Patient Engagement Advisory Committee; Notice of Meeting, 31767-31768 [2023-10609]
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Federal Register / Vol. 88, No. 96 / Thursday, May 18, 2023 / Notices
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Rosemary Addy, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6430,
Silver Spring, MD 20993–0002, 301–
796–2200, pedsdrugs@fda.hhs.gov; or
Diane Maloney, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pediatric Drug Development Under the
Pediatric Research Equity Act and the
Best Pharmaceuticals for Children Act:
Scientific Considerations.’’ This draft
guidance addresses selected clinical,
scientific, and ethical issues involved in
developing drugs for pediatric use when
such drugs are subject to PREA and/or
the BPCA. This draft guidance, along
with the draft guidance entitled
‘‘Pediatric Drug Development:
Regulatory Considerations—Complying
With the Pediatric Research Equity Act
and Qualifying for Pediatric Exclusivity
Under the Best Pharmaceuticals for
Children Act,’’ revises and replaces the
draft guidance entitled ‘‘How to Comply
with the Pediatric Research Equity
Act.’’ 1 This draft guidance also
addresses certain additional topics that
FDA has not previously addressed in
guidance.
The purpose of this draft guidance is
to assist industry in obtaining the data
and information needed to support
approval of drug products in pediatric
populations. Specifically, this draft
guidance describes considerations
regarding data in pediatric patients with
particular discussion regarding
formulation development, nonclinical
information, clinical pharmacology, and
safety information. Additionally, the
draft guidance discusses pediatric
extrapolation, timing of pediatric
studies, and drug development for the
neonatal population. This draft
guidance does not address the clinical
development of drugs that are not
subject to either PREA or the BPCA.
This draft guidance is being issued
consistent with FDA’s good guidance
II. The Paperwork Reduction Act of
1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR parts 50 and 56
for protection of human subjects and
institutional review boards, have been
approved under OMB control number
0910–0130. The collections of
information in 21 CFR 210 and 211 for
current good manufacturing practice
have been approved under OMB control
number 0910–0139. The collections of
information in 21 CFR part 312 for
investigational new drug applications
and 21 CFR part 314 for new drug
applications and abbreviated new drug
applications have been approved under
OMB control numbers 0910–0014 and
0910–0001, respectively. The
collections of information in 21 CFR
parts 601 and 610 for biologics license
applications have been approved under
OMB control number 0910–0338. The
collections of information in 42 U.S.C.
262(k) and 21 U.S.C. 379g for biosimilar
applications have been approved under
OMB control number 0910–0718. The
collections of information in 21 CFR
201.56 and 201.57 regarding labeling
requirements for prescription drugs
have been approved under OMB control
number 0910–0572. The collections of
information in 21 CFR part 201, subpart
C regarding over-the-counter products
have been approved under OMB control
number 0910–0340. The collections of
information in 21 CFR part 316
regarding orphan drug product
development are approved under OMB
control number 0910–0167.
1 This draft guidance also addresses certain topics
previously addressed in the guidance for industry
entitled ‘‘Qualifying for Pediatric Exclusivity Under
Section 505A of the Federal Food, Drug, and
Cosmetic Act.’’ That guidance was withdrawn
August 7, 2013 (78 FR 48175).
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
I. Background
lotter on DSK11XQN23PROD with NOTICES1
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Pediatric Drug Development Under
the Pediatric Research Equity Act and
the Best Pharmaceuticals for Children
Act: Scientific Considerations.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
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19:05 May 17, 2023
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31767
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10611 Filed 5–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Patient Engagement Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Center for Devices and Radiological
Health (CDRH) Patient Engagement
Advisory Committee (the Committee).
The general function of the committee is
to provide 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. The
meeting will be open to the public.
DATES: The meeting will take place
virtually on September 6, 2023, from 10
a.m. to 5:20 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. Information on how to
access the webcast will be made
available no later than 2 business days
prior to the meeting at https://
www.fda.gov/advisory-committees/
committees-and-meeting-materials/
patient-engagement-advisorycommittee. Select the link for the 2023
Meeting Materials.
FOR FURTHER INFORMATION CONTACT:
Letise Williams, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5407, Silver Spring,
SUMMARY:
E:\FR\FM\18MYN1.SGM
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31768
Federal Register / Vol. 88, No. 96 / Thursday, May 18, 2023 / Notices
MD 20993–0002, letise.williams@
fda.hhs.gov, 301–796–8398, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/advisory-committees and
scroll down to the appropriate advisory
committee meeting link or call the
advisory committee information line to
learn about possible modifications
before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On
September 6, 2023, the Committee will
discuss and make recommendations on
the topic of ‘‘Advancing Health Equity
in Medical Devices.’’ FDA CDRH is
committed to working toward ensuring
that all patients have access to highquality, safe, and effective medical
devices. This includes ensuring devices
are designed to be safe and effective
when used by various populations, are
evaluated in the diverse populations for
which they are intended, and that
patients and consumers have the
information they need to make
decisions about their health, care and
quality of life. Technology, including
digital health technology, may help
bridge gaps in health equity by
extending access and bringing
healthcare to patients at home, at work,
and in their communities. The
recommendations provided by the
committee will address considerations
for FDA and industry on these topics.
The Committee will consider ways to
advance access to devices that allow for
care outside a hospital or clinical care
setting—for example, in the home
setting. The Committee will also discuss
considerations for improving reach and
comprehension of FDA’s patient and
caregiver communications across
diverse demographic groups.
Additionally, the Committee will
discuss patient-focused considerations
for when a device should be evaluated
in diverse populations to support
marketing authorization.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
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Jkt 259001
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
materials and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
advisory-committees/committees-andmeeting-materials/patient-engagementadvisory-committee. Select the link for
the 2023 Meeting Materials. The
meeting will include slide presentations
with audio components to allow the
presentation of materials in a manner
that most closely resembles an in-person
advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person (see FOR FURTHER INFORMATION
CONTACT) on or before August 10, 2023.
Oral presentations from the public will
be scheduled on September 6, 2023,
between approximately 2:15 p.m. to
3:15 p.m. Eastern Time. Those
individuals interested in making formal
oral presentations should notify the
contact person on or before August 2,
2023. The notification should include a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Time allotted for each presentation may
be limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
August 3, 2023.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov, or 240–507–6496 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/advisorycommittees/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings for procedures on
public conduct during advisory
committee meetings.
PO 00000
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10609 Filed 5–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold an inperson meeting. The meeting will be
open to the public and public comment
will be heard during the meeting.
DATES: The meeting will be held June
15–16, 2023. The confirmed meeting
times and agenda will be posted on the
NVAC website at https://www.hhs.gov/
nvpo/nvac/meetings/ as soon
as they become available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
online at: https://www.hhs.gov/nvpo/
nvac/meetings/ at least one
week prior to the meeting. Preregistration is required for those who
wish to attend the meeting virtually or
participate in public comment. Please
register at https://www.hhs.gov/nvpo/
nvac/meetings/.
FOR FURTHER INFORMATION CONTACT: Ann
Aikin, Acting Designated Federal
Officer, Office of Infectious Disease and
HIV/AIDS Policy, U.S. Department of
Health and Human Services, Tower
Building, Room, 1101 Wootton
Parkway, Rockville, MD 20852. Email:
nvac@hhs.gov. Phone: 202–795–7697.
SUPPLEMENTARY INFORMATION: Pursuant
to section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of HHS was mandated to
establish the National Vaccine Program
to achieve optimal prevention of human
infectious diseases through
immunization and to achieve optimal
prevention against adverse reactions to
vaccines. The NVAC was established to
provide advice and make
recommendations to the Director of the
SUMMARY:
E:\FR\FM\18MYN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31767-31768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Patient Engagement Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) announces
a forthcoming public advisory committee meeting of the Center for
Devices and Radiological Health (CDRH) Patient Engagement Advisory
Committee (the Committee). The general function of the committee is to
provide 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. The meeting will be open to the
public.
DATES: The meeting will take place virtually on September 6, 2023, from
10 a.m. to 5:20 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. Information on how to access the
webcast will be made available no later than 2 business days prior to
the meeting at https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. Select the
link for the 2023 Meeting Materials.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring,
[[Page 31768]]
MD 20993-0002, [email protected], 301-796-8398, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area). A notice in the Federal Register about last-
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's website
at https://www.fda.gov/advisory-committees and scroll down to the
appropriate advisory committee meeting link or call the advisory
committee information line to learn about possible modifications before
the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On September
6, 2023, the Committee will discuss and make recommendations on the
topic of ``Advancing Health Equity in Medical Devices.'' FDA CDRH is
committed to working toward ensuring that all patients have access to
high-quality, safe, and effective medical devices. This includes
ensuring devices are designed to be safe and effective when used by
various populations, are evaluated in the diverse populations for which
they are intended, and that patients and consumers have the information
they need to make decisions about their health, care and quality of
life. Technology, including digital health technology, may help bridge
gaps in health equity by extending access and bringing healthcare to
patients at home, at work, and in their communities. The
recommendations provided by the committee will address considerations
for FDA and industry on these topics. The Committee will consider ways
to advance access to devices that allow for care outside a hospital or
clinical care setting--for example, in the home setting. The Committee
will also discuss considerations for improving reach and comprehension
of FDA's patient and caregiver communications across diverse
demographic groups. Additionally, the Committee will discuss patient-
focused considerations for when a device should be evaluated in diverse
populations to support marketing authorization.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background materials
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. Select the
link for the 2023 Meeting Materials. The meeting will include slide
presentations with audio components to allow the presentation of
materials in a manner that most closely resembles an in-person advisory
committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person (see FOR FURTHER
INFORMATION CONTACT) on or before August 10, 2023. Oral presentations
from the public will be scheduled on September 6, 2023, between
approximately 2:15 p.m. to 3:15 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person on or before August 2, 2023. The notification should
include a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August 3,
2023.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at [email protected], or 240-507-
6496 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10609 Filed 5-17-23; 8:45 am]
BILLING CODE 4164-01-P
