[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17811]


[[Page Unknown]]

[Federal Register: July 22, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 343

[Docket No. 94N-0255]

 

Over-the-Counter Marketing of Internal Analgesic, Antipyretic, 
and Antirheumatic 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 Arthritis Advisory 
Committee on effectiveness data requirements and labeling for over-the-
counter (OTC) marketing of internal analgesic, antipyretic and 
antirheumatic drug products scheduled for September 8 and 9, 1994. The 
background information is being made available to ensure that all 
interested parties are aware of the issues that are the subject of the 
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 August 15, 1994 , in order for 
written comments to be considered for discussion at the September 8 and 
9, 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 the 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, Center for Drug 
Evaluation and Research (HFD-9), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4695.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 11, 1994 (59 
FR 35375), FDA announced that a forthcoming joint meeting of the 
Nonprescription Drugs Advisory Committee and the Arthritis Advisory 
Committee on effectiveness data requirements and labeling for over-the-
counter (OTC) marketing of internal analgesic, antipyretic and 
antirheumatic drug products will be held on September 8 and 9, 1994. 
FDA is holding this meeting to discuss:
    (1) Data requirements to support specific types of indications for 
OTC analgesic drug products;
    (2) Recommendations for labeling indications for OTC analgesics; 
and
    (3) The current state of scientific knowledge in the areas of pain 
receptors, mechanism(s) of pain perception, and the basis for response 
to analgesic drug classes.
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-0255 to enable interested 
persons to submit comments or other relevant data on the background 
document.

    Dated: July 15, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-17811 Filed 7-21-94; 8:45 am]
BILLING CODE 4160-01-F