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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 March 15, 2004.

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 and monensin Type A medicated articles to make dry and liquid twoway combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter. The other NADA provides for use of ractopamine, monensin, and tylosin Type A
[[Page 12068]]
medicated articles to make dry and liquid threeway combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.

SUMMARY: Ractopamine,

SUPPLEMENTAL INFORMATION

Elanco Animal Health, A Division of Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141225 that provides for use of OPTAFLEXX (ractopamine hydrochloride) and RUMENSIN (monensin sodium) Type A medicated articles to make dry and liquid twoway combination Type B and Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed. Elanco Animal Health also filed NADA 141224 that provides for use of OPTAFLEXX, RUMENSIN, 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 E. bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in cattle fed in confinement for slaughter during the last 28 to 42 days on feed. The NADAs are approved as of January 27, 2004, and the regulations are amended in 21 CFR 558.355, 558.500, and 558.625 are 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 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. Section 558.355 is amended by adding paragraph (f)(7)(iii) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(7) * * *
(iii) Ractopamine alone or with tylosin as in Sec. 558.500. 3. Section 558.500 is amended in paragraph (d)(3) after ``7.5'' by adding ``or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0''; and by revising the table in paragraph (e)(2) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) Cattle
Ractopame Combination
in grams/ in grams/ Indications for use Limitations Sponsor

ton ton
(i) 8.2 to ........... Cattle fed in Feed 000986 24.6 confinement for continuously as slaughter: For sole ration increased rate of during the last weight gain and 28 to 42 days improved feed on feed. Not efficiency during for animals the last 28 to 42 intended for days on feed breeding
(ii) 8.2 Monensin 10 Cattle fed in As in paragraph 000986 to 24.6 to 30 confinement for (e)(2)(i) of slaughter: As in this section; paragraph (e)(2)(i) see Sec.
of this section; 558.355(d) of and for prevention this chapter and control of
coccidiosis due to
Eimeria bovis and
E. zuernii
(iii) ........... .................... ................ ....... [Reserved
]
(iv) 8.2 Monensin 10 Cattle fed in As in paragraph 000986 to 24.6 to 30, confinement for (e)(2)(i) of plus slaughter: As in this section; tylosin 8 paragraph (e)(2)(i) see Sec. Sec. to 10 of this section; 558.355(d) and for prevention and 558.625(c) of control of this chapter coccidiosis due to
E. bovis and E.
zuernii; and for
reduction of
incidence of liver
abscesses caused by
Fusobacterium
necrophorum and
Actinomyces
(Corynebacterium)
pyogenes
(v) ........... .................... ................ ....... [Reserved
]
(vi) 9.8 ........... Cattle fed in Feed 000986 to 24.6 confinement for continuously as slaughter: For sole ration increased rate of during the last weight gain, 28 to 42 days improved feed on feed. Not efficiency, and for animals increased carcass intended for leanness during the breeding
last 28 to 42 days
on feed
[[Page 12069]]
(vii) 9.8 Monensin 10 Cattle fed in As in paragraph 000986 to 24.6 to 30 confinement for (e)(2)(vi) of slaughter: As in this section; paragraph see Sec.
(e)(2)(vi) of this 558.355(d) of section; and for this chapter prevention and
control of
coccidiosis due to
E. bovis and E.
zuernii
(viii) ........... .................... ................ ....... [Reserved
]
(ix) 9.8 Monensin 10 Cattle fed in As in paragraph 000986 to 24.6 to 30, confinement for (e)(2)(vi) of plus slaughter: As in this section; tylosin 8 paragraph see Sec. Sec. to 10 (e)(2)(vi) of this 558.355(d) and section; for 558.625(c) of prevention and this chapter control of
coccidiosis due to
E. bovis and E.
zuernii; and for
reduction of
incidence of liver
abscesses caused by
Fusobacterium
necrophorum and
Actinomyces
(Corynebacterium)
pyogenes
(x) ........... .................... ................ ....... [Reserved
]
4. Section 558.625 is amended by revising paragraph (f)(2)(vii) to read as follows:
Sec. 558.625 Tylosin.
* * * * *
(f) * * *
(2) * * *
(vii) Ractopamine alone or with monensin as in Sec. 558.500. * * * * *

Dated: March 3, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 045755 Filed 31204; 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.