22116 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations

among the parties. The agreement shall

be made available, on request, to

representatives of the Department of

Transportation.

(2) The agreement shall provide that

all actions necessary to ensure

accessible boarding for passengers with

disabilities are completed as soon as

practicable, but no later than December

2, 1998, at large and medium

commercial service hub airports (those

with 1,200,000 or more annual

enplanements); December 2, 1999, for

small commercial service hub airports

(those with between 250,000 and

1,199,999 annual enplanements); or

December 2, 2000, for non-hub

commercial service primary airports

(those with between 10,000 and 249,999

annual enplanements). All air carriers

and airport operators involved are

jointly responsible for the timely and

complete implementation of the

agreement.

(3) Boarding assistance under the

agreement is not required in the

following situations:

(i) Access to aircraft with a capacity

of fewer than 19 or more than 30 seats;

(ii) Access to float planes;

(iii) Access to the following 19-seat

capacity aircraft models: the Fairchild

Metro, the Jetstream 31, and the Beech

1900 (C and D models);

(iv) Access to any other 19-seat

aircraft model determined by the

Department of Transportation to be

unsuitable for boarding assistance by

lift, ramp or other suitable device on the

basis of a significant risk of serious

damage to the aircraft or the presence of

internal barriers that preclude

passengers who use a boarding or aisle

chair to reach a non-exit row seat.

(4) When boarding assistance is not

required to be provided under

paragraph (c)(3) of this section, or

cannot be provided as required by

paragraphs (b) and (c) of this section

(e.g., because of mechanical problems

with a lift), boarding assistance shall be

provided by any available means to

which the passenger consents, except

hand-carrying as defined in 14 CFR

382.39(a)(2).

(5) The agreement shall ensure that all

lifts and other accessibility equipment

are maintained in proper working

condition.

(d)(1) Each airport operator shall

negotiate in good faith with each carrier

serving the airport concerning the

acquisition and use of boarding

assistance devices for aircraft with a

seating capacity of 31 or more

passengers where level entry boarding is

not otherwise available. The airport

operator and the carrier(s) shall, by no

later than March 4, 2002 sign a written

agreement allocating responsibility for

meeting the boarding assistance

requirements of this section between or

among the parties. The agreement shall

be made available, on request, to

representatives of the Department of

Transportation.

(2) The agreement shall provide that

all actions necessary to ensure

accessible boarding for passengers with

disabilities are completed as soon as

practicable, but no later than December

4, 2002. All air carriers and airport

operators involved are jointly

responsible for the timely and complete

implementation of the agreement.

(3) Level-entry boarding assistance

under the agreement is not required

with respect to float planes or with

respect to any widebody aircraft

determined by the Department of

Transportation to be unsuitable for

boarding assistance by lift, ramp, or

other device on the basis that no

existing boarding assistance device on

the market will accommodate the

aircraft without a significant risk of

serious damage to the aircraft or injury

to passengers or employees.

(4) When level-entry boarding

assistance is not required to be provided

under paragraph (d)(3) of this section, or

cannot be provided as required by

paragraphs (b) and (d) of this section

(e.g., because of mechanical problems

with a lift), boarding assistance shall be

provided by any available means to

which the passenger consents, except

hand-carrying as defined in 14 CFR

382.39(a)(2).

(5) The agreement shall ensure that all

lifts and other accessibility equipment

are maintained in proper working

condition.

(e) In the event that airport personnel

are involved in providing boarding

assistance, the airport shall ensure that

they are trained to proficiency in the use

of the boarding assistance equipment

used at the airport and appropriate

boarding assistance procedures that

safeguard the safety and dignity of

passengers.

Issued this 27th day of April 2001 at

Washington, DC.

Norman Y. Mineta,

Secretary of Transportation.

[FR Doc. 01–11201 Filed 5–1–01; 10:22 am]

BILLING CODE 4910–62–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529,

and 558

Animal Drugs, Feeds, and Related

Products; Tylosin Tartrate for

Injection, 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 by removing

those portions that reflect approval of 13

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 14,

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)

Elanco Animal Health, A Div. of Eli Lilly &

Co., Lilly Corporate Center, Indianapolis,

IN 46285.

NADA 12–585 Tylan Injectable (tylosin tartrate) .... 522.2640b (000986)

NADA 15–207 Hyferdex Injection (iron dextran

complex).

522.1183(c) (000986)

NADA 30–330 Tylocine Sulfa Tablets (sulfadiazine, sulfamerazine, sulfamethazine, tylosin).not applicable

Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations 22117

Sponsor NADA Number Product (Drug) 21 CFR Cite Affected

(Sponsor Drug Labeler Code)

NADA 31–962 Tylan plus Neomycin Eye Powder

(neomycin sulfate, tylosin).

524.2640 (000986)

NADA 40–123 Toptic Ointment (cephalonium,

flumethasone, iodochlorhydroxyquin,

piperocaine hydrochloride, polymyxin B sulfate).

524.321 (000986)

NADA 47–092 Tribodine (ticarbodine) .................... 520.2460a (000986)

NADA 47–353 Ferti-Cept (chorionic gonadotropin) 522.1081(b) (000986)

NADA 92–602 Cephalothin Discs (cephaloridine) .. 529.360 (000986)

NADA 96–678 Tribodine Capsules (ticarbodine) .... 520.2460b (000986)

Bioproducts, Inc., 320 Springside Dr., suite

300, Fairlawn, OH 44333–2435.

NADA 93-518 Tylan 10 Plus (tylosin phosphate) 558.625(b)(2) (051359)

Young’s, Inc., Roaring Spring, PA 16673 ..... NADA 96–162 Hog Grow-R-Mix-4000, Hog GrowR-Mix-800 (tylosin phosphate).558.625(b)(13) (035393)

Veterinary Laboratories, Inc., 12340 Santa

Fe Dr., Lenexa, KS 66215.

NADA 42–889 Oxytocin Injection (oxytocin) ........... 522.1680(b) (000857)

Webel Feeds, Inc., Pittsfield, IL 62363 ......... NADA 116–196 Webel Tylan Premix (tylosin phosphate).558.625(b)(73) (035098)

Following the withdrawal of approval

of these NADAs, Young’s, Inc., is no

longer the sponsor of any approved

applications. Therefore, 21 CFR

510.600(c) is amended to remove the

entries for the sponsor.

Elanco Animal Health’s NADA 30–

330 Tylocine Sulfa Tablets is not

codified in 21 CFR part 520. Therefore,

an amendment to the regulations for this

withdrawal is 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, 522, 524, and 529

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, 529, 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 ‘‘Young’s, Inc.’’,

and in the table in paragraph (c)(2) by

removing the entry ‘‘035393’’.

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.

§ 520.2460 [Removed]

4. Section 520.2460 Ticarbodine oral

dosage forms is removed.

§ 520.2460a [Removed]

5. Section 520.2460a Ticarbodine

tablets is removed.

§ 520.2460b [Removed]

6. Section 520.2460b Ticarbodine

capsules is removed.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

7. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.1081 [Amended]

8. Section 522.1081 Chorionic

gonadotropin for injection; chorionic

gonadotropin suspension is amended by

removing and reserving paragraph (b).

§ 522.1183 [Amended]

9. Section 522.1183 Iron

hydrogenated dextran injection is

amended by removing and reserving

paragraph (c).

§ 522.1680 [Amended]

10. Section 522.1680 Oxytocin

injection is amended in paragraph (b) by

removing ‘‘000857,’’.

§ 522.2640b [Removed]

11. Section 522.2640b Tylosin tartrate

for injection is removed.

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

12. The authority citation for 21 CFR

part 524 continues to read as follows:

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

§ 524.321 [Removed]

13. Section 524.321 Cephalonium,

polymyxin B sulfate, flumethasone,

iodochlorhydroxyquin, piperocaine

hydrochloride topical-otic ointment is

removed.

§ 524.2640 [Removed]

14. Section 524.2640 Tylosin,

neomycin eye powder is removed.

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

15. The authority citation for 21 CFR

part 529 continues to read as follows:

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

§ 529.360 [Removed]

16. Section 529.360 Cephalothin discs

is removed.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

17. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.625 [Amended]

18. Section 558.625 Tylosin is

amended by removing and reserving

paragraphs (b)(2), (b)(13), and (b)(73).

22118 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations

Dated: April 23, 2001.

Linda Tollefson,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 01–11070 Filed 5–2–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 558

Animal Drugs, Feeds, and Related

Products; Technical Amendments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is updating the

animal drug regulations to reflect

changes to previously approved new

animal drug applications (NADAs).

Several sponsors currently listed as

sponsors of approved applications and

specified in the animal drug approval

regulations are incorrect. This action is

being taken to improve the accuracy of

the regulations.

DATES: This rule is effective May 3,

2001.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7519 Standish Pl.,

Rockville, MD 20855, 301–827–4567.

SUPPLEMENTARY INFORMATION: FDA has

found several errors in the agency’s

regulations concerning approval of

animal drugs, feeds, and related

products including the list of sponsors

of approved applications. To correct

those errors, FDA is amending 21 CFR

510.600(c)(1) and (c)(2) to remove 28

sponsor names and their corresponding

drug labeler codes (DLCs) because the

firms are no longer the holders of any

approved NADAs. This document is

also amending the animal drug approval

regulations by correcting nonsubstantive

DLC errors in 21 CFR 522.2120, 558.274,

558.625, and 558.630.

Publication of this document

constitutes final action on these changes

under the Administrative Procedure Act

(5 U.S.C. 553). Notice and public

procedure are unnecessary because FDA

is merely correcting nonsubstantive

errors.

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 Part 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, 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 entries for ‘‘Albion

Laboratories, Inc.’’, ‘‘Balfour Guthrie &

Co.’’, ‘‘Diamond Shamrock Corp.’’,

‘‘DuPont Merck Pharmaceutical Co.’’,

‘‘Farmers Feed & Supply Co.’’,

‘‘Franklin Laboratories, Inc.’’, ‘‘Gland-OLac Co.’’, ‘‘Michael Gordon, Inc.’’,

‘‘Henwood Feed Additives’’, ‘‘Heska

Corp.’’, ‘‘Hubbard Milling Co.’’,

‘‘Lemmon Co.’’, ‘‘Mattox & Moore, Inc.’’,

‘‘McClellan Laboratories, Inc.’’, ‘‘Nixon

and Co.’’, ‘‘Osborn Laboratories, Inc.’’,

‘‘Peter Hand Foundation’’, ‘‘Premier

Malt Products, Inc.’’, ‘‘Protein Blenders,

Inc.’’, ‘‘The Rath Packing Co.’’, ‘‘Rhone

Merieux Canada, Inc.’’, ‘‘Shell Chemical

Co.’’, ‘‘Square Deal Fortification Co.’’,

‘‘Sterling Winthrop, Inc.’’, ‘‘Syntex

Animal Health, Inc.’’, ‘‘V.P.O., Inc.’’,

‘‘Vet-A-Mix, Inc.’’, and ‘‘Westchester

Veterinary Products, Inc.’’, and in the

table in paragraph (c)(2) by removing

the entries for ‘‘000033, 000056, 000693,

000934, 010290, 010290, 011461,

011485, 011789, 012190, 012487,

025001 026186, 027863, 028260,

032707, 033999, 036108, 043728,

043729, 043732, 043735, 043737,

043738, 043743, 043744, 047015,

049047, and 063604’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.2120 [Amended]

4. Section 522.2120 Spectinomycin

dihydrochloride injection is amended in

paragraph (b) by removing ‘‘Nos. 000033

and 059130’’ and adding in its place

‘‘No. 059130’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

5. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.274 [Amended]

6. Section 558.274 Hygromycin B is

amended by removing and reserving

paragraph (a)(5); by removing ‘‘011790

and’’ in paragraph (a)(7); and by

removing ‘‘026186,’’ from the ‘‘Sponsor’’

column in the table in paragraphs

(c)(1)(i) and (c)(1)(ii).

§ 558.625 [Amended]

7. Section 558.625 Tylosin is

amended by removing and reserving

paragraphs (b)(16), (b)(19), and (b)(34),

and in paragraph (b)(79) by removing

‘‘012286’’ and adding in its place

‘‘017519’’.

§ 558.630 [Amended]

8. Section 558.630 Tylosin and

sulfamethazine is amended in

paragraph (b)(8) by removing ‘‘,

026186’’.

Dated: April 23, 2001.

Linda Tollefson,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 01–11158 Filed 5–2–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Part 11

RIN 1076–AE15

Law and Order on Indian Reservations

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Temporary final rule and

request for comments.

SUMMARY: The Bureau of Indian Affairs

(BIA) is amending its regulations

contained in 25 CFR Part 11 to add the