Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 18628-18629 [2015-08014]
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18628
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:
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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
Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices
FOR FURTHER INFORMATION CONTACT:
ACTION:
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
UNITUXIN (dinutuximab),
manufactured by United Therapeutics
Corporation, meets the criteria for a
priority review voucher. UNITUXIN
(dinutuximab) is indicated, in
combination with granulocytemacrophage colony-stimulating factor
(GM–CSF), interleukin-2 (IL–2), and 13cis-retinoic acid (RA), for the treatment
of pediatric patients with high-risk
neuroblastoma who achieve at least a
partial response to prior first-line
multiagent, multimodality therapy.
Neuroblastoma is the most common
pediatric solid tumor occurring outside
the brain, and it is the most common
cancer in infants.
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
UNITUXIN (dinutuximab), 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. 2015–08014 Filed 4–6–15; 8:45 am]
BILLING CODE CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Food and Drug Administration
[Docket No. FDA–2014–D–1747]
Risk Evaluation and Mitigation
Strategies: Modifications and
Revisions; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
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17:46 Apr 06, 2015
Jkt 235001
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Risk Evaluation and Mitigation
Strategies: Modifications and
Revisions.’’ This guidance provides
information on how FDA will define
and process submissions for
modifications and revisions to risk
evaluation and mitigation strategies
(REMS), as well as information on what
types of changes to approved REMS will
be considered modifications of the
REMS and what types of changes will be
considered revisions of the REMS.
There are different procedures for
submission of REMS modifications and
revisions to FDA as well as different
timeframes for FDA review and action
of such changes. In addition, this
guidance provides information on how
REMS modifications and revisions
should be submitted to FDA and how
FDA intends to review and act on these
submissions. The definitions of REMS
modifications and revisions apply to all
types of REMS.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the guidance by June 8, 2015. Submit
either electronic or written comments
concerning the proposed collection of
information by June 8, 2015.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave. Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave. Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kristen Everett, Center for Drug
Evaluation and Research, Food and
SUMMARY:
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18629
Drug Administration, 10903 New
Hampshire Ave. Bldg. 22, Rm. 6484,
Silver Spring, MD 20993–0002, 301–
796–0453; or Stephen Ripley, 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:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Risk
Evaluation and Mitigation Strategies:
Modifications and Revisions.’’ This
guidance provides information on what
types of changes to approved REMS will
be considered modifications and what
types of changes will be considered
revisions. See section 505–1(h) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355–1(h)).
This guidance also provides information
on how REMS modifications and
revisions should be submitted to FDA
and how FDA intends to review and act
on these submissions.
If FDA determines that a REMS is
necessary to ensure that the benefits of
a drug outweigh its risks, FDA is
authorized to require a REMS for such
drugs under section 505–1 of the FD&C
Act,1 added by section 901 of the Food
and Drug Administration Amendments
Act of 2007 (Pub. L. 110–85).2 Section
505–1(g) and (h) of the FD&C Act
include provisions for the assessment
and modification of an approved REMS.
In 2009, FDA issued draft guidance on
the format and content of REMS, REMS
assessments, and proposed REMS
modifications. In that guidance, based
on the language of section 505–1(g) and
(h) of the FD&C Act before the
amendments made by the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144)
(FDASIA), FDA stated that any
proposed modification to an approved
REMS, including proposed changes to
materials that are appended to the
REMS document, must be submitted as
a proposed REMS modification in the
form of a prior approval supplement
and must include a REMS assessment.
The guidance stated that the proposed
1 Section 505–1 of the FD&C Act applies to
applications for prescription drugs submitted under
subsection 505(b) (i.e., new drug applications) or (j)
(i.e., abbreviated new drug applications) of the
FD&C Act (21 U.S.C. 355) and applications under
section 351 of the Public Health Service Act (i.e.,
biologics license applications).
2 See https://www.fda.gov/RegulatoryInformation/
Legislation/FederalFoodDrugand
CosmeticActFDCAct/SignificantAmendmentsto
theFDCAct/FoodandDrugAdministration
AmendmentsActof2007/default.htm.
E:\FR\FM\07APN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Pages 18628-18629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08014]
-----------------------------------------------------------------------
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 UNITUXIN (dinutuximab), manufactured by United Therapeutics
Corporation, meets the criteria for a priority review voucher.
[[Page 18629]]
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 UNITUXIN (dinutuximab), manufactured by United
Therapeutics Corporation, meets the criteria for a priority review
voucher. UNITUXIN (dinutuximab) is indicated, in combination with
granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-
2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric
patients with high-risk neuroblastoma who achieve at least a partial
response to prior first-line multiagent, multimodality therapy.
Neuroblastoma is the most common pediatric solid tumor occurring
outside the brain, and it is the most common cancer in infants.
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 UNITUXIN (dinutuximab), 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. 2015-08014 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 4164-01-P
