2020-08702. Agency Information Collection Request; 60-Day Public Comment Request

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement 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.

DATES:

Comments on the ICR must be received on or before June 23, 2020.

ADDRESSES:

Submit your comments to [e-mail] or by calling [phone].

FOR FURTHER INFORMATION CONTACT:

When submitting comments or requesting information, please include the document identifier 0990-0278-60D, and project title for reference, to Sherrette Funn, the Reports Clearance Officer, [e-mail], or call 202-795-7714.

SUPPLEMENTARY INFORMATION:

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. Information Collection Request Title: 0990-0278—Federalwide Assurance Form.

Abstract: Assistant Secretary for Health, Office for Human Research Protections is requesting a three year extension of the Federalwide Assurance (FWA). 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.

Likely Respondents: Institutions engaged in human subjects research that is conducted or supported by HHS.

Estimate Annualized Burden in Hours Table

Form name	Number of respondents	Number of responses per respondent	Hours per response	Response burden hours
Federalwide Assurance (FWA)	14,000	2.0	30/60	14,000

Dated: April 20, 2020.

Sherrette A. Funn,

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