Federal Register: RULES New Animal Drugs For Use in Animal Feed: [21 CFR Part 558]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: New Animal Drugs For Use in Animal Feed:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs For Use in Animal Feed; Zilpaterol

DATES: This rule is effective February 1, 2008.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of zilpaterol, monensin, and tylosin in threeway combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.

SUMMARY: Zilpaterol,

SUPPLEMENTAL INFORMATION

Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed NADA 141276 that provides for use of ZILMAX (zilpaterol hydrochloride), and RUMENSIN (monensin), and TYLAN (tylosin phosphate) Type A medicated articles to make dry and liquid threeway combination Type B and Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. The NADA is approved as of January 10, 2008, and the regulations in 21 CFR 558.355, 558.625, and 558.665 are amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(2) 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.

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. 801808.
List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 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 558NEW 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. In Sec. 558.355, add paragraph (f)(7)(iv) to read as follows: Sec. 558.355 Monensin.
* * * * *
(f) * * *
(7) * * *
[[Page 6019]]
(iv) Zilpaterol alone or in combination as in Sec. 558.665. 3. In Sec. 558.625, add paragraph (f)(2)(ix) to read as follows: Sec. 558.625 Tylosin.
* * * * *
(f) * * *
(2) * * *
(ix) Zilpaterol alone or in combination as in Sec. 558.665. 4. In Sec. 558.665, revise paragraph (e) to read as follows: Sec. 558.665 Zilpaterol.
* * * * *
(e) Conditions of use in cattle. It is administered in feed as follows:

Zilpaterol in Combination in

grams/ton grams/ton Indications for use Limitations Sponsor (1) 6.8 to ................. Cattle fed in confinement for Feed continuously as the sole 057926 provide 60 to slaughter: For increased rate ration during the last 20 to 90 mg/head/day of weight gain, improved feed 40 days on feed. Withdrawal efficiency, and increased period: 3 days. carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed.
(2) [Reserved] ................. .............................. .............................. ........... (3) [Reserved] ................. .............................. .............................. ........... (4) 6.8 to Monensin 10 to Cattle fed in confinement for As in paragraph (e)(1) of this 057926 provide 60 to 40, plus tylosin slaughter: As in paragraph section; see Sec. Sec. 90 mg/head/day 8 to 10 (e)(1) of this section; for 558.355(d) and 558.625(c) of prevention and control of this chapter. Monensin and coccidiosis due to Eimeria tylosin as provided by No. bovis and E. zuernii; and for 000986 in Sec. 510.600(c) reduction of incidence of of this chapter. liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.

Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E81903 Filed 13108; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Gerald L. Rushin, Center for Veterinary Medicine (HFV126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 2402768103, email:
gerald.rushin@cvm.fda.gov.