42 U.S.C. § 281 — Organization of National Institutes of Health

(a) Relation to Public Health Service. The National Institutes of Health (NIH) is an agency within the Public Health Service. (b) National research institutes and national centers. NIH's national research institutes and centers include 25 listed bodies — such as the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, several institutes for aging, allergy, arthritis, mental health, drug abuse, alcohol abuse, nursing, genome research, and others named in the law — plus the National Library of Medicine, the Fogarty International Center, and any other national center that existed separately within NIH as of January 14, 2007. (c) Division of Program Coordination, Planning, and Strategic Initiatives. (1) In general — Inside the Office of the Director of NIH, there is a Division of Program Coordination, Planning, and Strategic Initiatives. (2) Offices within Division — (A) The Division includes the Office of AIDS Research, the Office of Research on Women's Health, the Office of Behavioral and Social Sciences Research, the Office of Disease Prevention, the Office of Dietary Supplements, and any other office that was already in the Director's office as of January 14, 2007. The NIH Director can add more offices to the Division as needed. (B) Each office in the Division keeps the authority it had before January 15, 2007, and, as the NIH Director decides, must support the Division under the authorities in section 282(b)(7). (d) Organization. (1) Number of institutes and centers — NIH cannot have more than 27 national research institutes and centers total, counting any created under paragraph (2) or under prior law. (2) Reorganization of institutes — (A) The Secretary may create new national research institutes to research and support programs on a disease or health topic, but only if the Secretary decides it's necessary and gives Congress' relevant committees 180 days' written notice first. (B) The Secretary may also reorganize or abolish a national research institute that the Secretary decides is no longer needed, again only after 180 days' written notice to Congress. (3) Reorganization of Office of Director — After holding public hearings and getting the Secretary's approval, the NIH Director may reorganize the offices within the Director's own office if doing so would make programs run more efficiently. (4) Internal reorganization of institutes and centers — In the same way, after public hearings and the NIH Director's approval, the head of an institute or center may reorganize its own internal divisions if that would run its programs more efficiently. (e) Scientific Management Review Board for periodic organizational reviews. (1) In general — Within 60 days of January 15, 2007, the Secretary must set up an advisory council called the Scientific Management Review Board. (2) Duties — (A) At least once every 7 years, the Board must decide whether NIH's reorganization powers under subsection (d) should be used, and issue a report on its recommendations. (B) In writing that report, the Board must review NIH's research portfolio, identify scientific opportunities and public health needs, and — for any organizational change it seriously considers — analyze its budget and operational effects, weigh funding history for newer versus older institutes, estimate the resources needed, recommend how to allocate NIH's resources if the change happens, and analyze the effects on research progress. (C) The Board must consult with institute and center directors not on the Board, other NIH scientific leaders not on the Board, the institutes' and centers' advisory councils, groups representing the scientific community, and groups representing patients. (3) Composition of Board — The Board has the NIH Director as a permanent non-voting member, plus up to 21 voting members: (A) at least 9 institute or center directors picked to represent institutes with large and small budgets, older and newer institutes, and national centers; and (B) members from outside government appointed by the Secretary, including people representing universities that get NIH research funding and people representing private organizations that get NIH funding or know how NIH works. (4) Chair — The Secretary picks the Chair from the outside members, for a 2-year term. (5) Meetings — (A) The Board meets at the Chair's call or the NIH Director's request, at least 5 times per report, at a location the NIH Director approves. (B) For each report, at least one meeting must focus on the scientific community's needs, and at least one on patients' and families' needs. (C) The NIH Director must post a summary of each meeting online. (6) Compensation; term of office — Board members' pay and terms follow the same rules as another NIH advisory council under section 284a, except appointed members serve 5-year terms instead of 4. (7) Reports — (A) Each Board report goes to the House and Senate committees on energy/commerce, health, and appropriations, to the Secretary, and to officials with reorganization power (except any who served on the Board for that report). (B) The NIH Director must post each report online. (C) Within 18 months of January 15, 2007, the Board must send those committees a report on its own activities. (f) Organizational changes per recommendation of Scientific Management Review Board. (1) In general — If a Board report recommends an organizational change to an official who can make it, that official must, with the exceptions below, start the public process for the change within 100 days of the report and finish it within 3 years. (2) Inapplicability to certain reorganizations — This requirement does not apply to a recommendation to create, end, or combine institutes or centers, or to reorganize the Office of the Director. (3) Objection by Director of NIH — (A) The requirement also does not apply if, within 90 days of the report, the NIH Director sends Congress a report objecting to the change and explaining why. (B) The Director can object to all or part of a recommended change; any part not objected to must still be carried out. (4) Congressional review — A reorganization under subsection (d)(2) started this way must go through formal rulemaking and counts as a "major rule" subject to congressional review. (g) Definitions. (1) "Director of NIH" means the Director of the National Institutes of Health. (2) "National research institute" and "national center" mean an NIH agency that is either listed in subsection (b) and not ended under subsection (d)(2)(A), or created by the NIH Director under that subsection. (h) References to NIH. Anywhere else in this subchapter, "National Institutes of Health" includes its agencies.