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; technical amendment.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment

DATES: This rule is effective April 8, 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 approved, singleingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate in fourway combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.

SUMMARY: Zilpaterol; Technical Amendment,

SUPPLEMENTAL INFORMATION

Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed NADA 141280 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 fourway 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 (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 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. 558.342, 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 1. 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.
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. E87307 Filed 4708; 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@fda.hhs.gov.