Notice2024-31615
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
January 6, 2025
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 90 Issue 3 (Monday, January 6, 2025)</title>
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[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Notices]
[Page 658]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31615]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0481]
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 7, 2025.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#6b38030e19190e1f1f0e452d1e05052b030318450c041d"><span class="__cf_email__" data-cfemail="fcaf94998e8e99888899d2ba899292bc94948fd29b938a">[email protected]</span></a> or by calling
(202) 264-0041 and <a href="/cdn-cgi/l/email-protection#5d0d0f1c1d15150e731a120b"><span class="__cf_email__" data-cfemail="35656774757d7d661b727a63">[email protected]</span></a>
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0481-60D and
project title for reference, to Sherrette A. Funn, email:
<a href="/cdn-cgi/l/email-protection#6d3e05081f1f08191908432b1803032d05051e430a021b"><span class="__cf_email__" data-cfemail="07546f627575627373622941726969476f6f7429606871">[email protected]</span></a>, <a href="/cdn-cgi/l/email-protection#30606271707878631e777f66"><span class="__cf_email__" data-cfemail="50000211101818037e171f06">[email protected]</span></a> or call (202) 264-0041 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: For HHS/OASH Consultation Process,
Institutional Review Board (IRB) Records.
Type of Collection: Renewal, 3-year extension without change.
OMB No.: 0990-0481
Abstract: The Office of the Assistant Secretary for Health (OASH),
Office for Human Research Protections (OHRP) is requesting a 3-year
extension without change to the currently approved information
collection request, For OASH/HHS Consultation Process, Institutional
Review Board (IRB) Records, OMB No. 0990-0481. The purpose of the
collection is for OHRP to receive IRB records when an IRB or an
institution requests an HHS consultation process for proposed research
that is not otherwise approvable by an IRB involving, respectively: (1)
pregnant women, human fetuses and neonates; (2) prisoners; or, (3)
children, as subjects. The information that must be submitted to OHRP
by an IRB or institution includes the research protocol, consent form,
parental permission and child assent forms (if relevant), and other
relevant IRB records (e.g., IRB minutes). 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 meeting other procedural requirements.
Likely Respondents: IRBs.
Annualized Burden Hour Table
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Average
45 CFR part 46--HHS Number of Number of burden per Total burden
consultation process Respondent type respondents respondents response (in hours
provision hours)
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subpart B, Sec. 46. 207... IRBs.............. 3 1 1 3
subpart C, Sec. 46.306 IRBs.............. 3 1 1 3
(iii) and (iv).
subpart D, Sec. 46.407.... IRBs.............. 4 1 1 4
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Total................... .................. .............. .............. .............. 10
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Vivianna P. Cowl,
Paperwork Reduction Act Reports Clearance Officer, Health and Human
Services, Office of the Secretary.
[FR Doc. 2024-31615 Filed 1-3-25; 8:45 am]
BILLING CODE 4150-31-P
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