01-28765. 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: [e-mail].

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:

§ 558.62

Arsanilic acid.

* * * * *

(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: For growth promotion and feed efficiency; improving pigmentation	Withdraw 5 days before slaughter; as sole source of organic ­arsenic	015565
		2. Growing turkeys: For growth promotion and feed efficiency; improving pigmentation	.......do	015565
		3. Growing swine: For increased rate of weight gain and improved feed efficiency	.......do	015565
(ii) 90		Swine: As an aid in control of swine dysentery (hemorrhagic enteritis, bloody dysentery)	.......do	015565
*         *         *         *         *         *         *

* * * * *

Dated: November 6, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.