[Federal Register Volume 72, Number 194 (Tuesday, October 9, 2007)]
[Rules and Regulations]
[Pages 57199-57200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 516 and 556


New Animal Drugs; Florfenicol

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 conditional approval of an application for 
conditional approval of a new animal drug intended for a minor species 
filed by Schering-Plough Animal Health Corp. The application seeks 
conditional approval of the use of florfenicol by veterinary feed 
directive for the control of mortality in catfish due to columnaris 
disease associated with Flavobacterium columnare.

DATES: This rule is effective October 9, 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: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, filed an application for conditional 
approval (141-259) that provides for the use of AQUAFLOR-CA1 
(florfenicol), a Type A medicated article, by veterinary feed directive 
to formulate Type C medicated feed for the control of mortality in 
catfish due to columnaris disease associated with Flavobacterium 
columnare. In accordance with the Federal Food, Drug, and Cosmetic Act 
(the act), as amended by the Minor Use and Minor Species Animal Health 
Act of 2004 (MUMS Act), this drug is conditionally approved as of April 
13, 2007, and the regulations are amended by adding 21 CFR 516.1215 and 
by revising 21 CFR 556.283 to reflect the conditional approval of this 
application. The effect of this final rule is delayed until October 9, 
2007, pending establishment of part 516 (72 FR 41010, July 26, 2007).
    In accordance with the freedom of information provisions of 21 CFR 
part 20, a summary of safety and effectiveness data and information 
submitted to support conditional approval of this application for 
conditional approval may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville,

[[Page 57200]]

MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    AQUAFLOR-CA1 in the dosage form and for the intended uses 
conditionally approved by FDA under application number 141-259 
qualifies for 7 years of exclusive marketing rights beginning on the 
date of approval. This new animal drug qualifies for exclusive 
marketing rights under section 573(c) of the act (21 U.S.C. 360ccc-
2(c)) because it has been declared a designated new animal drug by FDA 
under section 573(a) of the act.
    FDA has determined under 21 CFR 25.33(d)(4) 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

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Part 556

    Animal drugs, Foods.

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 516 and 
556 are amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
1. The authority citation for 21 CFR part 516 continues to read as 
follows:

    Authority: 21 U.S.C. 360ccc-2, 371.

0
2. Add subpart E to read as follows:

Subpart E--Conditionally Approved New Animal Drugs For Minor Use 
and Minor Species


Sec.  516.1215  Florfenicol.

    (a) Specifications. Type A medicated article containing 500 grams 
(g) florfenicol per kilogram.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Labeling shall bear the following: 
``Conditionally approved by FDA pending a full demonstration of 
effectiveness under application number 141-259. Extra-label use of this 
drug in or on animal feed is strictly prohibited.''
    (d) Related tolerances. See Sec.  556.283 of this chapter.
    (e) Conditions of use--(1) Catfish--(i) Amount. Feed 182 to 1816 g 
florfenicol per ton of feed as a sole ration for 10 consecutive days to 
deliver 10 milligrams florfenicol per kilogram of fish.
    (ii) Indications for use. For the control of mortality due to 
columnaris disease associated with Flavobacterium columnare.
    (iii) Limitations. Feed containing florfenicol shall not be fed to 
catfish for more than 10 days. Following administration, fish should be 
reevaluated by a licensed veterinarian before initiating a further 
course of therapy. A dose-related decrease in hematopoietic/
lymphopoietic tissue may occur. The time required for hematopoietic/
lymphopoietic tissues to regenerate was not evaluated. The effects of 
florfenicol on reproductive performance have not been determined. Feeds 
containing florfenicol must be withdrawn 12 days prior to slaughter. 
Federal law limits this drug to use under the professional supervision 
of a licensed veterinarian. The expiration date of veterinary feed 
directives (VFDs) for florfenicol must not exceed 15 days from the date 
of prescribing. VFDs for florfenicol shall not be refilled. See Sec.  
558.6 of this chapter for additional requirements.
    (2) [Reserved]

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
4. In Sec.  556.283, revise paragraph (c) to read as follows:


Sec.  556.283  Florfenicol.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  516.1215, 520.955, 
522.955, and 558.261 of this chapter.

    Dated: September 27, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-19853 Filed 10-5-07; 8:45 am]
BILLING CODE 4160-01-S