[Federal Register: January 4, 2007 (Volume 72, Number 2)]
[Rules and Regulations]
[Page 262]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja07-7]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Florfenicol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Schering-Plough Animal Health Corp. The
supplemental NADA revises the nomenclature for a respiratory pathogen
in the label claim for florfenicol when used in swine drinking water
for the treatment of respiratory disease.
DATES: This rule is effective January 4, 2007.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit NJ 07901, filed a supplement to NADA 141-206 for
NUFLOR (florfenicol) 2.3% Concentrate Solution used to make medicated
drinking water for administration to swine for the treatment of
respiratory disease associated with several bacterial pathogens. The
supplemental NADA revises the nomenclature for a respiratory pathogen
in the label claim. The supplemental NADA is approved as of December 8,
2006, and the regulations in 21 CFR 520.955 are amended to reflect the
approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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 in 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 part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.955 [Amended]
0
2. In paragraph (d)(2) of Sec. 520.955, remove the words ``Type 2''.
Dated: December 21, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-22516 Filed 12-29-06; 8:45 am]
BILLING CODE 4160-01-S