42 U.S.C. § 282
The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) and as the Secretary may otherwise prescribe.
In carrying out the purposes of section 241 of this title, the Secretary, acting through the Director of NIH-
Chapter 10 of title 5 shall not apply to the duration of a peer review group appointed under paragraph (16). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States.
The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
The Director of NIH shall-
There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall-
The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.
The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments.
In this subsection:
The term "applicable clinical trial" means an applicable device clinical trial or an applicable drug clinical trial.
The term "applicable device clinical trial" means-
The term "applicable drug clinical trial" means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 355 of title 21 or to section 262 of this title.
For purposes of subclause (I), the term "clinical investigation" has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation).
For purposes of subclause (I), the term "phase I" has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation).
The term "clinical trial information" means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3).
The term "completion date" means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.
The term "device" means a device as defined in section 321(h) of title 21.
The term "drug" means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of this title.
The term "ongoing" means, with respect to a clinical trial of a drug or a device and to a date, that-
The term "responsible party", with respect to a clinical trial of a drug or device, means-
The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2).
To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the "registry data bank"). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.
The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include-
The Secretary may by regulation modify the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not reduce such clinical trial information.
The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:
Not later than 18 months after September 27, 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.
The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis.
The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared.
The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, September 27, 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of1 subparagraph (A)(ii) not later than the later of-
The Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in accordance with this paragraph is posted in the registry data bank not later than 30 days after such submission.
The Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in the registry data bank-
The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I).
An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered-
Beginning not later than 90 days after September 27, 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial-
The Secretary shall ensure that the registry data bank includes links to the following information:
The Secretary shall ensure that the registry data bank includes links to the following information:
The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to September 27, 2007, as available.
The Secretary, acting through the Director of NIH, shall-
Not later than 1 year after September 27, 2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:
A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.
The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.
A point of contact for scientific information about the clinical trial results.
Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.
To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after September 27, 2007, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph.
The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for-
The regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for-
The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories:
The results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine-
The regulations under this subparagraph shall also establish-
The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph.
The Secretary shall hold a public meeting no later than 18 months after September 27, 2007, to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph.
Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of-
An applicable clinical trial described in this clause is an applicable clinical trial subject to-
If the responsible party for an applicable clinical trial submits a certification that clause (iv) or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as required under the applicable clause.
With respect to an applicable clinical trial that is completed before the drug is initially approved under section 355 of title 21 or initially licensed under section 262 of this title, or the device is initially cleared under section 360(k) or initially approved under section 360e or 360j(m) of title 21, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m), as applicable.
With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under section 355 of title 21, licensing under section 262 of this title, or clearance under section 360(k), or approval under section 360e or 360j(m) of title 21 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date-
If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under section 262 of this title or section 355, 360(k), 360e, or 360j(m) of title 21, as applicable) of the use studied in the clinical trial.
The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years after the date a certification under clause (iii) was made to the Director of NIH, if an action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.
The Director of NIH may provide an extension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted. The Director of NIH may grant more than one such extension for a clinical trial.
The Commissioner of Food and Drugs shall notify the Director of NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph (5)(B) of such action not later than 30 days after such action.
The Director of NIH shall ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission.
The Secretary may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted.
Not later than 18 months after September 27, 2007, the Secretary shall by regulation determine the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for applicable clinical trials described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists.
If the Secretary fails to issue the regulation required by clause (i) by the date that is 24 months after September 27, 2007, clause (iii) shall take effect.
Upon the application of clause (ii), the Secretary shall include in the registry and results data bank for applicable clinical trials described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements:
A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial.
A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial.
In carrying out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the tables information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public.
Clinical trial information included in the registry and results data bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank pursuant to subparagraph (C).
A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial information for each applicable clinical trial that is required to be submitted under section 262 of this title or under section 355, 360(k), 360e, or 360j(m) of title 21 in an application or report for licensure, approval, or clearance of the drug or device for the use studied in the clinical trial.
Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry and results data bank of clinical trial information for such clinical trial is necessary to protect the public health-
A clinical trial described in this clause is-
The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates-
The Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual site status, location, and contact information, the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding updates, and information in such databases is presented in a manner that enables users to readily access each original element submission and to track the changes made by the updates. The Director of NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).
If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, including the Food and Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3).
The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee.
If the head of an agency referred to in clause (i), as applicable, verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to correct such non-compliance and submit the required clinical trial information.
The Secretary shall-
At the time of submission of an application under section 355 of title 21, section 360e of title 21, section 360j(m) of title 21, or section 262 of this title, or submission of a report under section 360(k) of title 21, such application or submission shall be accompanied by a certification that all applicable requirements of this subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial control numbers.
Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the publicly available information described in paragraph (3)(A) and any other information available to the Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under paragraph (3)(C).
If the Secretary determines that any clinical trial information was not submitted as required under this subsection, or was submitted but is false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such noncompliance by submitting the required revised clinical trial information not later than 30 days after such notification.
The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading in any particular.
Clause (i) shall not have the effect of-
If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice-
If the responsible party for an applicable clinical trial fails to submit the primary and secondary outcomes as required under section 2(A)(ii)(I)(ll),5 the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice that the responsible party is not in compliance by failing to register the primary and secondary outcomes in accordance with this chapter, and that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial.
The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: "The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.".
The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: "The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.".
The notice under clause (ii) for a violation described in clause (ii) shall include the following statement: "The entry for this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.".
The Director of NIH shall provide that the public may easily search the registry and results data bank for entries that include notices required under this subparagraph.
Nothing in this subsection (or under section 552 of title 5) shall require the Secretary to publicly disclose, by any means other than the registry and results data bank, information described in subparagraph (B).
Information described in this subparagraph is-
There are authorized to be appropriated to carry out this subsection $10,000,000 for each fiscal year.
Not later than 90 days after January 15, 2007, the Director of NIH shall establish within the Office of the Director an advisory council to be known as the "Council of Councils" (referred to in this subsection as the "Council") for the purpose of advising the Director on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives, including making recommendations with respect to the conduct and support of research described in subsection (b)(7).
The Council shall be composed of 27 members selected by the Director of NIH with approval from the Secretary from among the list of nominees under subparagraph (C).
In selecting the members of the Council, the Director of NIH shall ensure-
The Director of NIH shall maintain an updated list of individuals who have been nominated to serve on the Council, which list shall consist of the following:
The term of service for a member of the Council shall be 6 years, except as provided in subparagraphs (B) and (C).
Of the initial members selected for the Council, the Director of NIH shall designate-
Any member appointed to fill a vacancy occurring before the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member's term until a successor has taken office.
Not later than 2 years after December 13, 2016, and at least every 6 years thereafter, the Director of the National Institutes of Health shall develop and submit to the appropriate committees of Congress and post on the Internet website of the National Institutes of Health, a coordinated strategy (to be known as the "National Institutes of Health Strategic Plan") to provide direction to the biomedical research investments made by the National Institutes of Health, to facilitate collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine.
The strategy under paragraph (1) shall-
Strategic plans developed and updated by the national research institutes and national centers of the National Institutes of Health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national research institutes and national centers shall have a common template.
The Director of National Institutes of Health shall develop the strategic plan under paragraph (1) in consultation with the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.
The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out-
The authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office-
The Director of NIH shall, as appropriate, continue to consult with the directors of relevant institutes and centers of the National Institutes of Health, other relevant experts from such institutes and centers, and relevant experts within the Food and Drug Administration, to further the field of regenerative medicine using adult stem cells, including autologous stem cells, therapeutic tissue engineering products, human cell and tissue products, human gene therapies, and genetically modified cells.
1So in original. The word "of" probably should not appear.
2So in original. The second closing parenthesis probably should not appear.
3So in original.
4So in original. The second closing parenthesis probably should not appear.
5So in original. Probably should be "paragraph (2)(A)(ii)(I)(ll),".
42 U.S.C. § 282
EDITORIAL NOTES
REFERENCES IN TEXTThe General Schedule, referred to in subsec. (b)(16), is set out under section 5332 of Title 5, Government Organization and Employees.The National Literacy Act of 1991, referred to in subsec. (e)(5), is Pub. L. 102-73, 105 Stat. 333, which was repealed by Pub. L. 105-220, title II, §251(a)(2), Aug. 7, 1998, 112 Stat. 1079. For complete classification of this Act to the Code, see Tables.
CODIFICATION In subsec. (b)(14)(B), "section 8141 of title 40" substituted for "the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L. 107-217, §5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.
AMENDMENTS2022-Subsec. (b). Pub. L. 117-286 substituted "Chapter 10 of title 5" for "The Federal Advisory Committee Act" in concluding provisions.Subsec. (b)(26). Pub. L. 117-328, §2302, added par. (26).Subsec. (b)(27) to (29). Pub. L. 117-328, §2323, added pars. (27) to (29). 2021-Subsec. (o). Pub. L. 117-15 added subsec. (o).2018-Subsec. (n)(1)(C). Pub. L. 115-271 added subpar. (C). 2016-Subsec. (b)(4). Pub. L. 114-255, §2038(a)(1), amended par. (4) generally. Prior to amendment, text read as follows: "shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing minority and other health disparities;". Subsec. (b)(5). Pub. L. 114-255, §2031(a)(1), inserted ",and through the development, implementation, and updating of the strategic plan developed under subsection (m)" before semicolon.Subsec. (b)(8)(C), (D). Pub. L. 114-255, §2038(a)(2), added subpars. (C) and (D). Subsec. (b)(25). Pub. L. 114-255, §2014(a), added par. (25). Subsec. (j)(2)(D)(ii)(I). Pub. L. 114-255, §2051(1), inserted ",unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval" before semicolon. Subsec. (j)(2)(D)(iii), (iv). Pub. L. 114-255, §2051(2), added cls. (iii) and (iv).Subsec. (m). Pub. L. 114-255, §2031(a)(2), added subsec. (m).Subsec. (n). Pub. L. 114-255, §2036(a), added subsec. (n). 2014-Subsec. (b)(7). Pub. L. 113-94 amended par. (7) generally, enacting similar provisions and adding provisions relating to allocating funds appropriated pursuant to section 282a(a)(2) of this title for making grants for pediatric research. 2011-Subsec. (b)(24). Pub. L. 112-74, §221(d)(1), substituted "287a" for "282d".Subsec. (g). Pub. L. 112-74, §221(b)(5)(B), redesignated and transferred subsec. (g) of this section to subsec. (b) of section 285k of this title. 2010-Subsec. (b)(24). Pub. L. 111-148 added par. (24).2008-Subsec. (j)(3)(C). Pub. L. 110-316, §302(1), in introductory provisions, substituted "for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:" for "the following elements for drugs that are approved under section 355 of title 21 or licensed under section 262 of this title and devices that are cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21:".Subsec. (j)(3)(I)(i), (iii). Pub. L. 110-316, §302(2), substituted "applicable clinical trials described in subparagraph (C)" for "drugs described in subparagraph (C)".2007-Subsec. (a). Pub. L. 109-482, §102(f)(1)(A), substituted "Director of NIH who shall" for "Director of the National Institutes of Health (hereafter in this subchapter referred to as the 'Director of NIH') who shall".Subsec. (b). Pub. L. 109-482, §102(a)(5), substituted "paragraph (16)" for "paragraph (6)" in concluding provisions.Subsec. (b)(1). Pub. L. 109-482, §102(a)(6), added par. (1) and struck out former par. (1) which read as follows: "shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;". Subsec. (b)(2), (3). Pub. L. 109-482, §102(b), added pars. (2) and (3) and struck out former pars. (2) and (3) which read as follows:"(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health;"(3) shall assure that research at or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title;". Subsec. (b)(4). Pub. L. 110-85, §1104(2), inserted "minority and other" after "reducing". Pub. L. 109-482, §102(b), added par. (4). Former par. (4) redesignated (14).Subsec. (b)(5) to (22). Pub. L. 109-482, §102(a)(1)-(4), (b), added pars. (5) to (13), redesignated former pars. (4) to (11) and (14) as (14) to (22), respectively, in par. (21) inserted "and" at end, and struck out former pars. (12) and (13) which read as follows:"(12) after consultation with the Director of the Office of Research on Women's Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women's health that are identified under section 287d(b) of this title;"(13) may conduct and support research training-"(A) for which fellowship support is not provided under section 288 of this title; and"(B) which does not consist of residency training of physicians or other health professionals; and".Subsec. (b)(23). Pub. L. 110-85, §304(a), added par. (23).Subsec. (i). Pub. L. 109-482, §102(c), redesignated subsec. (j) as (i) and struck out former subsec. (i) which related to discretionary fund for use by the Director of NIH to carry out activities authorized in this chapter.Subsec. (i)(5). Pub. L. 109-482, §103(b)(1), struck out first sentence which read as follows: "For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary."Subsecs. (j), (k). Pub. L. 110-85, §801(a), added subsec. (j) and redesignated former subsec. (j) as (k). Former subsec. (k) redesignated (l). Pub. L. 109-482, §102(c)(2), (d), added subsec. (k) and redesignated former subsec. (k) as (j). Subsec. (l). Pub. L. 110-85, §801(a)(1), redesignated subsec. (k) as (l). Pub. L. 109-482, §102(c)(1), struck out subsec. (l) which read as follows: "The Director of NIH shall carry out the program established in part F of subchapter X of this chapter (relating to interagency research on trauma)." 2002-Subsec. (j)(3)(A). Pub. L. 107-109 which directed the amendment of the first sentence of subsec. (j)(3)(A) by substituting "trial sites," for "trial sites, and" and "in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children," for "in the trial,", was executed by making the substitutions in the second sentence, to reflect the probable intent of Congress. 1998-Subsec. (b)(13), (14). Pub. L. 105-392 added pars. (13) and (14).Subsec. (f). Pub. L. 105-362 inserted "and" at end of par. (1), substituted a period for ";and" at end of par. (2), and struck out par. (3) which read as follows: "annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including-"(A) a summary of the Associate Director's review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and"(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities." 1997-Subsecs. (j) to (l). Pub. L. 105-115 added subsec. (j) and redesignated former subsecs. (j) and (k) as (k) and (l), respectively.1993-Subsec. (b)(12). Pub. L. 103-43, §141(b), added par. (12).Subsec. (e)(5). Pub. L. 103-43, §210(b), added par. (5).Subsec. (f). Pub. L. 103-43, §201, substituted "other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall-" and pars. (1) to (3) for "other public and private entities. The Associate Director shall annually report to the Director of NIH on the prevention activities undertaken by the Associate Director. The report shall include a detailed statement of the expenditures made for the activities reported on and the personnel used in connection with such activities".Subsec. (g). Pub. L. 103-43, §202, added subsec. (g).Subsec. (h). Pub. L. 103-43, §206, added subsec. (h).Subsec. (i). Pub. L. 103-43, §208, added subsec. (i).Subsec. (j). Pub. L. 103-43, §210(c), added subsec. (j).Subsec. (k). Pub. L. 103-43, §303(b), added subsec. (k).1992-Subsec. (d)(1). Pub. L. 102-321 substituted "220" for "two hundred". 1988-Subsec. (b)(6). Pub. L. 100-607 inserted "and scientific program advisory committees" after "peer review groups".
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2007 AMENDMENT Amendment by Pub. L. 109-482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109-482 set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105-115 set out as a note under section 321 of Title 21, Food and Drugs.
EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102-321 effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102-321 set out as a note under section 236 of this title.
RULE OF CONSTRUCTION REGARDING CONTINUATION OF PROGRAMS Pub. L. 109-482, title I, §103(c), Jan. 15, 2007, 120 Stat. 3689, provided that: "The amendment of a program by a provision of subsection (b) [amending this section and sections 283a, 283d, 283g to 283i, 284e to 284j, 284l, 284m, 285a-9, 285a-10, 285b-7a, 285b-7b, 285c-9, 285d-6a, 285d-8, 285e-10, 285e-10a, 285f-2, 285f-3, 285g-5, 285g-9, 285g-10, 285n, 285o, 285o-2, 285o-4, 285p, 285r, 286a-1, 287a-2, 287a-3, 287a-4, 287c-11, 287c-31 to 287c-33, 288, 288-1, and former 288-5a of this title and repealing sections 285a-8, 285b-8, 285e-11, and 286a-2 of this title] may not be construed as terminating the authority of the Federal agency involved to carry out the program."
CONFIDENTIALITY Pub. L. 114-255, div. A, title II, §2014(b), Dec. 13, 2016, 130 Stat. 1051, provided that: "Nothing in the amendments made by subsection (a) [amending this section] authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, or [shall] be construed to require recipients of grants or cooperative agreements through the National Institutes of Health to share such information."
APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH Pub. L. 114-255, div. A, title II, §2038(i), Dec. 13, 2016, 130 Stat. 1067, provided that:"(1) INPUT FROM EXPERTS.-Not later than 180 days after the date of enactment of this Act [Dec. 13, 2016], the Director of the National Institutes of Health shall convene a workshop of experts on pediatric and older populations to provide input on-"(A) appropriate age groups to be included in research studies involving human subjects; and"(B) acceptable justifications for excluding participants from a range of age groups from human subjects research studies."(2) POLICY UPDATES.-Not later than 180 days after the conclusion of the workshop under paragraph (1), the Director of the National Institutes of Health shall make a determination with respect to whether the policies of the National Institutes of Health on the inclusion of relevant age groups in clinical studies need to be updated, and shall update such policies as appropriate. In making the determination, the Director of the National Institutes of Health shall take into consideration whether such policies-"(A) address the consideration of age as an inclusion variable in research involving human subjects; and "(B) identify the criteria for justification for any age-related exclusions in such research."(3) PUBLIC AVAILABILITY OF FINDINGS AND CONCLUSIONS.-The Director of the National Institutes of Health shall-"(A) make the findings and conclusions resulting from the workshop under paragraph (1) and updates to policies in accordance with paragraph (2), as applicable, available to the public on the Internet website of the National Institutes of Health; and"(B) ensure that age-related data reported in the triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032 [of Pub. L. 114-255]) are made available to the public on the Internet website of the National Institutes of Health."
ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH Pub. L. 114-255, div. A, title II, §20392039,, 130 Stat. 1068, provided that: "(a) ESTABLISHMENT.-Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the 'Advisory Committee'), appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a), to develop and issue recommendations through the Advisory Committee for a formal policy, which may incorporate or be informed by relevant existing and ongoing activities, to enhance rigor and reproducibility of scientific research funded by the National Institutes of Health."(b) CONSIDERATIONS.-In developing and issuing recommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate-"(1) preclinical experiment design, including analysis of sex as a biological variable;"(2) clinical experiment design, including-"(A) the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities;"(B) the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and"(C) the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities;"(3) applicable levels of rigor in statistical methods, methodology, and analysis;"(4) data and information sharing in accordance with applicable privacy laws and regulations; and"(5) any other matter the working group determines relevant."(c) POLICIES.-Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health shall consider the recommendations developed by the working group and issued by the Advisory Committee under subsection (a) and develop or update policies as appropriate."(d) REPORT.-Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall issue a report to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives regarding recommendations developed under subsection (a) and any subsequent policy changes implemented, to enhance rigor and reproducibility in scientific research funded by the National Institutes of Health. "(e) CONFIDENTIALITY.-Nothing in this section authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code."
DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY Pub. L. 110-85, title III, §305, Sept. 27, 2007, 121 Stat. 863, as amended by Pub. L. 112-144, title VI, §620(a), July 9, 2012, 126 Stat. 1064; Pub. L. 115-52, title V, §502(c), Aug. 18, 2017, 131 Stat. 1037; Pub. L. 117-180, div. F, title V, §50035003,, 136 Stat. 2167; Pub. L. 117-229, div. C, title III, §304, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117-328 div. FF, title III, §3104, Dec. 29, 2022, 136 Stat. 5807, provided that:"(a) IN GENERAL.- "(1) REQUEST FOR PROPOSALS.-Not later than 90 days after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development."(2) DETERMINATION ON GRANTS OR CONTRACTS.-Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section. "(b) APPLICATION.-A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require. "(c) USE OF FUNDS.-A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by-"(1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;"(2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;"(3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;"(4) assessing the scientific and medical merit of proposed pediatric device projects;"(5) providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and"(6) providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate."(d) COORDINATION.-"(1) NATIONAL INSTITUTES OF HEALTH.-Each consortium that receives a grant or contract under this section shall-"(A) coordinate with the National Institutes of Health's pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act [42 U.S.C. 282(b)(23)], as added by section 304(a) of this Act; and"(B) provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest."(2) FOOD AND DRUG ADMINISTRATION.-Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use."(3) EFFECTIVENESS AND OUTCOMES.-Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium."(e) AUTHORIZATION OF APPROPRIATIONS.-There are authorized to be appropriated to carry out this section $1,610,959 for the period beginning on October 1, 2022 and ending on December 23, 2022."[Pub. L. 117-328 div. FF, title III, §3104, Dec. 29, 2022, 136 Stat. 5807, which directed amendment of section 305(e) of Pub. L. 110-85 set out above, by substituting "$7,000,000 for each of fiscal years 2023 through 2027" for "$1,107,534 for the period beginning on October 1, 2022, and ending on December 23, 2022", could not be executed because "$1,107,534" did not appear after the intervening amendment by section 304 of Pub. L. 117-229.]
SURVEILLANCES Pub. L. 110-85, title VIII, §801(c), Sept. 27, 2007, 121 Stat. 921, provided that: "Not later than 12 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service Act [42 U.S.C. 282(j)], as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II) of such section 402(j) that is not a clinical trial."
PREEMPTION Pub. L. 110-85, title VIII, §801(d), Sept. 27, 2007, 121 Stat. 922, provided that: "(1) IN GENERAL.-Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the Public Health Service Act [42 U.S.C. 282(j)(3)(D)], as added by this section, no State or political subdivision of a State may establish or continue in effect any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database."(2) RULE OF CONSTRUCTION.-The fact of submission of clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act (as amended by this section), that relates to a use of a drug or device not included in the official labeling of the approved drug or device shall not be construed by the Secretary of Health and Human Services or in any administrative or judicial proceeding, as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. The availability of clinical trial information through the registry and results data bank under such subsection (j), if submitted in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)."
COLLABORATION AND REPORT Pub. L. 105-115, title I, §113(b), Nov. 21, 1997, 111 Stat. 2312, directed the Secretary of Health and Human Services, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs to collaborate to determine the feasibility of including device investigations within the scope of the data bank under subsec. (j) of this section, with the Secretary to report to Congress, not later than two years after Nov. 21, 1997, on the public health need, if any, for inclusion of device investigations within the scope of the data bank under subsec. (j), and on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations was required to be publicly disclosed.
CHRONIC FATIGUE SYNDROME; EXPERTS AND RESEARCH REPRESENTATIVES ON ADVISORY COMMITTEES AND BOARDS Pub. L. 103-43, title IX, §902(c), June 10, 1993, 107 Stat. 164, provided that: "The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall ensure that appropriate individuals with expertise in chronic fatigue syndrome or neuromuscular diseases and representative of a variety of disciplines and fields within the research community are appointed to appropriate National Institutes of Health advisory committees and boards."
THIRD-PARTY PAYMENTS REGARDING CERTAIN CLINICAL TRIALS AND CERTAIN LIFE-THREATENING ILLNESSES Pub. L. 103-43, title XIX, §1901(a), June 10, 1993, 107 Stat. 200, provided that: "The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall conduct a study for the purpose of-"(1) determining the policies of third-party payors regarding the payment of the costs of appropriate health services that are provided incident to the participation of individuals as subjects in clinical trials conducted in the development of drugs with respect to acquired immune deficiency syndrome, cancer, and other life-threatening illnesses; and"(2) developing recommendations regarding such policies."
PERSONNEL STUDY OF RECRUITMENT, RETENTION AND TURNOVER Pub. L. 103-43, title XIX, §19051905,, 107 Stat. 203, directed Secretary of Health and Human Services, acting through Director of National Institutes of Health, to conduct a study to review the retention, recruitment, vacancy and turnover rates of support staff, including firefighters, law enforcement, procurement officers, technicians, nurses and clerical employees, to ensure that National Institutes of Health is adequately supporting conduct of efficient, effective and high quality research for the American public, and to submit a report to Congress on results of such study not later than 1 year after June 10, 1993.
CHRONIC PAIN CONDITIONS Pub. L. 103-43, title XIX, §19071907,, 107 Stat. 204, directed Director of the National Institutes of Health to submit to Congress, not later than 2 years after June 10, 1993, a report and study on the incidence in the United States of cases of chronic pain, including chronic pain resulting from back injuries, reflex sympathetic dystrophy syndrome, temporomandibular joint disorder, post-herpetic neuropathy, painful diabetic neuropathy, phantom pain, and post-stroke pain, and the effect of such cases on the costs of health care in the United States.
SUPPORT FOR BIOENGINEERING RESEARCH Pub. L. 103-43, title XIX, §19121912,, 107 Stat. 206, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, to conduct a study for the purpose of determining the sources and amounts of public and private funding devoted to basic research in bioengineering, including biomaterials sciences, cellular bioprocessing, tissue and rehabilitation engineering, evaluating whether that commitment is sufficient to maintain the innovative edge that the United States has in these technologies, evaluating the role of the National Institutes of Health or any other Federal agency to achieve a greater commitment to innovation in bioengineering, and evaluating the need for better coordination and collaboration among Federal agencies and between the public and private sectors, and, not later than 1 year after June 10, 1993, to prepare and submit to Committee on Labor and Human Resources of Senate, and Committee on Energy and Commerce of House of Representatives, a report containing the findings of the study together with recommendations concerning the enactment of legislation to implement the results of such study.
MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR RESEARCH Pub. L. 103-43, title XX, §20022002,, 107 Stat. 208, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, not later than June 1, 1994, to present to Congress a master plan to provide for replacement or refurbishment of less than adequate buildings, utility equipment and distribution systems (including the resources that provide electrical and other utilities, chilled water, air handling, and other services that the Secretary, acting through the Director, deemed necessary), roads, walkways, parking areas, and grounds that underpin the laboratory and clinical facilities of the National Institutes of Health, and provided that the plan could make recommendations for the undertaking of new projects that are consistent with the objectives of this section, such as encircling the National Institutes of Health Federal enclave with an adequate chilled water conduit.
- Administrator
- The term "Administrator" means the Administrator of General Services.
- Advisory Committee
- The term "Advisory Committee" means the Green Building Advisory Committee established under section 484.1
- Consortium
- The term "Consortium" means the High-Performance Green Building Partnership Consortium created in response to section 17092(c)(1) of this title to represent the private sector in a public-private partnership to promote high-performance green buildings and zero-net-energy commercial buildings.
- Secretary
- The term "Secretary" means the Secretary of Housing and Urban Development.1See References in Text note below.
- Service
- The term "Service" means the Public Health Service;
- practices
- The term "practices" means design, financing, permitting, construction, commissioning, operation and maintenance, and other practices that contribute to achieving zero-net-energy buildings or facilities.
- project
- The terms "federally assisted housing" and "project" mean-(A) a public housing project (as such term is defined in section 3(b) of the United States Housing Act of 1937 [42 U.S.C. 1437a(b)] );(B) housing for which project-based assistance is provided under section 8 of the United States Housing Act of 1937 [42 U.S.C. 1437f] ;(C) housing that is assisted under section 1701q of title 12;(D) housing that is assisted under section 1701q of title 12, as such section existed before November 28, 1990;(E) housing financed by a loan or mortgage insured under section 1715l(d)(3) of title 12 that bears interest at a rate determined under the proviso of section 1715l(d)(5) of title 12;(F) housing insured, assisted, or held by the Secretary or a State or State agency under section 1715z-1 of title 12;(G) housing constructed or substantially rehabilitated pursuant to assistance provided under section 8(b)(2) of the United States Housing Act of 1937 [42 U.S.C. 1437f(b)(2)], as in effect before October 1, 1983, that is assisted under a contract for assistance under such section; and(H) housing that is assisted under section 80131 of this title.