Proposed Data Collection Submitted for Public Comment and Recommendations, 51431-51432 [2022-17986]
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Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
improvements to enhance data
collection, analysis, access, and
reporting capabilities of the Center.
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Department of Health and Human
Services. Candidates may submit
references from current HHS employees
if they wish, but at least one reference
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18:17 Aug 19, 2022
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must be submitted by a person not
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Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2022–17991 Filed 8–19–22; 8:45 am]
BILLING CODE 4163–18–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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®) 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.
SUMMARY:
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
51431
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: omb@
cdc.gov.
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
ADDRESSES:
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22AUN1
51432
Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
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®) 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.
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 EAIND.
CDC requests OMB approval for an
estimated 13,333 annual burden hours.
There is no cost to respondents other
than their time to participate.
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.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hrs.)
Total burden
(in hrs.)
Form name
Hospital/IRB Administrators ..............
5,000
1
1
5,000
Hospital/IRB Administrators ..............
CDC IRB Authorization Agreement
(for review).
CDC IRB Authorization Agreement
(for completion and submission to
CDC.
5,000
10
10/60
8,333
Total ...........................................
...........................................................
........................
........................
........................
13,333
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
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Food and Drug Administration
Submit written comments
(including recommendations) on the
collection of information by September
21, 2022.
[Docket No. FDA–2011–D–0893]
ADDRESSES:
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jspears on DSK121TN23PROD with NOTICES
Number
responses per
respondent
Number of
respondents
Type of respondent
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Center for Devices
and Radiological Health Appeals
Processes
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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19:27 Aug 19, 2022
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0738. Also include
the FDA docket number found in
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–45, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Center for Devices and Radiological
Health Appeals Processes
OMB Control Number 0910–0738—
Extension
This information collection supports
implementation of recommendations
found in FDA guidance. As discussed in
the document entitled ‘‘Guidance for
E:\FR\FM\22AUN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
