[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Rules and Regulations]
[Pages 19797-19798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7475]


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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 the approval of a supplemental new animal 
drug application (NADA) filed by Schering-Plough Animal Health Corp. 
The supplemental NADA provides for the use of florfenicol by veterinary 
feed directive (VFD) for the control of mortality in freshwater-reared 
salmonids due to coldwater disease associated with Flavobacterium 
psychrophilum.

DATES: This rule is effective April 20, 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 a supplement to NADA 141-246 that 
provides for use of AQUAFLOR (florfenicol), a type A medicated article, 
by VFD to formulate type C medicated feed for the control of mortality 
in freshwater-reared salmonids due to coldwater disease associated with 
F. psychrophilum. The supplemental application is approved as of March 
19, 2007, and the regulations are amended in 21 CFR 556.283, 558.4, and 
558.261 to reflect the approval.
    The single VFD order form for florfenicol includes both catfish and 
freshwater-reared salmonid indications because each comprises multiple 
species and is approved in each for use under similar directions and 
conditions of use.
    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 supplemental approval qualifies 
for 7 years of exclusive marketing rights beginning March 19, 2007, 
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. In Sec.  556.283, add paragraph (b)(4) to read as follows:


Sec.  556.283  Florfenicol.

* * * * *
    (b) * * *
    (4) Salmonids. The tolerance for florfenicol amine (the marker 
residue) in muscle/skin (the target tissues) is 1 ppm.
* * * * *

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, 
revise the entry in alphabetical order for ``Florfenicol'' to read as 
follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                               Category II
------------------------------------------------------------------------
                                                 Type B     Assay limits
        Drug           Assay limits percent      maximum     percent\1\
                            \1\ Type A           (100x)      Type B/C\2\
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
Florfenicol                           90-110  Swine feed:   Swine feed:
                                               n/a           85-115
                     .......................  Catfish       Catfish
                                               feed: n/a     feed: 80-
                                                             110
                     .......................  Salmonid      Salmonid
                                               feed: n/a     feed: 80-
                                                             110
------------------------------------------------------------------------

[[Page 19798]]

 
                              * * * * * * *
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\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 a Type C medicated feed.

* * * * *

0
5. In Sec.  558.261, revise paragraph (a)(2), paragraph (c)(2)(i), and 
the first two sentences of paragraph (e)(2)(iii); and add new paragraph 
(e)(3) to read as follows:


Sec.  558.261  Florfenicol.

    (a) * * *
    (2) 500 grams per kilogram for use as in paragraphs (e)(2) and 
(e)(3) of this section.
* * * * *
    (c) * * *
    (2) * * *
    (i) For catfish and freshwater-reared salmonids, must not exceed 15 
days from the date of issuance;
* * * * *
    (e) * * *
    (2) * * *
    (iii) * * * Feed containing florfenicol shall not be fed for more 
than 10 days. Following administration, fish should be reevaluated by a 
licensed veterinarian before initiating a further course of therapy. * 
* *
    (3) Freshwater-reared salmonids--(i) Amount. 10 milligrams 
florfenicol per kilogram of fish daily for 10 consecutive days.
    (ii) Indications for use. For the control of mortality due to 
coldwater disease associated with Flavobacterium psychrophilum.
    (iii) Limitations. Feed containing florfenicol shall not be fed for 
more than 10 days. Following administration, fish should be reevaluated 
by a licensed veterinarian before initiating a further course of 
therapy. The effects of florfenicol on reproductive performance have 
not been determined. Feeds containing florfenicol must be withdrawn 15 
days prior to slaughter.

    Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7475 Filed 4-19-07; 8:45 am]
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