2011-9063. 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 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 [e-mail], or call the Reports Clearance Office on [phone]. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 30-days.

Proposed Project: Federal-wide Assurance Forms—Extension—OMB No. 0990-0278—Assistant Secretary for Health, Office of Public Health and Science, Office for Human Research Protections.

Abstract: The Office for Human Research Protections (OHRP) is requesting a three year extension of the Federal-wide Assurance (FWA) forms. The FWA is designed to provide a simplified procedure for institutions engaged in 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 respondents are institutions engaged in human subjects research that is conducted or supported by HHS.

Estimated Annualized Burden in Hours Table

Form name	Number of respondents	Number of responses per respondent	Hours per response	Total burden hours
Federal-wide Assurance (FWA)	11,000	2	30/60	11,000

Mary Forbes,

Office of the Secretary, Paperwork Reduction, Act Reports Clearance Officer.