[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Notices]
[Pages 77159-77160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
                                                                                      Number        Avg. burden
          Type of respondent                   Form name            Number of     responses per    per response
                                                                   respondents      respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------


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]
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