[Federal Register Volume 66, Number 118 (Tuesday, June 19, 2001)]
[Notices]
[Pages 32952-32953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15405]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Agency Information Collection Activities: Proposed Collections; 
Comment Request

    The Department of Health and Human Services, Office of the 
Secretary will periodically publish summaries of proposed information 
collections projects and solicit public comments in compliance with the 
requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 
1995. To request more information on the project or to obtain a copy of 
the information collection plans and instruments, call the OS Reports 
Clearance Office on (202) 690-6207.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.
    Proposed Project 1. Protection of Human Subjects: Common Rule and 
HHS Regulations at 45 CFR Part 46-A Common Rule (56 FR 28003) and 
Department of Health and Human Services regulations (45 CFR part 46) 
establish common Federal policy for the protection of human subjects of 
government conducted or sponsored research. The Common Rule, published 
in 1991, requires applicant and awardee institutions to establish 
procedures to report, disclose, and keep required records for the 
protection of human subjects to include informed consent, assurances 
that an Institutional Review Board has been established, IRB 
recordkeeping and disclosure

[[Page 32953]]

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.

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                                                                   Annual No. of     Hours per
                 Section of rule and description                     responses       response      Total burden
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.103(a), .103(b) and .103(c)--assurances and underlying written            2,100          40              84,000
 policies and procedures........................................
.103(b)(3)--report change in IRB membership.....................             250            .083              20
.103(b)(5)--report problems, terminations, suspensions..........              42           8                 336
.103(f)--certification..........................................          26,600            .083           2,208
.103(b)(4)(i) and .109(d)--IRB disclosure of actions............          38,000           1              38,000
.103(b)(4)(ii)--proposed changes reported to IRB................             250            .083              20
.103(b)(5)--problems disclosed to IRB and institution...........              15           8                 120
.113--notice of suspension of IRB approval......................              30           8                 240
.116 and .117--informed consent.................................         140,000            .25           35,000
.115(a)--IRB recordkeeping......................................          23,000           1              23,000
                                                                 -----------------------------------------------
      Total.....................................................  ..............  ..............         182,944
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    Proposed Project 3. Optional Form 310: Protection of Human Subjects 
Assurance Identification/IRB Certification/Declaration of Exemption--
This form may be used by Federal agencies to implement the requirement 
of the Common Rule which requires that institutions submitting 
applications for Federal support of research involving human subjects 
submit certification of appropriate Institutional Review Board review 
and approval (Section _.103(f) of the Common Rule). The burden 
associated with this form is included in the table above.
    Please send comments 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 60 
days of this notice.

    Dated: June 13, 2001.
Kerry Weems,
Acting Deputy Assistant Secretary, Budget.
[FR Doc. 01-15405 Filed 6-18-01; 8:45 am]
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