[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Rules and Regulations]
[Pages 35949-35958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17169]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related Products; Chlortetracycline
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 five supplemental new animal
drug applications (NADA's) filed by Hoffmann-LaRoche, Inc., Pfizer,
Inc., ALPHARMA, Inc., ADM Animal Health & Nutrition Div., and PennField
Oil Co. The supplemental NADA's provide for the safe and effective use
of Type A medicated articles containing chlortetracycline (CTC) in the
feed of chickens, turkeys, swine, sheep, and calves, beef and
nonlactating dairy cattle for improved production efficiency and for
control and treatment of certain bacterial diseases susceptible to CTC.
The approvals reflect compliance with results of the National Academy
of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study
Group's (DESI) evaluation of the drug's effectiveness, and FDA's
conclusions concerning that evaluation.
EFFECTIVE DATE: July 9, 1996.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: The following sponsors have submitted
supplements to their approved NADA's:
Hoffmann-LaRoche, Inc., Nutley, NJ 07110 (formerly held by
American Cyanamid Co.), to NADA 48-761, which covers the Type A
medicated articles: Aureomix 293 (50 grams of
chlortetracycline hydrochloride per pound (g CTC HCl/lb)) and
Aureomycin 50, 70, 80, 90, and 100 (contain CTC calcium
complex equivalent to the indicated g/lb concentrations of CTC HCl);
Pfizer, Inc., 235 East 42d St., New York, NY 10017, to
NADA 92-286, which covers the Type A medicated articles CLTC
10, 20, 30, 50, and 70 (contain CTC calcium complex equivalent to the
indicated g/lb concentrations of CTC HCl) and to NADA 92-287, which
covers the Type A medicated articles CLTC 50 MR and 100 MR
(contain CTC calcium complex equivalent to the indicated g/lb
concentrations of CTC HCl);
ALPHARMA, Inc. (formerly A. L. Laboratories), One
Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, to NADA 46-699, which
covers the Type A medicated articles: CTC 100 MR (100 g CTC HCl/lb) and
CTC 10, CTC 50, CTC 65, CTC 70, and Micro CTC 100 (contains CTC calcium
complex equivalent to the indicated g/lb concentrations of CTC HCl);
ADM Animal Health & Nutrition Div., P.O. Box 2508, Fort
Wayne, IN 46801-2508 (formerly Feed Specialties Co., Inc.), to NADA 48-
480, which covers the Type A medicated article ChloratetTM 50
(contains CTC calcium complex equivalent to 50 g CTC HCI/lb); and
PennField Oil Co., 14040 Industrial Rd., Omaha, NE 68137,
to NADA 138-935, which covers the Type A medicated articles:
Chlortetracycline Premixes 50, 60, 70, 80, 100 (all contain CTC calcium
complex equivalent to the indicated g/lb concentrations of CTC HCl),
and 100 MR (100 g CTC HCl/lb).
The drug products were the subject of a NAS/NRC DESI evaluation of
effectiveness (DESI 0113NV). The findings were published in the Federal
Register of July 21, 1970 (35 FR 11646). NAS/NRC evaluated the drug
products as probably effective for growth promotion and feed efficiency
and for the treatment of animal diseases caused by pathogens sensitive
to chlortetracycline. NAS/NRC stated that:
(1) Claims made regarding ``for prevention of'' or ``to
prevent'' should be replaced with ``as an aid in the control of'' or
``to aid in the control of'''; (2) claims for growth promotion or
stimulation are disallowed and claims for faster gains and/or feed
efficiency should be stated as ``may result in faster gains and/or
improved feed efficiency under appropriate conditions''; (3) each
disease claim should be properly qualified as ``appropriate for use
in (name of disease) caused by pathogens sensitive to (name of
drug)''; if the disease cannot be so qualified the claim must be
dropped; (4) claims pertaining to egg production and hatchability
should be changed to ``May aid in maintaining egg production and
hatchability, under appropriate conditions, by controlling
pathogenic microorganisms''; (5) the labels should warn that treated
animals must actually be consuming enough medicated water or
medicated feed to provide a therapeutic dosage under the conditions
that prevail and, as a precaution, state the desired oral dose per
unit of animal weight per day for each species as a guide to
effective usage of the preparation in drinking water or feed; and
(6) effective blood levels are required for each recommended dosage.
FDA concurred with the NAS/NRC findings, interpreting the phrase
``* * * cannot be so qualified * * *'' in above item (3) to mean ``* *
* is not supported by adequate data * * *'' FDA reviewed all available
effectiveness data of products subject to the evaluation and concluded
that the data supported effectiveness for the control and treatment of
certain bacterial diseases susceptible to CTC in chickens, turkeys,
swine, sheep, calves, and cattle.
The NAS/NRC DESI evaluation is concerned only with the drugs'
effectiveness and safety to the treated animal. It does not take into
account the safety for food use of food derived from drug-treated
animals. Nothing herein will constitute a bar to further proceedings
with respect to questions of safety of the drugs or their metabolites
in food products derived from treated animals.
The five subject sponsors filed supplements that revised the
labeling of their products to comply with the findings of the NAS/NRC
review and FDA's conclusions concerning those findings. The
supplemental NADA's were approved as of February 16, 1996. The
revisions to Sec. 558.128 (21 CFR 558.128) list the NAS/NRC and FDA-
approved conditions of use for CTC-containing Type A medicated
articles.
Products which comply with the NAS/NRC findings and FDA's
conclusions regarding those findings are eligible for copying under the
Generic Animal Drug and Patent Term Restoration Act (GADPTRA) (see the
eighth in a series of policy letters issued to facilitate
implementation of GADPTRA that published in the Federal Register of
August 21, 1991 (56 FR 41561). Accordingly, sponsors may now
[[Page 35950]]
obtain approval of abbreviated new animal drug applications (ANADA's)
for these CTC Type A medicated articles.
FDA has incorporated within Sec. 558.128 a warning against use of
CTC feed in veal calves as part of a general effort to distinguish
between ruminating calves and preruminating calves based on information
indicating that withdrawal periods established in ruminating calves may
not be adequate for preruminating calves.
Also, the agency has removed in Sec. 558.128 the use of the fixed
combination for chlortetracycline and sulfamethazine to treat beef
cattle. FDA has recodified this approval in a separate section
(Sec. 558.140 (21 CFR 558.140)), as has been done for other fixed
combinations. In addition, the agency is using this occasion, of the
DESI finalization of the CTC Type A medicated articles, to amend those
portions of the regulations containing CTC combination feeds (see list
in Sec. 558.128(c)(5)) to revise the CTC claim language to make it
consistent with the NAS/NRC and FDA-approved conditions of use.
Furthermore, the agency is deleting the citations for CTC in
Sec. 510.515 (21 CFR 510.515). Section 510.515 defines antibiotic drugs
permitted in feed that were exempt from the requirement of
certification. GADPTRA (Pub. L. 100-670) signed on November 16, 1988,
removed the requirement for certification of antibiotic drugs for
animal use. In fact, in a final rule published in the Federal Register
of May 26, 1989 (54 FR 22741), the agency revoked the antibiotic
procedural regulations. The published exemption constituted a sanction
by the agency for use of the listed antibiotics. With the finalization
of the DESI evaluation of the CTC products, the sanction is obsolete.
Also, by deleting the CTC listing from Sec. 510.515, the agency is
correcting an error introduced when the regulation was published. Our
records indicate that concurrent cites to oxytetracycline in
Sec. 510.515(b)(7)(i) and (b)(17)(i) were incorrect, as oxytetracycline
was not considered a certifiable antibiotic animal drug; therefore, it
was incorrectly listed in Sec. 510.515.
In the Federal Register of October 21, 1977 (42 FR 56264), the then
Bureau of Veterinary Medicine issued a notice of opportunity for a
hearing (NOOH) on a proposal to withdraw approval of certain NADA's
listed in Sec. 558.15, for most subtherapeutic uses of tetracycline
(CTC and oxytetracycline) in animal feed. The NOOH was issued in
response to scientific research suggesting that subtherapeutic use of
such drugs has contributed to the pool of antibiotic-resistant
pathogenic microorganisms in food animals. Furthermore, research
indicated that the drug resistance could be transferred to pathogenic
organisms in humans. The NOOH is still pending and approval of these
supplements to finalize the DESI review process for CTC Type A
medicated articles does not constitute a bar to subsequent action to
withdraw approval on the grounds cited in the outstanding NOOH.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, 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)), these approvals for food-
producing animals do not qualify for marketing exclusivity because the
supplemental applications do not contain reports of new clinical or
field investigations (other than bioequivalence or residue studies) and
new human food safety studies (other than bioequivalence or residue
studies) essential to the approvals and conducted or sponsored by the
applicant.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects -
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
-Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
Sec. 510.515 [Amended]
2. Section 510.515 Animal feeds bearing or containing new animal
drugs subject to the provision of section 512(n) of the act is amended
in paragraph (b) by removing and reserving paragraphs (b)(7), (b)(17),
(b)(25), and (b)(29); by redesignating paragraphs (b)(10) and (b)(13)
as paragraphs (b)(1) and (b)(2); and in the table in paragraph (c) by
removing entries 6, 7, and 8 for ``Chlortetracycline.''
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
4. Section 558.55 is amended in the table in paragraph (d)(2) under
entries (i), (ii), and (iv) by revising the items for
``Chlortetracycline 100 to 200'' and by adding new items for
``Chlortetracycline 200 to 400'' to read as follows:
Sec. 558.55 Amprolium.
* * * * *
(d) * * *
(2) * * *
[[Page 35951]]
------------------------------------------------------------------------
Amprolium in Combination in Indications
grams per ton grams per ton for use Limitations Sponsor
------------------------------------------------------------------------
(i) * * *
* * * *
* * *
Chlortetracycli Chickens; Do not feed
ne 100 to 200. development to chickens
of active producing
immunity to eggs for
coccidiosis; human
control of consumption.
infectious Feed for 7
synovitis to 14 d.
caused by
Mycoplasma
synoviae
susceptible
to
chlortetracy
cline.
Chlortetracycli Chickens; Do not feed
ne 200 to 400. development to chickens
of active producing
immunity to eggs for
coccidiosis; human
control of consumption.
chronic Feed for 7
respiratory to 14 d.
disease
(CRD) and
air sac
infection
caused by M.
gallisepticu
m and E.
coli
susceptible
to
chlortetracy
cline.
* * * *
* * *
(ii) * * *
* * * *
* * *
Chlortetracycli Chickens; Do not feed
ne 100 to 200. prevention to chickens
of producing
coccidiosis eggs for
caused by E. human
tenella consumption.
only; Feed for 7
control of to 14 d.
infectious
synovitis
caused by M.
synoviae
susceptible
to
chlortetracy
cline.
Chlortetracycli Chickens; Do not feed
ne 200 to 400. prevention to chickens
of producing
coccidiosis eggs for
caused by E. human
tenella consumption.
only; Feed for 7
control of to 14 d.
chronic
respiratory
disease
(CRD) and
air sac
infection
caused by M.
gallisepticu
m and E.
coli
susceptible
to
chlortetracy
cline.
* * * *
* * *
(iv) * * *
* * * *
* * *
Chlortetracycli Chickens Do not feed
ne 100 to 200. where to chickens
immunity to producing
coccidiosis eggs for
is not human
desired; consumption.
prevention Feed for 7
of to 14 d.
coccidiosis;
control of
infectious
synovitis
caused by M.
synoviae
susceptible
to
chlortetracy
cline.
Chlortetracycli Chickens Do not feed
ne 200 to 400. where to chickens
immunity to producing
coccidiosis eggs for
is not human
desired; consumption.
control of Feed for 7
chronic to 14 d.
respiratory
disease
(CRD) and
air sac
infection
caused by M.
gallisepticu
m and E.
coli
susceptible
to
chlortetracy
cline.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
5. Section 558.58 is amended in the table in paragraph (d)(1) by
revising entry (iv) for the items ``Chlortetracycline 100 to 200'' and
``Chlortetracycline 200'' to read as follows:
Sec. 558.58 Amprolium and ethopabate.
* * * * *
(d) * * *
(1) * * *
[[Page 35952]]
------------------------------------------------------------------------
Amprolium and
ethopabate in Combination in Indications Limitations Sponsor
grams per ton grams per ton for use
------------------------------------------------------------------------
* * * *
* * *
(iv) * * *
* * * *
* * *
Chlortetracycl For chickens Do not feed
ine 100 to where to chickens
200. immunity to producing
coccidiosis eggs for
is not human
desired; consumption
prevention . Feed for
of 7 to 14 d.
coccidiosis
; control
of
infectious
synovitis
caused by
Mycoplasma
synoviae
susceptible
to
chlortetrac
ycline.
Chlortetracycl For chickens In low
ine 200 to where calcium
400. immunity to feed
coccidiosis containing
is not 0.8%
desired; dietary
prevention calcium and
of 1.5% sodium
coccidiosis sulfate;
; control feed
of chronic continuousl
respiratory y as sole
disease ration for
(CRD) and 7 to 14 d;
air sac do not feed
infection to chickens
caused by producing
M. eggs for
galliseptic human
um and E. consumption
coli .
susceptible
to
chlortetrac
ycline.
* * * *
* * *
------------------------------------------------------------------------
6. Section 558.128 is amended by revising paragraphs (a), (b), and
(c)(1); by removing paragraphs (c)(2) and (c)(3); and by redesignating
paragraphs (c)(4) and (c)(5) as paragraphs (c)(2) and (c)(3), to read
as follows:
Sec. 558.128 Chlortetracycline.
(a) Approvals. Type A medicated articles containing the following
concentrations of either chlortetracycline calcium complex equivalent
to chlortetracycline hydrochloride or, for products intended for use in
milk replacer, chlortetracycline hydrochloride:
(1) 50 to 100 grams per pound to 000004 in Sec. 510.600(c) of this
chapter.
(2) 50 to 100 grams per pound to 000069.
(3) 50 to 100 grams per pound to 046573.
(4) 50 grams per pound to 012286.
(5) 50 to 100 grams per pound to 053389 .
(b) Related tolerances. See Sec. 556.150 of this chapter.
(c)(1) It is used in feeds as follows:
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton 1. Chickens; increased Do not feed to 000004,
rate of weight gain chickens producing 000069,
and improved feed eggs for human 012286,
efficiency. consumption. 046573,
053389
2. Growing turkeys; Do not feed to turkeys do
increased rate of producing eggs for
weight gain and human consumption.
improved feed
efficiency.
3. Growing swine; do
increased rate of
weight gain and
improved feed
efficiency.
(ii) 20 to 50 g/ton Growing sheep; 000004,
increased rate of 000069,
weight gain and 046573,
improved feed 053389.
efficiency.
(iii) 50 to 100 g/ton Swine; reducing the 000004,
incidence of cervical 000069,
lymphadenitis (jowl 012286,
abscesses) caused by 046573,
Group E. Streptococci 053389
susceptible to
chlortetracycline.
(iv) 100 to 200 g/ton Chickens; control of Feed continuously for do
infectious synovitis 7 to 14 d; do not
caused by Mycoplasma feed to chickens
synoviae susceptible producing eggs for
to chlortetracycline. human consumption.
[[Page 35953]]
(v) 200 g/ton Turkeys; control of Feed continuously for do
infectious synovitis 7 to 14 d; do not
caused by M. synoviae feed to turkeys
susceptible to producing eggs for
chlortetracycline. human consumption.
(vi) 200 to 400 g/ton 1. Chickens; control of Feed continuously for do
chronic respiratory 7 to 14 d; do not
disease (CRD) and air feed to chickens
sac infection caused producing eggs for
by M. gallisepticum human consumption.
and E. coli
susceptible to
chlortetracycline.
2. Ducks; control and Feed in complete 000004
treatment of fowl ration to provide
cholera caused by from 8 to 28
Pasteurella multocida milligrams per pound
susceptible to of body weight per
chlortetracycline. day depending upon
age and severity of
disease, for not more
than 21 d.
(vii) 400 g/ton 1. Turkeys; control of Feed continuously for 000004,
hexamitiasis caused by 7 to 14 d; do not 000069,
Hexamita meleagrides feed to turkeys 012286,
susceptible to producing eggs for 046573,
chlortetracycline. human consumption. 053389
2. Turkey poults not do
over 4 weeks of age;
reduction of mortality
due to paratyphoid
caused by Salmonella
typhimurium
susceptible to
chlortetracycline.
3. Breeding swine; Feed continuously for do
control of not more than 14 d.
leptospirosis
(reducing the
incidence of abortion
and shedding of
leptospirae) caused by
Leptospira pomona
susceptible to
chlortetracycline.
(viii) 500 g/ton Chickens; reduction of Feed for 5 d; do not do
mortality due to E. feed to chickens
coli infections producing eggs for
susceptible to human consumption;
chlortetracycline. withdraw 24 h prior
to slaughter.
(ix)10 mg/g of finished Psittacine birds Feed continuously for 00004
feed daily. (cockatoos, macaws, 45 d; each bird
and parrots) suspected should consume daily
or known to be an amount of
infected with medicated feed equal
psittacosis caused by to one fifth of its
Chlamydia psittaci body weight. Warning:
sensitive to ``Psittacosis, avian
chlortetracycline. 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.''
(x) 0.1 mg/lb of body Calves (up to 250 lb); In milk replacers or 000004,
weight daily. for increased rate of starter feed; include 000069,
weight gain and on labeling the 012286,
improved feed warning: ``A 046573,
efficiency. withdrawal period has 053389
not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.''
(xi) 0.5 mg/lb of body Beef cattle (over 700 Withdraw 48 h prior to do
weight daily. lb); control of active slaughter.
infection of
anaplasmosis caused by
Anaplasma marginale
susceptible to
chlortetracycline.
(xii) 10 mg/lb of body 1. Calves, beef and Treat for not more do
weight nonlactating dairy than 5 d; in feed
cattle; treatment of excluding milk
bacterial enteritis replacers; withdraw
caused by E. coli and 10 d prior to
bacterial pneumonia slaughter except for
caused by P. multocida 24 h for sponsor
organisms susceptible 046573; include on
to chlortetracycline. labeling the warning:
``A withdrawal period
has not been
established for this
product in pre-
ruminating calves. Do
not use in calves to
be processed for
veal.''
[[Page 35954]]
2. Calves (up to 250 In milk replacers or
lb); treatment of starter feed; include
bacterial enteritis on labeling the
caused by E. coli warning: ``A
susceptible to withdrawal period has
chlortetracycline. not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.''
3. Swine; treatment of Feed for not more than 000004,
bacterial enteritis 14 d; withdraw 5 d 000069,
caused by E. coli and prior to slaughter 012286,
S. choleraesuis and for sponsor 012286. 046573,
bacterial pneumonia 053389
caused by P. multocida
susceptible to
chlortetracycline.
(xiii) 25 mg/lb of body Turkeys; control of Feed continuously for do
weight complicating bacterial 7 to 14 d; do not
organisms associated feed to turkeys
with bluecomb producing eggs for
(transmissible human consumption.
enteritis; coronaviral
enteritis) susceptible
to chlortetracycline.
(xiv) 25 to 70 mg/head/day Calves (250 to 400 lb); Include on labeling 000004,
increased rate of the warning: ``A 000069,
weight gain and withdrawal period has 012286,
improved feed not been established 046573,
efficiency. for this product in 053389
pre-ruminating
calves. Do not use in
calves to be
processed for veal.''
(xv) 70 mg/head/day Growing cattle (over do do
400 lb) increased rate
of weight gain,
improved feed
efficiency, and
reduction of liver
condemnation due to
liver abscesses.
(xvi) 80 mg/head/day Breeding sheep; 000004,
reducing the incidence 000069,
of (vibrionic) 046573,
abortion caused by 053389
Campylobacter fetus
infection susceptible
to chlortetracycline.
(xvii) 350 mg/head/day 1. Cattle (under 700 Withdraw 48 h prior to 000004,
lb); control of slaughter. 000069,
bacterial pneumonia 012286,
associated with 046573,
shipping fever complex 053389
caused by Pasteurella
spp. susceptible to
chlortetracycline.
2. Beef cattle (under do do
700 lb); control of
active infection of
anaplasmosis caused by
A. marginale
susceptible to
chlortetracycline.
----------------------------------------------------------------------------------------------------------------
* * * * *
7. New Sec. 558.140 is added to subpart B to read as follows:
Sec. 558.140 Chlortetracycline and sulfamethazine.
(a) Approvals. Type A medicated articles: 35 grams of
chlortetracycline per pound with 7.7 percent (35 grams) of
sulfamethazine to 000004 in Sec. 510.600(c) of this chapter.
(b) Related tolerances. See Secs. 556.150 and 556.670 of this
chapter.
(c) It is used in feed for beef cattle as follows:
(1) Amount per head per day. Chlortetracycline, 350 milligrams plus
sulfamethazine, 350 milligrams.
(2) Indications for use. Aid in the maintenance of weight gains in
the presence of respiratory disease such as shipping fever.
(3) Limitations. Feed for 28 days; withdraw 7 days prior to
slaughter.
8. Section 558.175 is amended by revising paragraph (c)(2)(ii) to
read as follows:
Sec. 558.175 Clopidol.
* * * * *
(c) * * *
(2) * * *
(ii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus
chlortetracycline 100 to 200 grams.
(a) Indications for use. Aid in the prevention of coccidiosis
caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati; control of infectious synovitis caused by
Mycoplasma synoviae susceptible to chlortetracycline.
(b) Limitations. Feed continuously as sole ration from the time
chicks are placed in floor pens for 7 to 14 days.
* * * * *
9. Section 558.195 is amended in the table in paragraph (d) in the
entry for ``27.2 (0.003pct)'' by removing the item for
``Chlortetracycline 200'' and adding in its place an item for
``Chlortetracycline 100 to 200'' and an item for ``Chlortetracycline
200 and 400'' to read as follow:
Sec. 558.195 Decoquinate.
* * * * *
(d) * * *
[[Page 35955]]
------------------------------------------------------------------------
Combination
Decoquinate in in grams per Indications Limitations Sponsor
grams per ton ton for use
------------------------------------------------------------------------
27.2
(0.003pct)
* * * *
* * *
Chlortetracyc Chickens; for Do not feed 011526
line 100 to the to chickens
200. prevention producing
of eggs for
coccidiosis human
caused by consumption;
Eimeria in low
tenella, E. calcium feed
necatrix, E. containing
mivati, E. 0.8 pct. of
acervulina, calcium;
E. maxima, feed
and E. continuously
brunetti; 7 to 14
control of days.
infectious
synovitis
caused by
Mycoplasma
synoviae
susceptible
to
chlortetracy
cline.
Chlortetracyc Chickens; for do 011526
line 200 to the
400. prevention
of
coccidiosis
caused by E.
tenella, E.
necatrix, E.
mivati , E.
acervulina,
E. maxima,
and E.
brunetti;
control of
chronic
respiratory
disease
(CRD) and
air sac
infection
caused by M.
gallisepticu
m and E.
coli
susceptible
to
chlortetracy
cline.
* * * *
* * *
------------------------------------------------------------------------
10. Section 558.274 is amended in the table in paragraph (c)(1)
under entry (i) by revising the item for ``Chlortetracycline 100 to
200'' and by adding a new item for ``Chlortetracycline 200 to 400'';
and under entry (ii) by removing the item for ``Chlortetracycline 100
to 200'' and adding in its place an item for ``Chlortetracycline 400''
to read as follows:
Sec. 558.274 Hygromycin B.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Hygromycin B Combination
in grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
(i) * * *
* * * *
* * *
Chlortetracyc Chickens; Do not feed
line 100 to control of to chickens
200. infestation producing
of large eggs for
roundworms human
(Ascaris consumption;
galli), feed for 7
cecal worms to 14 days;
(Heterakis withdraw 3
gallinae), days before
and slaughter.
capillary
worms
(Capillaria
obsignata);
control of
infectious
synovitis
caused by
Mycoplasma
synoviae
susceptible
to
chlortetracy
cline.
Chlortetracyc Chickens; do
line 200 to control of
400. infestation
of large
roundworms
(Ascaris
galli),
cecal worms
(H.
Gallinae),
and
capillary
worms
(Capillaria
obsignata);
control of
chronic
respiratory
disease
(CRD) and
air sac
infection
caused by
Mycoplasma
gallisepticu
m and
Escherichia
coli
susceptible
to
chlortetracy
cline.
* * * *
* * *
(ii) * * *
[[Page 35956]]
* * * *
* * *
Chlortetracyc Swine; Withdraw 15 d
line 400. control of before
infestation slaughter.
of large
roundworms
(Ascaris
suis),
nodular
worms
(Oesophagost
omum
dentatum)
and
whipworms
(Trichuris
suis);
treatment of
bacterial
enteritis
caused by E.
coli and
Salmonella
choleraesuis
and
bacterial
pneumonia
caused by P.
multocida
susceptible
to
chlortetracy
cline.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
11. Section 558.515 is amended by revising paragraphs (d)(1)(iii),
(d)(1)(iv), and (d)(1)(v)(b) to read as follows:
Sec. 558.515 Robenidine hydrochloride.
* * * * *
(d) * * *
(1) * * *
(iii) Amount per ton. Robenidine hydrochloride, 30 grams (0.0033
percent) plus chlortetracycline, 100 to 200 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima,
and E. necatrix; control of infectious synovitis caused by Mycoplasma
synoviae susceptible to chlortetracycline.
(b) Limitations. Withdraw 5 days prior to slaughter; do not feed to
chickens producing eggs for human consumption; feed continuously as
sole ration up to 14 days.
(iv) Amount per ton. Robenidine hydrochloride, 30 grams (0.0033
percent) plus chlortetracycline, 200 to 400 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima,
and E. necatrix; control of chronic respiratory disease (CRD) and air
sac infection caused by M. gallisepticum and E. coli susceptible to
chlortetracycline.
(b) Limitations. Withdraw 5 days prior to slaughter; do not feed to
chickens producing eggs for human consumption; feed continuously as
sole ration up to 14 days.
(v) * * *
(b) Limitations. Withdraw 5 days prior to slaughter; do not feed to
chickens producing eggs for human consumption; feed continuously up to
5 days.
* * * * *
12. Section 558.530 is amended by revising paragraph (a); by
redesignating paragraphs (d)(2), (d)(3), and (d)(4) as paragraphs
(d)(4), (d)(5), and (d)(6), by adding new paragraphs (d)(2) and (d)(3);
and by revising newly redesignated paragraph (d)(4) to read as set
forth below, and in newly redesignated paragraph (d)(6) by
redesignating paragraphs (d)(6)(i)(a) through (d) as paragraphs
(d)(6)(i)(A) through (D).:
Sec. 558.530 Roxarsone.
(a) Approvals. Type A medicated articles: (1) 10, 20, and 50
percent to 011526 in Sec. 510.600(c) of this chapter for use as in
paragraph (d)(1) of this section.
(2) 10, 20, 50, and 80 percent to 046573 in Sec. 510.600(c) of this
chapter for use as in paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of
this section.
* * * * *
(d) * * *
(2) Growing chickens--(i) Grams per ton. Roxarsone, 22.7 to 45.4
(0.0025 to 0.005 percent) plus chlortetracycline, 10 to 50.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation.
(B) Limitations. Do not feed to chickens producing eggs for human
consumption; withdraw 5 days before slaughter; as sole source of
organic arsenic; drug overdose or lack of water may result in leg
weakness; feed continuously throughout growing period.
(ii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005
percent) plus chlortetracycline, 100 to 200.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation; control of
infectious synovitis caused by Mycoplasma synoviae susceptible to
chlortetracycline.
(B) Limitations. See paragraph (d)(2)(i)(B) of this section except
feed continuously for 7 to 14 days.
(iii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005
percent) plus chlortetracycline, 200 to 400.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation; control of chronic
respiratory disease (CRD) and air sac infection caused by M.
gallisepticum and Escherichia coli susceptible to chlortetracycline.
(B) Limitations. See paragraph (d)(2)(i)(B) of this section except
feed continuously for 7 to 14 days.
(iv) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005
percent) plus chlortetracycline, 500.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation; reduction of
mortality due to E. coli infections susceptible to chlortetracycline.
(B) Limitations. See paragraph (d)(2)(i)(B) of this section except
feed for 5 days.
(3) Growing turkeys--(i) Grams per ton. Roxarsone 22.7 to 45.4
(0.0025 to 0.005 percent) plus chlortetracycline, 10 to 50.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation.
(B) Limitations. Do not feed to turkeys producing eggs for human
consumption; withdraw 5 days before slaughter; as sole source of
organic arsenic; drug overdose or lack of water may result in leg
weakness; feed continuously throughout growing season.
(ii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005
percent) plus chlortetracycline 200.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation; control of
infectious synovitis caused by
[[Page 35957]]
M. synoviae susceptible to chlortetracycline.
(B) Limitations. See paragraph (d)(3)(i)(B) of this section except
that the drug should only be fed continuously for 7 to 14 days.
(iii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005
percent) plus chlortetracycline, 400.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation; control of
hexamitiasis caused by Hexamita meleagrides susceptible to
chlortetracycline. Turkey poults not over 4 weeks of age: Reduction of
mortality due to paratyphoid caused by Salmonella typhimurium
susceptible to chlortetracycline.
(B) Limitations. See paragraph (d)(3)(i)(B) of this section except
that the drug should only be fed continuously for 7 to 14 days.
(iv) Amount. Roxarsone 22.7 to 45.4 grams per ton (0.0025 to 0.005
percent) plus chlortetracycline, 25 milligrams per pound of body weight
daily.
(A) Indications for use. For increased rate of weight gain,
improved feed efficiency, and improved pigmentation; control of
complicating bacterial organisms associated with bluecomb
(transmissible enteritis, coronaviral enteritis) susceptible to
chlortetracycline.
(B) Limitations. See paragraph (d)(3)(i)(B) of this section except
that the drug should only be fed continuously for 7 to 14 days.
(4) Growing-finishing swine--(i) Grams per ton. Roxarsone 22.7 to
34.1 (0.0025 to 0.00375 percent).
(A) Indications for use. For increased rate of weight gain and
improved feed efficiency.
(B) Limitations. Withdraw 5 days before slaughter; as sole source
of organic arsenic; feed continuously throughout growing season.
(ii) Grams per ton. Roxarsone 22.7 to 34.1 (0.0025 to 0.00375
percent) plus chlortetracycline, 400 (to administer 10 milligrams per
pound of body weight).
(A) Indications for use. For increased rate of weight gain and
improved feed efficiency; treatment of bacterial enteritis caused by E.
coli and S. choleraesuis and bacterial pneumonia caused by P. multocida
susceptible to chlortetracycline.
(B) Limitations. Withdraw 5 days before slaughter; as sole source
of organic arsenic; feed for not more than 14 days.
(iii) Grams per ton. Roxarsone 181.5 (0.02 percent).
(A) Indications for use. For the treatment of swine dysentery.
(B) Limitations. Feed for not more than 6 consecutive days; if
improvement is not observed, consult a veterinarian; withdraw 5 days
before slaughter; as a sole source or organic arsenic; animals must
consume enough medicated feed to provide a therapeutic dose.
(iv) Grams per ton. Roxarsone, 181.5 (0.02 percent) plus
chlortetracycline, 10 to 50.
(A) Indications for use. For the treatment of swine dysentery;
increased rate of weight gain and improved feed efficiency.
(B) Limitations. See paragraph (d)(4)(iii)(B) of this section.
(v) Grams per ton. Roxarsone, 181.5 (0.02 percent) plus
chlortetracycline, 400.
(A) Indications for use. For the treatment of swine dysentery;
treatment of bacterial enteritis caused by E. coli and S. choleraesuis
and bacterial pneumonia caused by P. multocida susceptible to
chlortetracycline.
(B) Limitations. See paragraph (d)(4)(iii)(B) of this section.
* * * * *
13. Section 558.680 is amended in the table in paragraph (c)(1)
under entries (i) and (ii) by revising the item for ``Chlortetracycline
100 to 200''; by removing the item for ``Chlortetracycline 200'' and
adding in its place an item for ``Chlortetracycline 200 to 400'' to
read as follows:
Sec. 558.680 Zoalene.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Zoalene in Combination in Indications for
grams/ton grams/ton use Limitations
------------------------------------------------------------------------
(i) * * *
* * * *
* * *
Chlortetracycli Replacement Do not feed to
ne 100 to 200. chickens; chickens
development of producing eggs
active immunity for human
to coccidiosis; consumption;
control of grower ration not
infectious to be fed to
synovitis caused birds over 14
by Mycoplasma weeks of age;
synoviae feed as in
susceptible to subtable in item
chlortetracycline (i).
.
Chlortetracycli Replacement Do not feed to
ne 200 to 400. chickens; chickens
development of producing eggs
active immunity for human
to coccidiosis; consumption;
control of grower ration not
chronic to be fed to
respiratory birds over 14
disease (CRD) and weeks of age;
air sac infection feed as in
caused by M. subtable in item
gallisepticum and (i).
Escherichia coli
susceptible to
chlortetracycline
.
* * * *
* * *
(ii) * * *
* * * *
* * *
Chlortetracycli Broiler chickens; Do not feed to
ne 100 to 200 prevention and chickens
control of producing eggs
coccidiosis; for human
control of consumption; feed
infectious continuously for
synovitis caused 7 to 14 d.
by M. synoviae
susceptible to
chlortetracycline
.
[[Page 35958]]
Chlortetracycli Broiler chickens; Do not feed to
ne 200 to 400 prevention and chickens
control of producing eggs
coccidiosis; for human
control of consumption; feed
chronic continuously for
respiratory 7 to 14 d.
disease (CRD) and
air sac infection
caused by M.
gallisepticum and
E. coli
susceptible to
chlortetracycline
.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
Dated: June 13, 1996.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 96-17169 Filed 7-8-96; 8:45 am]
BILLING CODE 4160-01-F