Pediatric Advisory Committee; Notice of Meeting, 62595 [E6-17965]
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Federal Register / Vol. 71, No. 207 / Thursday, October 26, 2006 / Notices
Dated: October 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–17932 Filed 10–25–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ycherry on PROD1PC64 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. The committee
also advises and makes
recommendations to the Secretary of
Health and Human Services under 21
CFR 50.54 and 45 CFR 46.407 on
research involving children as subjects
that is conducted or supported by the
Department of Health and Human
Services, when that research is also
regulated by FDA.
Date and Time: The meeting will be
held on November 16, 2006, from 8 a.m.
to 4 p.m.
Location: Advisory Committee
Conference Room, rm. 1066, 5630
Fishers Lane, Rockville, MD.
Contact Person: Jan Johannessen,
Office of Science and Health
Coordination, Office of the
Commissioner (HF–33), Food and Drug
Administration, 5600 Fishers Lane, (for
express delivery, rm. 14B–08),
Rockville, MD 20857, 301–827–6687, email: Jan.Johannessen@fda.hhs.gov or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
8732310001. Please call the Information
Line for up to date information on this
meeting.
Agenda: The Pediatric Advisory
Committee will hear and discuss a
report by the agency, as mandated in
section 17 of the Best Pharmaceuticals
for Children Act, on adverse event
reports for ertapenem (INVANZ),
gemcitabine (GEMZAR), glimepiride
(AMARYL), insulin aspart recombinant
(NOVOLOG), linezolid (ZYVOX),
meloxicam (MOBIC), ondansetron
VerDate Aug<31>2005
15:21 Oct 25, 2006
Jkt 211001
(ZOFRAN), oxcarbazepine
(TRILEPTAL), ritonavir (NORVIR),
rosiglitazone (AVANDIA), sirolimus
(RAPAMUNE). The committee will also
receive updates to adverse event reports
for atorvastatin (LIPITOR), citalopram
(CELEXA), oseltamivir (TAMIFLU),
oxybutynin (DITROPAN), and
simvastatin (ZOCOR), which were
requested by the Pediatric Advisory
Committee or its predecessor, the
Pediatric Subcommittee of the AntiInfective Drugs Advisory Committee,
when the reports were first presented.
The background material will become
available no later than 1 business day
before the meeting and will be posted
on FDA’s Web site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm. (Click on the year 2006
and scroll down to Pediatric 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 November 1, 2006.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. and 2:30 p.m. on November
16, 2006. Time allotted for each
presentation may be limited. Those
desiring to make 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 by
November 1, 2006.
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 Jan N.
Johannessen at least 7 days in advance
of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–17965 Filed 10–25–06; 8:45 am]
BILLING CODE 4160–01–S
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62595
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0408]
Draft Guidance for Industry and Food
and Drug Administration Staff; Annual
Reports for Approved Premarket
Approval Applications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Annual Reports for Approved
Premarket Approval Applications.’’ This
draft guidance document outlines the
information required by a certain FDA
regulation in periodic reports (usually
referred to as annual reports) and FDA’s
recommendations for the level of detail
that manufacturers should provide. This
draft guidance is not final nor is it in
effect at this time.
DATES: Submit written or electronic
comments on this draft guidance by
January 24, 2007. Submit written or
electronic comments on the collection
of information by December 26, 2006.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Annual Reports for
Approved Premarket Approval
Applications’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 240–276–
3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this draft guidance and the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
For device issues: Laura Byrd, Center
for Devices and Radiological Health
(HFZ–402), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301–
594–2186.
For biologics issues: Leonard Wilson,
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 71, Number 207 (Thursday, October 26, 2006)]
[Notices]
[Page 62595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17965]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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. The committee
also advises and makes recommendations to the Secretary of Health and
Human Services under 21 CFR 50.54 and 45 CFR 46.407 on research
involving children as subjects that is conducted or supported by the
Department of Health and Human Services, when that research is also
regulated by FDA.
Date and Time: The meeting will be held on November 16, 2006, from
8 a.m. to 4 p.m.
Location: Advisory Committee Conference Room, rm. 1066, 5630
Fishers Lane, Rockville, MD.
Contact Person: Jan Johannessen, Office of Science and Health
Coordination, Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane, (for express delivery, rm. 14B-08),
Rockville, MD 20857, 301-827-6687, e-mail: Jan.Johannessen@fda.hhs.gov
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 8732310001. Please call the
Information Line for up to date information on this meeting.
Agenda: The Pediatric Advisory Committee will hear and discuss a
report by the agency, as mandated in section 17 of the Best
Pharmaceuticals for Children Act, on adverse event reports for
ertapenem (INVANZ), gemcitabine (GEMZAR), glimepiride (AMARYL), insulin
aspart recombinant (NOVOLOG), linezolid (ZYVOX), meloxicam (MOBIC),
ondansetron (ZOFRAN), oxcarbazepine (TRILEPTAL), ritonavir (NORVIR),
rosiglitazone (AVANDIA), sirolimus (RAPAMUNE). The committee will also
receive updates to adverse event reports for atorvastatin (LIPITOR),
citalopram (CELEXA), oseltamivir (TAMIFLU), oxybutynin (DITROPAN), and
simvastatin (ZOCOR), which were requested by the Pediatric Advisory
Committee or its predecessor, the Pediatric Subcommittee of the Anti-
Infective Drugs Advisory Committee, when the reports were first
presented.
The background material will become available no later than 1
business day before the meeting and will be posted on FDA's Web site at
https://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2006
and scroll down to Pediatric 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
November 1, 2006. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. on November 16, 2006.
Time allotted for each presentation may be limited. Those desiring to
make 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 by November 1, 2006.
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 Jan N. Johannessen
at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-17965 Filed 10-25-06; 8:45 am]
BILLING CODE 4160-01-S
