Notice2023-03961
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
February 27, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 38 (Monday, February 27, 2023)</title>
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[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12362-12363]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03961]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-22HY]
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, ``Centralized Institutional Review for the
CDC Expanded Access Investigational New Device (EA-IND) for Use of
Tecovirimat (TPOXX[supreg]) for Treatment of Human Non-Variola
Orthopoxvirus Infections in Adults and Children (IND 116039/CDC
#6402),'' 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 August 22,
2022, to obtain comments from the public and affected agencies. CDC
received two comments 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.
Proposed Project
Centralized Institutional Review for the CDC Expanded Access
Investigational New Device (EA-IND) for ``Use of Tecovirimat
(TPOXX[supreg]) for Treatment of Human Non-Variola Orthopoxvirus
Infections in Adults and Children'' (IND 116039/CDC #6402)--New--Office
of Science (OS), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Monkeypox is a zoonosis, caused by the Orthopoxvirus (OPXV)
Monkeypox virus (MPXV), and is endemic to forested areas of West and
Central Africa. In humans, infection with MPXV can lead to a smallpox-
like illness with fatal outcomes in up to 11% of patients without prior
smallpox vaccination.
Since May 2022, clusters of monkeypox cases, have been reported in
19 countries that do not normally have monkeypox, and the number of
confirmed cases in the U.S. is rapidly increasing.
Tecovirimat (TPOXX) is FDA-approved for the treatment of human
smallpox disease caused by Variola virus in adults and children.
However, its use for other orthopoxvirus infections, including
monkeypox, is not approved by the FDA. CDC currently holds a non-
research expanded access Investigational New Drug (EA-IND) protocol
that allows for the use of tecovirimat for primary or early empiric
treatment of non-variola orthopoxvirus
[[Page 12363]]
infections, including monkeypox, in adults and children of all ages.
FDA regulations require that an Institutional Review Board (IRB)
review, approve and maintain oversight of the activities under the EA-
IND as set forth in 21 CFR parts 50, 56, and 312. The CDC IRB is
positioned to serve as the central IRB for review and approval of the
EA-IND consistent 21 CFR 56.114. This arrangement allows facilities to
use or rely on the CDC IRB for centralized review and approval for this
protocol in place of review by the site-specific IRB to help reduce
duplication of effort, delays, and increased expenses. Any facility
that receives tecovirimat for treatment of orthopoxvirus infection
under the EA-IND may elect to rely on the CDC IRB to meet FDA's
regulatory requirements.
The IRB review is required by FDA under the CDC's approved EA-IND.
Therefore, CDC must maintain records of which facilities have elected
to rely on the CDC IRB for centralized review and which facilities
elect to obtain IRB review on their own. CDC will use collected data to
track and document the institutions relying on the CDC IRB so they can
provide TPOXX treatment to their patients with monkeypox under the EA-
IND.
This collection was initially approved as an Emergency ICR in
August 2022 (OMB Control No. 0920-1366), and is being submitted here to
create a standard version of the collection. CDC requests OMB approval
for an estimated 1,333 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 hours)
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Hospital/IRB Administrators........... CDC IRB Authorization 500 1 1
Agreement (for review).
Hospital/IRB Administrators........... CDC IRB Authorization 500 10 10/60
Agreement (for
completion and
submission to CDC).
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2023-03961 Filed 2-24-23; 8:45 am]
BILLING CODE 4163-18-P
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