Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Vaccines and Related Biological Products Advisory Committee, 62380-62381 [2023-19496]
Download as PDF
<![CDATA[
62380
Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices
II. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
representative of the interests of the
tobacco manufacturing industry. Under
part 14 (21 CFR part 14), nominations
must include a current re´sume´ or
curriculum vitae for each nominee,
including current business address and/
or home address, telephone number,
and email address if available.
Nominations must also specify the
advisory committee for which the
nominee is recommended and must
acknowledge that the nominee is aware
of the nomination unless selfnominated. The nomination should be
sent to the FDA Advisory Committee
Membership Nomination Portal (see
ADDRESSES) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process. (Persons who
nominate themselves as nonvoting
industry representatives will not
participate in the selection process.)
ddrumheller on DSK120RN23PROD with NOTICES1
III. Selection Procedure
17:10 Sep 08, 2023
Dated: September 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19499 Filed 9–8–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Vaccines and
Related Biological Products Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of nonvoting industry
representatives to serve on the Vaccines
and Related Biological Products
Advisory Committee (VRBPAC) for the
Center for Biologics Evaluation and
Research notify FDA in writing. FDA is
also requesting nominations for a
nonvoting industry representative(s) to
serve on the VRBPAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by October 11, 2023 (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by October 11,
2023.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent via email to
Sussan Paydar (see FOR FURTHER
INFORMATION CONTACT). All nominations
SUMMARY:
The Agency is also seeking names of
organizations to participate in the
selection of the nonvoting
representative of the interests of the
tobacco manufacturing industry. Any
industry organization interested in
participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest in participating in
the selection group, attaching a
complete list of all organizations
participating in selection; and a list of
all non-voting nominees along with
their current re´sume´s. The letter will
also state that it is the responsibility of
the interested organizations on the
selection group to confer with one
another and to select a candidate and an
alternative as backup, within 60 days
after the receipt of the FDA letter, to
serve as the nonvoting member to
represent industry interests for the
TPSAC. The interested organizations are
not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
VerDate Sep<11>2014
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and part 14, relating
to advisory committees.
Jkt 259001
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
for nonvoting industry representatives
must be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal at:
https://www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website
at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Sussan Paydar or Valerie Vashio, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
1333, Silver Spring, MD 20993–0002,
202–657–8533, email: CBERVRBPAC@
fda.hhs.gov.
The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUPPLEMENTARY INFORMATION:
I. Vaccines and Related Biological
Products Advisory Committee
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
that are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and as required, any
other products for which the Food and
Drug Administration has regulatory
responsibility. The Committee also
considers the quality and relevance of
FDA’s research program which provides
scientific support for the regulation of
these products and makes appropriate
recommendations to the Commissioner
of Food and Drugs (the Commissioner).
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter via email stating that interest to
the FDA contact (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). Within the subsequent 30 days,
FDA will send a notification to each
organization that has expressed an
interest, attaching a complete list of all
such organizations and a list of all
nominees along with their current
re´sume´s. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
E:\FR\FM\11SEN1.SGM
11SEN1
Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals, to serve as a
nonvoting industry representative.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address and telephone number,
email address if available, and a signed
copy of the Acknowledgement and
Consent form available at the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). Nominations
must also specify the advisory
committee for which the nominee is
recommended. Nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14,
relating to advisory committees.
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19496 Filed 9–8–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2022–N–2396]
Chemistry, Manufacturing, and
Controls Development and Readiness
Pilot Program; Program
Announcement
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
year two opportunity for a limited
SUMMARY:
VerDate Sep<11>2014
17:10 Sep 08, 2023
Jkt 259001
number of applicants to participate in a
Chemistry, Manufacturing, and Controls
(CMC) Development and Readiness Pilot
(CDRP) program to facilitate the
expedited CMC development of
products under an investigational new
drug application (IND), where
warranted, based on the anticipated
clinical benefit of earlier patient access
to the products. FDA has implemented
this pilot program to facilitate CMC
readiness for selected Center for
Biologics Evaluation and Research
(CBER)- and Center for Drug Evaluation
and Research (CDER)-regulated products
with accelerated clinical development
timelines. To accelerate CMC
development and facilitate CMC
readiness, the pilot features increased
communication between FDA and
sponsors and explores the use of
science- and risk-based regulatory
approaches, such as those described in
FDA guidance, as applicable. This
notice outlines the eligibility criteria
and process for submitting a request to
participate in the pilot.
DATES: Starting October 2, 2023, FDA
will accept requests to participate in the
CDRP program. See the ‘‘Participation’’
section of this document for eligibility
criteria, instructions on how to submit
a request to participate, and selection
criteria and process.
FOR FURTHER INFORMATION CONTACT:
Tanya Clayton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4506,
Silver Spring, MD 20993–0002, 301–
796–0871; or Anne Taylor, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7256, Silver Spring, MD 20993–0002,
240–402–5683.
For general questions about the CDRP
Program for CBER: industry.biologics@
fda.hhs.gov.
For general questions about the CDRP
Program for CDER: cder-opq-opro-cradinquiries@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Development programs for CBER- and
CDER-regulated drugs and biologics
intended to diagnose, treat, or prevent a
serious disease or condition where there
is an unmet medical need may have
accelerated clinical development
timelines. Yet, marketing applications
for products in expedited development
programs still need to meet FDA’s
approval standards, including
manufacturing facility compliance with
current good manufacturing practice
(CGMP). Products with accelerated
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
62381
clinical development activities may face
challenges in expediting CMC
development activities to align with the
accelerated clinical timelines.
Successfully expediting CMC readiness
may require additional interactions with
FDA during product development and,
if applicable, warrant the use of scienceand risk-based regulatory approaches
allowing streamlining of CMC
development activities so that clinical
benefits of earlier patient access to these
products can be realized.
As described in the FDA Prescription
Drug User Fee Act (PDUFA) VII
Commitment Letter for fiscal years (FYs)
2023 Through 2027 (Ref. 1), FDA
implemented the CDRP program to
facilitate CMC readiness for selected
CBER- and CDER-regulated products
with accelerated clinical development
timelines in FY 2023. To accelerate
CMC development and facilitate CMC
readiness, the pilot features increased
communication between FDA and
sponsors and explores the use of
science- and risk-based regulatory
approaches, such as those described in
the FDA guidance for industry entitled
‘‘Expedited Programs for Serious
Conditions—Drugs and Biologics’’ (May
2014) (Ref. 2), as applicable.
FDA (CBER and CDER) is continuing
to conduct a CDRP to facilitate the CMC
development of selected products under
INDs that have expedited clinical
development timeframes, based on the
anticipated clinical benefits of earlier
patient access to the products. This
includes products with Breakthrough
Therapy (BT), Fast Track (FT), and
Regenerative Medicine Advance
Therapy (RMAT) designations. For
sponsors participating in the pilot, FDA
will provide product-specific CMC
advice during product development, to
include two additional CMC-focused
Type B meetings, as well as a limited
number of additional CMC-focused
discussions, based on readiness and
defined CMC milestones. The increased
communication between FDA review
staff and sponsors is intended to ensure
a mutual understanding of approaches
to completing CMC activities, including
what information should be provided at
the appropriate timepoint (i.e., at the
time of new drug application (NDA) or
biologics license application (BLA)
submission, prior to the end of the
review cycle, or post-approval) to
ensure CMC readiness for a marketing
application.
II. Participation
FDA will continuously accept
requests to participate in the CDRP
program. FDA will select no more than
nine proposals per fiscal year, with
E:\FR\FM\11SEN1.SGM
11SEN1
]]>Agencies
[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62380-62381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19496]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Vaccines and Related Biological Products
Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any industry organizations interested in participating in the
selection of nonvoting industry representatives to serve on the
Vaccines and Related Biological Products Advisory Committee (VRBPAC)
for the Center for Biologics Evaluation and Research notify FDA in
writing. FDA is also requesting nominations for a nonvoting industry
representative(s) to serve on the VRBPAC. A nominee may either be self-
nominated or nominated by an organization to serve as a nonvoting
industry representative. Nominations will be accepted for current
vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by October
11, 2023 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by October 11, 2023.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent via email to Sussan
Paydar (see FOR FURTHER INFORMATION CONTACT). All nominations for
nonvoting industry representatives must be submitted electronically by
accessing the FDA Advisory Committee Membership Nomination Portal at:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member of an FDA advisory committee can
also be obtained by visiting FDA's website at: https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Sussan Paydar or Valerie Vashio,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1333, Silver
Spring, MD 20993-0002, 202-657-8533, email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. Vaccines and Related Biological Products Advisory Committee
The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products that are intended for use in the prevention, treatment, or
diagnosis of human diseases, and as required, any other products for
which the Food and Drug Administration has regulatory responsibility.
The Committee also considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products and makes appropriate recommendations to the
Commissioner of Food and Drugs (the Commissioner).
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter via email stating that interest to the
FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). Within the subsequent 30
days, FDA will send a notification to each organization that has
expressed an interest, attaching a complete list of all such
organizations and a list of all nominees along with their current
r[eacute]sum[eacute]s. The letter will also state that it is the
responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for the committee. The interested organizations are not bound
by the list of nominees in selecting a candidate. However, if no
[[Page 62381]]
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self-nominate, and/or an organization may nominate
one or more individuals, to serve as a nonvoting industry
representative. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and telephone number, email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Committee Membership Nomination Portal
(see ADDRESSES) within 30 days of publication of this document (see
DATES). Nominations must also specify the advisory committee for which
the nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the committee. Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory
committees.
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19496 Filed 9-8-23; 8:45 am]
BILLING CODE 4164-01-P
