[Federal Register Volume 63, Number 163 (Monday, August 24, 1998)]
[Notices]
[Page 45073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98C-0676]


Warner-Jenkinson Co., Inc.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Warner-Jenkinson Co., Inc., has filed a petition proposing that the 
color additive regulations be amended to provide for the safe use of 
External D&C Violet No. 2 in coloring externally applied drug products.

FOR FURTHER INFORMATION CONTACT:  Vivian M. Gilliam, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3167.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 721(d)(1) (21 U.S.C. 379e(d)(1)), notice is given that a 
color additive petition (CAP 8C0261) has been filed by Warner-Jenkinson 
Co., Inc., 107 Wade Ave., South Plainfield, NJ 07080. The petition 
proposes to amend the color additive regulations to provide for the 
safe use of External D&C Violet No. 2 in coloring externally applied 
drug products.
    The agency has determined under 21 CFR 25.32(l) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: July 28, 1998.
Laura M. Tarantino,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 98-22569 Filed 8-21-98; 8:45 am]
BILLING CODE 4160-01-F