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/ Thursday, June 27, 2002
[Federal Register: June 27, 2002 (Volume 67, Number 124)]
[Rules and Regulations]
[Page 43248-43252]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn02-10]
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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; Chlortetracycline
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 Alpharma, Inc. The supplemental NADA
provides for the administration of Type C medicated feeds containing
chlortetracycline to cattle as a top dress on feed for the treatment of
enteritis and pneumonia.
DATES: This rule is effective June 27, 2002.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail:
jmessenh@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed a supplement to NADA 48-761 for
AUREOMYCIN 50, 90, or 100 (chlortetracycline) Type A medicated
articles. The supplemental NADA provides for the administration of Type
C medicated feeds containing chlortetracycline to calves, beef and
nonlactating dairy cattle as a top dress on feed to deliver 10
milligrams (mg) chlortetracycline per pound of body weight daily. These
medicated feeds are used for the treatment of bacterial enteritis
caused by Escherichia coli and
[[Page 43249]]
bacterial pneumonia caused by Pasteurella multocida susceptible to
chlortetracycline. The supplemental NADA is approved as of January 24,
2002, and the regulations are amended in 21 CFR 558.128 to reflect the
approval. The basis of approval is discussed in the freedom of
information summary.
Section 558.128 is also being amended to relocate a recently
assigned withdrawal time (64 FR 23539, May 3, 1999) to the
``Limitations'' column of the table describing conditions of use. This
is being done to improve the readability of the regulations.
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 for food-
producing animals qualifies for 3 years of marketing exclusivity
beginning January 24, 2002, because the application contains
substantial evidence of the effectiveness of the drug involved, any
studies of animal safety or, in the case of food-producing animals,
human food safety studies (other than bioequivalence or residue
studies) required for the approval 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 558.128 is amended by redesignating paragraphs (a), (b),
and (d) as paragraphs (b), (c), and (e), respectively; by adding new
paragraphs (a) and (d); and by revising newly redesignated paragraphs
(b) and (e) to read as follows:
Sec. 558.128 Chlortetracycline.
(a) Specifications. Type A medicated articles containing either
chlortetracycline calcium complex equivalent to chlortetracycline
hydrochloride or, for products intended for use in milk replacer,
chlortetracycline hydrochloride.
(b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
(1) Nos. 046573, 053389, and 066104: 50 to 100 grams per pound (g/
lb) of Type A medicated article.
(2) No. 017519: 50 g/lb of Type A medicated article.
* * * * *
(d) Special considerations. (1) In milk replacers or starter feed;
include on labeling the warning: ``A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal.''
(2) Manufacture for use in free-choice feeds as in paragraph
(e)(4)(iii) of this section must conform to Sec. 510.455 of this
chapter.
(3) When manufactured for use as in paragraph (e)(5)(iv) of this
section, include on labeling the warning: ``Psittacosis, avian
chlamydiosis, or ornithosis is a reportable communicable disease,
transmissible between wild and domestic birds, other animals, and man.
Contact appropriate public health and regulatory officials.''
(e) Conditions of use--(1) Chickens. It is used as follows:
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Chlortetracycline amount Indications for use Limitations Sponsor
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(i) 10 to 50 g/ton Chickens: For increased rate of . . . . . . . . . . . . . . . . 046573.
weight gain and improved feed . . . . . . . . . . . . . . . .
efficiency. . 017519,
046573,
Do not feed to chickens 053389,
producing eggs for human 066104.
consumption.
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(ii) 100 to 200 g/ton Chickens: For control of infectious 1. Feed continuously for 7 to 14 046573.
synovitis caused by Mycoplasma d.
synoviae susceptible to 017519,
chlortetracycline. 2. Feed continuously for 7 to 14 046573,
d; do not feed to chickens 053389,
producing eggs for human 066104.
consumption.
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(iii) 200 to 400 g/ton Chickens: For the control of chronic 1. Feed continuously for 7 to 14 046573.
respiratory disease (CRD) and air d.
sac infection caused by M. 017519,
gallisepticum and Escherichia coli 2. Feed continuously for 7 to 14 046573,
susceptible to chlortetracycline. d; do not feed to chickens 053389,
producing eggs for human 066104.
consumption.
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(iv) 500 g/ton Chickens: For the reduction of 1. Feed for 5 d. 046573.
mortality due to E. coli infections
susceptible to chlortetracycline. 2. Feed for 5 d; do not feed to 017519,
chickens producing eggs for 046573,
human consumption. 053389,
066104.
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[[Page 43250]]
(2) Turkeys. It is used as follows:
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Chlortetracycline amount Indications for use Limitations Sponsor
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(i) 10 to 50 g/ton Growing turkeys: For increased rate Do not feed to turkeys producing 017519,
of weight gain and improved feed eggs for human consumption. 046573,
efficiency. 053389,
066104.
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(ii) 200 g/ton Turkeys: For control of infectious Feed continuously for 7 to 14 d; 017519,
synovitis caused by M. synoviae do not feed to turkeys 046573,
susceptible to chlortetracycline. producing eggs for human 053389,
consumption. 066104.
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(iii) 400 g/ton 1. Turkeys: For control of Feed continuously for 7 to 14 d; 017519,
hexamitiasis caused by Hexamita do not feed to turkeys 046573,
meleagrides susceptible to producing eggs for human 053389,
chlortetracycline. consumption. 066104.
2. Turkey poults not over 4 weeks of 017519,
age: For reduction of mortality due 046573,
to paratyphoid caused by Salmonella 053389,
typhimurium susceptible to 066104.
chlortetracycline.
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(iv) 25 mg/lb of body Turkeys: For control of complicating Feed continuously for 7 to 14 d; 017519,
weight bacterial organisms associated with do not feed to turkeys 046573,
bluecomb (transmissible enteritis; producing eggs for human 053389,
coronaviral enteritis) susceptible consumption. 066104.
to chlortetracycline.
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(3) Swine. It is used as follows:
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Chlortetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton Growing swine: For increased rate of 017519,
weight gain and improved feed 046573,
efficiency. 053389,
066104.
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(ii) 50 to 100 g/ton Swine: For reducing the incidence of 017519,
cervical lymphadenitis (jowl 046573,
abscesses) caused by Group E. 053389,
Streptococci susceptible to 066104.
chlortetracycline.
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(iii) 400 g/ton Breeding swine: For the control of Feed continuously for not more 017519,
leptospirosis (reducing the than 14 d. 046573,
incidence of abortion and shedding 053389,
of leptospirae) caused by Leptospira 066104.
pomona susceptible to
chlortetracycline.
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(iv) 10 mg/lb of body 1. Swine: For the treatment of Feed approximately 400 g/t, 017519,
weight bacterial enteritis caused by E. varying with body weight and 046573,
coli and S. choleraesuis and feed consumption to provide 10 053389,
bacterial pneumonia caused by mg/lb per day. Feed for not 066104.
Pasteurella multocida susceptible to more than 14 d; withdraw 5 d
chlortetracycline. prior to slaughter for sponsor
017519.
2. Swine: For the control of porcine Feed for not more than 14 d. 046573.
proliferative enteropathies
(ileitis) caused by Lawsonia
intracellularis susceptible to
chlortetracycline.
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(4) Cattle. It is used as follows:
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Chlortetracycline amount Indications for use Limitations Sponsor
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(i) 0.1 mg/lb of body Calves (up to 250 lb): For increased See paragraph (d)(1) of this 017519,
weight daily. rate of weight gain and improved section. 046573,
feed efficiency. 053389,
066104.
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(ii) 0.5 mg/lb of body Beef cattle (over 700 lb); control of Withdraw 48 h prior to 017519,
weight daily. active infection of anaplasmosis slaughter. To sponsor No. 046573,
caused by Anaplasma marginale 046573: zero withdrawal time. 053389,
susceptible to chlortetracycline. To sponsor No. 053389: 1 d 066104.
withdrawal time.
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[[Page 43251]]
(iii) 0.5 to 2.0 mg/lb Beef cattle and nonlactating dairy In free-choice cattle feeds such 046573.
of body weight daily. cattle: As an aid in the control of as feed blocks or salt-mineral
active infection of anaplsmosis mixes manufactured from
caused by A. marginale susceptible approved Type A articles. See
to chlortetracycline. paragraph (d)(2) of this
section.
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(iv) 10 mg/lb of body 1. Calves, beef and nonlactating Feed approximately 400 g/ton, 017519,
weight daily. dairy cattle; treatment of bacterial varying with body weight and 046573,
enteritis caused by E. coli and feed consumption to provide 10 053389,
bacterial pneumonia caused by P. mg/lb per day. Treat for not 066104.
multocida organisms susceptible to more than 5 d; in feed
chlortetracycline. including milk replacers;
withdraw 10 d prior to
slaughter. To sponsor No.
053389: 1 d withdrawal time. To
sponsor No. 046573: zero
withdrawal time. See paragraph
(d)(1) of this section.
2. Calves (up to 250 lb): For the See paragraph (d)(1) of this 017519,
treatment of bacterial enteritis section. 046573,
caused by E. coli susceptible to 053389,
chlortetracycline. 066104.
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(v) 4,000 to 20,000 g/ Calves, beef and nonlactating dairy As a top dress, varying with 046573.
ton cattle; treatment of bacterial body weight and feed
enteritis caused by E. coli and consumption, to provide 10 mg/
bacterial pneumonia caused by P. lb per day. Treat for not more
multocida organisms susceptible to than 5 days. See paragraph
chlortetracycline. (d)(1) of this section.
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(vi) 25 to 70 mg/head/ Calves (250 to 400 lb): For increased See paragraph (d)(1) of this 017519,
day rate of weight gain and improved section. 046573,
feed efficiency. 053389,
066104.
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(vii) 70 mg/head/day Growing cattle (over 400 lb): For See paragraph (d)(1) of this 017519,
increased rate of weight gain, section. 046573,
improved feed efficiency, and 053389,
reduction of liver condemnation due 066104.
to liver abscesses.
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(viii) 350 mg/head/day 1. Beef cattle: For control of Withdraw 48 h prior to 017519,
bacterial pneumonia associated with slaughter. For sponsor 046573: 046573,
shipping fever complex caused by zero withdrawal time. For 053389,
Pasteurellaspp. susceptible to sponsor 053389: 1 d withdrawal 066104.
chlortetracycline. time.
2. Beef cattle (under 700 lb): For Withdraw 48 h prior to 017519,
control of active infection of slaughter. For sponsor 046573: 046573,
anaplasmosis caused by A. marginale zero withdrawal time. For 053389,
susceptible to chlortetracycline. sponsor 053389: 1 d withdrawal 066104.
time.
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(5) Minor species. It is used as follows:
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Chlortetracycline amount Indications for use Limitations Sponsor
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(i) 20 to 50 g/ton Growing sheep; increased rate of 046573,
weight gain and improved feed 053389,
efficiency. 066104.
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(ii) 80 mg/head/day Breeding sheep; reducing the 046573,
incidence of (vibrionic) abortion 053389,
caused by Campylobacter fetus 066104.
infection susceptible to
chlortetracycline.
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(iii) 200 to 400 g/ton Ducks: For the control and treatment Feed in complete ration to 046573.
of fowl cholera caused by P. provide from 8 to 28 mg/lb of
multocida susceptible to body weight per day depending
chlortetracycline. upon age and severity of
disease, for not more than 21
d. Do not feed to ducks
producing eggs for human
consumption.
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[[Page 43252]]
(iv) 10 mg/g of finished Psittacine birds (cockatoos, macaws, Feed continuously for 45 d; each 046573.
feed daily. and parrots) suspected or known to bird should consume daily an
be infected with psittacosis caused amount of medicated feed equal
by Chlamydia psittaci sensitive to to one fifth of its body
chlortetracycline. weight.
See paragraph (d)(3) of this
section.
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(6) Chlortetracycline. It may be used in accordance with this
section in combinations as follows:
(i) Amprolium in accordance with Sec. 558.55.
(ii) Amprolium plus ethopabate in accordance with Sec. 558.58.
(iii) Bacitracin methylene disalicylate in accordance with
Sec. 558.76.
(iv) Clopidol in accordance with Sec. 558.175.
(v) Decoquinate in accordance with Sec. 558.195.
(vi) Hygromycin B in accordance with Sec. 558.274.
(vii) Monensin in accordance with Sec. 558.355.
(viii) Robenidine hydrochloride in accordance with Sec. 558.515.
(ix) Roxarsone in accordance with Sec. 558.530.
(x) Salinomycin alone or with roxarsone in accordance with
Sec. 558.550.
(xi) Tiamulin in accordance with Sec. 558.600.
(xii) Zoalene in accordance with Sec. 558.680.
Dated: May 29, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 02-16161 Filed 6-26-02; 8:45 am]
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