Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 14055-14056 [2014-05410]
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Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices
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Comments: FDA is holding this public
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NewsEvents/WorkshopsConferences/
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default.htm. (Select this public
workshop from the posted events list.)
SUPPLEMENTARY INFORMATION:
I. Background
Thrombosis, or blood clot formation,
is a major complication in the use of
blood-contacting medical devices.
Thrombosis often leads to device
malfunction and severe adverse events
such as stroke or myocardial infarction.
To improve device quality and reduce
the occurrence of thrombus formation, it
is important to fully assess the
thrombogenic potential of a medical
device prior to clinical use and make
material or geometrical modifications if
necessary.
The current thrombogenicity test
paradigm relies heavily on animal
studies. For implanted devices, where
animal studies are often conducted to
assess safety and possible effectiveness,
thrombogenicity endpoints can also be
included. However, for many
interventional devices, where other
animal studies are not commonly
requested, FDA has traditionally
recommended a 4-hour in vivo canine
thrombogenicity test model for
assessment of thrombogenic potential.
Because there have been questions
about the consistency, reliability, and
clinical relevance of this 4-hour canine
thrombogenicity model, FDA is
interested in optimizing the conduct of
this in vivo test and/or identifying
alternative in vitro tests that provide
equivalent or improved clinical insight
into the potential for thrombogenicity of
medical devices while minimizing
expenses and animal use, if possible.
This workshop will bring together
academia, industry professionals, and
FDA regulators to discuss the
advantages, limitations, and
optimization of both in vivo and in vitro
thrombogenicity test methods, and
identify alternative in vitro tests that
show promising clinical relevance. We
will discuss testing methods related to
a broad range of blood contacting
devices, especially for cardiovascular
applications. Ideas generated during this
workshop may facilitate development of
new guidance and/or standards for
thrombogenicity testing that optimize
current in vivo methods and/or utilize
in vitro methods.
II. Topics for Discussion at the Public
Workshop
FDA seeks to address and receive
comments on the following topics:
1. Strengths, weaknesses, and
optimization of in vivo thrombogenicity
test methods;
2. Current methodologies for
conducting in vitro thrombogenicity
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14055
testing (e.g., blood conditions, static
versus dynamic methods, and different
test endpoints);
3. Correlation between in vitro/in vivo
thrombogenicity test results and clinical
outcomes;
4. Special testing considerations for
catheters, stents, grafts, ventricular
assist devices, and bypass circuit
components.
Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–05411 Filed 3–11–14; 8:45 am]
BILLING CODE 4160–01–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 VIMIZIM
(elosulfase alfa), manufactured by
BioMarin Pharmaceutical, Inc., meets
the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Vicki Moyer, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6467, Silver Spring,
MD 20993–0002, 301–796–2200, FAX:
301–796–9855, vicki.moyer@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
VIMIZIM (elosulfase alfa), manufactured
by BioMarin Pharmaceutical, Inc., meets
the criteria for a priority review
SUMMARY:
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Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices
voucher. VIMIZIM (elosulfase alfa) is
indicated for the treatment of
Mucopolysaccharidosis Type IV A
(Morquio A syndrome). Morquio A
syndrome is a rare congenital disorder
caused by the absence or
malfunctioning of an enzyme involved
in an important metabolic pathway,
leading to problems with bone
development, growth, and movement.
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
VIMIZIM (elosulfase alfa), go to the
Drugs@FDA Web site at https://www.
accessdata.fda.gov/scripts/cder/
drugsatfda/index.cfm.
Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–05410 Filed 3–11–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
National Health Service Corps
Ambassador Portal OMB No. 0915–
xxxx—New.
Abstract: The National Health Service
Corps (NHSC), administered by the
Health Resources and Services
Administration, is committed to
improving the health of the nation’s
underserved by uniting communities in
need with caring health professionals
and by supporting communities’ efforts
to build better systems of care. The
NHSC programs provide scholarships
and repay educational loans for primary
care physicians, dentists, nurse
practitioners, physician assistants,
behavioral health providers, and other
primary care providers who agree to
practice in areas of the country that
need them most. The NHSC invites
individuals who are affiliated with
academic, clinical, trade, and other
public health related organizations to
apply to be volunteers within the NHSC
Ambassador Program. NHSC
Ambassadors are dedicated volunteers
who help educate and inform
prospective NHSC members.
Ambassadors give their time and talents
to spread the word about the
opportunities available through the
NHSC and serve as additional local
resources for current NHSC members.
NHSC Ambassadors inspire and
motivate students and providers to
provide primary health care in
communities with limited access to
care.
The NHSC Ambassador Portal will
serve as both the application interface
for interested individuals to apply and
become NHSC Ambassadors, as well the
ADDRESSES:
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public-facing online searchable database
of Ambassador contact information.
Applicants will create individual
Ambassador profiles that will contain
information such as name, email
address(es), professional/employment
information (including organization
name and address or the school which
they attend), phone number(s), which
discipline of students and/or
professionals they interact with, and a
brief reason why they would like to be
an Ambassador. Completed applications
will be forwarded through the portal to
NHSC staff for approval. If approved,
the NHSC Ambassadors will have the
opportunity to add brief professional
biographies and social network
addresses to their profile. Assistance in
completing the application will be
provided through prompts via the
online portal and also through the
NHSC Customer Care Center, if
necessary.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to create a
database where interested parties can
search for NHSC Ambassadors (that
meet specific search criteria) to serve as
local resources on the NHSC programs.
The other purpose is that NHSC can
have access to volunteers who are
available to spread important
programmatic information on behalf of
the NHSC.
Likely Respondents: Individuals who
are affiliated with academic, clinical,
trade, and other public health related
organizations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
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]]>Agencies
[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14055-14056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05410]
-----------------------------------------------------------------------
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 VIMIZIM (elosulfase alfa), manufactured by BioMarin
Pharmaceutical, Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Vicki Moyer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6467, Silver Spring, MD 20993-0002, 301-
796-2200, FAX: 301-796-9855, vicki.moyer@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 VIMIZIM (elosulfase alfa), manufactured by BioMarin
Pharmaceutical, Inc., meets the criteria for a priority review
[[Page 14056]]
voucher. VIMIZIM (elosulfase alfa) is indicated for the treatment of
Mucopolysaccharidosis Type IV A (Morquio A syndrome). Morquio A
syndrome is a rare congenital disorder caused by the absence or
malfunctioning of an enzyme involved in an important metabolic pathway,
leading to problems with bone development, growth, and movement.
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 VIMIZIM (elosulfase alfa), go to the
Drugs@FDA Web site at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05410 Filed 3-11-14; 8:45 am]
BILLING CODE 4160-01-P
