[Federal Register Volume 59, Number 185 (Monday, September 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23774]
[[Page Unknown]]
[Federal Register: September 26, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94C-0312]
ProMedica International; 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
ProMedica International has filed a petition proposing that the color
additive regulations be amended to provide for the safe use of
[phthalocyaninato(2-)] copper as a color additive in nonabsorbable
polyvinylidene fluoride sutures intended for use in general and
ophthalmic surgery.
DATES: Written comments on the petitioner's environmental assessment by
October 26, 1994.
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: Mitchell Cheeseman, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3083.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (sec. 721(b)(5) (21 U.S.C. 379e(b)(5))), notice is given that a
color additive petition (CAP 4C0244) has been filed by ProMedica
International, 620 Newport Center Dr., suite 575, Newport Beach, CA
92660. The petition proposes to amend the color additive regulations in
Sec. 74.3045 [Phthalocyaninato(2-)] copper (21 CFR 74.3045) to provide
for the safe use of [phthalocyaninato(2-)] copper as a color additive
in nonabsorbable polyvinylidene fluoride sutures intended for use in
general and ophthalmic 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
public review and comment. Interested persons may, on or before October
26, 1994, 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: September 15, 1994.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety
and Applied Nutrition.
[FR Doc. 94-23774 Filed 9-23-94; 8:45 am]
BILLING CODE 4160-01-F
