[Federal Register Volume 72, Number 52 (Monday, March 19, 2007)]
[Rules and Regulations]
[Page 12730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 341

[Docket No. 1976N-0052G] (formerly Docket No. 76N-052G)


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.

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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 Sec.  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 Sec.  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.

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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

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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]

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2. Remove Sec.  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.
[FR Doc. E7-4957 Filed 3-16-07; 8:45 am]
BILLING CODE 4160-01-S