Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


Agency Information Collection Request. 30-Day Public Comment Request

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Office of the Secretary, HHS.




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.


Comments on the ICR must be received on or before May 14, 2021.


Submit your comments to or by calling (202) 795-7714.

Start Further Info


When submitting comments or requesting information, please include the document identifier 0990-0263-30D, and project title for reference, to Sherrette Funn, the Reports Clearance Officer, or Email:, or call 202-795-7714.

End Further Info End Preamble Start Supplemental 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.

Title of the Collection: The Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption Form.

Type of Collection: Extension.

OMB No. 0990-0263 Office of the Assistant Secretary for Health, Office for Human Research Protections.

Abstract: The Office of the Assistant Secretary for Health, Office for Human Research Protections is requesting a three-year extension of the Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption Form, OMB No. 0990-0263.

The information collected on the form is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the requirements of HHS regulations for the protection of human subjects at 45 CFR 46.103 for assurance identification and IRB certification and declare exemption status.

Likely Respondents: Institutions engaged in research involving human subjects where the research is supported by HHS. Institutional use of the form is also relied upon by other federal departments and agencies that have codified or follow the Federal Policy for the Protection of Human Subjects (Common Rule), which is codified for HHS at 45 CFR part 46, subpart A.Start Printed Page 19627

Annualized Burden Hour Table

Form nameNumber of respondentsNumber of responses per respondentHours per responseResponse burden hours
Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption14,00020.514,000
Start Signature

Sherrette A. Funn,

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

End Signature End Supplemental Information

[FR Doc. 2021-07620 Filed 4-13-21; 8:45 am]