61624 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for 14 CFR

Part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; EO 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ASO FL E5 Guntersville, AL [New]

Guntersville Municipal Airport, AL

(lat. 34°23′57′′ N, long. 86°16′12′′ W)

That airspace extending upward from 700

feet above the surface within a 6.3-mile

radius of Guntersville Municipal Airport,

excluding that airspace within the

Albertville, AL, Class E airspace area.

* * * * *

Issued in College Park, Georgia, on

November 3, 1997.

Nancy B. Shelton,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 97–30357 Filed 11–18–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and

558

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for 61 approved new

animal drug applications (NADA’s) from

Mallinckrodt Veterinary, Inc., to

Schering-Plough Animal Health Corp.

EFFECTIVE DATE: November 19, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION:

Mallinckrodt Veterinary, Inc.,

Mundelein, IL 60060, has informed FDA

that it has transferred the ownership of,

and all rights and interests in the

approved NADA’s to Schering-Plough

Animal Health Corp. The agency is

amending 21 CFR 510, 520, 522, 524,

and 558 to reflect the change of sponsor.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 520, 522, and 524

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, 524, 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 for ‘‘Mallinckrodt

Veterinary Inc.’’; and in the table in

paragraph (c)(2) by removing the entry

for ‘‘011716’’.

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.

§ 520.82a [Amended]

4. Section 520.82a Aminopropazine

fumarate tablets is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.82b [Amended]

5. Section 520.82b Aminopropazine

fumarate, neomycin sulfate tablets is

amended in paragraph (b) by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

§ 520.222 [Amended]

6. Section 520.222 Bunamidine

hydrochloride is amended in paragraph

(c) by removing ‘‘011716’’ and adding in

its place ‘‘000061’’.

§ 520.580 [Amended]

7. Section 520.580 Dichlorophene and

toluene capsules is amended in

paragraph (b)(2) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.622c [Amended]

8. Section 520.622c

Diethylcarbamazine citrate chewable

tablets is amended in paragraph (b)(5)

by removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 520.784 [Amended]

9. Section 520.784 Doxylamine

succinate tablets is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.863 [Amended]

10. Section 520.863 Ethylisobutrazine

hydrochloride tablets is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.1120a [Amended]

11. Section 520.1120a Haloxon

drench is amended in paragraph (c) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61625

§ 520.1120b [Amended]

12. Section 520.1120b Haloxon

boluses is amended in paragraph (c) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 520.1242a [Amended]

13. Section 520.1242a Levamisole

hydrochloride drench and drinking

water is amended in paragraph (c)(2) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 520.1242b [Amended]

14. Section 520.1242b Levamisole

hydrochloride tablet or oblet (bolus) is

amended in paragraph (c) by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

§ 520.1242g [Amended]

15. Section 520.1242g Levamisole

resinate and famphur paste is amended

in paragraph (c) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.1320 [Amended]

16. Section 520.1320 Mebendazole

oral is amended in paragraph (c) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 520.1326a [Amended]

17. Section 520.1326a Mebendazole

and trichlorfon powder is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.1326b [Amended]

18. Section 520.1326b Mebendazole

and trichlorfon paste is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.1720a [Amended]

19. Section 520.1720a

Phenylbutazone tablets and boluses is

amended in paragraph (b)(1) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 520.1720b [Amended]

20. Section 520.1720b

Phenylbutazone granules is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.1720c [Amended]

21. Section 520.1720c

Phenylbutazone paste is amended in

paragraph (b) by removing ‘‘010797 and

011716’’ and adding in its place

‘‘000061 and 010797’’.

§ 520.1805 [Amended]

22. Section 520.1805 Piperazine

phosphate with thenium closylate

tablets is amended in paragraph (b) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 520.2220b [Amended]

23. Section 520.2220b

Sulfadimethoxine tablets and boluses is

amended in paragraph (b)(3) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 520.2220c [Amended]

24. Section 520.2220c

Sulfadimethoxine oral suspension is

amended in paragraph (c) by removing

‘‘000069 and 011716’’ and adding in its

place ‘‘000061 and 000069’’.

§ 520.2362 [Amended]

25. Section 520.2362 Thenium

closylate tablets is amended in

paragraph (c) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.2610 [Amended]

26. Section 520.2610 Trimethoprim

and sulfadiazine tablets is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.2611 [Amended]

27. Section 520.2611 Trimethoprim

and sulfadiazine oral paste is amended

in paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 520.2612 [Amended]

28. Section 520.2612 Trimethoprim

and sulfadiazine oral suspension is

amended in paragraph (b) by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

29. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.82 [Amended]

30. Section 522.82 Aminopropazine

fumarate sterile solution injection is

amended in paragraph (b) by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

§ 522.150 [Amended]

31. Section 522.150 Azaperone

injection is amended in paragraph (b) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 522.784 [Amended]

32. Section 522.784 Doxylamine

succinate injection is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 522.863 [Amended]

33. Section 522.863 Ethylisobutrazine

hydrochloride injection is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 522.1155 [Amended]

34. Section 522.1155 Imidocarb

dipropionate sterile powder is amended

in paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 522.1244 [Amended]

35. Section 522.1244 Levamisole

phosphate injection is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 522.1503 [Amended]

36. Section 522.1503 Neostigmine

methylsulfate injection is amended in

paragraph (b) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 522.1704 [Amended]

37. Section 522.1704 Sodium

pentobarbital injection is amended in

paragraph (a)(2) by removing ‘‘011716’’

and adding in its place ‘‘000061’’.

§ 522.1720 [Amended]

38. Section 522.1720 Phenylbutazone

injection is amended in paragraph (b)(1)

by removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 522.2005 [Amended]

39. Section 522.2005 Propofol

injection is amended in paragraph (b) by

removing ‘‘011716’’ and adding in its

place ‘‘000061’’.

§ 522.2610 [Amended]

40. Section 522.2610 Trimethoprim

and sulfadiazine sterile suspension is

amended in paragraph (a)(2) by

removing ‘‘000856 and 011716’’ and

adding in its place ‘‘000061 and

000856’’.

§ 522.2680 [Amended]

41. Section 522.2680 Zeranol is

amended in paragraph (b) by removing

‘‘011716’’ and adding in its place

‘‘000061’’.

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

42. The authority citation for 21 CFR

part 524 continues to read as follows:

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

§ 524.154 [Amended]

43. Section 524.154 Bacitracin or

bacitracin zinc-neomycin sulfatepolymyxin B sulfate ophthalmic

ointment is amended in paragraph (a)(2)

by removing ‘‘011716’’ and adding in its

place ‘‘000061’’.
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