Federal Register / Vol. 61, No. 133 / Wednesday, July 10, 1996 / Rules and Regulations 36291

§ 522.1660 [Amended]

2. Section 522.1660 Oxytetracycline

injection is amended in paragraph

(c)(1)(iii) by revising the first sentence to

read ‘‘Administer intramuscularly,

intravenously, or subcutaneously at 3 to

5 milligrams level, intramuscularly or

subcutaneously at 9 milligrams

level.’’ * * *

Dated: June 25, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–17541 Filed 7–9–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; 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 a supplemental new animal

drug application (NADA) filed by

Hoffmann-La Roche, Inc. The

supplemental NADA provides for use of

a free-choice, mineral, Type C cattle

feed containing chlortetracycline (CTC)

for grazing beef cattle weighing over 700

pounds (lb) for control of active

anaplasmosis infections.

EFFECTIVE DATE: July 10, 1996.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0217.

SUPPLEMENTARY INFORMATION: HoffmannLa Roche, Inc., 340 Kingsland St.,

Nutley, NJ 07110, filed a supplement to

NADA 48–761, Aureomycin

(chlortetracycline) mineral, Type C

cattle feed containing 4 grams CTC per

lb. The supplement provides for freechoice feeding to grazing beef cattle

weighing over 700 lb at 0.0125 to 0.05

lb of Type C feed per 100 lb of body

weight per day (0.5 to 2.0 milligrams

(mg) CTC per lb of body weight per day)

for control of active infections of

anaplasmosis caused by Anaplasma

marginale susceptible to

chlortetracycline. The supplement is

approved as of July 10, 1996, and the

regulations are amended in 21 CFR

558.128(c)(4) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

With approval of this supplement,

cattle may be fed 0.5 to 2.0 mg CTC per

head per day. To provide for safe use at

the upper limit, a withdrawal time of 4

days prior to slaughter is provided.

Use of Type A medicated articles to

make free-choice CTC Type C medicated

feeds requires an approved Form FDA

1900 as in 21 CFR 510.455.

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)), this

supplemental approval qualifies for 3

years of marketing exclusivity beginning

July 10, 1996, because the supplemental

application contains reports of new

clinical or field investigations (other

than bioequivalence or residue studies)

or human food safety studies (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant. The 3

years of marketing exclusivity applies

only to the new claim for which the

supplement was approved.

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 in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.128 [Amended]

2. Section 558.128 Chlortetracycline is

amended in paragraph (c)(4) by

removing the phrase ‘‘daily minimum

intake of 0.5 milligram of

chlortetracycline per pound of body

weight to aid in the prevention of

anaplasmosis’’ and adding in its place

‘‘daily intake of 0.5 to 2.0 milligrams of

chlortetracycline per pound of body

weight to aid in the control of active

infection of anaplasmosis caused by

Anaplasma marginale susceptible to

chlortetracycline; discontinue use 4

days prior to slaughter’’.

Dated: May 31, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–17315 Filed 7–9–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Department of the Navy

32 CFR Part 706

Certifications and Exemptions Under

the International Regulations for

Preventing Collisions at Sea, 1972;

Amendment

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), to reflect that

the Deputy Assistant Judge Advocate

General (Admiralty) of the Navy has

determined that USS KINGFISHER

(MHC 56) is a vessel of the Navy which,

due to its special construction and

purpose, cannot fully comply with

certain provisions of the 72 COLREGS

without interfering with its special

functions as a naval ship. The intended

effect of this rule is to warn mariners in

waters where 72 COLREGS apply.

EFFECTIVE DATE: June 25, 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, Virginia,

22332–2400, Telephone Number: (703)

325–9744.

SUPPLEMENTARY INFORMATION: Pursuant

to the authority granted in 33 U.S.C.

1605, the Department of the Navy

amends 32 CFR Part 706. This

amendment provides notice that the

Deputy Assistant Judge Advocate

General (Admiralty) of the Navy, under