Source: https://www.federalregister.gov/documents/2008/04/08/E8-7307/new-animal-drugs-for-use-in-animal-feed-zilpaterol-technical-amendment
Timestamp: 2018-03-21 12:03:07
Document Index: 212567290

Matched Legal Cases: ['§\u2009558', '§\u2009510', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009510']

Federal Register :: New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment
New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment
A Rule by the Food and Drug Administration on 04/08/2008
This rule is effective April 8, 2008.
18958-18960 (3 pages)
https://www.federalregister.gov/d/E8-7307 https://www.federalregister.gov/d/E8-7307
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 approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate in four-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed NADA 141-280 that provides for use of ZILMAX (zilpaterol hydrochloride), and RUMENSIN (monensin USP), TYLAN (tylosin phosphate), and MGA (melengestrol acetate) Type A medicated articles to make dry and liquid four-way 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; and suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 20 to 40 days on feed. The NADA is approved as of February 29, 2008, and the regulations in 21 CFR 558.342 and 558.665 are amended to reflect the approval.
In addition, FDA has noticed that the codified indications for use of tylosin in combination with melengestrol and lasalocid are not consistent with the conditions of use approved for an abbreviated new animal drug application (71 FR 39204, July 12, 2006). At this time, the indications for use are revised to include the associated pathogens. This action is being taken to improve the accuracy of the regulations.
2. In § 558.342, revise paragraphs (e)(1)(iv) and (e)(2) to read as follows:
(1) * * *Start Printed Page 18959
(iv) 0.25 to 0.5 Lasalocid 100 to 360 plus tylosin 90. Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section; and for reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes. To administer 0.25 to 0.5 mg melengestrol acetate plus 100 to 360 mg lasalocid plus 90 mg tylosin/head/day: 1. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 10 to 30 g lasalocid and 8 to 10 g tylosin per ton; or 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/lb to 4.5 to 18 lb of a dry medicated feed containing 10 to 40 g tylosin per ton; or 3. Add 0.5 to 2.0 lb/head/day of a dry pelleted medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article), 50 to 720 mg lasalocid, and 45 to 180 mg tylosin/lb to a ration of nonmedicated feed. Lasalocid provided by No. 046573 and tylosin as tylosin phosphate by No. 000986 in § 510.600(c) of this chapter. 000009, 021641
(2) Melengestrol may also be used with:
(i) Ractopamine as in § 558.500 of this chapter.
(ii) Zilpaterol as in § 558.665 of this chapter.
3. In § 558.665, add paragraph (e)(5) to read as follows:
(5) 6.8 to provide 60 to 90 mg/head/day. Monensin 10 to 40, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat). As in paragraph (e)(1) of this section; see §§ 558.342(d), 558.355(d), and 558.625(c) of this chapter. Monensin and tylosin as provided by No. 000986; melengestrol acetate as provided by No. 000009 in § 510.600(c) of this chapter. 057926
[FR Doc. E8-7307 Filed 4-7-08; 8:45 am]