42 USC 282 - Director of National Institutes of Health

1 So in original. The word “of” probably should not appear.

subparagraph (A)(ii) not later than the later of—

2 So in original. The second closing parenthesis probably should not appear.

3 So in original.

paragraph (2)(C) and paragraph (3)(D)(ii)(II)).

4 So in original. The second closing parenthesis probably should not appear.

5 So in original. Probably should be “paragraph (2)(A)(ii)(I)(ll),”.

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.

Editorial Notes

References in Text

The General Schedule, referred to in subsec. (span)(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 Puspan. L. 102–73, July 25, 1991, 105 Stat. 333, which was repealed by Puspan. 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. (span)(14)(B), “section 8141 of title 40” substituted for “the Act of March 3, 1877 (40 U.S.C. 34)” on authority of Puspan. L. 107–217, § 5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.

Amendments

2022—Subsec. (span). Puspan. L. 117–286 substituted “Chapter 10 of title 5” for “The Federal Advisory Committee Act” in concluding provisions.

Subsec. (span)(26). Puspan. L. 117–328, § 2302, added par. (26).

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

2021—Subsec. (o). Puspan. L. 117–15 added subsec. (o).

2018—Subsec. (n)(1)(C). Puspan. L. 115–271 added subpar. (C).

2016—Subsec. (span)(4). Puspan. 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. (span)(5). Puspan. 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. (span)(8)(C), (D). Puspan. L. 114–255, § 2038(a)(2), added subpars. (C) and (D).

Subsec. (span)(25). Puspan. L. 114–255, § 2014(a), added par. (25).

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

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

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

2014—Subsec. (span)(7). Puspan. 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. (span)(24). Puspan. L. 112–74, § 221(d)(1), substituted “287a” for “282d”.

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

2010—Subsec. (span)(24). Puspan. L. 111–148 added par. (24).

2008—Subsec. (j)(3)(C). Puspan. 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). Puspan. L. 110–316, § 302(2), substituted “applicable clinical trials described in subparagraph (C)” for “drugs described in subparagraph (C)”.

2007—Subsec. (a). Puspan. 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. (span). Puspan. L. 109–482, § 102(a)(5), substituted “paragraph (16)” for “paragraph (6)” in concluding provisions.

Subsec. (span)(1). Puspan. 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. (span)(2), (3). Puspan. L. 109–482, § 102(span), 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. (span)(4). Puspan. L. 110–85, § 1104(2), inserted “minority and other” after “reducing”.

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

Subsec. (span)(5) to (22). Puspan. L. 109–482, § 102(a)(1)–(4), (span), 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(span) 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. (span)(23). Puspan. L. 110–85, § 304(a), added par. (23).

Subsec. (i). Puspan. 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). Puspan. L. 109–482, § 103(span)(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). Puspan. L. 110–85, § 801(a), added subsec. (j) and redesignated former subsec. (j) as (k). Former subsec. (k) redesignated (l).

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

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

Puspan. 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). Puspan. 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. (span)(13), (14). Puspan. L. 105–392 added pars. (13) and (14).

Subsec. (f). Puspan. 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). Puspan. L. 105–115 added subsec. (j) and redesignated former subsecs. (j) and (k) as (k) and (l), respectively.

1993—Subsec. (span)(12). Puspan. L. 103–43, § 141(span), added par. (12).

Subsec. (e)(5). Puspan. L. 103–43, § 210(span), added par. (5).

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

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

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

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

Subsec. (k). Puspan. L. 103–43, § 303(span), added subsec. (k).

1992—Subsec. (d)(1). Puspan. L. 102–321 substituted “220” for “two hundred”.

1988—Subsec. (span)(6). Puspan. 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 Puspan. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Puspan. L. 109–482, set out as a note under section 281 of this title.

Effective Date of 1997 Amendment

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

Effective Date of 1992 Amendment

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

Rule of Construction Regarding Continuation of Programs

Puspan. 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 (span) [amending this section and sections 283a, 283d, 283g to 283i, 284e to 284j, 284l, 284m, 285a–9, 285a–10, 285span–7a, 285span–7span, 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, 285span–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

Puspan. L. 114–255, div. A, title II, § 2014(span), 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(span)(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

Puspan. 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 Puspan. 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

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

“(a)Establishment.—Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the ‘Advisory Committee’), appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a), to develop and issue recommendations through the Advisory Committee for a formal policy, which may incorporate or be informed by relevant existing and ongoing activities, to enhance rigor and reproducibility of scientific research funded by the National Institutes of Health.

“(span)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(span)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”

Demonstration Grants for Improving Pediatric Device Availability

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

“(span)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(span)(23) of the Public Health Service Act [42 U.S.C. 282(span)(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.”

[Puspan. L. 117–328, div. FF, title III, § 3104, Dec. 29, 2022, 136 Stat. 5807, which directed amendment of section 305(e) of Puspan. 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 Puspan. L. 117–229.]

Surveillances

Puspan. 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

Puspan. 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

Puspan. L. 105–115, title I, § 113(span), 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

Puspan. 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

Puspan. 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

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

Chronic Pain Conditions

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

Support for Bioengineering Research

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

Master Plan for Physical Infrastructure for Research

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