Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Rules and Regulations 21281

The Class E airspace areas designated as

surface areas are published in paragraph

6002 and the Class E airspace areas

designated as an extension to a Class D

or Class E surface area are published in

paragraph 6004 in FAA Order 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, which is

incorporated by reference in 14 CFR

71.1. The Class E airspace designations

listed in this document would be

published subsequently in the Order.

The Rule

This amendment to 14 CFR part 71

revises the Class E airspace at Bethel,

AK, in two ways: (1) Reduces the

amount of controlled airspace required

southwest of the Bethel airport; and (2)

modifies the Class E (surface area)

airspace description to exclude the

Hanger Lake seaplane base operations.

The area will be depicted on

aeronautical charts for pilot reference.

The intended effects of this rule are: (1)

To reduce the controlled airspace for

IFR operations at Bethel, AK, thus

allowing for VFR operations at Napakiak

Airport during Special VFR operations

at Bethel Airport and (2) fix an

administrative oversight by adding the

Hanger Lake exclusion area to the Class

E airspace description.

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current. It,

therefore—(1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) 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,

when promulgated, 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; E.O. 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 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, is

amended as follows:

* * * * *

Paragraph 6002 Class E airspace designated

as surface areas.

* * * * *

AAL AK E2 Bethel, AK [REVISED]

Bethel Airport, AK

(Lat. 60°46′47′′ N., long. 161°50′17′′ W.)

Bethel VORTAC

(Lat. 60°47′05′′ N., long. 161°49′27′′ W.)

Within a 4.1-mile radius of the Bethel

Airport, excluding that portion below 1,100

feet MSL between the 061° radial and the

081° radial from 2.9 miles northeast of the

Bethel VORTAC. This Class E airspace area

is effective during the specific dates and

times established in advance by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory.

* * * * *

Paragraph 6004 Class E airspace designated

as an Extension to a Class D or Class E

surface area.

* * * * *

AAL AK E4 Bethel, AK [REVISED]

Bethel Airport, AK

(Lat. 60°46′47′′ N., long. 161°50′17′′ W.)

Bethel VORTAC

(Lat. 60°47′05′′ N., long. 161°49′27′′ W.)

That airspace extending upward from the

surface within 3 miles each side of the 022°

radial from the Bethel VORTAC, extending

from the 4.1-mile radius of the Bethel Airport

to 8.2 miles northeast of the airport,

excluding that portion below 1,100 feet MSL

between the 061° radial and the 081° radial

from 2.9 miles northeast of the Bethel

VORTAC, within 3.4 miles each side of the

Bethel VORTAC 006° radial, extending from

the 4.1-mile radius of the Bethel Airport to

11 miles north of the Bethel VORTAC and

within 3.5 miles each side of the Bethel

VORTAC 213° radial extending from the 4.1-

mile radius of the Bethel Airport to 5 miles

southwest of the airport.

* * * * *

Issued in Anchorage, AK, on April 23,

2001.

Trent S. Cummings,

Manager, Air Traffic Division, Alaskan

Region.

[FR Doc. 01–10669 Filed 4–27–01; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Oxytetracycline Hydrochloride Soluble

Powder

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

Alpharma, Inc. The NADA which

provides for a revised withdrawal time

for use of oxytetracycline hydrochloride

soluble powder in the drinking water of

turkeys and swine.

DATES: This rule is effective April 30,

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: Alpharma,

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, filed a supplement

to NADA 130–435 that provides for use

of Oxytet (oxytetracycline HCl) Soluble

for making medicated drinking water for

the treatment of various bacterial

diseases of livestock. The NADA

provides for a zero-day slaughter

withdrawal time after the use of the

product in drinking water of turkeys

and swine. The supplemental

application is approved as of November

29, 2000, and the regulations are

amended in 21 CFR 520.1660d to reflect

the approval. The basis of 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

21282 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Rules and Regulations

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 25.24(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 Subject in 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 part 520 is amended as follows:

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.

§ 520.1660d [Amended]

2. Section 520.1660d Oxytetracycline

hydrochloride soluble powder is

amended in the sixth sentence in

paragraphs (d)(1)(ii)(A)(3),

(d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by

removing ‘‘046573’’; in the last sentence

in paragraphs (d)(1)(ii)(A)(3),

(d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by

removing ‘‘No. 053389’’ and by adding

in its place ‘‘Nos. 046573 and 053389’’;

and in the fourth sentence in paragraph

(d)(1)(iii)(C) by removing ‘‘Nos. 046573

and 057561’’ and by adding in its place

‘‘No. 057561 and zero days those

products sponsored by No. 046573.’’

Dated: April 16, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–10621 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 556

Animal Drugs, Feeds, and Related

Products; Sarafloxacin for Poultry;

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 the

portions reflecting approval of two new

animal drug applications (NADAs) for

which the sponsor has requested

withdrawal of approval. The NADAs

provide for use of sarafloxacin to treat

poultry. In a notice published elsewhere

in this issue of the Federal Register,

FDA is withdrawing approval of two

NADAs sponsored by Abbott

Laboratories.

DATES: This rule is effective April 30,

2001.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: In a notice

published elsewhere in this issue of the

Federal Register, FDA is withdrawing

approval of two NADAs held by Abbott

Laboratories, North Chicago, IL 60064.

The NADAs provide for use of

sarafloxacin to treat poultry. NADA

141–017 provides for the use of

SaraFlox (sarafloxacin hydrochloride)

WSP and is under § 520.2095 (21 CFR

520.2095) and NADA 141–018 provides

for the use of SaraFlox (sarafloxacin

hydrochloride) Injection and is under

§ 522.2095 (21 CFR 522.2095). Relevant

information concerning tolerances for

residues of sarafloxacin in edible tissues

of poultry is under § 556.594 (21 CFR

556.594).

Abbott Laboratories requested

withdrawal of approval in response to

safety questions raised by FDA

regarding the products.

No other NADAs for use of

sarafloxacin have been approved.

Therefore, in accordance with the notice

of withdrawal of approvals, FDA is

amending the regulations to remove

§§ 520.2095, 522.2095, and 556.594

effective April 30, 2001.

The agency has determined under 21

CFR 25.33(g) 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

21 CFR Parts 520 and 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Food and

Drug Administration and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 520, 522, and 556 are

amended as follows:

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.

§ 520.2095 [Removed]

2. Section 520.2095 Sarafloxacin

soluble powder is removed.

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.

§ 522.2095 [Removed]

4. Section 522.2095 Sarafloxacin

solution for injection is removed.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

5. The authority citation for 21 CFR

part 556 continues to read as follows:

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

§ 556.594 [Removed]

6. Section 556.594 Sarafloxacin is

removed.

Dated: April 17, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–10069 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S