[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)] [Rules and Regulations] [Page 55693] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2012-22296] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 74 [Docket No. FDA-2011-C-0050] D&C Red No. 6 and D&C Red No. 7; Change in Specification; 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 August 7, 2012, for the final rule that published in the Federal Register of July 6, 2012 (77 FR 39921) and that revised the requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for ``Ether-soluble matter'' with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4- methylphenyl)azo]-2-naphthalenol. DATES: Effective Date Confirmed: August 7, 2012. FOR FURTHER INFORMATION CONTACT: Teresa A. 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 July 6, 2012, FDA amended the color additive regulations in Sec. Sec. 74.1306 and 74.1307 (21 CFR 74.1306 and 74.1307) by replacing the current specification for ``Ether-soluble matter'' with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4- methylphenyl)azo]-2-naphthalenol. FDA also removed Appendix A in 21 CFR part 74, which pertains to the ether-soluble matter specification. The changes to Sec. Sec. 74.1306 and 74.1307 also affect the color additive regulations in Sec. Sec. 74.2306 and 74.2307 (21 CFR 74.2306 and 74.2307) because the identity and specifications in Sec. Sec. 74.1306 and 74.1307 are referenced by Sec. Sec. 74.2306 and 74.2307. FDA gave interested persons until August 6, 2012, 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 July 6, 2012, 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, notice is given that no objections or requests for a hearing were filed in response to the July 6, 2012, final rule. Accordingly, the amendments issued thereby became effective August 7, 2012. Dated: September 5, 2012. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2012-22296 Filed 9-10-12; 8:45 am] BILLING CODE 4160-01-P