[Federal Register Volume 88, Number 208 (Monday, October 30, 2023)]
[Notices]
[Pages 74192-74193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-24AH; Docket No. CDC-2023-0087]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of Government information, invites the general public and other 
Federal agencies to comment on a proposed information collection, as 
required by the Paperwork Reduction Act of 1995. This notice invites 
comment on a proposed information collection project titled IRB 
Authorization Agreement for Human Research. The purpose of the data 
collection is to keep track of, and provide regulatory oversight for, 
those institutions that have elected to rely on the CDC IRB's review of 
research studies.

DATES: CDC must receive written comments on or before December 29, 
2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0087 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) or by U.S. mail to the address listed 
above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    IRB 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's review of research studies are required to complete a CDC 
IRB Authorization Agreement for Human Research and a Local Context 
Survey. The agreement and the survey will be used to provide regulatory 
oversight for human subjects research, maintain records and 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    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
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Hospital/Academic Institutions/ CDC IRB                      150               1               1             150
 IRB Administrators.             Authorization
                                 Agreement for
                                 Human Research
                                 (for review,
                                 completion and
                                 submission to
                                 CDC).
Hospital/Academic Institutions/ Local context                150               1               2             300
 IRB Administrators.             survey (for
                                 completion and
                                 submission to
                                 CDC.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             450
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[[Page 74193]]

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. 2023-23858 Filed 10-27-23; 8:45 am]
BILLING CODE 4163-18-P