75 FR 219 pgs. 69585-69586 - New Animal Drugs; Change of Sponsor; Sulfadiazine and Pyrimethamine Suspension
Type: RULEVolume: 75Number: 219Pages: 69585 - 69586
Docket number: [Docket No. FDA-2010-N-0002]
FR document: [FR Doc. 2010-28549 Filed 11-12-10; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor; Sulfadiazine and Pyrimethamine Suspension
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.
FOR 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.
SUPPLEMENTARY 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 CFR 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.
List 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:
PART 510-NEW ANIMAL DRUGS
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.
§ 510.600 [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".
PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 520.2215 [Amended]
4. In paragraph (b) of § 520.2215, remove "068718" and add in its place "055246".
Dated: 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