[Federal Register Volume 77, Number 4 (Friday, January 6, 2012)]
[Notices]
[Pages 797-799]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health 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 (40 FR 22859, May 27, 1975, as
amended most recently at 66 FR 6617, January 22, 2001, and redesignated
from Part HN as Part N at 60 FR 56605, November 9, 1995), is amended as
set forth below to establish the National Center for Advancing
Translational Science (NCATS), to abolish the National Center for
Research Review (NCRR), and to establish organizational components
within National Institute of General Medical Sciences (NIGMS), National
Institute on Minority Health and Health Disparities (NIMHD) and the NIH
Office of the Director (OD).
Section N-8, Organization and Functions, is amended as follows:
Immediately after the paragraph headed ``Division of Program
Coordination and Integration'' (N 875, formerly HN 875), insert the
following:
National Center for Advancing Translational Sciences (NCATS) (N 9,
formerly HN 9) (1) Provides leadership for a national program to
advance the discipline of translational science and catalyze the
generation of innovative methods and technologies that will enhance the
development, testing, and implementation of diagnostics and
therapeutics across a wide range of human diseases and conditions; (2)
conducts intramural research; (3) supports and coordinates research
projects through research grants, contracts, and other mechanisms; (4)
supports training in translational sciences; (5) collaborates with
organizations and other institutions engaged in translational research
and training activities; and (6) collects and disseminates research
findings and related information.
Office of the Director (OD) (N 91, formerly HN 91) (1) Develops and
provides leadership for the Center's translational science programs;
(2) manages and directs executive-level activities and functions; (3)
provides policy guidance and overall operational coordination for the
organizational units within NCATS; and (4) manages critical points of
contact and related information flows to respond to external inquiries.
Division of Pre-Clinical Innovation (DPI) (N 92, formerly HN 92)
(1) Plans, conducts, and supports research across the pre-clinical
phases of the translational science spectrum; (2) plans, conducts, and
supports research to develop new methods and technologies to enhance
pre-clinical processes; (3) plans, conducts, and supports research to
evaluate existing and developing approaches, technologies, and
processes in the pre-clinical spectrum; (4) supports training programs
relevant to pre-clinical phases of translational science; (5) allocates
resources to pre-clinical extramural and intramural investigators; (6)
collaborates with ICs and the scientists they support; and (7) consults
with stakeholders, including patients, industry, and regulators.
Division of Clinical Innovation (DCI) (N 93, formerly HN 93) (1)
Plans, conducts, and supports research across the clinical phases of
the translational science spectrum; (2) plans, conducts, and supports
research to develop new methods and technologies to enhance clinical
processes; (3) plans, conducts, and supports research to evaluate
existing and developing approaches, technologies, and processes in the
clinical spectrum; (4) supports training programs relevant to clinical
phases of translational science; (5) allocates resources to clinical
extramural and intramural investigators; (6) collaborates with ICs and
the scientists they support; and (7) consults with stakeholders,
including patients, industry, and regulators.
Executive Office (EO) (N 912, formerly HN 912) (1) Directs the
administrative management and financial management operations of NCATS;
(2) develops, administers, and directs NCATS' internal control
processes; (3) oversees development of and administers NCATS policies
and procedures for administrative, program management, and information
technology activities; and (4) oversees personnel management and
workforce planning.
Office of Grants Management and Scientific Review (OGMSR) (N 913,
formerly, HN 913) (1) Provides advice and assistance to the Director of
NCATS, NCATS Division Directors, and other NCATS officials on issues
related to policy and procedures for extramural activities; (2)
provides oversight and direction for scientific review and grants
management activities of NCATS; (3) coordinates NCATS small business
research programs and other special grants programs; (4) manages the
operations of the national advisory council for NCATS; and (5) provides
coordination, support, and staff services for committee management.
Office of Rare Diseases Research (ORDR) (N 914, formerly, HN 914)
(1) Guides and coordinates NIH-wide activities involving research into
combating and treating the broad array of rare (orphan) diseases; (2)
manages the NIH Rare Diseases and Orphan Products Coordinating
Committee (Trans-NIH Rare Diseases Working Group); (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 OD/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 Policy, Communications, and Strategic Alliances (OPCSA)
(N 915, formerly, HN 915) (1) Provides leadership and direction to the
planning, coordinating, reporting, analytical, evaluative, and
legislative functions that support NCATS program development, science
policy formulation, and overall program direction and decision-making
activities of the NCATS executive staff; (2) advises the NCATS Director
on policy matters pertaining to NCATS scientific programs; (3)
communicates information about NCATS programs and accomplishments to a
wide range of audiences; (4) advises the NCATS Director on effective
communications strategies; (5) fosters relationships and partnerships
with stakeholders; (6) assists in the development of content for
internal and external Web sites and audiences; (7) develops and
executes a strategy for education and training for the disciplines that
constitute translational science; (8) facilitates and supports
partnerships with NIH OD, other ICs, patient groups, other governmental
agencies, nonprofits and the private sector to achieve the goals of the
Center; and (9) oversees and manages NCATS technology transfer
activities including overseeing NCATS intellectual property, patent,
and licensing agreement portfolios.
Section N-D, Organization and Functions, is amended as follows:
Immediately after the paragraph headed
[[Page 798]]
``Office of Grants Management'' (N D43, formerly HN D43), insert the
following:
Office of Research Training and Capacity Building (ORTCB) (N E32,
formerly HN E32) (1) Plans, designs, develops and manages a diverse
portfolio of training and career development programs and activities;
(2) plans, develops, coordinates, supports and manages programs to
expand the Nation's capacity to conduct research at institutions
conducting and/or interested in minority health and health disparities
research; (3) provides technical assistance to faculty, institutions,
community groups and other organizations conducting and/or interested
in minority health and health disparities research; and (4) provides
support to improve, through construction, facilities conducting
biomedical and behavioral research on minority health and health
disparities.
Office of Innovation and Program Coordination (ORIPC) (N E33,
formerly HN E33) (1) Plans, stimulates, develops and supports a broad
extramural research program to include basic, behavioral and clinical
research on minority health and health disparity conditions including
research to prevent, diagnose and treat such conditions; (2) develops
innovative research programs and projects for the Institute that link
the biological and non-biological determinants of health; and (3) works
with the Office of the Director to coordinate inter- and intra-agency
programs and projects on minority health and health disparities.
Section N-R, Organization and Functions, is amended as follows:
Immediately after the paragraph headed ``Division of Research
Infrastructure'' (N RL, formerly HN RL), insert the following:
Division of Training, Workforce Development, and Diversity (DTWDD)
(N S5, formerly HN S5) (1) Serves as the focal point for the
Institute's efforts to foster research training and facilitate the
development of a diverse and inclusive biomedical research workforce;
(2) oversees and coordinates NIGMS policies related to diversity
activities, research training programs, and workforce development
efforts; (3) implements strategic plans to improve the effectiveness of
NIGMS' diversity and training programs; (4) promotes biomedical
research workforce diversity through innovative approaches, including
programs to increase the competitiveness of faculty at institutions
from states with limited NIH research support; and (5) collaborates
with NIH, DHHS, and other agencies, as well as the extramural
scientific community on these matters.
Division of Biomedical Technology, Bioinformatics, and
Computational Biology (DBTBCB) (N S7, formerly HN S7) (1) Plans,
directs, and administers a program of research grants, contracts, and
other funding mechanisms to support research and research training in
data management, analysis and visualization, computational modeling and
analysis of systems and networks, including biostatistical analyses, as
well as the development of new or improved technologies--in areas such
as high performance computing, molecular imaging, structural biology
and proteomics--which will be applied to advance biomedical research;
(2) defines the Institute's needs for database development and
applications, as well as collaborates with other NIH components and
federal agencies in developing policies in this area; (3) coordinates
the activities of the Biomedical Information Science and Technology
Initiative (BISTI) and the trans-NIH Biomedical Information Science and
Technology Initiative Committee (BISTIC) with related activities of
other federal agencies, NIH institutes, and public and private
entities; (4) analyzes national research efforts directed toward the
study of the above and makes recommendations to assist the National
Advisory General Medical Sciences Council or other advisory committees
or appointed groups to (a) participate in decisions about new or
continuing areas of program emphasis, or (b) determine the relative
scientific merit of applications for grant support; (5) maintains
surveillance over new research developments and identifies the need for
research in the areas of computational analysis of biological systems
at the cellular, subcellular, physiological and population systems
levels, as well as innovative technologies and instrumentation for
biomedical research which could be used by a wide range of biomedical
or clinical researchers and not limited to a specific organ or disease;
and (6) provides information to third parties such as universities,
other centers of biomedical research, and professional and lay
organizations about research needs and requirements of the Division.
Section N-AW, Organization and Functions, is amended as follows:
Immediately after the paragraph headed ``Office of Grants Management''
(N AV5, formerly HN AV5), insert the following:
Division of Program Coordination, Planning, and Strategic
Initiatives (DPCPSI) (N AW, formerly HN AW) (1) Identifies, reports on,
and provides support for 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; (2)
coordinates and provides support for research and activities related to
AIDS, behavioral and social sciences, women's health, disease
prevention, and dietary supplements; (3) applies resources (databases,
analytic tools, and methodologies) and develops specifications for new
resources in support of portfolio analyses and priority setting in
scientific areas of interest across NIH; (4) engages in activities
designed to ensure that NIH addresses important areas of emerging
scientific opportunities and public health challenges effectively; (5)
plans, conducts, coordinates, and supports program evaluations and
coordinates and prepares reports required by the Government Performance
and Results Modernization Act and related performance management
initiatives; (6) provides animal models, supports the identification
and development of new and improved animal models for the study of
human diseases, provides repositories for the storage and distribution
of genetically altered animal models, and supports specialized animal
research facilities for biomedical investigators; (7) supports the
development of research models; (8) supports research activities at
National Primate Research Centers; (9) provides oversight for the NIH
Chimpanzee Management Program (ChiMP) and provides a chimpanzee
sanctuary for the lifetime care of research chimpanzees that are no
longer needed for biomedical research; (10) supports the improvement of
the health and well-being of laboratory animals; (11) supports the
breeding of and accessibility to scarce research animals; (12) supports
training and career development for veterinarians engaged in research;
(13) provides access for biomedical researchers to an array of
biological materials and human biospecimens; (14) provides support to
improve biomedical and behavioral research facilities through
construction and renovation; and (15) plans, develops, coordinates, and
provides support for a science education program to improve science
literacy in adults and children and to attract young people to
biomedical and behavioral science careers.
Office of Research Infrastructure Programs (ORIP) (N AW9, formerly
HN
[[Page 799]]
AW9) (1) Provides support for resource activities and research to
identify, develop, characterize, and improve animal models for the
study of human disease; (2) assists institutions in complying with the
regulations and policies related to care and use of laboratory animals,
and supports the purchase of equipment for animal resources, transgenic
animal resources, and similar activities; (3) provides high-quality,
disease-free animal models and specialized animal research facilities
for biomedical investigators; (4) supports the development of and
access to a wide range of research models, including vertebrate and
invertebrate species; (5) provides access for biomedical researchers to
an array of biological materials and human biospecimens; (6) supports
research activities at National Primate Research Centers; (7) develops
and implements policies and provides programmatic oversight for the NIH
Chimpanzee Management Program (ChiMP); (8) provides a chimpanzee
sanctuary for the lifetime care of chimpanzees no longer needed for
biomedical research; (9) supports training and career development for
veterinarians engaged in research; (10) provides repositories for the
storage and distribution of genetically altered animal models; (11)
supports the breeding of and accessibility to scarce research animals;
(12) supports grants for the acquisition of state-of-the-art
instrumentation and integrated instrument systems; (13) provides
support for human tissue and organ research resources to meet the needs
of biomedical researchers, including those in academia, government, and
industry; (14) supports grants to expand, re-model, renovate, or alter
existing research facilities or to construct new research facilities,
including to improve laboratory animal facilities; and (15) coordinates
science education activities at the NIH, plans, develops, and
coordinates a comprehensive science education program to improve
science literacy in both adults and children and to attract young
people to biomedical and behavioral science careers; and develops and
supports grants designed to improve life science literacy throughout
the nation through educational programs.
Division of Comparative Medicine (DCM) (N AW92, formerly, HN AW92)
(1) Provides high-quality, disease-free animal models and specialized
animal research facilities for biomedical investigators; (2) supports
the development of and access to a wide range of research models,
including vertebrate and invertebrate species; (3) provides access for
biomedical researchers to an array of biological materials and human
biospecimens; (4) supports research activities at National Primate
Research Centers; (5) develops and implements policies and provides
programmatic oversight for the NIH Chimpanzee Management Program
(ChiMP); (6) provides a chimpanzee sanctuary for the lifetime care of
research chimpanzees that are no longer needed for biomedical research;
(7) supports the identification and development of new and improved
animal models for the study of human diseases; (8) supports improvement
of the health and well-being of laboratory animals; (9) supports
training and career development for veterinarians engaged in research;
(10) provides repositories for the storage and distribution of
genetically altered animal models; and (11) supports the breeding of
and accessibility to scarce research animals.
Division of Instruments, Infrastructure Resources, and Construction
(DIIRC) (N AW93, formerly, HN AW93) (1) Supports programs to expand the
Nation's capacity for the conduct of biomedical research; (2) supports
grants for the acquisition of state-of-the-art instrumentation and
integrated instrument systems; (3) provides support for human tissue
and organ research resources to meet the needs of biomedical
researchers, including those in academia, government, and industry; and
(4) supports grants to expand, re-model, renovate, or alter existing
research facilities or to construct new research facilities, including
to improve laboratory animal facilities.
Office of Science Education (OSE) (N AW94, formerly, HN AW94) (1)
Plans, develops, and coordinates a comprehensive science education
program to improve science literacy in both adults and children and to
attract young people to biomedical and behavioral science careers; (2)
develops and directs an extensive set of education initiatives in the
medical sciences targeted to students in grades K-16, educators, and
the public; (3) advises NIH leadership on science education issues; (4)
conducts, analyzes, and assesses research related to science education;
(5) collaborates within the NIH and with public and private sector
organizations to develop and coordinate science education activities;
and (6) serves as an information resource center providing access to
educational materials and activities related to medical science.
Delegations of Authority Statement: All delegations and
redelegations of authority to officers and employees of NIH that were
in effect immediately prior to the effective date of this
reorganization and are consistent with this reorganization shall
continue in effect, pending further redelegation.
Dated: December 30, 2011.
Francis S. Collins,
Director.
[FR Doc. 2012-54 Filed 1-5-12; 8:45 am]
BILLING CODE 4140-01-P