Animal Drugs, Feeds, and Related Products; Chlortetracycline

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