Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61627

‘‘Schering-Plough Animal Health’’ and

in paragraph (c)(2) in the entry for

‘‘000061’’ by removing the current

address and adding in its place the

address ‘‘1095 Morris Ave., Union, NJ

07083’’.

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 520.1616 [Amended]

2. Section 520.1616 Orbifloxacin

tablets is amended in the heading of

paragraph (d)(1) and in paragraph

(d)(1)(iii) by adding after the word

‘‘dogs’’ the phrase ‘‘and cats’’, and in

paragraph (d)(1)(iii) by removing the

phrase ‘‘2.5 milligrams per kilogram of

body weight’’ and the second, third, and

fourth sentences.

Dated: October 22, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–30411 Filed 11–18–97; 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

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 and bacitracin zinc Type A

medicated articles to make Type C

medicated feeds used for prevention of

coccidiosis in broiler and replacement

chickens and improved feed efficiency

in broiler chickens.

EFFECTIVE DATE: November 19, 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, is sponsor of

ANADA 200–205 that provides for

combining approved amprolium plus

ethopabate and bacitracin zinc Type A

medicated articles to make Type C

medicated feeds for broilers containing

amprolium 113.5 grams per ton (g/t)

plus ethopabate 36.3 g/t and bacitracin

zinc 4 to 50 g/t. The Type C medicated

feed is used: (1) 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 in broiler chickens and

replacement chickens where immunity

to coccidiosis is not desired, and for

increased rate of weight gain in broiler

chickens raised in floor pens; (2) 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 (3)

for improved feed efficiency in broiler

chickens.

Alpharma Inc.’s ANADA 200–205 is

approved as a generic copy of

Hoffmann-LaRoche, Inc.’s NADA 114–

794. The ANADA is approved as of

September 19, 1997, and the regulations

are amended in the table in 21 CFR

558.58(d)(1)(iii) to reflect the approval.

The basis for approval is discussed in

the freedom of information summary.

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.

§ 558.58 [Amended]

2. Section 558.58 Amprolium and

ethopabate is amended in paragraph

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

‘‘Bacitracin 4 to 50’’ in the columns

‘‘Limitations’’ and ‘‘Sponsor’’by

removing ‘‘000004’’ and adding in its

place ‘‘000004 and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–30409 Filed 11–18–97; 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; 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

changing the withdrawal time to zero

following certain uses of

chlortetracycline (CTC) in Type C cattle

feeds (including free-choice feeds).

EFFECTIVE DATE: November 19, 1997.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1638.

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

Nutley, NJ 07110–1199, filed

supplemental NADA 48–761 that

provides for decreasing the withdrawal

times for all National Academy of

Sciences/National Research Council

drug efficacy study implementation

(NAS/NRC DESI) approved uses of CTC

Type C medicated feeds (including freechoice feeds) for beef and nonlactating

dairy cattle and for control of

anaplasmosis and other claims to a zero

withdrawal time. The supplemental

NADA is approved as of September 23,

1997, and the regulations are amended

in § 558.128(d)(1) and (d)(2) (21 CFR

558.128(d)(1) and (d)(2)) to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

Also, in the revision of § 558.128

published in the Federal Register of
61628 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

July 9, 1996 (61 FR 35949), FDA

provided for approval of five

supplemental NADA’s to reflect

compliance with the results of the NAS/

NRC DESI review of the products and

FDA’s conclusions based on that study.

In that document, FDA failed to reflect

that Hoffmann-La Roche is the sponsor

of the product codified in

§ 558.128(d)(2) (see 53 FR 31316,

August 18, 1988). The sponsor was the

subject of a change of sponsor from

American Cyanamid published in the

Federal Register of April 24, 1996 (61

FR 18081). At this time, the paragraph

is amended to reflect the correct

sponsor.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

human food safety data and information

submitted to support approval of this

supplement 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.

FDA 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.

§ 558.128 [Amended]

2. Section 558.128 Chlortetracycline is

amended in the table in paragraph (d)(1)

in entry (xi) in the column

‘‘Limitations’’ by adding after the

existing text the sentence ‘‘For sponsor

000004 zero withdrawal time.’’, in entry

(xii) for indication 1., in the column

‘‘Limitations’’ by adding after the phrase

‘‘for sponsor 048573;’’ the phrase ‘‘zero

withdrawal for sponsor 000004;’’, in

entry (xvii) for indication 1., in the

column ‘‘Limitations’’ by adding after

the existing text the sentence ‘‘For

sponsor 000004 zero withdrawal time.’’,

and in paragraph (d)(2) by adding after

the number ‘‘(2)’’ the phrase ‘‘For

sponsor 000004:’’ and removing the

phrase ‘‘discontinue use 4 days prior to

slaughter’’.

Dated: November 3, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–30405 Filed 11–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Office of Justice Programs

28 CFR Part 50

[OJP–1078]

RIN 1121–AA37

Young American Medals Program

AGENCY: Office of Justice Programs,

Justice.

ACTION: Final rule.

SUMMARY: The United States Department

of Justice, Office of Justice Programs

(OJP), is publishing this final rule to

implement the regulations for the Young

American Medals Program as authorized

by the Youth Medals Act. The final rule

provides an outline of the program and

criteria for the awarding of the Young

American Medals for Bravery and

Service.

DATES: This regulation is effective as of

November 19, 1997.

FOR FURTHER INFORMATION CONTACT:

Ellen Wesley at (202) 616–3558.

SUPPLEMENTARY INFORMATION: Congress

authorized the Department of Justice to

promulgate rules and regulations

establishing medals under the Youth

Medals Act, codified at 42 U.S.C,

§ 1921, et seq. The Act establishes two

medals to be awarded under different

criteria to persons eighteen years of age

or younger at the time of the occurrence.

The first, the Young American Medal for

Bravery, 42 U.S.C. § 1921, is awarded to

a person who has exhibited exceptional

courage, extraordinary decisiveness,

presence of mind, and unusual

swiftness of action, regardless of his or

her own personal safety. The second

medal, the Young American Medal for

Service, 42 U.S.C. § 1922, is awarded to

a person who has displayed outstanding

character and service.

The final rule sets forth eligibility

criteria and application and

presentation procedures for the medals.

The Young American Medals

Committee, part of the Office of the

Attorney General, is authorized to issue

regulations for the establishment of the

two medals, and pursuant to that

authority is issuing this final rule.

The interim rule with request for

comments was published on September

19, 1996. No comments were received

before November 18, 1996, the end of

the comment period. Accordingly, the

interim rule amending 28 CFR part 50

which was published at 61 FR 49259 on

September 19, 1996, is adopted as a

final rule without change.

Regulatory Flexibility Act

The Assistant Attorney General,

Office of Justice Programs, in

accordance with the Regulatory

Flexibility Act (5 U.S.C. § 605(b)), has

reviewed this final rule and, by

approving it, certifies that the final rule

will not have a significant economic

impact on a substantial number of small

entities. The Assistant Attorney General,

Office of Justice Program determined

that the: (1) Final rule provides the

outline of a program governing the

award of medals to individuals for

bravery or service; and (2) the award of

such medals imposes no requirements

on small businesses or on small entities.

Paperwork Reduction Act

No information requirements are

contained in this final rule.

Executive Order 12866

This final rule has been reviewed in

accordance with Executive Order 12866,

§ 1(b), Principles of Regulation. The

Office of Justice Programs has

determined that this Final Rule is not a

‘‘significant regulatory action’’ under

Executive Order 12866 § 3(f), Regulatory

Planning and Review, and accordingly

this Final Rule has not been reviewed

by OMB.

Executive Order 12612

This regulation will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on

distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Unfunded Mandates Reform Act of

1995

This rule will not result in the

expenditure by State, local and tribal

governments, in the aggregate, or by the

private section, of $100,000,000 or more

in any one year, and it will not

significantly or uniquely affect small

governments. Therefore, no actions were