[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Rules and Regulations]
[Pages 69585-69586]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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.
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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
520 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.
Sec. 510.600 [Amended]
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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
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3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.2215 [Amended]
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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]
BILLING CODE 4160-01-P