[Federal Register Volume 67, Number 44 (Wednesday, March 6, 2002)]
[Notices]
[Pages 10216-10218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Amendment of Statement of Organization, Functions, and
Delegations of Authority for the Office of Human Research Protections
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of Public Health and Science, Office for Human
Research Protections.
ACTION: Notice.
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SUMMARY: This amendment describes modifications in the functions of the
Immediate Office of the Director, Office for Human Research Protection,
(OHRP), to include international functions, changes the name and
functions of the former Division of Policy and Assurance, establishes a
Division of Policy Planning and Special Projects, and updates the
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), Office for Human Research Protections
(OHRP), as last amended at
[[Page 10217]]
65 FR 37136, dated June 13, 2000, is being amended as following:
I. Part L, description of OHRP, is deleted in its entirety and
replaced with the following:
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) Providing
leadership for human research subjects protections within the
Department of Health and Human Services (DHHS) and for the U.S.
Government in cooperation with other Federal Agencies; (2) developing
and monitoring as well as exercising compliance oversight relative to
DHHS regulations for the protection of human subjects in research
conducted or supported by any component of the Department of Health and
Human Services; (3) promoting and coordinating appropriate DHHS
regulations, policies, and procedures both within DHHS and in
coordination with other Departments and Agencies in the Federal
Government; (4) establishing criteria for approval of assurances of
compliance for the protection of human subjects with both domestic and
foreign institutions engaged in DHHS-conducted or supported research
involving human subjects; (5) 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 instructional programs and
generating educational resource materials; (6) evaluating the
effectiveness of DHHS policies and programs for the protection of human
subjects; (7) serving as liaison to Presidential, Departmental,
Congressional, interagency, non-governmental, and international
commissions and boards to examine ethical issues in medicine and
research and exercises leadership in identifying and addressing such
ethical issues; and (8) promoting the development of approaches to
enhance and improve methods, particularly quality improvement at the
institutional level, to avoid unwarranted risks to humans participating
as subjects in research covered by applicable statutes.
II. Amend Part L, subpart 1, by replacing it in its entirety with
the following:
1. Office of the Director (ACN1)--The Office of the Director
reports to the Assistant Secretary for Health, and (1) provides
leadership within DHHS on ethical and other issues associated with
protection of human subjects in research; (2) supervises and manages
the development and promulgation of policies, procedures, and plans for
meeting the responsibilities set forth above; (3) advises the
Secretary, Assistant Secretary for Health and other DHHS officials on
ethical issues pertaining to medical, biomedical, behavioral, social,
health services, public health and other research, including all issues
relative to the implementation of DHHS Regulations for the Protection
of Human Subjects; (4) directs the development, implementation, and
compliance oversight activities for DHHS Regulations and for the
protection of human subjects; (5) establishes criteria for approval of
and exercises oversight of assurances of compliance for protection of
human subjects in all areas of human subject research; (6) maintains
liaison and coordinates policy implementation with components
throughout DHHS that conduct and support research involving human
subjects; (7) directs the implementation of quality improvement
programs through the development and implementation of educational and
instructional programs, including generation of resource materials
relating to the responsibilities of the research community for the
protection of human subjects; and (8) engages in international
activities related to human research subject protections, particularly
global efforts to achieve harmonization of policies and procedures and
for the building of global capacity to enhance protections for human
subjects participating in research.
III. Amend Part L, subpart 2, by replacing it in its entirety with
the following:
2. Division of Assurances and Quality Improvement (ACN 2)--(1)
Receives and approves assurances of compliance from research entities;
(2) provides liaison, guidance and regulatory interpretation to
research entities, investigators, Federal officials and the public; (3)
operates and maintains a registration system for institutional review
boards; (4) maintains and modifies as necessary assurance mechanisms
and procedures; (5) develops and conducts quality improvement
activities to improve protections for human research subjects; and (6)
develops and implements new procedures and instruments to ensure DHHS
human subjects protections regulations are appropriately and
effectively applied in a manner consistent with the changing needs of
the Federal Government, the research community and society.
III. Amend Part L, by adding a subpart 5 as follows:
5. Division of Policy Planning and Special Projects (ACN 5)--(1)
Maintains, develops, promulgates, and updates policy and guidance
documents regarding regulatory requirements, and ethical issues for
biomedical and behavioral research involving human subjects; (2)
coordinates appropriate DHHS regulations, policies and procedures with
other Departments and Agencies in the Federal Government; (3) conducts
public outreach and education or information programs to promote and
enhance public awareness of the activities of OHRP and human subject
protections; (4) provides staff support to the National Human Research
Protections Advisory Committee; (5) provides staff support to the Human
Subjects Research Subcommittee, Committee on Science, National Science
and Technology Council; (6) organizes and coordinates consultations
with panels of experts for research involving prisoners and children,
when required by DHHS regulations for the protection of human subjects
at 45 CFR 46.306 and 46.407, respectively; (7) coordinates responses to
requests for information, technical assistance and guidance from
Congress, other DHHS agencies, other Federal Departments and agencies,
and non-governmental entities; (8) coordinates responses to requests
for OHRP documents and information under the Freedom of Information
act; and (9) manages and conducts special projects as requested by the
Director, OHRP.
IV. Amend Part E, Chapter AC as follows:
E. Delegation of Authority: The Secretary's authority under Title
IV of the Public Health Service Act (42 U.S.C. 281 et seq.) has been
delegated to the Assistant Secretary for Health, 44 Fed. Reg. 46318
(August 7, 1979). Authority under Section 491 of the Public Health
Service Act (42 U.S.C. 289) is re-delegated to the Director, OHRP, to
perform all of the authorities previously delegated to the Assistant
Secretary for Health, 44 Fed. Reg. 46318. Consistent with the prior
delegation of authority to the Assistant Secretary for Health, this re-
delegation to the Director, OHRP, excludes the authorities to
promulgate regulations, submit reports to the President or the
Congress, approve organizational changes, and establish and select
members of national advisory councils and boards. Previous delegations
and re-delegations of authority under section 491 of the PHS act are
superceded.
V. Amend Part G, Chapter AC as follows:
G. Effective Date: The effective date of the foregoing amendments
to the
[[Page 10218]]
organization, functions and delegations of authority for the Office for
Human Research Protections is March 18, 2002.
Dated: February 28, 2002.
Eve E. Slater,
Assistant Secretary for Health.
[FR Doc. 02-5303 Filed 3-5-02; 8:45 am]
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