[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20064]


[[Page Unknown]]

[Federal Register: August 16, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Advisory Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the agenda of the joint subcommittee meeting of the 
Nonprescription Drugs Advisory Committee and Arthritis Advisory 
Committee on Over-the-Counter Internal Analgesic, Antipyretic, and 
Antirheumatic Drug Products, which was announced in the Federal 
Register of July 11, 1994 (59 FR 35375). The change is being made to 
add an additional topic for discussion. There are no other changes. 
This amendment will be announced at the beginning of the open portion 
of the meeting.

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, 
FDA announced that a joint subcommittee meeting of the Nonprescription 
Drugs Advisory Committee and the Arthritis Advisory Committee would be 
held on September 8 and 9, 1994. On page 35375, in the second column, 
the ``open committee discussion'' portion of this meeting is amended to 
read as follows:
    Open committee discussion. On September 8 and 9, 1994, the joint 
subcommittee will discuss effectiveness data requirements and proposed 
labeling indications for OTC analgesic drug products. The joint 
subcommittee will address topics such as: (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. On the afternoon of September 9, 1994, the 
joint subcommittee will also discuss the proposed changes in the format 
of labeling for OTC drug products.

    Dated: August 10, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-20064 Filed 8-15-94; 8:45 am]
BILLING CODE 4160-01-F