[Federal Register: May 24, 2002 (Volume 67, Number 101)]
[Rules and Regulations]
[Page 36512-36514]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my02-7]
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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; Lincomycin
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 supplemental new animal drug
application (NADA) filed by Pharmacia & Upjohn Co. The supplemental
NADA provides for the use of lincomycin in swine feed for the control
of porcine proliferative enteropathies (ileitis).
DATES: This rule is effective May 24, 2002.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7584, e-mail:
svaughn@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed a supplement to NADA 97-505 that
provides for use of LINCOMIX 20 (lincomycin hydrochloride) and LINCOMIX
50 Feed Medications in medicated swine feeds for the control of porcine
proliferative enteropathies (ileitis) caused by Lawsonia
intracellularis. The supplemental application is approved as of
February 28, 2002, and the regulations are amended in 21 CFR 558.325 to
reflect the approval. Section 558.325 is also being revised to reflect
a current format.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this supplemental
application may be seen in the Dockets Management Branch (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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies
for 3 years of marketing exclusivity beginning February 28, 2002,
because the application contains substantial evidence of the
effectiveness of the drug involved, any studies of animal safety
[[Page 36513]]
or, in the case of food-producing animals, human food safety studies
(other than bioequivalence or residue studies) required for approval of
the application and conducted or sponsored by the applicant.
The agency has determined under 21 CFR 25.33(a)(1) 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.
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
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
2. Section 558.325 is amended in paragraph (a) by removing
``paragraph (c)'' and in its place adding ``paragraph (d)''; by
revising paragraphs (a)(1), (a)(5), and (a)(13); in paragraph (b) by
removing ``in edible products''; and by revising paragraph (d) to read
as follows:
[sect] 558.325 Lincomycin.
(a) * * *
(1) No. 000009 for 20 and 50 grams per pound.
* * * * *
(5) No. 043733 for 8 and 20 grams per pound.
* * * * *
(13) No. 017800 for 2.5 and 8 grams per pound.
* * * * *
(d) Conditions of use--(1) Chickens. It is used in feed as follows:
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Lincomycin Indications for
grams/ton use Limitations Sponsor
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(i) 2 Broilers: For As lincomycin 000009
control of hydrochloride
necrotic monohydrate.
enteritis caused
by Clostridium
spp. or other
susceptible
organisms.
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(ii) 2 to 4 Broilers: For As lincomycin 000009
increased rate of hydrochloride
weight gain and monohydrate.
improved feed
efficiency.
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(2) Swine. It is used in feed as follows:
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Lincomycin Indications for
grams/ton use Limitations Sponsor
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(i) 20 Growing-finishing Feed as sole ration. 000009
swine: For Not to be fed to
increased rate of swine that weigh
weight gain. more than 250 pounds
(lb).
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(ii) 40 1. For control of Feed as sole ration; 000009
swine dysentery. for use in swine on 017800
premises with a 043733
history of swine
dysentery but where
symptoms have not
yet occurred, or
following use of
lincomycin at 100
grams (g)/ton for
treatment of swine
dysentery. Not to be
fed to swine that
weigh more than 250
lb.
2. For control of Feed as sole ration, 000009
porcine or following use of
proliferative lincomycin at 100 g/
enteropathies ton for control of
(ileitis) caused porcine
by Lawsonia proliferative
intracellularis. enteropathies
(ileitis). Not to be
fed to swine that
weigh more than 250
lb.
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(iii) 100 1. For treatment Feed as sole ration 000009
of swine for 3 weeks or until 017800
dysentery. signs of disease 043733
disappear. Not to be
fed to swine that
weigh more than 250
lb.
2. For control of Feed as sole ration 000009
porcine for 3 weeks or until
proliferative signs of disease
enteropathies disappear. Not to be
(ileitis) caused fed to swine that
by Lawsonia weigh more than 250
intracellularis. lb.
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(iv) 200 For reduction in Feed as sole ration 000009
the severity of for 3 weeks. Not to 017800
swine mycoplasmal be fed to swine that
pneumonia caused weigh more than 250
by Mycoplasma lb.
hyopneumoniae.
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(3) Lincomycin may also be used in combination with:
(i) Amprolium and ethopabate or amprolium and ethopabate with
roxarsone in accordance with [sect] 558.58.
(ii) Clopidol in accordance with [sect] 558.175.
(iii) Decoquinate in accordance with [sect] 558.195.
(iv) Fenbendazole as provided in [sect] 558.258.
(v) Halofuginone in accordance with [sect] 558.265.
(vi) Ivermectin as in [sect] 558.300.
(vii) Lasalocid alone or with roxarsone in accordance with [sect]
558.311.
(viii) Monensin alone or with roxarsone in accordance with [sect]
558.355.
(ix) Nicarbazin alone or with narasin or roxarsone as in [sect]
558.366.
(x) Pyrantel as in [sect] 558.485.
(xi) Robenidine in accordance with [sect] 558.515.
(xii) Roxarsone in accordance with [sect] 558.530.
(xiii) Salinomycin with or without roxarsone as in [sect] 558.550.
(xiv) Zoalene in accordance with [sect] 558.680.
[[Page 36514]]
Dated: May 14, 2002.
Acting Director,
Office of New Animal Drug Evaluation,Center for Veterinary Medicine.
[FR Doc. 02-13164 Filed 5-23-02; 8:45 am]
BILLING CODE 4160-01-S