[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
