[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]
BILLING CODE 4150-28-P