Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 54700 [2022-19276]
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Federal Register / Vol. 87, No. 172 / Wednesday, September 7, 2022 / Notices
See https://www.ssa.gov/OP_Home/
ssact/title05/0510.htm.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
[FR Doc. 2022–19231 Filed 9–6–22; 8:45 am]
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Proposal To Withdraw Approval of
MAKENA; Hearing; Correction
Food and Drug Administration,
HHS.
ACTION:
Notice of hearing; correction.
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Proposal To Withdraw
Approval of MAKENA; Hearing’’ that
appeared in the Federal Register of
August 17, 2022. The document
announced the hearing on the Center for
Drug Evaluation and Research’s
proposal to withdraw approval of
MAKENA (hydroxyprogesterone
caproate injection, 250 milligrams per
milliliter, once weekly), new drug
application 021945, held by Covis
Pharma Group/Covis Pharma GmbH.
The document was published with an
incorrect deadline. This document
corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring,
MD 20993, 240–402–5931,
rachael.linowes@fda.hhs.gov.
In the
Federal Register of August 17, 2022 (87
FR 50626), in FR Doc. 2022–17715, on
page 50628, the following correction is
made:
1. On page 50628, in the last
paragraph of the second column, in the
first sentence, ‘‘September 6, 2022’’ is
corrected to ‘‘September 14, 2022.’’
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Dated: September 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19293 Filed 9–6–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:50 Sep 06, 2022
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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 ZTALMY
(ganaxolone), manufactured by Marinus
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.
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 ZTALMY
(ganaxolone), manufactured by Marinus
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. ZTALMY
(ganaxolone) is indicated to treat
seizures associated with cyclindependent kinase-like 5 (CDKL5)
deficiency disorder in patients 2 years
of age 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 ZTALMY
(ganaxolone), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice.
SUMMARY:
[Docket No. FDA–2020–N–2029]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
[FR Doc. 2022–19276 Filed 9–6–22; 8:45 am]
BILLING CODE 4164–01–P
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
BILLING CODE 4184–83–P
Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Sfmt 4703
Solicitation of Nominations for
Membership To Serve on the Advisory
Commission on Childhood Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates for consideration
for appointment as members of the
Advisory Commission on Childhood
Vaccines (ACCV). The ACCV advises
the Secretary of HHS (Secretary) on
issues related to implementation of the
National Vaccine Injury Compensation
Program (VICP). HRSA is seeking
nominations of qualified candidates to
fill vacancies on the ACCV.
DATES: Written nominations for
membership on the ACCV will be
received on a continuous basis.
ADDRESSES: Nomination packages must
be submitted to the Director, Division of
Injury Compensation Programs, Health
Systems Bureau, HRSA, 5600 Fishers
Lane, Room 08N146B, Rockville,
Maryland 20857. Candidates can submit
electronic nomination packages by
email to Pita Gomez at ACCV@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Pita
Gomez, Principal Staff Liaison, Division
of Injury Compensation Programs,
Health Systems Bureau, HRSA at (301)
945–9386 or email at ACCV@hrsa.gov. A
copy of the ACCV charter and list of the
current membership is available on the
ACCV website at https://www.hrsa.gov/
advisory-committees/vaccines/
index.html.
SUMMARY:
The ACCV
was established by Title XXI of the
Public Health Service Act (the Act) and
advises the Secretary on issues related
to implementation of the VICP. The
ACCV meets at least four times each
calendar year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on the ACCV to fill open
positions. The Secretary appoints
members with the expertise needed to
fulfill the duties of the ACCV. The
SUPPLEMENTARY INFORMATION:
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 87, Number 172 (Wednesday, September 7, 2022)]
[Notices]
[Page 54700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19276]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1262]
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 ZTALMY (ganaxolone), manufactured by Marinus 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 ZTALMY
(ganaxolone), manufactured by Marinus Pharmaceuticals, Inc., meets the
criteria for a priority review voucher. ZTALMY (ganaxolone) is
indicated to treat seizures associated with cyclin-dependent kinase-
like 5 (CDKL5) deficiency disorder in patients 2 years of age 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 ZTALMY (ganaxolone), go to the ``[email protected]'' website
at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19276 Filed 9-6-22; 8:45 am]
BILLING CODE 4164-01-P
