Document ID: FDA-2011-C-0344-0005
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date
Posted Date: 2013-06-25T04:00Z

[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Rules and Regulations]
[Pages 37962-37963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15111]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463]

Listing of Color Additives Exempt From Certification; Reactive 
Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective 
Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of May 2, 2013, for the final rule that published in the 
Federal Register of April 1, 2013 (78 FR 19413), and that amended the 
color additive regulations to provide for the safe use of additional 
copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone 
(C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester 
(C.I. Reactive Blue 247) as color additives in contact lenses.

DATES: Effective date confirmed: May 2, 2013.

FOR FURTHER INFORMATION CONTACT: Regarding CAP 1C0291 (C.I. Reactive 
Blue 246): Judith Kidwell, Center for Food Safety and Applied Nutrition 
(HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740-3835, 240-402-1071. Regarding CAP 1C0292 (C.I. 
Reactive Blue 247): Teresa Croce, Center for Food Safety and Applied 
Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740-3835, 240-402-1281.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 1, 2013, we 
amended the color additive regulations in Sec. Sec.  73.3100 and 
73.3106 (21 CFR 73.3100 and 73.3106), respectively, to provide for the 
safe use of additional copolymers of 1,4-bis[(2-hydroxyethyl)amino]-
9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 
247) and additional copolymers of 1,4-bis[4-(2-
methacryloxyethyl)phenylamino] corrected the nomenclature for Reactive 
Blue 247 by inserting ``2-methyl'' before ``2-propenoic.''
    We gave interested persons until May 1, 2013, to file objections or 
requests for a hearing. We received no objections or requests for a 
hearing on the final rule. Therefore, we find that the effective date 
of the final rule that published in the Federal Register of April 1, 
2013, should be confirmed.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, and 
redelegated to the Director, Office of Food Additive Safety, we are 
giving notice that no objections or requests for a hearing were filed 
in response to the April 1, 2013, final rule. Accordingly, the 
amendments issued thereby became effective May 2, 2013.

[[Page 37963]]

    Dated: June 18, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2013-15111 Filed 6-24-13; 8:45 am]
BILLING CODE 4160-01-P