[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]
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