[Federal Register Volume 69, Number 227 (Friday, November 26, 2004)]
[Rules and Regulations]
[Pages 68783-68784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs; Monensin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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: <a href="/cdn-cgi/l/email-protection#f09594859292999eb093869dde969491de979f86"><span class="__cf_email__" data-cfemail="a2c7c6d7c0c0cbcce2c1d4cf8cc4c6c38cc5cdd4">[email protected]</span></a>.

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.


0
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

0
1. The authority citation for 21 CFR part 556 continues to read as 
follows:

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


0
2. Section 556.420 is amended by revising paragraph (b) and by adding 
paragraph (c) to read as follows:


Sec.  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 Sec. Sec.  520.1448 and 558.355 
of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
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:

[[Page 68784]]

Sec.  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.
[FR Doc. 04-26091 Filed 11-24-04; 8:45 am]
BILLING CODE 4160-01-S


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