Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 42686 [2017-19130]
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Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices
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Dated: September 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19129 Filed 9–8–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0809]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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 (the FD&C Act),
SUMMARY:
VerDate Sep<11>2014
16:34 Sep 08, 2017
Jkt 241001
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 KYMRIAH
(tisagenlecleucel), manufactured by
Novartis Pharmaceuticals Corporation,
meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Gretchen Opper, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
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 KYMRIAH
(tisagenlecleucel), manufactured by
Novartis Pharmaceuticals Corporation,
meets the criteria for a priority review
voucher. KYMRIAH (tisagenlecleucel) is
indicated for the treatment of patients
up to 25 years of age with B-cell
precursor acute lymphoblastic leukemia
(ALL) that is refractory or in second or
later relapse.
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 tohttps://www.fda.gov/ForIndustry/
DevelopingProductsfor
RareDiseasesConditions/
RarePediatricDiseasePriorityVoucher
Program/default.htm. For further
information about KYMRIAH
(tisagenlecleucel), go to the Center for
Biologics Evaluation and Research
cellular and gene therapy products Web
site at https://www.fda.gov/Biologics
BloodVaccines/CellularGeneTherapy
Products/ApprovedProducts/
default.htm.
SUPPLEMENTARY INFORMATION:
Dated: September 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19130 Filed 9–8–17; 8:45 am]
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Government and is available for
licensing to achieve expeditious
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applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
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Vince Contreras, 240–669–2823;
Vince.Contreras@nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
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Technology description follows.
SUMMARY:
Broadly Neutralizing Antibodies
Against HIV–1 Directed to the CD4
Binding Site of HIV Envelope Protein
Description of Technology
Inhibiting the ability of HIV–1, the
virus that causes AIDS, to infect cells is
one approach to both prevention and
treatment of HIV. Scientists at the
NIAID Vaccine Research Center have
isolated and characterized neutralizing
antibodies (VRC01, 02, 03, and 07) that
bind to the CD4 binding site of HIV–1
envelope glycoprotein gp120. These
human monoclonal antibodies can
potentially be used as a therapeutic to:
(1) Treat an HIV infection, (2) decrease
and prevent HIV-transmission from
mother to infant, and (3) be effectively
combined with anti-retroviral drug
therapy. Additionally, the antibodies
can be used for detection of HIV–1
infection in biological samples,
including body fluids; and tissues from
biopsies, autopsies, and pathology
specimens.
VRC01 has been tested in several
phase I clinical trials for safety and
pharmacokinetics in infants, adults, and
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[Federal Register Volume 82, Number 174 (Monday, September 11, 2017)]
[Notices]
[Page 42686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19130]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0809]
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 (the 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 KYMRIAH (tisagenlecleucel), manufactured by
Novartis Pharmaceuticals Corporation, meets the criteria for a priority
review voucher.
FOR FURTHER INFORMATION CONTACT: Gretchen Opper, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
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
KYMRIAH (tisagenlecleucel), manufactured by Novartis Pharmaceuticals
Corporation, meets the criteria for a priority review voucher. KYMRIAH
(tisagenlecleucel) is indicated for the treatment of patients up to 25
years of age with B-cell precursor acute lymphoblastic leukemia (ALL)
that is refractory or in second or later relapse.
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 tohttps://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about KYMRIAH (tisagenlecleucel), go to the Center for
Biologics Evaluation and Research cellular and gene therapy products
Web site at https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/default.htm.
Dated: September 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19130 Filed 9-8-17; 8:45 am]
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