New Animal Drugs for Use in Animal Feed: Zilpaterol; Technical Amendment
Federal Register: April 8, 2008 (Volume 73, Number 68)
Rules and Regulations
Page 18958-18960
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr08ap08-6
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration 21 CFR Part 558
New Animal Drugs for Use in Animal Feed; Zilpaterol; 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 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.
DATES: This rule is effective April 8, 2008.
FOR FURTHER INFORMATION CONTACT: Gerald L. Rushin, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8103, e-mail: gerald.rushin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
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
(HFA-305), 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. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds. 0
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 0 1. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371. 0 2. In Sec. 558.342, revise paragraphs (e)(1)(iv) and (e)(2) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
Page 18959
Melengestrol
Combination acetate in mg/ in mg/head/ Indications
Limitations
Sponsor head/day
day
for use
* * * * * * *
(iv) 0.25 to
Lasalocid 100 Heifers fed To administer
000009, 0.5
to 360 plus in
0.25 to 0.5
021641 tylosin 90. confinement mg for
melengestrol slaughter: acetate plus
As in
100 to 360 mg paragraph
lasalocid
(e)(1)(i)
plus 90 mg of this
tylosin/head/ section;
day: and for
-
Add 0.5 to reduced
2.0 lb/head/ incidence
day of a of liver
liquid or dry abscesses
medicated caused by
feed
Fusobacteri containing um
0.125 to 1.0 necrophorum mg and
melengestrol
Actinomyces acetate/lb to
(Corynebact a medicated erium)
feed pyogenes.
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
Sec. 510.600(c) of this chapter.
* * * * * * *
(2) Melengestrol may also be used with:
(i) Ractopamine as in Sec. 558.500 of this chapter.
(ii) Zilpaterol as in Sec. 558.665 of this chapter. 0 3. In Sec. 558.665, add paragraph (e)(5) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
Zilpaterol in grams/
Combination
Indications
Limitations
Sponsor ton
in grams/ton
for use
* * * * * * *
(5) 6.8 to
Monensin 10
Heifers fed
As in paragraph
057926 provide 60 to 40, plus in
(e)(1) of this to 90 mg/
tylosin 8 to confinement section; see head/day.
10, plus
for
Sec. Sec. melengestrol slaughter:
558.342(d), acetate to
As in
558.355(d), provide 0.25 paragraph
and 558.625(c) to 0.5 mg/
(e)(1) of
of this head/day.
this
chapter. section; for Monensin and prevention
tylosin as and control provided by of
No. 000986; coccidiosis melengestrol due to
acetate as
Eimeria
provided by bovis and E. No. 000009 in zuernii; for Sec. reduction of 510.600(c) of incidence of this chapter. liver abscesses caused by
Fusobacteriu m necrophorum and
Arcanobacter ium
(Actinomyces
) pyogenes; and for suppression of estrus
(heat).
Page 18960
Dated: March 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. E8-7307 Filed 4-7-08; 8:45 am
BILLING CODE 4160-01-S
