[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37046-37047]
From the Federal Register Online via the Government Printing 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 Sherette.funncoleman@hhs.gov, 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)
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Already Registered IRBs......................... 6,100 2 1 12,200
New IRBs........................................ 900 2 1 1,800
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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]
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