[Federal Register: December 4, 2006 (Volume 71, Number 232)]
[Rules and Regulations]
[Page 70304-70305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de06-11]
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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.
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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 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:
joan.gotthardt@fda.hhs.gov.
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.
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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
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Drug Assay limits percent\1\ Type A Type B maximum (100x) Assay limits percent\1\ Type B/C\2\
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* * * * * * *
Florfenicol 90-110 Swine feed: n/a Swine feed: 85-115
.................................. Catfish feed: n/a Catfish feed: 80-110
* * * * * * *
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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 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
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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]
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