Advisory Committee; Patient Engagement Advisory Committee; Renewal, 75290-75291 [2023-24212]
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Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices
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Mary Jones,
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[FR Doc. 2023–24185 Filed 11–1–23; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2809]
Advisory Committee; Patient
Engagement Advisory Committee;
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the Patient
Engagement Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Patient
Engagement Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the October 6, 2025,
expiration date.
DATES: Authority for the Patient
Engagement Advisory Committee would
have expired on October 6, 2025, unless
the Commissioner had formally
determined that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Letise Williams, Office of the Center
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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16:32 Nov 01, 2023
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Director, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5407, Silver Spring,
MD 20993–0002, 301–796–8398,
Letise.Williams@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Patient Engagement
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Patient Engagement Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective devices for human use
and, as required, any other product for
which FDA has regulatory
responsibility.
The Committee provides advice to the
Commissioner of Food and Drugs or
designee on complex scientific, issues
relating to medical devices, the
regulation of devices, and their use by
patients. Agency guidance and policies,
clinical trial or registry design, patient
preference study design, benefit-risk
determinations, device labeling, unmet
clinical needs, available alternatives,
patient reported outcomes, and devicerelated quality of life measures or health
status issues are among the topics that
may be considered by the Committee.
The Committee provides relevant skills
and perspectives to improve
communication of benefits, risks, and
clinical outcomes, and increase
integration of patient perspectives into
the regulatory process for medical
devices. It performs its duties by
identifying new approaches, promoting
innovation, recognizing unforeseen risks
or barriers, and identifying unintended
consequences that could result from
FDA policy.
Pursuant to its Charter, the Committee
shall consist of a core of nine voting
members, including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities who are knowledgeable in
areas such as clinical research, patient
experience, and healthcare needs of
patient groups in the United States, or
who are experienced in the work of
patient and health professional
organizations, methodologies for patient
reported outcomes and eliciting patient
preferences, and strategies for
communicating benefits, risks, and
clinical outcomes to patients and
research subjects, as well as other
relevant areas. Members will be invited
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to serve for overlapping terms of up to
4 years. Non-Federal members of this
committee will serve as either as Special
Government Employees or non-voting
representatives. Federal members will
serve as Regular Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who serves as an
individual, but who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. The Commissioner
or designee shall also have the authority
to select from a group of individuals
nominated by industry to serve
temporarily as nonvoting members who
are identified with industry interests.
The number of temporary members
selected for a particular meeting will
depend on the meeting topic.
The Commissioner or designee shall
also have the authority to select
members of other scientific and
technical FDA advisory committees
(normally not to exceed 10 members) to
serve temporarily as voting members
and to designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members); or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
committees-and-meeting-materials/
patient-engagement-advisory-committee
or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
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Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: October 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–24212 Filed 11–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4595]
Enforcement Policy for Certain
Supplements for Approved Premarket
Approval or Humanitarian Device
Exemption Submissions; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the final
guidance entitled ‘‘Enforcement Policy
for Certain Supplements for Approved
Premarket Approval (PMA) or
Humanitarian Device Exemption (HDE)
Submissions.’’ This guidance outlines
FDA’s policies and regulatory review
expectations after the COVID–19 public
health emergency (PHE) for certain
limited modifications affecting the
safety and effectiveness of a device
required to have an approved PMA or
the safety and probable benefit of a
device required to have an approved
HDE. This guidance has been
implemented without prior comment,
but it remains subject to comment in
accordance with the Agency’s good
guidance practices.
DATES: The announcement of the
guidance is published in the Federal
Register on November 2, 2023.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Electronic Submissions
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,
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16:32 Nov 01, 2023
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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
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–D–4595 for ‘‘Enforcement Policy
for Certain Supplements for Approved
Premarket Approval (PMA) or
Humanitarian Device Exemption (HDE)
Submissions.’’ Received comments 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.’’ The
Agency 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 to be made publicly
available, you can provide this
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75291
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Enforcement Policy
for Certain Supplements for Approved
Premarket Approval (PMA) or
Humanitarian Device Exemption (HDE)
Submissions’’ to the Office of Policy,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002 or to the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT:
Jhumur Banik, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2448, Silver Spring,
MD 20993–0002, 240–402–5239 or
Anne Taylor, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02NON1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75290-75291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24212]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2809]
Advisory Committee; Patient Engagement Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Patient Engagement Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the Patient
Engagement Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
October 6, 2025, expiration date.
DATES: Authority for the Patient Engagement Advisory Committee would
have expired on October 6, 2025, unless the Commissioner had formally
determined that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Office of the Center
Director, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver
Spring, MD 20993-0002, 301-796-8398, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Patient Engagement
Advisory Committee (the Committee). The Committee is a discretionary
Federal advisory committee established to provide advice to the
Commissioner. The Patient Engagement Advisory Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective devices for human use and, as
required, any other product for which FDA has regulatory
responsibility.
The Committee provides advice to the Commissioner of Food and Drugs
or designee on complex scientific, issues relating to medical devices,
the regulation of devices, and their use by patients. Agency guidance
and policies, clinical trial or registry design, patient preference
study design, benefit-risk determinations, device labeling, unmet
clinical needs, available alternatives, patient reported outcomes, and
device-related quality of life measures or health status issues are
among the topics that may be considered by the Committee. The Committee
provides relevant skills and perspectives to improve communication of
benefits, risks, and clinical outcomes, and increase integration of
patient perspectives into the regulatory process for medical devices.
It performs its duties by identifying new approaches, promoting
innovation, recognizing unforeseen risks or barriers, and identifying
unintended consequences that could result from FDA policy.
Pursuant to its Charter, the Committee shall consist of a core of
nine voting members, including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities who are
knowledgeable in areas such as clinical research, patient experience,
and healthcare needs of patient groups in the United States, or who are
experienced in the work of patient and health professional
organizations, methodologies for patient reported outcomes and
eliciting patient preferences, and strategies for communicating
benefits, risks, and clinical outcomes to patients and research
subjects, as well as other relevant areas. Members will be invited to
serve for overlapping terms of up to 4 years. Non-Federal members of
this committee will serve as either as Special Government Employees or
non-voting representatives. Federal members will serve as Regular
Government Employees. The core of voting members may include one
technically qualified member, selected by the Commissioner or designee,
who serves as an individual, but who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. The Commissioner or
designee shall also have the authority to select from a group of
individuals nominated by industry to serve temporarily as nonvoting
members who are identified with industry interests. The number of
temporary members selected for a particular meeting will depend on the
meeting topic.
The Commissioner or designee shall also have the authority to
select members of other scientific and technical FDA advisory
committees (normally not to exceed 10 members) to serve temporarily as
voting members and to designate consultants to serve temporarily as
voting members when: (1) expertise is required that is not available
among current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members); or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee
or by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees,
[[Page 75291]]
please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: October 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24212 Filed 11-1-23; 8:45 am]
BILLING CODE 4164-01-P
