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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 three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.
DATES:
This rule is effective July 22, 2009.
Start Further InfoFOR 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 InformationSUPPLEMENTARY INFORMATION:
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Start Printed Page 36112Worth, TX 76137, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs and one approved ANADA to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
Application No. (NADA/ANADA) 21 CFR Section Product Name 007-076 520.2325a Sulfa-Nox (sulfaquinoxaline) Liquid 008-244 520.2325a Sulfa-Nox (sulfaquinoxaline) Concentrate 049-729 520.2261a PURINA Sulfa (sulfamethazine) 200-318 524.1193 VIRBAMEC (ivermectin) Pour-On Accordingly, the agency is amending the regulations in 21 CFR 520.2261a, 520.2325a, and 524.1193 to reflect the transfer of ownership.
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 SubjectsList of Subjects in 21 CFR Parts 520 and 524
- Animal drugs
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 520 and 524 are amended as follows:
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment Part[Amended]2. In paragraph (a) of § 520.2261a, remove “051311 and 053501” and in its place add “053501 and 061623”.
End Amendment Part[Amended]3. In paragraph (a)(2) of § 520.2325a, remove “051311” and in its place add “061623”.
End Amendment Part Start PartPART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part4. The authority citation for 21 CFR part 524 continues to read as follows:
End Amendment Part[Amended]5. In paragraph (b) of § 524.1193 remove “051311” and in numerical sequence add “061623”.
End Amendment Part Start SignatureDated: July 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-17356 Filed 7-21-09; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Comments Received:
- 0 Comments
- Effective Date:
- 7/22/2009
- Published:
- 07/22/2009
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- E9-17356
- Dates:
- This rule is effective July 22, 2009.
- Pages:
- 36111-36112 (2 pages)
- Docket Numbers:
- Docket No. FDA-2009-N-0665
- PDF File:
- e9-17356.pdf
- CFR: (3)
- 21 CFR 524.1193
- 21 CFR 520.2261a
- 21 CFR 520.2325a