Animal drugs, feeds, and related products: Arsanilic acid; technical amendment,

[Federal Register: November 19, 2001 (Volume 66, Number 223)]

[Rules and Regulations]

[Page 57873]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19no01-18]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal Feeds; Arsanilic Acid; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the dose range of arsanilic acid for Type C medicated poultry feeds reported by the National Academy of Sciences/ National Research Council (NAS/NRC) Drug Efficacy Study in 1972. This action is being taken to improve the accuracy of the regulations.

DATES: This rule is effective November 19, 2001.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0212, e-mail: dmcrae@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug regulations do not reflect the dose range of arsanilic acid for Type C medicated poultry feeds reported to the agency by the NAS/NRC Drug Efficacy Study in 1972. At this time, the regulations are being amended in 21 CFR 558.62 to reflect a dose range of 45 to 90 grams per ton of medicated poultry feed.

Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors.

This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

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 part 558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

   Authority: 21 U.S.C. 360b, 371.

2. Section 558.62 is amended in the table in paragraph (c)(1) by revising entries (i) and (ii) to read as follows:

   Sec. 558.62 Arsanilic acid.

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   (c) * * *

   (1) * * *

   Arsanilic acid in grams per ton

   Combination in grams per ton Indications for use Limitations Sponsor

   (i) 45 to 90

   .......................... 1. Growing chickens: Withdraw 5 days

   015565 For growth

   before slaughter; promotion and feed as sole source of efficiency;

   organic arsenic. improving pigmentation. .......................... 2. Growing turkeys: .......do.......... 015565 For growth promotion and feed efficiency; improving pigmentation. ........................... 3. Growing swine: .......do.......... 015565 For increased rate of weight gain and improved feed efficiency. (ii) 90

   ........................... Swine: As an aid in .......do.......... 015565 control of swine dysentery (hemorrhagic enteritis, bloody dysentery).

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   Dated: November 6, 2001. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

   [FR Doc. 01-28765Filed11-16-01; 8:45 am]

   BILLING CODE 4160-01-S