[Federal Register Volume 59, Number 129 (Thursday, July 7, 1994)]
[Unknown Section]
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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