66986 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Robenidine and Bacitracin Zinc

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 an abbreviated new animal

drug application (ANADA) filed by

Alpharma Inc. The ANADA provides for

using approved robenidine and

bacitracin zinc Type A medicated

articles to make Type C medicated

broiler chicken feeds used for

prevention of coccidiosis and increased

rate of weight gain and improved feed

efficiency.

EFFECTIVE DATE: December 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–28), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is the sponsor of

ANADA 200–212 which provides for

combining approved robenidine and

bacitracin zinc Type A medicated

articles to make Type C medicated

broiler feeds containing robenidine

hydrochloride 30 grams per ton (g/t) and

bacitracin zinc 4 to 50 g/t for prevention

of coccidiosis caused by Eimeria tenella,

E. necatrix, E. acervulina, E. brunetti, E.

mivati, and E. maxima, and with

bacitracin zinc 4 to 30 g/t, for increased

rate of weight gain, and with bacitracin

zinc 27 to 50 g/t, for improved feed

efficiency.

Alpharma Inc.’s ANADA 200–212 is

approved as a generic copy of

Hoffmann-La Roche, Inc.’s NADA 96–

933. The ANADA is approved as of

December 23, 1997, and the regulations

are amended in 21 CFR

558.515(d)(1)(vi)(b) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

This approval is for use of two single

ingredient Type A medicated articles to

make combination drug Type C

medicated feeds. One ingredient,

robenidine, is a Category II drug as

defined in 21 CFR 558.3(b)(1)(ii). As

provided in 21 CFR 558.4(b), an

approved form FDA 1900 is required to

make Type C medicated feed from a

Category II drug. Under section 512(m)

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360b(m)), as amended by

the Animal Drug Availability Act of

1996 (Pub. L. 104–250), medicated feed

applications have been replaced by a

requirement for feed mill licenses.

Therefore, use of robenidine and

bacitracin zinc Type A medicated

articles to make Type C medicated feeds

as provided in NADA 200–212 is

limited to manufacture in a licensed

feed mill.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 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.

The agency has determined under 21

CFR 25.33 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

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: 21 U.S.C. 360b, 371.

§ 558.515 [Amended]

2. Section 558.515 Robenidine

hydrochloride is amended in paragraph

(d)(1)(vi)(b) by removing ‘‘000004 and

000061’’ and adding in its place

‘‘000004, 000061, and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33489 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Amprolium Plus Ethopabate

With Bacitracin Zinc and Roxarsone

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 an abbreviated new animal

drug application (ANADA) filed by

Alpharma Inc. The ANADA provides for

using approved amprolium plus

ethopabate with bacitracin zinc and

roxarsone Type A medicated articles to

make Type C medicated broiler chicken

feeds used as an aid in the prevention

of coccidiosis and increased rate of

weight gain in broiler chickens raised in

floor pens.

EFFECTIVE DATE: December 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, filed ANADA 200–

217 that provides for combining

approved amprolium plus ethopabate

with bacitracin zinc and roxarsone Type

A medicated articles to make Type C

medicated broiler feeds. The Type C

medicated feed containing amprolium

113.5 grams per ton (g/t) plus

ethopabate 36.3 g/t with bacitracin zinc

5 to 35 g/t and roxarsone 34 g/t, is used

as an aid in the prevention of

coccidiosis where severe exposure to

coccidiosis from Eimeria acervulina, E.

maxima, and E. brunetti is likely to

occur, and for increased rate of weight

gain in broiler chickens raised in floor

pens.

Alpharma Inc.’s ANADA 200–217

provides for using approved AMPROL

HI–E (Merck’s amprolium and

ethopabate NADA 13–461), ALBAC

(Alpharma Inc.’s bacitracin zinc

ANADA 200–223), and 3–NITRO

(Alpharma Inc.’s roxarsone NADA 7–

891) Type A medicated articles to make

the combination drug Type C medicated

feeds.

Alpharma Inc.’s ANADA 200–217 is

approved as a generic copy of Swisher

Feed Div.’s NADA 39–284. The ANADA

is approved as of December 23, 1997,

and the regulations are amended in 21
Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Rules and Regulations 66987

CFR 558.58(d)(1)(iii) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

This approval is for use of three Type

A medicated articles to make

combination drug Type C medicated

feeds. One ingredient, roxarsone, is a

Category II drug as defined in 21 CFR

558.3(b)(1)(ii). As provided in 21 CFR

558.4(b), an approved form FDA 1900 is

required to make Type C medicated feed

from a Category II drug. Under section

512(m) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360b(m)), as

amended by the Animal Drug

Availability Act of 1996 (Pub. L. 104–

250), medicated feed applications have

been replaced by a requirement for feed

mill licenses. Therefore, use of

amprolium plus ethopabate, bacitracin

zinc, and roxarsone Type A medicated

articles to make Type C medicated feeds

as provided in ANADA 200–217 is

limited to manufacture in a licensed

feed mill.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 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.

The agency has determined under 21

CFR 25.33(a)(1) 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

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: 21 U.S.C. 360b, 371.

§ 558.58 [Amended]

2. Section 558.58 Amprolium and

ethopabate is amended in paragraph

(d)(1)(iii) in the table in the entry for

‘‘Bacitracin 5 to 35 plus roxarsone 34

(0.00375%)’’ in the column

‘‘Limitations’’ by removing ‘‘No.

000004’’ and adding in its place ‘‘Nos.

000004 and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33488 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 25 and 602

[TD 8743]

RIN 1545–AU12

Sale of Residence From Qualified

Personal Residence Trust

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations.

SUMMARY: This document contains final

regulations permitting the reformation

of a personal residence trust or a

qualified personal residence trust in

order to comply with the applicable

requirements for such trusts. The final

regulations also provide that the

governing instruments of such trusts

must prohibit the sale of a residence

held in the trust to the grantor of the

trust, the grantor’s spouse, or an entity

controlled by the grantor or the grantor’s

spouse.

DATES: The regulations are effective

December 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Lane Damazo (202) 622–3090 (not a tollfree number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

The collection of information

contained in these final regulations has

been reviewed and approved by the

Office of Management and Budget in

accordance with the Paperwork

Reduction Act (44 U.S.C. 3507) under

control number 1545–1485. Responses

to this collection of information are

required in order to ensure the proper

collection of the gift tax.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless the collection of information

displays a valid control number.

The estimated annual burden per

respondent/recordkeeper varies from 3

hours to 3.25 hours, depending on

individual circumstances, with an

estimated average of 3.1 hours.

Comments concerning the accuracy of

this burden estimate and suggestions for

reducing this burden should be sent to

the Internal Revenue Service, Attn: IRS

Reports Clearance Officer T:FP,

Washington, DC 20224, and to the

Office of Management and Budget,

Attention: Desk Officer for the

Department of the Treasury, Office of

Information and Regulatory Affairs,

Washington, DC 20503.

Books or records relating to this

collection of information must be

retained as long as their contents may

become material in the administration

of any internal revenue law. Generally,

tax returns and tax return information

are confidential, as required by 26

U.S.C. 6103.

Background

On April 16, 1996, the IRS published

in the Federal Register a notice of

proposed rulemaking (formerly PS–004–

96) at 61 FR 16623. The IRS received

written and oral comments on the

proposed regulations and held a public

hearing on July 24, 1996. This document

adopts final regulations with respect to

this notice of proposed rulemaking.

Comments with respect to § 25.2702–

5(a)(2) indicated that the procedure

permitting reformation of trust

instruments will be helpful to taxpayers

and practitioners. It was suggested that

an additional reformation period be

made available for trusts for which the

gift tax return due date had passed

before the regulations became effective.

Accordingly, under the final

regulations, the trustees of trusts created

before January 1, 1997, are granted a 90-

day period after these regulations

become final in which to reform the

trust.

Some of the comments concerning the

amendments to § 25.2702–5(b) and (c)

agreed that the restrictions in the

proposed regulations on the sale of the

personal residence after the termination

of the grantor’s retained interest in a

personal residence trust or a qualified

personal residence trust further the

intent of Congress in enacting section

2702(a)(3)(A)(ii). Other comments stated

that the restrictions were not supported

by the statute. Treasury and the IRS

continue to believe that these

regulations are consistent with the

intent of Congress and carry out the

purpose of the personal residence

exception to section 2702.

Other comments suggested that the

final regulations should contain an

exception permitting the sale of the

residence to the grantor if the need

arises. Treasury and the IRS believe,

however, that a rule of this nature is not

necessary, since a grantor may lease the

residence after the retained term from a

trust or individual to which the