Document ID: FDA-2010-N-0002-0078
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor: Sulfadiazine and Pyrimethamine Suspension
Posted Date: 2010-11-15T05:00Z

[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Rules and Regulations]
[Pages 69585-69586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28549]

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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.

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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, Sec.  510.600 (21

[[Page 69586]]

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.

0
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

0
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.

Sec.  510.600  [Amended]

0
2. In Sec.  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

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.2215  [Amended]

0
4. In paragraph (b) of Sec.  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]
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