[Federal Register Volume 65, Number 114 (Tuesday, June 13, 2000)]
[Notices]
[Pages 37136-37137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Office of Public Health and Science, and National Institutes of 
Health, Office of the Director; Statement of Organization, Functions, 
and Delegations of Authority

    Part A, Office of the Secretary (OS) of the Statement of 
Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services (DHHS), Chapter AC, Office of 
Public Health and Science (OPHS), the Immediate Office (ACA) as last 
amended at 62 FR 5009-10, dated February 3, 1997; and Part N, the 
National Institutes of Health, Office of the Director (NA), Office of 
Extramural Research (NA3), Office for Protection from Research Risks, 
as last amended at 65 FR 11792, March 6, 2000, are being amended to 
reflect the transfer of the human research protection functions from 
the NIH to the newly established Office for Human Research Protections 
(OHRP), OPHS, within the OS. The OHRP will be headed by a Director who 
will report to the Assistant Secretary for Health.
    The changes are as follows:
    I. Under Part N, National Institutes of Health, Chapter NA, Office 
of Director, Office of Extramural Research (NA3), make the following 
changes:
    A. Delete the ``Office of Extramural Research (NA3)'' in its 
entirety and replace with the following:
    Office of Extramural Research (NA3)--(1) Acts on behalf of the NIH 
Director to provide guidance to the research institutes on the 
development and management of extramural (grant and cooperative 
agreement) research and training programs; (2) advises the NIH Director 
and staff on issues relating to extramural research activities; and (3) 
oversees the proper care and use of laboratory animals on behalf of the 
entire U.S. Public Health Service.
    B. Delete the ``Office for Protection from Research Risks (NA33)'' 
in its entirety.
    II. Under Part A, Chapter AC, Office of Public Health and Science, 
make the following changes:
    A. Delete Section AC.10 Organization in its entirety and replace 
with the following:
    Section AC.10 Organization. The Office of Public Health and Science 
(AC) is under the direction of the Assistant Secretary for Health and 
consists of the following components:

A. Immediate Office (ACA)
B. Office on Women's Health (ACB)
C. Office of Minority Health (ACC)
D. Office of the President's Council on Physical Fitness and Sports 
(ACE)
E. Office of Research Integrity (ACF)
F. Office of Population Affairs (ACG)
G. Office of International and Refugee Health (ACH)
H. Office of HIV/AIDS Policy (ACJ)
I. Office of Emergency Preparedness (ACK)
J. Office of Disease Prevention and Health Promotion (ACL)
K. Office of the Surgeon General (ACM)
L. Office for Human Research Protections (ACN)

    B. Amend Chapter AC.20 Functions, paragraph A, ``Office of Public 
Health and Science,'' paragraph titled, ``The Immediate Office (ACA)'' 
by adding the following new clause:
    (m) Responsible for overseeing human research subjects protections 
functions and related functions where research involves the use of 
human subjects.

[[Page 37137]]

    C. Under Section AC.20 Functions, add paragraph ``L. Office for 
Human Research Protections (ACN),'' to read as follows:
    L. Office for Human Research Protections (ACN)--The Office for 
Human Research Protections (OHRP) fulfills responsibilities set forth 
in the Public Health Service Act. These include: (1) Developing and 
monitoring as well as exercising compliance oversight relative to HHS 
Regulations for the protection of human subjects in research conducted 
or supported by any component of the Department of Health and Human 
Services; (2) coordinating appropriate HHS regulations, policies, and 
procedures both within HHS and in coordination with other Departments 
and Agencies in the Federal Government; (3) establishing criteria for 
and negotiation of Assurances of Compliance with institutions engaged 
in HHS-conducted or--supported research involving human subjects; (4) 
conducting programs of clarification and guidance for both the Federal 
and non-Federal sectors with respect to the involvement of humans in 
research; and directing the development and implementation of 
educational and instructural programs and generating educational 
resource materials; (5) evaluating the effectiveness of HHS policies 
and programs for the protection of human subjects; (6) serving as 
liaison to Presidential, Departmental, Congressional, interagency, and 
non-governmental commissions and boards established to examine ethical 
issues in medicine and research and exercises leadership in identifying 
and addressing such ethical issues; and (7) promoting the development 
of approaches to enhance and improve methods to avoid unwarranted risks 
to humans participating as subjects in research covered by applicable 
statutes and regulations.
    1. Office of the Director (ACN1)--The Office of the Director 
reports to the Assistant Secretary for Health, supervises and manages 
the development and promulgation of policies, procedures, and plans for 
meeting the responsibilities set forth above. Additionally, staff of 
this office advise the Secretary, Assistant Secretary for Health and 
other HHS officials on ethnical issues pertaining to medicine and 
biomedical and behavioral research, including all issues relative to 
the implementation of HHS Regulations for the Protection of Human 
Subjects. Directs the development, implementation, and compliance 
oversight activities for HHS Regulations and for the Protection of 
Human Subjects; exercises oversight and negotiates Assurances of 
Compliance in all areas of human subject research; maintains liaison 
and coordinates policy implementation with components throughout HHS 
that conduct or support research involving human subjects; and directs 
the development and implement of educational and instructional programs 
and generates resource materials relating to the responsibilities of 
the research community for the protection of human subjects.
    2. Division of Policy and Assurance (ACN 2)--(1) Negotiates 
Assurances of Compliance with research entities; (2) provides liaison, 
guidance, and regulatory interpretation to research entities, 
investigators, Federal officials, and the public; (3) maintains 
existing assurance mechanisms; and (4) develops and implements new 
procedures to ensure that HHS human subjects protection regulations are 
appropriately and effectively applied to the changing needs of the 
research community.
    3. Division of Compliance Oversight (ACN 3)--(1) Conducts inquiries 
and investigations into alleged noncompliance with HHS Regulations for 
Protection of Human Subjects; (2) prepares inquiry and investigative 
reports; (3) recommends remedial or corrective action as necessary to 
agency or Department officials as appropriate; and (4) conducts a 
program of oversight of awardee institution implementation of HHS 
Regulations for the Protection of Human Subjects.
    4. Division of Education and Development (ACN 4)--(1) Produces and 
coordinates conferences and workshops focusing on issues in human 
subjects protection; (2) promotes cooperative education and development 
efforts among external groups and consortia to improve human subjects 
protections and related processes; (3) promptly responds to requests 
for clarification and guidance regarding ethnical issues in biomedical 
and behavioral research involving human subjects; (4) provides 
technical assistance to institutions engaged in HHS-conducted or -
sponsored research involving human subjects; and, (5) maintains, 
promulgates, and updates educational and institutional review guidance 
materials.
    D. Continuation of Policy: Except as inconsistent with this 
reorganization, all statements of policy and interpretations with 
respect to the National Institutes of Health and the Office of the 
Secretary heretofore issued and in effect prior to this reorganization 
are continued in full force and effect.
    E. Delegation of Authority: All delegations and redelegations of 
authority made officials and employees of affected organizational 
components will continue in them or their successors pending further 
redelegation, provided they are consistent with this reorganization.
    F. Funds, Personnel, and Equipment: Transfer or organizations and 
functions affected by this reorganization shall be accompanied by 
direct and support funds, positions, personnel, records, equipment, 
supplies and other resources.
    G. Effective Date: The effective date of this reorganization is 
June 18, 2000.

Donna E. Shalala,
Secretary.
[FR Doc. 00-14803 Filed 6-12-00; 8:45 am]
BILLING CODE 4150-04-M