63622 Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Rules and Regulations

The sponsors requested withdrawal of

approval of the NADA’s because the

drug products are no longer being

marketed. This final rule removes 21

CFR 520.704, 522.514, and 522.1880,

and amends 21 CFR 522.540 and

522.1720 to reflect the withdrawal of

approval of these NADA’s.

In addition, 21 CFR 510.600(c) is

amended to remove the entries for the

three sponsors from the list of approved

drug sponsors because they no longer

hold any approved NADA’s.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 520 and 522

Animal drugs.

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, 520, and 522 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).

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entries for ‘‘Akorn, Inc.,’’

‘‘Parke-Davis, Division of WarnerLambert Co.,’’ and ‘‘Veterinary Research

and Development, Inc.’’ and in the table

in paragraph (c)(2) by removing the

entries for ‘‘000071,’’ ‘‘017478,’’ and

‘‘057428.’’

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 520.704 [Removed]

4. Section 520.704 Diphenylhydantoin

sodium capsules is removed.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

5. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 522.514 [Removed]

6. Section 522.514 Copper disodium

edetate injection is removed.

§ 522.540 [Amended]

7. Section 522.540 Dexamethasone

injection is amended by removing

paragraph (d)(2)(ii) and by redesignating

paragraph (d)(2)(iii) as paragraph

(d)(2)(ii).

§ 522.1720 [Amended]

8. Section 522.1720 Phenylbutazone

injection is amended in paragraph (b)(1)

by removing the phrase ‘‘000031,

017220, 015579, and 017478’’ and

adding in its place ‘‘000031, 017220,

and 015579’’.

§ 522.1880 [Removed]

9. Section 522.1880 Sterile

prednisolone suspension is removed.

Dated: December 4, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–30123 Filed 12–11–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Monensin

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

Elanco Animal Health, Division of Eli

Lilly and Co. The supplemental NADA

provides for use of an approved

monensin Type A medicated article to

make a revised formulation of a

monensin Type C medicated feed/freechoice mineral granule fed to pasture

cattle for increased rate of weight gain.

EFFECTIVE DATE: December 12, 1995.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–2701.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, Division of Eli Lilly and

Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed

supplemental NADA 95–735, which

provides for use of 80 grams(g) per

pound monensin Type A articles to

make a monensin Type C medicated

feed/free-choice mineral granule

containing 1,620 g per ton monensin.

The Type C feed/free-choice mineral

granules are fed to pasture cattle

(slaughter, stocker, feeder, and dairy

and beef replacement heifers) for

increased rate of weight gain. The

supplemental NADA provides for a

revised formulation Type C free-choice

mineral granule. The revised

formulation does not affect the safety or

effectiveness data and information upon

which the application is approved. The

supplemental NADA is approved as of

December 12, 1995, and the regulations

are amended in 21 CFR 558.355 by

adding new paragraph (f)(3)(x) to reflect

the approval.

Use of a Type A medicated article to

make a free-choice Type C medicated

feed/ mineral granule requires an

approved Form FDA 1900 as in 21 CFR

510.455.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval does not qualify for marketing

exclusivity because the supplement

does not contain reports of new clinical

or field investigations or new human

food safety studies (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant.

A freedom of information summary

for this approval is not required because

it involves approval of a revised

formulation which does not affect the

basis of approval of the product. A

summary of the data and information

submitted to support the original

approval may be seen in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, between 9 a.m. and 4 p.m.,

Monday through Friday.

The agency has determined under 21

CFR 25.24(d)(1)(iii) that this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

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:
Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Rules and Regulations 63623

Authority: Secs. 512, 701 of the Federal

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

360b, 371).

2. Section 558.355 is amended by

adding new paragraph (f)(3)(x) to read as

follows:

§ 558.355 Monensin.

* * * * *

(f) * * *

(3) * * *

(x) Amount per ton. Monensin, 1,620

grams as monensin sodium (810

milligrams per pound).

(a) Indications for use. For increased

rate of weight gain.

(b) Specifications. Use as free-choice

Type C medicated feed formulated as

mineral granules as follows:

Ingredient Percent International feed no.

Monocalcium phosphate (21% phosphorus, 15% calcium) 29.49 6–01–080

Sodium chloride (salt) 24.25 6–04–152

Dried cane molasses 20.0 4–04–152

Ground limestone (33% calcium) 13.75 6–02–632

Cane molasses 3.0 4–04–696

Processed grain by-products (as approved by AAFCO) 5.0

Vitamin/trace mineral premix1 2.5

Monensin Type A article, 80 grams per pound 1.01

Antidusting oil 1.0

1Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds.

Formulation modifications require FDA approval prior to marketing. The amount of selenium and ethylenediamine dihydroiodide (EDDI) must

comply with the published requirements. (For selenium see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).)

(c) Limitations. Medicated mineral

granules to be fed free-choice to pasture

cattle (slaughter, stocker, feeder, and

dairy and beef replacement heifers)

weighing more than 400 pounds. Feed

continuously on a free-choice basis at

the rate of 50 to 200 milligrams per head

per day. During the first 5 days of

feeding, cattle should receive no more

than 100 milligrams per day. Do not

feed additional salt or minerals. Do not

mix with grain or other feeds. Monensin

is toxic to cattle when consumed at

higher than approved levels. Stressed

and/or water deprived cattle should be

adapted to the pasture and to

unmedicated mineral supplement before

using this product. Do not feed to

lactating dairy cattle. Do not allow

horses, other equines, mature turkeys, or

guinea fowl access to feed containing

monensin. Ingestion of monensin by

horses and guinea fowl has been fatal.

The product’s effectiveness in cull cows

and bulls has not been established. Each

use of this free-choice Type C feed must

be the subject of an approved medicated

feed application (MFA or Form FDA

1900) or supplemental MFA as required

by § 510.455 of this chapter.

* * * * *

Dated: November 22, 1995.

Nicholas E. Weber,

Director, Division of Chemistry, Office of New

Animal Drug Evaluation, Center for

Veterinary Medicine.

[FR Doc. 95–30124 Filed 12–11–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 162

[CGD–94–026]

RIN 2115–AE78

Inland Waterways Navigation

Regulations; Wrangell Narrows, AK

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is increasing

the maximum width allowable for single

barge tows transiting Wrangell Narrows,

Alaska. In accordance with the goals of

the Presidential Regulatory Reinvention

Initiative, this action is being taken to

better meet maritime industry needs in

Southeast Alaska. The current size

restriction for single barge tows in

Wrangell Narrows is 80 feet in width

overall. An increase in the maximum

barge width to 100 feet in width overall

will allow barge operators to carry more

cargo on each barge to meet the

increasing needs of their Alaskan

consumers. Increasing the restriction to

100 feet in width overall will have no

adverse effects on navigation and

marine safety in Wrangell Narrows.

EFFECTIVE DATE: January 11, 1996.

ADDRESSES: Unless otherwise indicated,

documents referred to in this preamble

are available for inspection or copying

at the office of the Executive Secretary,

Marine Safety Council (G–LRA/3406)

(CGD 94–026), U.S. Coast Guard

Headquarters, 2100 Second Street SW.,

Washington, DC 20593–0001, or may be

delivered to room 3406 at the above

address between 8 a.m. and 3 p.m.,

Monday through Friday, except Federal

holidays. The telephone number is (202)

267–1477.

FOR FURTHER INFORMATION CONTACT:

Diane Schneider Appleby, Project

Manager, (202) 267–0352.

SUPPLEMENTARY INFORMATION:

Regulatory History

On September 15, 1995, the Coast

Guard published a notice of proposed

rulemaking entitled Inland Waterways

Navigation Regulations: Wrangell

Narrows, Alaska in the Federal Register

(60 FR 179). The Coast Guard received

four comments on the proposal. No

public meeting was requested, and none

was held.

Background and Purpose

Wrangell Narrows is a navigable

waterway of the United States located in

Southeast Alaska. It connects Frederick

Sound on the north end to Sumner

Strait on the south. It is approximately

24 miles long and narrows to 300 feet

in five places. The longest of the 300

foot wide sections is approximately 5.5

nautical miles in length. The other four

sections vary from approximately 600

yards to approximately 1.3 nautical

miles in length.

The primary users of Wrangell

Narrows are passenger ferries, log

carriers, pleasure craft and container

barges. Container barges are used to

transport consumer goods throughout

South East Alaska which is vital to the

every day life of Alaskan citizens.

The increased demand for consumer

goods in Southeast Alaska has created a

greater demand on providers of these

goods. The current regulations limit the

width of single barge tows allowed to