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Title 42 — The Public Health and Welfare

Part B · Chapter 6A — Public Health Service

§ 247d. Public health emergencies

Statutory text

(a)

Emergencies

If the Secretary determines, after consultation with such public health officials as may be necessary, that—

(1)

a disease or disorder presents a public health emergency; or

(2)

a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,

the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.

(b)

Public Health Emergency Fund

(1)

In general

There is established in the Treasury a fund to be designated as the “Public Health Emergency Fund” to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities. There is authorized to be appropriated to the Fund such sums as may be necessary.

(2)

Uses

The Secretary may use amounts in the Fund established under paragraph (1), to—

(A)

facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);

(B)

make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 247d–3a, 247d–3b, or 247d–3c of this title;

(C)

facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 247d–6b of this title), qualified countermeasures (as defined in section 247d–6a of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title), that are applicable to the public health emergency or potential public health emergency under paragraph (1);

(D)

strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under section 247d–4 of this title;

(E)

support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 300hh–11 of this title and the Medical Reserve Corps under section 300hh–15 of this title;

(F)

support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and

(G)

carry out other activities, as the Secretary determines applicable and appropriate.

(3)

Report

Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—

(A)

the expenditures made from the Public Health Emergency Fund in such fiscal year, including—

(i)

the amount obligated;

(ii)

the recipient or recipients of such obligated funds;

(iii)

the specific response activities such obligated funds will support; and

(iv)

the declared or potential public health emergency for which such funds were obligated; and

(B)

each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund.

(4)

Review

Not later than 2 years after , the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2).

(5)

GAO report

Not later than 4 years after , the Comptroller General of the United States shall—

(A)

conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and

(B)

submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.

(c)

Supplement not supplant

Funds appropriated under this section shall be used to rapidly respond to public health emergencies or potential public health emergencies and supplement and not supplant other Federal, State, and local public funds provided for activities under this chapter or funds otherwise provided for emergency response.

(d)

Data submittal and reporting deadlines

In any case in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are unable to comply with deadlines for the submission to the Secretary of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly after granting such an extension or waiver, the Secretary shall notify the Congress of such action and publish in the Federal Register a notice of the extension or waiver.

(e)

Temporary reassignment of State and local personnel during a public health emergency

(1)

Emergency reassignment of federally funded personnel

Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal organization’s designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this chapter, as appropriate.

(2)

Activation of emergency reassignment

(A)

Public health emergency

The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).

(B)

Contents of request

To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:

(i)

An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available.

(ii)

An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1).

(iii)

An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 247d–3a of this title.

(iv)

An identification of—

(I)

each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and

(II)

the number of personnel who would be so reassigned from each such program.

(v)

Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree.

(C)

Consideration

In reviewing a request for temporary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this chapter would be adversely affected by the reassignment.

(D)

Termination and extension

(i)

Termination

A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:

(I)

The Secretary’s determination that the public health emergency no longer exists.

(II)

Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility.

(ii)

Extension of reassignment flexibility

The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if—

(I)

the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and

(II)

the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B).

(3)

Voluntary nature of temporary reassignment of State and local personnel

(A)

In general

Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—

(i)

shall have the opportunity to volunteer for temporary reassignment; and

(ii)

shall not be required to agree to a temporary reassignment.

(B)

Prohibition on conditioning Federal awards

The Secretary may not condition the award of a grant, contract, or cooperative agreement under this chapter on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment.

(4)

Notice to Congress

The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of—

(A)

any initial request for temporary reassignment of personnel; and

(B)

any request for an extension of such temporary reassignment.

(5)

Guidance

The Secretary shall—

(A)

not later than 6 months after , issue proposed guidance on the temporary reassignment of personnel under this subsection; and

(B)

after providing notice and a 60-day period for public comment, finalize such guidance.

(6)

Report to Congress

Not later than 4 years after , the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—

(A)

a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes;

(B)

an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies;

(C)

an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;

(D)

an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and

(E)

recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.

(7)

Definitions

In this subsection—

(A)

the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25; and

(B)

the term “State” includes, in addition to the entities listed in the definition of such term in section 201 of this title, the Freely Associated States.

(8)

Sunset

This subsection shall terminate on .

(f)

Determination with respect to Paperwork Reduction Act waiver during a public health emergency

(1)

Determination

If the Secretary determines, after consultation with such public health officials as may be necessary, that—

(A)
(i)

the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or

(ii)

a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and

(B)

the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of chapter 35 of title 44 (commonly referred to as the Paperwork Reduction Act),

then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time.

(2)

Transparency

If the Secretary determines that a waiver is necessary under paragraph (1), the Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief justification for such waiver, the anticipated period of time such waiver will be in effect, and the agencies and offices within the Department of Health and Human Services to which such waiver shall apply, and update such information posted on the Internet website of the Department of Health and Human Services, as applicable.

(3)

Effectiveness of waiver

Any waiver under this subsection shall take effect on the date on which the Secretary posts information on the Internet website as provided for in this subsection.

(4)

Termination of waiver

Upon determining that the circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly update the Internet website of the Department of Health and Human Services to reflect the termination of such waiver.

(5)

Limitations

(A)

Period of waiver

The period of a waiver under paragraph (1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to subsection (a), and any immediate postresponse review regarding the public health emergency consistent with the requirements of this subsection.

(B)

Subsequent compliance

An initiative subject to a waiver under paragraph (1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of chapter 35 of title 44 and the Secretary shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver.

(g)

Certain appointments to support public health emergency responses

(1)

In general

In order to support the initial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to—

(A)

address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or

(B)

address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section.

(2)

Number of appointments

Each fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than—

(A)

400 individuals under paragraph (1)(A); and

(B)

100 individuals under paragraph (1)(B).

(3)

Compensation

The annual rate of basic pay of an individual appointed under this subsection shall be determined in accordance with chapter 51 and subchapter III of chapter 53 of title 5.

(4)

Reporting

The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including—

(A)

the number of positions filled through such authority;

(B)

the types of appointments of such positions;

(C)

the titles, occupational series, and grades of such positions;

(D)

the number of positions publicly noticed to be filled under such authority;

(E)

the number of qualified applicants who apply for such positions;

(F)

the qualification criteria for such positions; and

(G)

the demographic information of individuals appointed to such positions.

(5)

Notification to Congress

In the event the Secretary, within a single fiscal year, directly appoints more than 50 percent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include—

(A)

information on each such appointment within such fiscal year;

(B)

a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and

(C)

the additional number of personnel, if any, the Secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year.

(6)

Reports to Congress

Not later than , and annually thereafter for each fiscal year in which the authority under this subsection is used, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the total number of appointments filled under this subsection within the fiscal year and a description of how the positions relate to the requirements of subparagraph (A) or (B) of paragraph (1).

(7)

Sunset

The authority under this subsection shall expire on .

(h)

Stockpile depletion reporting

The Secretary shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under section 247d–6b(a) of this title to respond to a public health emergency declared by the Secretary under this section or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act [42 U.S.C. 5121 et seq.], and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, or major disaster, submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on—

(1)

the deployment of the contents of the stockpile in response to State, local, and Tribal requests;

(2)

the amount of such products that remain within the stockpile following such deployment; and

(3)

plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.

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.

  1. Pub. L. 106–505 title I § 102 · 114 Stat. 2314

    Enacted · 42 U.S.C. § 247d

    July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2315

    Source evidence

    Code source credit
    July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2315

    Enacted provision · exact public law section
    SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT. Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by striking section 319 and inserting the following: “SEC. 319. PUBLIC HEALTH EMERGENCIES. “(a) Emergencies.— If the Secretary determines, after consultation with such public health officials as may be necessary, that— “(1) a disease or disorder presents a public health emergency; or “(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). “(b) Public Health Emergency Fund.— “(1) In general.— There is established in the Treasury a fund to be designated as the ‘Public Health Emergency Fund’ to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection. There is authorized to be appropriated to the Fund such sums as may be necessary. “(2) Report.— Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing— “(A) the expenditures made from the Public Health Emergency Fund in such fiscal year; and “(B) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund. “(c) Supplement Not Supplant.— Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. “SEC. 319A. NATIONAL NEEDS TO COMBAT THREATS TO PUBLIC HEALTH. “(a) Capacities.— “(1) In general.— Not later than 1 year after the date of the enactment of this section, the Secretary, and such Administrators, Directors, or Commissioners, as may be appropriate, and in collaboration with State and local health officials, shall establish reasonable capacities that are appropriate for national, State, and local public health systems and the personnel or work forces of such systems. Such capacities shall be revised every 10 years, or more frequently as the Secretary determines to be necessary. “(2) Basis.— The capacities established under paragraph (1) shall improve, enhance or expand the capacity of national, State and local public health agencies to detect and respond effectively to significant public health threats, including major outbreaks of infections disease, pathogens resistant to antimicrobial agents and acts of bioterrorism. Such capacities may include the capacity to— “(A) recognize the clinical signs and epidemiological characteristic of significant outbreaks of infectious disease; “(B) identify disease-causing pathogens rapidly and accurately; “(C) develop and implement plans to provide medical care for persons infected with disease-causing agents and to provide preventive care as needed for individuals likely to be exposed to disease-causing agents; “(D) communicate information relevant to significant public health threats rapidly to local, State and national health agencies, and health care providers; or “(E) develop or implement policies to prevent the spread of infectious disease or antimicrobial resistance. “(b) Supplement Not Supplant.— Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. “(c) Technical Assistance.— The Secretary shall provide technical assistance to the States to assist such States in fulfilling the requirements of this section. “(d) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section $4,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006. “SEC. 319B. ASSESSMENT OF PUBLIC HEALTH NEEDS. “(a) Program Authorized.— Not later than 1 year after the Deadline. date of the enactment of this section and every 10 years thereafter, the Secretary shall award grants to States, or consortia of two or more States or political subdivisions of States, to perform, in collaboration with local public health agencies, an evaluation to determine the extent to which the States or local public health agencies can achieve the capacities applicable to State and local public health agencies described in subsection (a) of section 319A The Secretary shall provide technical assistance to States, or consortia of two or more States or political subdivisions of States, in addition to awarding such grants. “(b) Procedure.— “(1) In general.— A State, or a consortium of two or more States or political subdivisions of States, may contract with an outside entity to perform the evaluation described in subsection (a). “(2) Methods.— To the extent practicable, the evaluation described in subsection (a) shall be completed by using methods, to be developed by the Secretary in collaboration with State and local health officials, that facilitate the comparison of evaluations conducted by a State to those conducted by other States receiving funds under this section. “(c) Report.— Not later than 1 year after the date on which Deadline. a State, or a consortium of two or more States or political subdivisions of States, receives a grant under this subsection, such State, or a consortium of two or more States or political subdivisions of States, shall prepare and submit to the Secretary a report describing the results of the evaluation described in subsection (a) with respect to such State, or consortia of two or more States or political subdivisions of States. “(d) Supplement not Supplant.— Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. “(e) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section $45,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2003. “SEC. 319C. GRANTS TO IMPROVE STATE AND LOCAL PUBLIC HEALTH AGENCIES. “(a) Program Authorized.— The Secretary shall award competitive grants to eligible entities to address core public health capacity needs using the capacities developed under section 319A, with a particular focus on building capacity to identify, detect, monitor, and respond to threats to the public health. “(b) Eligible Entities.— A State or political subdivision of a State, or a consortium of two or more States or political subdivisions of States, that has completed an evaluation under section 319B(a), or an evaluation that is substantially equivalent as determined by the Secretary under section 319B(a), shall be eligible for grants under subsection (a). “(c) Use of Funds.— An eligible entity that receives a grant under subsection (a), may use funds received under such grant to— “(1) train public health personnel; “(2) develop, enhance, coordinate, or improve participation in an electronic network by which disease detection and public health related information can be rapidly shared among national, regional, State, and local public health agencies and health care providers; “(3) develop a plan for responding to public health emergencies, including significant outbreaks of infectious diseases or bioterrorism attacks, which is coordinated with the capacities of applicable national, State, and local health agencies and health care providers; and “(4) enhance laboratory capacity and facilities. “(d) Report.— No later than January 1, 2005, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report that describes the activities carried out under sections 319A, 319B, and 319C. “(e) Supplement Not Supplant.— Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. “(f) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section $50,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006. “SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND PREVENTION. “(a) Findings.— Congress finds that the Centers for Disease Control and Prevention have an essential role in defending against and combatting public health threats of the 21st century and requires secure and modern facilities that are sufficient to enable such Centers to conduct this important mission. “(b) Authorization of Appropriations.— For the purposes of achieving the mission of the Centers for Disease Control and Prevention described in subsection (a), for constructing new facilities and renovating existing facilities of such Centers, including laboratories, laboratory support buildings, health communication facilities, office buildings and other facilities and infrastructure, for better conducting the capacities described in section 319A, and for supporting related public health activities, there are authorized to be appropriated $180,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2010. “SEC. 319E. COMBATING ANTIMICROBIAL RESISTANCE. “(a) Task Force.— “(1) In general.— The Secretary shall establish an Antimicrobial Establishment. Resistance Task Force to provide advice and recommendations to the Secretary and coordinate Federal programs relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other organization in existence as of the date of the enactment of this section, to serve as such a task force, if such committee, or other organization meets the requirements of this section. “(2) Members of task force.— The task force described in paragraph (1) shall be composed of representatives from such Federal agencies, and shall seek input from public health constituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance. “(3) Agenda.— “(A) In general.— The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including— “(i) public health factors contributing to increasing antimicrobial resistance; “(ii) public health needs to detect and monitor antimicrobial resistance; “(iii) detection, prevention, and control strategies for resistant pathogens; “(iv) the need for improved information and data collection; “(v) the assessment of the risk imposed by pathogens presenting a threat to the public health; and “(vi) any other issues which the Secretary determines are relevant to antimicrobial resistance. “(B) Detection and Control.— The Secretary, in consultation with the task force described in paragraph (1) and State and local public health officials, shall— “(i) develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and “(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments. “(4) Meetings.— The task force described under paragraph (1) shall convene not less than twice a year, or more frequently as the Secretary determines to be appropriate. “(b) Research and Development of New Antimicrobial Drugs and Diagnostics.— The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established under subsection (a), shall conduct and support research, investigations, experiments, demonstrations, and studies in the health sciences that are related to— “(1) the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens; “(2) the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials; “(3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance; “(4) the sequencing of the genomes of priority pathogens as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a); and “(5) other relevant research areas. “(c) Education of Medical and Public Health Personnel.— The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Agency for Healthcare Research and Quality, members of the task force described in subsection (a), professional organizations and societies, and such other public health officials as may be necessary, shall— “(1) develop and implement educational programs to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics; “(2) develop and implement educational programs to instruct health care professionals in the prudent use of antibiotics; and “(3) develop and implement programs to train laboratory personnel in the recognition or identification of resistance in pathogens. “(d) Grants.— “(1) In general.— The Secretary shall award competitive grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance. “(2) Eligible entities.— Eligible entities for grants under paragraph (1) shall be State or local public health agencies, Indian tribes or tribal organizations, or other public or private nonprofit entities. “(3) Use of funds.— An eligible entity receiving a grant under paragraph (1) shall use funds from such grant for activities that are consistent with the factors identified by the task force under subsection (a)(3), which may include activities that— “(A) provide training to enable such entity to identify patterns of resistance rapidly and accurately; “(B) develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and “(C) develop and implement policies to control the spread of antimicrobial resistance. “(e) Grants for Demonstration Programs.— “(1) In general.— The Secretary shall award competitive grants to eligible entities to establish demonstration programs to promote judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens. “(2) Eligible entities.— Eligible entities for grants under paragraph (1) may include hospitals, clinics, institutions of long-term care, professional medical societies, or other public or private nonprofit entities. “(3) Technical assistance.— The Secretary shall provide appropriate technical assistance to eligible entities that receive grants under paragraph (1). “(f) Supplement Not Supplant.— Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. “(g) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006. “SEC. 319F. PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST ATTACK “(a) Working Group on Preparedness for Acts of Bioterrorism.— The Secretary, in coordination with the Secretary of Defense, shall establish a joint interdepartmental working group on preparedness and readiness for the medical and public health effects of a bioterrorist attack on the civilian population. Such joint working group shall— “(1) coordinate research on pathogens likely to be used in a bioterrorist attack on the civilian population as well as therapies to treat such pathogens; “(2) coordinate research and development into equipment to detect pathogens likely to be used in a bioterrorist attack on the civilian population and protect against infection from such pathogens; “(3) develop shared standards for equipment to detect and to protect against infection from pathogens likely to be used in a bioterrorist attack on the civilian population; and “(4) coordinate the development, maintenance, and procedures for the release of, strategic reserves of vaccines, drugs, and medical supplies which may be needed rapidly after a bioterrorist attack upon the civilian population. “(b) Working Group on the Public Health and Medical Consequences of Bioterrorism.— “(1) In general.— The Secretary, in collaboration with the Director of the Federal Emergency Management Agency, the Attorney General, and the Secretary of Agriculture, shall establish a joint interdepartmental working group to address the public health and medical consequences of a bioterrorist attack on the civilian population. “(2) Functions.— Such working group shall— “(A) assess the priorities for and enhance the preparedness of public health institutions, providers of medical care, and other emergency service personnel to detect, diagnose, and respond to a bioterrorist attack; and “(B) in the recognition that medical and public health professionals are likely to provide much of the first response to such an attack, develop, coordinate, enhance, and assure the quality of joint planning and training programs that address the public health and medical consequences of a bioterrorist attack on the civilian population between— “(i) local firefighters, ambulance personnel, police and public security officers, or other emergency response personnel; and “(ii) hospitals, primary care facilities, and public health agencies. “(3) Working group membership.— In establishing such working group, the Secretary shall act through the Assistant Secretary for Health and the Director of the Centers for Disease Control and Prevention. “(4) Coordination.— The Secretary shall ensure coordination and communication between the working groups established in this subsection and subsection (a). “(c) Grants.— “(1) In general.— The Secretary, in coordination with the working group established under subsection (b), shall, on a competitive basis and following scientific or technical review, award grants to or enter into cooperative agreements with eligible entities to enable such entities to increase their capacity to detect, diagnose, and respond to acts of bioterrorism upon the civilian population. “(2) Eligibility.— To be an eligible entity under this subsection, such entity must be a State, political subdivision of a State, a consortium of two or more States or political subdivisions of States, or a hospital, clinic, or primary care facility. “(3) Use of funds.— An entity that receives a grant under this subsection shall use such funds for activities that are consistent with the priorities identified by the working group under subsection (b), including— “(A) training health care professionals and public health personnel to enhance the ability of such personnel to recognize the symptoms and epidemiological characteristics of exposure to a potential bioweapon; “(B) addressing rapid and accurate identification of potential bioweapons; “(C) coordinating medical care for individuals exposed to bioweapons; and “(D) facilitating and coordinating rapid communication of data generated from a bioterrorist attack between national, State, and local health agencies, and health care providers. “(4) Coordination.— The Secretary, in awarding grants under this subsection, shall— “(A) notify the Director of the Office of Justice Programs, and the Director of the National Domestic Preparedness Office annually as to the amount and status of grants awarded under this subsection; and “(B) coordinate grants awarded under this subsection with grants awarded by the Office of Emergency Preparedness and the Centers for Disease Control and Prevention for the purpose of improving the capacity of health care providers and public health agencies to respond to bioterrorist attacks on the civilian population. “(5) Activities.— An entity that receives a grant under this subsection shall, to the greatest extent practicable, coordinate activities carried out with such funds with the activities of a local Metropolitan Medical Response System. “(d) Federal Assistance.— The Secretary shall ensure that the Department of Health and Human Services is able to provide such assistance as may be needed to State and local health agencies to enable such agencies to respond effectively to bioterrorist attacks. “(e) Education.— The Secretary, in collaboration with members of the working group described in subsection (b), and professional organizations and societies, shall— “(1) develop and implement educational programs to instruct public health officials, medical professionals, and other personnel working in health care facilities in the recognition and care of victims of a bioterrorist attack; and “(2) develop and implement programs to train laboratory personnel in the recognition and identification of a potential bioweapon. “(f) Future Resource Development.— The Secretary shall consult with the working group described in subsection (a), to develop priorities for and conduct research, investigations, experiments, demonstrations, and studies in the health sciences related to— “(1) the epidemiology and pathogenesis of potential bioweapons; “(2) the development of new vaccines or other therapeutics against pathogens likely to be used in a bioterrorist attack; “(3) the development of medical diagnostics to detect potential bioweapons; and “(4) other relevant research areas. “(g) General Accounting Office Report.— Not later than Deadline. 180 days after the date of the enactment of this section, the Comptroller General shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report that describee— “(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population; “(2) the coordination of the activities described in paragraph (1); “(3) the amount of Federal funds authorized or appropriated for the activities described in paragraph (1); and “(4) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population. “(h) Supplement Not Supplant.— Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. “(i) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section $215,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006. “SEC. 319G. DEMONSTRATION PROGRAM TO ENHANCE BIOTERRORISM TRAINING, COORDINATION, AND READINESS. “(a) In general.— The Secretary shall make grants to not more than three eligible entities to carry out demonstration programs to improve the detection of pathogens likely to be used in a bioterrorist attack, the development of plans and measures to respond to bioterrorist attacks, and the training of personnel involved with the various responsibilities and capabilities needed to respond to acts of bioterrorism upon the civilian population. Such awards shall be made on a competitive basis and pursuant to scientific and technical review. “(b) Eligible Entities.— Eligible entities for grants under subsection (a) are States, political subdivisions of States, and public or private non-profit organizations. “(c) Specific Criteria.— In making grants under subsection (a), the Secretary shall take into account the following factors: “(1) Whether the eligible entity involved is proximate to, and collaborates with, a major research university with expertise in scientific training, identification of biological agents, medicine, and life sciences. “(2) Whether the entity is proximate to, and collaborates with, a laboratory that has expertise in the identification of biological agents. “(3) Whether the entity demonstrates, in the application for the program, support and participation of State and local governments and research institutions in the conduct of the program. “(4) Whether the entity is proximate to, and collaborates with, or is, an academic medical center that has the capacity to serve an uninsured or underserved population, and is equipped to educate medical personnel. “(5) Such other factors as the Secretary determines to be appropriate. “(d) Duration of Award.— The period during which payments are made under a grant under subsection (a) may not exceed 5 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the payments. “(e) Supplement Not Supplant.— Grants under subsection (a) shall be used to supplement, and not supplant, other Federal, State, or local public funds provided for the activities described in such subsection. “(f) General Accounting Office Report.— Not later than 180 days after the conclusion of the demonstration programs carried out under subsection (a), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and the Committee on Commerce and the Committee on Appropriations of the House of Representatives, a report that describes the ability of grantees under such subsection to detect pathogens likely to be used in a bioterrorist attack, develop plans and measures for dealing with such threats, and train personnel involved with the various responsibilities and capabilities needed to deal with bioterrorist threats. “(g) Authorization of Appropriations.— There is authorized to be appropriated to carry out this section $6,000,000 for fiscal year 2001, and such sums as may be necessary through fiscal year 2006.”.

  2. Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 158 · 116 Stat. 594

    Substituted · 42 U.S.C. § 247d(a)

    Pub. L. 107–188, § 158, substituted “grants, providing awards for expenses, and” for “grants and” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 107–188, § 158, substituted “grants, providing awards for expenses, and” for “grants and” in concluding provisions.

    Enacted provision · exact public law section
    SEC. 158. CERTAIN AWARDS. Section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)) is amended in the matter after and below paragraph (2) by striking “grants and” and inserting “grants, providing awards for expenses, and”.

    Effective date note
    Pub. L. 107–188, title I, § 144(b), June 12, 2002, 116 Stat. 630, provided that: “The amendment made by subsection (a) [amending this section] applies to any public health emergency under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)], including any such emergency that was in effect as of the day before the date of the enactment of this Act [June 12, 2002]. In the case of such an emergency that was in effect as of such day, the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment.”

  3. Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 144(a) · 116 Stat. 594

    Inserted · 42 U.S.C. § 247d(a)

    Pub. L. 107–188, § 144(a), inserted at end of concluding provisions “Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–188, § 144(a), inserted at end of concluding provisions “Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.”

    Enacted provision · exact public law section
    (a) In General.— Section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)), is amended by adding at the end the following new sentence: “Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.”.

    Effective date note
    Pub. L. 107–188, title I, § 144(b), June 12, 2002, 116 Stat. 630, provided that: “The amendment made by subsection (a) [amending this section] applies to any public health emergency under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)], including any such emergency that was in effect as of the day before the date of the enactment of this Act [June 12, 2002]. In the case of such an emergency that was in effect as of such day, the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment.”

  4. Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 141 · 116 Stat. 594

    Added · 42 U.S.C. § 247d(d)

    Pub. L. 107–188, § 141, added subsec. (d)

    Source evidence

    Code amendment note
    Subsec. (d). Pub. L. 107–188, § 141, added subsec. (d).

    Enacted provision · exact public law section
    SEC. 141. REPORTING DEADLINES. Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following: “(d) Data Submittal and Reporting Deadlines.— In any case in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are unable to comply with deadlines for the submission to the Secretary of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. . Federal Register, publication. Before or promptly after granting such an extension or waiver, the Secretary shall notify the Congress of such action and publish in the Federal Register a notice of the extension or waiver.”.

    Effective date note
    Pub. L. 107–188, title I, § 144(b), June 12, 2002, 116 Stat. 630, provided that: “The amendment made by subsection (a) [amending this section] applies to any public health emergency under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)], including any such emergency that was in effect as of the day before the date of the enactment of this Act [June 12, 2002]. In the case of such an emergency that was in effect as of such day, the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment.”

  5. Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

    Pub. L. 113–5 title II § 201 · 127 Stat. 161

    Added · 42 U.S.C. § 247d(e)

    Pub. L. 113–5 added subsec. (e)

    Source evidence

    Code amendment note
    Subsec. (e). Pub. L. 113–5 added subsec. (e).

    Enacted provision · exact public law section
    SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.   Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following: “(e) Temporary Reassignment of State and Local Personnel During a Public Health Emergency.— “(1) Emergency reassignment of federally funded personnel.— Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal organization’s designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this Act, as appropriate. “(2) Activation of emergency reassignment.— “(A) Public health emergency.— The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a). “(B) Contents of request.— To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following: “(i) An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available. “(ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1). “(iii) An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 319C–1. “(iv) An identification of— “(I) each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and “(II) the number of personnel who would be so reassigned from each such program. “(v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree. “(C) Consideration.— In reviewing a request for temporary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this Act would be adversely affected by the reassignment. “(D) Termination and extension.— “(i) Termination.— A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following: “(I) The Secretary’s determination that the public health emergency no longer exists. “(II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility. “(ii) Extension of reassignment flexibility.— The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if— “(I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and “(II) the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B). “(3) Voluntary nature of temporary reassignment of state and local personnel.— “(A) In general.— Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization— “(i) shall have the opportunity to volunteer for temporary reassignment; and “(ii) shall not be required to agree to a temporary reassignment. “(B) Prohibition on conditioning federal awards.— The Secretary may not condition the award of a grant, contract, or cooperative agreement under this Act on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment. “(4) Notice to congress.— The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of— “(A) any initial request for temporary reassignment of personnel; and “(B) any request for an extension of such temporary reassignment. “(5) Guidance.— The Secretary shall— “(A) not later than 6 months after the enactment of this subsection, issue proposed guidance on the temporary reassignment of personnel under this subsection; and “(B) after providing notice and a 60-day period for public comment, finalize such guidance. “(6) Report to congress.— Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including— “(A) a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes; “(B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies; “(C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies; “(D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and “(E) recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity. “(7) Definitions.— In this subsection— “(A) the terms ‘Indian tribe’ and ‘tribal organization’ have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act; and “(B) the term ‘State’ includes, in addition to the entities listed in the definition of such term in section 2, the Freely Associated States. “(8) Sunset.— This subsection shall terminate on September 30, 2018.” .

  6. 21st Century Cures Act

    Pub. L. 114–255 div. A title III § 3087 · 130 Stat. 1033

    Added · 42 U.S.C. § 247d(f)

    Pub. L. 114–255 added subsec. (f)

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 114–255 added subsec. (f).

    Enacted provision · exact public law section
    SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH EMERGENCY.   Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following: “(f) Determination With Respect to Paperwork Reduction Act Waiver During a Public Health Emergency.— “(1) Determination.— If the Secretary determines, after consultation with such public health officials as may be necessary, that— “(A) (i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or “(ii) a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and “(B) the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act), then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time. “(2) Transparency.— If the Secretary determines that a waiver is necessary under paragraph (1), the Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief justification for such waiver, the anticipated period of time such waiver will be in effect, and the agencies and offices within the Department of Health and Human Services to which such waiver shall apply, and update such information posted on the Internet website of the Department of Health and Human Services, as applicable. “(3) Effectiveness of waiver.— Any waiver under this subsection shall take effect on the date on which the Secretary posts information on the Internet website as provided for in this subsection. “(4) Termination of waiver.— Upon determining that the circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly update the Internet website of the Department of Health and Human Services to reflect the termination of such waiver. “(5) Limitations.— “(A) Period of waiver.— The period of a waiver under paragraph (1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to subsection (a), and any immediate postresponse review regarding the public health emergency consistent with the requirements of this subsection. “(B) Subsequent compliance.— An initiative subject to a waiver under paragraph (1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of chapter 35 of title 44, United States Code, and the Secretary shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver.” .

  7. Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

    Pub. L. 116–22 § 206(1)(A) · 133 Stat. 905

    Substituted · 42 U.S.C. § 247d(b)(1)

    Pub. L. 116–22, § 206(1)(A), substituted “under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities.” for “under such subsection.”

    Source evidence

    Code amendment note
    Subsec. (b)(1). Pub. L. 116–22, § 206(1)(A), substituted “under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities.” for “under such subsection.”

    Enacted provision · exact public law section
    (A) in paragraph (1)— (i) in the first sentence, by inserting “or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency” before the period; and (ii) by inserting “The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities.” after the first sentence;

  8. Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

    Pub. L. 116–22 § 206(1)(B) · 133 Stat. 905

    1. Added · 42 U.S.C. § 247d(b)(2); 42 U.S.C. § 247d(b)(3)

      Pub. L. 116–22, § 206(1)(B), (C), added par. (2)

    2. Redesignated · 42 U.S.C. § 247d(b)(2); 42 U.S.C. § 247d(b)(3)

      Pub. L. 116–22, § 206(1)(B), (C), redesignated former par. (2) as (3)

    Source evidence

    Code amendment note
    Subsec. (b)(2), (3). Pub. L. 116–22, § 206(1)(B), (C), added par. (2) and redesignated former par. (2) as (3).

    Enacted provision · exact public law section
    (B) by redesignating paragraph (2) as paragraph (3);

  9. Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

    Pub. L. 116–22 § 206(1)(D) · 133 Stat. 905

    Added · 42 U.S.C. § 247d(b)(4); 42 U.S.C. § 247d(b)(5)

    Pub. L. 116–22, § 206(1)(D), added pars. (4) and (5)

    Source evidence

    Code amendment note
    Subsec. (b)(4), (5). Pub. L. 116–22, § 206(1)(D), added pars. (4) and (5).

    Enacted provision · exact public law section
    (D) by inserting after paragraph (3), as so redesignated, the following: “(4) Review.— Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2). “(5) GAO report.— Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Comptroller General of the United States shall— “(A) conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and “(B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.” ; and

  10. Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

    Pub. L. 116–22 § 206(2) · 133 Stat. 905

    1. Inserted · 42 U.S.C. § 247d(c)

      Pub. L. 116–22, § 206(2), inserted “rapidly respond to public health emergencies or potential public health emergencies and” after “used to”

    2. Substituted · 42 U.S.C. § 247d(c)

      Pub. L. 116–22, § 206(2), substituted “activities under this chapter or funds otherwise provided for emergency response.” for “activities under this section.”

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 116–22, § 206(2), inserted “rapidly respond to public health emergencies or potential public health emergencies and” after “used to” and substituted “activities under this chapter or funds otherwise provided for emergency response.” for “activities under this section.”

    Enacted provision · exact public law section
    (2) in subsection (c)— (A) by inserting “rapidly respond to public health emergencies or potential public health emergencies and” after “used to”; and (B) by striking “section.” and inserting “Act or funds otherwise provided for emergency response.”.

  11. Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

    Pub. L. 116–22 § 701(c) · 133 Stat. 905

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 116–22, § 701(c), substituted “2023” for “2018”

    Source evidence

    Code amendment note
    Subsec. (e)(8). Pub. L. 116–22, § 701(c), substituted “2023” for “2018”.

    Enacted provision · exact public law section
    (c) Temporary Reassignment.— Section 319(e)(8) (42 U.S.C. 247d(e)(8)) is amended by striking “2018” and inserting “2023”.

  12. Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act

    Pub. L. 117–328 § 2103(a)(1) · 136 Stat. 4459

    1. Added · 42 U.S.C. § 247d(b)(2)(F); 42 U.S.C. § 247d(b)(2)(G)

      Pub. L. 117–328, § 2103(a)(1), added subpar. (F)

    2. Redesignated · 42 U.S.C. § 247d(b)(2)(F); 42 U.S.C. § 247d(b)(2)(G)

      Pub. L. 117–328, § 2103(a)(1), redesignated former subpar. (F) as (G)

    Source evidence

    Code amendment note
    Subsec. (b)(2)(F), (G). Pub. L. 117–328, § 2103(a)(1), added subpar. (F) and redesignated former subpar. (F) as (G).

    Enacted provision · exact public law section
    (1) in paragraph (2)— (A) in subparagraph (E), by striking “and” at the end; (B) by redesignating subparagraph (F) as subparagraph (G); and (C) by inserting after subparagraph (E), the following: “(F) support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and” ; and

  13. Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act

    Pub. L. 117–328 § 2103(a)(2) · 136 Stat. 4459

    Amended · 42 U.S.C. § 247d(b)(3)(A)

    Pub. L. 117–328, § 2103(a)(2), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “the expenditures made from the Public Health Emergency Fund in such fiscal year; and”

    Source evidence

    Code amendment note
    Subsec. (b)(3)(A). Pub. L. 117–328, § 2103(a)(2), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “the expenditures made from the Public Health Emergency Fund in such fiscal year; and”.

    Enacted provision · exact public law section
    (2) by amending paragraph (3)(A) to read as follows: “(A) the expenditures made from the Public Health Emergency Fund in such fiscal year, including— “(i) the amount obligated; “(ii) the recipient or recipients of such obligated funds; “(iii) the specific response activities such obligated funds will support; and “(iv) the declared or potential public health emergency for which such funds were obligated; and” .

  14. Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act

    Pub. L. 117–328 § 2223(a) · 136 Stat. 4459

    Added · 42 U.S.C. § 247d(g)

    Pub. L. 117–328, § 2223(a), added subsec. (g)

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 117–328, § 2223(a), added subsec. (g).

    Enacted provision · exact public law section
    (a) Certain Appointments to Support Public Health Emergency Responses.— Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following: “(g) Certain Appointments to Support Public Health Emergency Responses.— “(1) In general.— In order to support the initial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, United States Code, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to— “(A) address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or “(B) address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section. “(2) Number of appointments.— Each fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than— “(A) 400 individuals under paragraph (1)(A); and “(B) 100 individuals under paragraph (1)(B). “(3) Compensation.— The annual rate of basic pay of an individual appointed under this subsection shall be determined in accordance with chapter 51 and subchapter III of chapter 53 of title 5, United States Code. “(4) Reporting.— The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including— “(A) the number of positions filled through such authority; “(B) the types of appointments of such positions; “(C) the titles, occupational series, and grades of such positions; “(D) the number of positions publicly noticed to be filled under such authority; “(E) the number of qualified applicants who apply for such positions; “(F) the qualification criteria for such positions; and “(G) the demographic information of individuals appointed to such positions. “(5) Notification to congress.— In the event the Secretary, within a single fiscal year, directly appoints more than 50 percent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include— “(A) information on each such appointment within such fiscal year; “(B) a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and “(C) the additional number of personnel, if any, the Secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year. “(6) Reports to congress.— Not later than September 30, 2023, and annually thereafter for each fiscal year in which the authority under this subsection is used, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the total number of appointments filled under this subsection within the fiscal year and a description of how the positions relate to the requirements of subparagraph (A) or (B) of paragraph (1). “(7) Sunset.— The authority under this subsection shall expire on September 30, 2028.” .

  15. Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act

    Pub. L. 117–328 § 2407 · 136 Stat. 4459

    Added · 42 U.S.C. § 247d(h)

    Pub. L. 117–328, § 2407, added subsec. (h)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 117–328, § 2407, added subsec. (h).

    Enacted provision · exact public law section
    SEC. 2407. ACTION REPORTING ON STOCKPILE DEPLETION.   Section 319 of the Public Health Service Act (42 U.S.C. 247d), as amended by section 2223, is further amended by adding at the end the following: “(h) Stockpile Depletion Reporting.— The Secretary shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under section 319F–2(a) to respond to a public health emergency declared by the Secretary under this section or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, or major disaster, submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on— “(1) the deployment of the contents of the stockpile in response to State, local, and Tribal requests; “(2) the amount of such products that remain within the stockpile following such deployment; and “(3) Plans. plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.” .

  16. Continuing Appropriations Act, 2024 and Other Extensions Act

    Pub. L. 118–15 div. B title III § 2332 · 137 Stat. 71

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 118–15 substituted “November 17, 2023” for “September 30, 2023”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 118–15 substituted “November 17, 2023” for “September 30, 2023”.

    Enacted provision · exact public law section
    SEC. 2332. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.   Section 319(e)(8) of the Public Health Service Act (42 U.S.C. 247d(e)(8)) is amended by striking “September 30, 2023” and inserting “November 17, 2023”.

  17. Further Continuing Appropriations and Other Extensions Act, 2024

    Pub. L. 118–22 div. B title II § 203(a) · 137 Stat. 112

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 118–22 substituted “January 19, 2024” for “November 17, 2023”

    Source evidence

    Code amendment note
    Subsec. (e)(8). Pub. L. 118–22 substituted “January 19, 2024” for “November 17, 2023”.

    Enacted provision · exact public law section
    (a) Section 319(e)(8) of the Public Health Service Act (42 U.S.C. 247d(e)(8)) is amended by striking “November 17, 2023” and inserting “January 19, 2024”.

  18. Pub. L. 118–35 div. B title I § 103(a) · 138 Stat. 5

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 118–35 substituted “March 8, 2024” for “January 19, 2024”

    Unresolved: Pub. L. 118–35 was not found in the local Statutes at Large index.

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 118–35 substituted “March 8, 2024” for “January 19, 2024”.

  19. Pub. L. 118–42 div. G title I § 103(a) · 138 Stat. 398

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 118–42 substituted “December 31, 2024” for “March 8, 2024”

    Unresolved: Pub. L. 118–42 was not found in the local Statutes at Large index.

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 118–42 substituted “December 31, 2024” for “March 8, 2024”.

  20. Pub. L. 118–158 div. C title I § 3103(a) · 138 Stat. 1763

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 118–158 substituted “March 31, 2025” for “December 31, 2024”

    Unresolved: Pub. L. 118–158 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (e)(8). Pub. L. 118–158 substituted “March 31, 2025” for “December 31, 2024”.

  21. Pub. L. 119–4 div. B title I § 2103(a) · 139 Stat. 41

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 119–4 substituted “September 30, 2025” for “March 31, 2025”

    Unresolved: Pub. L. 119–4 was not found in the local Statutes at Large index.

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 119–4 substituted “September 30, 2025” for “March 31, 2025”.

  22. Pub. L. 119–37 div. F title I § 6103(a) · 139 Stat. 630

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 119–37 substituted “January 30, 2026” for “September 30, 2025”

    Unresolved: Pub. L. 119–37 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (e)(8). Pub. L. 119–37 substituted “January 30, 2026” for “September 30, 2025”.

  23. Pub. L. 119–75 div. J title IV § 6403(a) · 140 Stat. 688

    Substituted · 42 U.S.C. § 247d(e)(8)

    Pub. L. 119–75 substituted “December 31, 2026” for “January 30, 2026”

    Unresolved: Pub. L. 119–75 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (e)(8). Pub. L. 119–75 substituted “December 31, 2026” for “January 30, 2026”.

20 of 26 references resolved to an enrolled provision · 6 unresolved

Editorial Notes

References in Text

The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (h), is Pub. L. 93–288, , 88 Stat. 143, which is classified principally to chapter 68 (§ 5121 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 5121 of this title and Tables.

Prior Provisions

A prior section 247d, act July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 98–49, , 97 Stat. 245; amended Pub. L. 100–607, title II, § 256(a), , 102 Stat. 3110; Pub. L. 102–321, title I, § 163(b)(2), , 106 Stat. 376; Pub. L. 102–531, title III, § 312(d)(2), , 106 Stat. 3504, authorized the Secretary to take appropriate action relating to public health emergencies, prior to repeal by Pub. L. 106–505, title I, § 102, , 114 Stat. 2315.

Another prior section 247d, act July 1, 1944, ch. 373, title III, § 319, formerly § 310, as added , Pub. L. 87–692, 76 Stat. 592, and amended and renumbered, which related to migrant health centers, was renumbered section 329 of act , by Pub. L. 95–626, title I, § 102(a), , 92 Stat. 3551, and transferred to section 254b of this title, prior to being omitted in the general amendment of subpart I (§ 254b et seq.) of part D of this subchapter by Pub. L. 104–299, § 2.

Amendments2002–2026 · 9 rounds

2026

Subsec. (e)(8). Pub. L. 119–75 substituted “” for “”.

2025

Subsec. (e)(8). Pub. L. 119–37 substituted “” for “”.

Pub. L. 119–4 substituted “” for “”.

2024

Subsec. (e)(8). Pub. L. 118–158 substituted “” for “”.

Pub. L. 118–42 substituted “” for “”.

Pub. L. 118–35 substituted “” for “”.

2023

Subsec. (e)(8). Pub. L. 118–22 substituted “” for “”.

Pub. L. 118–15 substituted “” for “”.

2022

Subsec. (b)(2)(F), (G). Pub. L. 117–328, § 2103(a)(1), added subpar. (F) and redesignated former subpar. (F) as (G).

Subsec. (b)(3)(A). Pub. L. 117–328, § 2103(a)(2), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “the expenditures made from the Public Health Emergency Fund in such fiscal year; and”.

Subsec. (g). Pub. L. 117–328, § 2223(a), added subsec. (g).

Subsec. (h). Pub. L. 117–328, § 2407, added subsec. (h).

2019

Subsec. (b)(1). Pub. L. 116–22, § 206(1)(A), substituted “under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities.” for “under such subsection.”

Subsec. (b)(2), (3). Pub. L. 116–22, § 206(1)(B), (C), added par. (2) and redesignated former par. (2) as (3).

Subsec. (b)(4), (5). Pub. L. 116–22, § 206(1)(D), added pars. (4) and (5).

Subsec. (c). Pub. L. 116–22, § 206(2), inserted “rapidly respond to public health emergencies or potential public health emergencies and” after “used to” and substituted “activities under this chapter or funds otherwise provided for emergency response.” for “activities under this section.”

Subsec. (e)(8). Pub. L. 116–22, § 701(c), substituted “2023” for “2018”.

2016

Subsec. (f). Pub. L. 114–255 added subsec. (f).

2013

Subsec. (e). Pub. L. 113–5 added subsec. (e).

2002

Subsec. (a). Pub. L. 107–188, § 158, substituted “grants, providing awards for expenses, and” for “grants and” in concluding provisions.

Pub. L. 107–188, § 144(a), inserted at end of concluding provisions “Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.”

Subsec. (d). Pub. L. 107–188, § 141, added subsec. (d).

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, .

Effective Date of 2002 Amendment

Pub. L. 107–188, title I, § 144(b), , 116 Stat. 630, provided that: “The amendment made by subsection (a) [amending this section] applies to any public health emergency under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)], including any such emergency that was in effect as of the day before the date of the enactment of this Act []. In the case of such an emergency that was in effect as of such day, the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment.”

Consideration of Unique Challenges in Noncontiguous States and Territories

Pub. L. 117–328, div. FF, title II, § 2115, , 136 Stat. 5726, provided that: “During any public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), the Secretary of Health and Human Services shall conduct quarterly meetings or consultations, as applicable or appropriate, with noncontiguous States and territories with regard to addressing unique public health challenges in such States and territories associated with such public health emergency.”

Funding for COVID–19 Vaccine Activities at the Centers for Disease Control and Prevention

Pub. L. 117–2, title II, § 2301, , 135 Stat. 37, provided that:

“(a)

In General.—

In addition to amounts otherwise available, there is appropriated to the Secretary of Health and Human Services (in this subtitle [subtitle D (§§ 2301–2305) of title II of Pub. L. 117–2, see Tables for classification] referred to as the ‘Secretary’) for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $7,500,000,000, to remain available until expended, to carry out activities to plan, prepare for, promote, distribute, administer, monitor, and track COVID–19 vaccines.

“(b)

Use of Funds.—

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in consultation with other agencies, as applicable, shall, in conducting activities referred to in subsection (a)—

“(1)

conduct activities to enhance, expand, and improve nationwide COVID–19 vaccine distribution and administration, including activities related to distribution of ancillary medical products and supplies related to vaccines; and

“(2)

provide technical assistance, guidance, and support to, and award grants or cooperative agreements to, State, local, Tribal, and territorial public health departments for enhancement of COVID–19 vaccine distribution and administration capabilities, including—

“(A)

the distribution and administration of vaccines licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) or authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) and ancillary medical products and supplies related to vaccines;

“(B)

the establishment and expansion, including staffing support, of community vaccination centers, particularly in underserved areas;

“(C)

the deployment of mobile vaccination units, particularly in underserved areas;

“(D)

information technology, standards-based data, and reporting enhancements, including improvements necessary to support standards-based sharing of data related to vaccine distribution and vaccinations and systems that enhance vaccine safety, effectiveness, and uptake, particularly among underserved populations;

“(E)

facilities enhancements;

“(F)

communication with the public regarding when, where, and how to receive COVID–19 vaccines; and

“(G)

transportation of individuals to facilitate vaccinations, including at community vaccination centers and mobile vaccination units, particularly for underserved populations.

“(c)

Supplemental Funding for State Vaccination Grants.—

“(1)

Definitions.—

In this subsection:

“(A)

Base formula.—

The term ‘base formula’ means the allocation formula that applied to the Public Health Emergency Preparedness cooperative agreement in fiscal year 2020.

“(B)

Alternative allocation.—

The term ‘alternative allocation’ means an allocation to each State, territory, or locality calculated using the percentage derived from the allocation received by such State, territory, or locality of the aggregate amount of fiscal year 2020 Public Health Emergency Preparedness cooperative agreement awards under section 319C–1 of the Public Health Service Act (42 U.S.C. 247d–3a).

“(2)

Supplemental funding.—

“(A)

In general.—

Not later than 21 days after the date of enactment of this Act [], the Secretary shall, out of amounts described in subsection (a), provide supplemental funding to any State, locality, or territory that received less of the amounts that were appropriated under title III of division M of Public Law 116–260 [see Tables for classification] for vaccination grants to be issued by the Centers for Disease Control and Prevention than such State, locality, or territory would have received had such amounts been allocated using the alternative allocation.

“(B)

Amount.—

The amount of supplemental funding provided under this subsection shall be equal to the difference between—

“(i)

the amount the State, locality, or territory received, or would receive, under the base formula; and

“(ii)

the amount the State, locality, or territory would receive under the alternative allocation.”

Funding for COVID–19 Testing, Contact Tracing, and Mitigation Activities

Pub. L. 117–2, title II, § 2401, , 135 Stat. 40, provided that:

“(a)

In General.—

In addition to amounts otherwise available, there is appropriated to the Secretary of Health and Human Services (in this subtitle [subtitle E (§§ 2401–2404) of title II of Pub. L. 117–2, see Tables for classification] referred to as the ‘Secretary’) for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $47,800,000,000, to remain available until expended, to carry out activities to detect, diagnose, trace, and monitor SARS–CoV–2 and COVID–19 infections and related strategies to mitigate the spread of COVID–19.

“(b)

Use of Funds.—

From amounts appropriated by subsection (a), the Secretary shall—

“(1)

implement a national, evidence-based strategy for testing, contact tracing, surveillance, and mitigation with respect to SARS–CoV–2 and COVID–19, including through activities authorized under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)];

“(2)

provide technical assistance, guidance, and support, and award grants or cooperative agreements to State, local, and territorial public health departments for activities to detect, diagnose, trace, and monitor SARS–CoV–2 and COVID–19 infections and related strategies and activities to mitigate the spread of COVID–19;

“(3)

support the development, manufacturing, procurement, distribution, and administration of tests to detect or diagnose SARS–CoV–2 and COVID–19, including through—

“(A)

support for the development, manufacture, procurement, and distribution of supplies necessary for administering tests, such as personal protective equipment; and

“(B)

support for the acquisition, construction, alteration, or renovation of non-federally owned facilities for the production of diagnostics and ancillary medical products and supplies where the Secretary determines that such an investment is necessary to ensure the production of sufficient amounts of such supplies;

“(4)

establish and expand Federal, State, local, and territorial testing and contact tracing capabilities, including—

“(A)

through investments in laboratory capacity, such as—

“(i)

academic and research laboratories, or other laboratories that could be used for processing of COVID–19 testing;

“(ii)

community-based testing sites and community-based organizations; or

“(iii)

mobile health units, particularly in medically underserved areas; and

“(B)

with respect to quarantine and isolation of contacts;

“(5)

enhance information technology, data modernization, and reporting, including improvements necessary to support sharing of data related to public health capabilities;

“(6)

award grants to, or enter into cooperative agreements or contracts with, State, local, and territorial public health departments to establish, expand, and sustain a public health workforce; and

“(7)

to cover administrative and program support costs necessary to conduct activities related to subparagraph (a).”

Importance of the Blood Supply

Pub. L. 116–136, div. A, title III, § 3226, , 134 Stat. 383, provided that:

“(a)

In General.—

The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall carry out a national campaign to improve awareness of, and support outreach to the public and health care providers about the importance and safety of blood donation and the need for donations for the blood supply during the public health emergency declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19.

“(b)

Awareness Campaign.—

In carrying out subsection (a), the Secretary may enter into contracts with one or more public or private nonprofit entities, to establish a national blood donation awareness campaign that may include television, radio, internet, and newspaper public service announcements, and other activities to provide for public and professional awareness and education.

“(c)

Consultation.—

In carrying out subsection (a), the Secretary shall consult with the Commissioner of Food and Drugs, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, and the heads of other relevant Federal agencies, and relevant accrediting bodies and representative organizations.

“(d)

Report to Congress.—

Not later than 2 years after the date of enactment of this Act [], the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report that shall include—

“(1)

a description of the activities carried out under subsection (a);

“(2)

a description of trends in blood supply donations; and

“(3)

an evaluation of the impact of the public awareness campaign, including any geographic or population variations.”

Reporting by Laboratories of Results of Tests To Detect SARS–CoV–2 or To Diagnose COVID–19

Pub. L. 116–136, div. B, title VIII, § 18115(a)–(c), , 134 Stat. 574, provided that:

“(a)

In General.—

Every laboratory that performs or analyzes a test that is intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19 shall report the results from each such test, to the Secretary of Health and Human Services in such form and manner, and at such timing and frequency, as the Secretary may prescribe until the end of the Secretary’s Public Health Emergency declaration with respect to COVID–19 or any extension of such declaration.

“(b)

Laboratories Covered.—

The Secretary may prescribe which laboratories must submit reports pursuant to this section.

“(c)

Implementation.—

The Secretary may make prescriptions under this section by regulation, including by interim final rule, or by guidance, and may issue such regulations or guidance without regard to the procedures otherwise required by section 553 of title 5, United States Code.”

Executive Documents

Executive Order No. 13987

Ex. Ord. No. 13987, , 86 F.R. 7019, organizing and mobilizing the United States government to provide a unified and effective response to combat COVID–19 and to provide United States leadership on global health and security, was revoked by Ex. Ord. No. 14148, § 2(c), , 90 F.R. 8237, and Ex. Ord. No. 14155, § 2(b), , 90 F.R. 8361. Positions of COVID–19 Response Coordinator and Deputy Coordinator of the COVID–19 Response, as established by section 2 of Ex. Ord. No. 13987 terminated, and responsibilities and duties transferred to Director of the Office of Pandemic Preparedness and Response Policy, by Ex. Ord. No. 14122, § 3, , 89 F.R. 27355, set out in a note under section 300hh–3 of this title.

Executive Order No. 13991

Ex. Ord. No. 13991, , 86 F.R. 7045, which required compliance with CDC guidelines with respect to wearing masks, maintaining physical distance, and other public health measures by Federal employees and contractors and all persons in Federal buildings or on Federal lands, and HHS promotion of public health best practices identified by the CDC, was revoked by Ex. Ord. No. 14122, § 2, , 89 F.R. 27355, set out in a note under section 300hh–3 of this title.

Executive Order No. 13994

Ex. Ord. No. 13994, , 86 F.R. 7189, which related to ensuring a data-driven response to COVID–19 and future high-consequence public health threats, was revoked by Ex. Ord. No. 14236, § 2(a), , 90 F.R. 13037.

Executive Order No. 13995

Ex. Ord. No. 13995, , 86 F.R. 7193, which related to ensuring an equitable pandemic response and recovery, was revoked by Ex. Ord. No. 14148, § 2(i), , 90 F.R. 8237.

Executive Order No. 13996

Ex. Ord. No. 13996, , 86 F.R. 7197, establishing the COVID–19Pandemic Testing Board and ensuring a sustainable public health workforce for COVID–19 and other biological threats, was revoked by Ex. Ord. No. 14148 § 2(j), , 90 F.R. 8237.

Executive Order No. 13997

Ex. Ord. No. 13997, , 86 F.R. 7201, improving and expanding access to care and treatments for COVID–19, was revoked by Ex. Ord. No. 14148, § 2(k), , 90 F.R. 8237.

Executive Order No. 13998

Ex. Ord. No. 13998, , 86 F.R. 7205, which related to promoting COVID–19 safety in domestic and international travel, was revoked by Ex. Ord. No. 14122, § 2, , 89 F.R. 27355, set out in a note under section 300hh–3 of this title.

Executive Order No. 13999

Ex. Ord. No. 13999, , 86 F.R. 7211, ensuring the health and safety of workers during the COVID–19 pandemic, was revoked by Ex. Ord. No. 14148, § 2(l), , 90 F.R. 8238.

Executive Order No. 14000

Ex. Ord. No. 14000, , 86 F.R. 7215, supporting the reopening and continuing operation of schools and early childhood education providers, was revoked by Ex. Ord. No. 14148, § 2(m), , 90 F.R. 8238.

Addressing the Long-Term Effects of COVID–19

Memorandum of President of the United States, , 87 F.R. 20995, provided:

Memorandum for the Heads of Executive Departments and Agencies

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. My Administration has made combating the coronavirus disease 2019 (COVID–19) pandemic, and guiding the Nation through the worst public health crisis in more than a century, our top priority. When I came into office, COVID–19 was wreaking havoc on our country—closing our businesses, keeping our kids out of school, and forcing us into isolation. Today, America has the tools to protect against COVID–19 and to dramatically decrease its risks. We move towards a future in which COVID–19 does not disrupt our daily lives and is something we prevent, protect against, and treat.

As we chart the path forward, we remember the more than 950,000 people in the United States lost to COVID–19. They were beloved parents, grandparents, children, siblings, spouses, neighbors, and friends. More than 200,000 children in the United States have lost a parent or caregiver to the disease. Each soul is irreplaceable, and the families and communities left behind are still reeling from profound loss. Many families and communities have already received support from Federal programs that help with the loss they have experienced. As we move forward, we commit to ensuring that families and communities can access these support programs and connect to resources they may need to help with their healing, health, and well-being.

At the same time, many of our family members, neighbors, and friends continue to experience negative long-term effects of COVID–19. Many individuals report debilitating, long-lasting effects of having been infected with COVID–19, often called “long COVID.” These symptoms can happen to anyone who has had COVID–19—including individuals across ages, races, genders, and ethnicities; individuals with or without disabilities; individuals with or without underlying health conditions; and individuals whether or not they had initial symptoms. Individuals experiencing long COVID report experiencing new or recurrent symptoms, which can include anxiety and depression, fatigue, shortness of breath, difficulty concentrating, heart palpitations, disordered sleep, chest and joint pain, headaches, and other symptoms. These symptoms can persist long after the acute COVID–19 infection has resolved. Even young people and otherwise healthy people have reported long COVID symptoms that last for many months. These symptoms may be affecting individuals’ ability to work, conduct daily activities, engage in educational activities, and participate in their communities. Our world-class research and public health organizations have begun the difficult work of understanding these new conditions, their causes, and potential prevention and treatment options. Our health care and support programs are working to help meet the needs of individuals experiencing the lasting effects of COVID–19. To organize the Federal Government’s response, executive departments and agencies (agencies) must work together to use the expertise, resources, and benefit programs of the Federal Government to ensure that we are accelerating scientific progress and providing individuals with the support and services they need.

In addition, the American public is grappling with a mental health crisis exacerbated by the pandemic. Too many have felt the effects of social isolation, sickness, economic insecurity, increased caregiver burdens, and grief. My Administration has made significant investments in mental health as well as substance use disorder prevention, treatment, and recovery support for the American public, including by expanding access to community-based behavioral health services. We are committed to advancing these behavioral health efforts in order to better identify the effects of the pandemic on mental health, substance use, and well-being, and to take steps to address these effects for the people we serve.

Our Nation can continue to protect the public—and spare countless families from the deepest pain imaginable—if everybody does their part. Today, we have numerous tools to protect ourselves and our loved ones from COVID–19—from vaccines to tests, treatments, masks, and more. My Administration recognizes the toll of this pandemic on the American public and commits to redoubling our efforts to support the American people in addressing the long-term effects of COVID–19 on their lives and on society.

Sec. 2. Organizing the Government-Wide Response to the Long-Term Effects of COVID–19. (a) The Secretary of Health and Human Services (Secretary) shall coordinate the Government-wide response to the long-term effects of COVID–19. My Administration will harness the full potential of the Federal Government, in coordination with public- and private-sector partners, to mount a full and effective response. The Secretary shall report on the coordination efforts to the Coordinator of the COVID–19 Response and Counselor to the President and to the Assistant to the President for Domestic Policy.

(b) The heads of agencies shall assist and provide information to the Secretary, consistent with applicable law, as may be necessary to carry out the Secretary’s duties described in subsection (a) of this section.

(c) In performing the duties described in subsection (a) of this section, the Secretary shall seek information from relevant nongovernmental experts, organizations, and stakeholders, including individuals affected directly by the long-term effects of COVID–19. The Secretary shall consider using all available legal authorities, as appropriate and consistent with applicable law, to assist in gathering relevant information, including a waiver under 42 U.S.C. 247d(f).

Sec. 3. Report on the Long-Term Effects of COVID–19. The Secretary, supported within the Department of Health and Human Services by the Assistant Secretary for Health and the Assistant Secretary for Mental Health and Substance Use, shall publish a public report within 120 days of the date of this memorandum [] outlining services and mechanisms of support across agencies to assist the American public in the face of the far-reaching and long-term effects of COVID–19. The report shall outline Federal Government services to support individuals experiencing long COVID, individuals and families experiencing a loss due to COVID–19, and all those grappling with mental health and substance use issues in the wake of this pandemic. The report shall also specifically address the long-term effects of COVID–19 on underserved communities and efforts to address disparities in availability and adoption of services and support for such communities.

Sec. 4. National Research Action Plan on Long COVID. (a) Coordinated efforts across the public and private sectors are needed to advance progress in prevention, diagnosis, treatment, and provision of services for individuals experiencing long COVID. The Secretary, supported by the Assistant Secretary for Health and in collaboration with the Secretary of Defense, the Secretary of Labor, the Secretary of Energy, and the Secretary of Veterans Affairs, shall coordinate a Government-wide effort to develop the first-ever interagency national research agenda on long COVID, to be reflected in a National Research Action Plan. The National Research Action Plan will build on ongoing efforts across the Federal Government, including the landmark RECOVER Initiative implemented by the National Institutes of Health. The Secretary shall release the jointly developed National Research Action Plan within 120 days of the date of this memorandum.

(b) The National Research Action Plan shall build upon existing research efforts and include strategies to:

(i) help measure and characterize long COVID in both children and adults, including with respect to its frequency, severity, duration, risk factors, and trends over time;

(ii) support the development of estimates on prevalence and incidence of long COVID disaggregated by demographic groups and symptoms;

(iii) better understand the epidemiology, course of illness, risk factors, and vaccine effectiveness in prevention of long COVID;

(iv) advance our understanding of the health and socioeconomic burdens on individuals affected by long COVID, including among different race and ethnicity groups, pregnant people, and those with underlying disabilities;

(v) foster development of new treatments and care models for long COVID based on a better understanding of the pathophysiological mechanisms of the SARS–CoV–2 virus;

(vi) inform decisions related to high-quality support, services, and interventions for long COVID;

(vii) improve data-sharing between agencies and academic and industry researchers about long COVID, to the extent permitted by law; and

(viii) specifically account for the pandemic’s effect on underserved communities and rural populations.

Sec. 5. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The Secretary is authorized and directed to publish this memorandum in the Federal Register.

J.R. Biden, Jr.

Credits

1944–2026 · 14 acts
  1. 1944July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 106–505, title I, § 102, , 114 Stat. 2315
  2. 2002amended Pub. L. 107–188, title I, §§ 141, 144(a), 158, , 116 Stat. 626, 630, 633
  3. 2013Pub. L. 113–5, title II, § 201, , 127 Stat. 170
  4. 2016Pub. L. 114–255, div. A, title III, § 3087, , 130 Stat. 1147
  5. 2019Pub. L. 116–22, title II, § 206, title VII, § 701(c), , 133 Stat. 925, 961
  6. 2022Pub. L. 117–328, div. FF, title II, §§ 2103(a), 2223(a), 2407, , 136 Stat. 5711, 5747, 5788
  7. 2023Pub. L. 118–15, div. B, title III, § 2332, , 137 Stat. 96
  8. 2023Pub. L. 118–22, div. B, title II, § 203(a), , 137 Stat. 120
  9. 2024Pub. L. 118–35, div. B, title I, § 103(a), , 138 Stat. 5
  10. 2024Pub. L. 118–42, div. G, title I, § 103(a), , 138 Stat. 398
  11. 2024Pub. L. 118–158, div. C, title I, § 3103(a), , 138 Stat. 1763
  12. 2025Pub. L. 119–4, div. B, title I, § 2103(a), , 139 Stat. 41
  13. 2025Pub. L. 119–37, div. F, title I, § 6103(a), , 139 Stat. 630
  14. 2026Pub. L. 119–75, div. J, title IV, § 6403(a), , 140 Stat. 688.
Show as published

(July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 106–505, title I, § 102, , 114 Stat. 2315; amended Pub. L. 107–188, title I, §§ 141, 144(a), 158, , 116 Stat. 626, 630, 633; Pub. L. 113–5, title II, § 201, , 127 Stat. 170; Pub. L. 114–255, div. A, title III, § 3087, , 130 Stat. 1147; Pub. L. 116–22, title II, § 206, title VII, § 701(c), , 133 Stat. 925, 961; Pub. L. 117–328, div. FF, title II, §§ 2103(a), 2223(a), 2407, , 136 Stat. 5711, 5747, 5788; Pub. L. 118–15, div. B, title III, § 2332, , 137 Stat. 96; Pub. L. 118–22, div. B, title II, § 203(a), , 137 Stat. 120; Pub. L. 118–35, div. B, title I, § 103(a), , 138 Stat. 5; Pub. L. 118–42, div. G, title I, § 103(a), , 138 Stat. 398; Pub. L. 118–158, div. C, title I, § 3103(a), , 138 Stat. 1763; Pub. L. 119–4, div. B, title I, § 2103(a), , 139 Stat. 41; Pub. L. 119–37, div. F, title I, § 6103(a), , 139 Stat. 630; Pub. L. 119–75, div. J, title IV, § 6403(a), , 140 Stat. 688.)

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