[Federal Register Volume 67, Number 33 (Tuesday, February 19, 2002)]
[Notices]
[Pages 7377-7378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


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

[[Page 7378]]

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
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                                                                    Annual number   Burden (hrs)    Total (hrs)
                 Section of rule and description                    of responses    per response      burden
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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,                    20,574          5             102,870
 recordkeeping...................................................
103(b)(4)--changes to IRB........................................          41,148          1              41,148
113--termination of IRB approval.................................             275          2                 550
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    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.

    Dated: February 11, 2002.
Kerry Weems,
Acting Deputy Assistant Secretary, Budget.
[FR Doc. 02-3984 Filed 2-15-02; 8:45 am]
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