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Notice

Agency Information Collection Request; 30-Day Public Comment Request

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Information about this document as published in the Federal Register.

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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

Form nameNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total burden hours
Already Registered IRBs6,1002112,200
New IRBs900211,800
Total14,000

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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