2010-24480. New Animal Drugs for Use in Animal Feeds; Melengestrol

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 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: [e-mail].

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 § 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 § 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

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.

§ 558.342

[Amended]

2. In § 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.