Notice2021-16159
Agency Information Collection Request; 60-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
July 29, 2021
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
<html>
<head>
<title>Federal Register, Volume 86 Issue 143 (Thursday, July 29, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40860-40861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New]
Agency Information Collection Request; 60-Day Public Comment
Request
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 September 27,
2021.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#02516a677070677676672c44776c6c426a6a712c656d74"><span class="__cf_email__" data-cfemail="b8ebd0ddcacaddccccdd96fecdd6d6f8d0d0cb96dfd7ce">[email protected]</span></a> 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 A. Funn, email:
<a href="/cdn-cgi/l/email-protection#207348455252455454450e66554e4e604848530e474f56"><span class="__cf_email__" data-cfemail="0a59626f78786f7e7e6f244c7f64644a626279246d657c">[email protected]</span></a>, or call (202) 795-7714 the Reports Clearance
Officer.
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: Institutional Review Board (IRB) Records
for HHS/OASH Consultation Process.
Type of Collection: New.
OMB No.: OS-0990-New.
Abstract: The Office of 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: Institutional Review Boards (IRBs).
[[Page 40861]]
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average
45 CFR part 46--HHS consultation process Number of responses per burden per Total burden
provision respondents respondents response hours
----------------------------------------------------------------------------------------------------------------
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
---------------------------------------------------------------
Total....................................... .............. .............. .............. 10
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-16159 Filed 7-28-21; 8:45 am]
BILLING CODE 4150-36-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 29, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.