[Federal Register Volume 70, Number 223 (Monday, November 21, 2005)]
[Rules and Regulations]
[Pages 70046-70047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22935]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


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 approval of a new animal drug application 
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides 
for the use of florfenicol by veterinary feed directive in catfish feed 
for the control of mortality due to enteric septicemia of catfish.

DATES: This rule is effective November 21, 2005.

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.gov.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed NADA 141-246 that provides for use 
of AQUAFLOR (florfenicol) Type A medicated article by veterinary feed 
directive to formulate Type C medicated feeds for the control of 
mortality due to enteric septicemia of catfish associated with 
Edwardsiella ictaluri. The NADA is approved as of October 24, 2005, and 
the regulations are amended in 21 CFR 556.283 and in part 558 (21 CFR 
part 558) by revising Sec.  558.4 and by adding new Sec.  558.261 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 573(c) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360ccc-2), this approval qualifies for 7 years of 
exclusive marketing rights beginning October 24, 2005, because the new 
animal drug has been declared a designated new animal drug by FDA under 
section 573(a) of the act.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    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 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

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 556 and 
558 are amended as follows:

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

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

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


0
2. Add paragraphs (b)(3) and (c) in Sec.  556.283 to read as follows:


Sec.  556.283  Florfenicol.

* * * * *

[[Page 70047]]

    (b) * * *
    (3) Catfish. The tolerance for florfenicol amine (the marker 
residue) in muscle (the target tissue) is 1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.955, 522.955, and 
558.261 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
4. In paragraph (d) of Sec.  558.4, in the ``Category II'' table, add 
an entry in alphabetical order for ``Florfenicol'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   CATEGORY II
----------------------------------------------------------------------------------------------------------------
                    Assay limits percent \1\                                   Assay limits percent \1\ Type B/C
      Drug                   Type A                 Type B maximum (100x)                     \2\
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
Florfenicol                             90-110                           n/a                              80-110
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make Type C medicated feed.

* * * * *

0
5. Add Sec.  558.261 to read as follows:


Sec.  558.261  Florfenicol.

    (a) Specifications. Type A medicated article containing 500 grams 
florfenicol per kilogram.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Special considerations--(1) Federal law limits this drug to use 
under the professional supervision of a licensed veterinarian. See 
Sec.  558.6 of this chapter for additional requirements.
    (2) The expiration date of veterinary feed directives (VFDs) for 
florfenicol must not exceed 15 days from the date of issuance. VFDs for 
florfenicol shall not be refilled.
    (d) Related tolerances. See Sec.  556.283 of this chapter.
    (e) Conditions of use--(1) Catfish--(i) Amount. 10 milligrams per 
kilogram of fish daily for 10 consecutive days.
    (ii) Indications for use. For the control of mortality due to 
enteric septicemia of catfish associated with Edwardsiella ictaluri.
    (iii) Limitations. Feed containing florfenicol shall not be fed to 
catfish for more than 10 days. Following 10 days administration, fish 
should be re-evaluated by a licensed veterinarian before reinitiating a 
further course of therapy. A dose-related decrease in hematopoietic/
lymphopoietic tissue may occur. The time required for the 
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.
    (2) [Reserved]

    Dated: November 8, 2005.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-22935 Filed 11-18-05; 8:45 am]
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