[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4100-4101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0263]


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 March 16, 
2021.

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 0990-0263-60D, 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--the Protection of 
Human Subjects: Assurance Identification/IRB Certification/Declaration 
of Exemption Form.
    Type of Collection: 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 is requesting a three-year 
extension of the Protection of Human Subjects: Assurance 
Identification/IRB Certification/Declaration of Exemption Form, OMB No. 
0990-0263.
    This form will facilitate prompt reporting of specific human 
subject

[[Page 4101]]

protection incidents to OHRP by organizations and institutions 
conducting or reviewing human subjects research, and will provide a 
simplified standardized format for the reports. 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.

                                          Annualized Burden Hour Table
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                                                                  Number of
                  Form name                      Number of      responses per      Hours per     Response burden
                                                respondents       respondent        response          hours
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Protection of Human Subjects: Assurance               14,000                2              0.5           14,000
 Identification/IRB Certification/
 Declaration of Exemption...................
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    Dated: January 12, 2021.
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. 2021-00934 Filed 1-14-21; 8:45 am]
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