Pediatric Advisory Committee; Notice of Meeting, 49272 [2013-19522]
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49272
Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Notices
IV. Electronic Access
Persons with access to the Internet
may obtain this draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: August 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–19532 Filed 8–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ehiers on DSK2VPTVN1PROD 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: 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 19, 2013, from 10
a.m. to 5:30 p.m. and September 20,
2013, from 8 a.m. to 1 p.m.
Location: Doubletree Hilton Hotel,
8727 Colesville Rd., Silver Spring, MD
20910, 301–589–5200 or visit the hotel’s
Web site at https://
doubletree3.hilton.com/en/hotels/
maryland/doubletree-by-hilton-hotelwashington-dc-silver-spring-DCASSDT/
index.html.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 301–796–
0885, email
walter.ellenberg@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://
VerDate Mar<15>2010
15:31 Aug 12, 2013
Jkt 229001
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: On September 19, 2013, and
September 20, 2013, the Pediatric
Advisory Committee (PAC) will meet to
discuss pediatric-focused safety
reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the for Pediatric
Research Equity Act (Pub. L. 108–155).
On September 19, 2013, the PAC will
meet to discuss Cervarix (human
papillomavirus Bivalent (Types 16 and
18) vaccine); Gammagard Liquid
(Immune Globulin Infusion (human));
Hemacord (hematopoietic progenitor
cells, cord blood); Copegus and Pegasys
(rivabirin and peginterferon alfa-2a);
Chantix (varenicline tartrate); Isentress
(raltegravir potassium); Intuniv
(guanfacine), Topamax (topiramate);
Faslodex (fulvestrant); Ixempra Kit
(ixabepilone); and Plavix (clopidogrel
bisulfate). An update on the drug
program for KidNet will be provided.
On September 20, 2013, the PAC will
meet to discuss the Berlin Heart EXCOR
Pediatric Ventricular Assist Device;
Melody Transcatheter Pulmonary Heart
Valve (TPV); and Elana Surgical Kit
(HUD). On September 20, 2013, the
committee will also receive and discuss
a report on the September 9 and 10,
2013, meeting of the Pediatric Ethics
Subcommittee of the PAC concerning
their discussion of the ethical issues
involved in the development of
pediatric medical countermeasures.
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
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 August 30, 2013.
Oral presentations from the public will
be scheduled on September 19, 2013,
between approximately 11:30 a.m. and
12 noon, and on September 20, 2013,
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
between 10:30 a.m. and 11 a.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 August 22, 2013. 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 26, 2013.
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 301–796–0885, email
walter.ellenberg@fda.hhs.gov, 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: August 6, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–19522 Filed 8–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\13AUN1.SGM
Notice.
13AUN1
]]>Agencies
[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Page 49272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-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 19, 2013, from
10 a.m. to 5:30 p.m. and September 20, 2013, from 8 a.m. to 1 p.m.
Location: Doubletree Hilton Hotel, 8727 Colesville Rd., Silver
Spring, MD 20910, 301-589-5200 or visit the hotel's Web site at https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-washington-dc-silver-spring-DCASSDT/.
Contact Person: Walter Ellenberg, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 301-796-0885, email
walter.ellenberg@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: On September 19, 2013, and September 20, 2013, the
Pediatric Advisory Committee (PAC) will meet to discuss pediatric-
focused safety reviews, as mandated by the Best Pharmaceuticals for
Children Act (Pub. L. 107-109) and the for Pediatric Research Equity
Act (Pub. L. 108-155).
On September 19, 2013, the PAC will meet to discuss Cervarix (human
papillomavirus Bivalent (Types 16 and 18) vaccine); Gammagard Liquid
(Immune Globulin Infusion (human)); Hemacord (hematopoietic progenitor
cells, cord blood); Copegus and Pegasys (rivabirin and peginterferon
alfa-2a); Chantix (varenicline tartrate); Isentress (raltegravir
potassium); Intuniv (guanfacine), Topamax (topiramate); Faslodex
(fulvestrant); Ixempra Kit (ixabepilone); and Plavix (clopidogrel
bisulfate). An update on the drug program for KidNet will be provided.
On September 20, 2013, the PAC will meet to discuss the Berlin Heart
EXCOR Pediatric Ventricular Assist Device; Melody Transcatheter
Pulmonary Heart Valve (TPV); and Elana Surgical Kit (HUD). On September
20, 2013, the committee will also receive and discuss a report on the
September 9 and 10, 2013, meeting of the Pediatric Ethics Subcommittee
of the PAC concerning their discussion of the ethical issues involved
in the development of pediatric medical countermeasures.
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 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
August 30, 2013. Oral presentations from the public will be scheduled
on September 19, 2013, between approximately 11:30 a.m. and 12 noon,
and on September 20, 2013, between 10:30 a.m. and 11 a.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
August 22, 2013. 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 26, 2013.
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
301-796-0885, email walter.ellenberg@fda.hhs.gov, 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: August 6, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-19522 Filed 8-12-13; 8:45 am]
BILLING CODE 4160-01-P
