[Federal Register: April 20, 2007 (Volume 72, Number 76)]
[Rules and Regulations]
[Page 19797-19798]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap07-8]
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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:
joan.gotthardt@fda.gov.
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
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3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
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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
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Type B Assay limits
Drug Assay limits percent maximum percent\1\
\1\ Type A (100x) Type B/C\2\
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* * * * * * *
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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
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[[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.
* * * * *
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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]
BILLING CODE 4160-01-S