[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Page 15866]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pulmonary-Allergy 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: Pulmonary-Allergy Drugs 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 June 6, 2005, from 8 
a.m. to 5:30 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Teresa A. Watkins, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane, rm. 
1093, Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512545. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will consider the safety and efficacy of new 
drug application (NDA) 50-799, proposed trade name PULMINIQ 
(cyclosporine, inhalation solution) Chiron Corp., for use in 
combination with standard immunosuppressive therapy to increase 
survival and prevent chronic rejection in patients receiving allogenic 
lung transplants.
    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 May 26, 2005. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before May 26, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 La'Nise Giles at 
301-827-7001 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: March 21, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-6087 Filed 3-28-05; 8:45 am]