[Federal Register Volume 72, Number 233 (Wednesday, December 5, 2007)]
[Rules and Regulations]
[Pages 68479-68480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23517]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Monensin USP

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 reflect approval of a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health. The supplemental NADA 
removes the requirement for 30-day expiration on labeling of monensin 
Type C medicated feeds for several classes of cattle and goats.

DATES: This rule is effective December 5, 2007.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: [email protected].

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 use of RUMENSIN 80 
(monensin) Type A medicated articles. The supplement removes the 
requirement for 30-day expiration on labeling of monensin Type C 
medicated feeds for several classes of cattle and goats. The 
supplemental NADA is approved as of November 9, 2007, and the 
regulations in 21 CFR 558.355 are amended to reflect the approval.
    In addition, the regulations are being amended to remove a 
redundant entry for combination use of monensin USP and melengestrol 
acetate, with or without tylosin phosphate, in medicated feed for 
heifers fed in confinement for slaughter. This action is being taken to 
improve the clarity of the regulations.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor 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. 801-808.

List of Subjects in 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 part 558 is 
amended as follows:

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

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

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

0
2. In Sec.  558.355, remove and reserve paragraphs (d)(2), (d)(3), and 
(f)(3)(viii); and revise paragraph (f)(6)(i)(b)(1) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (6) * * *
    (i) * * *
    (b) * * *
    (1) Feed continuously. Feed only to goats being fed in confinement. 
Do not

[[Page 68480]]

feed to lactating goats. Type C feeds may be manufactured from monensin 
liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 
and their labels must bear appropriate mixing directions, as defined in 
paragraph (d)(12) of this section. See special labeling considerations 
in paragraph (d) of this section.
* * * * *

    Dated: November 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-23517 Filed 12-4-07; 8:45 am]
BILLING CODE 4160-01-S