Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Rules and Regulations 23589

paragraph (c) and by removing

paragraph (d)(2)(iv).

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

9. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.274 [Amended]

10. Section 558.274 Hygromycin B is

amended as follows:

a. In paragraph (a)(2) by removing

‘‘016968 and’’;

b. By removing and reserving

paragraph (a)(3);

c. In paragraph (a)(4) by removing

‘‘016968,’’;

d. In the table in paragraph (c)(1) in

the fifth column of the first entry in

items (i) and (ii) by removing ‘‘016968,’’.

§ 558.625 [Amended]

11. Section 558.625 Tylosin is

amended by removing and reserving

paragraph (b)(17).

§ 558.630 [Amended]

12. Section 558.630 Tylosin and

sulfamethazine is amended by removing

and reserving paragraph (b)(4), and in

paragraph (b)(10) by removing

‘‘021780,’’.

Dated: May 2, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–11621 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

Tolerances for Residues of New

Animal Drugs in Food; Narasin

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 which provides

for establishing a tolerance for residues

of narasin in edible tissues of chickens.

DATES: This regulation is effective May

9, 2001.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, A Division of Eli Lilly

& Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed a

supplement to NADA 118–980 that

provides for the use of Monteban (36,

45, 54, 72, or 90 grams per pound

narasin activity), a Type A medicated

article. The supplement provides for

establishing a tolerance for residues of

narasin in the abdominal fat of

chickens. The supplement is approved

as of April 11, 2001, and 21 CFR

556.428 is amended to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

In addition, FDA is taking the

opportunity to codify the acceptable

daily intake for total residues of narasin

which was previously established.

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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, 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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 556

Animal drugs, Foods.

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 556 is amended as follows:

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

1. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.428 is revised to read

as follows:

§ 556.428 Narasin.

(a) Acceptable daily intake (ADI). The

ADI for total residues of narasin is 5

micrograms per kilogram of body weight

per day.

(b) Tolerances—(1) Chickens

(abdominal fat). The tolerance for

parent narasin (the marker residue) is

480 parts per billion.

(2) [Reserved]

Dated: May 1, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 01–11584 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Part 9

[T.D. ATF 452]

RIN 1512–AA07

River Junction Viticultural Area (98R–

192P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Final rule, Treasury Decision.

SUMMARY: The Bureau of Alcohol,

Tobacco and Firearms (ATF) is

establishing a viticultural area located

in southern San Joaquin County,

California, to be known as ‘‘River

Junction.’’ This viticultural area is the

result of a petition filed by Mr. Ronald

W. McManis. ATF believes that the

establishment of viticultural areas and

the subsequent use of viticultural area

names as appellations of origin in wine

labeling and advertising allow wineries

to designate the specific areas where the

grapes used to make the wine were

grown and enable consumers to better

identify the wines they purchase.

EFFECTIVE DATE: July 9, 2001.

FOR FURTHER INFORMATION CONTACT: Tim

DeVanney, Regulations Division, 650

Massachusetts Avenue, NW.,

Washington, DC 20226; Telephone (202)

927–8196.

SUPPLEMENTARY INFORMATION:

Background

On August 23, 1978, ATF published

Treasury Decision ATF–53 (43 FR

37672, 54624) revising regulations in 27

CFR part 4. These regulations allow the

establishment of definite American

viticultural areas (AVAs). The

regulations also allow the name of an