[Federal Register Volume 59, Number 10 (Friday, January 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1083]


[[Page Unknown]]

[Federal Register: January 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 347

[Docket No. 78N-0021]

 

Talc; Consumer Uses and Health Perspectives; Public Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings.

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SUMMARY: The Food and Drug Administration (FDA) and the International 
Society of Regulatory Toxicology and Pharmacology (ISRTP) are 
announcing forthcoming public meetings to discuss the latest 
toxicologic and epidemiologic studies and how they reflect on issues 
related to the safe use of talc in consumer products.

DATES: The meetings will be held on Monday, January 31, 1994, and 
Tuesday, February 1, 1994, 9 a.m. to 4:30 p.m. Registration by January 
15, 1994, is required. Interested persons, whether or not they are able 
to attend, may submit written comments on the skin protectant drug 
product aspects of the issues described in this notice by March 2, 
1994, referencing the docket number found in the heading of this 
document. Three copies of all comments are to be submitted, except that 
individuals may submit one copy.

ADDRESSES: The meetings will be held at the Lister Hill Auditorium, 
National Institutes of Health, Bethesda, MD. Submit written comments to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    Regarding registration and over-the-counter (OTC) skin protectant 
drug products contact: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5000.
    Regarding cosmetic products contact: John E. Bailey, Jr., Center 
for Food Safety and Applied Nutrition (HFS-100), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4530.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 20, 1990 (55 
FR 25204 at 25232), FDA proposed talc, 45 to 100 percent, as Category I 
(generally recognized as safe and effective and not misbranded) as an 
OTC skin protectant active ingredient for the treatment and prevention 
of diaper rash. Specific warnings and directions were proposed for 
powder products containing talc. The final monograph for OTC skin 
protectant drug products will be published in a future issue of the 
Federal Register. The discussion of talc at these public meetings may 
be considered by the agency in the preparation of this final monograph 
for OTC skin protectant drug products.
    The purpose of these meetings is to provide a forum for an updated 
discussion of the origins, manufacture, characterization, toxicology, 
and epidemiology of talc and related products. The principal focus will 
be on the latest toxicologic and epidemiologic studies, particularly as 
they reflect on the safe uses of talc in consumer products.
    The following topic areas will be discussed: (1) Characteristics of 
cosmetic-grade talc; (2) a history of the uses of talc in a variety of 
consumer products; (3) current quality control measures to insure 
safety; (4) the regulatory history of talc; (5) recent National 
Toxicology Program studies of chronic pulmonary exposure of rodents to 
talc and the relevance of these studies to human risk assessment; and 
(6) the significance of contrasting epidemiologic studies of talc 
exposure. Speakers and panelists will include well-known regulatory 
specialists, toxicologists, epidemiologists, pathologists, talc product 
manufacturers, talc production experts, and consumer representatives. A 
critical panel discussion by speakers and invited experts will complete 
each session.

    Dated: January 11, 1994
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-1083 Filed 1-12-94; 8:47 am]
BILLING CODE 4160-01-F