Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 31324 [2019-13944]
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31324
Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
Program Name: The National Center
for Benefits Outreach and Enrollment
(NCBOE).
Recipient: National Council on Aging
(NCOA).
Period of Performance: The award
will be issued for the current project
period of September 30, 2017 through
September 29, 2020.
Total Award Amount: $11,390,861 in
FY 2019.
Award Type: Cooperative Agreement
Supplement.
Statutory Authority: The Medicare
Improvements for Patients and
Providers Act of 2008—Section 119,
Public Law (Pub. L.) 110–275 as
amended by the Patient Protection and
Affordable Care Act of 2010 (Affordable
Care Act), reauthorized by the American
Taxpayer Relief Act of 2012 (ATRA) and
reauthorized by section 110 of the
Protecting Access to Medicare Act of
2014.
Basis for Award: The National
Council on Aging (NCOA) is currently
funded to carry out the NCBOE Project
for the period of September 30, 2017
through September 29, 2020. Much
work has already been completed and
further tasks are currently being
accomplished. It would be
unnecessarily time consuming and
disruptive to the NCBOE project and the
beneficiaries being served for the ACL to
establish a new grantee at this time
when critical services are presently
being provided in an efficient manner.
The NCOA is uniquely placed to
complete the work under the NCBOE
grant. Since 2001, the NCOA has been
the national leader in improving
benefits access to vulnerable older
adults. They have an unparalleled
history of working with community
based organizations to develop and
replicate outreach and enrollment
solutions, while maintaining and
enhancing technology to make it easier
and more efficient to find benefits. The
NCOA through NCBOE accomplishes its
mission by developing and sharing
tools, resources, best practices, and
strategies for benefits outreach and
enrollment via its online clearinghouse,
electronic and print publications,
webinars, and training and technical
assistance.
In addition, the NCOA has the
BenefitsCheckUp which is, by far, the
nation’s most comprehensive and
widely-used web-based service that
screens older and disabled adults with
limited incomes and resources and
informs them about public and private
benefits for which they are very likely
to be eligible. Since the
BenefitsCheckUp was launched in 2001,
over 7.6 million individuals have been
VerDate Sep<11>2014
19:58 Jun 28, 2019
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assisted to identify over $29.6 billion in
potential annual benefits. In addition to
a focus on Low-Income Subsidy and
Medicare Savings Programs, the
BenefitsCheckUp also includes more
than 2,500 benefits programs from all 50
states and DC, including the addition of
Medicaid expansion programs as part of
Affordable Care Act; over 50,000 local
offices for people to apply for benefits;
nearly 2,000 application forms in every
language in which they are available;
and user-friendly mapping tools that
allow streamlined access to program fact
sheets and application forms based
upon a person’s locality.
NCOA is successfully meeting all
programmatic goals under the current
NCBOE grant.
For Further Information Contact: For
further information or comments
regarding this program supplement,
contact Rebecca Kinney, U.S.
Department of Health and Human
Services, Administration for
Community Living, Center for Integrated
Programs, Office of Healthcare
Information and Counseling; telephone
(202) 795–7375; email Rebecca.Kinney@
acl.hhs.gov
Dated: June 24, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–13962 Filed 6–28–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–N–0809 and FDA–
2018–N–4609]
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.
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 KANUMA
(sebelipase alfa), manufactured by
Alexion Pharmaceuticals Inc., meets the
criteria for a priority review voucher.
KANUMA (sebelipase alfa), is indicated
for the treatment of patients with a
diagnosis of Lysosomal Acid Lipase
deficiency.
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 KANUMA
(sebelipase alfa), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: June 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13944 Filed 6–28–19; 8:45 am]
BILLING CODE 4164–01–P
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
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), 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 KANUMA
(sebelipase alfa), manufactured by
Alexion Pharmaceuticals Inc., meets the
criteria for a priority review voucher.
SUMMARY:
PO 00000
Frm 00038
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
[Docket No. FDA–2019–N–2430]
Request for Nominations on Device
Good Manufacturing Practice Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Device
Good Manufacturing Practice Advisory
Committee (DGMPAC) in the Center for
Devices and Radiological Health notify
SUMMARY:
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[Federal Register Volume 84, Number 126 (Monday, July 1, 2019)]
[Notices]
[Page 31324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13944]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2017-N-0809 and FDA-2018-N-4609]
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 KANUMA (sebelipase alfa), manufactured by Alexion Pharmaceuticals
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 KANUMA
(sebelipase alfa), manufactured by Alexion Pharmaceuticals Inc., meets
the criteria for a priority review voucher. KANUMA (sebelipase alfa),
is indicated for the treatment of patients with a diagnosis of
Lysosomal Acid Lipase deficiency.
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 KANUMA (sebelipase alfa), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: June 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13944 Filed 6-28-19; 8:45 am]
BILLING CODE 4164-01-P
