Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 16266 [2023-05364]
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
II. 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 part 312 relating
to investigational new drug applications
have been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 314 relating
to new drug applications have been
approved under OMB control number
0910–0001. The collections of
information in 21 CFR part 201 relating
to prescription product labeling
requirements have been approved under
OMB control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05396 Filed 3–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), 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
award of the priority review voucher.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:10 Mar 15, 2023
Jkt 259001
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that SKYCLARYS
(omaveloxolone), manufactured by
Reata Pharmaceuticals, Inc., meets the
criteria for a priority review voucher.
SKYCLARYS (omaveloxolone)
capsule is for the treatment of
Friedreich’s ataxia in adults and
adolescents aged 16 years and older.
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/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about SKYCLARYS
(omaveloxolone), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
AGENCY:
FDA has determined that SKYCLARYS
(omaveloxolone), approved February 28,
2023, and manufactured by Reata
Pharmaceuticals, Inc., meets the criteria
for 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.
[FR Doc. 2023–05364 Filed 3–15–23; 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 Blood
Products Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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 Blood
Products Advisory Committee (BPAC)
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 BPAC. 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 April 17, 2023 (see sections I
and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by April 17,
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
Christina Vert (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:
Christina Vert or Marie DeGregorio,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 1244, Silver Spring,
MD 20993–0002, 240–402–8054, email:
CBERBPAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUMMARY:
I. Blood Products Advisory Committee
BPAC reviews and evaluates available
data concerning the safety,
effectiveness, and appropriate use of
blood products derived from blood and
serum or biotechnology that are
E:\FR\FM\16MRN1.SGM
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[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Page 16266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05364]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0026]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), 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 award of the priority review voucher. FDA has determined
that SKYCLARYS (omaveloxolone), approved February 28, 2023, and
manufactured by Reata Pharmaceuticals, Inc., meets the criteria for 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:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
SKYCLARYS (omaveloxolone), manufactured by Reata Pharmaceuticals, Inc.,
meets the criteria for a priority review voucher.
SKYCLARYS (omaveloxolone) capsule is for the treatment of
Friedreich's ataxia in adults and adolescents aged 16 years and older.
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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about SKYCLARYS (omaveloxolone), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05364 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
