§ 290b. Establishment and duties of Foundation

Footnotes

1. 1 So in original. Probably should be “subsection”.
2. 2 See References in Text note below.

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. 1944

   National Institutes of Health Amendments of 1990

   Pub. L. 101–613 § 2 · 104 Stat. 3224

   Enacted · 42 U.S.C. § 290b

   July 1, 1944, ch. 373, title IV, § 499, formerly § 499A, as added Pub. L. 101–613, § 2, Nov. 16, 1990, 104 Stat. 3224

   Source evidence

   Code source credit
   July 1, 1944, ch. 373, title IV, § 499, formerly § 499A, as added Pub. L. 101–613, § 2, Nov. 16, 1990, 104 Stat. 3224

   Enacted provision · exact public law section
   SEC. 2. ESTABLISHMENT OF NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH. Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end thereof the following new part: “Part H— National Foundation for Biomedical Research “SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION. “(a) In General.— The Secretary shall establish a nonprofit corporation to be known as the National Foundation for Biomedical Research (hereafter in this section referred to as the ‘Foundation’). The Foundation shall not, except for the purposes of the Ethics in Government Act and the Technology Transfer Act, be an agency or instrumentality of the United States Government. “(b) Duties.— “(1) Establishment of fund for endowing research positions AT national institutes of health.— “(A) The Foundation shall establish a fund whose primary purpose shall be to provide endowments for positions at the National Institutes of Health to conduct biomedical research. Such positions may be held by scientists without regard to whether the scientists are employees of the Federal Government. “(B) In addition to the purpose described in subparagraph (A), the fund established under such subparagraph may be expended to recruit scientists to hold the positions endowed by the fund. “(C) The purposes for which an endowment under subparagraph (A) may be expended include support for the staffing, equipment, and quarters for the biomedical re-search conducted by scientists holding endowed positions under such subparagraph. “(2) Applicability of certain standards regarding non-federal researchers.— In the case of scientists holding endowed positions under paragraph (1)(A) who are not employees of the Federal Government, the Foundation shall negotiate a memorandum of understanding with the Director of the National Institutes of Health, subject to the approval of the Sec-retary, that specifies that any such scientist shall observe the ethical and procedural standards regulating research and re-search finding (including publications and patents) that are followed by scientists conducting research as employees of such Institutes, including standards under this Act, the Ethics in Government Act, and the Technology Transfer Act. “(3) Additional duties.— The Foundation shall provide for biennial audits of the financial condition of the Foundation. “(c) Board of Directors.— “(1) Composition.— “(A) The Foundation shall have a Board of Directors (hereafter referred to in this section as the ߢBoard’), which shall be composed of ex officio and appointed members in accordance with this subsection. All members of the Foundation shall be voting members. “(B) The ex officio members of the Council shall be— “(i) the Chairman and ranking minority member of the Subcommittee on Health and the Environment (Committee on Energy and Commerce) or their designees, in the case of the House of Representatives; “(ii) the Chairman and ranking minority member of the Committee on Labor and Human Resources or their designees, in the case of the Senate; and “(iii) the Director of the National Institutes of Health. “(C) The ex officio members of the Board under subparagraph (B) shall appoint to the Council 9 individuals from among a list of candidates to be provided by the National Academy of Science. Of such appointed members— “(i) 4 shall be representative of the general bio-medical field; “(ii) 2 shall be representatives of the general biobehavorial field; and “(iii) 3 shall be representatives of the general public. “(2) Chair.— The ex officio members of the Board under paragraph (1)(B) shall designate an appointed member of the Board to serve as the Chair of the Board. “(3) Terms and vacancies.— “(A) The term of office of each member of the Board appointed under paragraph (2)(C) shall be 5 years, except that the terms of offices for the initial appointed members of the Board shall expire as determined by the ex officio members and the Chair. “(B) Any vacancy in the membership of the Board shall be filled in the manner in which the original position was made and shall not affect the power of the remaining members to execute the duties of the Board. “(C) If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual. “(D) A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed. “(4) Compensation.— Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board. “(d) Incorporation.— The initial members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation. “(e) Nonprofit status.— The Foundation shall be considered to be a corporation under section 501(c) of the Internal Revenue Code of 1986, and shall be subject to the provisions of such section. “(f) Executive Director.— “(1) In general.— The Foundation shall have an Executive Director who shall be appointed by the Board and shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe. “(2) Compensation.— The rate of compensation of the Executive Director shall be fixed by the Board. “(g) Powers.— In carrying out subsection (b), the Foundation may— “(1) operate under the direction of its Board; “(2) adopt, alter, and use a corporate seal, which shall be judicially noticed; “(3) provide for 1 or more officers, employees, and agents, as may be necessary, define their duties, and require surety bonds or make other provisions against losses occasioned by acts of such persons; “(4) hire, promote, compensate, and discharge officers and employees of the Foundation; “(5) prescribe by its Board its bylaws, that shall be consistent with law, and that shall provide for the manner in which— “(A) its officers, employees, and agents are selected; “(B) its property is acquired, held, and transferred; “(C) its general operations are to be conducted; and “(D) the privileges granted by law are exercised and enjoyed; “(6) with the consent of any executive department or independent agency, use the information, services, staff, and facilities of such in carrying out this section; “(7) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction; “(8) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this subtitle; “(9) establish a mechanism for the selection of candidates, subject to the approval of the Director of the National Institutes of Health or the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, for the endowed scientific positions within the organizational structure of the intramural research programs of the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration and candidates for participation in the National Institutes of Health Scholars program; “(10) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material; “(11) take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees; “(12) accept, hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation; “(13) enter into such other contracts, leases, cooperative Government contracts. agreements, and other transactions as the Executive Director considers appropriate to conduct the activities of the Foundation; “(14) appoint other groups of advisors as may be determined necessary from time to time to carry out the functions of the Foundation; and “(15) exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this subtitle. “(h) Administrative Control.— No participant in the program established under this part shall exercise any administrative control over any Federal employee. “(i) Funding — “(1) Authorization of appropriations.— Subject to paragraph (2), for the purpose of carrying out this part, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 1995. “(2) Limitations.— “(A) Amounts appropriated under paragraph (1) or made available under subparagraph (C) may not be provided to the fund established under subsection (b)(1)(A). “(B) For the first fiscal year for which amounts are appropriated under paragraph (1), $200,000 is authorized to be appropriated. “(C) With respect to the first fiscal year for which amounts are appropriated under paragraph (1), the Secretary may, from amounts appropriated for such fiscal year for the programs of the Department of Health and Human Services, make available not more than $200,000 for carrying out this part, subject to subparagraph (A).”.

2. 1991

   Pub. L. 102–170 § 216(1) · 105 Stat. 1107

   Substituted · 42 U.S.C. § 290b(c)(1)(C)

   Pub. L. 102–170, § 216(1), substituted “11” for “9”

   Source evidence

   Code amendment note
   Subsec. (c)(1)(C). Pub. L. 102–170, § 216(1), substituted “11” for “9”.

3. 1991

   Pub. L. 102–170 § 216(2) · 105 Stat. 1107

   Substituted · 42 U.S.C. § 290b(c)(1)(C)(iii)

   Pub. L. 102–170, § 216(2), substituted “5” for “3”

   Source evidence

   Code amendment note
   Subsec. (c)(1)(C)(iii). Pub. L. 102–170, § 216(2), substituted “5” for “3”.

4. 1992

   ADAMHA Reorganization Act

   Pub. L. 102–321 title I § 163(b)(6) · 106 Stat. 323

   Struck · 42 U.S.C. § 290b(g)(9)

   Pub. L. 102–321 struck out “or the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration” after “Director of the National Institutes of Health” and “and the Alcohol, Drug Abuse, and Mental Health Administration” after “research programs of the National Institutes of Health”

   Source evidence

   Code amendment note
   Subsec. (g)(9). Pub. L. 102–321 struck out “or the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration” after “Director of the National Institutes of Health” and “and the Alcohol, Drug Abuse, and Mental Health Administration” after “research programs of the National Institutes of Health”.

   Enacted provision · exact public law section
   (6) in section 499A(g)(9) (42 U.S.C. 290b(g)(9))— (A) by striking out “or the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration”; and (B) by striking out “and the Alcohol, Drug Abuse, and Mental Health Administration”; and

5. 1993

   National Institutes of Health Revitalization Act of 1993

   Pub. L. 103–43 § 1701(1) · 107 Stat. 122

   1. Inserted · 42 U.S.C. § 290b(a)

      Pub. L. 103–43, § 1701(1), inserted “, acting through the Director of NIH,” after “Secretary shall”

   2. Struck · 42 U.S.C. § 290b(a)

      Pub. L. 103–43, § 1701(1), struck out “, except for the purposes of the Ethics in Government Act and the Technology Transfer Act,” after “shall not”

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 103–43, § 1701(1), inserted “, acting through the Director of NIH,” after “Secretary shall” and struck out “, except for the purposes of the Ethics in Government Act and the Technology Transfer Act,” after “shall not”.

   Enacted provision · exact public law section
   (1) in subsection (a)— (A) by inserting “, acting through the Director of NIH,” after “Secretary shall”; and (B) by striking “, except for” and all that follows through “Transfer Act,”;

6. 1993

   National Institutes of Health Revitalization Act of 1993

   Pub. L. 103–43 § 1701(3) · 107 Stat. 122

   1. Added · 42 U.S.C. § 290b(b)

      Pub. L. 103–43, § 1701(3), added subsec. (b)

   2. Struck · 42 U.S.C. § 290b(b)

      Pub. L. 103–43, § 1701(3), struck out heading and text of former subsec. (b). Text related to duties of Foundation

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 103–43, § 1701(3), added subsec. (b) and struck out heading and text of former subsec. (b). Text related to duties of Foundation.

   Enacted provision · exact public law section
   (3) by striking subsection (b) and inserting the following subsections: “(b) Purpose of Foundation.— The purpose of the Foundation shall be to support the National Institutes of Health in its mission, and to advance collaboration with biomedical researchers from universities, industry, and nonprofit organizations. “(c) Certain Activities of Foundation.— “(1) In general.— In carrying out subsection (b), the Foundation may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in sup-port of the following activities with respect to the purpose described in such subsection: “(A) A program to provide and administer endowed positions that are associated with the research program of the National Institutes of Health. Such endowments may be expended for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the endowed positions. “(B) A program to provide and administer fellowships and grants to research personnel in order to work and study in association with the National Institutes of Health. Such fellowships and grants may include stipends, travel, health insurance benefits and other appropriate expenses. The recipients of fellowships shall be selected by the donors and the Foundation upon the recommendation of the National Institutes of Health employees in the laboratory where the fellow would serve, and shall be subject to the agreement of the Director of the National Institutes of Health and the Executive Director of the Foundation. “(C) Supplementary programs to provide for— “(i) scientists of other countries to serve in research capacities in the United States in association with the National Institutes of Health or elsewhere, or opportunities for employees of the National Institutes of Health or other public health officials in the United States to serve in such capacities in other countries, or both; “(ii) the conduct and support of studies, projects, and research, which may include stipends, travel and other support for personnel in collaboration with national and international non-profit and for-profit organizations; “(iii) the conduct and support of forums, meetings, conferences, courses, and training workshops that may include undergraduate, graduate, post-graduate, and post-doctoral accredited courses and the maintenance of accreditation of such courses by the Foundation at the State and national level for college or continuing education credits or for degrees; “(iv) programs to support and encourage teachers and students of science at all levels of education and programs for the general public which promote the understanding of science; “(v) programs for writing, editing, printing, publishing, and vending of books and other materials; and “(vi) the conduct of other activities to carry out and support the purpose described in subsection (b). “(2) Fees.— The Foundation may assess fees for the provision of professional, administrative and management services by the Foundation in amounts determined reasonable and appropriate by the Executive Director. “(3) Authority of foundation.— The Foundation shall be the sole entity responsible for carrying out the activities described in this subsection.”;

7. 1993

   National Institutes of Health Revitalization Act of 1993

   Pub. L. 103–43 § 1701(3) · 107 Stat. 122

   Redesignated · 42 U.S.C. § 290b(c)

   Pub. L. 103–43, § 1701(3), added subsec. (c). Former subsec. (c) redesignated (d)

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 103–43, § 1701(3), added subsec. (c). Former subsec. (c) redesignated (d).

   Enacted provision · exact public law section
   (3) by striking subsection (b) and inserting the following subsections: “(b) Purpose of Foundation.— The purpose of the Foundation shall be to support the National Institutes of Health in its mission, and to advance collaboration with biomedical researchers from universities, industry, and nonprofit organizations. “(c) Certain Activities of Foundation.— “(1) In general.— In carrying out subsection (b), the Foundation may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in sup-port of the following activities with respect to the purpose described in such subsection: “(A) A program to provide and administer endowed positions that are associated with the research program of the National Institutes of Health. Such endowments may be expended for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the endowed positions. “(B) A program to provide and administer fellowships and grants to research personnel in order to work and study in association with the National Institutes of Health. Such fellowships and grants may include stipends, travel, health insurance benefits and other appropriate expenses. The recipients of fellowships shall be selected by the donors and the Foundation upon the recommendation of the National Institutes of Health employees in the laboratory where the fellow would serve, and shall be subject to the agreement of the Director of the National Institutes of Health and the Executive Director of the Foundation. “(C) Supplementary programs to provide for— “(i) scientists of other countries to serve in research capacities in the United States in association with the National Institutes of Health or elsewhere, or opportunities for employees of the National Institutes of Health or other public health officials in the United States to serve in such capacities in other countries, or both; “(ii) the conduct and support of studies, projects, and research, which may include stipends, travel and other support for personnel in collaboration with national and international non-profit and for-profit organizations; “(iii) the conduct and support of forums, meetings, conferences, courses, and training workshops that may include undergraduate, graduate, post-graduate, and post-doctoral accredited courses and the maintenance of accreditation of such courses by the Foundation at the State and national level for college or continuing education credits or for degrees; “(iv) programs to support and encourage teachers and students of science at all levels of education and programs for the general public which promote the understanding of science; “(v) programs for writing, editing, printing, publishing, and vending of books and other materials; and “(vi) the conduct of other activities to carry out and support the purpose described in subsection (b). “(2) Fees.— The Foundation may assess fees for the provision of professional, administrative and management services by the Foundation in amounts determined reasonable and appropriate by the Executive Director. “(3) Authority of foundation.— The Foundation shall be the sole entity responsible for carrying out the activities described in this subsection.”;

8. 1993

   National Institutes of Health Revitalization Act of 1993

   Pub. L. 103–43 § 1701(2) · 107 Stat. 122

   Redesignated · 42 U.S.C. § 290b(d)

   Pub. L. 103–43, § 1701(2), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (f)

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 103–43, § 1701(2), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (f).

   Enacted provision · exact public law section
   (2) by redesignating subsections (c), (d), (e), (f), (g), (h), and (i) as subsections (3), (f), (g), (h), (i), (j), and (m), respectively;

9. 1993

   National Institutes of Health Revitalization Act of 1993

   Pub. L. 103–43 § 1701(4)(A) · 107 Stat. 122

   1. Substituted · 42 U.S.C. § 290b(d)(1)

      Pub. L. 103–43, § 1701(4)(A), substituted “appointed members of the Board” for “members of the Foundation” in subpar. (C)

   2. Substituted · 42 U.S.C. § 290b(d)(1)

      Pub. L. 103–43, § 1701(4)(A), substituted “Board” for “Council” in subpar. (C)

   3. Substituted · 42 U.S.C. § 290b(d)(1)

      Pub. L. 103–43, § 1701(4)(A), substituted “appoint to the Board” for “appoint to the Council” in subpar. (C)

   4. Added · 42 U.S.C. § 290b(d)(1)

      Pub. L. 103–43, § 1701(4)(A), added subpars. (D) to (G)

   Source evidence

   Code amendment note
   Subsec. (d)(1). Pub. L. 103–43, § 1701(4)(A), substituted “appointed members of the Board” for “members of the Foundation” in subpar. (A), “Board” for “Council” in subpar. (B), and “appoint to the Board” for “appoint to the Council” in subpar. (C), and added subpars. (D) to (G).

   Enacted provision · exact public law section
   (A) in paragraph (1)— (i) by striking “members of the Foundation” in subparagraph (A) and inserting “appointed members of the Board”; (ii) by striking “Council” in subparagraph (B) and inserting “Board”; (iii) by striking “Council” in subparagraph (C) and inserting “Board”; and (iv) by adding at the end the following subparagraphs: “(D) (i) Not later than 30 days after the date of the enactment of the National Institutes of Health Revitalization Act of 1993, the Director of the National Institutes of Health shall convene a meeting of the ex officio members of the Board to— “(I) incorporate the Foundation and establish the general policies of the Foundation for carrying out the purposes of subsection (b), including the establishment of the bylaws of the Foundation; and “(II) appoint the members of the Board in accordance with subparagraph (C). “(ii) Upon the appointment of the members of the Board under clause (i)(II), the terms of service of the ex officio members of the Board as members of the Board shall terminate. “(E) The agreement of not less than three-fifths of the members of the ex officio members of the Board shall be required for the appointment of each member to the initial Board. “(F) No employee of the National Institutes of Health shall be appointed as a member of the Board. “(G) The Board may, through amendments to the bylaws of the Foundation, provide that the number of members of the Board shall be greater than the number specified in subparagraph (C).”;

10. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(4)(B) · 107 Stat. 122

    1. Amended · 42 U.S.C. § 290b(d)(2)

       Pub. L. 103–43, § 1701(4)(B), designated existing provisions as subpar. (A)

    2. Substituted · 42 U.S.C. § 290b(d)(2)

       Pub. L. 103–43, § 1701(4)(B), substituted “an individual to serve as the initial Chair” for “an appointed member of the Board to serve as the Chair”

    3. Added · 42 U.S.C. § 290b(d)(2)

       Pub. L. 103–43, § 1701(4)(B), added subpar. (B)

    Source evidence

    Code amendment note
    Subsec. (d)(2). Pub. L. 103–43, § 1701(4)(B), designated existing provisions as subpar. (A), substituted “an individual to serve as the initial Chair” for “an appointed member of the Board to serve as the Chair”, and added subpar. (B).

    Enacted provision · exact public law section
    (B) in paragraph (2)— (i) by striking “The ex officio” and inserting the following: “(A) The ex officio”; (ii) by striking “an appointed member of the Board to serve as the Chair” and inserting “an individual to serve as the initial Chair”; and (iii) by adding at the end the following subparagraph: “(B) Upon the termination of the term of service of the initial Chair of the Board, the appointed members of the Board shall elect a member of the Board to serve as the Chair of the Board.”;

11. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(4)(C) · 107 Stat. 122

    Substituted · 42 U.S.C. § 290b(d)(3)(A)

    Pub. L. 103–43, § 1701(4)(C), substituted “(1)(C)” for “(2)(C)”

    Source evidence

    Code amendment note
    Subsec. (d)(3)(A). Pub. L. 103–43, § 1701(4)(C), substituted “(1)(C)” for “(2)(C)”.

    Enacted provision · exact public law section
    (C) in paragraph (3)(A), by striking “(2)(C)” and inserting “(1)(C)” and

12. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(4)(D) · 107 Stat. 122

    Added · 42 U.S.C. § 290b(d)(5); 42 U.S.C. § 290b(d)(6)

    Pub. L. 103–43, § 1701(4)(D), added pars. (5) and (6)

    Source evidence

    Code amendment note
    Subsec. (d)(5), (6). Pub. L. 103–43, § 1701(4)(D), added pars. (5) and (6).

    Enacted provision · exact public law section
    (D) by adding at the end the following paragraphs: “(5) Meetings and quorum.— A majority of the members of the Board shall constitute a quorum for purposes of conducting the business of the Board. “(6) Certain bylaws.— “(A) In establishing bylaws under this subsection, the Board shall ensure that the following are provided for: “(i) Policies for the selection of the officers, employees, agents, and contractors of the Foundation. “(ii) Policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation. Policies with respect to ethical standards shall ensure that officers, employees and agents of the Foundation (including members of the Board) avoid encumbrances that would result in a conflict of interest, including a financial conflict of interest or a divided allegiance. Such policies shall include requirements for the provision of information concerning any ownership or controlling interest in entities related to the activities of the Foundation by such officers, employees and agents and their spouses and relatives. “(iii) Policies for the conduct of the general operations of the Foundation. “(iv) Policies for writing, editing, printing, publishing, and vending of books and other materials. “(B) In establishing bylaws under this subsection, the Board shall ensure that such bylaws (and activities carried out under the bylaws) do not— “(i) reflect unfavorably upon the ability of the Foundation or the National Institutes of Health to carry out its responsibilities or official duties in a fair and objective manner; or “(ii) compromise, or appear to compromise, the integrity of any governmental agency or program, or any officer or employee involved in such program.”;

13. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(2) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(e)

    Pub. L. 103–43, § 1701(2), redesignated subsec. (e) as (g)

    Source evidence

    Code amendment note
    Subsec. (e). Pub. L. 103–43, § 1701(2), redesignated subsec. (e) as (g).

    Enacted provision · exact public law section
    (2) by redesignating subsections (c), (d), (e), (f), (g), (h), and (i) as subsections (3), (f), (g), (h), (i), (j), and (m), respectively;

14. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(2) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(f)(h)

    Pub. L. 103–43, § 1701(2), redesignated subsecs. (d) to (f) as (f) to (h), respectively. Former subsecs. (g) and (h) redesignated (i) and (j), respectively

    Source evidence

    Code amendment note
    Subsecs. (f) to (h). Pub. L. 103–43, § 1701(2), redesignated subsecs. (d) to (f) as (f) to (h), respectively. Former subsecs. (g) and (h) redesignated (i) and (j), respectively.

    Enacted provision · exact public law section
    (2) by redesignating subsections (c), (d), (e), (f), (g), (h), and (i) as subsections (3), (f), (g), (h), (i), (j), and (m), respectively;

15. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(2) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(i)

    Pub. L. 103–43, § 1701(2), redesignated subsec. (g) as (i). Former subsec. (i) redesignated (m)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 103–43, § 1701(2), redesignated subsec. (g) as (i). Former subsec. (i) redesignated (m).

    Enacted provision · exact public law section
    (2) by redesignating subsections (c), (d), (e), (f), (g), (h), and (i) as subsections (3), (f), (g), (h), (i), (j), and (m), respectively;

16. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(A) · 107 Stat. 122

    Inserted · 42 U.S.C. § 290b(i)(4)

    Pub. L. 103–43, § 1701(5)(A), inserted before period at end “, and define the duties of the officers and employees”

    Source evidence

    Code amendment note
    Subsec. (i)(4). Pub. L. 103–43, § 1701(5)(A), inserted before period at end “, and define the duties of the officers and employees”.

    Enacted provision · exact public law section
    (A) in paragraph (4), by inserting “, and define the duties of the officers and employees” before the semicolon at the end;

17. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(B) · 107 Stat. 122

    1. Redesignated · 42 U.S.C. § 290b(i)(5); 42 U.S.C. § 290b(i)(6)

       Pub. L. 103–43, § 1701(5)(B), (C), redesignated par. (6) as (5)

    2. Struck · 42 U.S.C. § 290b(i)(5); 42 U.S.C. § 290b(i)(6)

       Pub. L. 103–43, § 1701(5)(B), (C), struck out former par. (5) which read as follows: “prescribe by its Board its bylaws, that shall be consistent with law, and that shall provide for the manner in which—

    Source evidence

    Code amendment note
    Subsec. (i)(5), (6). Pub. L. 103–43, § 1701(5)(B), (C), redesignated par. (6) as (5) and struck out former par. (5) which read as follows: “prescribe by its Board its bylaws, that shall be consistent with law, and that shall provide for the manner in which—

    “(A) its officers, employees, and agents are selected; “(B) its property is acquired, held, and transferred; “(C) its general operations are to be conducted; and “(D) the privileges granted by law are exercised and enjoyed;”.

    Enacted provision · exact public law section
    (B) by striking paragraph (5);

18. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(C) · 107 Stat. 122

    1. Redesignated · 42 U.S.C. § 290b(i)(7)

       Pub. L. 103–43, § 1701(5)(C), (D), redesignated par. (8) as (7)

    2. Redesignated · 42 U.S.C. § 290b(i)(7)

       Pub. L. 103–43, § 1701(5)(C), (D), substituted “part” for “subtitle”. Former par. (7) redesignated (6)

    Source evidence

    Code amendment note
    Subsec. (i)(7). Pub. L. 103–43, § 1701(5)(C), (D), redesignated par. (8) as (7) and substituted “part” for “subtitle”. Former par. (7) redesignated (6).

    Enacted provision · exact public law section
    (C) by redesignating paragraphs (6) through (14), as paragraphs (5) through (13), respectively;

19. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(C) · 107 Stat. 122

    1. Redesignated · 42 U.S.C. § 290b(i)(8)

       Pub. L. 103–43, § 1701(5)(C), (E), redesignated par. (9) as (8)

    2. Substituted · 42 U.S.C. § 290b(i)(8)

       Pub. L. 103–43, § 1701(5)(C), (E), substituted “establish a process for the selection of candidates for positions under subsection (c)” for “establish a mechanism for the selection of candidates, subject to the approval of the Director of the National Institutes of Health, for the endowed scientific positions within the organizational structure of the intramural research programs of the National Institutes of Health and candidates for participation in the National Institutes of Health Scholars program”

    Source evidence

    Code amendment note
    Subsec. (i)(8). Pub. L. 103–43, § 1701(5)(C), (E), redesignated par. (9) as (8) and substituted “establish a process for the selection of candidates for positions under subsection (c)” for “establish a mechanism for the selection of candidates, subject to the approval of the Director of the National Institutes of Health, for the endowed scientific positions within the organizational structure of the intramural research programs of the National Institutes of Health and candidates for participation in the National Institutes of Health Scholars program”.

    Enacted provision · exact public law section
    (C) by redesignating paragraphs (6) through (14), as paragraphs (5) through (13), respectively;

20. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(C) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(i)(9); 42 U.S.C. § 290b(i)(10)

    Pub. L. 103–43, § 1701(5)(C), redesignated pars. (10) and (11) as (9) and (10), respectively. Former par. (9) redesignated (8)

    Source evidence

    Code amendment note
    Subsec. (i)(9), (10). Pub. L. 103–43, § 1701(5)(C), redesignated pars. (10) and (11) as (9) and (10), respectively. Former par. (9) redesignated (8).

    Enacted provision · exact public law section
    (C) by redesignating paragraphs (6) through (14), as paragraphs (5) through (13), respectively;

21. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(C) · 107 Stat. 122

    1. Redesignated · 42 U.S.C. § 290b(i)(11)

       Pub. L. 103–43, § 1701(5)(C), (F), redesignated par. (12) as (11)

    2. Redesignated · 42 U.S.C. § 290b(i)(11)

       Pub. L. 103–43, § 1701(5)(C), (F), inserted “solicit” before “accept”. Former par. (11) redesignated (10)

    Source evidence

    Code amendment note
    Subsec. (i)(11). Pub. L. 103–43, § 1701(5)(C), (F), redesignated par. (12) as (11) and inserted “solicit” before “accept”. Former par. (11) redesignated (10).

    Enacted provision · exact public law section
    (C) by redesignating paragraphs (6) through (14), as paragraphs (5) through (13), respectively;

22. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(C) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(i)(12); 42 U.S.C. § 290b(i)(13)

    Pub. L. 103–43, § 1701(5)(C), redesignated pars. (13) and (14) as (12) and (13), respectively. Former par. (12) redesignated (11)

    Source evidence

    Code amendment note
    Subsec. (i)(12), (13). Pub. L. 103–43, § 1701(5)(C), redesignated pars. (13) and (14) as (12) and (13), respectively. Former par. (12) redesignated (11).

    Enacted provision · exact public law section
    (C) by redesignating paragraphs (6) through (14), as paragraphs (5) through (13), respectively;

23. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(G) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(i)(14)

    Pub. L. 103–43, § 1701(5)(G), (H), added par. (14). Former par. (14) redesignated (13)

    Source evidence

    Code amendment note
    Subsec. (i)(14). Pub. L. 103–43, § 1701(5)(G), (H), added par. (14). Former par. (14) redesignated (13).

    Enacted provision · exact public law section
    (G) by striking “and” at the end of paragraph (13) (as so redesignated);

24. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(5)(I) · 107 Stat. 122

    Substituted · 42 U.S.C. § 290b(i)(15)

    Pub. L. 103–43, § 1701(5)(I), substituted “part” for “subtitle”

    Source evidence

    Code amendment note
    Subsec. (i)(15). Pub. L. 103–43, § 1701(5)(I), substituted “part” for “subtitle”.

    Enacted provision · exact public law section
    (I) in paragraph (15), by striking “this subtitle” and inserting “this part”,

25. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(2) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(j)

    Pub. L. 103–43, § 1701(2), redesignated subsec. (h) as (j)

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 103–43, § 1701(2), redesignated subsec. (h) as (j).

    Enacted provision · exact public law section
    (2) by redesignating subsections (c), (d), (e), (f), (g), (h), and (i) as subsections (3), (f), (g), (h), (i), (j), and (m), respectively;

26. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(6) · 107 Stat. 122

    Added · 42 U.S.C. § 290b(k); 42 U.S.C. § 290b(l)

    Pub. L. 103–43, § 1701(6), added subsecs. (k) and (l)

    Source evidence

    Code amendment note
    Subsecs. (k), (l). Pub. L. 103–43, § 1701(6), added subsecs. (k) and (l).

    Enacted provision · exact public law section
    (6) by inserting after subsection (j) (as so redesignated), the following subsections: “(k) General Provisions.— “(1) Foundation integrity.— The members of the Board shall be accountable for the integrity of the operations of the Foundation and shall ensure such integrity through the development and enforcement of criteria and procedures relating to standards of conduct (including those developed under subsection (d)(2)(B)(i)(II)), financial disclosure statements, conflict of interest rules, recusal and waiver rules, audits and other matter determined appropriate by the Board. “(2) Financial conflicts of interest.— Any individual who is an officer, employee, or member of the Board of the Foundation may not (m accordance with policies and requirements developed under subsection (d)(2)(B)(i)(II)) personally or substantially participate in the consideration or determination by the Foundation of any matter that would directly or predictably affect any financial interest of the individual or a relative (as such term is defined in section 109(16) of the Ethics in Government Act of 1978) of the individual, of any business organization or other entity, or of which the individual is an officer or employee, or is negotiating for employment, or in which the individual has any other financial interest. “(3) Audits; availability of records.— The Foundation shall— “(A) provide for annual audits of the financial condition of the Foundation; and “(B) make such audits, and all other records, documents, and other papers of the Foundation, available to the Secretary and the Comptroller General of the United States for examination or audit. “(4) Reports.— “(A) Not later than 5 months following the end of each fiscal year, the Foundation shall publish a report describing the activities of the Foundation during the preceding fiscal year. Each such report shall include for the fiscal year involved a comprehensive statement of the operations, activities, financial condition, and accomplishments of the Foundation. “(B) With respect to the financial condition of the Foundation, each report under subparagraph (A) shall include the source, and a description of, all gifts or grants to the Foundation of real or personal property, and the source and amount of all gifts or grants to the Foundation of money. Each such report shall include a specification of any restrictions on the purposes for which gifts or grants to the Foundation may be used. “(C) The Foundation shall make copies of each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy. “(D) The Board shall annually hold a public meeting to summarize the activities of the Foundation and distribute written reports concerning such activities and the scientific results derived from such activities. “(5) Service of federal employees.— Federal employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its function, so long as the employees do not direct or control Foundation activities. “(6) Relationship with existing entities.— The Foundation may, pursuant to appropriate agreements, merge with, acquire, or use the resources of existing nonprofit private corporations with missions similar to the purposes of the Foundation, such as the Foundation for Advanced Education in the Sciences. “(7) Intellectual property rights.— The Board shall adopt written standards with respect to the ownership of any intellectual property rights derived from the collaborative efforts of the Foundation prior to the commencement of such efforts. “(8) National institutes of health amendments of 1990.— The activities conducted in support of the National Institutes of Health Amendments of 1990 (Public Law 101–613), and the amendments made by such Act, shall not be nullified by the enactment of this section. “(9) Limitation of activities.— The Foundation shall exist solely as an entity to work in collaboration with the research programs of the National Institutes of Health. The Foundation may not undertake activities (such as the operation of independent laboratories or competing for Federal research funds) that are independent of those of the National Institutes of Health research programs. “(10) Transfer of funds.— The Foundation may not transfer funds to the National Institutes of Health. “(l) Duties of the Director.— “(1) Applicability of certain standards to non-federal employees.— In the case of any individual who is not an employee of the Federal Government and who serves in association with the National Institutes of Health, with respect to financial assistance received from the Foundation, the Foundation may not provide the assistance of, or otherwise permit the work at the National Institutes of Health to begin until a memorandum of understanding between the individual and the Director of the National Institutes of Health, or the designee of such Director, has been executed specifying that the individual shall be subject to such ethical and procedural standards of conduct relating to duties performed at the National Institutes of Health, as the Director of the National Institutes of Health determines is appropriate. “(2) Support services.— The Director of the National Institutes of Health may provide facilities, utilities and support services to the Foundation if it is determined by the Director to be advantageous to the research programs of the National Institutes of Health.”;

27. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(7) · 107 Stat. 122

    Amended · 42 U.S.C. § 290b(m)

    Pub. L. 103–43, § 1701(7), amended heading and text of subsec. (m) generally. Prior to amendment, text read as follows:

    Source evidence

    Code amendment note
    Subsec. (m). Pub. L. 103–43, § 1701(7), amended heading and text of subsec. (m) generally. Prior to amendment, text read as follows:

    “(1) Authorization of appropriations.—Subject to paragraph (2), for the purpose of carrying out this part, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 1995. “(2) Limitations.— “(A) Amounts appropriated under paragraph (1) or made available under subparagraph (C) may not be provided to the fund established under subsection (b)(1)(A) of this section. “(B) For the first fiscal year for which amounts are appropriated under paragraph (1), $200,000 is authorized to be appropriated. “(C) With respect to the first fiscal year for which amounts are appropriated under paragraph (1), the Secretary may, from amounts appropriated for such fiscal year for the programs of the Department of Health and Human Services, make available not more than $200,000 for carrying out this part, subject to subparagraph (A).”

    Enacted provision · exact public law section
    (7) in subsection (m) (as so redesignated), by amending the subsection to read as follows: “(m) Funding.— “(1) Authorization of appropriations.— For the purpose of carrying out this part, there is authorized to be appropriated an aggregate $200,000 for the fiscal years 1994 and 1995. “(2) Limitation regarding other funds.— Amounts appropriated under any provision of law other than paragraph (1) may not be expended to establish or operate the Foundation.”; and

28. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(2) · 107 Stat. 122

    Redesignated · 42 U.S.C. § 290b(m)

    Pub. L. 103–43, § 1701(2), redesignated subsec. (i) as (m)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 103–43, § 1701(2), redesignated subsec. (i) as (m).

    Enacted provision · exact public law section
    (2) by redesignating subsections (c), (d), (e), (f), (g), (h), and (i) as subsections (3), (f), (g), (h), (i), (j), and (m), respectively;

29. 1993

    National Institutes of Health Revitalization Act of 1993

    Pub. L. 103–43 § 1701(8) · 107 Stat. 122

    Added · 42 U.S.C. § 290b(n)

    Pub. L. 103–43, § 1701(8), added subsec. (n)

    Source evidence

    Code amendment note
    Subsec. (n). Pub. L. 103–43, § 1701(8), added subsec. (n).

    Enacted provision · exact public law section
    (8) by adding at the end the following subsection: “(n) Report on Adequacy of Compliance.— “(1) In general.— With respect to the mission and function of the Foundation, the Comptroller General of the United States shall conduct an audit to determine— “(A) whether the Foundation is in compliance with the guidelines established under this section; and “(B) whether the procedures utilized under this section are adequate to prevent conflicts of interest involving the Foundation, the employees of the Foundation or members of the Board of the Foundation. “(2) Report.— Not later than 18 months after the date on which the Foundation is incorporated, the Comptroller General of the United States shall complete the audit required under paragraph (1) and prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings made with respect to such audit.”.

30. 1996

    General Accounting Office Act of 1996

    Pub. L. 104–316 title I § 122(b) · 110 Stat. 3826

    Struck · 42 U.S.C. § 290b(n)

    Pub. L. 104–316 struck out subsec. (n) which required Comptroller General to conduct audit and prepare report to Congress on adequacy of compliance of the Foundation with guidelines established under this section

    Source evidence

    Code amendment note
    Subsec. (n). Pub. L. 104–316 struck out subsec. (n) which required Comptroller General to conduct audit and prepare report to Congress on adequacy of compliance of the Foundation with guidelines established under this section.

    Enacted provision · exact public law section
    (b) Audit of National Foundation for Biomedical Research.— Section 499(n) of the Public Health Service Act (42 U. S. C. 290b(n)) is repealed.

31. 1998

    Health Professions Education Partnerships Act of 1998

    Pub. L. 105–392 § 418(2)(A) · 112 Stat. 3524

    Substituted · 42 U.S.C. § 290b(a)

    Pub. L. 105–392, § 418(2)(A), substituted “Foundation for the National Institutes of Health” for “National Foundation for Biomedical Research”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 105–392, § 418(2)(A), substituted “Foundation for the National Institutes of Health” for “National Foundation for Biomedical Research”.

    Enacted provision · exact public law section
    (A) in subsection (a), by striking “National Foundation for Biomedical Research” and inserting “Foundation for the National Institutes of Health”;

32. 1998

    Health Professions Education Partnerships Act of 1998

    Pub. L. 105–392 § 418(2)(B) · 112 Stat. 3524

    Struck and inserted · 42 U.S.C. § 290b(k)(10)

    Pub. L. 105–392, § 418(2)(B), struck out “not” after “may” and inserted at end “Any funds transferred under this paragraph shall be subject to all Federal limitations relating to federally-funded research.”

    Source evidence

    Code amendment note
    Subsec. (k)(10). Pub. L. 105–392, § 418(2)(B), struck out “not” after “may” and inserted at end “Any funds transferred under this paragraph shall be subject to all Federal limitations relating to federally-funded research.”

    Enacted provision · exact public law section
    (B) in subsection (k)( 10)— (i) by striking “not”; and (ii) by adding at the end the following: “Any funds transferred under this paragraph shall be subject to all Federal limitations relating to federally-funded research.”; and

33. 1998

    Health Professions Education Partnerships Act of 1998

    Pub. L. 105–392 § 418(2)(C) · 112 Stat. 3524

    Substituted · 42 U.S.C. § 290b(m)(1)

    Pub. L. 105–392, § 418(2)(C), substituted “$500,000 for each fiscal year” for “$200,000 for the fiscal years 1994 and 1995”

    Source evidence

    Code amendment note
    Subsec. (m)(1). Pub. L. 105–392, § 418(2)(C), substituted “$500,000 for each fiscal year” for “$200,000 for the fiscal years 1994 and 1995”.

    Enacted provision · exact public law section
    (C) in subsection (m)(1), by striking “$200,000” and all that follows through “1995” and inserting “$500,000 for each fiscal year”.

34. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(1) · 115 Stat. 1408

    Inserted · 42 U.S.C. § 290b(b)

    Pub. L. 107–109, § 13(1), inserted “(including collection of funds for pediatric pharmacologic research)” after “mission”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 107–109, § 13(1), inserted “(including collection of funds for pediatric pharmacologic research)” after “mission”.

    Enacted provision · exact public law section
    (1) in subsection (b), by inserting “(including collection of funds for pediatric pharmacologic research)” after “mission”;

35. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(2) · 115 Stat. 1408

    1. Added · 42 U.S.C. § 290b(c)(1)(C); 42 U.S.C. § 290b(c)(1)(D)

       Pub. L. 107–109, § 13(2), added subpar. (C)

    2. Redesignated · 42 U.S.C. § 290b(c)(1)(C); 42 U.S.C. § 290b(c)(1)(D)

       Pub. L. 107–109, § 13(2), redesignated former subpar. (C) as (D)

    Source evidence

    Code amendment note
    Subsec. (c)(1)(C), (D). Pub. L. 107–109, § 13(2), added subpar. (C) and redesignated former subpar. (C) as (D).

    Enacted provision · exact public law section
    (2) in subsection (c)(1)— (A) by redesignating subparagraph (C) as subparagraph (D); and (B) by inserting after subparagraph (B) the following: “(C) A program to collect funds for pediatric pharmacologic research and studies listed by the Secretary pursuant to section 409I(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(C)).”;

36. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(3)(A)(i) · 115 Stat. 1408

    Added · 42 U.S.C. § 290b(d)(1)(B)(iv)

    Pub. L. 107–109, § 13(3)(A)(i), added cl. (iv)

    Source evidence

    Code amendment note
    Subsec. (d)(1)(B)(iv). Pub. L. 107–109, § 13(3)(A)(i), added cl. (iv).

    Enacted provision · exact public law section
    (i) in subparagraph (B)— (I) in clause (ii), by striking “and” at the end; (II) in clause (iii), by striking the period and inserting “; and”; and (III) by adding at the end the following: “(iv) the Commissioner of Food and Drugs.”; and

37. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(3)(A)(ii) · 115 Stat. 1408

    1. Added · 42 U.S.C. § 290b(d)(1)(C)

       Pub. L. 107–109, § 13(3)(A)(ii), added subpar. (C)

    2. Struck · 42 U.S.C. § 290b(d)(1)(C)

       Pub. L. 107–109, § 13(3)(A)(ii), struck out former subpar. (C) which read as follows: “The ex officio members of the Board under subparagraph (B) shall appoint to the Board 11 individuals from among a list of candidates to be provided by the National Academy of Science. Of such appointed members—

    Source evidence

    Code amendment note
    Subsec. (d)(1)(C). Pub. L. 107–109, § 13(3)(A)(ii), added subpar. (C) and struck out former subpar. (C) which read as follows: “The ex officio members of the Board under subparagraph (B) shall appoint to the Board 11 individuals from among a list of candidates to be provided by the National Academy of Science. Of such appointed members—

    “(i) 4 shall be representative of the general biomedical field; “(ii) 2 shall be representatives of the general biobehavorial field; and “(iii) 5 shall be representatives of the general public.”

    Enacted provision · exact public law section
    (ii) by striking subparagraph (C) and inserting the following: “(C) The ex officio members of the Board under subparagraph (B) shall appoint to the Board individuals from among a list of candidates to be provided by the National Academy of Science. Such appointed members shall include— “(i) representatives of the general biomedical field; “(ii) representatives of experts in pediatric medicine and research; “(iii) representatives of the general biobehavioral field, which may include experts in biomedical ethics; and “(iv) representatives of the general public, which may include representatives of affected industries.”; and

38. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(3)(B) · 115 Stat. 1408

    Changed · 42 U.S.C. § 290b(d)(2)(B)

    Pub. L. 107–109, § 13(3)(B), realigned margin

    Source evidence

    Code amendment note
    Subsec. (d)(2)(B). Pub. L. 107–109, § 13(3)(B), realigned margin.

    Enacted provision · exact public law section
    (B) in paragraph (2), by realigning the margin of subparagraph (B) to align with subparagraph (A);

39. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(5) · 115 Stat. 1408

    Redesignated · 42 U.S.C. § 290b(e)(g)

    Pub. L. 107–109, § 13(5), redesignated subsecs. (f) to (h) as (e) to (g), respectively

    Source evidence

    Code amendment note
    Subsec. (e) to (g). Pub. L. 107–109, § 13(5), redesignated subsecs. (f) to (h) as (e) to (g), respectively.

    Enacted provision · exact public law section
    (5) by redesignating subsections (f) through (m) as subsections (e) through (1), respectively;

40. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(5) · 115 Stat. 1408

    1. Redesignated · 42 U.S.C. § 290b(h)

       Pub. L. 107–109, § 13(5), (6), redesignated subsec. (i) as (h)

    2. Redesignated · 42 U.S.C. § 290b(h)

       Pub. L. 107–109, § 13(5), (6), substituted “solicit,” for “solicit” in par. (11). Former subsec. (h) redesignated (g)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 107–109, § 13(5), (6), redesignated subsec. (i) as (h) and substituted “solicit,” for “solicit” in par. (11). Former subsec. (h) redesignated (g).

    Enacted provision · exact public law section
    (5) by redesignating subsections (f) through (m) as subsections (e) through (1), respectively;

41. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(5) · 115 Stat. 1408

    Redesignated · 42 U.S.C. § 290b(i)

    Pub. L. 107–109, § 13(5), redesignated subsec. (j) as (i). Former subsec. (i) redesignated (h)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 107–109, § 13(5), redesignated subsec. (j) as (i). Former subsec. (i) redesignated (h).

    Enacted provision · exact public law section
    (5) by redesignating subsections (f) through (m) as subsections (e) through (1), respectively;

42. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(5) · 115 Stat. 1408

    Redesignated · 42 U.S.C. § 290b(j)

    Pub. L. 107–109, § 13(5), redesignated subsec. (k) as (j). Former subsec. (j) redesignated (i)

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 107–109, § 13(5), redesignated subsec. (k) as (j). Former subsec. (j) redesignated (i).

    Enacted provision · exact public law section
    (5) by redesignating subsections (f) through (m) as subsections (e) through (1), respectively;

43. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(7) · 115 Stat. 1408

    Struck · 42 U.S.C. § 290b(j)(1)

    Pub. L. 107–109, § 13(7), struck out “(including those developed under subsection (d)(2)(B)(i)(II))” after “procedures relating to standards of conduct”

    Source evidence

    Code amendment note
    Subsec. (j)(1). Pub. L. 107–109, § 13(7), struck out “(including those developed under subsection (d)(2)(B)(i)(II))” after “procedures relating to standards of conduct”.

    Enacted provision · exact public law section
    (7) in paragraphs (1) and (2) of subsection (j) (as so redesignated), by striking “(including those developed under subsection (d)(2)(B)(i)(II))” each place it appears.

44. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(7) · 115 Stat. 1408

    Struck · 42 U.S.C. § 290b(j)(2)

    Pub. L. 107–109, § 13(7), which directed striking out “(including those developed under subsection (d)(2)(B)(i)(II))” in par. (2), could not be executed because those words do not appear in par. (2)

    Source evidence

    Code amendment note
    Subsec. (j)(2). Pub. L. 107–109, § 13(7), which directed striking out “(including those developed under subsection (d)(2)(B)(i)(II))” in par. (2), could not be executed because those words do not appear in par. (2).

    Enacted provision · exact public law section
    (7) in paragraphs (1) and (2) of subsection (j) (as so redesignated), by striking “(including those developed under subsection (d)(2)(B)(i)(II))” each place it appears.

45. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(5) · 115 Stat. 1408

    Redesignated · 42 U.S.C. § 290b(k)

    Pub. L. 107–109, § 13(5), redesignated subsec. (l) as (k). Former subsec. (k) redesignated (j)

    Source evidence

    Code amendment note
    Subsec. (k). Pub. L. 107–109, § 13(5), redesignated subsec. (l) as (k). Former subsec. (k) redesignated (j).

    Enacted provision · exact public law section
    (5) by redesignating subsections (f) through (m) as subsections (e) through (1), respectively;

46. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(4) · 115 Stat. 1408

    1. Amended · 42 U.S.C. § 290b(k)(9)

       Pub. L. 107–109, § 13(4), designated existing provisions as subpar. (A)

    2. Inserted · 42 U.S.C. § 290b(k)(9)

       Pub. L. 107–109, § 13(4), inserted subpar. heading

    3. Added · 42 U.S.C. § 290b(k)(9)

       Pub. L. 107–109, § 13(4), added subpars. (B) and (C)

    Source evidence

    Code amendment note
    Subsec. (k)(9). Pub. L. 107–109, § 13(4), designated existing provisions as subpar. (A), inserted subpar. heading, and added subpars. (B) and (C).

    Enacted provision · exact public law section
    (4) in subsection (k)(9)— (A) by striking “The Foundation” and inserting the following: “(A) In general.— The Foundation”; and (B) by adding at the end the following: “(B) Gifts, grants, and other donations.— “(i) In general.— Gifts, grants, and other donations to the Foundation may be designated for pediatric research and studies on drugs, and funds so designated shall be used solely for grants for research and studies under subsection (c)(1)(C). “(ii) Other gifts.— Other gifts, grants, or donations received by the Foundation and not described in clause (i) may also be used to support such pediatric research and studies. “(iii) Report.— The recipient of a grant for research and studies shall agree to provide the Director of the National Institutes of Health and the Commissioner of Food and Drugs, at the conclusion of the research and studies— “(I) a report describing the results of the research and studies; and “(II) all data generated in connection with the research and studies. “(iv) Action by the commissioner of food and drugs.— The Commissioner of Food and Drugs shall take appropriate action in response to a report received under clause (iii) in accordance with paragraphs (7) through (12) of section 4091(c), including negotiating with the holders of approved applications for the drugs studied for any labeling changes that the Commissioner determines to be appropriate and requests the holders to make. “(C) Applicability.— Subparagraph (A) does not apply to the program described in subsection (c)(1)(C).”;

47. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 13(5) · 115 Stat. 1408

    Redesignated · 42 U.S.C. § 290b(l); 42 U.S.C. § 290b(m)

    Pub. L. 107–109, § 13(5), redesignated subsec. (m) as (l). Former subsec. (l) redesignated (k)

    Source evidence

    Code amendment note
    Subsecs. (l), (m). Pub. L. 107–109, § 13(5), redesignated subsec. (m) as (l). Former subsec. (l) redesignated (k).

    Enacted provision · exact public law section
    (5) by redesignating subsections (f) through (m) as subsections (e) through (1), respectively;

48. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(1)(A)(i) · 120 Stat. 3675

    Amended · 42 U.S.C. § 290b(d)(1)(D)(ii)

    Pub. L. 109–482, § 107(1)(A)(i), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “Upon the appointment of the members of the Board under clause (i)(II), the terms of service of the ex officio members of the Board as members of the Board shall terminate.”

    Source evidence

    Code amendment note
    Subsec. (d)(1)(D)(ii). Pub. L. 109–482, § 107(1)(A)(i), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “Upon the appointment of the members of the Board under clause (i)(II), the terms of service of the ex officio members of the Board as members of the Board shall terminate.”

    Enacted provision · exact public law section
    (i) by amending subparagraph (D)(ii) to read as follows: “(ii) Termination. Upon the appointment of the appointed members of the Board under clause (i)(II), the terms of service as members of the Board of the ex officio members of the Board described in clauses (i) and (ii) of subparagraph (B) shall terminate. The ex officio members of the Board described in clauses (iii) and (iv) of subparagraph (B) shall continue to serve as ex officio members of the Board.” ; and

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

49. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(1)(A)(ii) · 120 Stat. 3675

    Inserted · 42 U.S.C. § 290b(d)(1)(G)

    Pub. L. 109–482, § 107(1)(A)(ii), inserted “appointed” after “that the number of”

    Source evidence

    Code amendment note
    Subsec. (d)(1)(G). Pub. L. 109–482, § 107(1)(A)(ii), inserted “appointed” after “that the number of”.

    Enacted provision · exact public law section
    (ii) in subparagraph (G), by inserting “appointed” after “that the number of”;

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

50. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(1)(B) · 120 Stat. 3675

    Amended · 42 U.S.C. § 290b(d)(3)(B)

    Pub. L. 109–482, § 107(1)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “Any vacancy in the membership of the Board shall be filled in the manner in which the original position was made and shall not affect the power of the remaining members to execute the duties of the Board.”

    Source evidence

    Code amendment note
    Subsec. (d)(3)(B). Pub. L. 109–482, § 107(1)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “Any vacancy in the membership of the Board shall be filled in the manner in which the original position was made and shall not affect the power of the remaining members to execute the duties of the Board.”

    Enacted provision · exact public law section
    (B) by amending paragraph (3)(B) to read as follows: “(B) Any vacancy in the membership of the appointed members of the Board shall be filled in accordance with the bylaws of the Foundation established in accordance with paragraph (6), and shall not affect the power of the remaining appointed members to execute the duties of the Board.” ; and

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

51. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(1)(C) · 120 Stat. 3675

    Inserted · 42 U.S.C. § 290b(d)(5)

    Pub. L. 109–482, § 107(1)(C), inserted “appointed” after “majority of the”

    Source evidence

    Code amendment note
    Subsec. (d)(5). Pub. L. 109–482, § 107(1)(C), inserted “appointed” after “majority of the”.

    Enacted provision · exact public law section
    (C) in paragraph (5), by inserting “appointed” after “majority of the”;

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

52. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(2)(A) · 120 Stat. 3675

    Substituted · 42 U.S.C. § 290b(j)(2)

    Pub. L. 109–482, § 107(2)(A), substituted “subsection (d)(6)” for “subsection (d)(2)(B)(i)(II)”

    Source evidence

    Code amendment note
    Subsec. (j)(2). Pub. L. 109–482, § 107(2)(A), substituted “subsection (d)(6)” for “subsection (d)(2)(B)(i)(II)”.

    Enacted provision · exact public law section
    (A) in paragraph (2), by striking “(d)(2)(B)(i)(II)” and inserting “(d)(6)”;

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

53. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(2)(B)(i) · 120 Stat. 3675

    Inserted · 42 U.S.C. § 290b(j)(4)(A)

    Pub. L. 109–482, § 107(2)(B)(i), inserted “, including an accounting of the use of amounts transferred under subsection (l)” before period at end

    Source evidence

    Code amendment note
    Subsec. (j)(4)(A). Pub. L. 109–482, § 107(2)(B)(i), inserted “, including an accounting of the use of amounts transferred under subsection (l)” before period at end.

    Enacted provision · exact public law section
    (i) in subparagraph (A), by inserting “, including an accounting of the use of amounts transferred under subsection (l)” before the period at the end; and

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

54. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(2)(B)(ii) · 120 Stat. 3675

    1. Added · 42 U.S.C. § 290b(j)(4)(C)

       Pub. L. 109–482, § 107(2)(B)(ii), added subpar. (C)

    2. Struck · 42 U.S.C. § 290b(j)(4)(C)

       Pub. L. 109–482, § 107(2)(B)(ii), struck out former subpar. (C) which read as follows: “The Foundation shall make copies of each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy.”

    Source evidence

    Code amendment note
    Subsec. (j)(4)(C). Pub. L. 109–482, § 107(2)(B)(ii), added subpar. (C) and struck out former subpar. (C) which read as follows: “The Foundation shall make copies of each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy.”

    Enacted provision · exact public law section
    (ii) by striking subparagraph (C) and inserting the following: “(C) The Foundation shall make copies of each report submitted under subparagraph (A) available— “(i) Public information. for public inspection, and shall upon request provide a copy of the report to any individual for a charge that shall not exceed the cost of providing the copy; and “(ii) to the appropriate committees of Congress.” ; and

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

55. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(2)(C) · 120 Stat. 3675

    Substituted · 42 U.S.C. § 290b(j)(10)

    Pub. L. 109–482, § 107(2)(C), substituted “of Health and the National Institutes of Health may accept transfers of funds from the Foundation” for “of Health”

    Source evidence

    Code amendment note
    Subsec. (j)(10). Pub. L. 109–482, § 107(2)(C), substituted “of Health and the National Institutes of Health may accept transfers of funds from the Foundation” for “of Health”.

    Enacted provision · exact public law section
    (C) in paragraph (10), by striking “of Health.” and inserting “of Health and the National Institutes of Health may accept transfers of funds from the Foundation.”; and

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

56. 2007

    National Institutes of Health Reform Act of 2006

    Pub. L. 109–482 § 107(3) · 120 Stat. 3675

    1. Added · 42 U.S.C. § 290b(l)

       Pub. L. 109–482, § 107(3), added subsec. (l)

    2. Struck · 42 U.S.C. § 290b(l)

       Pub. L. 109–482, § 107(3), struck out former subsec. (l) which related to authorization of appropriations and limitation regarding other funds

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 109–482, § 107(3), added subsec. (l) and struck out former subsec. (l) which related to authorization of appropriations and limitation regarding other funds.

    Enacted provision · exact public law section
    (3) by striking subsection (l) and inserting the following: “(l) Funding.— From amounts appropriated to the National Institutes of Health, for each fiscal year, the Director of NIH shall transfer not less than $500,000 and not more than $1,250,000 to the Foundation.” .

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

57. 2007

    Best Pharmaceuticals for Children Act of 2007

    Pub. L. 110–85 title V § 502(c) · 121 Stat. 823

    Substituted · 42 U.S.C. § 290b(c)(1)(C)

    Pub. L. 110–85 substituted “and studies for which the Secretary issues a certification in the affirmative under section 355a(n)(1)(A) of title 21” for “and studies listed by the Secretary pursuant to section 284m(a)(1)(A) of this title and referred under section 355a(d)(4)(C) of title 21”. Amendment, which directed striking out language ending with “section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C)’ ” in the original, was executed by striking out language ending with “section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(C))” in the original to reflect the probable intent of Congress. That language had been translated as “section 355a(d)(4)(C) of title 21” for purposes of codification

    Source evidence

    Code amendment note
    Subsec. (c)(1)(C). Pub. L. 110–85 substituted “and studies for which the Secretary issues a certification in the affirmative under section 355a(n)(1)(A) of title 21” for “and studies listed by the Secretary pursuant to section 284m(a)(1)(A) of this title and referred under section 355a(d)(4)(C) of title 21”. Amendment, which directed striking out language ending with “section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C)’ ” in the original, was executed by striking out language ending with “section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(C))” in the original to reflect the probable intent of Congress. That language had been translated as “section 355a(d)(4)(C) of title 21” for purposes of codification.

    Enacted provision · exact public law section
    (c) Foundation for the National Institutes of Health.— Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking “and studies listed by the Secretary pursuant to section 409I(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C)’ ” and inserting “and studies for which the Secretary issues a certification in the affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act”.

58. 2010

    Cures Acceleration Network Act of 2009

    Pub. L. 111–148 title X § 10409(c) · 124 Stat. 119

    Added · 42 U.S.C. § 290b(c)(1)(E)

    Pub. L. 111–148 added subpar. (E)

    Source evidence

    Code amendment note
    Subsec. (c)(1)(E). Pub. L. 111–148 added subpar. (E).

    Enacted provision · exact public law section
    (c) Accepting Gifts To Support the Cures Acceleration Network.— Section 499(c)(1) of the Public Health Service Act (42 U.S.C. 290b(c)(1)) is amended by adding at the end the following: “(E) The Cures Acceleration Network described in section 402C.” .

59. 2011

    Department of Health and Human Services Appropriations Act, 2012

    Pub. L. 112–74 div. F title II § 221(d)(4) · 125 Stat. 1090

    Substituted · 42 U.S.C. § 290b(c)(1)(E)

    Pub. L. 112–74 substituted “section 287a” for “section 282d”

    Source evidence

    Code amendment note
    Subsec. (c)(1)(E). Pub. L. 112–74 substituted “section 287a” for “section 282d”.

    Enacted provision · exact public law section
    (4) in section 499(c)(1)(E) (42 U.S.C. 290b(c)(1)(E)), by striking “section 402C” and inserting “section 480”.

60. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 title V § 509(f) · 126 Stat. 993

    Struck · 42 U.S.C. § 290b(c)(1)(C)

    Pub. L. 112–144 struck out “for which the Secretary issues a certification in the affirmative under section 355a(n)(1)(A) of title 21” before period at end

    Source evidence

    Code amendment note
    Subsec. (c)(1)(C). Pub. L. 112–144 struck out “for which the Secretary issues a certification in the affirmative under section 355a(n)(1)(A) of title 21” before period at end.

    Enacted provision · exact public law section
    (f) Foundation of National Institutes of Health.— Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking “for which the Secretary issues a certification in the affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act”.

61. 2022

    Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act

    Pub. L. 117–101 § 2(b) · 136 Stat. 47

    Substituted · 42 U.S.C. § 290b(l)

    Pub. L. 117–101 substituted “$1,250,000 and not more than $5,000,000” for “$500,000 and not more than $1,250,000”

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 117–101 substituted “$1,250,000 and not more than $5,000,000” for “$500,000 and not more than $1,250,000”.

    Enacted provision · exact public law section
    (b) Foundation for the National Institutes of Health.— Section 499(l) of the Public Health Service Act (42 U.S.C. 290b(l)) is amended by striking “$500,000 and not more than $1,250,000” and inserting “$1,250,000 and not more than $5,000,000”.

62. 2022

    Pub. L. 117–286 § 4(c)(39) · 136 Stat. 4196

    Substituted · 42 U.S.C. § 290b(j)(2)

    Pub. L. 117–286 substituted “section 13101(16) of title 5)” for “section 109(16) of the Ethics in Government Act of 1978)”

    Source evidence

    Code amendment note
    Subsec. (j)(2). Pub. L. 117–286 substituted “section 13101(16) of title 5)” for “section 109(16) of the Ethics in Government Act of 1978)”.

    Enacted provision · exact public law section
    (39) Section 499(j)(2) of the Public Health Service Act (42 U.S.C. 290b(j)(2)) is amended by striking “section 109(16) of the Ethics in Government Act of 1978)” and inserting “section 13101(16) of title 5, United States Code)”.

78 of 80 references resolved to an enrolled provision · 2 partial