02-3984. Agency Information Collection Activities: Submission for OMB Review; Comment Request

The Department of Health and Human Services, Office of the Secretary publishes a list of information collections it has submitted to the Office of Management and Budget (OMB) for clearance in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) and 5 CFR 1320.5. The following are those information collections recently submitted to OMB.

Protection of Human Subjects: Common Rule (56 FR 28003) and HHS Regulations at 45 CFR Part 46—999-0020—The Common Rule (56 FR 28003) establishes Federal policy for the protection of human subjects of Federal government conducted or sponsored research. The Common Rule, published in 1991, request applicant and awardee institutions to establish procedures to report, disclose and maintain required records to include informed consent, assurances that an Institutional Review Board (IRB) has been established, IRB recordkeeping and disclosure requirements and certification that projects have been reviewed by the IRB. Respondents: Individuals, Business or other for-profit, Non-profit institutions, Federal, State, Local or Tribal Governments.

Burden Information

Section of rule and description	Annual number of responses	Burden (hrs) per response	Total (hrs) burden
103(a)-(c)—assurances	3,300	3	9,900
Written policies and procedures	1,800	13.89	27,000
103(b)(3)—change IRB membership	500	1	500
103(b)(5)—incident reporting (non-compliance cases)	120	80	9,600
103(b)(5)—incident reporting (other)	275	4	1,100
103(f)—certification	20,574	.083	1,708
103(b), 116, 117, 115(a) IRB actions, informed consent, recordkeeping	20,574	5	102,870
103(b)(4)—changes to IRB	41,148	1	41,148
113—termination of IRB approval	275	2	550

Total Burden: 194,376 hours.

OMB Desk Officer: Allison Herron Eydt.

Copies of the information collection packages listed above can be obtained by calling the OS Reports Clearance Officer on [phone]. Written comments and recommendations for the proposed information collection should be sent directly to the OMB desk officer designated above at the following address: Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.

Comments may also be sent to Cynthia Agens Bauer, OS Reports Clearance Officer, Room 503H, Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. Written comments should be received within 30 days of this notice.

Dated: February 11, 2002.

Kerry Weems,

Acting Deputy Assistant Secretary, Budget.