[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Pages 78361-78362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0260]


Agency Information Collection Request; 30-Day Public Comment 
Request

AGENCY: Office of the Secretary.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 
Department of Health and Human Services (HHS), is publishing the 
following summary of a proposed information collection request for 
public comment. Interested persons are invited to send comments 
regarding this burden estimate or any other aspect of this collection 
of information, including any of the following subjects: (1) The 
necessity and utility of the proposed information collection for the 
proper performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden. To obtain copies of the 
supporting statement and any related forms for the proposed paperwork 
collections referenced above, e-mail your request, including your 
address, phone number, OMB number, and OS document identifier, to 
[email protected], or call the Reports Clearance Office on 
(202) 690-5683. Written comments and recommendations for the proposed 
information collections must be directed to the OS Paperwork Clearance 
Officer at the above e-mail address within 30 days.
    Proposed Project: Protection of Human Subjects: Assurance of 
Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed 
Consent/Consent Documentation--OMB No. 0990-0260--Office for Human 
Research Protections.
    Abstract: Section 491(a) of Public Law 99-158 states that the 
Secretary of HHS shall by regulation require that each entity applying 
for HHS support (e.g., a grant, contract, or cooperative agreement) to 
conduct research involving human subjects submit to HHS assurances 
satisfactory to the Secretary that it has established an institutional 
review board (IRB) to review the research in order to ensure protection 
of the rights and welfare of the human research subjects. IRBs are 
boards, committees, or groups formally designated by an entity to 
review, approve, and have continuing oversight of research involving 
human subjects.
    Pursuant to the requirement of the Public Law 99-158, HHS 
promulgated regulations at 45 CFR part 46, subpart A, the basic HHS 
Policy for the Protection of Human Subjects. The June 18, 1991 adoption 
of the common Federal Policy (56 FR 28003) by 15 departments and 
agencies implements a recommendation of the President's Commission for 
the Study of Ethical Problems in Medicine and Biomedical and Behavioral 
Research which was established on November 9, 1974, by Pub. L. 95-622. 
The Common Rule is based on HHS regulations at 45 CFR part 46, subpart 
A, the basic HHS Policy for the Protection of Human Subjects.
    The respondents for this collection are institutions engaged in 
such research. Institutional adherence to the Common Rules also is 
required by other federal departments and agencies that have codified 
or follow the Common Rule which is identical to 45 CFR part 46, subpart 
A. The information being requested related to the Common Rule should be 
readily available to the institution or organization that registers the 
IRB.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                      Title                         respondents    responses per   response (in        hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
.103(b)(4), .109(d) IRB Actions, .116 and .117             6,000           39.33               1         235,980
 Informed Consent...............................

[[Page 78362]]

 
.115(a) IRB Recordkeeping.......................           6,000           15                 10         900,000
.103(b)(5) Incident Reporting, .113 Suspension             6,000            0.5            45/60           2,250
 or Termination Reporting.......................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       1,138,230
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Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
 [FR Doc. E8-30274 Filed 12-19-08; 8:45 am]
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