Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations 35949

Bulletin MD11–28A082, dated May 14, 1996.

This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from McDonnell Douglas Corporation, 3855

Lakewood Boulevard, Long Beach, California

90846, Attention: Technical Publications

Business Administration, Department C1–

L51 (2–60). Copies may be inspected at the

FAA, Transport Airplane Directorate, 1601

Lind Avenue, SW., Renton, Washington; or at

the FAA, Los Angeles Aircraft Certification

Office, Transport Airplane Directorate, 3960

Paramount Boulevard, Lakewood, California;

or at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

(h) This amendment becomes effective on

July 24, 1996.

Issued in Renton, Washington, on July 1,

1996.

S.R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 96–17217 Filed 7–8–96; 8:45 am]

BILLING CODE 4910–13–P

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 § 558.128 (21 CFR

558.128) list the NAS/NRC and FDAapproved conditions of use for CTCcontaining 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
35950 Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations

obtain approval of abbreviated new

animal drug applications (ANADA’s) for

these CTC Type A medicated articles.

FDA has incorporated within

§ 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

§ 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 (§ 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

§ 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 § 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 § 510.515, the agency is

correcting an error introduced when the

regulation was published. Our records

indicate that concurrent cites to

oxytetracycline in § 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

§ 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 § 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 antibioticresistant 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 § 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).

§ 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:

§ 558.55 Amprolium.

* * * * *

(d) * * *

(2) * * *
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations 35951

Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor

(i) * * *

* * * * * * *

Chlortetracycline 100 to 200. Chickens; development of

active immunity to coccidiosis; control of infectious synovitis caused

by Mycoplasma

synoviae susceptible to

chlortetracycline.

Do not feed to chickens

producing eggs for

human consumption.

Feed for 7 to 14 d.

Chlortetracycline 200 to 400. Chickens; development of

active immunity to coccidiosis; control of

chronic respiratory disease (CRD) and air sac

infection caused by M.

gallisepticum and E.

coli susceptible to

chlortetracycline.

Do not feed to chickens

producing eggs for

human consumption.

Feed for 7 to 14 d.

* * * * * * *

(ii) * * *

* * * * * * *

Chlortetracycline 100 to 200. Chickens; prevention of

coccidiosis caused by

E. tenella only; control

of infectious synovitis

caused by M. synoviae

susceptible to

chlortetracycline.

Do not feed to chickens

producing eggs for

human consumption.

Feed for 7 to 14 d.

Chlortetracycline 200 to 400. Chickens; prevention of

coccidiosis caused by

E. tenella only; control

of chronic respiratory

disease (CRD) and air

sac infection caused by

M. gallisepticum and E.

coli susceptible to

chlortetracycline.

Do not feed to chickens

producing eggs for

human consumption.

Feed for 7 to 14 d.

* * * * * * *

(iv) * * *

* * * * * * *

Chlortetracycline 100 to 200. Chickens where immunity

to coccidiosis is not desired; prevention of coccidiosis; control of infectious synovitis caused

by M. synoviae susceptible to chlortetracycline.

Do not feed to chickens

producing eggs for

human consumption.

Feed for 7 to 14 d.

Chlortetracycline 200 to 400. Chickens where immunity

to coccidiosis is not desired; control of chronic

respiratory disease

(CRD) and air sac infection caused by M.

gallisepticum and E.

coli susceptible to

chlortetracycline.

Do not feed to chickens

producing eggs for

human consumption.

Feed for 7 to 14 d.

* * * * * * *

* * * * *

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:

§ 558.58 Amprolium and ethopabate.

* * * * *

(d) * * *

(1) * * *
35952 Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations

Amprolium and ethopabate in

grams per ton Combination in grams per ton Indications for use Limitations Sponsor

* * * * * * *

(iv) * * *

* * * * * * *

Chlortetracycline 100 to 200. For chickens where immunity to coccidiosis is

not desired; prevention

of coccidiosis; control of

infectious synovitis

caused by Mycoplasma

synoviae susceptible to

chlortetracycline.

Do not feed to chickens

producing eggs for

human consumption.

Feed for 7 to 14 d.

Chlortetracycline 200 to 400. For chickens where immunity to coccidiosis is

not desired; prevention

of coccidiosis; control of

chronic respiratory disease (CRD) and air sac

infection caused by M.

gallisepticum and E.

coli susceptible to

chlortetracycline.

In low calcium feed containing 0.8% dietary calcium and 1.5% sodium

sulfate; feed continuously as sole ration for

7 to 14 d; do not feed

to chickens producing

eggs for human consumption.

* * * * * * *

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:

§ 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 § 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 § 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 rate of

weight gain and improved feed

efficiency.

Do not feed to chickens producing eggs for human consumption.000004,

000069,

012286,

046573,

053389

2. Growing turkeys; increased

rate of weight gain and improved feed efficiency.

Do not feed to turkeys producing

eggs for human consumption.

do

3. Growing swine; increased rate

of weight gain and improved

feed efficiency.

do

(ii) 20 to 50 g/ton Growing sheep; increased rate of

weight gain and improved feed

efficiency.

000004,

000069,

046573,

053389.

(iii) 50 to 100 g/ton Swine; reducing the incidence of

cervical lymphadenitis (jowl abscesses) caused by Group E.

Streptococci susceptible to

chlortetracycline.

000004,

000069,

012286,

046573,

053389

(iv) 100 to 200 g/ton Chickens; control of infectious

synovitis caused by Mycoplasma synoviae susceptible to

chlortetracycline.

Feed continuously for 7 to 14 d;

do not feed to chickens producing eggs for human consumption.

do
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations 35953

Chlortetracycline amount Combination Indications for use Limitations Sponsor

(v) 200 g/ton Turkeys; control of infectious synovitis caused by M. synoviae

susceptible to chlortetracycline.

Feed continuously for 7 to 14 d;

do not feed to turkeys producing eggs for human consumption.

do

(vi) 200 to 400 g/ton 1. Chickens; control of chronic

respiratory disease (CRD) and

air sac infection caused by M.

gallisepticum and E. coli susceptible to chlortetracycline.

Feed continuously for 7 to 14 d;

do not feed to chickens producing eggs for human consumption.

do

2. Ducks; control and treatment

of fowl cholera caused by

Pasteurella multocida susceptible to chlortetracycline.

Feed in complete ration to provide from 8 to 28 milligrams

per pound of body weight per

day depending upon age and

severity of disease, for not

more than 21 d.

000004

(vii) 400 g/ton 1. Turkeys; control of

hexamitiasis caused by

Hexamita meleagrides susceptible to chlortetracycline.

Feed continuously for 7 to 14 d;

do not feed to turkeys producing eggs for human consumption.

000004,

000069,

012286,

046573,

053389

2. Turkey poults not over 4

weeks of age; reduction of

mortality due to paratyphoid

caused by Salmonella

typhimurium susceptible to

chlortetracycline.

do

3. Breeding swine; control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by

Leptospira pomona susceptible

to chlortetracycline.

Feed continuously for not more

than 14 d.

do

(viii) 500 g/ton Chickens; reduction of mortality

due to E. coli infections susceptible to chlortetracycline.

Feed for 5 d; do not feed to

chickens producing eggs for

human consumption; withdraw

24 h prior to slaughter.

do

(ix)10 mg/g of finished feed daily. Psittacine birds (cockatoos, macaws, and parrots) suspected

or known to be infected with

psittacosis caused by

Chlamydia psittaci sensitive to

chlortetracycline.

Feed continuously for 45 d; each

bird should consume daily an

amount of medicated feed

equal to one fifth of its body

weight. 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.’’

00004

(x) 0.1 mg/lb of body weight daily. Calves (up to 250 lb); for increased rate of weight gain

and improved feed efficiency.

In milk replacers or starter feed;

include on 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.’’

000004,

000069,

012286,

046573,

053389

(xi) 0.5 mg/lb of body weight daily. Beef cattle (over 700 lb); control

of active infection of

anaplasmosis caused by

Anaplasma marginale susceptible to chlortetracycline.

Withdraw 48 h prior to slaughter. do

(xii) 10 mg/lb of body weight 1. Calves, beef and nonlactating

dairy cattle; treatment of bacterial enteritis caused by E. coli

and bacterial pneumonia

caused by P. multocida organisms susceptible to

chlortetracycline.

Treat for not more than 5 d; in

feed excluding milk replacers;

withdraw 10 d prior to slaughter except for 24 h for sponsor

046573; include on 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.’’

do
35954 Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations

Chlortetracycline amount Combination Indications for use Limitations Sponsor

2. Calves (up to 250 lb); treatment of bacterial enteritis

caused by E. coli susceptible

to chlortetracycline.

In milk replacers or starter feed;

include on 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.’’

3. Swine; treatment of bacterial

enteritis caused by E. coli and

S. choleraesuis and bacterial

pneumonia caused by P.

multocida susceptible to

chlortetracycline.

Feed for not more than 14 d;

withdraw 5 d prior to slaughter

for sponsor 012286.

000004,

000069,

012286,

046573,

053389

(xiii) 25 mg/lb of body weight Turkeys; control of complicating

bacterial organisms associated

with bluecomb (transmissible

enteritis; coronaviral enteritis)

susceptible to chlortetracycline.

Feed continuously for 7 to 14 d;

do not feed to turkeys producing eggs for human consumption.

do

(xiv) 25 to 70 mg/head/day Calves (250 to 400 lb); increased

rate of weight gain and improved feed efficiency.

Include on 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.’’

000004,

000069,

012286,

046573,

053389

(xv) 70 mg/head/day Growing cattle (over 400 lb) increased rate of weight gain,

improved feed efficiency, and

reduction of liver condemnation

due to liver abscesses.

do do

(xvi) 80 mg/head/day Breeding sheep; reducing the incidence of (vibrionic) abortion

caused by Campylobacter

fetus infection susceptible to

chlortetracycline.

000004,

000069,

046573,

053389

(xvii) 350 mg/head/day 1. Cattle (under 700 lb); control

of bacterial pneumonia associated with shipping fever complex caused by Pasteurella

spp. susceptible to

chlortetracycline.

Withdraw 48 h prior to slaughter. 000004,

000069,

012286,

046573,

053389

2. Beef cattle (under 700 lb);

control of active infection of

anaplasmosis caused by A.

marginale susceptible to

chlortetracycline.

do do

* * * * *

7. New § 558.140 is added to subpart

B to read as follows:

§ 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

§ 510.600(c) of this chapter.

(b) Related tolerances. See §§ 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:

§ 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:

§ 558.195 Decoquinate.

* * * * *

(d) * * *
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations 35955

Decoquinate in grams per ton Combination in grams per ton Indications for use Limitations Sponsor

27.2 (0.003pct)

* * * * * * *

Chlortetracycline 100 to 200. Chickens; for the prevention

of coccidiosis caused by

Eimeria tenella, E. necatrix,

E. mivati, E. acervulina, E.

maxima, and E. brunetti;

control of infectious synovitis caused by Mycoplasma

synoviae susceptible to

chlortetracycline.

Do not feed to chickens producing eggs for human consumption; in low calcium

feed containing 0.8 pct. of

calcium; feed continuously

7 to 14 days.

011526

Chlortetracycline 200 to 400. Chickens; for the 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. gallisepticum and E. coli

susceptible to

chlortetracycline.

do 011526

* * * * * * *

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:

§ 558.274 Hygromycin B.

* * * * *

(c) * * *

(1) * * *

Hygromycin B in grams per ton Combination in grams per ton Indications for use Limitations Sponsor

(i) * * *

* * * * * * *

Chlortetracycline 100 to 200. Chickens; control of infestation of large roundworms

(Ascaris galli), cecal worms

(Heterakis gallinae), and

capillary worms (Capillaria

obsignata); control of infectious synovitis caused by

Mycoplasma synoviae susceptible to chlortetracycline.

Do not feed to chickens producing eggs for human consumption; feed for 7 to 14

days; withdraw 3 days before slaughter.

Chlortetracycline 200 to 400. Chickens; control of 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

gallisepticum and

Escherichia coli susceptible

to chlortetracycline.

do

* * * * * * *

(ii) * * *
35956 Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations

Hygromycin B in grams per ton Combination in grams per ton Indications for use Limitations Sponsor

* * * * * * *

Chlortetracycline 400. Swine; control of infestation of

large roundworms (Ascaris

suis), nodular worms

(Oesophagostomum

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

chlortetracycline.

Withdraw 15 d before slaughter.

* * * * * * *

* * * * *

11. Section 558.515 is amended by

revising paragraphs (d)(1)(iii), (d)(1)(iv),

and (d)(1)(v)(b) to read as follows:

§ 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).:

§ 558.530 Roxarsone.

(a) Approvals. Type A medicated

articles: (1) 10, 20, and 50 percent to

011526 in § 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 § 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
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations 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:

§ 558.680 Zoalene.

* * * * *

(c) * * *

(1) * * *

Zoalene in grams/ton Combination in grams/ton Indications for use Limitations

(i) * * *

* * * * * * *

Chlortetracycline 100 to 200. Replacement chickens; development

of active immunity to coccidiosis;

control of infectious synovitis

caused by Mycoplasma synoviae

susceptible to chlortetracycline.

Do not feed to chickens producing

eggs for human consumption;

grower ration not to be fed to birds

over 14 weeks of age; feed as in

subtable in item (i).

Chlortetracycline 200 to 400. Replacement chickens; development

of active immunity to coccidiosis;

control of chronic respiratory disease (CRD) and air sac infection

caused by M. gallisepticum and

Escherichia coli susceptible to

chlortetracycline.

Do not feed to chickens producing

eggs for human consumption;

grower ration not to be fed to birds

over 14 weeks of age; feed as in

subtable in item (i).

* * * * * * *

(ii) * * *

* * * * * * *

Chlortetracycline 100 to 200 Broiler chickens; prevention and control of coccidiosis; control of infectious synovitis caused by M.

synoviae susceptible to

chlortetracycline.

Do not feed to chickens producing

eggs for human consumption; feed

continuously for 7 to 14 d.
35958 Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations

Zoalene in grams/ton Combination in grams/ton Indications for use Limitations

Chlortetracycline 200 to 400 Broiler chickens; prevention and control of coccidiosis; control of chronic

respiratory disease (CRD) and air

sac infection caused by M.

gallisepticum and E. coli susceptible to chlortetracycline.

Do not feed to chickens producing

eggs for human consumption; feed

continuously for 7 to 14 d.

* * * * * * *

* * * * *

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

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

24 CFR Part 941

[Docket No. FR–3919–N–04]

Office of the Assistant Secretary for

Public and Indian Housing; Public/

Private Partnerships for the MixedFinance Development of Public

Housing Units Extension of Public

Comment Deadline on Interim Rule

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Notice of Extension of Public

Comment Deadline on Interim Rule.

SUMMARY: On May 2, 1996, HUD

published an interim rule that added a

new subpart F to the public housing

development program at 24 CFR part

941. Under this new subpart, a public

housing authority (PHA) was authorized

to provide to a non-PHA entity public

housing development and operating

funds for the development and

operation of the resulting public

housing units. In addition, the rule

clarified that replacement public

housing units for public housing units

that have been demolished could be

built on the original public housing site,

or in the same neighborhood, if the

number of such replacement units was

significantly fewer than the number of

units demolished. The May 2, 1996

interim rule provided for the public

comment period to expire on July 1,

1996. This notice extends the public

comment period to September 15, 1996.

DATES: Comment Due Date: September

15, 1996.

ADDRESSES: Interested persons are

invited to submit comments on the

interim rule to the Office of the General

Counsel, Rules Docket Clerk, Room

10276, Department of Housing and

Urban Development, 451 Seventh Street,

SW., Washington, DC 20410–0500.

Communications should refer to the

above docket number and title. A copy

of each communication submitted will

be available for public inspection and

copying during regular business hours

at the above address.

FOR FURTHER INFORMATION CONTACT: Bill

Flood, Office of Capital Improvements,

Office of Public and Indian Housing,

U.S. Department of Housing and Urban

Development, 451 Seventh Street, SW.,

Room 4134, Washington, DC 20410–

0500, telephone (202) 708–1640, ext.

4185; (TTY): (202) 708–9300 or 1–800–

877–8339. (Except for the ‘‘800’’

telephone number, these are not toll-free

numbers.)

SUPPLEMENTARY INFORMATION: On May 2,

1996, HUD published an interim rule

(61 FR 19708) that added a new subpart

F to the public housing development

program at 24 CFR part 941. Under this

interim rule, a PHA is authorized to

provide a portion of its HUD-awarded

development and operating funds to a

non-PHA entity for the entity to own,

develop and operate the resulting public

housing units. The non-PHA entity may

develop and operate the public housing

units using public and private financing

(i.e., as a ‘‘mixed-finance’’ project), and

to develop solely public housing units

or a combination of public housing,

shallow subsidy, and market rate units.

In addition, the May 2, 1996 interim

rule added a new paragraph (c)(3) to

HUD’s existing site and neighborhood

standards at § 941.202. This purpose of

this provision was to clarify HUD’s

existing authority to approve the

building of replacement public housing

units for public housing units that have

been demolished on either the original

public housing site, or in the same

neighborhood, if the number of such

replacement public housing units is

significantly fewer than the number of

public housing units demolished. This

authority was affirmed by the passage of

section 1002(a)(9) of Pub. L. 104–19

(approved July 27, 1995) which

explicitly authorized HUD to approve

the building of replacement public

housing units under such

circumstances.

Extension of Public Comment Period

The May 2, 1996 interim rule

provided for a 60-day public comment

period which is scheduled to close on

July 1, 1996. Because of the significant

public interest in this rule, HUD is

extending the public comment period to

September 15, 1996.

Dated: June 28, 1996.

Michael B. Janis,

General Deputy, Assistant Secretary for Public

and Indian Housing.

[FR Doc. 96–17177 Filed 7–8–96; 8:45 am]

BILLING CODE 4210–33–M

DEPARTMENT OF DEFENSE

Department of the Navy

32 CFR Part 706

Certifications and Exemptions Under

the International Regulations for

Preventing Collisions at Sea, 1972

AGENCY: Department of the Navy, DoD.

ACTION: Final rule.

SUMMARY: The Department of the Navy

is amending its certifications and

exemptions under the International

Regulations for Preventing Collisions at

Sea, 1972 (72 COLREGS). The Deputy

Assistant Judge Advocate General

(Admiralty) of the Navy has determined

that a prior certification of

noncompliance for USS SEAWOLF

(SSN 21) should be amended. The

intended effect of this rule is to warn

mariners in waters where 72 COLREGS

apply.

EFFECTIVE DATE: March 4, 1996.

FOR FURTHER INFORMATION CONTACT:

Captain R. R. Pixa, JAGC, U.S. Navy;

Admiralty Counsel, Office of the Judge

Advocate General Navy Department,

200 Stovall Street, Alexandria, VA

22332–2400, Telephone number: (703)

325–9744.