The Secretary shall, acting through the Director of NIH, establish a nonprofit corporation to be known as the Foundation for the National Institutes of Health (hereafter in this section referred to as the “Foundation”). The Foundation shall not be an agency or instrumentality of the United States Government.
The purpose of the Foundation shall be to support the National Institutes of Health in its mission (including collection of funds for pediatric pharmacologic research), and to advance collaboration with biomedical researchers from universities, industry, and nonprofit organizations.
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.
The Foundation shall be the sole entity responsible for carrying out the activities described in this subsection.
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.
A majority of the appointed members of the Board shall constitute a quorum for purposes of conducting the business of the Board.
The initial members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.
The Foundation shall be considered to be a corporation under section 501(c) of title 26, and shall be subject to the provisions of such section.
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.
The rate of compensation of the Executive Director shall be fixed by the Board.
No participant in the program established under this part shall exercise any administrative control over any Federal employee.
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, financial disclosure statements, conflict of interest rules, recusal and waiver rules, audits and other matter determined appropriate by the Board.
Any individual who is an officer, employee, or member of the Board of the Foundation may not (in accordance with policies and requirements developed under subsection (d)(6)) 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.
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.
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.
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.
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.1
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.
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).
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.
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) 2
Subparagraph (A) does not apply to the program described in subsection (c)(1)(C).
The Foundation may transfer funds to the National Institutes of Health and the National Institutes of Health may accept transfers of funds from the Foundation. Any funds transferred under this paragraph shall be subject to all Federal limitations relating to federally-funded research.
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.
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.
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.
Section 109(16) of the Ethics in Government Act of 1978, referred to in subsec. (j)(2), is section 109(16) of Pub. L. 95–521, which is set out in the Appendix to Title 5, Government Organization and Employees.
The National Institutes of Health Amendments of 1990, referred to in subsec. (j)(8), is Pub. L. 101–613,
Section 284m of this title, referred to in subsec. (j)(9)(B)(iv), was amended generally by Pub. L. 110–85, title V, § 502(b),
A prior section 499 of act
2012—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.
2011—Subsec. (c)(1)(E). Pub. L. 112–74 substituted “section 287a” for “section 282d”.
2010—Subsec. (c)(1)(E). Pub. L. 111–148 added subpar. (E).
2007—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.
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.”
Subsec. (d)(1)(G). Pub. L. 109–482, § 107(1)(A)(ii), inserted “appointed” after “that the number of”.
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.”
Subsec. (d)(5). Pub. L. 109–482, § 107(1)(C), inserted “appointed” after “majority of the”.
Subsec. (j)(2). Pub. L. 109–482, § 107(2)(A), substituted “subsection (d)(6)” for “subsection (d)(2)(B)(i)(II)”.
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.
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.”
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”.
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.
2002—Subsec. (b). Pub. L. 107–109, § 13(1), inserted “(including collection of funds for pediatric pharmacologic research)” after “mission”.
Subsec. (c)(1)(C), (D). Pub. L. 107–109, § 13(2), added subpar. (C) and redesignated former subpar. (C) as (D).
Subsec. (d)(1)(B)(iv). Pub. L. 107–109, § 13(3)(A)(i), added cl. (iv).
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.”
Subsec. (d)(2)(B). Pub. L. 107–109, § 13(3)(B), realigned margin.
Subsec. (e) to (g). Pub. L. 107–109, § 13(5), redesignated subsecs. (f) to (h) as (e) to (g), respectively.
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).
Subsec. (i). Pub. L. 107–109, § 13(5), redesignated subsec. (j) as (i). Former subsec. (i) redesignated (h).
Subsec. (j). Pub. L. 107–109, § 13(5), redesignated subsec. (k) as (j). Former subsec. (j) redesignated (i).
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”.
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).
Subsec. (k). Pub. L. 107–109, § 13(5), redesignated subsec. (l) as (k). Former subsec. (k) redesignated (j).
Subsec. (k)(9). Pub. L. 107–109, § 13(4), designated existing provisions as subpar. (A), inserted subpar. heading, and added subpars. (B) and (C).
Subsecs. (l), (m). Pub. L. 107–109, § 13(5), redesignated subsec. (m) as (l). Former subsec. (l) redesignated (k).
1998—Subsec. (a). Pub. L. 105–392, § 418(2)(A), substituted “Foundation for the National Institutes of Health” for “National Foundation for Biomedical Research”.
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.”
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”.
1996—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.
1993—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”.
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.
Subsec. (c). Pub. L. 103–43, § 1701(3), added subsec. (c). Former subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 103–43, § 1701(2), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (f).
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).
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).
Subsec. (d)(3)(A). Pub. L. 103–43, § 1701(4)(C), substituted “(1)(C)” for “(2)(C)”.
Subsec. (d)(5), (6). Pub. L. 103–43, § 1701(4)(D), added pars. (5) and (6).
Subsec. (e). Pub. L. 103–43, § 1701(2), redesignated subsec. (e) as (g).
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.
Subsec. (i). Pub. L. 103–43, § 1701(2), redesignated subsec. (g) as (i). Former subsec. (i) redesignated (m).
Subsec. (i)(4). Pub. L. 103–43, § 1701(5)(A), inserted before period at end “, and define the duties of the officers and employees”.
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;”.
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).
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”.
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).
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).
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).
Subsec. (i)(14). Pub. L. 103–43, § 1701(5)(G), (H), added par. (14). Former par. (14) redesignated (13).
Subsec. (i)(15). Pub. L. 103–43, § 1701(5)(I), substituted “part” for “subtitle”.
Subsec. (j). Pub. L. 103–43, § 1701(2), redesignated subsec. (h) as (j).
Subsecs. (k), (l). Pub. L. 103–43, § 1701(6), added subsecs. (k) and (l).
Subsec. (m). Pub. L. 103–43, § 1701(7), amended heading and text of subsec. (m) generally. Prior to amendment, text read as follows:
“(1)
“(2)
“(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).”
Pub. L. 103–43, § 1701(2), redesignated subsec. (i) as (m).
Subsec. (n). Pub. L. 103–43, § 1701(8), added subsec. (n).
1992—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”.
1991—Subsec. (c)(1)(C). Pub. L. 102–170, § 216(1), substituted “11” for “9”.
Subsec. (c)(1)(C)(iii). Pub. L. 102–170, § 216(2), substituted “5” for “3”.
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress,
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. 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,
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.
Amendment by Pub. L. 102–321 effective