2011-5147. Amendments to General Regulations of the Food and Drug Administration; Confirmation of Effective Date

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Direct final rule; confirmation of effective date.

SUMMARY:

The Food and Drug Administration (FDA) is confirming the effective date of April 14, 2011, for the final rule that appeared in the Federal Register of November 30, 2010 (75 FR 73951). The direct final rule amends certain general regulations of FDA to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act, by revising the Agency's regulations to require tobacco products to be subject to the same general requirements that apply to other FDA-regulated products. This document confirms the effective date of the direct final rule.

DATES:

Effective date confirmed: April 14, 2011.

FOR FURTHER INFORMATION CONTACT:

Gerie A. Voss, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., rm. 204G, Rockville, MD 20850, 1-877-CTP-1373.

SUPPLEMENTARY INFORMATION:

In the Federal Register of November 30, 2010 (75 FR 73951), FDA solicited comments concerning the direct final rule for a 75-day period ending February 14, 2011. FDA stated that the effective date of the direct final rule would be on April 14, 2011, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1, 14, and 17 are amended. Accordingly, the amendments issued thereby are effective.

Dated: March 2, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.