[Federal Register Volume 60, Number 204 (Monday, October 23, 1995)]
[Notices]
[Pages 54379-54380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26153]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95C-0399]


United States Surgical Corp.; 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 
United States Surgical Corp. has filed a petition proposing that the 
color additive regulations be amended to provide for the safe use of 
D&C Violet No. 2 as a color additive in glycolide/dioxanone/
trimethylene carbonate tripolymer absorbable sutures for general 
surgery.

DATES: Written comments on the petitioner's environmental assessment by 
November 22, 1995.

ADDRESSES: 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: -Ellen M. Waldron, -Center for Food 
Safety and Applied Nutrition (HFS-216), -Food and Drug Administration, 
-200 C St. SW., -Washington, DC 20204,- 202-606-0202.
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 5C0248) has been filed by United States 
Surgical Corp., 150 Glover Ave., Norwalk, CT 06856. The petition 
proposes to amend the color additive regulations in Sec. 74.3602 D&C 
Violet No. 2 (21 CFR 74.3602) to provide for the safe use of D&C Violet 
No. 2 as a color additive in glycolide/dioxanone/trimethylene carbonate 
tripolymer absorbable sutures for general surgery.
    The potential environmental impact of this action is being 
reviewed. To encourage public participation consistent with regulations 
promulgated under the National Environmental Policy Act (40 CFR 1501.4 
(b)), the agency is placing the environmental assessment submitted with 
the petition that is the subject of this notice on public display at 
the Dockets Management Branch (address above) for 

[[Page 54380]]
public review and comment. Interested persons may, on or before 
November 22, 1995, submit to the Dockets Management Branch (address 
above) written comments. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place 
on public display any amendments to, or comments on, the petitioner's 
environmental assessment without further announcement in the Federal 
Register. If, based on its review, the agency finds that an 
environmental impact statement is not required and this petition 
results in a regulation, the notice of availability of the agency's 
finding of no significant impact and the evidence supporting that 
finding will be published with the regulation in the Federal Register 
in accordance with 21 CFR 25.40(c).

    Dated: October 10, 1995.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 95-26153 Filed 10-20-95; 8:45 am]
BILLING CODE 4160-01-F