Request for Nominations of a Nonvoting Representative of the Interest of the Tobacco Manufacturing Industry on the Tobacco Products Scientific Advisory Committee, 62379-62380 [2023-19499]
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Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices
II. Paperwork Reduction Act of 1995
ddrumheller on DSK120RN23PROD with NOTICES1
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20903, daphne.guinn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Clinical Pharmacology Considerations
for Peptide Drug Products.’’ This draft
guidance, when finalized, will represent
FDA’s current thinking on the conduct
of certain clinical pharmacology studies
during the development of peptide drug
products.
The term ‘‘peptide’’ refers to any
polymer composed of 40 or fewer amino
acids. In general, if a peptide meets the
definition of a drug and does not
otherwise meet the statutory definition
of a ‘‘biological product’’ or a ‘‘device,’’
it would be regulated as a drug under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and be subject to all the
‘‘drug’’ requirements under the FD&C
Act and FDA’s regulations, including
the requirement that new drugs must be
approved under section 505(c) of the
FD&C Act before they can be marketed
in interstate commerce. However,
peptide drug products can have product
characteristics that may be similar, in
certain respects, to biological products,
and as such, there are other FDA
guidances on biological products that
discuss scientific principles that could
also be applicable to peptide drug
products.
The ‘‘Clinical Pharmacology
Considerations for Peptide Drug
Products’’ draft guidance, when
finalized, will provide
recommendations to assist industry in
the development of peptide drug
products. Specifically, this guidance
describes FDA’s recommendations
regarding clinical pharmacology
considerations for peptide drug product
development programs, including organ
impairment, DDIs, assessing QTc
prolongation risk, and immunogenicity
risk and impact on PK, safety, and
efficacy assessment. This guidance
provides recommendations on when
these assessments may be appropriate.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This draft guidance, when finalized,
will represent the current thinking of
FDA on ‘‘Clinical Pharmacology
Considerations for Peptide Drug
Products.’’ 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.
VerDate Sep<11>2014
17:10 Sep 08, 2023
Jkt 259001
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by OMB under the PRA. The
collections of information in 21 CFR
part 312 have been approved under
OMB Control No. 0910–0014. The
collections of information in 21 CFR
part 314 have been approved under
OMB Control No. 0910–0001. The
collections of information in 21 CFR
part 201 have been approved under
OMB Control No. 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19456 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–3681]
Request for Nominations of a
Nonvoting Representative of the
Interest of the Tobacco Manufacturing
Industry on the Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for a nonvoting
representative of the interests of the
tobacco manufacturing industry to serve
on the Tobacco Products Scientific
Advisory Committee (TPSAC), in the
Center for Tobacco Products. 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. A
nominee may either be self-nominated
or nominated by an organization. In
addition, FDA is requesting that any
industry organizations interested in
SUMMARY:
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62379
participating in the selection of a
nonvoting representative of the interests
of the tobacco manufacturing industry
to serve on the TPSAC, notify FDA in
writing. Nominations will be accepted
for either the representative to serve on
TPSAC or for the selection group
effective with this notice.
DATES: Nomination materials for
prospective candidates should be sent to
FDA by October 11, 2023. Concurrently,
any industry organization interested in
participating in the selection of an
appropriate nonvoting member to
represent the interests of the tobacco
manufacturing industry must send a
letter stating that interest to FDA by
October 11, 2023 (see sections I and II
of this document for further details).
ADDRESSES: All nominations for
nonvoting representatives of the
interests of the tobacco manufacturing
industry may be submitted
electronically by accessing the FDA
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
All statements of interest from
industry organizations interested in
participating in the selection process of
nonvoting representatives of the
interests of the tobacco manufacturing
industry nomination should be sent to
Serina Hunter-Thomas (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products,
Food and Drug Administration,
Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993–0002, 1–877–
287–1373 (choose Option 5), email:
TPSAC@fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for a nonvoting
representative of the interests of the
tobacco manufacturing industry on the
TPSAC.
I. General Description of the Committee
Duties
The TPSAC advises the Commissioner
of Food and Drugs (the Commissioner)
or designee in discharging
responsibilities related to the regulation
of tobacco products. The TPSAC
reviews and evaluates safety,
dependence, or health issues relating to
tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
E:\FR\FM\11SEN1.SGM
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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
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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
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]]>Agencies
[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62379-62380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19499]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3681]
Request for Nominations of a Nonvoting Representative of the
Interest of the Tobacco Manufacturing Industry on the Tobacco Products
Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for a nonvoting representative of the interests of the
tobacco manufacturing industry to serve on the Tobacco Products
Scientific Advisory Committee (TPSAC), in the Center for Tobacco
Products. 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. A
nominee may either be self-nominated or nominated by an organization.
In addition, FDA is requesting that any industry organizations
interested in participating in the selection of a nonvoting
representative of the interests of the tobacco manufacturing industry
to serve on the TPSAC, notify FDA in writing. Nominations will be
accepted for either the representative to serve on TPSAC or for the
selection group effective with this notice.
DATES: Nomination materials for prospective candidates should be sent
to FDA by October 11, 2023. Concurrently, any industry organization
interested in participating in the selection of an appropriate
nonvoting member to represent the interests of the tobacco
manufacturing industry must send a letter stating that interest to FDA
by October 11, 2023 (see sections I and II of this document for further
details).
ADDRESSES: All nominations for nonvoting representatives of the
interests of the tobacco manufacturing industry may be submitted
electronically by accessing the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm.
All statements of interest from industry organizations interested
in participating in the selection process of nonvoting representatives
of the interests of the tobacco manufacturing industry nomination
should be sent to Serina Hunter-Thomas (see FOR FURTHER INFORMATION
CONTACT).
FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products, Food and Drug Administration,
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993-0002, 1-877-287-1373 (choose Option 5), email:
[email protected].
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.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a
nonvoting representative of the interests of the tobacco manufacturing
industry on the TPSAC.
I. General Description of the Committee Duties
The TPSAC advises the Commissioner of Food and Drugs (the
Commissioner) or designee in discharging responsibilities related to
the regulation of tobacco products. The TPSAC reviews and evaluates
safety, dependence, or health issues relating to tobacco products and
provides appropriate advice, information, and recommendations to the
Commissioner.
[[Page 62380]]
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 r[eacute]sum[eacute] 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 self-nominated. 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.)
III. Selection Procedure
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 r[eacute]sum[eacute]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.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and part 14, relating to advisory committees.
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
