42 U.S.C. § 282 — Director of National Institutes of Health

Page 632 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 tion] and the amendments made by this Act may not be construed as affecting the authorities of the national research institutes and national centers that were in effect under the Public Health Service Act [42 U.S.C. 201 et seq.] on the day before the date of the enactment of this Act [Jan. 15, 2007], subject to the authorities of the Secretary of Health and Human Services and the Director of NIH under section 401 of the Public Health Service Act [42 U.S.C. 281] (as amended by section 101 of this Act). For purposes of the preceding sentence, the terms ‘national research institute’, ‘national cen- ter’, and ‘Director of NIH’ have the meanings given such terms in such section 401.’’ STUDY OF THE USE OF CENTERS OF EXCELLENCE AT THE NATIONAL INSTITUTES OF HEALTH Pub. L. 107–84, § 7, Dec. 18, 2001, 115 Stat. 829, required the Secretary of Health and Human Services to con- tract, not later than 60 days after Dec. 18, 2001, with the Institute of Medicine to conduct a study on the impact of, need for, and other issues associated with Centers of Excellence at the National Institutes of Health and complete the study and submit a report not later than one year after the date of the contract. REPORT ON MEDICAL USES OF BIOLOGICAL AGENTS IN DEVELOPMENT OF DEFENSES AGAINST BIOLOGICAL WARFARE Pub. L. 103–43, title XIX, § 1904, June 10, 1993, 107 Stat. 203, directed Secretary of Health and Human Services, in consultation with Secretary of Defense and with heads of other appropriate executive agencies, to report to Congress, not later than 12 months after June 10, 1993, on the appropriateness and impact of the National Institutes of Health assuming responsibility for the conduct of all Federal research, development, testing, and evaluation functions relating to medical counter- measures against biowarfare threat agents. RESEARCH ON LUPUS ERYTHEMATOSUS Pub. L. 99–158, § 5, Nov. 20, 1985, 99 Stat. 880, as amend- ed by Pub. L. 102–531, title III, § 312(f), Oct. 27, 1992, 106 Stat. 3506, directed Secretary of Health and Human Re- sources to establish a Lupus Erythematosus Coordi- nating Committee to plan, develop, coordinate, and im- plement comprehensive Federal initiatives in research on Lupus Erythematosus, provided for composition of committee and meetings, and directed Committee to prepare a report for Congress on its activities, to be submitted not later than 18 months after Nov. 20, 1985, with Committee to terminate one month after the re- port was submitted. INTERAGENCY COMMITTEE ON LEARNING DISABILITIES Pub. L. 99–158, § 9, Nov. 20, 1985, 99 Stat. 882, directed Director of the National Institutes of Health, not later than 90 days after Nov. 20, 1985, to establish an Inter- agency Committee on Learning Disabilities to review and assess Federal research priorities, activities, and findings regarding learning disabilities (including cen- tral nervous system dysfunction in children), provided for composition of the Committee, directed Committee to report to Congress on its activities not later than 18 months after Nov. 20, 1985, and provided that the Com- mittee terminate 90 days after submission of the re- port. § 282. Director of National Institutes of Health (a) Appointment The National Institutes of Health shall be headed by the Director of NIH who shall be ap- pointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under sub- section (b) and as the Secretary may otherwise prescribe. (b) Duties and authority In carrying out the purposes of section 241 of this title, the Secretary, acting through the Di- rector of NIH— (1) shall carry out this subchapter, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and oper- ation of programs and activities within the National Institutes of Health; (2) shall coordinate and oversee the oper- ation of the national research institutes, na- tional centers, and administrative entities within the National Institutes of Health; (3) shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordina- tion across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the re- search portfolio of the National Institutes of Health is balanced and free of unnecessary du- plication, and takes advantage of collabo- rative, cross-cutting research; (4) shall assemble accurate data to be used to assess research priorities, including— (A) information to better evaluate sci- entific opportunity, public health burdens, and progress in reducing health disparities; and (B) data on study populations of clinical research, funded by or conducted at each na- tional research institute and national cen- ter, which— (i) specifies the inclusion of— (I) women; (II) members of minority groups; (III) relevant age categories, including pediatric subgroups; and (IV) other demographic variables as the Director of the National Institutes of Health determines appropriate; (ii) is disaggregated by research area, condition, and disease categories; and (iii) is to be made publicly available on the Internet website of the National Insti- tutes of Health; (5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, and through the development, implementa- tion, and updating of the strategic plan devel- oped under subsection (m); (6) shall ensure that the resources of the Na- tional Institutes of Health are sufficiently al- located for research projects identified in stra- tegic plans; (7)(A) shall, through the Division of Program Coordination, Planning, and Strategic Initia- tives— (i) identify research that represents impor- tant areas of emerging scientific opportuni- ties, rising public health challenges, or knowledge gaps that deserve special empha- sis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national re- search institutes or national centers, or Page 633 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 would otherwise benefit from strategic co- ordination and planning; (ii) include information on such research in reports under section 283 of this title; and (iii) in the case of such research supported with funds referred to in subparagraph (B)— (I) require as appropriate that proposals include milestones and goals for the re- search; (II) require that the proposals include timeframes for funding of the research; and (III) ensure appropriate consideration of proposals for which the principal investi- gator is an individual who has not pre- viously served as the principal investi- gator of research conducted or supported by the National Institutes of Health; (B)(i) may, with respect to funds reserved under section 282a(c)(1) of this title for the Common Fund, allocate such funds to the na- tional research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and (ii) shall, with respect to funds appropriated to the Division of Program Coordination, Planning, and Strategic Initiatives pursuant to section 282a(a)(2) of this title, allocate such funds to the national research institutes and national centers for making grants for pedi- atric research that is identified under subpara- graph (A) and shall prioritize, as appropriate, such pediatric research that does not dupli- cate existing research activities of the Na- tional Institutes of Health; and (C) may assign additional functions to the Division in support of responsibilities identi- fied in subparagraph (A), as determined appro- priate by the Director; (8) shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and cen- ters— (A) preserve an emphasis on investigator- initiated research project grants, including with respect to research involving collabora- tion between 2 or more such institutes or centers; (B) when appropriate, maximize investi- gator-initiated research project grants in their annual research portfolios; (C) foster collaboration between clinical research projects funded by the respective national research institutes and national centers that— (i) conduct research involving human subjects; and (ii) collect similar data; and (D) encourage the collaboration described in subparagraph (C) to— (i) allow for an increase in the number of subjects studied; and (ii) utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities; (9) shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title and that, after such review, the research is reviewed in accordance with section 289a–1(a)(2) of this title by the appro- priate advisory council under section 284a of this title before the research proposals are ap- proved for funding; (10) shall have authority to review and ap- prove the establishment of all centers of excel- lence recommended by the national research institutes; (11)(A) shall oversee research training for all of the national research institutes and Na- tional Research Service Awards in accordance with section 288 of this title; and (B) may conduct and support research train- ing— (i) for which fellowship support is not pro- vided under section 288 of this title; and (ii) that does not consist of residency training of physicians or other health pro- fessionals; (12) may, from funds appropriated under sec- tion 282a(b) of this title, reserve funds to pro- vide for research on matters that have not re- ceived significant funding relative to other matters, to respond to new issues and sci- entific emergencies, and to act on research op- portunities of high priority; (13) may, subject to appropriations Acts, col- lect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences; (14) for the national research institutes and administrative entities within the National Institutes of Health— (A) may acquire, construct, improve, re- pair, operate, and maintain, at the site of such institutes and entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal prop- erty, and (B) may acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adja- cent to the District of Columbia for use for a period not to exceed ten years; (15) may secure resources for research con- ducted by or through the National Institutes of Health; (16) may, without regard to the provisions of title 5 governing appointments in the competi- tive service, and without regard to the provi- sions of chapter 51 and subchapter III of chap- ter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups and scientific program advisory committees as are needed to carry out the requirements of this subchapter and appoint and pay the members of such groups, except that officers and em- ployees of the United States shall not receive additional compensation for service as mem- bers of such groups; (17) may secure for the National Institutes of Health consultation services and advice of per- sons from the United States or abroad; (18) may use, with their consent, the serv- ices, equipment, personnel, information, and facilities of other Federal, State, or local pub- Page 634 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 lic agencies, with or without reimbursement therefor; (19) may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment; (20) may accept voluntary and uncompen- sated services; (21) may perform such other administrative functions as the Secretary determines are needed to effectively carry out this sub- chapter; (22) may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals sub- ject to the provisions of chapter 74 of title 38; (23) shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric med- ical device development; (24) implement the Cures Acceleration Net- work described in section 287a of this title; (25) may require recipients of National Insti- tutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of— (A) human research participants, including with respect to privacy, security, informed consent, and protected health information; and (B) proprietary interests, confidential commercial information, and the intellec- tual property rights of the funding recipient; (26) shall consult with the Assistant Sec- retary for Preparedness and Response, the Di- rector of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Preven- tion, and the heads of other Federal agencies and offices, as appropriate, regarding research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging infectious diseases, chemical, radio- logical, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats; (27) shall consult with the Director of the Of- fice of National Security within the Depart- ment of Health and Human Services, the As- sistant Secretary for Preparedness and Re- sponse, the Director of National Intelligence, the Director of the Federal Bureau of Inves- tigation, and the heads of other appropriate agencies on a regular basis, regarding bio- medical research conducted or supported by the National Institutes of Health that may af- fect or be affected by matters of national secu- rity; (28) shall ensure that recipients of awards from the National Institutes of Health, and, as appropriate and practicable, entities collabo- rating with such recipients, have in place and are adhering to appropriate technology prac- tices and policies for the security of identifi- able, sensitive information, including informa- tion collected, stored, managed, or analyzed by domestic and non-domestic entities; and (29) shall ensure that recipients of awards from the National Institutes of Health are in compliance with the terms and conditions of such award, which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipi- ents of the award. Chapter 10 of title 5 shall not apply to the dura- tion of a peer review group appointed under paragraph (16). The members of such a group shall be individuals who by virtue of their train- ing or experience are eminently qualified to per- form 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. (c) Availability of substances and organisms for research The Director of NIH may make available to in- dividuals and entities, for biomedical and behav- ioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (in- cluding payment for them) as the Secretary de- termines appropriate. (d) Services of experts or consultants; number; payment of expenses, conditions, recovery (1) The Director of NIH may obtain (in accord- ance with section 3109 of title 5, but without re- gard to the limitation in such section on the pe- riod of service) the services of not more than 220 experts or consultants, with scientific or other professional qualifications, for the National In- stitutes of Health. (2)(A) Except as provided in subparagraph (B), experts and consultants whose services are ob- tained under paragraph (1) shall be paid or reim- bursed, in accordance with title 5, for their trav- el to and from their place of service and for other expenses associated with their assign- ment. (B) Expenses specified in subparagraph (A) shall not be allowed in connection with the as- signment of an expert or consultant whose serv- ices are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is short- er, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Sec- retary. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subpara- graph. (e) Dissemination of research information The Director of NIH shall— (1) advise the agencies of the National Insti- tutes of Health on medical applications of re- search; (2) coordinate, review, and facilitate the sys- tematic identification and evaluation of, clini- cally relevant information from research con- Page 635 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 ducted by or through the national research in- stitutes; (3) promote the effective transfer of the in- formation described in paragraph (2) to the health care community and to entities that require such information; (4) monitor the effectiveness of the activities described in paragraph (3); and (5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded by the National Institutes of Health and intended for the gen- eral public are in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (Public Law 102–73). (f) Associate Director for Prevention; functions There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Asso- ciate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the na- tional research institutes and the coordination of such programs among the national research institutes and between the national research in- stitutes and other public and private entities, including elementary, secondary, and post-sec- ondary schools. The Associate Director shall— (1) annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs; and (2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemina- tion, using advanced technologies to the max- imum extent practicable, of research results to such entities. (g) Transferred (h) Increased participation of women and dis- advantaged individuals in biomedical and behavioral research The Secretary, acting through the Director of NIH and the Directors of the agencies of the Na- tional Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, pro- vide for an increase in the number of women and individuals from disadvantaged backgrounds (in- cluding racial and ethnic minorities) in the fields of biomedical and behavioral research. (i) Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (1)(A) The Secretary, acting through the Di- rector of NIH, shall establish, maintain, and op- erate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection re- ferred to as the ‘‘data bank’’). The activities of the data bank shall be integrated and coordi- nated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar informa- tion. (B) The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appro- priate agencies of the National Institutes of Health (including the National Library of Medi- cine), and the Director of the Centers for Dis- ease Control and Prevention. (2) In carrying out paragraph (1), the Sec- retary shall collect, catalog, store, and dissemi- nate the information described in such para- graph. The Secretary shall disseminate such in- formation through information systems, which shall include toll-free telephone communica- tions, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care pro- viders, and to researchers. (3) The data bank shall include the following: (A) A registry of clinical trials (whether fed- erally or privately funded) of experimental treatments for serious or life-threatening dis- eases and conditions under regulations pro- mulgated pursuant to section 355(i) of title 21, which provides a description of the purpose of each experimental drug, either with the con- sent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for partici- pation in the clinical trials, a description of the location of trial sites, a point of contact for those wanting to enroll in the trial, and a description of whether, and through what pro- cedure, the manufacturer or sponsor of the in- vestigation of a new drug will respond to re- quests for protocol exception, with appro- priate safeguards, for single-patient and ex- panded protocol use of the new drug, particu- larly in children, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol. (B) Information pertaining to experimental treatments for serious or life-threatening dis- eases and conditions that may be available— (i) under a treatment investigational new drug application that has been submitted to the Secretary under section 360bbb(c) of title 21; or (ii) as a Group C cancer drug (as defined by the National Cancer Institute). The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the spon- sor, including information concerning poten- tial toxicities or adverse effects associated with the use or administration of such experi- mental treatments. (4) The data bank shall not include informa- tion relating to an investigation if the sponsor has provided a detailed certification to the Sec- retary that disclosure of such information would substantially interfere with the timely enroll- ment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written de- termination that such disclosure would not sub- stantially interfere with such enrollment. (5) Fees collected under section 379h of title 21 shall not be used in carrying out this subsection. Page 636 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 (j) Expanded clinical trial registry data bank (1) Definitions; requirement (A) Definitions In this subsection: (i) Applicable clinical trial The term ‘‘applicable clinical trial’’ means an applicable device clinical trial or an applicable drug clinical trial. (ii) Applicable device clinical trial The term ‘‘applicable device clinical trial’’ means— (I) a prospective clinical study of health outcomes comparing an interven- tion with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the pri- mary outcome measure relates to feasi- bility and not to health outcomes); and (II) a pediatric postmarket surveil- lance as required under section 360l of title 21. (iii) Applicable drug clinical trial (I) In general The term ‘‘applicable drug clinical trial’’ means a controlled clinical inves- tigation, other than a phase I clinical in- vestigation, of a drug subject to section 355 of title 21 or to section 262 of this title. (II) Clinical investigation 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). (III) Phase I 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). (iv) Clinical trial information The term ‘‘clinical trial information’’ means, with respect to an applicable clin- ical trial, those data elements that the re- sponsible party is required to submit under paragraph (2) or under paragraph (3). (v) Completion date The term ‘‘completion date’’ means, with respect to an applicable clinical trial, the date that the final subject was exam- ined 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. (vi) Device The term ‘‘device’’ means a device as de- fined in section 321(h) of title 21. (vii) Drug The term ‘‘drug’’ means a drug as de- fined in section 321(g) of title 21 or a bio- logical product as defined in section 262 of this title. (viii) Ongoing The term ‘‘ongoing’’ means, with respect to a clinical trial of a drug or a device and to a date, that— (I) 1 or more patients is enrolled in the clinical trial; and (II) the date is before the completion date of the clinical trial. (ix) Responsible party The term ‘‘responsible party’’, with re- spect to a clinical trial of a drug or device, means— (I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or (II) the principal investigator of such clinical trial if so designated by a spon- sor, grantee, contractor, or awardee, so long as the principal investigator is re- sponsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to pub- lish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information. (B) Requirement The Secretary shall develop a mechanism by which the responsible party for each ap- plicable clinical trial shall submit the iden- tity and contact information of such respon- sible party to the Secretary at the time of submission of clinical trial information under paragraph (2). (2) Expansion of clinical trial registry data bank with respect to clinical trial informa- tion (A) In general (i) Expansion of data bank To enhance patient enrollment and pro- vide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this sub- section, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the ‘‘reg- istry data bank’’). The Director of NIH shall ensure that the registry data bank is made publicly available through the Inter- net. (ii) Content The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include— (I) descriptive information, including— (aa) a brief title, intended for the lay public; (bb) a brief summary, intended for the lay public; (cc) the primary purpose; (dd) the study design; (ee) for an applicable drug clinical trial, the study phase; Page 637 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 1 So in original. The word ‘‘of’’ probably should not appear. (ff) study type; (gg) the primary disease or condition being studied, or the focus of the study; (hh) the intervention name and intervention type; (ii) the study start date; (jj) the expected completion date; (kk) the target number of subjects; and (ll) outcomes, including primary and secondary outcome measures; (II) recruitment information, includ- ing— (aa) eligibility criteria; (bb) gender; (cc) age limits; (dd) whether the trial accepts healthy volunteers; (ee) overall recruitment status; (ff) individual site status; and (gg) in the case of an applicable drug clinical trial, if the drug is not ap- proved under section 355 of title 21 or licensed under section 262 of this title, specify whether or not there is ex- panded access to the drug under sec- tion 360bbb of title 21 for those who do not qualify for enrollment in the clin- ical trial and how to obtain informa- tion about such access; (III) location and contact information, including— (aa) the name of the sponsor; (bb) the responsible party, by official title; and (cc) the facility name and facility contact information (including the city, State, and zip code for each clin- ical trial location, or a toll-free num- ber through which such location infor- mation may be accessed); and (IV) administrative data (which the Secretary may make publicly available as necessary), including— (aa) the unique protocol identifica- tion number; (bb) other protocol identification numbers, if any; and (cc) the Food and Drug Administra- tion IND/IDE protocol number and the record verification date. (iii) Modifications The Secretary may by regulation modify the requirements for clinical trial infor- mation under this paragraph, if the Sec- retary provides a rationale for why such a modification improves and does not reduce such clinical trial information. (B) Format and structure (i) Searchable categories The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the reg- istry data bank by 1 or more of the fol- lowing criteria: (I) The disease or condition being stud- ied in the clinical trial, using Medical Subject Headers (MeSH) descriptors. (II) The name of the intervention, in- cluding any drug or device being studied in the clinical trial. (III) The location of the clinical trial. (IV) The age group studied in the clin- ical trial, including pediatric subpopula- tions. (V) The study phase of the clinical trial. (VI) The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a pri- vate industry source, or a university or other organization. (VII) The recruitment status of the clinical trial. (VIII) The National Clinical Trial num- ber or other study identification for the clinical trial. (ii) Additional searchable category Not later than 18 months after Sep- tember 27, 2007, the Director of NIH shall ensure that the public may search the en- tries of the registry data bank by the safe- ty issue, if any, being studied in the clin- ical trial as a primary or secondary out- come. (iii) Other elements The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other ele- ments as the Director deems necessary on an ongoing basis. (iv) Format The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared. (C) Data submission 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 de- scribed in of 1 subparagraph (A)(ii) not later than the later of— (i) 90 days after September 27, 2007; (ii) 21 days after the first patient is en- rolled in such clinical trial; or (iii) in the case of a clinical trial that is not for a serious or life-threatening dis- ease or condition and that is ongoing on September 27, 2007, 1 year after September 27, 2007. (D) Posting of data (i) Applicable drug clinical trial 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 reg- istry data bank not later than 30 days after such submission. Page 638 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 (ii) Applicable device clinical trial The Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accord- ance with this paragraph is posted publicly in the registry data bank— (I) not earlier than the date of clear- ance under section 360(k) of title 21, or approval under section 360e or 360j(m) of title 21, as applicable, for a device that was not previously cleared or approved, and not later than 30 days after such date, unless the responsible party affirm- atively 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; or (II) for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary. (iii) Option to make certain clinical trial information available earlier 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 clin- ical trial be publicly posted prior to the date of clearance or approval, in accord- ance with clause (ii)(I). (iv) Combination products An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered— (I) an applicable drug clinical trial, if the Secretary determines under section 353(g) of title 21 that the primary mode of action of such product is that of a drug or biological product; or (II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device. (3) Expansion of registry data bank to include results of clinical trials (A) Linking registry data bank to existing re- sults (i) In general 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 in- volved is approved or after the device in- volved is cleared or approved, the Sec- retary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial— (I) not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device in- volved; or (II) not later than 30 days after the re- sults information described in clause (ii) becomes publicly available. (ii) Required information (I) FDA information The Secretary shall ensure that the registry data bank includes links to the following information: (aa) If an advisory committee consid- ered at a meeting an applicable clin- ical trial, any posted Food and Drug Administration summary document re- garding such applicable clinical trial. (bb) If an applicable drug clinical trial was conducted under section 355a or 355c of title 21, a link to the posted Food and Drug Administration assess- ment of the results of such trial. (cc) Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any. (dd) For an applicable drug clinical trial, the Food and Drug Administra- tion action package for approval docu- ment required under section 355(l)(2) of title 21. (ee) For an applicable device clinical trial, in the case of a premarket appli- cation under section 360e of title 21, the detailed summary of information respecting the safety and effectiveness of the device required under section 360j(h)(1) of title 21, or, in the case of a report under section 360(k) of title 21, the section 360(k) summary of the safe- ty and effectiveness data required under section 807.95(d) of title 21, Code of Federal Regulations (or any suc- cessor regulation). (II) NIH information The Secretary shall ensure that the registry data bank includes links to the following information: (aa) Medline citations to any publi- cations focused on the results of an ap- plicable clinical trial. (bb) The entry for the drug that is the subject of an applicable drug clin- ical trial in the National Library of Medicine database of structured prod- uct labels, if available. (iii) Results for existing data bank entries The Secretary may include the links de- scribed in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to September 27, 2007, as avail- able. (B) Inclusion of results The Secretary, acting through the Direc- tor of NIH, shall— (i) expand the registry data bank to in- clude the results of applicable clinical trials (referred to in this subsection as the ‘‘registry and results data bank’’); (ii) ensure that such results are made publicly available through the Internet; (iii) post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and (iv) in consultation with experts on risk communication, provide information with Page 639 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 the information included under subpara- graph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the pub- lic. (C) Basic results Not later than 1 year after September 27, 2007, the Secretary shall include in the reg- istry and results data bank for each applica- ble 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 ap- proved under section 360e or 360j(m) of title 21, the following elements: (i) Demographic and baseline characteris- tics of patient sample 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, in- cluding the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any. (ii) Primary and secondary outcomes 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 out- come measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical signifi- cance of such outcome measures. (iii) Point of contact A point of contact for scientific informa- tion about the clinical trial results. (iv) Certain agreements Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law pro- tecting the privacy of participants) be- tween the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investi- gator) 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 meet- ing or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial. (D) Expanded registry and results data bank (i) Expansion by rulemaking To provide more complete results infor- mation and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after Sep- tember 27, 2007, the Secretary shall by reg- ulation expand the registry and results data bank as provided under this subpara- graph. (ii) Clinical trials (I) Approved products The regulations under this subpara- graph shall require the inclusion of the results information described in clause (iii) for— (aa) each applicable drug clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title; and (bb) each applicable device clinical trial for a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21. (II) Unapproved products The regulations under this subpara- graph shall establish whether or not the results information described in clause (iii) shall be required for— (aa) an applicable drug clinical trial for a drug that is not approved under section 355 of title 21 and not licensed under section 262 of this title (whether approval or licensure was sought or not); and (bb) an applicable device clinical trial for a device that is not cleared under section 360(k) of title 21 and not approved under section 360e or section 360j(m) of title 21 (whether clearance or approval was sought or not). (iii) Required elements The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories: (I) A summary of the clinical trial and its results that is written in non-tech- nical, understandable language for pa- tients, if the Secretary determines that such types of summary can be included without being misleading or pro- motional. (II) A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included with- out being misleading or promotional. (III) The full protocol or such informa- tion on the protocol for the trial as may be necessary to help to evaluate the re- sults of the trial. (IV) Such other categories as the Sec- retary determines appropriate. (iv) Results submission The results information described in clause (iii) shall be submitted to the Direc- tor of NIH for inclusion in the registry and results data bank as provided by subpara- graph (E), except that the Secretary shall by regulation determine— (I) whether the 1-year period for sub- mission of clinical trial information de- scribed in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months; (II) whether the clinical trial informa- tion described in clause (iii) should be re- quired to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and re- sults data bank before the effective date Page 640 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 2 So in original. The second closing parenthesis probably should not appear. of the regulations issued under this sub- paragraph; and (III) in the case when the clinical trial information described in clause (iii) is required to be submitted for the applica- ble clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account— (aa) the certification process under subparagraph (E)(iii) when approval, li- censure, or clearance is sought; and (bb) whether there should be a delay of submission when approval, licen- sure, or clearance will not be sought. (v) Additional provisions The regulations under this subparagraph shall also establish— (I) a standard format for the submis- sion of clinical trial information under this paragraph to the registry and re- sults data bank; (II) additional information on clinical trials and results that is written in non- technical, understandable language for patients; (III) considering the experience under the pilot quality control project de- scribed in paragraph (5)(C), procedures for quality control, including using rep- resentative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-pro- motional; (IV) the appropriate timing and re- quirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked; (V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary out- come measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and (VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C). (vi) Consideration of World Health Organi- zation data set The Secretary shall consider the status of the consensus data elements set for re- porting clinical trial results of the World Health Organization when issuing the reg- ulations under this subparagraph. (vii) Public meeting The Secretary shall hold a public meet- ing no later than 18 months after Sep- tember 27, 2007, to provide an opportunity for input from interested parties with re- gard to the regulations to be issued under this subparagraph. (E) Submission of results information (i) In general 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 re- sults data bank the clinical trial informa- tion described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under sub- paragraph (D), after the earlier of— (I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); 2 or (II) the actual date of completion. (ii) Clinical trials described An applicable clinical trial described in this clause is an applicable clinical trial subject to— (I) paragraph (2)(C); and (II)(aa) subparagraph (C); or (bb) the regulations issued under sub- paragraph (D). (iii) Delayed submission of results with cer- tification 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 subpara- graphs (C) and (D) as required under the applicable clause. (iv) Seeking initial approval of a drug or device 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 Di- rector of NIH for inclusion in the registry and results data bank the clinical trial in- formation described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such sec- tion 355, licensed under such section 262, cleared under such section 360(k), or ap- proved under such section 360e or 360j(m), as applicable. (v) Seeking approval of a new use for the drug or device (I) In general 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 appli- cation 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 in- cluded in the labeling of the approved Page 641 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and re- sults data bank the clinical trial infor- mation described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date— (aa) the new use of the drug or device is approved under such section 355, li- censed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m); (bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or not clear- ing the submission, a not approvable letter, or a not substantially equiva- lent letter for the new use of the drug or device under such section 355, 262, 360(k), 360e, or 360j(m); or (cc) except as provided in subclause (III), the application or premarket no- tification under such section 355, 262, 360(k), 360e, or 360j(m) is withdrawn without resubmission for no less than 210 days. (II) Requirement that each clinical trial in application be treated the same If a manufacturer makes a certifi- cation under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a cer- tification with respect to each applicable clinical trial that is required to be sub- mitted in an application or report for li- censure, approval, or clearance (under section 262 of this title or section 355, 360(k), 360e, or 360j(m) of title 21, as ap- plicable) of the use studied in the clin- ical trial. (III) Two-year limitation The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clin- ical trial information subject to sub- clause (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 oc- curred by such date. (vi) Extensions The Director of NIH may provide an ex- tension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial sub- mits 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. (F) Notice to Director of NIH 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. (G) Posting of data The Director of NIH shall ensure that the clinical trial information described in sub- paragraphs (C) and (D) for an applicable clin- ical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission. (H) Waivers regarding certain clinical trial results The Secretary may waive any applicable requirements of this paragraph for an appli- cable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary cir- cumstances justify the waiver and that pro- viding the waiver is consistent with the pro- tection 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 appro- priate committees of Congress of the waiver and provide an explanation for why the waiver was granted. (I) Adverse events (i) Regulations Not later than 18 months after Sep- tember 27, 2007, the Secretary shall by reg- ulation determine the best method for in- cluding in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for applicable clinical trials de- scribed in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists. (ii) Default If the Secretary fails to issue the regula- tion required by clause (i) by the date that is 24 months after September 27, 2007, clause (iii) shall take effect. (iii) Additional elements 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 ad- dition to the clinical trial information de- scribed in subparagraph (C), the following elements: (I) Serious adverse events A table of anticipated and unantici- pated serious adverse events grouped by organ system, with number and fre- quency of such event in each arm of the clinical trial. (II) Frequent adverse events A table of anticipated and unantici- pated adverse events that are not in- cluded in the table described in sub- clause (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. Page 642 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 3 So in original. 4 So in original. The second closing parenthesis probably should not appear. (iv) Posting of other information In carrying out clause (iii), the Sec- retary shall, in consultation with experts in risk communication, post with the ta- bles information to enhance patient under- standing and to ensure such tables do not mislead patients or the lay public. (v) Relation to subparagraph (C) 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). (4) Additional submissions of clinical trial in- formation (A) Voluntary submissions A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not sub- ject to paragraph (2)(C), may submit com- plete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial in- formation for each applicable clinical trial that is required to be submitted under sec- tion 262 of this title or under section 355, 360(k), 360e, or 360j(m) of title 21 in an appli- cation or report for licensure, approval, or clearance of the drug or device for the use studied in the clinical trial. (B) Required submissions (i) In general 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— (I) the Secretary may require by noti- fication that such information be sub- mitted to the Secretary in accordance with paragraphs (2) and (3) except with regard to timing of submission; (II) unless the responsible party sub- mits a certification under paragraph (3)(E)(iii), such information shall be sub- mitted not later than 30 days after the date specified by the Secretary in the notification; and (III) failure to comply with the re- quirements under subclauses (I) and (II) shall be treated as a violation of the cor- responding requirement of such para- graphs. (ii) Clinical trials described A clinical trial described in this clause is— (I) an applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or for a device that is cleared under section 360(k) of title 21 or ap- proved under section 360e or section 360j(m) of title 21, whose completion date is on or after the date 10 years before September 27, 2007; or (II) an applicable clinical trial that is described by both by 3 paragraph (2)(C) and paragraph (3)(D)(ii)(II)).4 (C) Updates to clinical trial data bank (i) Submission of updates The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and re- sults data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates— (I) shall be provided not less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period; (II) shall include identification of the dates of any such changes; (III) not later than 30 days after the re- cruitment status of such clinical trial changes, shall include an update of the recruitment status; and (IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete. (ii) Public availability of updates The Director of NIH shall make updates submitted under clause (i) publicly avail- able in the registry data bank. Except with regard to overall recruitment status, indi- vidual site status, location, and contact information, the Director of NIH shall en- sure 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 submis- sions or any preceding updates, and infor- mation in such databases is presented in a manner that enables users to readily ac- cess 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 sec- ondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll). (5) Coordination and compliance (A) Clinical trials supported by grants from Federal agencies (i) Grants from certain Federal agencies If an applicable clinical trial is funded in whole or in part by a grant from any agen- cy of the Department of Health and Human Services, including the Food and Drug Administration, the National Insti- tutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certifi- cation that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3). Page 643 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 5 So in original. Probably should be ‘‘paragraph (2)(A)(ii)(I)(ll),’’. (ii) Verification by Federal agencies The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each ap- plicable clinical trial for which a grantee is the responsible party has been sub- mitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee. (iii) Notice and opportunity to remedy If the head of an agency referred to in clause (i), as applicable, verifies that a grantee has not submitted clinical trial in- formation 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 clin- ical trial information. (iv) Consultation with other Federal agen- cies The Secretary shall— (I) consult with other agencies that conduct research involving human sub- jects in accordance with any section of part 46 of title 45, Code of Federal Regu- lations (or any successor regulations), to determine if any such research is an ap- plicable clinical trial; and (II) develop with such agencies proce- dures comparable to those described in clauses (i), (ii), and (iii) to ensure that clinical trial information for such appli- cable clinical trial is submitted under paragraphs (2) and (3). (B) Certification to accompany drug, biologi- cal product, and device submissions At the time of submission of an applica- tion under section 355 of title 21, section 360e of title 21, section 360j(m) of title 21, or sec- tion 262 of this title, or submission of a re- port under section 360(k) of title 21, such ap- plication or submission shall be accom- panied by a certification that all applicable requirements of this subsection have been met. Where available, such certification shall include the appropriate National Clin- ical Trial control numbers. (C) Quality control (i) Pilot quality control project Until the effective date of the regula- tions 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 de- termine 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 informa- tion described in paragraph (3)(A) and any other information available to the Sec- retary about applicable clinical trials to verify the accuracy of the clinical trial in- formation submitted under paragraph (3)(C). (ii) Notice of compliance If the Secretary determines that any clinical trial information was not sub- mitted as required under this subsection, or was submitted but is false or misleading in any particular, the Secretary shall no- tify the responsible party and give such party an opportunity to remedy such non- compliance by submitting the required re- vised clinical trial information not later than 30 days after such notification. (D) Truthful clinical trial information (i) In general The clinical trial information submitted by a responsible party under this sub- section shall not be false or misleading in any particular. (ii) Effect Clause (i) shall not have the effect of— (I) requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial in- volved; or (II) requiring clinical trial information described in paragraph (3)(D) to be sub- mitted for purposes of paragraph (3)(C). (E) Public notices (i) Notice of violations If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as re- quired under paragraphs (2) or (3), the Di- rector of NIH shall include in the registry and results data bank entry for such clin- ical trial a notice— (I) that the responsible party is not in compliance with this chapter by— (aa) failing to submit required clin- ical trial information; or (bb) submitting false or misleading clinical trial information; (II) of the penalties imposed for the violation, if any; and (III) whether the responsible party has corrected the clinical trial information in the registry and results data bank. (ii) Notice of failure to submit primary and secondary outcomes 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 pri- mary and secondary outcomes in accord- ance with this chapter, and that the pri- mary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial. (iii) Failure to submit statement The notice under clause (i) for a viola- tion described in clause (i)(I)(aa) shall in- Page 644 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 clude 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.’’. (iv) Submission of false information state- ment The notice under clause (i) for a viola- tion described in clause (i)(I)(bb) shall in- clude the following statement: ‘‘The entry for this clinical trial was found to be false or misleading and therefore not in compli- ance with the law.’’. (v) Non-submission of statement The notice under clause (ii) for a viola- tion described in clause (ii) shall include the following statement: ‘‘The entry for this clinical trial did not contain informa- tion on the primary and secondary out- comes at the time of submission, as re- quired by law. This may or may not have any bearing on the accuracy of the infor- mation in the entry.’’. (vi) Compliance searches The Director of NIH shall provide that the public may easily search the registry and results data bank for entries that in- clude notices required under this subpara- graph. (6) Limitation on disclosure of clinical trial in- formation (A) In general Nothing in this subsection (or under sec- tion 552 of title 5) shall require the Sec- retary to publicly disclose, by any means other than the registry and results data bank, information described in subparagraph (B). (B) Information described Information described in this subpara- graph is— (i) information submitted to the Direc- tor of NIH under this subsection, or infor- mation of the same general nature as (or integrally associated with) the informa- tion so submitted; and (ii) information not otherwise publicly available, including because it is protected from disclosure under section 552 of title 5. (7) Authorization of appropriations There are authorized to be appropriated to carry out this subsection $10,000,000 for each fiscal year. (k) Day care for children of employees (1) The Director of NIH may establish a pro- gram to provide day care services for the em- ployees of the National Institutes of Health similar to those services provided by other Fed- eral agencies (including the availability of day care service on a 24-hour-a-day basis). (2) Any day care provider at the National In- stitutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee. (3) For purposes regarding the provision of day care services, the Director of NIH may enter into rental or lease purchase agreements. (l) Council of Councils (1) Establishment 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’’ (re- ferred 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). (2) Membership (A) In general The Council shall be composed of 27 mem- bers selected by the Director of NIH with ap- proval from the Secretary from among the list of nominees under subparagraph (C). (B) Certain requirements In selecting the members of the Council, the Director of NIH shall ensure— (i) the representation of a broad range of disciplines and perspectives; and (ii) the ongoing inclusion of at least 1 representative from each national research institute whose budget is substantial rel- ative to a majority of the other institutes. (C) Nomination The Director of NIH shall maintain an up- dated list of individuals who have been nom- inated to serve on the Council, which list shall consist of the following: (i) For each national research institute and national center, 3 individuals nomi- nated by the head of such institute or cen- ter from among the members of the advi- sory council of the institute or center, of which— (I) two shall be scientists; and (II) one shall be from the general pub- lic or shall be a leader in the field of pub- lic policy, law, health policy, economics, or management. (ii) For each office within the Division of Program Coordination, Planning, and Strategic Initiatives, 1 individual nomi- nated by the head of such office. (iii) Members of the Council of Public Representatives. (3) Terms (A) In general The term of service for a member of the Council shall be 6 years, except as provided in subparagraphs (B) and (C). (B) Terms of initial appointees Of the initial members selected for the Council, the Director of NIH shall des- ignate— (i) nine for a term of 6 years; (ii) nine for a term of 4 years; and (iii) nine for a term of 2 years. (C) Vacancies Any member appointed to fill a vacancy occurring before the expiration of the term Page 645 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 for which the member’s predecessor was ap- pointed shall be appointed only for the re- mainder of that term. A member may serve after the expiration of that member’s term until a successor has taken office. (m) National Institutes of Health Strategic Plan (1) In general 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 Inter- net 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 collabora- tion across the institutes and centers, to le- verage scientific opportunity, and to advance biomedicine. (2) Requirements The strategy under paragraph (1) shall— (A) identify strategic research priorities and objectives across biomedical research, including— (i) an assessment of the state of bio- medical and behavioral research, including areas of opportunity with respect to basic, clinical, and translational research; (ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions; (iii) emerging scientific opportunities, rising public health challenges, and sci- entific knowledge gaps; and (iv) the identification of near-, mid-, and long-term scientific needs; (B) consider, in carrying out subparagraph (A)— (i) disease burden in the United States and the potential for return on investment to the United States; (ii) rare diseases and conditions; (iii) biological, social, and other deter- minants of health that contribute to health disparities; and (iv) other factors the Director of Na- tional Institutes of Health determines ap- propriate; (C) include multi-institute priorities, in- cluding coordination of research among in- stitutes and centers; (D) include strategic priorities for funding research through the Common Fund, in ac- cordance with section 282a(c)(1)(C) of this title; (E) address the National Institutes of Health’s proposed and ongoing activities re- lated to training and the biomedical work- force; and (F) describe opportunities for collabora- tion with other agencies and departments, as appropriate. (3) Use of plans 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 man- ner 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. (4) Consultation The Director of National Institutes of Health shall develop the strategic plan under paragraph (1) in consultation with the direc- tors of the national research institutes and na- tional centers, researchers, patient advocacy groups, and industry leaders. (n) Unique research initiatives (1) In general The Director of NIH may approve, after con- sideration of a proposal under paragraph (2)(A), requests by the national research insti- tutes and centers, or program officers within the Office of the Director to engage in trans- actions other than a contract, grant, or coop- erative agreement with respect to projects that carry out— (A) the Precision Medicine Initiative under section 289g–5 of this title; (B) subsection (b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under section 282a(c)(1) of this title for purposes of carrying out such subsection (b)(7) may be used to engage in such other transactions; or (C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding lead- ing to the prevention, diagnosis, or treat- ment of diseases and disorders, or research urgently required to respond to a public health threat. (2) Requirements The authority provided under this sub- section may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions au- thority described in such paragraph if the in- stitute, center, or office— (A) submits a proposal to the Director of NIH for the use of such authority before con- ducting or supporting the research, includ- ing why the use of such authority is essen- tial to promoting the success of the project; (B) receives approval for the use of such authority from the Director of NIH; and (C) for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activi- ties of the institute, center, or office relat- ing to such research. (o) Regenerative medicine The Director of NIH shall, as appropriate, con- tinue to consult with the directors of relevant institutes and centers of the National Institutes of Health, other relevant experts from such in- stitutes 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, Page 646 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 therapeutic tissue engineering products, human cell and tissue products, human gene therapies, and genetically modified cells. (July 1, 1944, ch. 373, title IV, § 402, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 823; amended Pub. L. 100–607, title I, § 111, Nov. 4, 1988, 102 Stat. 3052; Pub. L. 102–321, title I, § 163(b)(3), July 10, 1992, 106 Stat. 376; Pub. L. 103–43, title I, § 141(b), title II, §§ 201, 202, 206, 208, 210(b), (c), title III, § 303(b), June 10, 1993, 107 Stat. 139, 144, 148–150, 153; Pub. L. 105–115, title I, § 113(a), Nov. 21, 1997, 111 Stat. 2310; Pub. L. 105–362, title VI, § 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 105–392, title IV, § 409, Nov. 13, 1998, 112 Stat. 3589; Pub. L. 107–109, § 15(c)(2), Jan. 4, 2002, 115 Stat. 1420; Pub. L. 109–482, title I, §§ 102(a)–(d), (f)(1)(A), 103(b)(1), Jan. 15, 2007, 120 Stat. 3681, 3683, 3684, 3687; Pub. L. 110–85, title III, § 304(a), title VIII, § 801(a), title XI, § 1104(2), Sept. 27, 2007, 121 Stat. 863, 904, 975; Pub. L. 110–316, title III, § 302, Aug. 14, 2008, 122 Stat. 3524; Pub. L. 111–148, title X, § 10409(b), Mar. 23, 2010, 124 Stat. 978; Pub. L. 112–74, div. F, title II, § 221(b)(5)(B), (d)(1), Dec. 23, 2011, 125 Stat. 1089, 1090; Pub. L. 113–94, § 3(a), Apr. 3, 2014, 128 Stat. 1086; Pub. L. 114–255, div. A, title II, §§ 2014(a), 2031(a), 2036(a), 2038(a), 2051, Dec. 13, 2016, 130 Stat. 1051, 1054, 1062, 1064, 1074; Pub. L. 115–271, title VII, § 7041, Oct. 24, 2018, 132 Stat. 4016; Pub. L. 117–15, § 4, May 26, 2021, 135 Stat. 278; Pub. L. 117–286, § 4(a)(231), Dec. 27, 2022, 136 Stat. 4331; Pub. L. 117–328, div. FF, title II, §§ 2302, 2323, Dec. 29, 2022, 136 Stat. 5757, 5767; Pub. L. 118–228, §§ 2(3), 3(b), Jan. 4, 2025, 138 Stat. 2822.) Editorial Notes REFERENCES IN TEXT The General Schedule, referred to in subsec. (b)(16), is set out under section 5332 of Title 5, Government Orga- nization and Employees. The National Literacy Act of 1991, referred to in sub- sec. (e)(5), is Pub. L. 102–73, July 25, 1991, 105 Stat. 333, which was repealed by Pub. L. 105–220, title II, § 251(a)(2), Aug. 7, 1998, 112 Stat. 1079. For complete clas- sification of this Act to the Code, see Tables. CODIFICATION In subsec. (b)(14)(B), ‘‘section 8141 of title 40’’ sub- stituted 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. AMENDMENTS 2025—Subsec. (b)(7)(B)(ii). Pub. L. 118–228, § 3(b), in- serted ‘‘and shall prioritize, as appropriate, such pedi- atric research that does not duplicate existing research activities of the National Institutes of Health’’ before ‘‘; and’’. Pub. L. 118–228, § 2(3), substituted ‘‘the Division of Program Coordination, Planning, and Strategic Initia- tives’’ for ‘‘the Common Fund’’. 2022—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 informa- tion 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 sub- section (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), in- serted ‘‘, unless the responsible party affirmatively re- quests 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 pro- visions relating to allocating funds appropriated pursu- ant 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), sub- stituted ‘‘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 in- troductory 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 ap- proved under section 360e or 360j(m) of title 21:’’. Subsec. (j)(3)(I)(i), (iii). Pub. L. 110–316, § 302(2), sub- stituted ‘‘applicable clinical trials described in sub- paragraph (C)’’ for ‘‘drugs described in subparagraph (C)’’. 2007—Subsec. (a). Pub. L. 109–482, § 102(f)(1)(A), sub- stituted ‘‘Director of NIH who shall’’ for ‘‘Director of the National Institutes of Health (hereafter in this sub- chapter 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 pro- visions. 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 enti- ties 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 ac- cordance with section 289a of this title;’’. Subsec. (b)(4). Pub. L. 110–85, § 1104(2), inserted ‘‘mi- nority 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 Page 647 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 (11) and (14) as (14) to (22), respectively, in par. (21) in- serted ‘‘and’’ at end, and struck out former pars. (12) and (13) which read as follows: ‘‘(12) after consultation with the Director of the Of- fice of Research on Women’s Health, shall ensure that resources of the National Institutes of Health are suffi- ciently 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 sub- sec. (j) as (i) and struck out former subsec. (i) which re- lated 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 trau- ma).’’ 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 in- vestigation 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: ‘‘an- nually prepare and submit to the Director of NIH a re- port concerning the prevention and dissemination ac- tivities undertaken by the Associate Director, includ- ing— ‘‘(A) a summary of the Associate Director’s review of existing dissemination policies and techniques to- gether 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 re- ported 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, sec- ondary, and post-secondary schools. The Associate Di- rector 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 activi- ties 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 sci- entific program advisory committees’’ after ‘‘peer re- view 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 assist- ance, 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 in- volved 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 amend- ments 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 sec- tion 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 re- search studies involving human subjects; and ‘‘(B) acceptable justifications for excluding partici- pants from a range of age groups from human sub- jects 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 poli- cies of the National Institutes of Health on the inclu- sion of relevant age groups in clinical studies need to Page 648 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 be updated, and shall update such policies as appro- priate. In making the determination, the Director of the National Institutes of Health shall take into con- sideration whether such policies— ‘‘(A) address the consideration of age as an inclu- sion 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 CONCLU- SIONS.—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 appli- cable, 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 sec- tion 2032 [of Pub. L. 114–255]) are made available to the public on the Internet website of the National In- stitutes of Health.’’ ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH Pub. 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 Sec- retary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Com- mittee 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 rec- ommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate— ‘‘(1) preclinical experiment design, including anal- ysis of sex as a biological variable; ‘‘(2) clinical experiment design, including— ‘‘(A) the diversity of populations studied for clin- ical research, with respect to biological, social, and other determinants of health that contribute to health disparities; ‘‘(B) the circumstances under which summary in- formation regarding biological, social, and other factors that contribute to health disparities should be reported; and ‘‘(C) the circumstances under which clinical stud- ies, 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 meth- ods, methodology, and analysis; ‘‘(4) data and information sharing in accordance with applicable privacy laws and regulations; and ‘‘(5) any other matter the working group deter- mines relevant. ‘‘(c) POLICIES.—Not later than 18 months after the date of enactment of this Act, the Director of the Na- tional Institutes of Health shall consider the rec- ommendations 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 In- stitutes 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 pol- icy changes implemented, to enhance rigor and repro- ducibility in scientific research funded by the National Institutes of Health. ‘‘(e) CONFIDENTIALITY.—Nothing in this section au- thorizes 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 sec- tion 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, § 5003, Sept. 30, 2022, 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 pro- posals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section. ‘‘(b) APPLICATION.—A nonprofit consortium that de- sires 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 re- quire. ‘‘(c) USE OF FUNDS.—A nonprofit consortium that re- ceives a grant or contract under this section shall fa- cilitate the development, production, and distribution of pediatric medical devices by— ‘‘(1) encouraging innovation and connecting quali- fied individuals with pediatric device ideas with po- tential manufacturers; ‘‘(2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device de- velopment, and marketing; ‘‘(3) connecting innovators and physicians to exist- ing Federal and non-Federal resources, including re- sources from the Food and Drug Administration, the National Institutes of Health, the Small Business Ad- ministration, the Department of Energy, the Depart- ment 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 applica- tion for a pediatric device, where appropriate. ‘‘(d) COORDINATION.— ‘‘(1) NATIONAL INSTITUTES OF HEALTH.—Each consor- tium that receives a grant or contract under this sec- tion 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 Page 649 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 ‘‘(B) provide to the National Institutes of Health any identified pediatric device needs that the con- sortium lacks sufficient capacity to address or those needs in which the consortium has been un- able to stimulate manufacturer interest. ‘‘(2) FOOD AND DRUG ADMINISTRATION.—Each consor- tium that receives a grant or contract under this sec- tion shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the ap- plication for approval or clearance of devices labeled for pediatric use. ‘‘(3) EFFECTIVENESS AND OUTCOMES.—Each consor- tium that receives a grant or contract under this sec- tion 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 exe- cuted because ‘‘$1,107,534’’ did not appear after the in- tervening 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 re- quirement 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 compli- ance 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 in- formation through the registry and results data bank under such subsection (j), if submitted in compliance with such subsection, shall not be considered as label- ing, 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 Serv- ices, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs to collaborate to determine the feasibility of including device inves- tigations within the scope of the data bank under sub- sec. (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 infor- mation relating to such device investigations was re- quired 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 Na- tional Institutes of Health, shall ensure that appro- priate individuals with expertise in chronic fatigue syndrome or neuromuscular diseases and representa- tive of a variety of disciplines and fields within the re- search community are appointed to appropriate Na- tional 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 Na- tional 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 par- ticipation 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, § 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, re- cruitment, 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 qual- ity 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, § 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 sym- pathetic dystrophy syndrome, temporomandibular joint disorder, post-herpetic neuropathy, painful dia- betic 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, § 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 deter- mining the sources and amounts of public and private funding devoted to basic research in bioengineering, in- cluding 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 Page 650 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282a technologies, evaluating the role of the National Insti- tutes 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 Com- mittee on Energy and Commerce of House of Represent- atives, a report containing the findings of the study to- gether with recommendations concerning the enact- ment of legislation to implement the results of such study. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR RESEARCH Pub. 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 Con- gress a master plan to provide for replacement or refur- bishment of less than adequate buildings, utility equip- ment and distribution systems (including the resources that provide electrical and other utilities, chilled water, air handling, and other services that the Sec- retary, acting through the Director, deemed necessary), roads, walkways, parking areas, and grounds that un- derpin the laboratory and clinical facilities of the Na- tional 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. § 282a. Authorization of appropriations (a) In general (1) This subchapter For purposes of carrying out this sub- chapter, there are authorized to be appro- priated— (A) $30,331,309,000 for fiscal year 2007; (B) $32,831,309,000 for fiscal year 2008; (C) such sums as may be necessary for fis- cal year 2009; (D) $34,851,000,000 for fiscal year 2018; (E) $35,585,871,000 for fiscal year 2019; and (F) $36,472,442,775 for fiscal year 2020. (2) Funding for pediatric research initiative For the purpose of carrying out section 282(b)(7)(B)(ii) of this title, there is authorized to be appropriated to the Division of Program Coordination, Planning, and Strategic Initia- tives, out of the Pediatric Research Initiative Fund described in section 9008 of title 26, and in addition to amounts otherwise made avail- able under paragraph (1) of this subsection, $12,600,000 for each of fiscal years 2024 through 2028. (b) Office of the Director Of the amount authorized to be appropriated under subsection (a) for a fiscal year, there are authorized to be appropriated for programs and activities under this subchapter carried out through the Office of the Director of NIH such sums as may be necessary for each of the fiscal years 2007 through 2009. (c) Trans-NIH research (1) Common Fund (A) Account For the purpose of allocations under sec- tion 282(b)(7)(B)(i) of this title (relating to research identified by the Division of Pro- gram Coordination, Planning, and Strategic Initiatives), there is established an account to be known as the Common Fund. (B) Reservation (i) In general Of the total amount appropriated under subsection (a)(1) for fiscal year 2007 or any subsequent fiscal year, the Director of NIH shall reserve an amount for the Common Fund, subject to any applicable provisions in appropriations Acts. (ii) Minimum amount For each fiscal year, the percentage con- stituted by the amount reserved under clause (i) relative to the total amount ap- propriated under subsection (a)(1) for such year may not be less than the percentage constituted by the amount so reserved for the preceding fiscal year relative to the total amount appropriated under sub- section (a)(1) for such preceding fiscal year, subject to any applicable provisions in appropriations Acts. (C) Common Fund strategic planning report As part of the National Institutes of Health Strategic Plan required under sec- tion 282(m) of this title, the Secretary, act- ing through the Director of NIH, shall sub- mit a report to the Congress containing a strategic plan for funding research described in section 282(b)(7)(A)(i) of this title (includ- ing personnel needs) through the Common Fund. Each such plan shall include the fol- lowing: (i) An estimate of the amounts deter- mined by the Director of NIH to be appro- priate for maximizing the potential of such research. (ii) An estimate of the amounts deter- mined by the Director of NIH to be suffi- cient only for continuing to fund research activities previously identified by the Di- vision of Program Coordination, Planning, and Strategic Initiatives. (iii) An estimate of the amounts deter- mined by the Director of NIH to be nec- essary to fund research described in sec- tion 282(b)(7)(A)(i) of this title— (I) that is in addition to the research activities described in clause (ii); and (II) for which there is the most sub- stantial need. (D) Evaluation During the 6-month period following the end of the first fiscal year for which the total amount reserved under subparagraph (B) is equal to 5 percent of the total amount appropriated under subsection (a)(1) for such fiscal year, the Secretary, acting through the Director of NIH, in consultation with the advisory council established under section 282(k) of this title, shall submit rec- ommendations to the Congress for changes regarding amounts for the Common Fund. (2) Trans-NIH research reporting (A) Limitation With respect to the total amount appro- priated under subsection (a) for fiscal year