Pediatric Advisory Committee; Notice of Meeting, 30126 [05-10436]
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30126
Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices
information within the meaning of the
Freedom of Information Act and FDA’s
implementing regulations (21 CFR
20.61).
Unless disclosure is required under
the Freedom of Information Act as
amended (5 U.S.C. 552), as determined
by the freedom of information officials
of the Department of Health and Human
Services or by a court, data contained in
the portions of this application that
have been specifically identified by
page number, paragraph, etc., by the
applicant as containing restricted
information, shall not be used or
disclosed except for evaluation
purposes.
Dated: May 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–10435 Filed 5–20–05; 2:41 pm]
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.
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 the
Department of Health and Human
Services (DHHS) under 45 CFR 46.407
on research involving children as
subjects that is conducted or supported
by DHHS, when that research is also
regulated by FDA.
Date and Time: The meeting will be
held on Wednesday, June 29, 2005, from
12:30 p.m. to 5 p.m. and on Thursday,
June 30, 2005, from 8 a.m. to 5 p.m.
Location: The Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Jan N. Johannessen,
Office of Science and Health
Coordination of the Office of the
Commissioner (HF–33), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, rm. 14C–06),
VerDate jul<14>2003
17:52 May 24, 2005
Jkt 205001
Rockville, MD 20857, 301–827–6687, or
by e-mail: jjohannessen@fda.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: On Wednesday, June 29,
2005, the committee will hear and
discuss the recommendation of the
Pediatric Ethics Subcommittee from its
meeting on June 28, 2005, regarding a
referral by an Institution Review Board
of a proposed clinical investigation
involving children as subjects that is
regulated by FDA and is conducted or
supported by DHHS. The committee
will also discuss a report by the agency
on Adverse Event Reporting, as
mandated in section 17 of the Best
Pharmaceuticals for Children Act
(BPCA), for ethinyl estradiol;
norgestimate (ORTHO TRI-CYCLEN),
ciprofloxacin (CIPRO), tolterodine
(DETROL LA), leflunomide (ARAVE),
paricalcitol (ZEMPLAR), zolmitriptan
(ZOMIG), dorzolamide (TRUSOPT).
On Thursday, June 30, 2005, the
committee will discuss a report by the
agency on Adverse Event Reporting, as
mandated in section 17 of the BPCA, for
methylphendidate (CONCERTA and
other methtylphenidates).
The background material will become
available no later than the day before
the meeting and will be posted under
the Pediatric Advisory Committee (PAC)
Docket site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm. (Click
on the year 2005 and scroll down to
PAC meetings).
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 by June 17, 2005. Oral
presentations from the public will be
scheduled on Wednesday, June 29,
2005, between approximately 3:20 p.m.
and 3:50 p.m., and Thursday, June 30,
2005, between approximately 1:30 p.m.
and 2:30 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person by June 17, 2005, 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.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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 notify Jan
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: May 19, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–10436 Filed 5–24–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0184]
Pediatric Ethics Subcommittee of the
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of the Pediatric Ethics
Subcommittee of the Pediatric Advisory
Committee of the Food and Drug
Administration (FDA). The meeting will
be open to the public.
Name of Committee: Pediatric Ethics
Subcommittee of the Pediatric Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Pediatric
Advisory Committee on certain
regulatory issues with regard to FDA
and Department of Health and Human
Services (HHS).
Date and Time: The meeting will be
held on June 28, 2005, from 8:30 a.m.
to 4 p.m.
Addresses: Electronic copies of the
documents for public review can be
viewed at the Pediatric Advisory
Committee (PAC) Docket site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm. (Click on the year 2005
and scroll down to Pediatric Ethics
Subcommittee meeting for 06–28–05.)
Electronic comments should be
submitted to https://www.fda.gov/
dockets/ecomments. Select Docket No.
2005N–0184, entitled ‘‘Surfactant IRB
Referral’’ and follow the prompts to
submit your statement. Written
comments should be submitted to
Division of Dockets Management (HFA–
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 70, Number 100 (Wednesday, May 25, 2005)]
[Notices]
[Page 30126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10436]
-----------------------------------------------------------------------
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 the
Department of Health and Human Services (DHHS) under 45 CFR 46.407 on
research involving children as subjects that is conducted or supported
by DHHS, when that research is also regulated by FDA.
Date and Time: The meeting will be held on Wednesday, June 29,
2005, from 12:30 p.m. to 5 p.m. and on Thursday, June 30, 2005, from 8
a.m. to 5 p.m.
Location: The Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Jan N. Johannessen, Office of Science and Health
Coordination of the Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, rm. 14C-06),
Rockville, MD 20857, 301-827-6687, or by e-mail: jjohannessen@fda.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: On Wednesday, June 29, 2005, the committee will hear and
discuss the recommendation of the Pediatric Ethics Subcommittee from
its meeting on June 28, 2005, regarding a referral by an Institution
Review Board of a proposed clinical investigation involving children as
subjects that is regulated by FDA and is conducted or supported by
DHHS. The committee will also discuss a report by the agency on Adverse
Event Reporting, as mandated in section 17 of the Best Pharmaceuticals
for Children Act (BPCA), for ethinyl estradiol; norgestimate (ORTHO
TRI-CYCLEN), ciprofloxacin (CIPRO), tolterodine (DETROL LA),
leflunomide (ARAVE), paricalcitol (ZEMPLAR), zolmitriptan (ZOMIG),
dorzolamide (TRUSOPT).
On Thursday, June 30, 2005, the committee will discuss a report by
the agency on Adverse Event Reporting, as mandated in section 17 of the
BPCA, for methylphendidate (CONCERTA and other methtylphenidates).
The background material will become available no later than the day
before the meeting and will be posted under the Pediatric Advisory
Committee (PAC) Docket site at https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm. (Click on the year 2005 and scroll down to PAC meetings).
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 by June 17, 2005.
Oral presentations from the public will be scheduled on Wednesday, June
29, 2005, between approximately 3:20 p.m. and 3:50 p.m., and Thursday,
June 30, 2005, between approximately 1:30 p.m. and 2:30 p.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person by June 17,
2005, 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.
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 notify Jan 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: May 19, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-10436 Filed 5-24-05; 8:45 am]
BILLING CODE 4160-01-S
