E8-10637. Statement of Organization, Functions, and Delegations of Authority

The Statement of Organization, Functions, and Delegations of Authority Part N, National Institutes of Health (NIH), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (DHHS) (40 FR 22859, May 27, 1975, as amended most recently at 71 FR 46495, August 14, 2006, and redesignated from Part HN as Part N at 60 FR 56605, November 9, 1995), is amended as set forth below to reflect the establishment of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), National Institutes of Health. The National Institutes of Health Reform Act of 2006 (Pub. L. 109-482) establishes and provides the authorities of DPCPSI and transfers the following organizations in their entirety to DPCPSI: Office of AIDS Research (OAR); Office of Research on Women's Health (ORWH); Office of Behavioral and Social Sciences Research (OBSSR); Office of Disease Prevention (ODP); Office of Dietary Supplements (ODS); Office of Rare Diseases (ORD), to be retitled as the Office of Rare Diseases Research (ORDR). Also transferring to DPCPSI are the Office of Portfolio Analysis and Strategic Initiatives (OPASI), Division of Resource Development and Analysis (DRDA), Division of Strategic Coordination (DSC), Division of Evaluation and Systematic Assessments (DESA), and Office of Medical Applications of Research (OMAR), ODP. The following organizations are abolished: OAR; ORWH; OBSSR; ODP; ODS, ODP; ORD, ODP; OMAR, ODP; and OPASI.

I. Section N-B, Organization and Functions, is amended as follows:

A. Immediately after the paragraph headed “NIH Ethics Office (NAT, formerly HNAT)” insert the following:

Division of Program Coordination, Planning, and Strategic Initiatives (NA W, formerly HNA 149). (1) Identifies and reports on research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between two or more Institutes and Centers (ICs), or would otherwise benefit from strategic coordination and planning; and (2) coordinates research and activities related to AIDS, behavioral and social sciences, women's health, disease prevention, rare diseases, and dietary supplements.

Office of AIDS Research (NA W2, formerly HNA W2). (1) Develops a comprehensive strategic plan that identifies and establishes objectives, priorities, and policy statements governing the conduct and support of all NIH AIDS research activities; (2) develops and presents to OMB and the President an annual scientifically justified budget estimate for NIH AIDS-related research activities; (3) submits an alternate AIDS budget to the Secretary and the Director, NIH, in accordance with the strategic plan; (4) receives and disburses all appropriated funds for NIH AIDS research activities to the NIH ICs in accordance with the strategic plan; (5) directs the planning, coordination, and integration of all AIDS research activities across and throughout the NIH ICs; (6) evaluates NIH HIV/AIDS research programs developed for the strategic plan and carried out by the ICs; (7) administers a discretionary fund for the support, through the ICs, of AIDS research; (8) advises the NIH director and senior staff on the development of NIH-wide policy issues related to AIDS research, and serves as principal liaison with HHS Operating Divisions (OPDIVs) and Staff Divisions (STAFFDIVs), other Federal Government agencies, and the Office for National AIDS Policy; (9) represents the NIH director on all outside AIDS-related committees requiring NIH participation; (10) provides staff support to the OAR Advisory Council, NIH AIDS Executive Committee, and the Coordinating Committees for each AIDS research discipline at NIH; (11) develops policy on laboratory safety for AIDS researchers and monitors the AIDS surveillance program; (12) develops and maintains an information database on intramural/extramural AIDS activities and prepares special or recurring reports as needed; (13) develops information strategies to assure that the public is informed of NIH AIDS research activities; (14) recommends solutions to ethical and legal issues arising from NIH intramural/extramural AIDS research; (15) facilitates collaboration in AIDS research between government, industry, and educational institutions; and (16) fosters and develops plans for NIH involvement in international AIDS research activities.

Office of Research on Women's Health (NA W3, formerly HNA W3). (1) Advises the NIH Director, DPCPSI Director, and other key officials on matters relating to research on women's health; (2) strengthens and enhances research related to diseases, disorders, and conditions that affect women; (3) ensures that research conducted and supported by NIH adequately addresses issues regarding women's health; (4) ensures that women are appropriately represented in biomedical and biobehavioral research studies supported by the NIH; (5) develops opportunities for and supports recruitment, retention, reentry, and advancement of women in biomedical careers; and (6) supports research on women's health issues.

Office of Behavioral and Social Sciences Research (NA W4, formerly HNA W4). (1) Advises the NIH Director, DPCPSI Director, and other key officials on matters relating to research on the role of human behavior in the development of health, prevention of disease, and therapeutic intervention; (2) coordinates research projects in the behavioral and social sciences conducted or supported by the NIH ICs; (3) identifies research projects that deserve expanded effort and support by the ICs; and (4) develops research projects in cooperation with the ICs.

Office of Disease Prevention (NA W5, formerly HNA W5). (1) Coordinates the activities of disease prevention, rare diseases, dietary supplements, and medical applications of research, and advises the NIH Director, DPCPSI Director, and other key officials on the following: (a) Research related to disease prevention, and promotion of disease prevention research; (b) research related to dietary supplements and their role in disease prevention; (c) research and activities related to rare diseases; and (d) medical applications of research, including drugs, procedures, devices and other technology developed from basic biomedical research at NIH; (2) provides guidance to the research institutes on research related to disease prevention; (3) coordinates and facilitates the systematic identification of research activities pertinent to all aspects of disease prevention, including: (a) Identification of risk factors for disease; (b) risk assessment, identification, and development of biologic, environmental, and behavioral interventions to prevent disease occurrence or progression of presymptomatic disease; and (c) the conduct of field trials and demonstrations to assess interventions and encourage their adoption, if warranted; (4) identifies, coordinates, and encourages fundamental research aimed at elucidating the chain of causation of acute and chronic diseases; (5) coordinates and facilitates clinically relevant NIH-sponsored research bearing on disease prevention, including interventions to prevent the progression of detectable but asymptomatic disease; (6) promotes the coordinating linkage for research institutes on biobehavioral modification toward prevention of disease; (7) coordinates with OMAR to promote the effective transfer of identified safe and efficacious preventive interventions to the health care community and the public; (8) works with the research institutes to initiate and develop Request for Applications (RFA), Program Announcements (PA), and Requests for Proposals (RFP) to enhance disease prevention program development; and sponsors, singly or in combination with other organizations, workshops and conferences on disease prevention; (9) provides a link between the disease prevention and health promotion activities of the research institutes of the NIH, the Surgeon General and Assistant Secretary for Health, and the Secretary, (10) monitors the effectiveness and progress of disease prevention and health promotion activities of the NIH; and (11) reports expenditures and personnel involved in prevention activities at NIH.

Office of Dietary Supplements (NA W52, formerly HNA W52). (1) Advises the Associate Director for Disease Prevention and provides guidance to the research institutes on research related to the health benefits of dietary supplements and their role in disease prevention; (2) conducts, promotes, and coordinates research at NIH relating to dietary supplements; (3) collects and compiles the results of scientific research relating to dietary supplements; (4) serves as principal advisor to the Secretary and PHS components on non-regulatory issues relating to dietary supplements; and (5) compiles and maintains a database of scientific research and funding.

Office of Rare Diseases Research (NA W53, formerly HNA W53). (1) Guides and coordinates NIH-wide activities involving research into combating and treating the broad array of rare diseases (orphan diseases); (2) manages the NIH Rare Diseases and Orphan Products Coordinating Committee; (3) develops and maintains a centralized database on rare diseases; (4) coordinates and provides liaison with Federal and non-Federal national and international organizations concerned with rare disease research and orphan products development; (5) advises the Office of the Director, NIH, on matters relating to NIH-sponsored research activities that involve rare diseases and conditions; and (6) responds to requests for information on highly technical matters and matters of public policy relative to rare diseases and orphan products.

Office of Medical Applications of Research (NA W54, formerly HNA W54). (1) Advises the Associate Director for Disease Prevention and provides guidance to the research institutes on medical applications of research; (2) coordinates, reviews, and facilitates the systematic identification and evaluation of clinically relevant NIH research program information; (3) promotes the effective transfer of this information to the health care community and, through the Office of Health Technology Assessment, National Center for Health Services Research and Health Care Technology Assessment (NCHSRHCTA), to those agencies requiring this information; (4) provides a link between technology assessment activities of the research institutes of the NIH and the NCHSRHCTA; and (5) monitors the effectiveness and progress of the assessment and transfer activities of the NIH.

Office of Portfolio Analysis and Strategic Initiatives (NA W6, formerly HNA W6). Supports regular trans-NIH scientific planning and initiatives and the successful and adaptive priority setting process for identifying areas of scientific and health improvement opportunities.

Division of Resource Development and Analysis (NA W62, formerly HNA W62). (1) Uses resources (databases, analytic tools, and methodologies) and develops specifications for new resources, when needed, to conduct assessments based on NIH and other databases in support of portfolio analyses and priority setting in scientific areas of interest across NIH; (2) serves as a resource for portfolio management at the programmatic level; and (3) ensures that NIH addresses important areas of emerging scientific opportunities and public health challenges effectively.

Division of Strategic Coordination (NA W63, formerly HNA W63). (1) Integrates information and develops recommendations to inform NIH's priority-setting and decision making processes with respect to strategic initiatives; (2) addresses exceptional scientific opportunities and emerging public health needs; (3) provides the NIH Director with the information needed to allocate resources effectively for trans-NIH efforts; and (4) identifies trans-NIH initiatives for consideration and evaluation by both outside advisors and NIH leadership.

Division of Evaluation and Systematic Assessments (NA W64, formerly HNA W64). Plans, conducts, coordinates, and supports program evaluations, including, but not limited to, IC specific program and project evaluations; trans-NIH evaluations, including Roadmap initiatives; and systematic assessments required by the Government Performance and Results Act and the OMB Program Assessment Rating Tool.

II. Under the heading “Office of the Director (NA, formerly HNA)” delete in their entirety the following headed paragraphs: “Office of Research on Women's Health (NAG, formerly HNAG)”; the “Office of AIDS Research (NA5, formerly HNA5)”; the “Office of Behavioral and Social Sciences Research (NAH, formerly HNAH)”; the “Office of Disease Prevention (NA2, formerly HNA2)”; the “Office of Medical Applications of Research (NA23, formerly HNA23)”; the “Office of Dietary Supplements (NA25, formerly HNA25)”; the “Office of Rare Diseases (NA26, formerly HNA26)”; the “Office of Portfolio Analysis and Strategic Initiatives (NAU, formerly HNAU)”; the “Division of Resource Development and Analysis (NA, formerly HNAU2)”; the “Division of Strategic Coordination (NAU3, formerly HNAU3)”; and the “Division of Evaluation and Systematic Assessments (NAU4, formerly HNAU4).”

III. Delegations of Authority: All delegations and redelegations of authority to officers and employees of NIH which were in effect immediately prior to the effective date of this reorganization and are consistent with this reorganization shall continue in effect in them or their successors, pending further redelegation.

Dated: May 6, 2008.

Michael O. Leavitt,

Secretary.