-
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 sulfadiazine and pyrimethamine oral suspension from Animal Health Pharmaceuticals, LLC, to Pegasus Laboratories, Inc.
DATES:
This rule is effective November 15, 2010.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: steven.vaughn@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO 64506, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-240 for REBALANCE (sulfadiazine and pyrimethamine) Antiprotozoal Oral Suspension to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. Accordingly, the regulations are amended in 21 CFR 520.2215 to reflect this change of sponsorship.
Following this change of sponsorship, Animal Health Pharmaceuticals, LLC, is no longer the sponsor of an approved application. Accordingly, § 510.600 (21 Start Printed Page 69586CFR 510.600) is being amended to remove the entries for this firm.
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
21 CFR Part 510
- Administrative practice and procedure
- Animal drugs
- Labeling
- Reporting and recordkeeping requirements
21 CFR Part 520
- 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 510 and 520 are amended as follows:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]2. In § 510.600, in the table in paragraph (c)(1) remove the entry for “Animal Health Pharmaceuticals, LLC”; and in the table in paragraph (c)(2) remove the entry for “068718”.
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]4. In paragraph (b) of § 520.2215, remove “068718” and add in its place “055246”.
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: November 8, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010-28549 Filed 11-12-10; 8:45 am]
BILLING CODE 4160-01-P
Document Information
- Comments Received:
- 0 Comments
- Effective Date:
- 11/15/2010
- Published:
- 11/15/2010
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2010-28549
- Dates:
- This rule is effective November 15, 2010.
- Pages:
- 69585-69586 (2 pages)
- Docket Numbers:
- Docket No. FDA-2010-N-0002
- Topics:
- Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements
- PDF File:
- 2010-28549.pdf
- CFR: (2)
- 21 CFR 510.600
- 21 CFR 520.2215