Notice2022-17986
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
August 22, 2022
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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 161 (Monday, August 22, 2022)</title>
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[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51431-51432]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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: 404-639-7118;
Email: <a href="/cdn-cgi/l/email-protection#422d2f20022126216c252d34"><span class="__cf_email__" data-cfemail="9bf4f6f9dbf8fff8b5fcf4ed">[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
[[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.)
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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.
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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]
BILLING CODE 4163-18-P
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