Notice2021-28566
Agency Information Collection Request. 30-Day Public Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 5, 2022
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 3 (Wednesday, January 5, 2022)</title>
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[Federal Register Volume 87, Number 3 (Wednesday, January 5, 2022)]
[Notices]
[Pages 462-463]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28566]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new]
Agency Information Collection Request. 30-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 February 4,
2022.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, <a href="/cdn-cgi/l/email-protection#e3b08b86919186979786cda5968d8da38b8b90cd848c95"><span class="__cf_email__" data-cfemail="f5a69d90878790818190dbb3809b9bb59d9d86db929a83">[email protected]</span></a>
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
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: For HHS/OHRP Consultation Process,
Institutional Review Board Records.
Type of Collection: New OMB No. 0990-XXXX.
Abstract: The Assistant Secretary for Health, Office for Human
Research Protections is requesting a new approval from the Office of
Management and Budget of the Office for Human Research Protections
(OHRP) requirement that Institutional Review Board records be submitted
when an IRB or its institution request an HHS consultation process, for
proposed research involving, respectively: (1) Pregnant women, human
fetuses and neonates; (2) prisoners; or, (3) children, as subjects that
are not otherwise approval by an IRB. The Office of the Assistant
Secretary for Health, on behalf of the Secretary of HHS, may determine
that such research can be conducted or supported by HHS after
consulting with experts and allowing for public review of, and comment
on, the proposed research.
Likely Respondents: IRBs.
Table--Annualized Burden Hour
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Number of Average burden
45 CFR part 46--HHS consultation process Number of responses per per response Total burden
provision respondents respondent (in hours) hours
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Subpart B, Sec. 46. 207....................... 3 1 1 3
Subpart C, Sec. 46.306 (iii) and (iv)......... 3 1 1 3
Subpart D, Sec. 46.407........................ 4 1 1 4
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[[Page 463]]
Total....................................... .............. .............. .............. 10
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-28566 Filed 1-4-22; 8:45 am]
BILLING CODE 4150-36-P
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