Animal drugs, feeds, and related products: Decoquinate,

[Federal Register: November 17, 2004 (Volume 69, Number 221)]

[Rules and Regulations]

[Page 67263-67265]

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

[DOCID:fr17no04-2]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal Feeds; Decoquinate; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

SUMMARY: The Food and Drug Administration (FDA) is amending its animal drug regulations to more accurately describe the approved feeding instructions for decoquinate Type C medicated feeds for cattle and calves, including nonruminating veal calves, and for young sheep and young goats. This action is being made to improve the accuracy of the regulations.

DATES: This rule is effective November 17, 2004.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV 6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: george.haibel@fda.gov.

SUPPLEMENTARY INFORMATION: FDA has found that the April 1, 2004, edition of the Code of Federal Regulations part 500 to 599 (21 CFR 500 to 599) does not reflect the feeding instructions for decoquinate in Type C medicated feeds for cattle and calves, including nonruminating veal calves, and for young sheep and young goats approved under NADA 39-417 (67 FR 72370, December 5, 2002). At this time, FDA is amending the regulations to correct this error in Sec. 558.195. An inaccurate and unnecessary description of a Type B medicated feed is also being removed. These changes are being made to improve the accuracy of the regulations.

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 558

Animal drugs, Animal feeds.

0 Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner

[[Page 67264]]

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

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

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

0 2. Section 558.195 is amended by revising paragraphs (e)(2)(i), (e)(2)(ii), and (e)(3)(ii) in the table to read as follows:

Sec. 558.195 Decoquinate.

* * * * *

(e) * * *

(2) * * *

Combination in Decoquinate in grams/ton

grams/ton

Indications for use

Limitations

Sponsor

(i) 12.9 to 90.8

................... Cattle (including

Feed Type C feed or

046573 ruminating and

milk replacer to nonruminating calves provide 22.7 and veal calves): For milligrams (mg) per prevention of

100 pounds (lb) of coccidiosis caused by body weight (0.5 mg/ Eimeria bovis and E. kg) per day. Feed at zuernii

least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section

(ii) 90.9 to 535.7

................... Cattle (including

Feed Type C medicated

046573 ruminating and

feed supplements as a nonruminating calves top dress or mix into and veal calves): As the daily ration to in paragraph (e)(2)(i) provide 22.7 mg per of this section

100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section

* * * * * * *

(3) * * *

Combination in Decoquinate in grams/ton

grams/ton

Indications for use

Limitations

Sponsor

* * * * * * *

(ii) 90.9 to 535.7

................... 1. Young sheep: As in Feed Type C medicated

046573 item 1 of paragraph feed supplements as a (e)(3)(i) of this

top dress or mix into section

the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food ................... 2. Young goats: As in Feed Type C medicated ........... item 2 of paragraph feed supplements as a (e)(3)(i) of this

top dress or mix into section

the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for food

* * * * * * *

[[Page 67265]]

Dated: November 4, 2004. Stephen F. Sundlof, Director, Center for Veterinary Medicine .

[FR Doc. 04-25441 Filed 11-16-04; 8:45 am]

BILLING CODE 4160-01-S