[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51431-51432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day0-22-22HY; Docket No. CDC-2022-0099]


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 the opportunity 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, Centralized Institutional Review for the CDC Expanded Access 
Investigational New Drug (EA-IND) for Use of Tecovirimat 
(TPOXX[supreg]) for Treatment of Human Non-Variola Orthopoxvirus 
Infections. This proposed project is essential to CDC's Monkeypox 
emergency response and is designed to assist healthcare providers to 
provide tecovirimat (TPOXX) treatment to patients with monkeypox under 
the EA-IND.

DATES: CDC must receive written comments on or before October 21, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0099 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: 404-639-7118; 
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

[[Page 51432]]

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

    Centralized Institutional Review for the CDC Expanded Access 
Investigational New Drug (EA-IND) for Use of Tecovirimat 
(TPOXX[supreg]) for Treatment of Human Non-Variola Orthopoxvirus 
Infections--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 (also known as 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 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 tecovirimat (TPOXX) 
treatment to their patients with monkeypox under the EA-IND.
    CDC requests OMB approval for an estimated 13,333 annual burden 
hours. There is no cost to respondents other than their time to 
participate.

                                        Estimated Annualized Burden Hours
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                                                                      Number      Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Hospital/IRB Administrators...  CDC IRB                    5,000               1               1           5,000
                                 Authorization
                                 Agreement (for
                                 review).
Hospital/IRB Administrators...  CDC IRB                    5,000              10           10/60           8,333
                                 Authorization
                                 Agreement (for
                                 completion and
                                 submission to
                                 CDC.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          13,333
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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. 2022-17986 Filed 8-19-22; 8:45 am]
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