[Federal Register Volume 73, Number 95 (Thursday, May 15, 2008)]
[Notices]
[Pages 28124-28126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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-

[[Page 28125]]

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

[[Page 28126]]

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.
 [FR Doc. E8-10637 Filed 5-14-08; 8:45 am]
BILLING CODE 4140-01-M