61626 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

§ 524.155 [Amended]

44. Section 524.155 Bacitracin zincpolymyxin B sulfate-neomycin sulfatehydrocortisone or hydrocortisone

acetate ophthalmic ointment is

amended in paragraph (a)(1) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 524.900 [Amended]

45. Section 524.900 Famphur is

amended in paragraph (c) by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

§ 524.1240 [Amended]

46. Section 524.1240 Levamisole is

amended in paragraph (b) by removing

‘‘010042 and 011716’’ and adding in its

place ‘‘000061 and 010042’’.

§ 524.1443 [Amended]

47. Section 524.1443 Miconazole

nitrate cream; miconazole nitrate lotion;

miconazole nitrate spray is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 524.1742 [Amended]

48. Section 524.1742 N-

(Mercaptomethyl) phthalimide S-(O,Odimethyl phosphorodithioate)

emulsifiable liquid is amended in

paragraph (b) by removing ‘‘011536 and

011716’’ and adding in its place

‘‘000061 and 011536’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

49. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.175 [Amended]

50. Section 558.175 Clopidol is

amended in paragraph (c)(1)(iii)(b) and

(c)(1)(iv)(b) by removing ‘‘011716’’ and

adding in its place ‘‘000061’’.

§ 558.195 [Amended]

51. Section 558.195 Decoquinate is

amended in the table in paragraph (d),

under the ‘‘Limitations’’ column by

removing ‘‘011716’’ wherever it appears

and adding in its place ‘‘000061’’.

§ 558.254 [Amended]

52. Section 558.254 Famphur is

amended in paragraph (a) by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

§ 558.311 [Amended]

53. Section 558.311 Lasalocid is

amended in the table in paragraph

(e)(1)(ii), under the ‘‘Limitations’’

column, 5th paragraph, by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

§ 558.515 [Amended]

54. Section 558.515 Robenidine

hydrochloride is amended in paragraph

(d)(1)(vi)(b) by removing ‘‘011716’’ and

adding in its place ‘‘000061’’.

Dated: November 3, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–30337 Filed 11–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

Oral Dosage Form New Animal Drugs;

Orbifloxacin Tablets

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

Schering-Plough Animal Health. The

supplemental NADA provides for

veterinary prescription use of

orbifloxacin tablets for management of

diseases in cats associated with bacteria

susceptible to orbifloxacin.

EFFECTIVE DATE: NOVEMBER 19, 1997.

FOR FURTHER INFORMATION CONTACT:

Joseph J. Bertone, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1692.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095

Morris Ave., Union, NJ 07083, is

sponsor of NADA 141–081 OrbaxTM

(orbifloxacin) tablets that provide for

veterinary prescription use in dogs for

management of diseases associated with

bacteria susceptible to orbifloxacin. The

sponsor filed a supplemental NADA

providing for veterinary prescription

use of orbifloxacin tablets for

management of diseases in cats

associated with bacteria susceptible to

orbifloxacin. The supplemental NADA

is approved as of September 18, 1997,

and the regulations are amended in 21

CFR 520.1616 to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

Furthermore, certain limitations,

although required in the labeling, are

not required in the regulation. Those

limitations are removed from the

regulation at this time.

Also, the sponsor’s address has been

changed. At this time, the address in the

list of sponsors of approved applications

in 21 CFR 510.600(c)(1) and (c)(2) is

amended to reflect the new address.

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 supplemental

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.

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

supplemental approval qualifies for 3

years of marketing exclusivity beginning

September 18, 1997, because the

supplemental application contains

substantial evidence of the effectiveness

of the drug involved or studies of target

animal safety required for approval and

conducted or sponsored by the

applicant. Three years marketing

exclusivity is limited to use of

orbifloxacin tablets for cats.

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

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 520

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 and 520 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

paragraph (c)(1) in the entry for
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