E8-1441. 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 received within 30 days of this notice directly to the OS OMB Desk Officer all comments must be faxed to OMB at 202-395-6974.

Proposed Project: Federal-wide Assurance Forms-Extension—OMB No. 0990-0278—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 forms were designed to provide a simplified procedure for institutions engaged in HHS-conducted or supported research to satisfy the assurance requirements of section 49(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. Data is collected as needed.

Estimated Annualized Burden Table

Forms	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
FWA 0278	10,000	2	45/60	15,000

Terry Nicolosi,

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