Notice2024-21571
Agency Forms Undergoing Paperwork Reduction Act Review
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
September 20, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 183 (Friday, September 20, 2024)</title>
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[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Notices]
[Pages 77159-77160]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21571]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-24AH]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Institutional Review Board Authorization
Agreement for Human Research'' to the Office of Management and Budget
(OMB) for review and approval. CDC previously published a ``Proposed
Data Collection Submitted for Public Comment and Recommendations''
notice on October 30, 2023, to obtain comments from the public and
affected agencies. CDC received one comment related to the previous
notice. This notice serves to allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. 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. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
[[Page 77160]]
Proposed Project
Institutional Review Board Authorization Agreement for Human
Research--New--Office of Science (OS), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC Human Research Protection Office (HRPO) often receives
requests from outside institutions seeking to rely on the CDC
Institutional Review Board (IRB) for review of a research study. This
arrangement also allows multiple institutions to use, or rely on, the
CDC IRB for centralized review and approval of research studies instead
of review by the site-specific IRBs, which helps reduce duplication of
effort, delays, and expenses. To meet regulatory requirements,
institutions that elect to rely on the CDC IRB are required to complete
a CDC IRB Authorization Agreement for Human Research and a Local
Context Survey. The goal is to use the agreement and survey to provide
regulatory oversight for human subjects research, to maintain records,
and to track those institutions that have elected to rely on the CDC
IRB for review.
CDC requests OMB approval for an estimated 450 annual burden hours.
There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
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Number Avg. burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hrs.)
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Hospital/Academic Institutions/IRB CDC IRB Authorization 150 1 1
Administrators. Agreement for Human
Research (for review,
completion, and
submission to CDC).
Hospital/Academic Institutions/IRB Local context survey 150 1 2
Administrators. (for completion and
submission to CDC).
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-21571 Filed 9-19-24; 8:45 am]
BILLING CODE 4163-18-P
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