[Federal Register Volume 74, Number 55 (Tuesday, March 24, 2009)]
[Notices]
[Pages 12362-12363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6429]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0279]


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, 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 
received within 30 days of this notice

[[Page 12363]]

directly to the OS OMB Desk Officer all comments must be faxed to OMB 
at 202-395-6974.
    Proposed Project: Institutional Review Board/Independent Ethics 
Committee Forms Modification-OMB No. 0990-0279--Office for Human 
Research Protections.
    Abstract: The Office for Human Research Protections (OHRP) is 
requesting a modification to the current Institutional Review Board 
(IRB) Independent Ethics Committee (IEC) Registration Form designed to 
provide a simplified procedure for institutions engaged in Department 
of Health and Human Services (HHS) conducted or supported research to 
satisfy the assurance requirements of Section 491(a) of the Public 
Health Service Act and HHS regulations for the protection of human 
subjects at 45 CFR 46.103. The form is being modified to be consistent 
with IRB-Registration requirements that are included in the Office for 
Human Research Protections (OHRP) and the Food and Drug Administration 
(FDA) final rules on IRB registration requirements. 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.

                                        Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                    Form name                       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
IRB Registration 0990-0279......................           6,000               2               1          12,000
FDA-IRB.........................................           1,000               2               1           2,000
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          14,000
----------------------------------------------------------------------------------------------------------------


Terry Nicolosi,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. E9-6429 Filed 3-23-09; 8:45 am]
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