Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 54515 [2022-19155]
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Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Notices
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Dated: August 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19156 Filed 9–2–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
manufactured by BioMarin
Pharmaceutical, Inc., meets the criteria
for receipt of a priority review voucher.
ACTION:
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
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.
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) FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that VOXZOGO (vosoritide)
manufactured by BioMarin
Pharmaceutical, Inc., meets the criteria
for a priority review voucher.
VOXZOGO (vosoritide) is indicated to
increase linear growth in pediatric
patients with achondroplasia who are 5
years of age and older with open
epiphyses.
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/
DevelopingProductsfor
RareDiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about VOXZOGO (vosoritide), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[Docket No. FDA–2018–N–1262]
[FR Doc. 2022–19155 Filed 9–2–22; 8:45 am]
BILLING CODE 4164–01–P
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
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)
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 VOXZOGO (vosoritide)
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:04 Sep 02, 2022
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[CIS No. 2721–22; DHS Docket No. USCIS–
2022–0007]
Implementation of Employment
Authorization for Individuals Covered
by Deferred Enforced Departure for
Liberians
U.S. Citizenship and
Immigration Services (USCIS),
Department of Homeland Security.
AGENCY:
PO 00000
Frm 00067
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54515
Notice of Employment
Authorization for Individuals Covered
by Deferred Enforced Departure (DED).
On June 27, 2022, President
Joseph Biden issued a memorandum to
the Secretary of State and the Secretary
of Homeland Security (Secretary)
determining that it was in the foreign
policy interest of the United States to
defer, through June 30, 2024, the
removal of certain Liberian nationals,
and individuals having no nationality
who last habitually resided in Liberia,
who are present in the United States
and to provide them with employment
authorization documentation. The
memorandum directed the Secretary to
make provision for immediate
allowance of employment authorization
for such individuals. This Notice
provides information about Deferred
Enforced Departure (DED) for certain
eligible Liberian nationals, and
individuals having no nationality who
last habitually resided in Liberia, and
provides information on how eligible
individuals may apply for DED-based
Employment Authorization Documents
(EADs) with USCIS. Through this
notice, DHS is providing employment
authorization, including procedures for
obtaining related documentation, for
covered individuals through June 30,
2024, and automatically extending the
validity of DED-based EADs bearing a
Category Code of A–11 and a ‘‘Card
Expires’’ date of March 30, 2020,
January 10, 2021, or June 30, 2022,
through June 30, 2024. Finally, this
Notice provides instructions for DEDeligible Liberians, or individuals
without nationality who last habitually
resided in Liberia, on how to file for
travel authorization.
DATES: The extension and expansion of
DED and employment authorization for
noncitizens covered by DED for
Liberians is effective June 27, 2022,
through June 30, 2024. Employment
authorization and the procedures for
obtaining EADs in this Notice apply to
any of the following individuals who
are not subject to any of the
ineligibilities described in President
Biden’s memorandum to the Secretaries
of State and Homeland Security:
noncitizens who are Liberian nationals,
or individuals having no nationality
who last habitually resided in Liberia,
regardless of country of birth, who were
covered by DED as of June 30, 2022; as
well as to Liberian nationals, or
individuals having no nationality who
last habitually resided in Liberia,
regardless of country of birth, who have
been continuously physically present in
the United States since May 20, 2017.
Liberian nationals, and individuals
E:\FR\FM\06SEN1.SGM
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[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Page 54515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19155]
-----------------------------------------------------------------------
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) 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 VOXZOGO (vosoritide) manufactured by BioMarin Pharmaceutical,
Inc., meets the criteria for receipt of 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) FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined that VOXZOGO (vosoritide) manufactured by BioMarin
Pharmaceutical, Inc., meets the criteria for a priority review voucher.
VOXZOGO (vosoritide) is indicated to increase linear growth in
pediatric patients with achondroplasia who are 5 years of age and older
with open epiphyses.
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 VOXZOGO (vosoritide), 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. 2022-19155 Filed 9-2-22; 8:45 am]
BILLING CODE 4164-01-P
