[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Rules and Regulations]
[Pages 39414-39415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18693]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 98C-0041]


Listing of Color Additives for Coloring Sutures; 
[Phthalocyaninato(2-)] Copper; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of June 2, 1999, for the final rule that appeared in the 
Federal Register of April 30, 1999 (64 FR 23185), and amended the color 
additive regulations to provide for the safe use of 
[phthalocyaninato(2-)] copper in coloring nonabsorbable sutures for 
general and opthalmic surgery made from a blend of poly(vinylidene 
fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene).

DATES: Effective date confirmed: June 2, 1999.

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: In the Federal Register of April 30, 1999 
(64 FR 23185), FDA amended 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 in coloring 
nonabsorbable sutures for

[[Page 39415]]

general and opthalmic surgery made from a blend of poly(vinylidene 
fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene).
     FDA gave interested persons until June 1, 1999, to file objections 
or requests for a hearing. The agency received no objections or 
requests for a hearing on the final rule. Therefore, FDA finds that the 
effective date of the final rule that published in the Federal Register 
of April 30, 1999, should be confirmed.

 List of Subjects in 21 CFR Part 74

     Color additives, Cosmetics, Drugs.
     Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and 
under authority delegated to the Commissioner of Food and Drugs (21 CFR 
5.10), notice is given that no objections or requests for a hearing 
were filed in response to the April 30, 1999, final rule. Accordingly, 
the amendments issued thereby became effective June 2, 1999.

    Dated: July 15, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-18693 Filed 7-21-99; 8:45 am]
BILLING CODE 4160-01-F