E6-19203. New Animal Drugs for Use in Animal Feeds; Monensin

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 simplify the organization of special labeling requirements for formulations (Type A medicated articles, Type B and Type C medicated feeds) containing monensin sodium. This action is being taken to improve the clarity of the regulations.

DATES:

This rule is effective November 14, 2006.

FOR FURTHER INFORMATION CONTACT:

Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6856, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

On October 28, 2004, FDA approved a supplemental new animal drug application (sNADA 95-735) filed by Elanco Animal Health for RUMENSIN (monensin sodium) Type A medicated article adding use in a new class of cattle (dairy cows) for increased milk production efficiency (69 FR 68783, November 26, 2004). On December 15, 2005, FDA approved another supplement to NADA 95-735 for use in dairy cow component feeding systems (71 FR 1689, January 11, 2006). The approval of each of these new conditions of use resulted in the amendment of the animal drug regulations for monensin in § 558.355 (21 CFR 558.355).

Since these approvals for use of monensin in dairy cow feeds as well as beef cattle feeds, FDA has become aware of confusion regarding which statements on the approved Type A medicated article labeling also appear on the approved representative labeling (Blue Bird labeling) for Type B and Type C medicated feeds for each class of cattle. At this time, the regulations are being amended in § 558.355 to simplify the organization of special labeling requirements for formulations (Type A medicated articles, Type B and Type C medicated feeds) containing monensin sodium. This action is being taken to improve the clarity of the regulations.

Publication of this document constitutes final action on this change under the Administrative Procedures Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors.

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

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

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

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

2. Amend § 558.355 as follows:

a. Revise paragraphs (d)(6) through (d)(11);

b. Remove paragraph (d)(13); and

c. Revise the second sentence of paragraph (f)(3)(xiii)(B), the third sentence of paragraph (f)(3)(xiv)(B), and the sixth sentence of paragraph (f)(6)(i)(b)(1).

The revisions read as follows:

§ 558.355

Monensin.

(d) * * *

(6) All formulations containing monensin shall bear the following caution statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.

(7) Type A medicated articles containing monensin intended for use in cattle and goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following statements:

(i) Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions.

(ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats.

(iii) Must be thoroughly mixed in feeds before use.

(iv) Do not feed undiluted.

(v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result.

(vi) Do not feed to lactating goats.

(vii) If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing.

(viii) A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(ix) You may notice the following: 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. Have a comprehensive and ongoing nutritional, reproductive, and herd health program in place when feeding monensin to dairy cows.

(x) Inadequate mixing (recirculation or agitation) of monensin liquid Type B or Type C medicated feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats.

(8) Type A medicated articles containing monensin intended for use in chickens shall bear the caution statements specified in paragraphs (d)(6), (d)(7)(iii), and (d)(7)(iv) of this section.

(9) Type B feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (f)(3)(i) through (f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i) through (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.

(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and (f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i) through (d)(7)(iv), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.

(iii) Goats: See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi) of this section.

(10) Type C feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (f)(3)(i) through (f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.

(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and (f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.

(iii) Goats: See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this section.

(11) Type B and Type C liquid feeds requiring recirculation or agitation that contain monensin and are intended for use in cattle (including dairy cows) and goats shall bear the caution statement specified in paragraph (d)(7)(x) of this section.

(f) * * *

(3) * * *

(xiii) * * *

(B) * * * See special labeling considerations in paragraph (d) of this section.

(xiv) * * *

(B) * * * See special labeling considerations in paragraph (d) of this section.

(6) * * *

(i) * * *

(b) * * *

(1) * * * See special labeling considerations in paragraph (d) of this section.

Dated: October 31, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.