Skip to Content

Rule

New Animal Drugs; Change of Sponsor; Sometribove Zinc Suspension

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sometribove zinc suspension from Monsanto Co. to Elanco Animal Health, A Division of Eli Lilly & Co.

DATES:

This rule is effective October 16, 2009.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: david.newkirk@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 140-872 for POSILAC (sometribove zinc suspension) to Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285. Accordingly, the regulations are amended in 21 CFR 522.2112 to reflect this change of sponsorship.

Following this change of sponsorship, Monsanto Co. is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Monsanto Co.

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.

Start List of Subjects

List of Subjects

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority Start Amendment Part

2. In § 510.600, in the table in paragraph (c)(1) remove the entry for “Monsanto Co.”; and in the table in paragraph (c)(2) remove the entry for “000911”.

End Amendment Part Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

3. The authority citation for

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

4. In paragraph (b) of § 522.2112, remove “000911” and add in its place “000986”.

End Amendment Part Start Signature

Dated: October 9, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E9-24881 Filed 10-15-09; 8:45 am]

BILLING CODE 4160-01-S