E7-4957. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending its regulations to change the location of a section in an over-the-counter (OTC) drug monograph. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

DATES:

This rule is effective March 19, 2007.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993, 301-796-2090.

SUPPLEMENTARY INFORMATION:

FDA published the final monograph (FM) for cold, cough, allergy, bronchodilator, and antiasthmatic combination drug products for OTC human use in the Federal Register of December 23, 2002 (67 FR 78158). In that FM, FDA inadvertently added § 341.40 (21 CFR 341.40) to subpart C of the monograph, when that section should have been added to subpart B of the monograph. Accordingly, FDA is now moving § 341.40 from subpart C to subpart B of the monograph.

Publication of this document constitutes final action on this change under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedures are unnecessary because FDA is merely implementing a change in the location of a section in an OTC drug monograph. No other changes are being made to that section of the monograph.

List of Subjects in 21 CFR Part 341

• Labeling
• Over-the-counter drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 341 is amended as follows:

PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

1. The authority citation for 21 CFR part 341 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Subpart B—Active Ingredients [Amended]

2. Remove § 341.40 Permitted combinations of active ingredients from subpart C and add it to subpart B of part 341.

Dated: March 12, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.