[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37046-37047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0279; 30-day Notice]


Agency Information Collection Request; 30-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.
    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, is publishing the following 
summary of a proposed collection 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, email 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. Send written comments and 
recommendations for the proposed information collections within 30 days 
of this notice directly to the OS OMB Desk Officer; faxed to OMB at 
202-395-5806.
    Proposed Project: Institutional Review Board Form--Extension--OMB 
No. 0990-0279--Office for Human Research Protections
    Abstract: The Office for Human Research Protections (OHRP) and the 
Food and Drug Administration (FDA) are requesting a three-year 
extension of the OMB No. 0990-0279, Institutional Review Board (IRB) 
Registration Form. This form was modified in 2009 to be consistent with 
IRB registration requirements that were adopted in July 2009 by OHRP 
and FDA, respectively. Respondents for this information collection are 
institutions or organizations operating IRBs designated by an 
institution under an assurance of compliance approved for federalwide 
use by OHRP under 45 CFR 46.103(a) and that review human subjects 
research conducted or supported by HHS, or, in the case of FDA's 
regulation, each IRB in the United States that reviews clinical 
investigations regulated by FDA under sections 505(i) or 520(g) of the 
Federal Food, Drug and Cosmetic Act; and each IRB in the United States 
that reviews clinical investigations that are intended to support 
applications for research or marketing permits for FDA-regulated 
products.

                                    Total Estimated Annualized Burden--Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                    Form name                       respondents    responses per   response (in        hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Already Registered IRBs.........................           6,100               2               1          12,200
New IRBs........................................             900               2               1           1,800
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          14,000
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[[Page 37047]]

Keith A. Tucker,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2012-15033 Filed 6-19-12; 8:45 am]
BILLING CODE 4150-36-P