Epilepsy Program, 59197-59198 [2012-23656]
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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anti-Infective
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 28, 2012, from 8 a.m.
to 5 p.m.
Location: DoubleTree by Hilton Hotel
Washington DC—Silver Spring, The
Ballroom, 8727 Colesville Rd., Silver
Spring, MD. The hotel’s phone number
is 301–589–5200.
Contact Person: Diane Goyette, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
AIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
the safety and efficacy of new drug
application (NDA) 204384, bedaquiline
tablets, submitted by Janssen
Therapeutics, Division of Janssen
Products, LP. The proposed indication
(use) for this product is for the treatment
of patients with multi-drug resistant
pulmonary tuberculosis.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
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appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 13, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 2, 2012. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 5, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Diane
Goyette at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 18, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–23573 Filed 9–25–12; 8:45 am]
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59197
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Epilepsy Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Noncompetitive
Program Expansion Supplement Award
to the Epilepsy Foundation of America.
AGENCY:
The Health Resources and
Services Administration will be issuing
noncompetitive supplemental funding
under the Maternal and Child Health
Bureau’s Epilepsy Program to the
Epilepsy Foundation of America
(U23MC19824) to support additional
evaluation activities.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Epilepsy Foundation of America.
Amount of the Noncompetitive
Supplemental Funding: $250,700.
SUMMARY:
Authority: Section 501(a)(2) of the Social
Security Act, as amended.
CFDA Number: 93.110.
Project Period: September 1, 2012,
through August 31, 2013, for a total of
12 months.
Justification for the Exception to
Competition: The Epilepsy Foundation
of America currently contracts with
Mathematica to evaluate the HRSA
Epilepsy Program. There is a need to
increase their allotted award through
program expansion supplemental funds
to support additional evaluation
activities for Year 3. Mathematica will
conduct a more comprehensive
evaluation of the entire Epilepsy
Program in order to determine the
extent to which the program has
addressed the legislative requirements,
increased access to care in medically
underserved areas, and developed/
implemented evidence-based strategies
to achieve the legislative purpose of the
program. As a result of the evaluation,
a quality improvement strategy for the
Epilepsy Program will be developed and
implemented by the Quality
Improvement (QI) contractor. Results
should provide a more comprehensive
understanding of the impact across the
entire program. Indicators and measures
developed will also be used for the next
competitive cycle to track performance,
quality and outcomes within the context
of the legislation and the newly
published Institute of Medicine
recommendations for the Epilepsies,
focusing on evaluating prevention
efforts.
Mathematica, John Snow Inc. (QI
Contractor), and the Epilepsy
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59198
Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Notices
Foundation of America will work
collectively to develop an evaluation
plan that will contain state, local,
community/stakeholder and family
perspectives on the overall impact of
services for the Epilepsy Program.
FOR FURTHER INFORMATION CONTACT:
Diana Denboba, Chief, Integrated
Services Branch, Division of Services for
Children with Special Health Needs,
Maternal and Child Health Bureau,
HRSA, 5600 Fishers Lane, Room 13–61,
Rockville, Maryland 20857, via email at
ddenboba@hrsa.gov or call 301–443–
2370.
Dated: September 20, 2012.
Mary K. Wakefield,
Administrator.
[FR Doc. 2012–23656 Filed 9–25–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Projects: Fungal Secondary Metabolites.
Date: October 10, 2012.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Richard Panniers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2212,
MSC 7890, Bethesda, MD 20892, (301) 435–
1741, pannierr@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Innovative Neuroscience K–12
Education.
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Date: October 23–24, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Jonathan Arias, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5170,
MSC 7840, Bethesda, MD 20892, 301–435–
2406, ariasj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Surgical
Sciences and Bioengineering.
Date: October 23, 2012.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Malgorzata Klosek, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188,
MSC 7849, Bethesda, MD 20892, (301) 435–
2211, klosekm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Healthcare
Delivery and Methodologies Academic
Research Enhancement Review.
Date: October 24, 2012.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814,
Contact Person: Melinda Jenkins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3156,
MSC 7770, Bethesda, MD 20892, 301–437–
7872, jenkinsml2@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Drug
Discovery for the Nervous System.
Date: October 24, 2012.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Geoffrey G. Schofield,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040–A,
MSC 7850, Bethesda, MD 20892, 301–435–
1235, geoffreys@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Electrical Signaling, Ion Transport,
and Arrhythmias Study Section.
Date: October 25, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301)435–
1195, Chengy5@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Acute Neural Injury and Epilepsy
Study Section.
Date: October 25–26, 2012.
Time: 8 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Avenue NW., Washington, DC 20037,
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group;
Molecular Oncogenesis Study Section.
Date: October 25–26, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Nywana Sizemore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6204,
MSC 7804, Bethesda, MD 20892, 301–435–
1718, sizemoren@csr.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Musculoskeletal Rehabilitation Sciences
Study Section.
Date: October 25–26, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Mayflower Park Hotel, 405 Olive
Way, Seattle, WA 98101.
Contact Person: Jo Pelham, BA, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4102, MSC 7814, Bethesda, MD
20892, (301) 435–1786, pelhamj@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 19, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–23623 Filed 9–25–12; 8:45 am]
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[Federal Register Volume 77, Number 187 (Wednesday, September 26, 2012)]
[Notices]
[Pages 59197-59198]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Epilepsy Program
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of Noncompetitive Program Expansion Supplement Award to
the Epilepsy Foundation of America.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration will be
issuing noncompetitive supplemental funding under the Maternal and
Child Health Bureau's Epilepsy Program to the Epilepsy Foundation of
America (U23MC19824) to support additional evaluation activities.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: Epilepsy Foundation of America.
Amount of the Noncompetitive Supplemental Funding: $250,700.
Authority: Section 501(a)(2) of the Social Security Act, as
amended.
CFDA Number: 93.110.
Project Period: September 1, 2012, through August 31, 2013, for a
total of 12 months.
Justification for the Exception to Competition: The Epilepsy
Foundation of America currently contracts with Mathematica to evaluate
the HRSA Epilepsy Program. There is a need to increase their allotted
award through program expansion supplemental funds to support
additional evaluation activities for Year 3. Mathematica will conduct a
more comprehensive evaluation of the entire Epilepsy Program in order
to determine the extent to which the program has addressed the
legislative requirements, increased access to care in medically
underserved areas, and developed/implemented evidence-based strategies
to achieve the legislative purpose of the program. As a result of the
evaluation, a quality improvement strategy for the Epilepsy Program
will be developed and implemented by the Quality Improvement (QI)
contractor. Results should provide a more comprehensive understanding
of the impact across the entire program. Indicators and measures
developed will also be used for the next competitive cycle to track
performance, quality and outcomes within the context of the legislation
and the newly published Institute of Medicine recommendations for the
Epilepsies, focusing on evaluating prevention efforts.
Mathematica, John Snow Inc. (QI Contractor), and the Epilepsy
[[Page 59198]]
Foundation of America will work collectively to develop an evaluation
plan that will contain state, local, community/stakeholder and family
perspectives on the overall impact of services for the Epilepsy
Program.
FOR FURTHER INFORMATION CONTACT: Diana Denboba, Chief, Integrated
Services Branch, Division of Services for Children with Special Health
Needs, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Room
13-61, Rockville, Maryland 20857, via email at ddenboba@hrsa.gov or
call 301-443-2370.
Dated: September 20, 2012.
Mary K. Wakefield,
Administrator.
[FR Doc. 2012-23656 Filed 9-25-12; 8:45 am]
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