditures made by the Federal Government for activities respecting such diseases in such fiscal year; and “(4) contains the Advisory Board’s recommendations (if any) Post, p. 848. Expiration date. for changes in the plan referred to in section 433. “(k) Each Advisory Board shall expire on September 30, 1988. “(l) The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board in existence on the date of enactment Ante, p. 820. of the Health Research Extension Act of 1985 shall terminate upon the appointment of a successor Board under subsection (a). The Secretary shall make appointments to the Advisory Boards established under subsection (a) before the expiration of 90 days after such date. The members of the Boards in existence on such date may be appointed, in accordance with subsections (b) and (d), to the Boards established under subsection (a) for diabetes and digestive diseases, except that at least one-half of the members of the National Diabetes Advisory Board in existence on the date of enactment of the Health Research Extension Act of 1985 shall be appointed to the National Diabetes Advisory Board first established under subsection (a). “Sec. 431. “research and training centers (a) (1) Consistent with applicable recommendations of the National Commission on Diabetes, the Director of the Institute shall provide for the development or substantial expansion of centers for research and training in diabetes mellitus and related endocrine and metabolic diseases. Each center developed or expanded under this subsection shall— “(A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research and training qualifications as may be prescribed by the Secretary; and “(B) conduct— “(i) research in the diagnosis and treatment of diabetes mellitus and related endocrine and metabolic diseases and the complications resulting from such diseases; “(ii) training programs for physicians and allied health personnel in current methods of diagnosis and treatment of such diseases and complications, and in research in diabetes; and “(iii) information programs for physicians and allied health personnel who provide primary care for patients with such diseases or complications. “(2) A center may use funds provided under paragraph (1) to provide stipends for nurses and allied health professionals enrolled in research training programs described in paragraph (1)(B)(ii). “(b) Consistent with applicable recommendations of the National Digestive Diseases Advisory Board, the Director shall provide for the development or substantial expansion of centers for research in digestive diseases and related functional, congenital, metabolic disorders, and normal development of the digestive tract. Each center developed or expanded under this subsection— “(1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research qualifications as may be prescribed by the Secretary; “(2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of digestive diseases and nutritional disorders and related functional, congenital, or metabolic complications resulting from such diseases or disorders; “(3) shall encourage research into and programs for— Physicians. “(A) providing information for patients with such diseases and the families of such patients, physicians and others who care for such patients, and the general public; “(B) model programs for cost effective and preventive patient care; and “(C) training physicians and scientists in research on such diseases, disorders, and complications; and “(4) may perform research and participate in epidemiological studies and data collection relevant to digestive diseases and disorders and disseminate such research, studies, and data to the health care profession and to the public. “(c) The Director shall provide for the development or substantial expansion of centers for research in kidney and urologic diseases. Each center developed or expanded under this subsection— “(1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research qualifications as may be prescribed by the Secretary; “(2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of kidney and urologic diseases; “(3) shall encourage research into and programs for— Physicians. “(A) providing information for patients with such diseases, disorders, and complications and the families of such patients, physicians and others who care for such patients, and the general public; “(B) model programs for cost effective and preventive patient care; and “(C) training physicians and scientists in research on such diseases; and “(4) may perform research and participate in epidemiological studies and data collection relevant to kidney and urologic diseases in order to disseminate such research, studies, and data to the health care profession and to the public. “(d) Insofar as practicable, centers developed or expanded under this section should be geographically dispersed throughout the United States and in environments with proven research capabilities. Support of a center under this section may be for a period of not to exceed five years and such period may be extended by the Director of the Institute for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. “Sec. 432. “advisory council subcommittees There are established within the advisory council for the Institute appointed under section 406 a subcommittee on diabetes and endocrine and metabolic diseases, a subcommittee on digestive diseases and nutrition, and a subcommittee on kidney, urologic, and hematologic diseases. The subcommittees shall be composed of members of the advisory council who are outstanding in the diagnosis, prevention, and treatment of the diseases for which the subcommittees are established and members of the advisory council who are leaders in the fields of education and public affairs. Grants. Contracts. The subcommittees are authorized to review applications made to the Director of the Institute for grants for research and training projects relating to the diagnosis, prevention, and treatment of the diseases for which the subcommittees are established and shall recommend to the advisory council those applications and contracts that the subcommittees determine will best carry out the purposes of the Institute. The subcommittees shall also review and evaluate the diabetes and endocrine and metabolic diseases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases programs of the Institute and recommend to the advisory council such changes in the administration of such programs as the subcommittees determine are necessary. “Sec. 433. “biennial report The Director of the Institute shall prepare for inclusion in the biennial report made under section 407 a description of the Institute’s activities— “(1) under the current diabetes plan under the National 42 USC 201 note. Diabetes Mellitus Research and Education Act; and “(2) under the current digestive diseases plan formulated under the Arthritis, Diabetes, and Digestive Diseases Amendments 42 USC 201 note. of 1976. The description submitted by the Director shall include an evaluation Ante, p. 846. of the activities of the centers supported under section 431. “Subpart 4— National Institute of Arthritis and Musculoskeletal and Skin Diseases “Sec. 435. “purpose of the institute The general purpose of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of research and training, the dissemination of health information, and other programs with respect to arthritis and musculoskeletal and skin diseases, including sports-related disorders. “Sec. 436. “national arthritis and musculoskeletal diseases program (a) The Director of the Institute, with the advice of the Institute’s advisory council, shall prepare and transmit to the Director of NIH a plan for a national arthritis and musculoskeletal diseases program to expand, intensify, and coordinate the activities of the Institute respecting arthritis and musculoskeletal diseases. The plan shall include such comments and recommendations as the Director of the Institute determines appropriate. The Director of the Institute shall periodically review and revise such plan and shall transmit any revisions of such plan to the Director of NIH. “(b) Activities under the national arthritis and musculoskeletal diseases program shall be coordinated with the other national research institutes to the extent that such institutes have responsibilities respecting arthritis and musculoskeletal diseases, and shall, at least, provide for— “(1) investigation into the epidemiology, etiology, and prevention of all forms of arthritis and musculoskeletal diseases, including sports-related disorders, primarily through the support of basic research in such areas as immunology, genetics, biochemistry, microbiology, physiology, bioengineering, and any other scientific discipline which can contribute important knowledge to the treatment and understanding of arthritis and musculoskeletal diseases; “(2) research into the development, trial, and evaluation of techniques, drugs, and devices used in the diagnosis, treatment, including medical rehabilitation, and prevention of arthritis and musculoskeletal diseases; “(3) research on the refinement, development, and evaluation of technological devices that will replace or be a substitute for damaged bone, muscle, and joints and other supporting structures; and “(4) the establishment of mechanisms to monitor the causes of athletic injuries and identify ways of preventing such injuries on scholastic athletic fields. “(c) The Director of the Institute shall carry out the national arthritis and musculoskeletal diseases program in accordance with the plan prepared under subsection (a) and any revisions of such plan made under such subsection. “Sec. 437. “research and training The Director of the Institute shall— 42 USC 285d–2. “(1) carry out programs of support for research and training (other than training for which National Research Service Awards may be made under section 487) in the diagnosis, Post, p. 869. prevention, and treatment of arthritis and musculoskeletal and skin diseases, including support for training in medical schools, graduate clinical training, graduate training in epidemiology, epidemiology studies, clinical trials, and interdisciplinary research programs; and “(2) establish programs of evaluation, planning, and dissemination of knowledge related to such research and training. “Sec. 438. “data system and information clearinghouse (a) The Director of the Institute shall establish the 42 USC 285d–3. National Arthritis and Musculoskeletal and Skin Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with arthritis and musculoskeletal and skin diseases, including where possible, data involving general populations for the purpose of detection of individuals with a risk of developing arthritis and musculoskeletal and skin diseases. “(b) The Director of the Institute shall establish the National Arthritis and Musculoskeletal and Skin Diseases Information Clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of arthritis and musculoskeletal and skin diseases by health professionals, patients, and the public. “Sec. 439. “interagency coordinating committees (a) For the purpose of— 42 USC 285d–4. “(1) better coordination of the research activities of all the national research institutes relating to arthritis, musculoskeletal diseases, and skin diseases, including sports-related disorders; and “(2) coordinating the aspects of all Federal health programs and activities relating to arthritis, musculoskeletal diseases, and skin diseases in order to assure the adequacy and technical soundness of such programs and activities and in order to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities, Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee, establishment. Skin Diseases Interagency Coordinating Committee, establishment. the Secretary shall establish an Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and a Skin Diseases Interagency Coordinating Committee (hereafter in this section individually referred to as a ‘Committee’). “(b) Each Committee shall be composed of the Directors of each of the national research institutes and divisions involved in research regarding the diseases with respect to which the Committee is established, the Chief Medical Director of the Veterans’ Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and representatives of all other Federal departments and agencies (as determined by the Secretary) whose programs involve health functions or responsibilities relevant to arthritis and musculoskeletal diseases or skin diseases, as the case may be. Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four times a year. “(c) Not later than 120 days after the end of each fiscal year, each Committee shall prepare and transmit to the Secretary, the Director of NIH, the Director of the Institute, and the advisory council for the Institute a report detailing the activities of the Committee in such fiscal year in carrying out paragraphs (1) and (2) of subsection (a). “Sec. 440. “arthritis and musculoskeletal diseases demonstration projects (a) The Director of the Institute may make grants to public and private nonprofit entities to establish and support projects for the development and demonstration of methods for screening, detection, and referral for treatment of arthritis and musculoskeletal diseases and for the dissemination of information on such methods to the health and allied health professions. Activities under such projects shall be coordinated with Federal, State, local, and regional health agencies, centers assisted under section Post, p. 851. 441, and the data system established under subsection (c). “(b) Projects supported under this section shall include— “(1) programs which emphasize the development and demonstration of new and improved methods of screening and early detection, referral for treatment, and diagnosis of individuals with a risk of developing arthritis and musculoskeletal diseases; “(2) programs which emphasize the development and demonstration of new and improved methods for patient referral from local hospitals and physicians to appropriate centers for early diagnosis and treatment; “(3) programs which emphasize the development and demonstration of new and improved means of standardizing patient data and recordkeeping; “(4) programs which emphasize the development and demonstration of new and improved methods of dissemination of knowledge about the programs, methods, and means referred to in paragraphs (1), (2), and (3) of this subsection to health and allied health professionals; “(5) programs which emphasize the development and demonstration Public information. of new and improved methods for the dissemination to the general public of information— “(A) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treatment, and of following an appropriate regimen; and “(B) to discourage the promotion and use of unapproved and ineffective diagnostic, preventive treatment, and control methods for arthritis and unapproved and ineffective drugs and devices for arthritis and musculoskeletal diseases; and “(6) projects for investigation into the epidemiology of all forms and aspects of arthritis and musculoskeletal diseases, including investigations into the social, environmental, behavioral, nutritional, and genetic determinants and influences involved in the epidemiology of arthritis and musculoskeletal diseases. “(c) The Director shall provide for the standardization of patient data and recordkeeping for the collection, storage, analysis, retrieval, and dissemination of such data in cooperation with projects assisted under this section, centers assisted under section 441, and Infra. other persons engaged in arthritis and musculoskeletal disease programs. “Sec. 441. “multipurpose arthritis and musculoskeletal diseases centers (a) The Director of the Institute shall, after consultation 42 USC 285d. with the advisory council for the Institute, provide for the development, modernization, and operation (including staffing and other operating costs such as the costs of patient care required for research) of new and existing centers for arthritis and musculoskeletal diseases. For purposes of this section, the term ‘modernization’ means the alteration, remodeling, improvement, expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent necessary to make them suitable for use as centers described in the preceding sentence. “(b) Each center assisted under this section shall— “(1) (A) use the facilities of a single institution or a consortium of cooperating institutions, and (B) meet such qualifications as may be prescribed by the Secretary; and “(2) conduct— “(A) basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of arthritis and musculoskeletal diseases and complications resulting from arthritis and musculoskeletal diseases, including research into implantable biomaterials and biomechanical and other orthopedic procedures; “(B) training programs for physicians, scientists, and Physicians. other health and allied health professionals; “(C) information and continuing education programs for Education. Physicians. physicians and other health and allied health professionals who provide care for patients with arthritis and musculoskeletal diseases; and “(D) programs for the dissemination to the general public of information— “(i) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treatment, and of following an appropriate regimen; and “(ii) to discourage the promotion and use of unapproved and ineffective diagnostic, preventive, treatment, and control methods and unapproved and ineffective drugs and devices. A center may use funds provided under subsection (a) to provide stipends for health professionals enrolled in training programs described in paragraph (2)(B). “(c) Each center assisted under this section may conduct programs to— “(1) establish the effectiveness of new and improved methods of detection, referral, and diagnosis of individuals with a risk of developing arthritis and musculoskeletal diseases; “(2) disseminate the results of research, screening, and other activities, and develop means of standardizing patient data and recordkeeping; and “(3) develop community consultative services to facilitate the referral of patients to centers for treatment. “(d) The Director of the Institute shall, insofar as practicable, provide for an equitable geographical distribution of centers assisted Children and youth. under this section. The Director shall give appropriate consideration to the need for centers especially suited to meeting the needs of children affected by arthritis and musculoskeletal diseases. “(e) Support of a center under this section may be for a period of not to exceed five years. Such period may be extended by the Director of the Institute for one or more additional periods of not more than five years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. “Sec. 442. “advisory board (a) The Secretary shall establish in the Institute the National Arthritis Advisory Board (hereafter in this section referred to as the ‘Advisory Board’). “(b) The Advisory Board shall be composed of eighteen appointed members and nonvoting, ex officio members, as follows: “(1) The Secretary shall appoint— “(A) twelve members from individuals who are scientists, physicians, and other health professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines relevant to arthritis, musculoskeletal diseases, and skin diseases; and “(B) six members from the general public who are knowledgeable with respect to such diseases, including at least one member who is a person who has such a disease and one member who is a parent of a person who has such a disease. Of the appointed members at least five shall by virtue of training or experience be knowledgeable in health education, nursing, data systems, public information, or community program development. “(2) The following shall be ex officio members of the Advisory Board: “(A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Director of the Centers for Disease Control, the Chief Medical Director of the Veterans’ Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and “(B) such other officers and employees of the United States as the Secretary determines necessary for the Advisory Board to carry out its functions. “(c) Members of the Advisory Board who are officers or employees Government organization and employees. of the Federal Government shall serve as members of the Advisory Board without compensation in addition to that received in their regular public employment. Other members of the Advisory Board shall receive compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the 5 USC 5332. performance of their duties as members of the Advisory Board. “(d) The term of office of an appointed member of the Advisory Board is four years. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member’s term until a successor has taken office. If a vacancy occurs in the Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred. “(e) The members of the Advisory Board shall select a chairman from among the appointed members. “(f) The Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, and (through contracts or other arrangements) with such administrative support services and facilities, such information, and such services of consultants, as the Secretary determines are necessary for the Advisory Board to carry out its functions. “(g) The Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year. “(h) The Advisory Board shall— “(1) review and evaluate the implementation of the plan prepared under section 436(a) and periodically update the plan Ante, p. 848. to ensure its continuing relevance; “(2) for the purpose of assuring the most effective use and organization of resources respecting arthritis, musculoskeletal diseases and skin diseases, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and “(3) maintain liaison with other advisory bodies for Federal agencies involved in the implementation of such plan, the inter-agency coordinating committees for such diseases established Ante, p. 849. under section 439, and with key non-Federal entities involved in activities affecting the control of such diseases. “(i) In carrying out its functions, the Advisory Board may establish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities. “(j) The Advisory Board shall prepare an annual report for the Secretary which— “(1) describes the Advisory Board’s activities in the fiscal year for which the report is made; “(2) describes and evaluates the progress made in such fiscal year in research, treatment, education, and training with respect to arthritis, musculoskeletal diseases, and skin diseases; “(3) summarizes and analyzes expenditures made by the Federal Government for activities respecting such diseases in such fiscal year for which the report is made; and “(4) contains the Advisory Board’s recommendations (if any) Ante, p. 848. for changes in the plan prepared under section 436(a). “(k) The National Arthritis Advisory Board in existence on the Ante, p. 820. date of enactment of the Health Research Extension Act of 1985 shall terminate upon the appointment of a successor Board under subsection (a). The Secretary shall make appointments to the Advisory Board established under subsection (a) before the expiration of 90 days after such date. The member of the Board in existence on such date may be appointed, in accordance with subsections (b) and (d), to the Advisory Board established under subsection (a). “Subpart 5— National Institute on Aging “Sec. 443. “purpose of the institute The general purpose of the National Institute on Aging (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of biomedical, social, and behavioral research, training, health information dissemination, and other programs with respect to the aging process and the diseases and other special problems and needs of the aged. “Sec. 444. “special functions (a) In carrying out the training responsibilities under this Act or any other Act for health and allied health professions personnel, the Secretary shall take appropriate steps to insure the education and training of adequate numbers of allied health, nursing, and paramedical personnel in the field of health care for the aged. “(b) The Director of the Institute shall conduct scientific studies to measure the impact on the biological, medical, social, and psychological aspects of aging of programs and activities assisted or conducted by the Department of Health and Human Services. “(c) The Director of the Institute shall carry out public information and education programs designed to disseminate as widely as possible the findings of research sponsored by the Institute, other relevant aging research and studies, and other information about the process of aging which may assist elderly and near-elderly persons in dealing with, and all Americans in understanding, the problems and processes associated with growing older. “(d) The Director of the Institute shall make grants to public and Grants. private nonprofit institutions to conduct research relating to Alzheimer’s Disease. “Sec. 445. “alzheimer’s disease centers (a) (1) The Director of the Institute may enter into Contracts. Grants. 42 USC 285e–2. cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of advanced diagnostic, prevention, and treatment methods for Alzheimer’s Disease. “(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute’s advisory council. “(b) Federal payments made under a cooperative agreement or grant under subsection (a) may be used for— “(1) construction (notwithstanding any limitation under section 496); Post, p. 877. “(2) staffing and other basic operating costs, including such patient care costs as are required for research; “(3) training, including training for allied health professionals; and “(4) demonstration purposes. As used in this subsection, the term ‘construction’ does not include the acquisition of land, and the term ‘training’ does not include research training for which National Research Service Awards may be provided under section 487. Post, p. 869. “(c) Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. “Subpart 6— National Institute of Allergy and Infectious Diseases “Sec. 446. “purpose of the institute The general purpose of the National Institute of Allergy 42 USC 285f. and Infectious Diseases is the conduct and support of research, training, health information dissemination, and other programs with respect to allergic and immunologic diseases and disorders and infectious diseases. “Subpart 7— National Institute of Child Health and Human Development “Sec. 448. “purpose of the institute The general purpose of the National Institute of Child Health and Human Development (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of research, training, health information dissemination, and other programs with respect to maternal health, child health, mental retardation, human growth and development, including prenatal development, population research, and special health problems and requirements of mothers and children. “Sec. 449. “sudden infant death syndrome The Director of the Institute shall conduct and support research which specifically relates to sudden infant death syndrome. “Sec. 450. “mental retardation research The Director of the Institute shall conduct and support research and related activities into the causes, prevention, and treatment of mental retardation. “Sec. 451. “associate director for prevention (a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of health problems of mothers and children. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine. “(b) The Associate Director for Prevention shall prepare for inclusion Ante, p. 831. in the biennial report made under section 407 a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities. “Subpart 8— National Institute of Dental Research “Sec. 453. “purpose of the institute The general purpose of the National Institute of Dental Research is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, prevention, and methods of diagnosis and treatment of dental and oral diseases and conditions. “Subpart 9— National Eye Institute “Sec. 455. “purpose of the institute The general purpose of the National Eye Institute (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind. The Director of the Institute may carry out a program of Grants. grants for public and private nonprofit vision research facilities. “Subpart 10— National Institute of Neurological and Communicative Disorders and Stroke “Sec. 457. “purpose of the institute The general purpose of the National Institute of Neurological 42 USC 285j. and Communicative Disorders and Stroke (hereafter in this subpart referred to as the ‘Institute’) is the conduct and support of research, training, health information dissemination, and other programs with respect to neurological disease and disorder, stroke, and disorders of human communication. “Sec. 458. “spinal cord regeneration research The Director of the Institute shall conduct and support 42 USC 285j–1. research into spinal cord regeneration. “Sec. 459. “bioengineering research The Director of the Institute shall make grants or enter Grants. Contracts. 42 USC 285j–2. into contracts for research on the means to overcome paralysis of the extremities through electrical stimulation and the use of computers. “Subpart 11— National Institute of General Medical Sciences “Sec. 461. “purpose of the institute The general purpose of the National Institute of General 42 USC 285k. Medical Sciences is the conduct and support of research, training, and, as appropriate, health information dissemination, and other programs with respect to general or basic medical sciences and related natural or behavioral sciences which have significance for two or more other national research institutes or are outside the general area of responsibility of any other national research institute. “Subpart 12— National Institute of Environmental Health Sciences “Sec. 463. “purpose of the institute The general purpose of the National Institute of 42 USC 285l. Environmental Health Sciences is the conduct and support of research, training, health information dissemination, and other programs with respect to factors in the environment that affect human health, directly or indirectly. “Part D— National Library of Medicine “Subpart 1— General Provisions “Sec. 465. “purpose, establishment, and functions of the national library of medicine (a) In order to assist the advancement of medical and 42 USC 286. related sciences and to aid the dissemination and exchange of scientific and other information important to the progress of medicine and to the public health, there is established the National Library of Medicine (hereafter in this part referred to as the ‘Library’). “(b) The Secretary, through the Library and subject to subsection (d), shall— “(1) acquire and preserve books, periodicals, prints, films, recordings, and other library materials pertinent to medicine; “(2) organize the materials specified in paragraph (1) by appropriate cataloging, indexing, and bibliographical listings; “(3) publish and disseminate the catalogs, indexes, and bibliographies referred to in paragraph (2); “(4) make available, through loans, photographic or other copying procedures, or otherwise, such materials in the Library as the Secretary determines appropriate; “(5) provide reference and research assistance; and “(6) engage in such other activities as the Secretary determines appropriate and as the Library’s resources permit. “(c) The Secretary may exchange, destroy, or otherwise dispose of any books, periodicals, films, and other library materials not needed for the permanent use of the Library. “(d) (1) The Secretary may, after obtaining the advice and recommendations of the Board of Regents, prescribe rules under which the Library will— “(A) provide copies of its publications or materials, “(B) will make available its facilities for research, or “(C) will make available its bibliographic, reference, or other services, to public and private entities and individuals. “(2) Rules prescribed under paragraph (1) may provide for making available such publications, materials, facilities, or services— “(A) without charge as a public service, “(B) upon a loan, exchange, or charge basis, or “(C) in appropriate circumstances, under contract arrangements made with a public or other nonprofit entity. “(e) Whenever the Secretary, with the advice of the Board of Regents, determines that— “(1) in any geographic area of the United States there is no regional medical library adequate to serve such area; “(2) under criteria prescribed for the administration of section Post, p. 862. 475, there is a need for a regional medical library to serve such area; and “(3) because there is no medical library located in such area which, with financial assistance under section 475, can feasibly be developed into a regional medical library adequate to serve such area, the Secretary may establish, as a branch of the Library, a regional medical library to serve the needs of such area. “(f) Section 2101 shall be applicable to the acceptance and administration of gifts made for the benefit of the Library or for carrying out any of its functions, and the Board of Regents shall make recommendations to the Secretary relating to establishment within the Library of suitable memorials to the donors. “(g) For purposes of this part, the terms ‘medicine’ and ‘medical’, Post, p. 859. except when used in section 466, include preventive and therapeutic medicine, dentistry, pharmacy, hospitalization, nursing, public health, and the fundamental sciences related thereto, and other related fields of study, research, or activity. “Sec. 466. “board of regents (a) (1) (A) The Board of Regents of the National Library 42 USC 286a. of Medicine consists of ex officio members and ten members appointed by the Secretary. “(B) The ex officio members are the Surgeons General of the Public Health Service, the Army, the Navy, and the Air Force, the Chief Medical Director of the Veterans’ Administration, the Dean of the Uniformed Services University of the Health Sciences, the Assistant Director for Biological, Behavioral, and Social Sciences of the National Science Foundation, the Director of the National Agricultural Library, and the Librarian of Congress (or their designees). “(C) The appointed members shall be selected from among leaders in the various fields of the fundamental sciences, medicine, dentistry, public health, hospital administration, pharmacology, health communications technology, or scientific or medical library work, or in public affairs. At least six of the appointed members shall be selected from among leaders in the fields of medical, dental, or public health research or education. “(2) The Board shall annually elect one of the appointed members to serve as chairman until the next election. The Secretary shall designate a member of the Library staff to act as executive secretary of the Board. “(b) The Board shall advise, consult with, and make recommendations to the Secretary on matters of policy in regard to the Library, including such matters as the acquisition of materials for the Library, the scope, content, and organization of the Library’s services, and the rules under which its materials, publications, facilities, and services shall be made available to various kinds of users. The Secretary shall include in the annual report of the Secretary to the Congress a statement covering the recommendations made by the Board and the disposition thereof. The Secretary may use the services of any member of the Board in connection with matters related to the work of the Library, for such periods, in addition to conference periods, as the Secretary may determine. “(c) Each appointed member of the Board shall hold office for a term of four years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the predecessor of such member was appointed shall be appointed for the remainder of such term. None of the appointed members shall Prohibition. be eligible for reappointment within one year after the end of the preceding term of such member. “Sec. 467. “library facilities There are authorized to be appropriated amounts sufficient Public buildings and grounds. 42 USC 286a–1. for the erection and equipment of suitable and adequate buildings and facilities for use of the Library. The Administrator of General Services may acquire, by purchase, condemnation, donation, or otherwise, a suitable site or sites, selected by the Secretary in accordance with the direction of the Board, for such buildings and facilities and to erect thereon, furnish, and equip such buildings and facilities. The amounts authorized to be appropriated by this section include the cost of preparation of drawings and specifications, supervision of construction, and other administrative expenses incident to Contracts. the work. The Administrator of General Services shall prepare the plans and specifications, make all necessary contracts, and supervise construction. “Subpart 2— Financial Assistance “Sec. 469. “authorization of appropriations For the purpose of grants and contracts under sections 472, 473, 474, 475, and 476, there are authorized to be appropriated $12,000,000 for fiscal year 1986, $13,000,000 for fiscal year 1987, and $14,000,000 for fiscal year 1988. Funds appropriated under this section shall remain available for such purposes until the end of the fiscal year immediately following the fiscal year for which they were appropriated. “Sec. 470. “definitions As used in this subpart— “(1) the term ‘medical library’ means a library related to the sciences related to health; and “(2) the term ‘sciences related to health’ includes medicine, osteopathy, dentistry, and public health, and fundamental and applied sciences when related thereto. “Sec. 471. “national medical libraries assistance advisory board (a) The Board of Regents of the National Library of Medicine shall also serve as the National Medical Libraries Assistance Advisory Board (hereafter in this subpart referred to as the ‘Board’). “(b) The Board shall advise and assist the Secretary in the preparation of general regulations and with respect to policy matters arising in the administration of this subpart. “(c) The Secretary may use the services of any member of the Board, in connection with matters related to the administration of this part for such periods, in addition to conference periods, as the Secretary may determine. “(d) Appointed members of the Board who are not otherwise in the employ of the United States, while attending conferences of the Board or otherwise serving at the request of the Secretary in connection with the administration of this subpart, shall be entitled to receive compensation, per diem in lieu of subsistence, and travel expenses in the same manner and under the same conditions as that 42 USC 210. prescribed under section 208(c) when attending conferences, traveling, or serving at the request of the Secretary in connection with the Board’s function under this section. “Sec. 472. “grants for training in medical library sciences The Secretary shall make grants— “(1) to individuals to enable them to accept traineeships and fellowships leading to postbaccalaureate academic degrees in the field of medical library science, in related fields pertaining to sciences related to health, or in the field of the communication of information; “(2) to individuals who are librarians or specialists in information on sciences relating to health, to enable them to undergo intensive training or retraining so as to attain greater competence in their occupations (including competence in the fields of automatic data processing and retrieval); “(3) to assist appropriate public and private nonprofit institutions in developing, expanding, and improving training programs in library science and the field of communications of information pertaining to sciences relating to health; and “(4) to assist in the establishment of internship programs in established medical libraries meeting standards which the Secretary shall prescribe. “Sec. 473. “assistance for special scientific projects, and for research and development in medical library science and related fields (a) The Secretary shall make grants to physicians and Grants. Physicians. 42 USC 286b–4. other practitioners in the sciences related to health, to scientists, and to public or nonprofit private institutions on behalf of such physicians, other practitioners, and scientists for the compilation of existing, or the writing of original, contributions relating to scientific, social, or cultural advancements in sciences related to health. In making such grants, the Secretary shall make appropriate arrangements under which the facilities of the Library and the facilities of libraries of public and private nonprofit institutions of higher learning may be made available in connection with the projects for which such grants are made. “(b) The Secretary shall make grants to appropriate public or Contracts. private nonprofit institutions and enter into contracts with appropriate persons, for purposes of carrying out projects of research, investigations, and demonstrations in the field of medical library science and related activities and for the development of new techniques, systems, and equipment, for processing, storing, retrieving, and distributing information pertaining to sciences related to health. “Sec. 474. “grants for establishing, expanding, and improving the basic resources of medical libraries and related instrumentalities (a) The Secretary shall make grants of money, materials, 42 USC 286b–5. or both, to public or private nonprofit medical libraries and related scientific communication instrumentalities for the purpose of establishing, expanding, and improving their basic medical library or related resources. A grant under this subsection may be used for— “(1) the acquisition of books, journals, photographs, motion picture and other films, and other similar materials; “(2) cataloging, binding, and other services and procedures for processing library resource materials for use by those who are served by the library or related instrumentality; “(3) the acquisition of duplication devices, facsimile equipment, film projectors, recording equipment, and other equipment to facilitate the use of the resources of the library or related instrumentality by those who are served by it; and “(4) the introduction of new technologies in medical librarianship. “(b) (1) The amount of any grant under this section to any medical library or related instrumentality shall be determined by the Secretary on the basis of the scope of library or related services provided by such library or instrumentality in relation to the population and purposes served by it. In making a determination of the scope of services served by any medical library or related instrumentality, the Secretary shall take into account— “(A) the number of graduate and undergraduate students making use of the resources of such library or instrumentality; “(B) the number of physicians and other practitioners in the Physicians. sciences related to health utilizing the resources of such library or instrumentality; “(C) the type of supportive staffs, if any, available to such library or instrumentality; “(D) the type, size, and qualifications of the faculty of any school with which such library or instrumentality is affiliated; “(E) the staff of any hospital or hospitals or of any clinic or clinics with which such library or instrumentality is affiliated; and “(F) the geographic area served by such library or instrumentality and the availability within such area of medical library or related services provided by other libraries or related instrumentalities. “(2) Grants to such medical libraries or related instrumentalities under this section shall be in such amounts as the Secretary may by regulation prescribe with a view to assuring adequate continuing financial support for such libraries or instrumentalities from other sources during and after the period for which grants are provided, except that in no case shall any grant under this section to a medical library or related instrumentality for any fiscal year exceed $500,000. “Sec. 475. “grants and contracts for establishment of regional medical libraries (a) The Secretary, with the advice of the Board, shall make grants to and enter into contracts with existing public or private nonprofit medical libraries so as to enable each of them to serve as the regional medical library for the geographical area in which it is located. “(b) The uses for which grants and contracts under this section may be employed include the— “(1) acquisition of books, journals, and other similar materials; “(2) cataloging, binding, and other procedures for processing library resource materials for use by those who are served by the library; “(3) acquisition of duplicating devices and other equipment to facilitate the use of the resources of the library by those who are served by it; “(4) acquisition of mechanisms and employment of personnel for the speedy transmission of materials from the regional library to local libraries in the geographic area served by the regional library; and “(5) planning for services and activities under this section. “(c) (1) Grants and contracts under this section shall only be made to or entered into with medical libraries which agree— “(A) to modify and increase their library resources, and to supplement the resources of cooperating libraries in the region, so as to be able to provide adequate supportive services to all libraries in the region as well as to individual users of library services; and “(B) to provide free loan services to qualified users and make available photoduplicated or facsimile copies of biomedical materials which qualified requesters may retain. “(2) The Secretary, in awarding grants and contracts under this section, shall give priority to medical libraries having the greatest potential of fulfilling the needs for regional medical libraries. In determining the priority to be assigned to any medical library, the Secretary snail consider— “(A) the adequacy of the library (in terms of collections, personnel, equipment, and other facilities) as a basis for a regional medical library; and “(B) the size and nature of the population to be served in the region in which the library is located “(d) Grants and contracts under this section for basic resource materials to a library may not exceed— “(1) 50 percent of the library’s annual operating expense (exclusive of Federal financial assistance under this part) for the preceding year; or “(2) in case of the first year in which the library receives a grant under this section for basic resource materials, 50 percent of its average annual operating expenses over the past three years (or if it had been in operation for less than three years, its annual operating expenses determined by the Secretary in accordance with regulations). “Sec. 476. “financial support of biomedical scientific publications (a) The Secretary, with the advice of the Board, shall Grants. Contracts. Education. 42 USC 286b–7. make grants to, and enter into appropriate contracts with, public or private nonprofit institutions of higher education and individual scientists for the purpose of supporting biomedical scientific publications of a nonprofit nature and to procure the compilation, writing, editing, and publication of reviews, abstracts, indices, handbooks, bibliographies, and related matter pertaining to scientific works and scientific developments. “(b) Grants under subsection (a) in support of any single periodical publication may not be made for more than three years, except in those cases in which the Secretary determines that further support is necessary to carry out the purposes of subsection (a). “Sec. 477. “grant payments, records, and audit (a) Payments under grants made under sections 472, Regulations. 42 USC 286b–8. Ante, pp. 860–862; supra. 473, 474, 475, and 476 may be made in advance or by way of reimbursement and in such installments as the Secretary shall prescribe by regulation after consultation with the Board. “(b) (1) Each recipient of a grant under this subpart shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit. “(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of such recipients that are pertinent to any grant received under this subpart. “Part E— Other Agencies of NIH “Subpart 1— Division of Research Resources “Sec. 479. “general purpose The general purpose of the Division of Research Resources is to strengthen and enhance the research environments of entities engaged in health-related research by developing and supporting essential research resources. “Sec. 480. “advisory council (a) (1) The Secretary shall appoint an advisory council for the Division of Research Resources which shall advise, assist, consult with, and make recommendations to the Secretary and the Director of the Division on matters related to the activities carried out by and through the Division and the policies respecting such activities. “(2) The advisory council for the Division of Research Resources may recommend to the Secretary acceptance, in accordance with section 2101, of conditional gifts for study, investigations, and research and for the acquisition of grounds or construction, equipping, or maintenance of facilities for the Division. “(3) The advisory council for the Division— “(A) (i) may make recommendations to the Director of the Division respecting research conducted at the Division, “(ii) may review applications for grants and cooperative agreements for research or training and recommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and “(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the Division; “(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspects of human health with respect to which the Division is concerned and with the approval of the Director of the Division make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and “(C) may appoint subcommittees and convene workshops and conferences. “(b) (1) The advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. “(2) The ex officio members of the advisory council shall consist of— “(A) the Secretary, the Director of NIH, the Director of the Division of Research Resources, the Chief Medical Director of the Veterans’ Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and “(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions. “(3) The members of the advisory council who are not ex officio members shall be appointed as follows: “(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behavioral or social sciences) relevant to the activities of the Division. “(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management. “(4) Members of the advisory council who are officers or employees Government organization and employees. of the United States shall not receive any compensation for service on the advisory council. The other members of the advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule. 5 USC 5332 note. “(c) The term of office of an appointed member of the advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member’s term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs. “(d) The chairman of the advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the Division of Research Resources to be the chairman of the advisory council. The term of office of the chairman shall be two years. “(e) The advisory council shall meet at the call of the chairman or upon the request of the Director of the Division of Research Resources, but at least three times each fiscal year. The location of the meetings of the advisory council is subject to the approval of the Director of the Division. “(f) The Director of the Division of Research Resources shall designate a member of the staff of the Division to serve as the executive secretary of the advisory council. The Director of the Division shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of the Division shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council. “(g) The advisory council may prepare, for inclusion in the biennial Infra. report made under section 481, (1) comments respecting the activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the Division of Research Resources in meeting its objectives, and (3) recommendations respecting the future directions and program and Reports. policy emphasis of the Division. The advisory council may prepare such additional reports as it may determine appropriate. “(h) This section does not terminate the membership of the advisory council for the Division of Research Resources which was in existence on the date of enactment of the Health Research Extension Act of 1985. After such date— “(1) the Secretary shall make appointments to such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section; “(2) the advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and “(3) the Director of the Division of Research Resources shall perform for such advisory council the functions prescribed by this section. “Sec. 481. “biennial report The Director of the Division of Research Resources, after consultation with the advisory council for the Division, shall Ante, p. 826. prepare for inclusion in the biennial report made under section 403 a biennial report which shall consist of a description of the activities of the Division and program policies of the Director of the Division in the fiscal years respecting which the report is prepared. The Director of the Division may prepare such additional reports as the Director determines appropriate. The Director of the Division shall provide the advisory council of the Division an opportunity for the Ante, p. 864. submission of the written comments referred to in section 480(g). “Subpart 2— John E. Fogarty International Center for Advanced Study in the Health Sciences “Sec. 482. “general purpose The general purpose of the John E. Fogarty International Center for Advanced Study in the Health Sciences is to— “(1) facilitate the assembly of scientists and others in the biomedical, behavioral, and related fields for discussion, study, and research relating to the development of health science internationally; “(2) provide research programs, conferences, and seminars to further international cooperation and collaboration in the life sciences; “(3) provide postdoctorate fellowships for research training in the United States and abroad and promote exchanges of senior scientists between the United States and other countries; “(4) coordinate the activities of the National Institutes of Health concerned with the health sciences internationally; and “(5) receive foreign visitors to the National Institutes of Health. “Subpart 3— National Center for Nursing Research “Sec. 483. “purpose of the center The general purpose of the National Center for Nursing 42 USC 287c. Research (hereafter in this subpart referred to as the ‘Center’) is the conduct and support of, and dissemination of information respecting, basic and clinical nursing research, training, and other programs in patient care research. “Sec. 484. “specific authorities To carry out section 483, the Director of the Center may Fellowships. Supra. 42 USC 287c–1. provide research training and instruction and establish, in the enter and other nonprofit institutions, research traineeships and fellowships in the study and investigation of the prevention of disease, health promotion, and the nursing care of individuals with and the families of individuals with acute and chronic illnesses. The Director of the Center may provide individuals receiving such training and instruction or such traineeships or fellowships with such stipends and allowances (including amounts for travel and subsistence and dependency allowances) as the Director determines necessary. The Director may make grants to nonprofit institutions to Grants. provide such training and instruction and traineeships and fellowships. “Sec. 485. “advisory council (a) (1) The Secretary shall appoint an advisory council 42 USC 287c–2. for the Center which shall advise, assist, consult with, and make recommendations to the Secretary and the Director of the Center on matters related to the activities carried out by and through the Center and the policies respecting such activities. “(2) The advisory council for the Center may recommend to the Gifts and property. 42 USC 800aa Secretary acceptance, in accordance with section 2101, of conditional gifts for study, investigations, and research and for the acquisition of grounds or construction, equipping, or maintenance of facilities for the Center. “(3) The advisory council for the Center— “(A) (i) may make recommendations to the Director of the Grants. Contracts. Center respecting research conducted at the Center, “(ii) may review applications for grants and cooperative agreements for research or training and recommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and “(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the Center; “(B) may collect, by correspondence or by personal investigation, Public information. information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspects of human health with respect to which the Center is concerned and with the approval of the Director of the Center make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and “(C) may appoint subcommittees and convene workshops and conferences. “(b) (1) The advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. “(2) The ex officio members of the advisory council shall consist of— “(A) the Secretary, the Director of NIH, the Director of the Center, the Chief Nursing Officer of the Veterans’ Administration, the Assistant Secretary of Defense for Health Affairs, the Director of the Division of Nursing of the Health Resources and Services Administration (or the designees of such officers), and “(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions. “(3) The members of the advisory council who are not ex officio members shall be appointed as follows: “(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behavioral or social sciences) relevant to the activities of the Center. Of the members appointed pursuant to this subparagraph, at least seven shall be professional nurses who are recognized experts in the area of clinical practice, education, or research. “(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management. “(4) Members of the advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The other members of the advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the 5 USC 5332 note. annual rate in effect for grade GS–18 of the General Schedule. “(c) The term of office of an appointed member of the advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member’s term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs. “(d) The chairman of the advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the Center to be the chairman of the advisory council. The term of office of the chairman shall be two years. “(e) The advisory council shall meet at the call of the chairman or upon the request of the Director of the Center, but at least three times each fiscal year. The location of the meetings of the advisory council is subject to the approval of the Director of the Center. “(f) The Director of the Center shall designate a member of the staff of the Center to serve as the executive secretary of the advisory council. The Director of the Center shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of the Center shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council. “(g) The advisory council may prepare, for inclusion in the biennial report made under section 486, (1) comments respecting the Infra. activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the Center in meeting its objectives, and (3) recommendations respecting the future directions and program and policy emphasis of the Center. The advisory council may prepare such additional reports as it may determine appropriate. “Sec. 486. “biennial report The Director of the Center after consultation with the 42 USC 287c–3. advisory council for the Center, shall prepare for inclusion in the biennial report made under section 403 a biennial report which shall Ante, p. 826. consist of a description of the activities of the Center and program policies of the Director of the Center in the fiscal years respecting which the report is prepared. The Director of the Center may prepare such additional reports as the Director determines appropriate. The Director of the Center shall provide the advisory council of the Center an opportunity for the submission of the written comments referred to in section 485(g). Ante, p. 867. “Part F— Awards and Training “Sec. 487. “national research service awards (a) (1) The Secretary shall— 42 USC 288. “(A) provide National Research Service Awards for— “(i) biomedical and behavioral research at the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration in matters relating to the cause, diagnosis, prevention, and treatment of the diseases or other health problems to which the activities of the National Institutes of Health and Administration are directed; “(ii) training at the National Institutes of Health and at the Administration of individuals to undertake such research; “(iii) biomedical and behavioral research and health services research (including research in primary medical care) at public and nonprofit private entities; and “(iv) predoctoral and post-doctoral training at public and private institutions of individuals to undertake biomedical and behavioral research; and “(B) make grants to public and nonprofit private institutions Grants. to enable such institutions to make National Research Service Awards for research (and training to undertake biomedical and behavioral research) in the matters described in subparagraph (A)(i) to individuals selected by such institutions. A reference in this subsection to the National Institutes of Health or the Alcohol, Drug Abuse, and Mental Health Administration shall be considered to include the institutes, agencies, divisions, and bureaus included in the National Institutes of Health or under the Administration, as the case may be. “(2) National Research Service Awards may not be used to support residency training of physicians and other health professionals. “(3) In awarding National Research Service Awards under this section, the Secretary shall take account of the Nation’s overall need for biomedical research personnel by giving special consideration to physicians who agree to undertake a minimum of two years of biomedical research. “(b) (1) No National Research Service Award may be made by the Secretary to any individual unless— “(A) the individual has submitted to the Secretary an application therefor and the Secretary has approved the application; “(B) the individual provides, in such form and manner as the Secretary shall by regulation prescribe, assurances satisfactory to the Secretary that the individual will meet the service requirement of subsection (c); and “(C) in the case of a National Research Service Award for a purpose described in subsection (a)(I)(A)(iii), the individual has been sponsored (in such manner as the Secretary may by regulation require) by the institution at which the research or training under the award will be conducted. Regulations. An application for an award shall be in such form, submitted in such manner, and contain such information, as the Secretary may by regulation prescribe. “(2) The making of grants under subsection (a)(1)(B) for National Research Service Awards shall be subject to review and approval by the appropriate advisory councils within the Department of Health and Human Services (A) whose activities relate to the research or training under the awards, or (B) for the entity at which such research or training will be conducted. “(3) No grant may be made under subsection (a)(1)(B) unless an application therefor has been submitted to and approved by the Secretary. Such application shall be in such form, submitted in such manner, and contain such information, as the Secretary may by regulation prescribe. Subject to the provisions of this section (other than paragraph (1)), National Research Service Awards made under a grant under subsection (a)(1)(B) shall be made in accordance with such regulations as the Secretary shall prescribe. “(4) The period of any National Research Service Award made to any individual under subsection (a) may not exceed— “(A) five years in the aggregate for predoctoral training; and “(B) three years in the aggregate for post-doctoral training; unless the Secretary for good cause shown waives the application of such limit to such individual. “(5) National Research Service Awards shall provide for such stipends, tuition, fees, and allowances (including travel and subsistence expenses and dependency allowances), adjusted periodically to reflect increases in the cost of living, for the recipients of the awards as the Secretary may deem necessary. A National Research Service Award made to an individual for research or research training at a non-Federal public or nonprofit private institution shall also provide for payments to be made to the institution for the cost of support services (including the cost of faculty salaries, supplies, equipment, general research support, and related items) provided such individual by such institution. The amount of any such payments to any institution shall be determined by the Secretary and shall bear a direct relationship to the reasonable costs of the institution for establishing and maintaining the quality of its biomedical and behavioral research and training programs. “(c) (1) Each individual who is awarded a National Research Service Award (other than an individual who is a prebaccalaureate student who is awarded a National Research Service Award for research training) shall, in accordance with paragraph (3), engage in health research or teaching or any combination thereof which is in accordance with the usual patterns of academic employment, for a period computed in accordance with paragraph (2). “(2) For each month for which an individual receives a National Research Service Award which is made for a period in excess of twelve months, such individual shall engage in one month of health research or teaching or any combination thereof which is in accordance with the usual patterns of academic employment. “(3) The requirement of paragraph (1) shall be complied with by Regulation. any individual to whom it applies within such reasonable period of time, after the completion of such individual’s award, as the Secretary shall by regulation prescribe. The Secretary shall by regulation prescribe the type of research and teaching in which an individual may engage to comply with such requirement and such other requirements respecting research and teaching as the Secretary considers appropriate. “(4) (A) If any individual to whom the requirement of paragraph (1) is applicable mils, within the period prescribed by paragraph (3), to comply with such requirements, the United States shall be entitled to recover from such individual an amount determined in accordance with the formula— A=φ⁡(t−st) in which ‘A’ is the amount the United States is entitled to recover; ‘φ’ is the sum of the total amount paid under one or more National Research Service Awards to such individual; ‘t’ is the total number of months in such individual’s service obligation; and ‘s’ is the number of months of such obligation served by such individual in accordance with paragraphs (1) and (2) of this subsection. “(B) Any amount which the United States is entitled to recover under subparagraph (A) shall, within the three-year period beginning on the date the United States becomes entitled to recover such amount, be paid to the United States. Until any amount due the United States under subparagraph (A) on account of any National Research Service Award is paid, there shall accrue to the United States interest on such amount at a rate fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date the United States becomes entitled to such amount. “(5) (A) Any obligation of an individual under paragraph (1) shall be canceled upon the death of such individual. “(B) The Secretary shall by regulation provide for the waiver or Regulation. suspension of any such obligation applicable to any individual whenever compliance by such individual is impossible or would involve substantial hardship to such individual or would be against equity and good conscience. “(d) There are authorized to be appropriated to make payments under National Research Service Awards and under grants for such awards $244,000,000 for fiscal year 1986, $260,000,000 for fiscal year 1987, and $275,000,000 for fiscal year 1988. Of the amounts appropriated under this subsection— “(1) not less than 15 percent shall be made available for payments under National Research Service Awards provided by the Secretary under subsection (a)(I)(A); “(2) not less than 50 percent shall be made available for grants under subsection (a)(1)(B) for National Research Service Awards; “(3) one-half of one percent shall be made available for payments under National Research Service Awards which (A) are made to individuals affiliated with entities which have received 42 USC 295g, 295g–4, 295g–6. grants or contracts under section 780,784, or 786, and (B) are for research in primary medical care; and one-half of one percent shall be made available for payments under National Research Service Awards made for health services research by the National Center for Health Services Research and Health Care 98 Stat. 2819. 42 USC 242b. Prohibition. Technology Assessment under section 304(a)(3); and “(4) not more than 4 percent may be obligated for National Research Service Awards for periods of three months or less. “Sec. 488. “visiting scientist awards (a) The Secretary may make awards (hereafter in this section referred to as ‘Visiting Scientist Awards’) to outstanding scientists who agree to serve as visiting scientists at institutions of postsecondary education which have significant enrollments of disadvantaged students. Visiting Scientist Awards shall be made by the Secretary to enable the faculty and students of such institutions to draw upon the special talents of scientists from other institutions for the purpose of receiving guidance, advice, and instruction with regard to research, teaching, and curriculum development in the biomedical and behavioral sciences and such other aspects of these sciences as the Secretary shall deem appropriate. “(b) The amount of each Visiting Scientist Award shall include such sum as shall be commensurate with the salary or remuneration which the individual receiving the award would have been entitled to receive from the institution with which the individual has, or had, a permanent or immediately prior affiliation. Eligibility for and terms of Visiting Scientist Awards shall be determined in accordance with regulations the Secretary shall prescribe. “Sec. 489. “studies respecting biomedical and behavioral research personnel (a) The Secretary shall, in accordance with subsection (b), arrange for the conduct of a continuing study to— “(1) establish (A) the Nation’s overall need for biomedical and behavioral research personnel, (B) the subject areas in which such personnel are needed and the number of such personnel needed in each such area, and (C) the kinds and extent of training which should be provided such personnel; “(2) assess (A) current training programs available for the training of biomedical and behavioral research personnel which are conducted under this Act, at or through national research institutes under the National Institutes of Health and institutes under the Alcohol, Drug Abuse, and Mental Health Administration, and (B) other current training programs available for the training of such personnel; “(3) identify the kinds of research positions available to and held by individuals completing such programs; “(4) determine, to the extent feasible, whether the programs referred to in clause (B) of paragraph (2) would be adequate to meet the needs established under paragraph (1) if the programs referred to in clause (A) of paragraph (2) were terminated; and “(5) determine what modifications in the programs referred to in paragraph (2) are required to meet the needs established under paragraph (1). “(b) (1) The Secretary shall request the National Academy of Sciences to conduct the study required by subsection (a) under an arrangement under which the actual expenses incurred by such Academy in conducting such study will be paid by the Secretary. If the National Academy of Sciences is willing to do so, the Secretary shall enter into such an arrangement with such Academy for the conduct of such study. “(2) If the National Academy of Sciences is unwilling to conduct such study under such an arrangement, then the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associations under which such groups or associations will conduct such study and prepare and submit the reports thereon as provided in subsection (c). “(3) The National Academy of Sciences or other group or association conducting the study required by subsection (a) shall conduct such study in consultation with the Director of NIH. “(c) A report on the results of the study required under subsection Report. (a) shall be submitted by the Secretary to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate at least once every four years. “Part G— General Provisions “Sec. 491. “institutional review boards; ethics guidance program (a) The Secretary shall by regulation require that each Regulations. Grants. Contracts. Human rights. 42 USC 289. entity which applies for a grant, contract, or cooperative agreement under this Act for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an ‘Institutional Review Board’) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research. “(b) (1) The Secretary shall establish a program within the Department of Health and Human Services under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately. “(2) The Secretary shall establish a process for the prompt and appropriate response to information provided to the Director of NIH respecting incidences of violations of the rights of human subjects of research for which funds have been made available under this Act. The process shall include procedures for the receiving of reports of such information from recipients of funds under this Act and taking appropriate action with respect to such violations. “Sec. 492. “peer review requirements (a) (1) The Secretary, acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of— “(A) applications made for grants and cooperative agreements under tins Act for biomedical and behavioral research; and “(B) applications made for biomedical and behavioral research and development contracts to be administered through the National Institutes of Health. “(2) Regulations promulgated under paragraph (1) shall require that the review of applications made for grants, contracts, and cooperative agreements required by the regulations be conducted— “(A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on the date of the date of enactment of the Health Research Extension Ante, p. 820. Act of 1985 to grants under this Act for biomedical and behavioral research, and “(B) to the extent practical, by technical and scientific peer review groups performing such review on or before such date, and shall authorize such review to be conducted by groups appointed Ante, pp. 823, 826. under sections 402(b)(6) and 405(c)(3). “(b) The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that— “(1) the reviewing entity be provided a written description of the research to be reviewed, and “(2) the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity, and shall authorize such review to be conducted by groups appointed under sections 402(b)(6) and 405(c)(3). “Sec. 493. “protection against scientific fraud (a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this Act for any project or program which involves the conduct of biomedical or behavioral research submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that such entity— “(1) has established (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research conducted at or sponsored by such entity; and “(2) will report to the Secretary any investigation of alleged scientific fraud which appears substantial. “(b) The Director of NIH shall establish a process for the prompt and appropriate response to information provided the Director of NIH respecting scientific fraud in connection with projects for which funds have been made available under this Act. The process shall include procedures for the receiving of reports of such information from recipients of funds under this Act and taking appropriate action with respect to such fraud. “Sec. 494. “research on public health emergencies (a) If the Secretary determines, after consultation with Grants. Contracts. 42 USC 289c. the Director of NIH, the Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the Director of NIH— “(1) shall expedite the review by advisory councils under section 406 and by peer review groups under section 492 of Ante, pp. 828, 874. applications for grants for research on such disease or disorder or proposals for contracts for such research; “(2) shall exercise the authority in section 3709 of the Revised Statutes (41 U.S.C. 5) respecting public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for such research; “(3) may provide administrative supplemental increases in existing grants and contracts to support new research relevant to such disease or disorder; and “(4) shall disseminate, to health professionals and the public, Public information. information on the cause, prevention, and treatment of such disease or disorder that has been developed in research assisted under this section. The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half the original amount of the grant or contract. “(b) Not later than 90 days after the end of a fiscal year, the Report. Secretary shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate on actions taken under subsection (a) in such fiscal year. “Sec. 495. “animals in research (a) The Secretary, acting through the Director of NIH, 42 USC 289d. shall establish guidelines for the following: “(1) The proper care of animals to be used in biomedical and behavioral research. “(2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall require— “(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and “(B) appropriate presurgical and post-surgical veterinary medical and nursing care for animals in such research. Such guidelines shall not be construed to prescribe methods of Prohibition. research. “(3) The organization and operation of animal care committees in accordance with subsection (b). “(b) (1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this Act (including the National Institutes of Health and the national research institutes) to assure compliance with the guidelines established under subsection (a). “(2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the committee is established, shall be composed of not fewer than three members, and shall include at least one individual who has no association with such entity and at least one doctor of veterinary medicine. “(3) Each animal care committee of a research entity shall— “(A) review the care and treatment of animals in all animal study areas and facilities of the research entity at least semi-annually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment; “(B) keep appropriate records of reviews conducted under subparagraph (A); and “(C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a certification that Reports. the review has been conducted, and (ii) reports of any violations of guidelines established under subsection (a) or assurances required under paragraph (1) which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations. Reports filed under subparagraph (C) shall include any minority views filed by members of the committee. “(c) The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health or any national research institute to include in its application or contract proposal, submitted after the expiration of the twelve-month period beginning on the date of enactment of this section— “(1) assurances satisfactory to the Director of NIH that— “(A) the applicant meets the requirements of the guidelines established under paragraphs (1) and (2) of subsection (a) and has an animal care committee which meets the requirements of subsection (b); and “(B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the applicant have available to them instruction or training in the humane practice of animal maintenance and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and “(2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract. Notwithstanding subsection (a)(2) of section 553 of title 5, United States Code, regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section. “(d) If the Director of NIH determines that— “(1) the conditions of animal care, treatment, or use in an entity which is receiving a grant, contract, or cooperative agreement involving research on animals under this title do not meet applicable guidelines established under subsection (a); “(2) the entity has been notified by the Director of NIH of such determination and has been given a reasonable opportunity to take corrective action; and “(3) no action has been taken by the entity to correct such conditions; the Director of NIH shall suspend or revoke such grant or contract under such conditions as the Director determines appropriate. “(e) No guideline or regulation promulgated under subsection (a) Prohibition. or (c) may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential. “Sec. 496. “use of appropriations under this title Appropriations to carry out the purposes of this title District of Columbia. 42 USC 289e. shall be available for the acquisition of land or the erection of buildings only if so specified. Such appropriations, unless otherwise expressly provided, may be expended in the District of Columbia for— “(1) personal services; “(2) stenographic recording and translating services; “(3) travel expenses (including the expenses of attendance at meetings when specifically authorized by the Secretary); “(4) rental; “(5) supplies and equipment; “(6) purchase and exchange of medical books, books of reference, directories, periodicals, newspapers, and press clippings; “(7) purchase, operation, and maintenance of passenger motor vehicles; “(8) printing and binding (in addition to that otherwise provided by law); and “(9) all other necessary expenses in carrying out this title. Such appropriations may be expended by contract if deemed necessary, without regard to section 3709 of the Revised Statutes (41 U.S.C. 5). “Sec. 497. “gifts The Secretary may, in accordance with section 2101, 42 USC 300aa. 42 USC 289f. accept conditional gifts for the National Institutes of Health or a national research institute or for the acquisition of grounds or for the erection, equipment, or maintenance of facilities for the National Institutes of Health or a national research institute. Donations of $50,000 or over for the National Institutes of Health or a national research institute for carrying out the purposes of this title may be acknowledged by the establishment within the National Institutes of Health or a national research institute of suitable memorials to the donors. “Sec. 498. “fetal research (a) The Secretary may not conduct or support any Prohibition. 42 USC 299g. research or experimentation, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation— “(1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or “(2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means. “(b) In administering the regulations for the protection of human research subjects which— “(1) apply to research conducted or supported by the Secretary; “(2) involve living human fetuses in utero; and “(3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations; or any successor to such regulations, the Secretary shall require that the risk standard (published in section 46.102(g) of such part 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term. “(c) (1) The Biomedical Ethics Advisory Committee appointed under section 381 shall conduct a study of the nature, advisability, and biomedical and ethical implications of exercising any waiver of the risk standard published in section 46.102(g) of such part 46 (or Report. any successor to such regulations). The Committee shall complete the study and report its findings to the Biomedical Ethics Board established under section 381 not later than the expiration of thirty Report. months after the date of enactment of this section. The report shall include the recommendations, if any, of the Committee on the advisability of the authority for such a waiver and the circumstances under which such a waiver might be granted. The Biomedical Ethics Board shall transmit the report to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate. “(2) During the thirty-six-month period beginning on the date of enactment of this section, the Secretary may not grant (under section 46.211 of part 45 of title 46 of the Code of Federal Regulations or any successor to such section) a modification or waiver for fetal research. “(3) Effective October 31, 1988, paragraph (2) is repealed. “Sec. 499. “construction of title This title shall not be construed as limiting (1) the functions or authority of the Secretary under section 301 or of any officer or agency of the United States, relating to the study, prevention, diagnosis, and treatment of any disease for which a separate national research institute is established under this title, or (2) the expenditure of any funds therefor.”
1988
National Institute on Deafness and Other Communication Disorders and Health Research Extension Act of 1988
Pub. L. 100–607 title I § 111 · 102 Stat. 3048
Inserted · 42 U.S.C. § 282(b)(6)
Pub. L. 100–607 inserted “and scientific program advisory committees” after “peer review groups”
Source evidence
Code amendment note
Subsec. (b)(6). Pub. L. 100–607 inserted “and scientific program advisory committees” after “peer review groups”.
Enacted provision · exact public law section
SEC. 111. APPOINTMENT AND AUTHORITY OF THE DIRECTOR. Section 402(b)(6) (42 U.S.C, 282(b)(6)) is amended by inserting “and scientific program advisory committees” after “scientific peer review groups”.
1992
ADAMHA Reorganization Act
Pub. L. 102–321 title I § 163(b)(3) · 106 Stat. 323
Substituted · 42 U.S.C. § 282(d)(1)
Pub. L. 102–321 substituted “220” for “two hundred”
Source evidence
Code amendment note
Subsec. (d)(1). Pub. L. 102–321 substituted “220” for “two hundred”.
Enacted provision · exact public law section
(3) in section 402(d)(l) (42 U.S.C. 282(d)(l)), by striking out “two hundred” and inserting in lieu thereof “220”;
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 141(b) · 107 Stat. 122
Added · 42 U.S.C. § 282(b)(12)
Pub. L. 103–43, § 141(b), added par. (12)
Source evidence
Code amendment note
Subsec. (b)(12). Pub. L. 103–43, § 141(b), added par. (12).
Enacted provision · exact public law section
(b) Requirement of Sufficient Allocation of Resources of Institutes.— Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended— (1) in paragraph (10), by striking “and” after the semicolon at the end; (2) in paragraph (11), by striking the period at the end and inserting “; and”; and (3) by inserting after paragraph (11) the following paragraph: “(12) after consultation with the Director of the Office of Research on Women’s Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women’s health that are identified under section 486(b).”
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 210(b) · 107 Stat. 122
Added · 42 U.S.C. § 282(e)(5)
Pub. L. 103–43, § 210(b), added par. (5)
Source evidence
Code amendment note
Subsec. (e)(5). Pub. L. 103–43, § 210(b), added par. (5).
Enacted provision · exact public law section
(b) Literacy Requirements.— Section 402(e) of the Public Health Service Act (42 U.S.C. 282(e)) is amended— (1) in paragraph (3), by striking “and” at the end; (2) in paragraph (4), by striking the period and inserting “; and”; and (3) by adding at the end the following paragraph: “(5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded by the National Institutes of Health and intended for the general public are in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (Public Law 1022013;73).”.
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 201 · 107 Stat. 122
Substituted · 42 U.S.C. § 282(f)
Pub. L. 103–43, § 201, substituted “other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—” and pars. (1) to (3) for “other public and private entities. The Associate Director shall annually report to the Director of NIH on the prevention activities undertaken by the Associate Director. The report shall include a detailed statement of the expenditures made for the activities reported on and the personnel used in connection with such activities”
Source evidence
Code amendment note
Subsec. (f). Pub. L. 103–43, § 201, substituted “other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—” and pars. (1) to (3) for “other public and private entities. The Associate Director shall annually report to the Director of NIH on the prevention activities undertaken by the Associate Director. The report shall include a detailed statement of the expenditures made for the activities reported on and the personnel used in connection with such activities”.
Enacted provision · exact public law section
SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINATION. Section 402(f) of the Public Health Service Act (42 U.S.C. 282(D) is amended by striking “other public and private entities.” and all that follows through the end and inserting “ other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall— “(1) annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs; “(2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemination, using advanced technologies to the maximum extent practicable, of research results to such entities; and “(3) annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including— “(A) a summary of the Associate Director’s review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and “(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities.”.
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 202 · 107 Stat. 122
Added · 42 U.S.C. § 282(g)
Pub. L. 103–43, § 202, added subsec. (g)
Source evidence
Code amendment note
Subsec. (g). Pub. L. 103–43, § 202, added subsec. (g).
Enacted provision · exact public law section
SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARDING CERTAIN STATES AND RESEARCHERS. Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by adding at the end the following subsection: “(g) (1) (A) In the case of entities described in subparagraph (B), the Director of NIH, acting through the Director of the National Center for Research Resources, shall establish a program to enhance the competitiveness of such entities in obtaining funds from the national research institutes for conducting biomedical and behavioral research. “(B) The entities referred to in subparagraph (A) are entities that conduct biomedical and behavioral research and are located in a State in which the aggregate success rate for applications to the national research institutes for assistance for such research by the entities in the State has historically constituted a low success rate of obtaining such funds, relative to such aggregate rate for such entities in other States. “(C) With respect to enhancing competitiveness for purposes of subparagraph (A), the Director of NIH, in carrying out the program established under such subparagraph, may— “(i) provide technical assistance to the entities involved, including technical assistance in the preparation of applications for obtaining funds from the national research institutes; “(ii) assist the entities in developing a plan for biomedical or behavioral research proposals; and “(iii) assist the entities in implementing such plan. “(2) The Director of NIH shall establish a program of supporting projects of biomedical or behavioral research whose principal researchers are individuals who have not previously served as the principal researchers of such projects supported by the Director.”.
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 206 · 107 Stat. 122
Added · 42 U.S.C. § 282(h)
Pub. L. 103–43, § 206, added subsec. (h)
Source evidence
Code amendment note
Subsec. (h). Pub. L. 103–43, § 206, added subsec. (h).
Enacted provision · exact public law section
SEC. 206. INCREASED PARTICIPATION OF WOMEN AND DISADVANTAGED INDIVIDUALS IN FIELDS OF BIOMEDICAL AND BEHAVIORAL RESEARCH. Section 402 of the Public Health Service Act, as amended by section 202 of this Act, is amended by adding at the end the following subsection: “(h) The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.”.
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 208 · 107 Stat. 122
Added · 42 U.S.C. § 282(i)
Pub. L. 103–43, § 208, added subsec. (i)
Source evidence
Code amendment note
Subsec. (i). Pub. L. 103–43, § 208, added subsec. (i).
Enacted provision · exact public law section
SEC. 208. DISCRETIONARY FUND OF DIRECTOR OF NATIONAL INSTITUTES OF HEALTH. Section 402 of the Public Health Service Act, as amended by section 206 of this Act, is amended by adding at the end the following subsection: “(i) (1) There is established a fund, consisting of amounts appropriated under paragraph (3) and made available for the fund, for use by the Director of NIH to carry out the activities authorized in this Act for the National Institutes of Health. The purposes for which such fund may be expended include— “(A) providing for research on matters that have not received significant funding relative to other matters, responding to new issues and scientific emergencies, and acting on research opportunities of high priority; “(B) supporting research that is not exclusively within the authority or any single agency of such Institutes; and “(C) purchasing or renting equipment and quarters for activities of such Institutes. “(2) Not later than February 10 of each fiscal year, the Secretary Reports. shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the activities undertaken and expenditures made under this section during the preceding fiscal year. The report may contain such comments of the Secretary regarding this section as the Secretary determines to be appropriate. “(3) For the purpose of carrying out this subsection, there Appropriation authorization. are authorized to be appropriated $25,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996”.
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 210(c) · 107 Stat. 122
Added · 42 U.S.C. § 282(j)
Pub. L. 103–43, § 210(c), added subsec. (j)
Source evidence
Code amendment note
Subsec. (j). Pub. L. 103–43, § 210(c), added subsec. (j).
Enacted provision · exact public law section
(c) Day Care Regarding Children of Employees.— Section 402 of the Public Health Service Act, as amended by section 208 of this Act, is amended by adding at the end the following subsection: “(j) (1) The Director of NIH may establish a program to provide day care services for the employees of the National Institutes of Health similar to those services provided by other Federal agencies (including the availability of day care service on a 24-hour-a-day basis). “(2) Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee. “(3) For purposes regarding the provision of day care services, the Director of NIH may enter into rental or lease purchase agreements.”.
1993
National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 § 303(b) · 107 Stat. 122
Added · 42 U.S.C. § 282(k)
Pub. L. 103–43, § 303(b), added subsec. (k)
Source evidence
Code amendment note
Subsec. (k). Pub. L. 103–43, § 303(b), added subsec. (k).
Enacted provision · exact public law section
SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM FOR TRAUMA RESEARCH. (a) In General.— Title XII of the Public Health Service Act (42 U.S.C. 300d et seq.), as amended by title VI of Public Law 102–321 (106 Stat. 433) and section 304 of Public Law 102–408 (106 Stat. 2084), is amended by adding at the end the following part: “Part F— Interagency Program for Trauma Research “SEC. 1261. ESTABLISHMENT OF PROGRAM. “(a) In General.— The Secretary, acting through the Director of the National Institutes of Health (in this section referred to as the ‘Director’), shall establish a comprehensive program of conducting basic and clinical research on trauma (in this section referred to as the ‘Program’). The Program shall include research regarding the diagnosis, treatment, rehabilitation, and general management of trauma. “(b) Plan for Program.— “(1) In general.— The Director, in consultation with the Trauma Research Interagency Coordinating Committee established under subsection (g), shall establish and implement a plan for carrying out the activities of the Program, including the activities described in subsection (d). All such activities shall be carried out in accordance with the plan. The plan shall be periodically reviewed, and revised as appropriate. “(2) Submission to congress.— Not later than December 1, 1993, the Director shall submit the plan required in paragraph (1) to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, together with an estimate of the funds needed for each of the fiscal years 1994 through 1996 to implement the plan. “(c) Participating Agencies; Coordination and Collaboration.— The Director— “(1) shall provide for the conduct of activities under the Program by the Directors of the agencies of the National Institutes of Health involved in research with respect to trauma; “(2) shall ensure that the activities of the Program are coordinated among such agencies; and “(3) shall, as appropriate, provide for collaboration among such agencies in carrying out such activities. “(d) Certain Activities of Program.— The Program shall include— “(1) studies with respect to all phases of trauma care, including prehospital, resuscitation, surgical intervention, critical care, infection control, wound healing, nutritional care and support, and medical rehabilitation care; “(2) basic and clinical research regarding the response of the body to trauma and the acute treatment and medical rehabilitation of individuals who are the victims of trauma; and “(3) basic and clinical research regarding trauma care for pediatric and geriatric patients. “(e) Mechanisms of Support.— In carrying out the Program, the Director, acting through the Directors of the agencies referred to in subsection (c)(1), may make grants to public and nonprofit entities, including designated trauma centers. “(f) Resources.— The Director shall assure the availability of appropriate resources to carry out the Program, including the plan established under subsection (b) (including the activities described in subsection (d)). “(g) Coordinating Committee.— “(1) In general.— There shall be established a Trauma Research Interagency Coordinating Committee (in this section referred to as the ‘Coordinating Committee’). “(2) Duties.— The Coordinating Committee shall make recommendations regarding— “(A) the activities of the Program to be carried out by each of the agencies represented on the Committee and the amount of funds needed by each of the agencies for such activities; and “(B) effective collaboration among the agencies in carrying out the activities. “(3) Composition.— The Coordinating Committee shall be composed of the Directors of each of the agencies that, under subsection (c), have responsibilities under the Program, and any other individuals who are practitioners in the trauma field as designated by the Director of the National Institutes of Health. “(h) Definitions.— For purposes of this section: “(1) The term ‘designated trauma center’ has the meaning given such term in section 1231(1). “(2) The term ‘Director’ means the Director of the National Institutes of Health. “(3) The term ‘trauma’ means any serious injury that could result in loss of life or in significant disability and that would meet prehospital triage criteria for transport to a designated trauma center”. (b) Conforming Amendment.— Section 402 of the Public Health Service Act, as amended by section 210(c) of this Act, is amended by adding at the end the following subsection: “(k) The Director of NIH shall carry out the program established in part F of title XII (relating to interagency research on trauma).”.
1997
Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 title I § 113(a) · 111 Stat. 2296
1. Added · 42 U.S.C. § 282(j)(l)
  Pub. L. 105–115 added subsec. (j)
2. Redesignated · 42 U.S.C. § 282(j)(l)
  Pub. L. 105–115 redesignated former subsecs. (j) and (k) as (k) and (l), respectively
Source evidence
Code amendment note
Subsecs. (j) to (l). Pub. L. 105–115 added subsec. (j) and redesignated former subsecs. (j) and (k) as (k) and (l), respectively.
Enacted provision · exact public law section
(a) In General.— Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended— (1) by redesignating subsections (j) and (k) as subsections (k) and (1), respectively; and (2) by inserting after subsection (i) the following: Establishment. “(j) (1) (A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the ‘data bank’). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information. “(B) The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention. “(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers. “(3) The data bank shall include the following: “(A) A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to section 505(i) of the Federal Food, Drug, and Cosmetic Act, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, and a point of contact for those wanting to enroll in the trial, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol. “(B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available— “(i) under a treatment investigational new drug application that has been submitted to the Secretary under section 561(c) of the Federal Food, Drug, and Cosmetic Act; or “(ii) as a Group C cancer drug (as defined by the National Cancer Institute). The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments. “(4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment. “(5) For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary. Fees collected under section 736 of the Federal Food, Drug, and Cosmetic Act shall not be used in carrying out this subsection.”.
1998
Federal Reports Elimination Act of 1998
Pub. L. 105–362 title VI § 601(a)(1)(A) · 112 Stat. 3280
1. Inserted · 42 U.S.C. § 282(f)
  Pub. L. 105–362 inserted “and” at end of par. (1)
2. Substituted · 42 U.S.C. § 282(f)
  Pub. L. 105–362 substituted a period for “; and” at end of par. (2)
3. Struck · 42 U.S.C. § 282(f)
  Pub. L. 105–362 struck out par. (3) which read as follows: “annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including—
Source evidence
Code amendment note
Subsec. (f). Pub. L. 105–362 inserted “and” at end of par. (1), substituted a period for “; and” at end of par. (2), and struck out par. (3) which read as follows: “annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including—
“(A) a summary of the Associate Director’s review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and “(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities.”
Enacted provision · exact public law section
(A) Section 402(f) (42 U.S.C. 282(f)) is amended— (i) in paragraph (1), by inserting “and” at the end; (ii) in paragraph (2), by striking and” and inserting a period; and (iii) by striking paragraph (3) (relating to annual reports on disease prevention).
1998
Health Professions Education Partnerships Act of 1998
Pub. L. 105–392 title IV § 409 · 112 Stat. 3524
Added · 42 U.S.C. § 282(b)(13); 42 U.S.C. § 282(b)(14)
Pub. L. 105–392 added pars. (13) and (14)
Source evidence
Code amendment note
Subsec. (b)(13), (14). Pub. L. 105–392 added pars. (13) and (14).
Enacted provision · exact public law section
SEC. 409. AUTHORITY OF THE DIRECTOR OF NIH. Section 402(b) of the Public Health Service Act (42 U.S.C.282(b)) is amended— (1) in paragraph (11), by striking “and” at the end thereof; (2) in paragraph (12), by striking the period and inserting a semicolon; and (3) by adding after paragraph (12), the following new paragraphs: “(13) may conduct and support research training— “(A) for which fellowship support is not provided under section 487; and “(B) which does not consist of residency training of physicians or other health professionals; and “(14) may appoint physicians, dentists, and other healthcare professionals, subject to the provisions of title 5, United States Code, relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of chapter 74 of title 38, United States Code.”.
2002
Best Pharmaceuticals for Children Act
Pub. L. 107–109 § 15(c)(2) · 115 Stat. 1408
1. Substituted · 42 U.S.C. § 282(j)(3)(A)
  Pub. L. 107–109, which directed the amendment of the first sentence of subsec. (j)(3)(A) by substituting “trial sites,” for “trial sites, and” was executed by making the substitutions in the second sentence, to reflect the probable intent of Congress
2. Substituted · 42 U.S.C. § 282(j)(3)(A)
  Pub. L. 107–109, which directed the amendment of the first sentence of subsec. (j)(3)(A) by substituting “in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children,” for “in the trial,” was executed by making the substitutions in the second sentence, to reflect the probable intent of Congress
Source evidence
Code amendment note
Subsec. (j)(3)(A). Pub. L. 107–109, which directed the amendment of the first sentence of subsec. (j)(3)(A) by substituting “trial sites,” for “trial sites, and” and “in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children,” for “in the trial,”, was executed by making the substitutions in the second sentence, to reflect the probable intent of Congress.
Enacted provision · exact public law section
(2) Amendment of the public health service act.— Section 402(j)(3)(A) of the Public Health Service Act (42 U.S.C. 282(j)(3)(A)) is amended in the first sentence— (A) by striking “trial sites, and” and inserting “trial sites,”; and (B) by striking “in the trial,” and inserting “in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children,”.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(f)(1)(A) · 120 Stat. 3675
Substituted · 42 U.S.C. § 282(a)
Pub. L. 109–482, § 102(f)(1)(A), substituted “Director of NIH who shall” for “Director of the National Institutes of Health (hereafter in this subchapter referred to as the ‘Director of NIH’) who shall”
Source evidence
Code amendment note
Subsec. (a). Pub. L. 109–482, § 102(f)(1)(A), substituted “Director of NIH who shall” for “Director of the National Institutes of Health (hereafter in this subchapter referred to as the ‘Director of NIH’) who shall”.
Enacted provision · exact public law section
(A) in section 402(a), 42 USC 282. by striking “Director of the National Institutes of Health” and all that follows through “who shall” and inserting “Director of NIH who shall”; and
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(a)(5) · 120 Stat. 3675
Substituted · 42 U.S.C. § 282(b)
Pub. L. 109–482, § 102(a)(5), substituted “paragraph (16)” for “paragraph (6)” in concluding provisions
Source evidence
Code amendment note
Subsec. (b). Pub. L. 109–482, § 102(a)(5), substituted “paragraph (16)” for “paragraph (6)” in concluding provisions.
Enacted provision · exact public law section
(5) in the matter after and below paragraph (22) (as so redesignated), by striking “paragraph (6)” and inserting “paragraph (16)”; and
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(a)(6) · 120 Stat. 3675
1. Added · 42 U.S.C. § 282(b)(1)
  Pub. L. 109–482, § 102(a)(6), added par. (1)
2. Struck · 42 U.S.C. § 282(b)(1)
  Pub. L. 109–482, § 102(a)(6), struck out former par. (1) which read as follows: “shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;”
Source evidence
Code amendment note
Subsec. (b)(1). Pub. L. 109–482, § 102(a)(6), added par. (1) and struck out former par. (1) which read as follows: “shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;”.
Enacted provision · exact public law section
(6) by striking “the Secretary” in the matter preceding paragraph (1) and all that follows through paragraph (1) and inserting the following: “the Secretary, acting through the Director of NIH— “(1) shall carry out this title, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;” .
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(b) · 120 Stat. 3675
1. Added · 42 U.S.C. § 282(b)(2); 42 U.S.C. § 282(b)(3)
  Pub. L. 109–482, § 102(b), added pars. (2) and (3)
2. Struck · 42 U.S.C. § 282(b)(2); 42 U.S.C. § 282(b)(3)
  Pub. L. 109–482, § 102(b), struck out former pars. (2) and (3) which read as follows:
Source evidence
Code amendment note
Subsec. (b)(2), (3). Pub. L. 109–482, § 102(b), added pars. (2) and (3) and struck out former pars. (2) and (3) which read as follows:
“(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health; “(3) shall assure that research at or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title;”.
Enacted provision · exact public law section
(b) Additional Authorities.— Section 402(b) of the Public Health Service Act, as amended by subsection (a) of this section, is amended by striking paragraphs (2) and (3) and inserting the following: “(2) shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities within the National Institutes of Health; “(3) shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research; “(4) shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; “(5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health; “(6) shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans; “(7) (A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives— “(i) identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning; “(ii) include information on such research in reports under section 403; and “(iii) in the case of such research supported with funds referred to in subparagraph (B)— “(I) require as appropriate that proposals include milestones and goals for the research; “(II) require that the proposals include timeframes for funding of the research; and “(III) ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health; “(B) may, with respect to funds reserved under section 402A(c)(1) for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and “(C) may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director; “(8) shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers— “(A) preserve an emphasis on investigator-initiated research project grants, including with respect to research involving collaboration between 2 or more such institutes or centers; and “(B) when appropriate, maximize investigator-initiated research project grants in their annual research portfolios; “(9) shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 492 and that, after such review, the research is reviewed in accordance with section 492A(a)(2) by the appropriate advisory council under section 406 before the research proposals are approved for funding; “(10) shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes; “(11) (A) shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section 487; and “(B) may conduct and support research training— “(i) for which fellowship support is not provided under section 487; and “(ii) that does not consist of residency training of physicians or other health professionals; “(12) may, from funds appropriated under section 402A(b), reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority; “(13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;” .
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(b) · 120 Stat. 3675
Redesignated · 42 U.S.C. § 282(b)(4)
Pub. L. 109–482, § 102(b), added par. (4). Former par. (4) redesignated (14)
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 109–482, § 102(b), added par. (4). Former par. (4) redesignated (14).
Enacted provision · exact public law section
(b) Additional Authorities.— Section 402(b) of the Public Health Service Act, as amended by subsection (a) of this section, is amended by striking paragraphs (2) and (3) and inserting the following: “(2) shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities within the National Institutes of Health; “(3) shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research; “(4) shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; “(5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health; “(6) shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans; “(7) (A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives— “(i) identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning; “(ii) include information on such research in reports under section 403; and “(iii) in the case of such research supported with funds referred to in subparagraph (B)— “(I) require as appropriate that proposals include milestones and goals for the research; “(II) require that the proposals include timeframes for funding of the research; and “(III) ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health; “(B) may, with respect to funds reserved under section 402A(c)(1) for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and “(C) may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director; “(8) shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers— “(A) preserve an emphasis on investigator-initiated research project grants, including with respect to research involving collaboration between 2 or more such institutes or centers; and “(B) when appropriate, maximize investigator-initiated research project grants in their annual research portfolios; “(9) shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 492 and that, after such review, the research is reviewed in accordance with section 492A(a)(2) by the appropriate advisory council under section 406 before the research proposals are approved for funding; “(10) shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes; “(11) (A) shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section 487; and “(B) may conduct and support research training— “(i) for which fellowship support is not provided under section 487; and “(ii) that does not consist of residency training of physicians or other health professionals; “(12) may, from funds appropriated under section 402A(b), reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority; “(13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;” .
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(a)(1) · 120 Stat. 3675
1. Added · 42 U.S.C. § 282(b)(5)(22)
  Pub. L. 109–482, § 102(a)(1)–(4), (b), added pars. (5) to (13)
2. Redesignated · 42 U.S.C. § 282(b)(5)(22)
  Pub. L. 109–482, § 102(a)(1)–(4), (b), redesignated former pars. (4) to (11) and (14) as (14) to (22), respectively, in par. (21) inserted “and” at end
3. Struck · 42 U.S.C. § 282(b)(5)(22)
  Pub. L. 109–482, § 102(a)(1)–(4), (b), struck out former pars. (12) and (13) which read as follows:
Source evidence
Code amendment note
Subsec. (b)(5) to (22). Pub. L. 109–482, § 102(a)(1)–(4), (b), added pars. (5) to (13), redesignated former pars. (4) to (11) and (14) as (14) to (22), respectively, in par. (21) inserted “and” at end, and struck out former pars. (12) and (13) which read as follows:
“(12) after consultation with the Director of the Office of Research on Women’s Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women’s health that are identified under section 287d(b) of this title; “(13) may conduct and support research training— “(A) for which fellowship support is not provided under section 288 of this title; and “(B) which does not consist of residency training of physicians or other health professionals; and”.
Enacted provision · exact public law section
(1) by redesignating paragraph (14) as paragraph (22);
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(c) · 120 Stat. 3675
1. Redesignated · 42 U.S.C. § 282(i)
  Pub. L. 109–482, § 102(c), redesignated subsec. (j) as (i)
2. Struck · 42 U.S.C. § 282(i)
  Pub. L. 109–482, § 102(c), struck out former subsec. (i) which related to discretionary fund for use by the Director of NIH to carry out activities authorized in this chapter
Source evidence
Code amendment note
Subsec. (i). Pub. L. 109–482, § 102(c), redesignated subsec. (j) as (i) and struck out former subsec. (i) which related to discretionary fund for use by the Director of NIH to carry out activities authorized in this chapter.
Enacted provision · exact public law section
(c) Certain Authorities.— Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended— (1) by striking subsections (i) and (l); and (2) by redesignating subsections (j) and (k) as subsections (i) and (j), respectively.
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 103(b)(1) · 120 Stat. 3675
Struck · 42 U.S.C. § 282(i)(5)
Pub. L. 109–482, § 103(b)(1), struck out first sentence which read as follows: “For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary.”
Source evidence
Code amendment note
Subsec. (i)(5). Pub. L. 109–482, § 103(b)(1), struck out first sentence which read as follows: “For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary.”
Enacted provision · exact public law section
(1) by striking the first sentence of paragraph (5) of section 402(i) (as redesignated by section 102(b));
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(c)(2) · 120 Stat. 3675
1. Added · 42 U.S.C. § 282(j); 42 U.S.C. § 282(k)
  Pub. L. 109–482, § 102(c)(2), (d), added subsec. (k)
2. Redesignated · 42 U.S.C. § 282(j); 42 U.S.C. § 282(k)
  Pub. L. 109–482, § 102(c)(2), (d), redesignated former subsec. (k) as (j)
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 109–482, § 102(c)(2), (d), added subsec. (k) and redesignated former subsec. (k) as (j).
Enacted provision · exact public law section
(2) by redesignating subsections (j) and (k) as subsections (i) and (j), respectively.
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
National Institutes of Health Reform Act of 2006
Pub. L. 109–482 § 102(c)(1) · 120 Stat. 3675
Struck · 42 U.S.C. § 282(l)
Pub. L. 109–482, § 102(c)(1), struck out subsec. (l) which read as follows: “The Director of NIH shall carry out the program established in part F of subchapter X of this chapter (relating to interagency research on trauma).”
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 109–482, § 102(c)(1), struck out subsec. (l) which read as follows: “The Director of NIH shall carry out the program established in part F of subchapter X of this chapter (relating to interagency research on trauma).”
Enacted provision · exact public law section
(1) by striking subsections (i) and (l); and
Effective date note
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.
2007
Food and Drug Administration Amendments Act of 2007
Pub. L. 110–85 § 1104(2) · 121 Stat. 823
Inserted · 42 U.S.C. § 282(b)(4)
Pub. L. 110–85, § 1104(2), inserted “minority and other” after “reducing”
Source evidence
Code amendment note
Subsec. (b)(4). Pub. L. 110–85, § 1104(2), inserted “minority and other” after “reducing”.
Enacted provision · exact public law section
(2) 42 USC 282. in section 402(b)(4), by inserting “minority and other” after “reducing”;
2007
Pediatric Medical Device Safety and Improvement Act of 2007
Pub. L. 110–85 § 304(a) · 121 Stat. 823
Added · 42 U.S.C. § 282(b)(23)
Pub. L. 110–85, § 304(a), added par. (23)
Source evidence
Code amendment note
Subsec. (b)(23). Pub. L. 110–85, § 304(a), added par. (23).
Enacted provision · exact public law section
(a) Contact Point for Available Funding.— Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended— (1) in paragraph (21), by striking “and” after the semicolon at the end; (2) in paragraph (22), by striking the period at the end and inserting “; and”; and (3) by inserting after paragraph (22) the following: “(23) shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.” .
2007
Food and Drug Administration Amendments Act of 2007
Pub. L. 110–85 § 801(a) · 121 Stat. 823
1. Added · 42 U.S.C. § 282(j); 42 U.S.C. § 282(k)
  Pub. L. 110–85, § 801(a), added subsec. (j)
2. Redesignated · 42 U.S.C. § 282(j); 42 U.S.C. § 282(k)
  Pub. L. 110–85, § 801(a), redesignated former subsec. (j) as (k). Former subsec. (k) redesignated (l)
Source evidence
Code amendment note
Subsecs. (j), (k). Pub. L. 110–85, § 801(a), added subsec. (j) and redesignated former subsec. (j) as (k). Former subsec. (k) redesignated (l).
Enacted provision · exact public law section
(a) In General.— Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by— (1) redesignating subsections (j) and (k) as subsections (k) and (l), respectively; and (2) inserting after subsection (i) the following: “(j) Expanded Clinical Trial Registry Data Bank.— “(1) Definitions; requirement.— “(A) Definitions.— In this subsection: “(i) Applicable clinical trial.— The term ‘applicable clinical trial’ means an applicable device clinical trial or an applicable drug clinical trial. “(ii) Applicable device clinical trial.— The term ‘applicable device clinical trial’ means— “(I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and “(II) a pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and Cosmetic Act. “(iii) Applicable drug clinical trial.— “(I) In general.— The term ‘applicable drug clinical trial’ means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of this Act. “(II) Clinical investigation.— For purposes of subclause (I), the term ‘clinical investigation’ has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation). “(III) Phase i.— For purposes of subclause (I), the term ‘phase I’ has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation). “(iv) Clinical trial information.— The term ‘clinical trial information’ means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3). “(v) Completion date.— The term ‘completion date’ means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. “(vi) Device.— The term ‘device’ means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act. “(vii) Drug.— The term ‘drug’ means a drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act or a biological product as defined in section 351 of this Act. “(viii) Ongoing.— The term ‘ongoing’ means, with respect to a clinical trial of a drug or a device and to a date, that— “(I) 1 or more patients is enrolled in the clinical trial; and “(II) the date is before the completion date of the clinical trial. “(ix) Responsible party.— The term ‘responsible party’, with respect to a clinical trial of a drug or device, means— “(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or “(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information. “(B) Requirement.— The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2). “(2) Expansion of clinical trial registry data bank with respect to clinical trial information.— “(A) In general.— “(i) Expansion of data bank.— To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the ‘registry data bank’). The Public information. Internet. Director of NIH shall ensure that the registry data bank is made publicly available through the Internet. “(ii) Content.— The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include— “(I) descriptive information, including— “(aa) a brief title, intended for the lay public; “(bb) a brief summary, intended for the lay public; “(cc) the primary purpose; “(dd) the study design; “(ee) for an applicable drug clinical trial, the study phase; “(ff) study type; “(gg) the primary disease or condition being studied, or the focus of the study; “(hh) the intervention name and intervention type; “(ii) the study start date; “(jj) the expected completion date; “(kk) the target number of subjects; and “(ll) outcomes, including primary and secondary outcome measures; “(II) recruitment information, including— “(aa) eligibility criteria; “(bb) gender; “(cc) age limits; “(dd) whether the trial accepts healthy volunteers; “(ee) overall recruitment status; “(ff) individual site status; and “(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access; “(III) location and contact information, including— “(aa) the name of the sponsor; “(bb) the responsible party, by official title; and “(cc) the facility name and facility contact information (including the city, State, and zip code for each clinical trial location, or a toll-free number through which such location information may be accessed); and “(IV) administrative data (which the Secretary may make publicly available as necessary), including— “(aa) the unique protocol identification number; “(bb) other protocol identification numbers, if any; and “(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date. “(iii) Modifications.— The Secretary may by regulation modify the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not reduce such clinical trial information. “(B) Format and structure.— “(i) Searchable categories.— The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria: “(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors. “(II) The name of the intervention, including any drug or device being studied in the clinical trial. “(III) The location of the clinical trial. “(IV) The age group studied in the clinical trial, including pediatric subpopulations. “(V) The study phase of the clinical trial. “(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization. “(VII) The recruitment status of the clinical trial. “(VIII) The National Clinical Trial number or other study identification for the clinical trial. “(ii) Additional searchable category.— Not later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome. “(iii) Other elements.— The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis. “(iv) Format.— The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared. “(C) Data submission.— The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, the date of the enactment of the Food and Drug Administration Amendments Act of 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of subparagraph (A)(ii) not later than the later of— “(i) 90 days after such date of enactment; “(ii) 21 days after the first patient is enrolled in such clinical trial; or “(iii) in the case of a clinical trial that is not for a serious or life-threatening disease or condition and that is ongoing on such date of enactment, 1 year after such date of enactment. “(D) Posting of data.— “(i) Applicable drug clinical trial.— The Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in accordance with this paragraph is posted in the registry data bank not later than 30 days after such submission. “(ii) Applicable device clinical trial.— The Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in the registry data bank— “(I) not earlier than the date of clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or approval under section 515 or 520(m) of such Act, as applicable, for a device that was not previously cleared or approved, and not later than 30 days after such date; or “(II) for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary. “(3) Expansion of registry data bank to include results of clinical trials.— “(A) Linking registry data bank to existing results.— “(i) In general.— Beginning not later than 90 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial— “(I) not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or “(II) not later than 30 days after the results information described in clause (ii) becomes publicly available. “(ii) Required information.— “(I) FDA information.— The Secretary shall ensure that the registry data bank includes links to the following information: “(aa) If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug Administration summary document regarding such applicable clinical trial. “(bb) If an applicable drug clinical trial was conducted under section 505A or 505B of the Federal Food, Drug, and Cosmetic Act, a link to the posted Food and Drug Administration assessment of the results of such trial. “(cc) Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any. “(dd) For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under section 505(l)(2) of the Federal Food, Drug, and Cosmetic Act. “(ee) For an applicable device clinical trial, in the case of a premarket application under section 515 of the Federal Food, Drug, and Cosmetic Act, the detailed summary of information respecting the safety and effectiveness of the device required under section 520(h)(1) of such Act, or, in the case of a report under section 510(k) of such Act, the section 510(k) summary of the safety and effectiveness data required under section 807.95(d) of title 21, Code of Federal Regulations (or any successor regulation). “(II) NIH information.— The Secretary shall ensure that the registry data bank includes links to the following information: “(aa) Medline citations to any publications focused on the results of an applicable clinical trial. “(bb) The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available. “(iii) Results for existing data bank entries.— The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to enactment of the Food and Drug Administration Amendments Act of 2007, as available. “(B) Inclusion of results.— The Secretary, acting through the Director of NIH, shall— “(i) expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the ‘registry and results data bank’); “(ii) Public information. Internet. ensure that such results are made publicly available through the Internet; “(iii) post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and “(iv) in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public. “(C) Basic results.— Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall include in the registry and results data bank the following elements for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act and devices that are cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act: “(i) Demographic and baseline characteristics of patient sample.— A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any. “(ii) Primary and secondary outcomes.— The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures. “(iii) Point of contact.— A point of contact for scientific information about the clinical trial results. “(iv) Certain agreements.— Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial. “(D) Expanded registry and results data bank.— “(i) Expansion by rulemaking.— To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph. “(ii) Clinical trials.— “(I) Approved products.— The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for— “(aa) each applicable drug clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act; and “(bb) each applicable device clinical trial for a device that is cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act. “(II) Unapproved products.— The regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for— “(aa) an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal Food, Drug, and Cosmetic Act and not licensed under section 351 of this Act (whether approval or licensure was sought or not); and “(bb) an applicable device clinical trial for a device that is not cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act and not approved under section 515 or section 520(m) of such Act (whether clearance or approval was sought or not). “(iii) Required elements.— The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories: “(I) A summary of the clinical trial and its results that is written in non-technical, understandable language for patients, if the Secretary determines that such types of summary can be included without being misleading or promotional. “(II) A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included without being misleading or promotional. “(III) The full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial. “(IV) Such other categories as the Secretary determines appropriate. “(iv) Results submission.— The results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine— “(I) whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months; “(II) whether the clinical trial information described in clause (iii) should be required to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and results data bank before the effective date of the regulations issued under this subparagraph; and “(III) in the case when the clinical trial information described in clause (iii) is required to be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account— “(aa) the certification process under subparagraph (E)(iii) when approval, licensure, or clearance is sought; and “(bb) whether there should be a delay of submission when approval, licensure, or clearance will not be sought. “(v) Additional provisions.— The regulations under this subparagraph shall also establish— “(I) a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank; “(II) additional information on clinical trials and results that is written in nontechnical, understandable language for patients; “(III) Procedures. considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional; “(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked; “(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and “(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C). “(vi) Consideration of world health organization data set.— The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph. “(vii) Public meeting.— The Secretary shall hold a public meeting no later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph. “(E) Submission of results information.— “(i) In general.— Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of— “(I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); or “(II) the actual date of completion. “(ii) Clinical trials described.— An applicable clinical trial described in this clause is an applicable clinical trial subject to— “(I) paragraph (2)(C); and “(II) (aa) subparagraph (C); or “(bb) the regulations issued under subparagraph (D). “(iii) Delayed submission of results with certification.— If the responsible party for an applicable clinical trial submits a certification that clause (iv) or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as required under the applicable clause. “(iv) Seeking initial approval of a drug or device.— With respect to an applicable clinical trial that is completed before the drug is initially approved under section 505 of the Federal Food, Drug, and Cosmetic Act or initially licensed under section 351 of this Act, or the device is initially cleared under section 510(k) or initially approved under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such section 505, licensed under such section 351, cleared under such section 510(k), or approved under such section 515 or 520(m), as applicable. “(v) Seeking approval of a new use for the drug or device.— “(I) In general.— With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act, licensing under section 351 of this Act, or clearance under section 510(k), or approval under section 515 or 520(m), of the Federal Food, Drug, and Cosmetic Act for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date— “(aa) the new use of the drug or device is approved under such section 505, licensed under such section 351, cleared under such section 510(k), or approved under such section 515 or 520(m); “(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 505, 351, 510(k), 515, or 520(m); or “(cc) except as provided in subclause (III), the application or premarket notification under such section 505, 351, 510(k), 515, or 520(m) is withdrawn without resubmission for no less than 210 days. “(II) Requirement that each clinical trial in application be treated the same.— If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under section 351 of this Act or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, as applicable) of the use studied in the clinical trial. “(III) Two-year limitation.— The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years after the date a certification under clause (iii) was made to the Director of NIH, if an action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date. “(vi) Extensions.— The Director of NIH may provide an extension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted. The Director of NIH may grant more than one such extension for a clinical trial. “(F) Notice to director of nih.— The Commissioner of Food and Drugs shall notify the Director of NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph (5)(B) of such action not later than 30 days after such action. “(G) Posting of data.— The Director of NIH shall ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission. “(H) Waivers regarding certain clinical trial results.— The Secretary may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Deadline. Notification. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted. “(I) Adverse events.— “(i) Regulations.— Not Deadline. later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall by regulation determine the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for drugs described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists. “(ii) Default.— If the Effective date. Secretary fails to issue the regulation required by clause (i) by the date that is 24 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, clause (iii) shall take effect. “(iii) Additional elements.— Upon the application of clause (ii), the Secretary shall include in the registry and results data bank for drugs described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements: “(I) Serious adverse events.— A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial. “(II) Frequent adverse events.— A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial. “(iv) Posting of other information.— In carrying out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the tables information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public. “(v) Relation to subparagraph (c).— Clinical trial information included in the registry and results data bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank pursuant to subparagraph (C). “(4) Additional submissions of clinical trial information.— “(A) Voluntary submissions.— A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial information for each applicable clinical trial that is required to be submitted under section 351 or under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act in an application or report for licensure, approval, or clearance of the drug or device for the use studied in the clinical trial. “(B) Required submissions.— “(i) In general.— Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry and results data bank of clinical trial information for such clinical trial is necessary to protect the public health— “(I) the Secretary may require by notification that such information be submitted to the Secretary in accordance with paragraphs (2) and (3) except with regard to timing of submission; “(II) Deadline. unless the responsible party submits a certification under paragraph (3)(E)(iii), such information shall be submitted not later than 30 days after the date specified by the Secretary in the notification; and “(III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of the corresponding requirement of such paragraphs. “(ii) Clinical trials described.— A clinical trial described in this clause is— “(I) an applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act or for a device that is cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or section 520(m) of such Act, whose completion date is on or after the date 10 years before the date of the enactment of the Food and Drug Administration Amendments Act of 2007; or “(II) an applicable clinical trial that is described by both by paragraph (2)(C) and paragraph (3)(D)(ii)(II)). “(C) Updates to clinical trial data bank.— “(i) Submission of updates.— The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates— “(I) shall be provided not less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period; “(II) shall include identification of the dates of any such changes; “(III) not later than 30 days after the recruitment status of such clinical trial changes, shall include an update of the recruitment status; and “(IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete. “(ii) Public availability of updates.— The Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual site status, location, and contact information, the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding updates, and information in such databases is presented in a manner that enables users to readily access each original element submission and to track the changes made by the updates. The Director of NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll). “(5) Coordination and compliance.— “(A) Clinical trials supported by grants from federal agencies.— “(i) Grants from certain federal agencies.— If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, including the Food and Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3). “(ii) Verification by federal agencies.— The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee. “(iii) Notice and opportunity to remedy.— If the head of an agency referred to in clause (i), as applicable, verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to correct such non-compliance and submit the required clinical trial information. “(iv) Consultation with other federal agencies.— The Secretary shall— “(I) consult with other agencies that conduct research involving human subjects in accordance with any section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such research is an applicable clinical trial; and “(II) Procedures. develop with such agencies procedures comparable to those described in clauses (i), (ii), and (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under paragraphs (2) and (3). “(B) Certification to accompany drug, biological product, and device submissions.— At the time of submission of an application under section 505 of the Federal Food, Drug, and Cosmetic Act, section 515 of such Act, section 520(m) of such Act, or section 351 of this Act, or submission of a report under section 510(k) of such Act, such application or submission shall be accompanied by a certification that all applicable requirements of this subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial control numbers. “(C) Quality control.— “(i) Pilot quality control project.— Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the publicly available information described in paragraph (3)(A) and any other information available to the Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under paragraph (3)(C). “(ii) Notice of compliance.— If the Secretary determines that any clinical trial information was not submitted as required under this subsection, or was submitted but is false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such noncompliance by submitting the required revised clinical trial information not later than 30 days after such notification. “(D) Truthful clinical trial information.— “(i) In general.— The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading in any particular. “(ii) Effect.— Clause (i) shall not have the effect of— “(I) requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial involved; or “(II) requiring clinical trial information described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C). “(E) Public notices.— “(i) Notice of violations.— If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice— “(I) that the responsible party is not in compliance with this Act by— “(aa) failing to submit required clinical trial information; or “(bb) submitting false or misleading clinical trial information; “(II) of the penalties imposed for the violation, if any; and “(III) whether the responsible party has corrected the clinical trial information in the registry and results data bank. “(ii) Notice of failure to submit primary and secondary outcomes.— If the responsible party for an applicable clinical trial fails to submit the primary and secondary outcomes as required under section 2(A)(ii)(I)(ll), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice that the responsible party is not in compliance by failing to register the primary and secondary outcomes in accordance with this act, and that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial. “(iii) Failure to submit statement.— The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: ‘The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.’. “(iv) Submission of false information statement.— The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: ‘The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.’. “(v) Non-submission of statement.— The notice under clause (ii) for a violation described in clause (ii) shall include the following statement: ‘The entry for this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.’. “(vi) Compliance searches.— The Director of NIH shall provide that the public may easily search the registry and results data bank for entries that include notices required under this subparagraph. “(6) Limitation on disclosure of clinical trial information.— “(A) In general.— Nothing in this subsection (or under section 552 of title 5, United States Code) shall require the Secretary to publicly disclose, by any means other than the registry and results data bank, information described in subparagraph (B). “(B) Information described.— Information described in this subparagraph is— “(i) information submitted to the Director of NIH under this subsection, or information of the same general nature as (or integrally associated with) the information so submitted; and “(ii) information not otherwise publicly available, including because it is protected from disclosure under section 552 of title 5, United States Code. “(7) Authorization of appropriations.— There are authorized to be appropriated to carry out this subsection $10,000,000 for each fiscal year.” .
2007
Food and Drug Administration Amendments Act of 2007
Pub. L. 110–85 § 801(a)(1) · 121 Stat. 823
Redesignated · 42 U.S.C. § 282(l)
Pub. L. 110–85, § 801(a)(1), redesignated subsec. (k) as (l)
Source evidence
Code amendment note
Subsec. (l). Pub. L. 110–85, § 801(a)(1), redesignated subsec. (k) as (l).
Enacted provision · exact public law section
(1) redesignating subsections (j) and (k) as subsections (k) and (l), respectively; and
2008
Pub. L. 110–316 § 302(1) · 122 Stat. 3509
Substituted · 42 U.S.C. § 282(j)(3)(C)
Pub. L. 110–316, § 302(1), in introductory provisions, substituted “for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:” for “the following elements for drugs that are approved under section 355 of title 21 or licensed under section 262 of this title and devices that are cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21:”
Source evidence
Code amendment note
Subsec. (j)(3)(C). Pub. L. 110–316, § 302(1), in introductory provisions, substituted “for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:” for “the following elements for drugs that are approved under section 355 of title 21 or licensed under section 262 of this title and devices that are cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21:”.
Enacted provision · exact public law section
(1) in the matter preceding clause (i) in subparagraph (C), by striking “the following elements” and all that follows through “520(m) of such Act:” and inserting “for each applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act or a device that is cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act, the following elements:”; and
2008
Pub. L. 110–316 § 302(2) · 122 Stat. 3509
Substituted · 42 U.S.C. § 282(j)(3)(I)(i); 42 U.S.C. § 282(j)(3)(I)(iii)
Pub. L. 110–316, § 302(2), substituted “applicable clinical trials described in subparagraph (C)” for “drugs described in subparagraph (C)”
Source evidence
Code amendment note
Subsec. (j)(3)(I)(i), (iii). Pub. L. 110–316, § 302(2), substituted “applicable clinical trials described in subparagraph (C)” for “drugs described in subparagraph (C)”.
Enacted provision · exact public law section
(2) in clauses (i) and (iii) of subparagraph (I), by striking the term “drugs described in subparagraph (C)” each place such term appears and inserting “applicable clinical trials described in subparagraph (C)”.
2010
Cures Acceleration Network Act of 2009
Pub. L. 111–148 title X § 10409(b) · 124 Stat. 119
Added · 42 U.S.C. § 282(b)(24)
Pub. L. 111–148 added par. (24)
Source evidence
Code amendment note
Subsec. (b)(24). Pub. L. 111–148 added par. (24).
Enacted provision · exact public law section
(b) Requirement for the Director of NIH To Establish a Cures Acceleration Network.— Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended— (1) in paragraph (22), by striking “and” at the end; (2) in paragraph (23), by striking the period and inserting “; and”; and (3) by inserting after paragraph (23), the following: “(24) implement the Cures Acceleration Network described in section 402C.” .
2011
Department of Health and Human Services Appropriations Act, 2012
Pub. L. 112–74 § 221(d)(1) · 125 Stat. 1089
Substituted · 42 U.S.C. § 282(b)(24)
Pub. L. 112–74, § 221(d)(1), substituted “287a” for “282d”
Source evidence
Code amendment note
Subsec. (b)(24). Pub. L. 112–74, § 221(d)(1), substituted “287a” for “282d”.
Enacted provision · exact public law section
(1) in section 402(b)(24) (42 U.S.C. 282(b)(24)), by striking “402C” and inserting “480”;
2011
Department of Health and Human Services Appropriations Act, 2012
Pub. L. 112–74 § 221(b)(5)(B) · 125 Stat. 1089
Redesignated · 42 U.S.C. § 282(g)
Pub. L. 112–74, § 221(b)(5)(B), redesignated and transferred subsec. (g) of this section to subsec. (b) of section 285k of this title
Source evidence
Code amendment note
Subsec. (g). Pub. L. 112–74, § 221(b)(5)(B), redesignated and transferred subsec. (g) of this section to subsec. (b) of section 285k of this title.
Enacted provision · exact public law section
(B) 42 USC 282, 285k. by moving subsection (g) of section 402 to the end of section 461, as amended, and redesignating that subsection as subsection (b); and
2014
Gabriella Miller Kids First Research Act
Pub. L. 113–94 § 3(a) · 128 Stat. 1085
1. Amended · 42 U.S.C. § 282(b)(7)
  Pub. L. 113–94 amended par. (7) generally, enacting similar provisions
2. Added · 42 U.S.C. § 282(b)(7)
  Pub. L. 113–94 adding provisions relating to allocating funds appropriated pursuant to section 282a(a)(2) of this title for making grants for pediatric research
Source evidence
Code amendment note
Subsec. (b)(7). Pub. L. 113–94 amended par. (7) generally, enacting similar provisions and adding provisions relating to allocating funds appropriated pursuant to section 282a(a)(2) of this title for making grants for pediatric research.
Enacted provision · exact public law section
(a) Allocation of NIH Funds in Common Fund for Pediatric Research.— Paragraph (7) of section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended to read as follows: “(7) (A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives— “(i) identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning; “(ii) include information on such research in reports under section 403; and “(iii) in the case of such research supported with funds referred to in subparagraph (B)— “(I) require as appropriate that proposals include milestones and goals for the research; “(II) require that the proposals include timeframes for funding of the research; and “(III) ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health; “(B) (i) may, with respect to funds reserved under section 402A(c)(1) for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and “(ii) shall, with respect to funds appropriated to the Common Fund pursuant to section 402A(a)(2), allocate such funds to the national research institutes and national centers for making grants for pediatric research that is identified under subparagraph (A); and “(C) may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director;” .
2016
21st Century Cures Act
Pub. L. 114–255 § 2038(a)(1) · 130 Stat. 1033
Amended · 42 U.S.C. § 282(b)(4)
Pub. L. 114–255, § 2038(a)(1), amended par. (4) generally. Prior to amendment, text read as follows: “shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing minority and other health disparities;”
Source evidence
Code amendment note
Subsec. (b)(4). Pub. L. 114–255, § 2038(a)(1), amended par. (4) generally. Prior to amendment, text read as follows: “shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing minority and other health disparities;”.
Enacted provision · exact public law section
(1) by amending paragraph (4) to read as follows: “(4) shall assemble accurate data to be used to assess research priorities, including— “(A) information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and “(B) data on study populations of clinical research, funded by or conducted at each national research institute and national center, which— “(i) specifies the inclusion of— “(I) women; “(II) members of minority groups; “(III) relevant age categories, including pediatric subgroups; and “(IV) other demographic variables as the Director of the National Institutes of Health determines appropriate; “(ii) is disaggregated by research area, condition, and disease categories; and “(iii) is to be made publicly available on the Internet website of the National Institutes of Health;” ; and
2016
21st Century Cures Act
Pub. L. 114–255 § 2031(a)(1) · 130 Stat. 1033
Inserted · 42 U.S.C. § 282(b)(5)
Pub. L. 114–255, § 2031(a)(1), inserted “, and through the development, implementation, and updating of the strategic plan developed under subsection (m)” before semicolon
Source evidence
Code amendment note
Subsec. (b)(5). Pub. L. 114–255, § 2031(a)(1), inserted “, and through the development, implementation, and updating of the strategic plan developed under subsection (m)” before semicolon.
Enacted provision · exact public law section
(1) in subsection (b)(5), by inserting before the semicolon the following: “, and through the development, implementation, and updating of the strategic plan developed under subsection (m)”; and
2016
21st Century Cures Act
Pub. L. 114–255 § 2038(a)(2) · 130 Stat. 1033
Added · 42 U.S.C. § 282(b)(8)(C); 42 U.S.C. § 282(b)(8)(D)
Pub. L. 114–255, § 2038(a)(2), added subpars. (C) and (D)
Source evidence
Code amendment note
Subsec. (b)(8)(C), (D). Pub. L. 114–255, § 2038(a)(2), added subpars. (C) and (D).
Enacted provision · exact public law section
(2) in paragraph (8)— (A) in subparagraph (A), by striking “and” at the end; and (B) by adding at the end the following: “(C) foster collaboration between clinical research projects funded by the respective national research institutes and national centers that— “(i) conduct research involving human subjects; and “(ii) collect similar data; and “(D) encourage the collaboration described in subparagraph (C) to— “(i) allow for an increase in the number of subjects studied; and “(ii) utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;” .
2016
21st Century Cures Act
Pub. L. 114–255 § 2014(a) · 130 Stat. 1033
Added · 42 U.S.C. § 282(b)(25)
Pub. L. 114–255, § 2014(a), added par. (25)
Source evidence
Code amendment note
Subsec. (b)(25). Pub. L. 114–255, § 2014(a), added par. (25).
Enacted provision · exact public law section
(a) In General.— Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended— (1) in paragraph (23), by striking “and” at the end; (2) in paragraph (24), by striking the period and inserting “; and”; and (3) by inserting after paragraph (24) the following: “(25) may require recipients of National Institutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of— “(A) human research participants, including with respect to privacy, security, informed consent, and protected health information; and “(B) proprietary interests, confidential commercial information, and the intellectual property rights of the funding recipient.” .
2016
21st Century Cures Act
Pub. L. 114–255 § 2051(1) · 130 Stat. 1033
Inserted · 42 U.S.C. § 282(j)(2)(D)(ii)(I)
Pub. L. 114–255, § 2051(1), inserted “, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval” before semicolon
Source evidence
Code amendment note
Subsec. (j)(2)(D)(ii)(I). Pub. L. 114–255, § 2051(1), inserted “, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval” before semicolon.
Enacted provision · exact public law section
(1) in clause (ii)(I), by inserting before the semicolon “, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval”; and
2016
21st Century Cures Act
Pub. L. 114–255 § 2051(2) · 130 Stat. 1033
Added · 42 U.S.C. § 282(j)(2)(D)(iii); 42 U.S.C. § 282(j)(2)(D)(iv)
Pub. L. 114–255, § 2051(2), added cls. (iii) and (iv)
Source evidence
Code amendment note
Subsec. (j)(2)(D)(iii), (iv). Pub. L. 114–255, § 2051(2), added cls. (iii) and (iv).
Enacted provision · exact public law section
(2) by adding at the end the following: “(iii) Option to make certain clinical trial information available earlier.— The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I). “(iv) Combination products.— An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered— “(I) an applicable drug clinical trial, if the Secretary determines under section 503(g) of the Federal Food, Drug, and Cosmetic Act that the primary mode of action of such product is that of a drug or biological product; or “(II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.” .
2016
21st Century Cures Act
Pub. L. 114–255 § 2031(a)(2) · 130 Stat. 1033
Added · 42 U.S.C. § 282(m)
Pub. L. 114–255, § 2031(a)(2), added subsec. (m)
Source evidence
Code amendment note
Subsec. (m). Pub. L. 114–255, § 2031(a)(2), added subsec. (m).
Enacted provision · exact public law section
(2) by adding at the end the following: “(m) National Institutes of Health Strategic Plan.— “(1) In general.— Not later than 2 years after the date of enactment of the 21st Century Cures Act, and at least every 6 years thereafter, the Director of the National Institutes of Health shall develop and submit to the appropriate committees of Congress and post on the Internet website of the National Institutes of Health, a coordinated strategy (to be known as the ‘National Institutes of Health Strategic Plan’) to provide direction to the biomedical research investments made by the National Institutes of Health, to facilitate collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine. “(2) Requirements.— The strategy under paragraph (1) shall— “(A) identify strategic research priorities and objectives across biomedical research, including— “(i) an assessment of the state of biomedical and behavioral research, including areas of opportunity with respect to basic, clinical, and translational research; “(ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions; “(iii) emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps; and “(iv) the identification of near-, mid-, and long-term scientific needs; “(B) consider, in carrying out subparagraph (A)— “(i) disease burden in the United States and the potential for return on investment to the United States; “(ii) rare diseases and conditions; “(iii) biological, social, and other determinants of health that contribute to health disparities; and “(iv) other factors the Director of National Institutes of Health determines appropriate; “(C) include multi-institute priorities, including coordination of research among institutes and centers; “(D) include strategic priorities for funding research through the Common Fund, in accordance with section 402A(c)(1)(C); “(E) address the National Institutes of Health’s proposed and ongoing activities related to training and the biomedical workforce; and “(F) describe opportunities for collaboration with other agencies and departments, as appropriate. “(3) Use of plans.— Strategic plans developed and updated by the national research institutes and national centers of the National Institutes of Health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national research institutes and national centers shall have a common template. “(4) Consultation.— The Director of National Institutes of Health shall develop the strategic plan under paragraph (1) in consultation with the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.” .
2016
21st Century Cures Act
Pub. L. 114–255 § 2036(a) · 130 Stat. 1033
Added · 42 U.S.C. § 282(n)
Pub. L. 114–255, § 2036(a), added subsec. (n)
Source evidence
Code amendment note
Subsec. (n). Pub. L. 114–255, § 2036(a), added subsec. (n).
Enacted provision · exact public law section
(a) In General.— Section 402 of the Public Health Service Act (42 U.S.C. 282), as amended by section 2031, is further amended by adding at the end the following: “(n) Unique Research Initiatives.— “(1) In general.— The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out— “(A) the Precision Medicine Initiative under section 498E; or “(B) section 402(b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under section 402A(c)(1) for purposes of carrying out such section 402(b)(7) may be used to engage in such other transactions. “(2) Requirements.— The authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office— “(A) submits a proposal to the Director of NIH for the use of such authority before conducting or supporting the research, including why the use of such authority is essential to promoting the success of the project; “(B) receives approval for the use of such authority from the Director of NIH; and “(C) for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activities of the institute, center, or office relating to such research.” .
2018
Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act
Pub. L. 115–271 title VII § 7041 · 132 Stat. 3894
Added · 42 U.S.C. § 282(n)(1)(C)
Pub. L. 115–271 added subpar. (C)
Source evidence
Code amendment note
Subsec. (n)(1)(C). Pub. L. 115–271 added subpar. (C).
Enacted provision · exact public law section
SEC. 7041. UNIQUE RESEARCH INITIATIVES. Section 402(n)(1) of the Public Health Service Act (42 U.S.C. 282(n)(1)) is amended— (1) in subparagraph (A), by striking “or”; (2) in subparagraph (B), by striking the period and inserting “; or”; and (3) by adding at the end the following: “(C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat.” .
2021
Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021
Pub. L. 117–15 § 4 · 135 Stat. 277
Added · 42 U.S.C. § 282(o)
Pub. L. 117–15 added subsec. (o)
Source evidence
Code amendment note
Subsec. (o). Pub. L. 117–15 added subsec. (o).
Enacted provision · exact public law section
SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDICINE. Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by adding at the end the following: “(o) Regenerative Medicine.— The Director of NIH shall, as appropriate, continue to consult with the directors of relevant institutes and centers of the National Institutes of Health, other relevant experts from such institutes and centers, and relevant experts within the Food and Drug Administration, to further the field of regenerative medicine using adult stem cells, including autologous stem cells, therapeutic tissue engineering products, human cell and tissue products, human gene therapies, and genetically modified cells.” .
2022
Pub. L. 117–286 § 4(a)(231) · 136 Stat. 4196
Substituted · 42 U.S.C. § 282(b)
Pub. L. 117–286 substituted “Chapter 10 of title 5” for “The Federal Advisory Committee Act” in concluding provisions
Source evidence
Code amendment note
Subsec. (b). Pub. L. 117–286 substituted “Chapter 10 of title 5” for “The Federal Advisory Committee Act” in concluding provisions.
Enacted provision · exact public law section
(231) Section 402(b) (matter after last paragraph) of the Public Health Service Act (42 U.S.C. 282(b) (matter after last paragraph)) is amended by striking “The Federal Advisory Committee Act” and inserting “Chapter 10 of title 5, United States Code,”.
2022
Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act
Pub. L. 117–328 § 2302 · 136 Stat. 4459
Added · 42 U.S.C. § 282(b)(26)
Pub. L. 117–328, § 2302, added par. (26)
Source evidence
Code amendment note
Subsec. (b)(26). Pub. L. 117–328, § 2302, added par. (26).
Enacted provision · exact public law section
SEC. 2302. IMPROVING MEDICAL COUNTERMEASURE RESEARCH COORDINATION. Section 402(b) in the Public Health Service Act (42 U.S.C. 282(b)) is amended— (1) in paragraph (24), by striking “and” at the end; (2) in paragraph (25), by striking the period and inserting a semicolon; and (3) by inserting after paragraph (25) the following: “(26) shall consult with the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal agencies and offices, as appropriate, regarding research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging infectious diseases, chemical, radiological, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats;” .
2022
Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act
Pub. L. 117–328 § 2323 · 136 Stat. 4459
Added · 42 U.S.C. § 282(b)(27)(29)
Pub. L. 117–328, § 2323, added pars. (27) to (29)
Source evidence
Code amendment note
Subsec. (b)(27) to (29). Pub. L. 117–328, § 2323, added pars. (27) to (29).
Enacted provision · exact public law section
SEC. 2323. DUTIES OF THE DIRECTOR. Section 402(b) in the Public Health Service Act (42 U.S.C. 282(b)), as amended by section 2302, is further amended by inserting after paragraph (26) (as added by section 2302) the following: “(27) shall consult with the Director of the Office of National Security within the Department of Health and Human Services, the Assistant Secretary for Preparedness and Response, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other appropriate agencies on a regular basis, regarding biomedical research conducted or supported by the National Institutes of Health that may affect or be affected by matters of national security; “(28) shall ensure that recipients of awards from the National Institutes of Health, and, as appropriate and practicable, entities collaborating with such recipients, have in place and are adhering to appropriate technology practices and policies for the security of identifiable, sensitive information, including information collected, stored, managed, or analyzed by domestic and non-domestic entities; and “(29) shall ensure that recipients of awards from the National Institutes of Health are in compliance with the terms and conditions of such award, which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipients of the award.” .
2025
Pub. L. 118–228 § 3(b) · 138 Stat. 2822
Inserted · 42 U.S.C. § 282(b)(7)(B)(ii)
Pub. L. 118–228, § 3(b), inserted “and shall prioritize, as appropriate, such pediatric research that does not duplicate existing research activities of the National Institutes of Health” before “; and”
Unresolved: Pub. L. 118–228 was not found in the local Statutes at Large index.
Source evidence
Code amendment note
Subsec. (b)(7)(B)(ii). Pub. L. 118–228, § 3(b), inserted “and shall prioritize, as appropriate, such pediatric research that does not duplicate existing research activities of the National Institutes of Health” before “; and”.
2025
Pub. L. 118–228 § 2(3) · 138 Stat. 2822
Substituted · 42 U.S.C. § 282(b)(7)(B)(ii)
Pub. L. 118–228, § 2(3), substituted “the Division of Program Coordination, Planning, and Strategic Initiatives” for “the Common Fund”
Unresolved: Pub. L. 118–228 was not found in the local Statutes at Large index.
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 118–228, § 2(3), substituted “the Division of Program Coordination, Planning, and Strategic Initiatives” for “the Common Fund”.

60 of 62 references resolved to an enrolled provision · 2 unresolved

Editorial Notes

References in Text

The General Schedule, referred to in subsec. (b)(16), is set out under section 5332 of Title 5, Government Organization and Employees.

The National Literacy Act of 1991, referred to in subsec. (e)(5), is Pub. L. 102–73, July 25, 1991, 105 Stat. 333, which was repealed by Pub. L. 105–220, title II, § 251(a)(2), Aug. 7, 1998, 112 Stat. 1079. For complete classification of this Act to the Code, see Tables.

Codification

In subsec. (b)(14)(B), “section 8141 of title 40” substituted for “the Act of March 3, 1877 (40 U.S.C. 34)” on authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.

Amendments1988–2025 · 16 rounds

2025

Subsec. (b)(7)(B)(ii). Pub. L. 118–228, § 3(b), inserted “and shall prioritize, as appropriate, such pediatric research that does not duplicate existing research activities of the National Institutes of Health” before “; and”.

Pub. L. 118–228, § 2(3), substituted “the Division of Program Coordination, Planning, and Strategic Initiatives” for “the Common Fund”.

2022

Subsec. (b). Pub. L. 117–286 substituted “Chapter 10 of title 5” for “The Federal Advisory Committee Act” in concluding provisions.

Subsec. (b)(26). Pub. L. 117–328, § 2302, added par. (26).

Subsec. (b)(27) to (29). Pub. L. 117–328, § 2323, added pars. (27) to (29).

2021

Subsec. (o). Pub. L. 117–15 added subsec. (o).

2018

Subsec. (n)(1)(C). Pub. L. 115–271 added subpar. (C).

2016

Subsec. (b)(4). Pub. L. 114–255, § 2038(a)(1), amended par. (4) generally. Prior to amendment, text read as follows: “shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing minority and other health disparities;”.

Subsec. (b)(5). Pub. L. 114–255, § 2031(a)(1), inserted “, and through the development, implementation, and updating of the strategic plan developed under subsection (m)” before semicolon.

Subsec. (b)(8)(C), (D). Pub. L. 114–255, § 2038(a)(2), added subpars. (C) and (D).

Subsec. (b)(25). Pub. L. 114–255, § 2014(a), added par. (25).

Subsec. (j)(2)(D)(ii)(I). Pub. L. 114–255, § 2051(1), inserted “, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval” before semicolon.

Subsec. (j)(2)(D)(iii), (iv). Pub. L. 114–255, § 2051(2), added cls. (iii) and (iv).

Subsec. (m). Pub. L. 114–255, § 2031(a)(2), added subsec. (m).

Subsec. (n). Pub. L. 114–255, § 2036(a), added subsec. (n).

2014

Subsec. (b)(7). Pub. L. 113–94 amended par. (7) generally, enacting similar provisions and adding provisions relating to allocating funds appropriated pursuant to section 282a(a)(2) of this title for making grants for pediatric research.

2011

Subsec. (b)(24). Pub. L. 112–74, § 221(d)(1), substituted “287a” for “282d”.

Subsec. (g). Pub. L. 112–74, § 221(b)(5)(B), redesignated and transferred subsec. (g) of this section to subsec. (b) of section 285k of this title.

2010

Subsec. (b)(24). Pub. L. 111–148 added par. (24).

2008

Subsec. (j)(3)(C). Pub. L. 110–316, § 302(1), in introductory provisions, substituted “for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:” for “the following elements for drugs that are approved under section 355 of title 21 or licensed under section 262 of this title and devices that are cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21:”.

Subsec. (j)(3)(I)(i), (iii). Pub. L. 110–316, § 302(2), substituted “applicable clinical trials described in subparagraph (C)” for “drugs described in subparagraph (C)”.

2007

Subsec. (a). Pub. L. 109–482, § 102(f)(1)(A), substituted “Director of NIH who shall” for “Director of the National Institutes of Health (hereafter in this subchapter referred to as the ‘Director of NIH’) who shall”.

Subsec. (b). Pub. L. 109–482, § 102(a)(5), substituted “paragraph (16)” for “paragraph (6)” in concluding provisions.

Subsec. (b)(1). Pub. L. 109–482, § 102(a)(6), added par. (1) and struck out former par. (1) which read as follows: “shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;”.

Subsec. (b)(2), (3). Pub. L. 109–482, § 102(b), added pars. (2) and (3) and struck out former pars. (2) and (3) which read as follows:

“(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health;

“(3) shall assure that research at or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title;”.

Subsec. (b)(4). Pub. L. 110–85, § 1104(2), inserted “minority and other” after “reducing”.

Pub. L. 109–482, § 102(b), added par. (4). Former par. (4) redesignated (14).

Subsec. (b)(5) to (22). Pub. L. 109–482, § 102(a)(1)–(4), (b), added pars. (5) to (13), redesignated former pars. (4) to (11) and (14) as (14) to (22), respectively, in par. (21) inserted “and” at end, and struck out former pars. (12) and (13) which read as follows:

“(12) after consultation with the Director of the Office of Research on Women’s Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women’s health that are identified under section 287d(b) of this title;

“(13) may conduct and support research training—

“(A) for which fellowship support is not provided under section 288 of this title; and

“(B) which does not consist of residency training of physicians or other health professionals; and”.

Subsec. (b)(23). Pub. L. 110–85, § 304(a), added par. (23).

Subsec. (i). Pub. L. 109–482, § 102(c), redesignated subsec. (j) as (i) and struck out former subsec. (i) which related to discretionary fund for use by the Director of NIH to carry out activities authorized in this chapter.

Subsec. (i)(5). Pub. L. 109–482, § 103(b)(1), struck out first sentence which read as follows: “For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary.”

Subsecs. (j), (k). Pub. L. 110–85, § 801(a), added subsec. (j) and redesignated former subsec. (j) as (k). Former subsec. (k) redesignated (l).

Pub. L. 109–482, § 102(c)(2), (d), added subsec. (k) and redesignated former subsec. (k) as (j).

Subsec. (l). Pub. L. 110–85, § 801(a)(1), redesignated subsec. (k) as (l).

Pub. L. 109–482, § 102(c)(1), struck out subsec. (l) which read as follows: “The Director of NIH shall carry out the program established in part F of subchapter X of this chapter (relating to interagency research on trauma).”

2002

Subsec. (j)(3)(A). Pub. L. 107–109, which directed the amendment of the first sentence of subsec. (j)(3)(A) by substituting “trial sites,” for “trial sites, and” and “in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children,” for “in the trial,”, was executed by making the substitutions in the second sentence, to reflect the probable intent of Congress.

1998

Subsec. (b)(13), (14). Pub. L. 105–392 added pars. (13) and (14).

Subsec. (f). Pub. L. 105–362 inserted “and” at end of par. (1), substituted a period for “; and” at end of par. (2), and struck out par. (3) which read as follows: “annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including—

“(A) a summary of the Associate Director’s review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and

“(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities.”

1997

Subsecs. (j) to (l). Pub. L. 105–115 added subsec. (j) and redesignated former subsecs. (j) and (k) as (k) and (l), respectively.

1993

Subsec. (b)(12). Pub. L. 103–43, § 141(b), added par. (12).

Subsec. (e)(5). Pub. L. 103–43, § 210(b), added par. (5).

Subsec. (f). Pub. L. 103–43, § 201, substituted “other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—” and pars. (1) to (3) for “other public and private entities. The Associate Director shall annually report to the Director of NIH on the prevention activities undertaken by the Associate Director. The report shall include a detailed statement of the expenditures made for the activities reported on and the personnel used in connection with such activities”.

Subsec. (g). Pub. L. 103–43, § 202, added subsec. (g).

Subsec. (h). Pub. L. 103–43, § 206, added subsec. (h).

Subsec. (i). Pub. L. 103–43, § 208, added subsec. (i).

Subsec. (j). Pub. L. 103–43, § 210(c), added subsec. (j).

Subsec. (k). Pub. L. 103–43, § 303(b), added subsec. (k).

1992

Subsec. (d)(1). Pub. L. 102–321 substituted “220” for “two hundred”.

1988

Subsec. (b)(6). Pub. L. 100–607 inserted “and scientific program advisory committees” after “peer review groups”.

Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of Title 21, Food and Drugs.

Effective Date of 1992 Amendment

Amendment by Pub. L. 102–321 effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as a note under section 236 of this title.

Rule of Construction Regarding Continuation of Programs

Pub. L. 109–482, title I, § 103(c), Jan. 15, 2007, 120 Stat. 3689, provided that: “The amendment of a program by a provision of subsection (b) [amending this section and sections 283a, 283d, 283g to 283i, 284e to 284j, 284l, 284m, 285a–9, 285a–10, 285b–7a, 285b–7b, 285c–9, 285d–6a, 285d–8, 285e–10, 285e–10a, 285f–2, 285f–3, 285g–5, 285g–9, 285g–10, 285n, 285o, 285o–2, 285o–4, 285p, 285r, 286a–1, 287a–2, 287a–3, 287a–4, 287c–11, 287c–31 to 287c–33, 288, 288–1, and former 288–5a of this title and repealing sections 285a–8, 285b–8, 285e–11, and 286a–2 of this title] may not be construed as terminating the authority of the Federal agency involved to carry out the program.”

Confidentiality

Pub. L. 114–255, div. A, title II, § 2014(b), Dec. 13, 2016, 130 Stat. 1051, provided that: “Nothing in the amendments made by subsection (a) [amending this section] authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, or [shall] be construed to require recipients of grants or cooperative agreements through the National Institutes of Health to share such information.”

Appropriate Age Groupings in Clinical Research

Pub. L. 114–255, div. A, title II, § 2038(i), Dec. 13, 2016, 130 Stat. 1067, provided that:

“(1)
Input from experts.—
Not later than 180 days after the date of enactment of this Act [Dec. 13, 2016], the Director of the National Institutes of Health shall convene a workshop of experts on pediatric and older populations to provide input on—
“(A)
appropriate age groups to be included in research studies involving human subjects; and
#
“(B)
acceptable justifications for excluding participants from a range of age groups from human subjects research studies.
#
#
“(2)
Policy updates.—
Not later than 180 days after the conclusion of the workshop under paragraph (1), the Director of the National Institutes of Health shall make a determination with respect to whether the policies of the National Institutes of Health on the inclusion of relevant age groups in clinical studies need to be updated, and shall update such policies as appropriate. In making the determination, the Director of the National Institutes of Health shall take into consideration whether such policies—
“(A)
address the consideration of age as an inclusion variable in research involving human subjects; and
#
“(B)
identify the criteria for justification for any age-related exclusions in such research.
#
#
“(3)
Public availability of findings and conclusions.—
The Director of the National Institutes of Health shall—
“(A)
make the findings and conclusions resulting from the workshop under paragraph (1) and updates to policies in accordance with paragraph (2), as applicable, available to the public on the Internet website of the National Institutes of Health; and
#
“(B)
ensure that age-related data reported in the triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032 [of Pub. L. 114–255]) are made available to the public on the Internet website of the National Institutes of Health.”
#
#

Enhancing the Rigor and Reproducibility of Scientific Research

Pub. L. 114–255, div. A, title II, § 2039, Dec. 13, 2016, 130 Stat. 1068, provided that:

“(a)
Establishment.—
Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the ‘Advisory Committee’), appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a), to develop and issue recommendations through the Advisory Committee for a formal policy, which may incorporate or be informed by relevant existing and ongoing activities, to enhance rigor and reproducibility of scientific research funded by the National Institutes of Health.
#
“(b)
Considerations.—
In developing and issuing recommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate—
“(1)
preclinical experiment design, including analysis of sex as a biological variable;
#
“(2)
clinical experiment design, including—
“(A)
the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities;
#
“(B)
the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and
#
“(C)
the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities;
#
#
“(3)
applicable levels of rigor in statistical methods, methodology, and analysis;
#
“(4)
data and information sharing in accordance with applicable privacy laws and regulations; and
#
“(5)
any other matter the working group determines relevant.
#
#
“(c)
Policies.—
Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health shall consider the recommendations developed by the working group and issued by the Advisory Committee under subsection (a) and develop or update policies as appropriate.
#
“(d)
Report.—
Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall issue a report to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives regarding recommendations developed under subsection (a) and any subsequent policy changes implemented, to enhance rigor and reproducibility in scientific research funded by the National Institutes of Health.
#
“(e)
Confidentiality.—
Nothing in this section authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”
#

Demonstration Grants for Improving Pediatric Device Availability

Pub. L. 110–85, title III, § 305, Sept. 27, 2007, 121 Stat. 863, as amended by Pub. L. 112–144, title VI, § 620(a), July 9, 2012, 126 Stat. 1064; Pub. L. 115–52, title V, § 502(c), Aug. 18, 2017, 131 Stat. 1037; Pub. L. 117–180, div. F, title V, § 5003, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, § 304, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, § 3104, Dec. 29, 2022, 136 Stat. 5807, provided that:

“(a)
In General.—
“(1)
Request for proposals.—
Not later than 90 days after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development.
#
“(2)
Determination on grants or contracts.—
Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section.
#
#
“(b)
Application.—
A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require.
#
“(c)
Use of Funds.—
A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by—
“(1)
encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
#
“(2)
mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;
#
“(3)
connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;
#
“(4)
assessing the scientific and medical merit of proposed pediatric device projects;
#
“(5)
providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and
#
“(6)
providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.
#
#
“(d)
Coordination.—
“(1)
National institutes of health.—
Each consortium that receives a grant or contract under this section shall—
“(A)
coordinate with the National Institutes of Health’s pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act [42 U.S.C. 282(b)(23)], as added by section 304(a) of this Act; and
#
“(B)
provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest.
#
#
“(2)
Food and drug administration.—
Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use.
#
“(3)
Effectiveness and outcomes.—
Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium.
#
#
“(e)
Authorization of Appropriations.—
There are authorized to be appropriated to carry out this section $1,610,959 for the period beginning on October 1, 2022 and ending on December 23, 2022.”
#

[Pub. L. 117–328, div. FF, title III, § 3104, Dec. 29, 2022, 136 Stat. 5807, which directed amendment of section 305(e) of Pub. L. 110–85, set out above, by substituting “$7,000,000 for each of fiscal years 2023 through 2027” for “$1,107,534 for the period beginning on October 1, 2022, and ending on December 23, 2022”, could not be executed because “$1,107,534” did not appear after the intervening amendment by section 304 of Pub. L. 117–229.]

Surveillances

Pub. L. 110–85, title VIII, § 801(c), Sept. 27, 2007, 121 Stat. 921, provided that: “Not later than 12 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service Act [42 U.S.C. 282(j)], as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II) of such section 402(j) that is not a clinical trial.”

Preemption

Pub. L. 110–85, title VIII, § 801(d), Sept. 27, 2007, 121 Stat. 922, provided that:

“(1)
In general.—
Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the Public Health Service Act [42 U.S.C. 282(j)(3)(D)], as added by this section, no State or political subdivision of a State may establish or continue in effect any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database.
#
“(2)
Rule of construction.—
The fact of submission of clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act (as amended by this section), that relates to a use of a drug or device not included in the official labeling of the approved drug or device shall not be construed by the Secretary of Health and Human Services or in any administrative or judicial proceeding, as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. The availability of clinical trial information through the registry and results data bank under such subsection (j), if submitted in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).”
#

Collaboration and Report

Pub. L. 105–115, title I, § 113(b), Nov. 21, 1997, 111 Stat. 2312, directed the Secretary of Health and Human Services, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs to collaborate to determine the feasibility of including device investigations within the scope of the data bank under subsec. (j) of this section, with the Secretary to report to Congress, not later than two years after Nov. 21, 1997, on the public health need, if any, for inclusion of device investigations within the scope of the data bank under subsec. (j), and on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations was required to be publicly disclosed.

Chronic Fatigue Syndrome; Experts and Research Representatives on Advisory Committees and Boards

Pub. L. 103–43, title IX, § 902(c), June 10, 1993, 107 Stat. 164, provided that: “The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall ensure that appropriate individuals with expertise in chronic fatigue syndrome or neuromuscular diseases and representative of a variety of disciplines and fields within the research community are appointed to appropriate National Institutes of Health advisory committees and boards.”

Third-Party Payments Regarding Certain Clinical Trials and Certain Life-Threatening Illnesses

Pub. L. 103–43, title XIX, § 1901(a), June 10, 1993, 107 Stat. 200, provided that:

“The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall conduct a study for the purpose of—
“(1)
determining the policies of third-party payors regarding the payment of the costs of appropriate health services that are provided incident to the participation of individuals as subjects in clinical trials conducted in the development of drugs with respect to acquired immune deficiency syndrome, cancer, and other life-threatening illnesses; and
#
“(2)
developing recommendations regarding such policies.”
#

Personnel Study of Recruitment, Retention and Turnover

Pub. L. 103–43, title XIX, § 1905, June 10, 1993, 107 Stat. 203, directed Secretary of Health and Human Services, acting through Director of National Institutes of Health, to conduct a study to review the retention, recruitment, vacancy and turnover rates of support staff, including firefighters, law enforcement, procurement officers, technicians, nurses and clerical employees, to ensure that National Institutes of Health is adequately supporting conduct of efficient, effective and high quality research for the American public, and to submit a report to Congress on results of such study not later than 1 year after June 10, 1993.

Chronic Pain Conditions

Pub. L. 103–43, title XIX, § 1907, June 10, 1993, 107 Stat. 204, directed Director of the National Institutes of Health to submit to Congress, not later than 2 years after June 10, 1993, a report and study on the incidence in the United States of cases of chronic pain, including chronic pain resulting from back injuries, reflex sympathetic dystrophy syndrome, temporomandibular joint disorder, post-herpetic neuropathy, painful diabetic neuropathy, phantom pain, and post-stroke pain, and the effect of such cases on the costs of health care in the United States.

Support for Bioengineering Research

Pub. L. 103–43, title XIX, § 1912, June 10, 1993, 107 Stat. 206, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, to conduct a study for the purpose of determining the sources and amounts of public and private funding devoted to basic research in bioengineering, including biomaterials sciences, cellular bioprocessing, tissue and rehabilitation engineering, evaluating whether that commitment is sufficient to maintain the innovative edge that the United States has in these technologies, evaluating the role of the National Institutes of Health or any other Federal agency to achieve a greater commitment to innovation in bioengineering, and evaluating the need for better coordination and collaboration among Federal agencies and between the public and private sectors, and, not later than 1 year after June 10, 1993, to prepare and submit to Committee on Labor and Human Resources of Senate, and Committee on Energy and Commerce of House of Representatives, a report containing the findings of the study together with recommendations concerning the enactment of legislation to implement the results of such study.

Master Plan for Physical Infrastructure for Research

Pub. L. 103–43, title XX, § 2002, June 10, 1993, 107 Stat. 208, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, not later than June 1, 1994, to present to Congress a master plan to provide for replacement or refurbishment of less than adequate buildings, utility equipment and distribution systems (including the resources that provide electrical and other utilities, chilled water, air handling, and other services that the Secretary, acting through the Director, deemed necessary), roads, walkways, parking areas, and grounds that underpin the laboratory and clinical facilities of the National Institutes of Health, and provided that the plan could make recommendations for the undertaking of new projects that are consistent with the objectives of this section, such as encircling the National Institutes of Health Federal enclave with an adequate chilled water conduit.

Credits

1944–2025 · 20 acts

1944July 1, 1944, ch. 373, title IV, § 402, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 823
1988amended Pub. L. 100–607, title I, § 111, Nov. 4, 1988, 102 Stat. 3052
1992Pub. L. 102–321, title I, § 163(b)(3), July 10, 1992, 106 Stat. 376
1993Pub. L. 103–43, title I, § 141(b), title II, §§ 201, 202, 206, 208, 210(b), (c), title III, § 303(b), June 10, 1993, 107 Stat. 139, 144, 148–150, 153
1997Pub. L. 105–115, title I, § 113(a), Nov. 21, 1997, 111 Stat. 2310
1998Pub. L. 105–362, title VI, § 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285
1998Pub. L. 105–392, title IV, § 409, Nov. 13, 1998, 112 Stat. 3589
2002Pub. L. 107–109, § 15(c)(2), Jan. 4, 2002, 115 Stat. 1420
2007Pub. L. 109–482, title I, §§ 102(a)–(d), (f)(1)(A), 103(b)(1), Jan. 15, 2007, 120 Stat. 3681, 3683, 3684, 3687
2007Pub. L. 110–85, title III, § 304(a), title VIII, § 801(a), title XI, § 1104(2), Sept. 27, 2007, 121 Stat. 863, 904, 975
2008Pub. L. 110–316, title III, § 302, Aug. 14, 2008, 122 Stat. 3524
2010Pub. L. 111–148, title X, § 10409(b), Mar. 23, 2010, 124 Stat. 978
2011Pub. L. 112–74, div. F, title II, § 221(b)(5)(B), (d)(1), Dec. 23, 2011, 125 Stat. 1089, 1090
2014Pub. L. 113–94, § 3(a), Apr. 3, 2014, 128 Stat. 1086
2016Pub. L. 114–255, div. A, title II, §§ 2014(a), 2031(a), 2036(a), 2038(a), 2051, Dec. 13, 2016, 130 Stat. 1051, 1054, 1062, 1064, 1074
2018Pub. L. 115–271, title VII, § 7041, Oct. 24, 2018, 132 Stat. 4016
2021Pub. L. 117–15, § 4, May 26, 2021, 135 Stat. 278
2022Pub. L. 117–286, § 4(a)(231), Dec. 27, 2022, 136 Stat. 4331
2022Pub. L. 117–328, div. FF, title II, §§ 2302, 2323, Dec. 29, 2022, 136 Stat. 5757, 5767
2025Pub. L. 118–228, §§ 2(3), 3(b), Jan. 4, 2025, 138 Stat. 2822.

Show as published

(July 1, 1944, ch. 373, title IV, § 402, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 823; amended Pub. L. 100–607, title I, § 111, Nov. 4, 1988, 102 Stat. 3052; Pub. L. 102–321, title I, § 163(b)(3), July 10, 1992, 106 Stat. 376; Pub. L. 103–43, title I, § 141(b), title II, §§ 201, 202, 206, 208, 210(b), (c), title III, § 303(b), June 10, 1993, 107 Stat. 139, 144, 148–150, 153; Pub. L. 105–115, title I, § 113(a), Nov. 21, 1997, 111 Stat. 2310; Pub. L. 105–362, title VI, § 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 105–392, title IV, § 409, Nov. 13, 1998, 112 Stat. 3589; Pub. L. 107–109, § 15(c)(2), Jan. 4, 2002, 115 Stat. 1420; Pub. L. 109–482, title I, §§ 102(a)–(d), (f)(1)(A), 103(b)(1), Jan. 15, 2007, 120 Stat. 3681, 3683, 3684, 3687; Pub. L. 110–85, title III, § 304(a), title VIII, § 801(a), title XI, § 1104(2), Sept. 27, 2007, 121 Stat. 863, 904, 975; Pub. L. 110–316, title III, § 302, Aug. 14, 2008, 122 Stat. 3524; Pub. L. 111–148, title X, § 10409(b), Mar. 23, 2010, 124 Stat. 978; Pub. L. 112–74, div. F, title II, § 221(b)(5)(B), (d)(1), Dec. 23, 2011, 125 Stat. 1089, 1090; Pub. L. 113–94, § 3(a), Apr. 3, 2014, 128 Stat. 1086; Pub. L. 114–255, div. A, title II, §§ 2014(a), 2031(a), 2036(a), 2038(a), 2051, Dec. 13, 2016, 130 Stat. 1051, 1054, 1062, 1064, 1074; Pub. L. 115–271, title VII, § 7041, Oct. 24, 2018, 132 Stat. 4016; Pub. L. 117–15, § 4, May 26, 2021, 135 Stat. 278; Pub. L. 117–286, § 4(a)(231), Dec. 27, 2022, 136 Stat. 4331; Pub. L. 117–328, div. FF, title II, §§ 2302, 2323, Dec. 29, 2022, 136 Stat. 5757, 5767; Pub. L. 118–228, §§ 2(3), 3(b), Jan. 4, 2025, 138 Stat. 2822.)