Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes, 51432-51433 [2022-18065]
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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.
VerDate Sep<11>2014
19:27 Aug 19, 2022
Jkt 256001
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
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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
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51433
Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
Industry and Food and Drug
Administration Staff; Center for Devices
and Radiological Health (CDRH)
Appeals Processes’’ (July 2019), there
are various processes by which appeals
requests regarding review of decisions
or actions by CDRH may be submitted
to the Agency. The guidance is available
for download from our website at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/center-devices-andradiological-health-cdrh-appealsprocesses. The guidance document
provides general format and content
recommendations in this regard,
discusses applicable regulations with
regard to the timing of such
submissions, and describes the
collection of information not expressly
specified under existing regulations
such as the submission of the request for
review, minor clarifications as part of
the request, and supporting information.
While CDRH already possesses in the
administrative file the information that
would form the basis of a decision on
a matter under appeal, the submission
of information as recommended in the
guidance regarding the appeal request
itself, as well as data and information
relied on by the requestor in the appeal,
will help facilitate timely resolution of
the decision under review. We are
accounting for burden respondents may
incur as a result of these Agency
recommendations in this collection
request. Additional information about
the CDRH appeals process is described
in the companion guidance entitled
‘‘Center for Devices and Radiological
Health (CDRH) Appeals Processes:
Questions and Answers About 517A—
Guidance for Industry and Food and
Drug Administration Staff’’ (March
2020), also available for download from
our website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/center-devicesand-radiological-health-cdrh-appealsprocesses-questions-and-answers-about517a.
In the Federal Register of February
18, 2022 (87 FR 9365) we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
CDRH Appeals Processes: Guidance for Industry and
FDA Staff
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Recommended format and content elements .....................
35
1
35
8
280
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate 35 requests will be
submitted annually to review decisions
and actions by CDRH employees, we
attribute one respondent per
submission, and we assume each
request will take 8 hours to prepare.
Based on our evaluation of the
information collection since last OMB
approval, we have made no adjustments
to the currently approved burden
estimate.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18065 Filed 8–19–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
jspears on DSK121TN23PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice; Quality
System Regulation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
18:17 Aug 19, 2022
Jkt 256001
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on recordkeeping
requirements related to the medical
devices current good manufacturing
practice (CGMP) quality system (QS)
regulation (CGMP/QS regulation).
DATES: Either electronic or written
comments on the collection of
information must be submitted by
October 21, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 21, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
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Fmt 4703
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Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
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]]>Agencies
[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51432-51433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18065]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0893]
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.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Submit written comments (including recommendations) on the
collection of information by September 21, 2022.
ADDRESSES: 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 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,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
[[Page 51433]]
Industry and Food and Drug Administration Staff; Center for Devices and
Radiological Health (CDRH) Appeals Processes'' (July 2019), there are
various processes by which appeals requests regarding review of
decisions or actions by CDRH may be submitted to the Agency. The
guidance is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes. The
guidance document provides general format and content recommendations
in this regard, discusses applicable regulations with regard to the
timing of such submissions, and describes the collection of information
not expressly specified under existing regulations such as the
submission of the request for review, minor clarifications as part of
the request, and supporting information. While CDRH already possesses
in the administrative file the information that would form the basis of
a decision on a matter under appeal, the submission of information as
recommended in the guidance regarding the appeal request itself, as
well as data and information relied on by the requestor in the appeal,
will help facilitate timely resolution of the decision under review. We
are accounting for burden respondents may incur as a result of these
Agency recommendations in this collection request. Additional
information about the CDRH appeals process is described in the
companion guidance entitled ``Center for Devices and Radiological
Health (CDRH) Appeals Processes: Questions and Answers About 517A--
Guidance for Industry and Food and Drug Administration Staff'' (March
2020), also available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes-
questions-and-answers-about-517a.
In the Federal Register of February 18, 2022 (87 FR 9365) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
CDRH Appeals Processes: Guidance for Industry and FDA Staff Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended format and content elements............................ 35 1 35 8 280
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate 35 requests will be submitted annually to review
decisions and actions by CDRH employees, we attribute one respondent
per submission, and we assume each request will take 8 hours to
prepare. Based on our evaluation of the information collection since
last OMB approval, we have made no adjustments to the currently
approved burden estimate.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18065 Filed 8-19-22; 8:45 am]
BILLING CODE 4164-01-P
