Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 18628 [2015-08016]
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Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices
Regency, 1209 L Street, Sacramento,
California 95814
• July 30, 2015—Oklahoma Indian Head
Start Coalition Conference,
DoubleTree at Warren Place, 6110
South Yale Avenue, Tulsa, Oklahoma
74136
• August 17, 2015—Northwest Indian
Head Start Association Conference,
Holiday Inn Grand Montana, 5500
Midland Road, Billings, Montana
59101
FOR FURTHER INFORMATION CONTACT:
Robert Bialas, Regional Program
Manager, Region XI, Office of Head
Start, email Robert.Bialas@acf.hhs.gov
or phone (202) 205–9497. Additional
information and online meeting
registration is available at https://eclkc.
ohs.acf.hhs.gov/hslc/hs/calendar/
tc2015.
The
Department of Health and Human
Services (HHS) announces OHS Tribal
Consultations for leaders of Tribal
Governments operating Head Start and
Early Head Start programs.
The agenda for the scheduled OHS
Tribal Consultations in Sacramento,
California, Tulsa, Oklahoma, and
Billings, Montana, will be organized
around the statutory purposes of Head
Start Tribal Consultations related to
meeting the needs of American Indian/
Alaska Native children and families,
taking into consideration funding
allocations, distribution formulas, and
other issues affecting the delivery of
Head Start services in their geographic
locations. In addition, OHS will share
actions taken and in progress to address
the issues and concerns raised in 2014
OHS Tribal Consultations.
The Consultation Sessions will be
conducted with elected or appointed
leaders of Tribal Governments and their
designated representatives [42 U.S.C.
9835, Section 640(l)(4)(A)]. Designees
must have a letter from the Tribal
Government authorizing them to
represent the tribe prior to the
Consultation Sessions. Other
representatives of tribal organizations
and Native nonprofit organizations are
welcome to attend as observers.
A detailed report of the Consultation
Sessions will be prepared and made
available within 45 days of the
Consultation Sessions to all Tribal
Governments receiving funds for Head
Start and Early Head Start programs.
Tribes wishing to submit written
testimony for the report should send
testimony to Robert Bialas at
Robert.Bialas@acf.hhs.gov either prior
to the Consultation Sessions or within
30 days after the meeting.
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SUPPLEMENTARY INFORMATION:
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17:46 Apr 06, 2015
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OHS will summarize oral testimony
and comments from each Consultation
Session in the report without
attribution, along with topics of concern
and recommendations. OHS has sent
hotel and logistical information for the
California, Oklahoma, and Montana
Consultation Sessions to tribal leaders
via email and posted information on the
Early Childhood Learning and
Knowledge Center Web site at https://
eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/
tc2015.
Dated: March 26, 2015.
Ann Linehan,
Acting Director, Office of Head Start.
[FR Doc. 2015–07958 Filed 4–6–15; 8:45 am]
BILLING CODE CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0229]
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),
as amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
rare pediatric disease product
applications that meet certain criteria.
FDA has determined that CHOLBAM
(cholic acid), manufactured by
Asklepion Pharmaceuticals, LLC, meets
the criteria for a priority review
voucher.
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 issuance of a priority
review voucher to the sponsor of a rare
pediatric disease product application.
Under section 529 of the FD&C Act (21
U.S.C. 360ff), added by FDASIA, FDA
will award priority review vouchers to
sponsors of rare pediatric disease
product applications that meet certain
criteria. FDA has determined that
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
CHOLBAM (cholic acid), manufactured
by Asklepion Pharmaceuticals, LLC,
meets the criteria for a priority review
voucher. CHOLBAM (cholic acid) is a
bile acid indicated for the treatment of
bile acid synthesis disorders due to
single enzyme defects and as adjunctive
treatment of peroxisomal disorders,
including Zellweger spectrum disorders
in patients who exhibit manifestations
of liver disease or steatorrhea or
complications from decreased fat
soluble vitamin absorption. Bile acid
synthesis disorders is a group of rare
congenital disorders caused by the
absence or malfunction of an enzyme
involved in an important metabolic
pathway, leading to a failure to produce
normal bile acids.
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/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm.
For further information about
CHOLBAM (cholic acid), go to the
Drugs@FDA Web site at https://
www.accessdata.fda.gov/scripts/cder/
drugsatfda/index.cfm.
Dated: April 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–08016 Filed 4–6–15; 8:45 am]
BILLING CODE CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0229]
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),
as amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
rare pediatric disease product
applications that meet certain criteria.
FDA has determined that UNITUXIN
(dinutuximab), manufactured by United
Therapeutics Corporation, meets the
criteria for a priority review voucher.
SUMMARY:
E:\FR\FM\07APN1.SGM
07APN1
]]>Agencies
[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Page 18628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08016]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0229]
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 rare pediatric disease
product applications that meet certain criteria. FDA has determined
that CHOLBAM (cholic acid), manufactured by Asklepion Pharmaceuticals,
LLC, meets the criteria for a priority review voucher.
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 issuance of a priority
review voucher to the sponsor of a rare pediatric disease product
application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), added
by FDASIA, FDA will award priority review vouchers to sponsors of rare
pediatric disease product applications that meet certain criteria. FDA
has determined that CHOLBAM (cholic acid), manufactured by Asklepion
Pharmaceuticals, LLC, meets the criteria for a priority review voucher.
CHOLBAM (cholic acid) is a bile acid indicated for the treatment of
bile acid synthesis disorders due to single enzyme defects and as
adjunctive treatment of peroxisomal disorders, including Zellweger
spectrum disorders in patients who exhibit manifestations of liver
disease or steatorrhea or complications from decreased fat soluble
vitamin absorption. Bile acid synthesis disorders is a group of rare
congenital disorders caused by the absence or malfunction of an enzyme
involved in an important metabolic pathway, leading to a failure to
produce normal bile acids.
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 CHOLBAM (cholic acid), go to the
Drugs@FDA Web site at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
Dated: April 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08016 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 4164-01-P
