Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 53880 [2018-23308]
Download as PDF
<![CDATA[
53880
Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–23291 Filed 10–24–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—RFA–CE19–
001; Correction
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—RFA–
CE19–001; October 30–November 2,
2018, 8:30 a.m.–5:00 p.m., EDT which
was published in the Federal Register
on August 23, 2018 Volume 83, Number
164, pages 42655–42656.
The date should read as follows:
October 29, 2018, 3:00 p.m.–5:00 p.m.,
EDT, October 30–November 2, 2018,
8:00 a.m.–5:00 p.m., EDT.
FOR FURTHER INFORMATION CONTACT:
Mikel L. Walters, M.A., Ph.D., Scientific
Review Official, NCIPC, CDC, 4770
Buford Highway NE, Mailstop F–63,
Atlanta, Georgia 30341, (404)639–0913;
mwalters@cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–23297 Filed 10–24–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
daltland on DSKBBV9HB2PROD with NOTICES
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:
18:10 Oct 24, 2018
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@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), 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 REVCOVI
(elapegademase-lvlr) Injection,
manufactured by Leadiant Bioscience
Inc., meets the criteria for a priority
review voucher. REVCOVI
(elapegademase-lvlr) Injection is
indicated for the treatment of Adenosine
Deaminase-Severe Combined
Immunodeficiency (ADA–SCID) in
pediatric and adult patients.
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 REVCOVI
(elapegademase-lvlr) Injection, go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23308 Filed 10–24–18; 8:45 am]
Notice.
VerDate Sep<11>2014
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 REVCOVI
(elapegademase-lvlr) Injection,
manufactured by Leadiant Bioscience
Inc., meets the criteria for a priority
review voucher.
SUMMARY:
BILLING CODE 4164–01–P
Jkt 247001
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3462]
Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs.’’ The draft guidance
addresses the verification systems that
manufacturers, repackagers, wholesale
distributors, and dispensers must have
in place to comply with the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the Drug Supply
Chain Security Act (DSCSA).
Specifically, this draft guidance covers
the statutory verification system
requirements that include quarantine
and investigation of a product
determined to be suspect and
quarantine and disposition of a product
determined to be illegitimate. The draft
guidance also addresses the statutory
requirement for notification to the
Agency of a product that has been
cleared by a manufacturer, repackager,
wholesale distributor, or dispenser after
a suspect product investigation because
it is determined that the product is not
an illegitimate product.
DATES: Submit either electronic or
written comments on the draft guidance
by December 24, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Page 53880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23308]
-----------------------------------------------------------------------
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 REVCOVI (elapegademase-lvlr) Injection, manufactured by Leadiant
Bioscience Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9856, 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
REVCOVI (elapegademase-lvlr) Injection, manufactured by Leadiant
Bioscience Inc., meets the criteria for a priority review voucher.
REVCOVI (elapegademase-lvlr) Injection is indicated for the treatment
of Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) in
pediatric and adult patients.
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 REVCOVI (elapegademase-lvlr) Injection, go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23308 Filed 10-24-18; 8:45 am]
BILLING CODE 4164-01-P
