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 Cellular, Tissue, and Gene Therapies Advisory Committee, 4316-4317 [2024-01154]
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4316
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
State Enforcement Notifications—21
CFR 100.2(d)
OMB Control Number 0275—Extension
This information collection supports
Agency regulations. Specifically, section
310(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
337(b)) authorizes a State to enforce
certain sections of the FD&C Act in their
own name and within their own
jurisdiction. However, before doing so,
a State must provide notice to FDA
according to § 100.2 (21 CFR 100.2). The
information required in a letter of
notification under § 100.2(d) enables us
to identify the food against which a
State intends to take action and to
advise that State whether Federal
enforcement action against the food has
been taken or is in process. With certain
narrow exceptions, Federal enforcement
action precludes State action under the
FD&C Act.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.2(d); notification ............................................................
1
1
1
10
10
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
The estimated reporting burden for
§ 100.2(d) is minimal because
enforcement notifications are seldom
used by States. During the last 3 years,
we have not received any new
enforcement notifications; therefore, we
estimate that one or fewer notifications
will be submitted annually. Although
we have not received any new
enforcement notifications in the last 3
years, these information collection
provisions should be extended to
provide for the potential future need of
a State government to submit
enforcement notifications informing us
when it intends to take enforcement
action under the FD&C Act against a
particular food located in the State.
Dated: January 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01238 Filed 1–22–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–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 Cellular,
Tissue, and Gene Therapies 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 a nonvoting industry
representative to serve on the Cellular,
Tissue, and Gene Therapies Advisory
Committee (CTGTAC) 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 CTGTAC. 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
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
must send a letter stating that interest to
FDA by February 22, 2024 (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by February 22,
2024.
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
Cicely Reese or Marie DeGregorio (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/FACTRS
Portal/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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Cicely Reese or Marie DeGregorio,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 1232, Silver Spring,
MD 20993–0002, 240–620–9987, email:
CBERCTGTAC@fda.hhs.gov.
The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23JAN1.SGM
23JAN1
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
I. Cellular, Tissue, and Gene Therapies
Advisory Committee
The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies, and
xenotransplantation products, which are
intended for transplantation,
implantation, infusion, and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair, or replacement of
tissues for various conditions. 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.
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
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
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III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nomination
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
VerDate Sep<11>2014
17:41 Jan 22, 2024
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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: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01154 Filed 1–22–24; 8:45 am]
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FDA is
announcing the approval of a product
redeeming a rare pediatric disease
priority review voucher. Under section
529 of the FD&C Act (21 U.S.C. 360ff),
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that VEOZAH
(fezolinetant) meets the redemption
criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about VEOZAH (fezolinetant), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01163 Filed 1–22–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) authorizes FDA to
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA is required to
publish notice of the issuance of priority
review vouchers as well as the approval
of products redeeming a priority review
voucher. FDA has determined that
VEOZAH (fezolinetant), approved May
12, 2023, meets the criteria for
redeeming a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; The National Health Service
Corps Loan Repayment Programs
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 25, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
SUMMARY:
E:\FR\FM\23JAN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4316-4317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01154]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-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 Cellular, Tissue, and Gene Therapies 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 a nonvoting industry representative to serve on the
Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) 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 CTGTAC. 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 February
22, 2024 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by February 22, 2024.
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 Cicely
Reese or Marie DeGregorio (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: Cicely Reese or Marie DeGregorio,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1232, Silver
Spring, MD 20993-0002, 240-620-9987, email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
[[Page 4317]]
I. Cellular, Tissue, and Gene Therapies Advisory Committee
The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies, and xenotransplantation products,
which are intended for transplantation, implantation, infusion, and
transfer in the prevention and treatment of a broad spectrum of human
diseases and in the reconstruction, repair, or replacement of tissues
for various conditions. 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.
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
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. Nomination 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: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01154 Filed 1-22-24; 8:45 am]
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