[Federal Register Volume 71, Number 232 (Monday, December 4, 2006)]
[Rules and Regulations]
[Pages 70304-70305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20398]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; 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 new animal drug application 
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides 
for the use of a florfenicol Type A medicated article by veterinary 
feed directive to formulate swine feed used for the control of 
respiratory disease.

DATES:  This rule is effective December 4, 2006.

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 NADA 141-264 that provides for use 
of NUFLOR (florfenicol), an antibiotic, a Type A medicated article by 
veterinary feed directive to formulate Type C medicated feeds used for 
the control of swine respiratory disease (SRD) associated with 
Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus 
suis, and Bordetella bronchiseptica in groups of swine in buildings 
experiencing an outbreak of SRD. The NADA is approved as of November 3, 
2006, and the regulations are amended in 21 CFR 558.4 and 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 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning November 3, 2006.
    The agency has determined under 21 CFR 25.33(d)(5) 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 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 part 558 is 
amended as follows:

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

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

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

0
2. In paragraph (d) of Sec.  558.4, in the ``Category II'' table, 
revise the entry for ``Florfenicol'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                                       CATEGORY II
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Drug                     Assay limits percent\1\ Type A        Type B maximum (100x)          Assay limits percent\1\ Type B/C\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      * * * * * * *
Florfenicol                                                          90-110               Swine feed: n/a                             Swine feed: 85-115
                                         ..................................             Catfish feed: n/a                           Catfish feed: 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
3. In Sec.  558.261, revise paragraphs (a) and (c)(2); redesignate 
paragraph (e)(1) as paragraph (e)(2); and add new paragraphs (c)(3) and 
(e)(1) to read as follows:


Sec.  558.261  Florfenicol.

    (a) Specifications. Type A medicated articles containing 
florfenicol in the following concentrations:
    (1) 40 grams per kilogram for use as in paragraph (e)(1) of this 
section.
    (2) 500 grams per kilogram for use as in paragraph (e)(2) of this 
section.
* * * * *
    (c) * * *
    (2) The expiration date of veterinary feed directives (VFDs) for 
florfenicol medicated feeds:
    (i) For catfish must not exceed 15 days from the date of issuance;
    (ii) For swine must not exceed 90 days from the date of issuance.
    (3) VFDs for florfenicol shall not be refilled.
* * * * *
    (e) * * *
    (1) Swine--(i) Amount. Feed 182 grams per ton of feed (200 parts 
per million) continuously as the sole ration for 5 days.
    (ii) Indications for use. For the control of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, 
Pasteurella multocida, Streptococcus suis, and Bordetella 
bronchiseptica in groups of swine in buildings experiencing an outbreak 
of SRD.
    (iii) Limitations. The safety of florfenicol on swine reproductive 
performance, pregnancy, and lactation

[[Page 70305]]

has not been determined. Feeds containing florfenicol must be withdrawn 
13 days prior to slaughter.
* * * * *

    Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-20398 Filed 12-1-06; 8:45 am]
BILLING CODE 4160-01-S