Notice2023-23858
Proposed Data Collection Submitted for Public Comment and Recommendations
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
October 30, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 208 (Monday, October 30, 2023)</title>
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[Federal Register Volume 88, Number 208 (Monday, October 30, 2023)]
[Notices]
[Pages 74192-74193]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#e7888a85a7848384c9808891"><span class="__cf_email__" data-cfemail="3b5456597b585f58155c544d">[email protected]</span></a>.
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.
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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
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