[Federal Register Volume 59, Number 129 (Thursday, July 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16364]


[[Page Unknown]]

[Federal Register: July 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 341

[Docket No. 94N-0232]

 

Over-the-Counter Marketing of Antiasthma Drug Products; 
Background Document for Advisory Committee Meeting; Availability; 
Establishment of a Public Docket and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Availability of background document; establishment of a public 
docket and request for comments.

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SUMMARY: The Food and Drug Administration is announcing the 
availability of a background document for the joint meeting of the 
Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy 
Drugs Advisory Committee, on the over-the-counter (OTC) marketing of 
antiasthma drug products. Elsewhere in this issue of the Federal 
Register, the agency is announcing the joint meeting. This action is 
being taken to ensure that all interested parties are aware of the 
issues that are the subject of the joint committee discussion. FDA is 
also announcing that it is establishing a public docket for comments, 
views, and other information submitted to the agency on these subjects 
from interested persons.

DATES: Submit written comments by September 30, 1994, in order for 
written comments to be considered for discussion at the November 14, 
1994, advisory committee meeting.

ADDRESSES: Submit written comments or relevant data and requests for 
single copies of the background document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857. Comments and requests should be 
identified with the docket number found in brackets in the heading of 
this document. Send two self-addressed adhesive labels to assist the 
branch in processing your requests. Three copies of written comments 
should be submitted, except that individuals may submit one copy. The 
background document and received comments are available for public 
examination at the Dockets Management Branch (address above), between 9 
a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger, or Leander B. Madoo, 
Center for Drug Evaluation and Research (HFD-9), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695.

SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the Federal 
Register, FDA is announcing a forthcoming joint meeting of the 
Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy 
Drugs Advisory Committee, on OTC marketing of antiasthma drug products. 
FDA is holding this meeting to discuss:
    (1) OTC bronchodilator drug products currently available and 
possible pending changes in their status;
    (2) Whether there is a population for which OTC antiasthma drug 
products are appropriate;
    (3) The general question of whether antiasthma drug products should 
be available OTC;
    (4) Antiasthma drug products currently available by prescription 
only that could be considered for OTC status; and
    (5) Data requirements necessary to support conversion of 
prescription antiasthma drug products to OTC status.
The purpose of this meeting is to address specific topics and questions 
contained in the background document that could result in future 
rulemaking.
    FDA has established public docket no. 94N-0232 to enable interested 
persons to submit comments or other relevant data on the background 
document that could result in future rulemaking.


    Dated: June 30, 1994.
 Linda A. Suydam,
 Interim Deputy Commissioner for Operations.
[FR Doc. 94-16364 Filed 7-6-94; 8:45 am]
BILLING CODE 4160-01-F