[Federal Register Volume 61, Number 159 (Thursday, August 15, 1996)]
[Notices]
[Pages 42433-42435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20776]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Organization, Functions, and Delegations of 
Authority

    Part H, Chapter HN (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 61 FR 36737, July 12, 1996), is amended to 
reflect the reorganization of the Office of the Director, NIH (OD/NIH) 
(HNA). The reorganization consists of the following: (1) In the Office 
of the Director (HNA) establish the Office of Program Coordination 
(HNAN), Office of Community Liaison (HNAP), Office of Legislative 
Policy and Analysis (HNAQ) (elevated from the Office of Science Policy 
and Technology Transfer, Office of Legislative Policy and Analysis 
[HNA67]), and Executive Office (HNAR). (2) In the Office of Disease 
Prevention (HNA2) establish the Office of Dietary Supplements (HNA25); 
the Office of Rare Diseases (HNA26) (transferred intact from the Office 
of Science Policy and Technology Transfer, Office of Rare Disease 
Research [HNA6533]); and the Office for Alternative Medicine (HNA27) 
(transferred intact from the Office of Science Policy and Technology 
Transfer, Office for Alternative Medicine [HNA6532]). (3) In the Office 
of Intramural Research (HNA4) establish the Office of Technology 
Transfer (HNA46) (transferred intact from the Office of Science Policy 
and Technology Transfer, Office of Technology Transfer [HNA68]); and 
establish the Office of Loan Repayment and Scholarship (HNA47). (4) 
Retitle the Office of Science Policy and Technology Transfer (HNA6) to 
the Office of Science Policy (OSP) (HNA6); elevate and rename the 
Recombinant DNA Branch (HNA6534) to the Office of Recombinant DNA 
Activities (HNA69); rename the Office of Strategic Planning and 
Evaluation (HNA66) to the Office of Science Policy and Operations 
Research (HNA66); abolish the Science Policy Studies Center (HNA65); 
and elevate and rename the Science Education Policy Branch (HNA6535) to 
Office of Science Education (HNA63).
    Section HN-B, Organization and Functions, is amended as follows:
    (1) Under the heading Office of the Director (HNA), insert the 
following:
    Office of Program Coordination (HNAN). Provides essential support 
functions for the Office of the Director, including: (1) all Executive 
Secretariat functions, including correspondence control and tracking; 
(2) Committee Management functions for all of NIH, which consist of 
setting policy for all Advisory Committees, Councils, and Boards, 
providing oversight on reports and other documentation, serving as a 
liaison with Department committee management staff, and providing 
technical guidance and information relevant to the operations of 
advisory bodies; and (3) other primary support functions.
    Office of Community Liaison (HNAP). (1) Advises the Director and 
the Deputy Director, NIH, on policies, programs, and issues involving 
the NIH and its community; (2) plans and directs activities to promote 
collaboration and cooperation between the NIH and its community; (3) 
conducts and oversees studies, projects, and evaluations designed to 
address problems, questions, and issues of community concern and 
environmental impact; (4) ensures that NIH activities that affect the 
community involve community representation at all levels of design, 
review, and implementation; and (5) ensures effective communication and 
collaboration on policy and programs involving the community between 
the OD and the operating components of the NIH.
    Office of Legislative Policy and Analysis (HNAQ). (1) Advises the 
NIH Director, Deputy Director, OD staff, and the ICDs on the full range 
of legislative issues, and provides leadership and direction for NIH 
legislative analysis, development, and liaison; (2) identifies, 
analyzes, and reports on legislative developments relevant to NIH 
programs and activities and the national biomedical research effort; 
(3) plans and develops new legislative proposals and monitors their 
progress through the legislative process, including changes in the 
statutory base of NIH activities; (4) assesses, monitors, and manages 
the NIH relationship with the NIH Congressional Authorizing and 
Appropriations Committees and takes necessary action to facilitate 
improvements in these relationships; (5) provides coordination on NIH 
legislative matters with the Department, the Congress, Federal 
Agencies, and other non-Federal national and international 
organizations; (6) coordinates the preparation of testimony or 
statements for the OD/NIH before congressional committees or other 
groups; and (7) develops special reports, staff documents or other 
studies concerning NIH interests, activities, and relationships.
    Executive Office (HNAR). Serves in both a staff and operational 
capacity for all administrative support activities for the Office of 
the Director, excluding the Office of Research Services.
    (2) Under the heading Office of Director (HNA), Office of Disease 
Prevention (HNA2), insert the following:
    Office of Dietary Supplements (HNA25). (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, Department of Health and Human Services and 
the agencies of the Public Health Service on non-regulatory issues 
relating to dietary supplements; and (5) compiles and maintains a 
database of scientific research and funding.
    Office of Rare Diseases (HNA26). (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

[[Page 42434]]

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 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 for Alternative Medicine (HNA27). (1) Advises the OD/NIH on 
the study of alternative medicine; (2) guides and coordinates the NIH-
wide activities involving alternative medicine; (3) responds to 
requests for information on highly technical matters and matters of 
public policy relative to alternative medicine; (4) identifies specific 
research efforts receiving support that are related to the assessment 
or validation of alternative medicine; and (5) determines the 
appropriate studies needed to evaluate alternative medicine.
    (3) Under the heading Office of the Director (HNA), Office of 
Intramural Research (HNA4), insert the following:
    Office of Technology Transfer (NHA46). (1) Develops policy and 
procedures for NIH, CDC, and FDA to follow for the implementation of 
Cooperative Research and Development Agreements (CRADAs), patent 
licenses, and other technology transfers; (2) implements Patent Policy 
Board decisions and policies; (3) drafts, negotiates, and periodically 
revises model forms and agreements; (4) provides advice to ICDs on 
licenses and agreements; (5) develops policy statements on various 
technology transfer issues; (6) tracks the OTT budget and prepares an 
annual status report on the OD/NIH; (7) provides coordination and 
management of the goals, functions, and operations of the Division of 
Technology Development and Transfer and the Division of Technology 
Transfer Support; (8) coordinates and provides planning and liaison 
support for international CRADAs and technology transfers (9) creates 
and implements special programs relating to technology transfer by 
State and local governments and universities; (10) drafts and presents 
congressional testimony, and drafts technology transfer-related 
responses to other congressional inquiries; (11) provides operational 
management activities; (12) assists the Office of the General Counsel 
(OGC) in evaluating patent-related litigation matters; (13) 
participates with OGC or independently negotiates settlements or 
contested matters with licensees or other parties involved with NIH/
CDC/FDA in technology transfer or utilization matters; (14) represents 
the NIH/CDC/FDA in technology transfer or utilization matters; (15) 
represents the above agencies at a variety of professional conferences 
and other public fora; (16) investigates special issues; (17) evaluates 
the need for and develops new programs in technology management and 
technology transfer for the above agencies; (18) develops licensing 
strategies for NIH/CDC/FDA intramural and CRADA inventions; (19) 
negotiates licenses and other technology transfers; (20) works with 
scientist inventors, contract attorneys, and others in preparing patent 
applications and prosecuting these applications at the Patent Office 
level; (21) handles infringements in consultation with the OGC at the 
Patent Office level; and (22) makes recommendations to the OGC for 
referral of matters to the Department of Justice.
    Office of Loan Repayment and Scholarship (HNA47). (1) Advises the 
Deputy Director for Intramural Research on matters pertaining to the 
development and management of educational loan repayment/forgiveness 
programs; (2) administers individual loan repayment contracts; (3) 
maintains contact and negotiates repayment schedules with educational 
lenders; (4) provides fiscal oversight for loan repayment funds; (5) 
formulates and recommends policies on loan repayment programs for 
intramural and extramural programs; (6) provides staff support to the 
loan repayment review committees; (7) analyzes applicant eligibility 
requests and recommends review by loan repayment committees; (8) serves 
as executive secretary for the loan repayment review committees; (9) 
performs a variety of activities involving the recruitment of 
postdoctoral fellows to the intramural research programs, including 
information dissemination and site-visits; (10) responds to inquiries 
from the PHS, Federal and private agencies concerning loan repayment 
program development; (11) administers the undergraduate scholarship 
program and all activities attendant to the operations of the 
undergraduate scholarship program; and (12) administers the NRC 
Research Associates Program.
    (4) Under the heading Office of the Director (HNA), Office of 
Science Policy and Technology Transfer (HNA6), (a) delete the title and 
substitute the following: Office of Science Policy (HNA6); (b) delete 
the title of the Office of Strategic Planning and Evaluation (HNA66) 
and substitute Office of Science Policy and Operations Research 
(HNA66); (c) delete the title and functional statement in their 
entirety of the Science Policy Studies Center (HNA65), the Office for 
Alternative Medicine (HNA6532), the Office of Rare Disease Research 
(HNA6533), the Recombinant DNA Branch (HNA6534), the Science Education 
Policy Branch (HNA6535), the Office of Legislative Policy and Analysis 
(HNA67), and the Office of Technology Transfer (HNA68).
    (5) Under the heading Office of the Director (HNA), Office of 
Science Policy (HNA6), insert the following:
    Office of Science Education (HNA63). Plans, develops, and 
coordinates a comprehensive science education program to strengthen and 
enhance efforts of the NIH to attract young people to biomedical and 
behavioral science careers and to improve science literacy in both 
adults and children. The Office: (1) develops, supports, and directs 
new program initiatives at all levels with special emphasis on 
targeting students in grades K-16, their educators and parents, and the 
general public; (2) advises NIH leadership on science education issues; 
(3) examines and evaluates research and emerging trends in science 
education and literacy for policy-making; (4) works closely with NIH 
extramural, intramural, women's health, laboratory animal research, and 
minority program offices on science education special issues and 
programs to assure coordination of NIH efforts; (5) works with NIH ICDs 
to enhance communication of science education activities; and (6) works 
cooperatively with other public and private sector organizations to 
develop and coordinate activities.
    Office of Recombinant DNA Activities (HNA69). (1) Develops and 
implements NIH policies and procedures for the safe conduct of 
recombinant DNA activities, including human gene therapy; (2) reviews 
and evaluates the composition of Institutional Biosafety Committees; 
(3) develops registries of activities related to recombinant DNA 
research and human gene therapy; (4) coordinates and provides liaison 
with Federal and non-Federal national and international organizations 
concerned with recombinant DNA and human gene therapy activities; (5) 
provides advice to the OD/NIH, other Federal agencies, and State 
regulatory organizations concerning recombinant research and human gene 
therapy; and (6) responds to requests for information on highly 
technical matters and matters of public

[[Page 42435]]

policy related to recombinant DNA and human gene therapy activities.

    Dated: August 1, 1996.
Harold Varmus,
Director, NIH.
[FR Doc. 96-20776 Filed 8-14-96; 8:45 am]
BILLING CODE 4140-01-M