23588 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558

Animal Drugs, Feeds, and Related

Products; Trichlorfon, etc.; Withdrawal

of Approval of NADAs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to remove those

portions that reflect approval of 11 new

animal drug applications (NADAs)

listed below. In a notice published

elsewhere in this issue of the Federal

Register, FDA is withdrawing approval

of the NADAs.

DATES: This rule is effective May 21,

2001.

FOR FURTHER INFORMATION CONTACT:

Pamela K. Esposito, Center for

Veterinary Medicine (HFV–210), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

5593.

SUPPLEMENTARY INFORMATION: The

following sponsors have requested that

FDA withdraw approval of the NADAs

listed below because the products are no

longer manufactured or marketed:

Sponsor NADA Number Product

(Drug)

21 CFR Cite Affected

(Sponsor Drug Labeler Code)

Purina Mills, Inc., P.O. Box 66812, St. Louis,

MO 63166–6812.

NADA 48–915 Purina Bot Control (trichlorfon) ..... 520.2520a (017800)

Golden Sun Feeds, Inc., 111 South Fifth St.,

Estherville, IA 51334.

NADA 97–567 Tylan 10 Premix (tylosin phosphate).558.625(b)(17) (021780)

...................................................................... NADA 97–615 Swine Med-A-Mix TS 8000 Premix,

Tylan 5, 10, 20, 40 Sulfa-G (tylosin phosphate and sulfamethazine).

558.630(b)(4) and (b)(10) (021780)

Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318–1093.NADA 110–440 Hygromix Hygrowormer

Hyanthelmix (hygromycin B).

558.274(a)(2), (a)(3), (a)(4), (c)(1)(i), and

(c)(1)(ii) (016968)

Steris Laboratories Inc., 620 North 51st

Ave., Phoenix, AZ 85043–4705.

NADA 45–578 Lidocaine Hydrochloride With Epinephrine Injection 2%.522.1258 (000402)

...................................................................... NADA 44–585 Oxytocin Injection ........................... 522.1680 (000402)

...................................................................... NADA 45–737 Sodium Pentobarbital Injection ....... 522.1704(b) (000402)

...................................................................... NADA 45–848 Phenylbutazone Injection ................ 522.1720 (000402)

...................................................................... NADA 110–349 Dexamethasone Injection ............. 522.540(c)(2) (000402)

...................................................................... NADA 110–350 Dexamethasone Injection ............. 522.540(b)(2)(ii) (000402)

...................................................................... NADA 117–973 Prednisolone Sodium Succinate

for Injection.

522.1884(c) (000402)

Following the withdrawal of approval

of these NADAs, Golden Sun Feeds,

Inc., is no longer the sponsor of any

approved applications. Therefore, 21

CFR 510.600(c) is amended to remove

entries for the sponsor.

Steris Laboratories currently has

another approved application for

dexamethasone injection (NADA 104–

606). Therefore, the regulation is not

amended to reflect the withdrawal of

approval of NADA 110–349

(dexamethasone injection).

Steris Laboratories NADA 44–585

oxytocin injection is not codified under

21 CFR 522.1680 oxytocin injection.

Also, Steris Laboratories NADA 45–848

phenylbutazone injection is not codified

under 21 CFR 522.1720 phenylbutazone

injection. Therefore, amendments of the

cited regulations are not required.

As provided below, the animal drug

regulations are amended to reflect the

withdrawal of approvals.

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

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 520 and 522

Animal drugs.

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 parts 510, 520, 522, and 558 are

amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

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 entry ‘‘Golden Sun Feeds,

Inc.’’, and in the table in paragraph

(c)(2) by removing the entry ‘‘021780’’.

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

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

§ 520.2520a [Removed]

4. Section 520.2520a Trichlorfon oral

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: 21 U.S.C. 360b.

§ 522.1258 [Removed]

6. Section 522.1258 Lidocaine

injection with epinephrine is removed.

§ 522.1704 [Amended]

7. Section 522.1704 Sodium

pentobarbital injection is amended by

removing and reserving paragraph (b).

§ 522.1884 [Amended]

8. Section 522.1884 Prednisolone

sodium succinate injection is amended

by removing the second sentence of

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