[Federal Register Volume 68, Number 204 (Wednesday, October 22, 2003)]
[Notices]
[Pages 60392-60393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26627]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Amendment of Statement of Organization Functions and Delegations 
of Authority for the Office for Human Research Protections

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: This amendment revises the description of the immediate Office 
of the Director, Office for Human Research Protections (OHRP), to 
include support functions for the Secretary's Advisory Committee on 
Human Research Protections; changes the name and expands the functions 
of the former Division of Policy Planning and Special Projects; expands 
the functions of the Division of Education and Development; and 
dissolves the current Division of Assurances and Quality Improvement.
    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 67 FR 10216, dated March 6, 2002, is being 
amended as follows:
    I. Amend Part L, subpart 1, as follows:
    A. Delete ``and'' before ``(8),''
    B. Delete ``.'' at the end of subpart 1,
    C. Add to the end of subpart 1 the following:
; and (9) provides staff support for the Secretary's Advisory Committee 
on Human Research Protections.
    II. Amend Part L, subpart 2, by deleting it in its entirety and 
replacing it with the following:
    2. Division of Policy and Assurances (ACN 2)--(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) 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; 
(4) coordinates responses to requests for information, technical 
assistance, and guidance from Congress, other DHHS agencies, other 
Federal Departments and agencies, and non-governmental entities; (5) 
coordinates responses to requests for OHRP documents and information 
under the Freedom of Information Act; (6) Negotiates Assurances of 
Compliance with research entities; (7) provides liaison, guidance, and 
regulatory interpretation to research entities, investigators, Federal 
officials, and the public; (8) maintains and modifies, as necessary, 
existing assurance mechanisms; and (9) operates and maintains a 
registration system for institutional review boards; and (10) develops 
and implements new procedures to ensure that DHHS human subjects 
protection regulations are appropriately and effectively applied to the 
changing needs of the research community.
    III. Amend Part L, subpart 4 by deleting it in its entirety and 
replacing it with the following:
    4. Division of Education and Development (ACN4)--(1) Develops and 
conducts education conferences, workshops and other training tools, and 
quality improvement activities to improve protections for human 
research subjects; (2) provides liaison to Federal officials and 
guidance and regulatory interpretation to research entities, 
investigators, and the public regarding ethical issues in biomedical 
and behavioral research involving human subjects; (3) provides 
technical assistance to institutions engaged in

[[Page 60393]]

DHHS-conducted or sponsored research involving human subjects; (4) 
maintains, promulgates, and updates educational guidance materials and 
quality improvement activities and materials related to protection of 
human research subjects; (5) conducts public outreach and education or 
information programs to promote and enhance public awareness of the 
activities of OHRP and human subject protections; and (6) provides 
staff support to the Human Subjects Research Subcommittee, Committee on 
Science, National Science and Technology Council.
    VI. Amend Part L, subpart 5 by deleting it in its entirety.
    G. Effective Date: The foregoing amendments to the organization and 
functions of the Office for Human Research Protections are effective 
immediately.

    Dated: October 14, 2003.
Cristina V. Beato,
Acting Assistant Secretary for Health.
[FR Doc. 03-26627 Filed 10-21-03; 8:45 am]
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