[Federal Register Volume 62, Number 84 (Thursday, May 1, 1997)]
[Notices]
[Page 23781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11238]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97C-0171]
Closure Medical Corp.; Filing of Color Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Closure Medical Corp. filed a petition proposing that the color
additive regulations be amended to provide for the safe use of D&C
Violet No. 2 to color 2-octyl cyanoacrylate topical tissue adhesives.
DATES: Written comments on the petitioner's environmental assessment by
June 2, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3089.
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 7C0250) has been filed by Closure Medical
Corp., 5265 Capital Blvd., Raleigh, NC 27616. 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 to
color 2-octyl cyanoacrylate topical tissue adhesives.
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
public review and comment. Interested persons may, on or before June 2,
1997, 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: April 16, 1997.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and
Applied Nutrition.
[FR Doc. 97-11238 Filed 4-30-97; 8:45 am]
BILLING CODE 4160-01-F
