[Federal Register Volume 68, Number 195 (Wednesday, October 8, 2003)]
[Notices]
[Page 58116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25443]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pediatric Subcommittee of the Anti-Infective Drugs 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 Subcommittee of the Anti-Infective 
Drugs Advisory Committee.
    General Function of the Subcommittee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 29, 2003, from 8 
a.m. to 5:30 p.m. and October 30, 2003, from 8 a.m. to 3:30 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD, 
301-556-2046.
    Contact Person: Thomas H. Perez, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, e-mail: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12530. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On October 29, 2003, the subcommittee will meet between 8 
a.m. and 3:30 p.m., to discuss the risk assessment and possible risk 
management strategies for hypothalamic pituitary adrenal (HPA) axis 
suppression in children who are treated for skin disorders with topical 
corticosteroids. Following this, from approximately 3:45 p.m. to 5:30 
p.m., the agency will report to the subcommittee on Adverse Event 
Reporting as mandated in section 17 of the Best Pharmaceuticals for 
Children Act (BPCA). The products to be discussed during this portion 
of the meeting include ZYRTEC (cetirizine), BUSULFEX (busulfan), COZAAR 
(losartan), NOLVADEX (tamoxifen), ACCUPRIL (quinapril), and SERZONE 
(nefazodone).
    On October 30, 2003, the subcommittee will meet between 8 a.m. and 
3:30 p.m., to discuss how to approach long-term monitoring for cancer 
occurrence among patients treated for atopic dermatitis with topical 
immunosuppressants.
    The background material for this meeting will be posted on the 
Internet when available or 1 working day before the meeting at http:// 
www.fda.gov/ohrms/dockets/ac/menu.htm.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person by October 21, 
2003. On October 29, 2003, oral presentations from the public will be 
scheduled between approximately 12:30 p.m. and 1:30 p.m. for issues 
related to atopic dermatitis, and between approximately 4:30 p.m. and 5 
p.m. for issues related to section 17 of the BPCA. On October 30, 2003, 
oral presentations from the public will be scheduled between 
approximately 12:30 p.m. and 1:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person by October 21, 2003, 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 Thomas Perez 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 2, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-25443 Filed 10-7-03; 8:45 am]
BILLING CODE 4160-01-S