[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23249-23250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9323]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier OS-0990-0279]


Agency Information Collection Request; 60-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 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, email your 
request, including your address, phone number, OMB number, and OS 
document identifier, to <a href="/cdn-cgi/l/email-protection#c794afa2b5a2b3b3a2e9a1b2a9a9a4a8aba2aaa6a987afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="d685beb3a4b3a2a2b3f8b0a3b8b8b5b9bab3bbb7b896bebea5f8b1b9a0">[email protected]</span></a>, 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 email 
within 60 days.
    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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                    Form name                       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
IRB Registration--0279..........................           6,100               2               1          12,200
                                                             900               2               1           1,800
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          14,000
----------------------------------------------------------------------------------------------------------------



[[Page 23250]]

Keith A. Tucker,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2012-9323 Filed 4-17-12; 8:45 am]
BILLING CODE 4150-36-P


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