[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12362-12363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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.

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
----------------------------------------------------------------------------------------------------------------
                                                                                      Number        Avg. burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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