04-26091. New Animal Drugs; Monensin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for use of monensin Type A medicated articles to formulate Type B and Type C medicated feeds used for increased milk production efficiency in dairy cows.

DATES:

This rule is effective November 26, 2004.

FOR FURTHER INFORMATION CONTACT:

Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855; 301-827-0232; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 95 735 that provides for the use of RUMENSIN 80 (monensin sodium) Type A medicated article to formulate Type B and Type C medicated feeds used for increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows. The supplemental NADA is approved as of October 28, 2004, and the regulations in 21 CFR 556.420 and 558.355 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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 carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management (see previous paragraph).

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning October 28, 2004.

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

21 CFR Part 556

• Animal drugs
• Foods

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 parts 556 and 558 are amended as follows:

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

1. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.420 is amended by revising paragraph (b) and by adding paragraph (c) to read as follows:

§ 556.420

Monensin.

* * * * *

(b) Tolerances. The tolerances for residues of monensin are:

(1) Cattle—(i) Edible tissues. 0.05 part per million (ppm).

(ii) Milk. Not required.

(2) Goats—(i) Edible tissues. 0.05 ppm.

(ii) [Reserved]

(3) Chickens, turkeys, and quail. A tolerance for residues of monensin in chickens, turkeys, and quail is not required.

(c) Related conditions of use. See §§ 520.1448 and 558.355 of this chapter.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

4. Section 558.355 is amended by revising paragraph (d)(7)(vi); and by adding paragraphs (d)(13) and (f)(3)(xiii) to read as follows:

§ 558.355

Monensin.

* * * * *

(d) * * *

(7) * * *

(vi) A withdrawal time has not been established for preruminating calves. Do not use in calves to be processed for veal.

* * * * *

(13) The labeling of Type B and Type C (liquid and dry) medicated feeds intended for use in dairy cows shall bear the following caution statements: You may notice: Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Increased incidence of cystic ovaries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin.

* * * * *

(f) * * *

(3) * * *

(xiii) Amount per ton. Monensin, 11 to 22 grams.

(A) Indications for use. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows.

(B) Limitations. Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See paragraphs (d)(2), (d)(5), (d)(6), (d)(7)(i), (d)(7)(ii), (d)(7)(iii), (d)(7)(vi), (d)(8), and (d)(12) of this section.

* * * * *

Dated: November 10, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.