[Federal Register: June 2, 2004 (Volume 69, Number 106)]
[Notices]               
[Page 31126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn04-63]                         


[[Page 31126]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Pulmonary-Allergy Drugs Advisory 
Committee. This meeting was announced in the Federal Register of May 
11, 2004 (69 FR 26169). The amendment is being made to reflect a change 
in the location portion of the meeting, a clarification in the agenda 
portion of the meeting, and a change in the procedure portion regarding 
the time for the open public hearing session. There are no other 
changes.

FOR FURTHER INFORMATION CONTACT: Shalini Jain, 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, FAX: 301-827-6776, or e-mail: 
jains@cder.fda.gov, 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 11, 2004, FDA 
announced that a meeting of the Pulmonary-Allergy Drugs Advisory 
Committee will be held on June 10, 2004. On page 26170, in the first 
column, the location, agenda, and procedure portions of the meeting are 
amended to read as follows:
    Location: Holiday Inn, Two Montgomery Village Ave., Gaithersburg, 
MD.
    Agenda: The committee will discuss whether the use of 
chlorofluorocarbons (CFCs) as propellants in albuterol metered-dose 
inhalers (MDIs) is no longer an essential use under the criteria as set 
forth in the Code of Federal Regulations (21 CFR Sec.  2.125(g)).
    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 24, 2004. 
Oral presentations from the public will be scheduled between 
approximately 12:30 p.m. to 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 May 24, 2004, 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.
    This notice is given under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: May 25, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-12365 Filed 5-28-04; 8:45 am]

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