42 U.S.C. § 283 — Triennial reports of Director of NIH

Page 652 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282b scribed in section 402(b)(7)(B)(ii) of the Public Health Service Act [42 U.S.C. 282(b)(7)(B)(ii)], as added by subsection (a).’’ § 282b. Electronic coding of grants and activities The Secretary, acting through the Director of NIH, shall establish an electronic system to uni- formly code research grants and activities of the Office of the Director and of all the national re- search institutes and national centers. The elec- tronic system shall be searchable by a variety of codes, such as the type of research grant, the re- search entity managing the grant, and the pub- lic health area of interest. When permissible, the Secretary, acting through the Director of NIH, shall provide information on relevant lit- erature and patents that are associated with re- search activities of the National Institutes of Health. (July 1, 1944, ch. 373, title IV, § 402B, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3689.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section applicable only with respect to amounts ap- propriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as an Effective Date of 2007 Amendment note under section 281 of this title. § 282c. Public access to funded investigators’ final manuscripts The Director of the National Institutes of Health (‘‘NIH’’) shall require in the current fis- cal year and thereafter that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon accept- ance for publication, to be made publicly avail- able no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. (Pub. L. 111–8, div. F, title II, § 217, Mar. 11, 2009, 123 Stat. 782.) Editorial Notes CODIFICATION Section was enacted as part of the Department of Health and Human Services Appropriations Act, 2009, and also as part of the Departments of Labor, Health and Human Services, and Education, and Related Agen- cies Appropriations Act, 2009, and the Omnibus Appro- priations Act, 2009, and not as part of the Public Health Service Act which comprises this chapter. § 282d. Transferred Editorial Notes CODIFICATION Section, act July 1, 1944, ch. 373, title IV, § 402C, as added Pub. L. 111–148, title X, § 10409(d), Mar. 23, 2010, 124 Stat. 978, which related to the Cures Acceleration Network, was renumbered section 480 of act July 1, 1944, by Pub. L. 112–74, div. F, title II, § 221(c)(1)(A), Dec. 23, 2011, 125 Stat. 1089, and transferred to section 287a of this title. § 283. Triennial reports of Director of NIH (a) In general The Director of NIH shall submit to the Con- gress on a triennial basis a report in accordance with this section. The first report shall be sub- mitted not later than 1 year after January 15, 2007. Each such report shall include the fol- lowing information: (1) An assessment of the state of biomedical and behavioral research. (2) A description of the activities conducted or supported by the agencies of the National Institutes of Health and policies respecting the programs of such agencies. (3) A description of intra-National Institutes of Health activities, including— (A) identification of the percentage of funds made available by each national re- search institute and national center with re- spect to each applicable fiscal year for con- ducting or supporting research that involves collaboration between the institute or cen- ter and 1 or more other national research in- stitutes or national centers; and (B) recommendations for promoting co- ordination of information among the centers of excellence. (4) A catalog of all the research activities of the agencies, prepared in accordance with the following: (A) The catalog shall, for each such activ- ity— (i) identify the agency or agencies in- volved; (ii) state whether the activity was car- ried out directly by the agencies or was supported by the agencies and describe to what extent the agency was involved; and (iii) identify whether the activity was carried out through a center of excellence. (B) In the case of clinical research, the catalog shall, as appropriate, identify study populations by demographic variables, in- cluding biological and social variables and relevant age categories (such as pediatric subgroups), and determinants of health, that contribute to research on minority health and health disparities. (C) Research activities listed in the cata- log shall include, where applicable, the fol- lowing: (i) Epidemiological studies and longitu- dinal studies. (ii) Disease registries, information clear- inghouses, and other data systems. (iii) Public education and information campaigns. (iv) Training activities, including— (I) National Research Service Awards and Clinical Transformation Science Awards; (II) graduate medical education pro- grams, including information on the number and type of graduate degrees awarded during the period in which the programs received funding under this subchapter; (III) investigator-initiated awards for postdoctoral training and postdoctoral training funded through research grants; Page 653 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 283 (IV) a breakdown by demographic vari- ables and other appropriate categories; and (V) an evaluation and comparison of outcomes and effectiveness of various training programs. (v) Clinical trials, including a breakdown of participation by study populations and demographic variables, including relevant age categories (such as pediatric sub- groups), information submitted by each national research institute and national center to the Director of National Insti- tutes of Health under section 289a–2(f) of this title, and such other information as may be necessary to demonstrate compli- ance with section 289a–2 of this title and other applicable requirements regarding inclusion of demographic groups. (vi) Translational research activities with other agencies of the Public Health Service. (5) A summary of the research activities throughout the agencies, which summary shall be organized by the following categories, where applicable: (A) Cancer. (B) Neurosciences. (C) Life stages, human development, and rehabilitation. (D) Organ systems. (E) Autoimmune diseases. (F) Genomics. (G) Molecular biology and basic science. (H) Technology development. (I) Chronic diseases, including pain and palliative care. (J) Infectious diseases and bioterrorism. (K) Minority health and health disparities. (L) Such additional categories as the Di- rector determines to be appropriate. (6) A review of each entity receiving funding under this subchapter in its capacity as a cen- ter of excellence (in this paragraph referred to as a ‘‘center of excellence’’), including the fol- lowing— (A) an evaluation of the performance and research outcomes of each center of excel- lence; and (B) recommendations for improving the ef- fectiveness, efficiency, and outcomes of the centers of excellence. (b) Requirement regarding disease-specific re- search activities In a report under subsection (a), the Director of NIH, when reporting on research activities re- lating to a specific disease, disorder, or other ad- verse health condition, shall— (1) present information in a standardized for- mat; (2) identify the actual dollar amounts obli- gated for such activities; and (3) include a plan for research on the specific disease, disorder, or other adverse health con- dition, including a statement of objectives re- garding the research, the means for achieving the objectives, a date by which the objectives are expected to be achieved, and justifications for revisions to the plan. (c) Additional reports In addition to reports required by subsections (a) and (b), the Director of NIH or the head of a national research institute or national center may submit to the Congress such additional re- ports as the Director or the head of such insti- tute or center determines to be appropriate. (July 1, 1944, ch. 373, title IV, § 403, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3689; amended Pub. L. 110–85, title XI, § 1104(3), Sept. 27, 2007, 121 Stat. 975; Pub. L. 114–255, div. A, title II, § 2032, Dec. 13, 2016, 130 Stat. 1056.) Editorial Notes PRIOR PROVISIONS A prior section 283, act July 1, 1944, ch. 373, title IV, § 403, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 826; amended Pub. L. 100–607, title I, § 112, Nov. 4, 1988, 102 Stat. 3052, required a biennial report by the Direc- tor to the President and Congress, prior to repeal by Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3689. AMENDMENTS 2016—Pub. L. 114–255, § 2032(1), substituted ‘‘Triennial’’ for ‘‘Biennial’’ in section catchline. Subsec. (a). Pub. L. 114–255, § 2032(2)(A), substituted ‘‘triennial’’ for ‘‘biennial’’ in introductory provisions. Subsec. (a)(3). Pub. L. 114–255, § 2032(2)(B), amended par. (3) generally. Prior to amendment, par. (3) read as follows: ‘‘Classification and justification for the prior- ities established by the agencies, including a strategic plan and recommendations for future research initia- tives to be carried out under section 282(b)(7) of this title through the Division of Program Coordination, Planning, and Strategic Initiatives.’’ Subsec. (a)(4)(B). Pub. L. 114–255, § 2032(2)(C)(i), sub- stituted ‘‘demographic variables, including biological and social variables and relevant age categories (such as pediatric subgroups), and determinants of health,’’ for ‘‘demographic variables and other variables’’. Subsec. (a)(4)(C)(v). Pub. L. 114–255, § 2032(2)(C)(ii), substituted ‘‘demographic variables, including relevant age categories (such as pediatric subgroups), informa- tion submitted by each national research institute and national center to the Director of National Institutes of Health under section 289a–2(f) of this title, and such’’ for ‘‘demographic variables and such’’ and ‘‘and other applicable requirements regarding inclusion of demo- graphic groups’’ for ‘‘(regarding inclusion of women and minorities in clinical research)’’. Subsec. (a)(6). Pub. L. 114–255, § 2032(2)(D), substituted ‘‘the following—’’ for ‘‘the following:’’ in introductory provisions, ‘‘an evaluation’’ for ‘‘An evaluation’’ and ‘‘; and’’ for the period in subpar. (A), redesignated sub- par. (C) as (B) and substituted ‘‘recommendations’’ for ‘‘Recommendations’’, and struck out former subpars. (B) and (D), which read as follows: ‘‘(B) Recommendations for promoting coordination of information among the centers of excellence. ‘‘(D) If no additional centers of excellence have been funded under this subchapter since the previous report under this section, an explanation of the rea- sons for not funding any additional centers.’’ 2007—Subsec. (a)(4)(C)(iv)(III). Pub. L. 110–85 inserted ‘‘and postdoctoral training funded through research grants’’ before semicolon at end. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section applicable only with respect to amounts ap- propriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as an Page 654 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 283a 1 So in original. Probably should be ‘‘(b)’’. Effective Date of 2007 Amendment note under section 281 of this title. § 283a. Annual reporting to increase interagency collaboration and coordination (a) Collaboration with other HHS agencies On an annual basis, the Director of NIH shall submit to the Secretary a report on the activi- ties of the National Institutes of Health involv- ing collaboration with other agencies of the De- partment of Health and Human Services. (b) Clinical trials Each calendar year, the Director of NIH shall submit to the Commissioner of Food and Drugs a report that identifies each clinical trial that is registered during such calendar year in the databank of information established under sec- tion 282(i) of this title. (c) Human tissue samples On an annual basis, the Director of NIH shall submit to the Congress a report that describes how the National Institutes of Health and its agencies store and track human tissue samples. (d) First report The first report under subsections (a), (b), and (c) shall be submitted not later than 1 year after January 15, 2007. (July 1, 1944, ch. 373, title IV, § 403A, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3691.) Editorial Notes PRIOR PROVISIONS A prior section 403A of act July 1, 1944, was renum- bered section 403D and is classified to section 283a–3 of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section applicable only with respect to amounts ap- propriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as an Effective Date of 2007 Amendment note under section 281 of this title. § 283a–1. Annual reporting to prevent fraud and abuse (a) Whistleblower complaints (1) In general On an annual basis, the Director of NIH shall submit to the Inspector General of the Depart- ment of Health and Human Services, the Sec- retary, the Committee on Energy and Com- merce and the Committee on Appropriations of the House of Representatives, and the Com- mittee on Health, Education, Labor, and Pen- sions and the Committee on Appropriations of the Senate a report summarizing the activi- ties of the National Institutes of Health relat- ing to whistleblower complaints. (2) Contents For each whistleblower complaint pending during the year for which a report is sub- mitted under this subsection, the report shall identify the following: (A) Each agency of the National Institutes of Health involved. (B) The status of the complaint. (C) The resolution of the complaint to date. (b) First report The first report under subsection (a) shall be submitted not later than 1 year after January 15, 2007. (July 1, 1944, ch. 373, title IV, § 403B, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3691; amended Pub. L. 114–255, div. A, title II, § 2042(b), Dec. 13, 2016, 130 Stat. 1073.) Editorial Notes AMENDMENTS 2016—Subsecs. (b), (c). Pub. L. 114–255 redesignated subsec. (c) as (b), substituted ‘‘subsection (a)’’ for ‘‘sub- sections (a) and (b)’’, and struck out former subsec. (b), which related to annual report by the Director of NIH on experts and consultants whose services were ob- tained by the National Institutes of Health or its agen- cies. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section applicable only with respect to amounts ap- propriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as an Effective Date of 2007 Amendment note under section 281 of this title. § 283a–2. Annual reporting regarding training of graduate students for doctoral degrees (a) In general Each institution receiving an award under this subchapter for the training of graduate students for doctoral degrees shall annually report to the Director of NIH, with respect to graduate stu- dents supported by the National Institutes of Health at such institution— (1) the percentage of such students admitted for study who successfully attain a doctoral degree; and (2) for students described in paragraph (1), the average time between the beginning of graduate study and the receipt of a doctoral degree. (3) 1 Provision of information to applicants Each institution described in subsection (a) shall provide to each student submitting an ap- plication for a program of graduate study at such institution the information described in paragraphs (1) and (2) of such subsection with re- spect to the program or programs to which such student has applied. (July 1, 1944, ch. 373, title IV, § 403C, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3692; amended Pub. L. 110–85, title XI, § 1104(5), Sept. 27, 2007, 121 Stat. 975; Pub. L. 114–255, div. A, title II, § 2042(c), Dec. 13, 2016, 130 Stat. 1073.) Editorial Notes PRIOR PROVISIONS A prior section 403C of act July 1, 1944, was renum- bered section 403D and is classified to section 283a–3 of this title.