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Notice

Agency Information Collection Request. 60-Day Public Comment Request

This document has a comment period that ends in 29 days. (11/23/2020) Submit a formal comment

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Start Preamble

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 November 23, 2020.

ADDRESSES:

Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795-7714.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

When submitting comments or requesting information, please include the document identifier 0990-New-60D, and project title for reference, to Sherrette Funn, the Reports Clearance Officer, Sherrette.funn@hhs.gov, or call 202-795-7714.

End Further Info End Preamble Start Supplemental Information

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.

Title of the Collection: Incident Report Form.

Type of Collection: 0990-NEW/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 approval for three years of a new information collection on the OHRP Incident Report Form. This form will facilitate prompt reporting of specific human subject protection incidents to Start Printed Page 59538OHRP by organizations and institutions conducting or reviewing human subject research, and will provide a simplified standardized format for the reports. The information collected on the form will help OHRP to ensure the safety of human research subjects involved in non-exempt HHS-conducted or—supported research and to ensure that the research is conducted in accordance with the HHS Protection of Human Subjects regulations at 45 CFR part 46.

Likely Respondents: Institutions or organizations conducting non-exempt HHS-conducted or—supported human subjects research.

Annualized Burden Hour Table

FormsRespondentsResponses per respondentNumber of responsesHours per responseTotal burden hours
Incident Report Form50015000.5250
Incident Report Form20024000.5200
Incident Report Form10033000.5150
Total600
Start Signature

Dated: September 16, 2020.

Sherrette A. Funn,

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

End Signature End Supplemental Information

[FR Doc. 2020-20832 Filed 9-21-20; 8:45 am]

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