83 FR 53880 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 207 (October 25, 2018)

Page Range		53880-53880
FR Document		2018-23308

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.

Federal Register, Volume 83 Issue 207 (Thursday, October 25, 2018)

[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Page 53880]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23308]


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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 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

53880 Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices

Jeffrey M. Zirger, SUMMARY: The Food and Drug DEPARTMENT OF HEALTH AND
Acting Chief, Information Collection Review Administration (FDA) is announcing the HUMAN SERVICES
Office, Office of Scientific Integrity, Office issuance of a priority review voucher to
of the Associate Director for Science, Office the sponsor of a rare pediatric disease Food and Drug Administration
of the Director, Centers for Disease Control
and Prevention.
product application. The Federal Food, [Docket No. FDA–2018–D–3462]
Drug, and Cosmetic Act (FD&C Act), as
[FR Doc. 2018–23291 Filed 10–24–18; 8:45 am]
amended by the Food and Drug Verification Systems Under the Drug
BILLING CODE 4163–18–P Supply Chain Security Act for Certain
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award Prescription Drugs; Draft Guidance for
priority review vouchers to sponsors of Industry; Availability
DEPARTMENT OF HEALTH AND
HUMAN SERVICES approved rare pediatric disease product AGENCY: Food and Drug Administration,
applications that meet certain criteria. HHS.
Centers for Disease Control and FDA is required to publish notice of the ACTION: Notice of availability.
Prevention award of the priority review voucher.
FDA has determined that REVCOVI SUMMARY: The Food and Drug
Disease, Disability, and Injury (elapegademase-lvlr) Injection, Administration (FDA or Agency) is
Prevention and Control Special manufactured by Leadiant Bioscience announcing the availability of a draft
Emphasis Panel (SEP)—RFA–CE19– guidance for industry entitled
Inc., meets the criteria for a priority
001; Correction ‘‘Verification Systems Under the Drug
review voucher.
Supply Chain Security Act for Certain
Notice is hereby given of a change in FOR FURTHER INFORMATION CONTACT: Prescription Drugs.’’ The draft guidance
the meeting of the Disease, Disability, Althea Cuff, Center for Drug Evaluation addresses the verification systems that
and Injury Prevention and Control manufacturers, repackagers, wholesale
and Research, Food and Drug
Special Emphasis Panel (SEP)—RFA– distributors, and dispensers must have
Administration, 10903 New Hampshire
CE19–001; October 30–November 2, in place to comply with the Federal
Ave., Silver Spring, MD 20993–0002,
2018, 8:30 a.m.–5:00 p.m., EDT which Food, Drug, and Cosmetic Act (FD&C
301–796–4061, Fax: 301–796–9856,
was published in the Federal Register Act), as amended by the Drug Supply
on August 23, 2018 Volume 83, Number email: althea.cuff@fda.hhs.gov.
Chain Security Act (DSCSA).
164, pages 42655–42656. SUPPLEMENTARY INFORMATION: FDA is Specifically, this draft guidance covers
The date should read as follows: announcing the issuance of a priority the statutory verification system
October 29, 2018, 3:00 p.m.–5:00 p.m., review voucher to the sponsor of an requirements that include quarantine
EDT, October 30–November 2, 2018, approved rare pediatric disease product and investigation of a product
8:00 a.m.–5:00 p.m., EDT. application. Under section 529 of the determined to be suspect and
FOR FURTHER INFORMATION CONTACT: FD&C Act (21 U.S.C. 360ff), which was quarantine and disposition of a product
Mikel L. Walters, M.A., Ph.D., Scientific added by FDASIA, FDA will award determined to be illegitimate. The draft
Review Official, NCIPC, CDC, 4770 priority review vouchers to sponsors of guidance also addresses the statutory
Buford Highway NE, Mailstop F–63, approved rare pediatric disease product requirement for notification to the
Atlanta, Georgia 30341, (404)639–0913; applications that meet certain criteria. Agency of a product that has been
mwalters@cdc.gov. FDA has determined that REVCOVI cleared by a manufacturer, repackager,
The Chief Operating Officer, Centers (elapegademase-lvlr) Injection, wholesale distributor, or dispenser after
for Disease Control and Prevention, has manufactured by Leadiant Bioscience a suspect product investigation because
been delegated the authority to sign Inc., meets the criteria for a priority it is determined that the product is not
Federal Register notices pertaining to review voucher. REVCOVI an illegitimate product.
announcements of meetings and other (elapegademase-lvlr) Injection is DATES: Submit either electronic or
committee management activities, for indicated for the treatment of Adenosine written comments on the draft guidance
both the Centers for Disease Control and Deaminase-Severe Combined by December 24, 2018 to ensure that the
Prevention and the Agency for Toxic Immunodeficiency (ADA–SCID) in Agency considers your comment on this
Substances and Disease Registry. draft guidance before it begins work on
pediatric and adult patients.
Sherri Berger, the final version of the guidance.
For further information about the Rare
Chief Operating Officer, Centers for Disease Pediatric Disease Priority Review ADDRESSES: You may submit comments
Control and Prevention. Voucher Program and for a link to the on any guidance at any time as follows:
[FR Doc. 2018–23297 Filed 10–24–18; 8:45 am] full text of section 529 of the FD&C Act, Electronic Submissions
BILLING CODE 4163–18–P go to https://www.fda.gov/ForIndustry/ Submit electronic comments in the
DevelopingProductsforRareDiseases following way:
DEPARTMENT OF HEALTH AND
Conditions/RarePediatricDiseasePriority • Federal eRulemaking Portal:
VoucherProgram/default.htm. For https://www.regulations.gov. Follow the
HUMAN SERVICES
further information about REVCOVI instructions for submitting comments.
Food and Drug Administration (elapegademase-lvlr) Injection, go to the Comments submitted electronically,
‘‘Drugs@FDA’’ website at https:// including attachments, to https://
[Docket No. FDA–2018–N–1262] www.accessdata.fda.gov/scripts/cder/ www.regulations.gov will be posted to
daltland on DSKBBV9HB2PROD with NOTICES

daf/. the docket unchanged. Because your
Issuance of Priority Review Voucher; comment will be made public, you are
Rare Pediatric Disease Product Dated: October 22, 2018.
solely responsible for ensuring that your
Leslie Kux,
AGENCY: Food and Drug Administration, comment does not include any
Associate Commissioner for Policy. confidential information that you or a
HHS.
[FR Doc. 2018–23308 Filed 10–24–18; 8:45 am] third party may not wish to be posted,
ACTION: Notice.
BILLING CODE 4164–01–P such as medical information, your or

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Document Created: 2018-10-25 01:43:18
Document Modified: 2018-10-25 01:43:18

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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]
FR Citation		83 FR 53880

83 FR 53880 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 207 (October 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration