[Federal Register: May 25, 2005 (Volume 70, Number 100)]
[Notices]
[Page 30126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my05-122]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pediatric Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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]
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