Document ID: FDA-2009-N-0665-0054
Agency: fda
Document Type: Notice
Title: New Animal Drugs; Change of Sponsor; Sometribove Zinc Suspension
Posted Date: 2009-10-16T04:00Z

[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Rules and Regulations]               
[Page 53164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc09-10]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs; Change of Sponsor; Sometribove Zinc Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION:  Final rule.

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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.

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.

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.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

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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 parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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

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2. In Sec.  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''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec.  522.2112  [Amended]

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4. In paragraph (b) of Sec.  522.2112, remove ``000911'' and add in its 
place ``000986''.

    Dated: October 9, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-24881 Filed 10-15-09; 8:45 am]

BILLING CODE 4160-01-S