Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product, 51277 [2015-20833]
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Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
There are currently 15 active ADSSP
grantees engaged in the development of
dementia-capable systems in their state
to support individuals with ADRD and
their caregivers. ACL will provide
additional resources to support the
expansion of promising program
activities under existing ADSSP projects
in the states of Minnesota and Ohio.
Both the Minnesota and Ohio grantees
are engaged in projects that are building
the dementia-capability of their state
systems that merit expansion. The state
of Minnesota will expand on their
existing program efforts to build strong
linkages between a Health Care Partner
(HCP) and Community Based
Organizations (CBO). The state of Ohio
will expand on their existing ADSSP
project goal to enrich the lives of
veterans suffering from cognitive and
physical challenges and their caregivers
by expanding Ohio’s Music &
MemorySM program living in their
homes and communities.
Justification: ACL is committed to the
success, continued expansion and
sustainability of ADSSP projects. Each
of the identified existing cooperative
agreement projects has components
within them from which the
communities that they serve will benefit
and merit uninterrupted expansion. To
ensure uninterrupted continuation
toward achieving and exceeding their
goals and objectives and expansion of
program efforts, ACL plans to issue oneyear non-competing awards to both the
Minnesota Board on Aging and the Ohio
Department on Aging.
I. Agency Contact
For further information or comments
regarding this action, contact Erin Long,
U.S. Department of Health and Human
Services, Administration for
Community Living, Administration on
Aging, Washington, DC 20201;
telephone (202) 357–3448; fax (202)
357–3549; email Erin.Long@acl.hhs.gov.
Dated: August 11, 2015.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2015–20796 Filed 8–21–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2014–N–0229]
Use of Rare Pediatric Disease Priority
Review Voucher; Approval of a Drug
Product
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:48 Aug 21, 2015
Jkt 235001
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
recent approval of a drug product under
an application for which the sponsor
redeemed a rare pediatric disease
priority review voucher. 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 redeem priority review vouchers
submitted by sponsors of product
applications that might otherwise not
qualify for priority review. These
vouchers entitle the holder of such a
voucher to priority review of a single
human drug application submitted
under the FD&C Act or the Public
Health Service Act. FDA has approved
PRALUENT (alirocumab), manufactured
by Sanofi-Aventis U.S. Inc., under a
priority review.
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4842, FAX: 301–796–9858,
email: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the recent approval of a
drug product under an application for
which the sponsor redeemed a rare
pediatric disease priority review
voucher. Under section 529 of the FD&C
Act (21 U.S.C. 360ff), added by FDASIA,
FDA will grant a priority review for a
new drug or biological product
application that redeems a priority
review voucher, even if that product
might not otherwise qualify for a
priority review. FDA has recently
approved PRALUENT (alirocumab),
manufactured by Sanofi-Aventis U.S.
Inc., under a priority review.
PRALUENT (alirocumab) is indicated as
an adjunct to diet and maximally
tolerated statin therapy for the treatment
of adults with heterozygous familial
hypercholesterolemia or clinical
atherosclerotic cardiovascular disease,
who require additional lowering of lowdensity lipoprotein cholesterol.
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
PRALUENT (alirocumab), go to the
Drugs@FDA Web site at https://
www.accessdata.fda.gov/scripts/cder/
drugsatfda/index.cfm.
SUMMARY:
PO 00000
Frm 00082
Fmt 4703
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51277
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20833 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2489]
Receipt of Notice That a Patent
Infringement Complaint Was Filed
Against a Biosimilar Applicant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6208, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
SUMMARY:
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0229]
Use of Rare Pediatric Disease Priority Review Voucher; Approval
of a Drug Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
recent approval of a drug product under an application for which the
sponsor redeemed a rare pediatric disease priority review voucher. 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 redeem priority review vouchers submitted by sponsors
of product applications that might otherwise not qualify for priority
review. These vouchers entitle the holder of such a voucher to priority
review of a single human drug application submitted under the FD&C Act
or the Public Health Service Act. FDA has approved PRALUENT
(alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a
priority review.
FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842,
FAX: 301-796-9858, email: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is announcing the recent approval of a
drug product under an application for which the sponsor redeemed a rare
pediatric disease priority review voucher. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), added by FDASIA, FDA will grant a priority
review for a new drug or biological product application that redeems a
priority review voucher, even if that product might not otherwise
qualify for a priority review. FDA has recently approved PRALUENT
(alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a
priority review. PRALUENT (alirocumab) is indicated as an adjunct to
diet and maximally tolerated statin therapy for the treatment of adults
with heterozygous familial hypercholesterolemia or clinical
atherosclerotic cardiovascular disease, who require additional lowering
of low-density lipoprotein cholesterol.
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 PRALUENT (alirocumab), go to the
Drugs@FDA Web site at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20833 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P
