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 Start Printed Page 7378projects have been reviewed by the IRB. Respondents: Individuals, Business or other for-profit, Non-profit institutions, Federal, State, Local or Tribal Governments.
|Section of rule and description||Annual number of responses||Burden (hrs) per response||Total (hrs) burden|
|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(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 (202) 690-6207. 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.Start Signature
Dated: February 11, 2002.
Acting Deputy Assistant Secretary, Budget.
[FR Doc. 02-3984 Filed 2-15-02; 8:45 am]
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