Pediatric Advisory Committee; Notice of Meeting, 38320-38321 [2014-15683]
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Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
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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:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Neglected Tropical Diseases of the
Developing World: Developing Drugs for
Treatment or Prevention.’’ The purpose
of this guidance is to assist sponsors in
the development of drugs for the
treatment or prevention of NTDs as
defined in section 524(a)(3) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360n(a)(3)).
NTDs are infectious diseases that are
generally rare or absent in developed
countries, but are often widespread in
developing countries. The availability of
new drugs that are safe and effective for
treatment or prevention of NTDs could
provide public health benefit for overall
global health.
This guidance addresses general
issues in drug development and
implementation of clinical trials for
NTDs. FDA will review and comment
on drug development plans and will
review new drug applications or
biologics license applications for new
drugs for NTDs, regardless of where the
clinical development program takes
place. Specifically, the guidance
provides a general overview of
nonclinical development
considerations, as well as clinical
development considerations and
regulatory paradigms. Other activities in
the Center for Drug Evaluation and
Research that pertain to NTDs are
summarized in the guidance. Listings of
guidance documents that are most
relevant to drug development for NTDs
are included in the guidance.
This guidance finalizes the draft
guidance issued August 24, 2011.
Comments on the draft guidance were
considered while finalizing this
guidance. Specifically, changes from the
draft guidance include descriptions of
new regulatory designations (Qualified
Infectious Disease Product;
Breakthrough Therapy).
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This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on developing drugs
for the treatment or prevention of
neglected tropical diseases of the
developing world. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 and
21 CFR part 314 have been approved
under OMB control numbers 0910–0014
and 0910–0001.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either http:
//www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15801 Filed 7–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00045
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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: Pediatric
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 September 23, 2014, from 8 a.m.
to 5:30 p.m.
Location: Bethesda Marriott, 5151
Pooks Hill Rd., Bethesda, MD 20814.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5154,
Silver Spring, MD 20993–0002, 301–
796–0885, 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 link, or call the advisory
committee information line to learn
about possible modifications before
coming to the meeting.
Agenda: The Pediatric Advisory
Committee will meet to discuss
pediatric-focused safety reviews, as
mandated by the Best Pharmaceuticals
for Children Act and the Pediatric
Research Equity Act for: AFINITOR
DISPERZ (everolimus); Berlin Heart
EXCOR® Pediatric Ventricular Assist
Device; CONTEGRA® Pulmonary
Valved Conduit; DYMISTA (azelastine
hydrochloride; fluticasone propionate);
Elana Surgical Kit; ENTERRA Therapy
System; LEVAQUIN (levofloxacin);
LEXIVA (fosamprenavir calcium);
QNASL (beclomethasone
diproprionate), Medtronic Melody®
Transcatheter Pulmonary Valve;
MENHIBRIX (Meningococcal Groups C
and Y and Haemophilus b Tetanus
Toxoid Conjugate Vaccine); SINGULAIR
(montelukast sodium); TREANDA
(bendamustine hydrochloride);
VERAMYST (fluticasone furoate);
VIREAD (tenofovirdisoproxil fumarate);
and VOLUVEN (6% hydroxyethyl starch
130/0.4 in 0.9% sodium chloride
injection).
FDA intends to make background
material available to the public no later
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38321
Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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
appropriate advisory committee 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 August 25, 2014.
Oral presentations from the public will
be scheduled between approximately
11:30 a.m. and 12:30 p.m. on September
23, 2014. 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 August 15, 2014. 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 August 18, 2014.
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 Walter
Ellenberg 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: June 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15683 Filed 7–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Ryan White HIV/AIDS Program, AIDS
Education and Training Centers,
Graduate Medical Education Grant
Under the Ryan White HIV/AIDS
Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of a Class Deviation from
Competition Requirements for the HIV/
AIDS Bureau’s (HAB) Ryan White HIV/
AIDS Program, AIDS Education and
Training Centers (AETC), Graduate
Medical Education (GME) Program
(H4A).
AGENCY:
HRSA will be issuing noncompetitive awards under the Ryan
White HIV/AIDS Program, AETC/GME
Program. Approximately $450,000 will
be made available in the form of a grant
to current grantees (listed in chart
below) during the budget period of July
1, 2014, through June 30, 2015. This
will: (1) Continue the current cohort and
provide support for one additional
cohort of graduate medical residents; (2)
continue to provide workforce
development that is integral to the
national interest through meeting
National HIV/AIDS Strategy goals, and
that enhances the implementation of the
Affordable Care Act; and (3) provide a
more robust program evaluation that
will yield sufficient data; and aid
HRSA/HAB in future decisions
regarding the replication and the
viability of a subsequent GME
competition. The scope of work does
not change.
SUMMARY:
Grantee/organization name
Grant No.
Yale University ..................................................................................................
Research Foundation of the State University of New York (SUNY) ................
Family Medicine Residency of Idaho ...............................................................
H4AHA22762
H4AHA22761
H4AHA22760
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Intended
recipients of the awards are the three
incumbent grantees of record (listed in
chart below). The amount of the noncompetitive awards is $150,000 per
grantee.
SUPPLEMENTARY INFORMATION:
Authority: Section 2692 of the Public
Health Service Act, 42, U.S.C. 300ff–111.
CFDA Number: 93.145
Project period: July 1, 2014, through
June 30, 2015.
Justification: The GME Program,
which has three funded grantees: Yale
University (H4AHA22762), Research
Foundation of the State University of
New York (H4AHA22761), and Family
Medicine Residency of Idaho
(H4AHA22760), is scheduled to end
June 30, 2014. The Ryan White HIV/
AIDS AETC/GME Program seeks to
provide a one-time non-competitive
award in order to avoid interruption in
continued HIV primary medical care
education at these three universities by
completing the current cohort and
producing one more cohort of graduates,
thus providing additional time to
accurately assess and evaluate the
success of the program. This is a
primary care training group, which
helps link critical HIV/AIDS resources
within and across communities to help
expand the clinician workforce capacity
to meet the growing demand for HIV
care by training their medical residents.
The purpose of the GME program
(which ties directly to the shortage of
primary health care providers in HIV/
AIDS care in the United States) is to
fund public and nonprofit private
entities and schools, and academic
health science centers in order to
expand opportunities to train medical
residents in HIV/AIDS care and
treatment. Grant funds are requested in
order to accomplish this purpose and
meet the three objectives described in
the above summary. This funding is
intended to bridge the gap until this
GME program may be competed again.
FOR FURTHER INFORMATION CONTACT:
Diana Travieso Palow, Branch Chief,
HIV Education Branch, Division of
Training and Capacity Development,
HAB/HRSA 5600 Fishers Lane,
Rockville, MD 20857, by email at
DPalow@hrsa.gov, or by phone at (301)
443–4405.
State
FY 2014
Supplemental
funding
CT
NY
ID
E:\FR\FM\07JYN1.SGM
$150,000
150,000
150,000
07JYN1
Revised project end
date
June 30, 2015.
June 30, 2015.
June 30, 2015
]]>Agencies
[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38320-38321]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15683]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Pediatric Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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: Pediatric 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 September 23, 2014, from
8 a.m. to 5:30 p.m.
Location: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD
20814.
Contact Person: Walter Ellenberg, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154,
Silver Spring, MD 20993-0002, 301-796-0885, 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 link, or call the advisory committee information
line to learn about possible modifications before coming to the
meeting.
Agenda: The Pediatric Advisory Committee will meet to discuss
pediatric-focused safety reviews, as mandated by the Best
Pharmaceuticals for Children Act and the Pediatric Research Equity Act
for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR[supreg]
Pediatric Ventricular Assist Device; CONTEGRA[supreg] Pulmonary Valved
Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate);
Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin);
LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate),
Medtronic Melody[supreg] Transcatheter Pulmonary Valve; MENHIBRIX
(Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid
Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA
(bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD
(tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch
130/0.4 in 0.9% sodium chloride injection).
FDA intends to make background material available to the public no
later
[[Page 38321]]
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 appropriate advisory committee 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
August 25, 2014. Oral presentations from the public will be scheduled
between approximately 11:30 a.m. and 12:30 p.m. on September 23, 2014.
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
August 15, 2014. 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 August 18, 2014.
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 Walter Ellenberg 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: June 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15683 Filed 7-3-14; 8:45 am]
BILLING CODE 4164-01-P
