[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Pages 59537-59538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-xxxx]


Agency Information Collection Request. 60-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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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 [email protected] or by calling 
(202) 795-7714.

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, [email protected], 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.
    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

[[Page 59538]]

OHRP 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
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                                                  Responses per      Number of       Hours per     Total burden
             Forms                 Respondents      respondent       responses       response          hours
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Incident Report Form...........             500                1             500             0.5             250
Incident Report Form...........             200                2             400             0.5             200
Incident Report Form...........             100                3             300             0.5             150
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    Total......................  ..............  ...............  ..............  ..............             600
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    Dated: September 16, 2020.
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. 2020-20832 Filed 9-21-20; 8:45 am]
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