[Federal Register Volume 77, Number 4 (Friday, January 6, 2012)]
[Notices]
[Pages 797-799]
From the Federal Register Online via the Government Publishing 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

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``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