Pub. L. 109-482, tit. I, sec. 104
REPORTS.
SEC. 104. REPORTS. (a) Report of Director of NIH.—The Public Health Service Act (42 U.S.C. 201 et seq.), as amended by section 103(a) of this Act, is amended—(1) by redesignating section 403A as section 403C; (2) in section 1710(a), by striking “section 403A” and inserting “section 403C”; and (3) by striking section 403 and inserting the following sections: “SEC. 402B. ELECTRONIC CODING OF GRANTS AND ACTIVITIES. “The Secretary, acting through the Director of NIH, shall establish an electronic system to uniformly code research grants and activities of the Office of the Director and of all the national research institutes and national centers. The electronic system shall be searchable by a variety of codes, such as the type of research grant, the research entity managing the grant, and the public health area of interest. When permissible, the Secretary, acting through the Director of NIH, shall provide information on relevant literature and patents that are associated with research activities of the National Institutes of Health. “SEC. 403. BIENNIAL REPORTS OF DIRECTOR OF NIH. “(a) In General.—The Director of NIH shall submit to the Congress on a biennial basis a report in accordance with this section. The first report shall be submitted not later than 1 year after the date of the enactment of the National Institutes of Health Reform Act of 2006. Each such report shall include the following 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) Classification and justification for the priorities established by the agencies, including a strategic plan and recommendations for future research initiatives to be carried out under section 402(b)(7) through the Division of Program Coordination, Planning, and Strategic Initiatives. “(4) A catalog of all the research activities of the agencies, prepared in accordance with the following: “(A) The catalog shall, for each such activity—“(i) identify the agency or agencies involved; “(ii) state whether the activity was carried 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. 120 STAT. 3690“(B) In the case of clinical research, the catalog shall, as appropriate, identify study populations by demographic variables and other variables that contribute to research on minority health and health disparities. “(C) Research activities listed in the catalog shall include, where applicable, the following: “(i) Epidemiological studies and longitudinal studies. “(ii) Disease registries, information clearinghouses, 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 programs, including information on the number and type of graduate degrees awarded during the period in which the programs received funding under this title; “(III) investigator-initiated awards for postdoctoral training; “(IV) a breakdown by demographic variables 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 and such other information as may be necessary to demonstrate compliance with section 492B (regarding inclusion of women and minorities in clinical research). “(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 Director determines to be appropriate. “(6) A review of each entity receiving funding under this title in its capacity as a center of excellence (in this paragraph referred to as a ‘center of excellence’), including the following: “(A) An evaluation of the performance and research outcomes of each center of excellence. 120 STAT. 3691“(B) Recommendations for promoting coordination of information among the centers of excellence. “(C) Recommendations for improving the effectiveness, efficiency, and outcomes of the centers of excellence. “(D) If no additional centers of excellence have been funded under this title since the previous report under this section, an explanation of the reasons for not funding any additional centers. “(b) Requirement Regarding Disease-Specific Research Activities.—In a report under subsection (a), the Director of NIH, when reporting on research activities relating to a specific disease, disorder, or other adverse health condition, shall—“(1) present information in a standardized format; “(2) identify the actual dollar amounts obligated for such activities; and “(3) include a plan for research on the specific disease, disorder, or other adverse health condition, including a statement of objectives regarding 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 reports as the Director or the head of such institute or center determines to be appropriate. “SEC. 403A. 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 activities of the National Institutes of Health involving collaboration with other agencies of the Department 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 section 402(i). “(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 the date of the enactment of the National Institutes of Health Reform Act of 2006. “SEC. 403B. 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 Department of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate a report summarizing the activities 120 STAT. 3692 of the National Institutes of Health relating to whistleblower complaints. “(2) Contents.—For each whistleblower complaint pending during the year for which a report is submitted 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) Experts and Consultants.—On an annual basis, the Director of NIH shall submit to the Inspector General of the Department of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate a report that—“(1) identifies the number of experts and consultants, including any special consultants, whose services are obtained by the National Institutes of Health or its agencies; “(2) specifies whether such services were obtained under section 207(f), section 402(d), or other authority; “(3) describes the qualifications of such experts and consultants; “(4) describes the need for hiring such experts and consultants; and “(5) if such experts and consultants make financial disclosures to the National Institutes of Health or any of its agencies, specifies the income, gifts, assets, and liabilities so disclosed. “(c) First Report.—The first report under subsections (a) and (b) shall be submitted not later than 1 year after the date of the enactment of the National Institutes of Health Reform Act of 2006. “SEC. 403C. ANNUAL REPORTING REGARDING TRAINING OF GRADUATE STUDENTS FOR DOCTORAL DEGREES. “(a) In General.—Each institution receiving an award under this title for the training of graduate students for doctoral degrees shall annually report to the Director of NIH, with respect to each degree-granting program at such institution—“(1) the percentage of 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) Provision of information to applicants.—Each institution described in subsection (a) shall provide to each student submitting an application for a program of graduate study at such institution the information described in paragraphs (1) and (2) of such subsection with respect to the program or programs to which such student has applied.” . (b) Striking of Other Reporting Requirements for NIH.—(1) Public health service act; title iv.—Title IV of the Public Health Service Act, as amended by section 103(b) of this Act, is amended—(A) in section 404E(b)—(i) by amending paragraph (3) to read as follows: 120 STAT. 3693 “(3) Coordination of centers.—The Director of NIH shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication between such centers.”; and (ii) by striking subsection (f) and redesignating subsection (g) as subsection (f); (B) in section 404F(b)(1), by striking subparagraphs (F) and (G); (C) by striking section 407; (D) in section 409C(b), by striking paragraph (4) and redesignating paragraphs (5) and (6) as paragraphs (4) and (5), respectively; (E) in section 409E, by striking subsection (d); (F) in section 417C, by striking subsection (f); (G) in section 424B(a)—(i) in paragraph (1), by adding “and” after the semicolon at the end; (ii) in paragraph (2), by striking “; and” and inserting a period; and (iii) by striking paragraph (3); (H) in section 429, by striking subsections (c) and (d); (I) in section 442, by striking subsection (j) and redesignating subsection (k) as subsection (j); (J) in section 464D, by striking subsection (j); (K) in section 464E, by striking subsection (e); (L) in section 464T, by striking subsection (e); (M) in section 481A, by striking subsection (h); (N) in section 485E, by striking subsection (k); (O) in section 485H—(i) by striking “(a)” and all that follows through “The Secretary,” and inserting “The Secretary,”; and (ii) by striking subsection (b); and (P) in section 494—(i) by striking “(a) If the Secretary” and inserting “If the Secretary”; and (ii) by striking subsection (b). (2) Public health service act; other provisions.—The Public Health Service Act (42 U.S.C. 201 et seq.) is amended—(A) in section 399E, by striking subsection (e); (B) in section 1122—(i) by striking “(a) From the sums” and inserting “From the sums”; and (ii) by striking subsections (b) and (c); (C) by striking section 2301; (D) in section 2354, by striking subsection (b) and redesignating subsection (c) as subsection (b); (E) in section 2356, by striking subsection (e) and redesignating subsections (f) and (g) as subsections (e) and (f), respectively; and (F) in section 2359(b)—(i) by striking paragraph (2); (ii) by striking “(b) Evaluation and Report” and all that follows through “Not later than 5 years” and inserting “(b) Evaluation.—Not later than 5 years”; (iii) by redesignating subparagraphs (A) through (C) as paragraphs (1) through (3), respectively; and 120 STAT. 3694(iv) by moving each of paragraphs (1) through (3) (as so redesignated) 2 ems to the left. (3) Other acts.—Provisions of Federal law are amended as follows: (A) Section 7 of Public Law 97–414 is amended—(i) in subsection (a)—(I) in paragraph (2), by inserting “and” at the end; (II) in paragraph (3), by striking “; and” and inserting a period; and (III) by striking paragraph (4); and (ii) in subsection (b), by striking the last sentence of paragraph (3). (B) Title III of Public Law 101–557 (42 U.S.C. 242q et seq.) is amended by striking section 304 and redesignating section 305 and 306 as sections 304 and 305, respectively. (C) Section 4923 of Public Law 105–33 is amended by striking subsection (b). (D) Public Law 106–310 is amended by striking section 105. (E) Section 1004 of Public Law 106–310 is amended by striking subsection (d). (F) Section 3633 of Public Law 106–310 (as amended by section 2502 of Public Law 107–273) is repealed. (G) Public Law 106–525 is amended by striking section 105.(H) Public Law 107–84 is amended by striking section 6.(I) Public Law 108–427 is amended by striking section 3 and redesignating sections 4 and 5 as sections 3 and 4, respectively.