[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-
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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
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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