04-12365. Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: [phone], or e-mail: [e-mail], 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 § 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.