[Federal Register Volume 75, Number 189 (Thursday, September 30, 2010)]
[Rules and Regulations]
[Pages 60308-60309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0002]


New Animal Drugs for Use in Animal Feeds; Melengestrol

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to more accurately reflect the recent approval of two 
supplemental new animal drug applications (NADAs) filed by Pharmacia & 
Upjohn Co., a Division of Pfizer, Inc. The supplemental NADAs provided 
for increased levels of monensin in two-way Type C medicated feeds 
containing melengestrol acetate and monensin, and in three-way Type C 
medicated feeds containing melengestrol acetate, monensin, and tylosin 
phosphate for heifers fed in confinement for slaughter. These 
amendments are being made to improve the accuracy of the regulations.

DATES:  This rule is effective September 30, 2010.

FOR FURTHER INFORMATION CONTACT:  Suzanne J. Sechen, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8105, email: 
[email protected].

SUPPLEMENTARY INFORMATION:  Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed supplements 
to NADA 125-476 for use of liquid MGA 500 (melengestrol acetate) and 
RUMENSIN (monensin, USP) single-ingredient Type A medicated articles to 
make two-way Type C medicated feeds and to NADA 138-870 for use of 
liquid MGA 500, RUMENSIN, and TYLAN (tylosin phosphate) single-
ingredient Type A medicated articles to make three-way Type C medicated 
feeds for heifers fed in confinement for slaughter. The supplemental 
NADAs provided for use of increased levels of monensin, previously 
approved for single-ingredient monensin Type C medicated feeds under 
NADA 95-735 (72 FR 653, January 8, 2007). The supplements were approved 
in October 2009 and the regulations were amended in Sec.  558.342 (21 
CFR 558.342) (74 FR 59911, November 19, 2009; 74 FR 61029, November 23, 
2009).
    Labeling submitted with these supplements also provided for use of 
a dry MGA 200 Type A medicated article in formulating both the two-way 
and three-way combination feeds with increased levels of monensin. This 
was consistent with the February 2009 supplemental approvals under NADA 
125-476 and NADA 138-870 of these same two-way and three-way 
combinations using dry MGA 200 for conditions of use that had been 
originally approved under Pharmacia & Upjohn Co.'s NADA 124-309 and 
NADA 138-792. Approval of these supplements in this manner was 
intended, in part, to simplify administration of the two-way and three-
way combinations under a single NADA file for each combination and to 
treat Pharmacia & Upjohn's applications in a manner consistent with 
similar applications held by other sponsors. As of February 2009, NADA 
124-309 and NADA 138-792 no longer contained the most current approved 
labeling and were administratively considered part of NADA 125-476 and 
NADA 138-870, respectively.
    FDA has noticed that the regulations in Sec.  558.342 contain 
entries for use of monensin in these two-way and three-way combinations 
at the lower use levels. At this time, the regulations are being 
amended to reflect the conditions of use described in labeling approved 
in October 2009 under NADA 125-476 and NADA 138-870. These amendments 
are being made to improve the accuracy of the regulations.
    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.

[[Page 60309]]


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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

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

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


Sec.  558.342   [Amended]

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2. In Sec.  558.342, in the table in paragraphs (e)(1)(v), (e)(1)(vi), 
and (e)(1)(vii), in the ``Sponsor'' column, remove ``000009,''.

    Dated: September 24, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-24480 Filed 9-29-10; 8:45 am]
BILLING CODE 4160-01-S