[Federal Register Volume 60, Number 144 (Thursday, July 27, 1995)]
[Rules and Regulations]
[Pages 38479-38480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18447]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 202, 500, 501, and 510


Animal Drugs, Feeds, and Related Products; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration is amending the animal drug 
regulations to reflect a change in several cross-references to the 
Federal Food, Drug, and Cosmetic Act (the act). These changes resulted 
from enactment 

[[Page 38480]]
of the Nutritional Labeling and Education Act of 1993 (NLEA). By making 
these changes to the animal drug regulations those who rely on these 
regulations will be better able to understand and adhere to the 
requirements of the regulations.

FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary 
Medicine (HFV-238), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1737.

EFFECTIVE DATE: July 27, 1995.

SUPPLEMENTARY INFORMATION: As a result of enactment of the NLEA, 
certain cross-references to the act in 21 CFR Chapter I are incorrect. 
Under section 3 of the NLEA, entitled ``Technical Amendments to the 
Federal Food, Drug, and Cosmetic Act,'' paragraph (r) provides for 
several amendments to section 512 of the act (21 U.S.C. 360b). The 
amendments changed the cites for two definitions under section 201 of 
the act (21 U.S.C. 321), specifically the cites for ``new animal drug'' 
and ``animal feeds'' were changed from ``201(w)'' to ``201(v)'' and 
from ``201(x)'' to ``201(w),'' respectively. This document amends 
Secs.  202.1, 500.26, 501.4, and 510.413 (21 CFR 202.1, 500.26, 501.4, 
and 510.413) of the animal drug regulations to conform to those 
changes.
    Publication of this document constitutes final action on these 
changes. Under the Administrative Procedure Act (5 U.S.C. 553(b)), FDA 
finds for good cause that due notice and public procedure is 
unnecessary. This document only corrects various technical errors 
introduced by enactment of the NLEA. By making these changes to the 
animal drug regulations, those who rely on these regulations, including 
regulated industry, will be better able to understand and adhere to the 
requirements of the regulations. Therefore, FDA concludes that good 
cause exists for proceeding directly to a final rule.
    The agency has determined under 21 CFR 25.24(a)(9) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects

21 CFR Part 202

    Advertising, Prescription drugs.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated 
biphenyls (PCB's).

21 CFR Part 501

    Animal foods, Labeling, Packaging and containers, Reporting and 
recordkeeping requirements.

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 202, 
500, 501, and 510 are amended as follows:

PART 202--PRESCRIPTION DRUG ADVERTISING

    1. The authority citation for 21 CFR part 202 continues to read as 
follows:

    Authority: Secs. 201, 301, 502, 505, 507, 512, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 352, 355, 
357, 360b, 371).

Sec. 202.1   [Amended]

    2. Section 202.1 Prescription-drug advertisements is amended in 
paragraph (e)(4)(i)(b)(3) by removing ``201(w)'' and adding in its 
place ``201(v)''.

PART 500--GENERAL

    3. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority:  Secs. 201, 301, 402, 403, 409, 501, 502, 503, 512, 
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 
342, 343, 348, 351, 352, 353, 360b, 371).

Sec. 500.26   [Amended]

    4. Section 500.26 Timed-release dosage form drugs is amended in 
paragraph (a) by removing ``201(w)'' and adding in its place 
``201(v)''.

Sec. 500.27   [Amended]-

    5. Section 500.27 Methylene blue-containing drugs for use in 
animals is amended in paragraph (a)(3) by removing ``201(w)'' and 
adding in its place ``201(v)''.

PART 501--ANIMAL FOOD LABELING

    6. The authority citation for 21 CFR part 501 continues to read as 
follows:

    Authority:  Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

Sec.  501.4   [Amended]

    7. Section 501.4 Animal food; designation of ingredients is amended 
in paragraph (b)(13) by removing ``201(x)'' and adding in its place 
``201(w)''.

PART 510--NEW ANIMAL DRUGS

    8. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

Sec. 510.413   [Amended]

    9. Section 510.413 Chloroform used as an ingredient (active or 
inactive) in animal drug products is amended in paragraph (b) by 
removing ``201(w)'' and adding in its place ``201(v)''.


    Dated: July 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-18447 Filed 7-26-95; 8:45 am]
BILLING CODE 4160-01-F