03-26627. 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.

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 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.