Food and Drug Administration, HHS.
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.
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
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 DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part 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 DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd 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.
Director, Center for Veterinary Medicine.
[FR Doc. E9-24881 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S