Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products and Related Authorities, 44369-44370 [2023-14714]
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Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) demonstrate an
affiliation with and/or active
participation in consumer or
community-based organizations, (2) be
able to analyze technical data, (3)
understand research design, (4) discuss
benefits and risks, and (5) evaluate the
safety and efficacy of products under
review. The consumer representative
should be able to represent the
consumer perspective on issues and
actions before the advisory committee;
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 45 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or re´sume´.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
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IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations must include a
current, complete re´sume´ or curriculum
vitae for each nominee and a signed
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17:29 Jul 11, 2023
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copy of the Acknowledgement and
Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES), and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Nominations must also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms of up to 4
years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. After
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–14690 Filed 7–11–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1149]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Emergency Use
Authorization of Medical Products and
Related Authorities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
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44369
The Food and Drug
Administration (FDA, Agency, or we) 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 August 11,
2023.
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 0910–0595. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Emergency Use Authorization of
Medical Products and Related
Authorities
OMB Control Number 0910–0595—
Revision
This information collection helps
support FDA’s implementation of
sections 564, 564A, and 564B of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb–3, 360bbb–3a, and
360bbb–3b), which govern the
authorization of medical products for
use in emergencies. The statutes
authorize FDA to permit the
introduction into interstate commerce a
drug, device, or biological product
intended for use in an actual or
potential emergency. The purpose of
these provisions is to sustain and
strengthen national preparedness for
public health, military, and domestic
emergencies involving chemical,
biological, radiological, and nuclear
agents, including emerging infectious
disease threats.
We are revising the information
collection to discuss the guidance
document entitled, ‘‘Transition Plan for
Medical Devices Issued Emergency Use
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44370
Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices
Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID–19),’’
announced in the Federal Register of
March 27, 2023 (88 FR 18144). The
guidance document describes a phasedin approach intended to help avoid
disruption in device supply and help
facilitate compliance with applicable
legal requirements. The
recommendations discussed in the
guidance document result in the onetime collection of information intended
to ensure an orderly and transparent
transition from temporary policies
established during the COVID–19 public
health emergency to normal operations.
In the Federal Register of December
23, 2021 (86 FR 72978), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. However, upon further
review, we find the recommendations
discussed in the guidance document
apply to specific medical devices
already issued EUAs and characterize
the activity as non-standardized
followup designed to clarify responses
to approved collections of information,
i.e., plans for continued compliance
unique to that medical device issued an
EUA. We therefore believe the activity
constitutes the collection of nonidentical and/or followup information,
as defined under 5 CFR 1320.3. At the
same time, we expect some degree of
fluctuation in submissions under 21
CFR 814.20, as a result of
implementation of the medical device
transition plan. Information collection
associated with 21 CFR part 814 is
currently approved in OMB control
number 0910–0231.
Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–14714 Filed 7–11–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2023–N–2653]
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Nonprescription Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
SUMMARY:
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meeting of the Nonprescription Drugs
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
September 11, 2023, from 9 a.m. to 5:30
p.m. Eastern Time and September 12,
2023, from 9 a.m. to 2:30 p.m. Eastern
Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–2653.
Please note that late, untimely filed
comments will not be considered. The
docket will close on September 8, 2023.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 8, 2023.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
August 25, 2023, will be provided to the
Committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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
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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
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–2653 for ‘‘Nonprescription
Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information be made publicly
available, you can provide this
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]]>Agencies
[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44369-44370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14714]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1149]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Emergency Use
Authorization of Medical Products and Related Authorities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 August 11, 2023.
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 0910-0595. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Emergency Use Authorization of Medical Products and Related Authorities
OMB Control Number 0910-0595--Revision
This information collection helps support FDA's implementation of
sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b), which govern the
authorization of medical products for use in emergencies. The statutes
authorize FDA to permit the introduction into interstate commerce a
drug, device, or biological product intended for use in an actual or
potential emergency. The purpose of these provisions is to sustain and
strengthen national preparedness for public health, military, and
domestic emergencies involving chemical, biological, radiological, and
nuclear agents, including emerging infectious disease threats.
We are revising the information collection to discuss the guidance
document entitled, ``Transition Plan for Medical Devices Issued
Emergency Use
[[Page 44370]]
Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19),''
announced in the Federal Register of March 27, 2023 (88 FR 18144). The
guidance document describes a phased-in approach intended to help avoid
disruption in device supply and help facilitate compliance with
applicable legal requirements. The recommendations discussed in the
guidance document result in the one-time collection of information
intended to ensure an orderly and transparent transition from temporary
policies established during the COVID-19 public health emergency to
normal operations.
In the Federal Register of December 23, 2021 (86 FR 72978), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. However, upon further review, we find the
recommendations discussed in the guidance document apply to specific
medical devices already issued EUAs and characterize the activity as
non-standardized followup designed to clarify responses to approved
collections of information, i.e., plans for continued compliance unique
to that medical device issued an EUA. We therefore believe the activity
constitutes the collection of non-identical and/or followup
information, as defined under 5 CFR 1320.3. At the same time, we expect
some degree of fluctuation in submissions under 21 CFR 814.20, as a
result of implementation of the medical device transition plan.
Information collection associated with 21 CFR part 814 is currently
approved in OMB control number 0910-0231.
Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14714 Filed 7-11-23; 8:45 am]
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