Browse: Departments   Dates   Agencies  

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs; Ractopamine

DATES: This rule is effective August 18, 2004. [[Page 51174]]

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two new animal drug applications (NADAs) filed by Elanco Animal Health. One NADA provides for use of ractopamine, melengestrol, and monensin Type A medicated articles to make threeway combination Type C medicated feeds for heifers fed in confinement for slaughter. The other NADA provides for use of ractopamine, melengestrol, monensin, and tylosin Type A medicated articles to make fourway combination Type C medicated feeds for heifers fed in confinement for slaughter.

SUMMARY: Ractopamine,

SUPPLEMENTAL INFORMATION

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141234 that provides for use of OPTAFLEXX (ractopamine hydrochloride), MGA (melengestrol acetate), and RUMENSIN (monensin sodium) Type A medicated articles to make threeway combination 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 suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Elanco Animal Health also filed NADA 141233 that provides for use of OPTAFLEXX, MGA, RUMENSIN, and TYLAN (tylosin phosphate) Type A medicated articles to make fourway combination 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 E. bovis and E. zuernii; for suppression of estrus (heat); and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. The NADAs are approved as of July 2, 2004, and the regulations in 21 CFR 558.342, 558.355, 558.500, and 558.625 are amended to reflect the approvals. The basis of approval is discussed in the freedom of information summaries.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and effectiveness data and information submitted to support approval of these applications 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 these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor environmental impact statement is required for either.

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. Section 558.342 is amended by adding paragraph (e)(2) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(2) Melengestrol may also be used with ractopamine alone or in combination as in Sec. 558.500 of this chapter.
Sec. 558.355 [Amended]
3. Section 558.355 is amended in paragraph (f)(7)(iii) by removing ``with tylosin'' and by adding in its place ``in combination''. 4. Section 558.500 is amended by adding paragraphs (e)(2)(viii) and (e)(2)(x) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
* * * * *
(2) Cattle
Ractopamine in Combination in Indications
grams/ton grams/ton for use Limitations Sponsor * * * * * * *
(viii) 9.8 to Monensin 10 to Heifers fed in As in 000986 24.6 30, plus confinement paragraph
melengestrol for (e)(2)(vi) acetate to slaughter: As of this
provide 0.25 in paragraph section; see to 0.5 mg/ (e)(2)(vi) of Sec. Sec. head/day this section; 558.342(d) for and
prevention 558.355(d) and control of this
of chapter.
coccidiosis Melengestrol due to acetate as Eimeria bovis provided by and E. No. 000009 zuernii; and in Sec.
for 510.600(c) suppression of this
of estrus chapter.
(heat).
[[Page 51175]]
* * * * * * *
(x) 9.8 to Monensin 10 to Heifers fed in As in 000986 24.6 30, plus confinement paragraph
tylosin 8 to for (e)(2)(vi) 10, plus slaughter: As of this
melengestrol in paragraph section; see acetate to (e)(2)(vi) of Sec. Sec. provide 0.25 this section; 558.342(d), to 0.5 mg/ for 558.355(d), head/day prevention and
and control 558.625(c) of of this
coccidiosis chapter.
due to Melengestrol Eimeria bovis acetate as and E. provided by zuernii; for No. 000009 reduction of in Sec.
incidence of 510.600(c) liver of this
abscesses chapter.
caused by
Fusobacterium
necrophorum
and
Actinomyces
(Corynebacter
ium)
pyogenes; and
for
suppression
of estrus
(heat).
Sec. 558.625 [Amended]
5. Section 558.625 is amended in paragraph (f)(2)(vii) by removing ``with monensin'' and by adding in its place ``in combination''.

Dated: July 27, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0418843 Filed 81704; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Eric S. Dubbin, Center for Veterinary Medicine (HFV126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270232, email: edubbin@cvm.fda.gov.