Federal Register / Vol. 65, No. 200 / Monday, October 16, 2000 / Rules and Regulations 61089

Texarkana, AR; INT Texarkana 037° and Hot

Springs, AR, 225° radials; Hot Springs; to

Little Rock, AR.

* * * * *

Issued in Washington, DC, on October 5,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–26512 Filed 10–13–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

14 CFR Part 383

[Docket No. OST 2000–8058]

RIN 2105–AC92

Civil Penalties

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

SUMMARY: The Wendell H. Ford

Aviation Investment and Reform Act for

the 21st Century (AIR 21) revised

several civil penalty provisions

applicable to violations of the aviation

economic requirements of Title 49. By

this rule, the Department of

Transportation (Department) is

modifying its regulations to reflect these

revised civil penalties. This rule also

reviews those civil penalties unaffected

by the recent statutory amendments to

determine whether they should be

adjusted to recognize inflation that has

occurred since the adoption of part 383

in 1997. This review is required under

the Federal Civil Penalties Inflation

Adjustment Act of 1990 and the Debt

Collection Improvement Act of 1996.

EFFECTIVE DATE: This rule is effective on

November 15, 2000. However, the

statutory amendments it reflects became

effective on April 5, 2000, by their own

terms.

FOR FURTHER INFORMATION CONTACT:

Nicholas Lowry, Attorney, Office of

Aviation Enforcement and Proceedings

(C–70), Department of Transportation,

400 Seventh Street, SW., Washington,

DC 20590, (202) 366–9349.

SUPPLEMENTARY INFORMATION:

I. Civil Penalty Adjustments Required

by AIR 21.

The Wendell H. Ford Aviation

Investment and Reform Act for the 21st

Century (AIR 21) among other things

amended the statutory provisions

proscribing discriminatory practices in

air transportation and the civil penalties

for violations of those provisions.

Section 706 of AIR 21 creates a new

section 40127 of Title 49 which

specifically prohibits discrimination by

air carriers or foreign air carriers on the

basis of race, color, national origin,

religion, sex or ancestry. In addition,

section 707(a) of AIR 21 extended the

anti-discrimination provisions of 49

U.S.C. 41705, the Air Carrier Access

Act, which formerly applied only to air

carriers, to foreign air carriers, as well.

With respect to the civil penalties the

Department may impose, section 707(b)

of AIR 21 amended the provisions of 49

U.S.C. 46301(a)(3) to apply a $10,000

maximum civil penalty to each violation

of section 41705. In addition, section

222 of AIR 21 established $2,500 as the

maximum civil penalty amount for each

violation of section 40127 or 41712 (the

latter of which prohibits unfair and

deceptive trade practices and unfair

methods of competition).

The recent legislation does not affect

the civil penalty provisions applicable

to violations of all other aviation

economic requirements, or Department

rules or orders not proscribed or issued

under section 40127, 41705 or 41712.

For example, penalties for violations of

reporting requirements, cases involving

certain unauthorized operations, or

cases involving violations of other

Department orders or rules not issued

pursuant to the authority of 49 U.S.C.

40127, 41705, or 41712, remain at the

current level of $1,100 per violation

under AIR 21.

II. Inflation Adjustment of Other Civil

Penalty Provisions

The Debt Collection Improvement Act

of 1996 (Pub. L. 104–134, sec. 31001)

requires each agency to adjust each civil

monetary penalty within its jurisdiction

by the inflation adjustment described in

section 5 of the Federal Civil Penalties

Inflation Adjustment Act of 1990 (Pub.

L. 101–410). Section 5 requires the

adjustment to be rounded to the nearest

multiple of $1,000 for penalties greater

than $1,000 and less than or equal to

$10,000. The adjustment is to be the

percentage increase in the Consumer

Price Index (CPI) from June of the

calendar year in which the penalty was

last adjusted to June of the year

preceding the year in which the revision

is proposed. Under the 1996 act,

agencies are to review civil penalties

which they administer at least once

every four years. The civil penalties to

which the adjustment would apply here

are those civil penalty provisions not

affected by AIR 21, that is, penalties for

all violations other than cases involving

49 U.S.C. 40127, 41705, or 41712 or

regulations or orders issued thereunder.

Since the total inflation as measured

by the CPI between June 1997 and June

2000 was approximately 7 percent, an

appropriate increase in the civil penalty

amount would be $77. In view of the

rounding provision of the statute,

therefore, no adjustment of the civil

penalty amount is warranted at this

time.

III. Waiver of Notice of Proposed

Rulemaking

In developing this final rule, we are

waiving the usual notice of proposed

rulemaking and public comment

procedures set forth in the

Administrative Procedure Act (APA) (5

U.S.C. 553). The APA provides an

exception to the notice and comment

procedures when an agency finds there

is good cause for dispensing with such

procedures on the basis that they are

impracticable, unnecessary or contrary

to the public interest. We have

determined that under 5 U.S.C.

553(b)(3)(B) good cause exists for

dispensing with the notice of proposed

rulemaking and public comment

procedures for this rule. Specifically,

this rulemaking is required by the

Wendell H. Ford Aviation Investment

and Reform Act for the 21st Century, the

Federal Civil Penalties Inflation

Adjustment Act of 1990, and the Debt

Collection Improvement Act of 1996,

with no issues of policy discretion.

Accordingly, we believe that

opportunity for prior comment is

unnecessary and contrary to the public

interest, and are issuing these revised

regulations as a final rule.

IV. Regulatory Impact Statement

Executive Order 12866 and DOT

Regulatory Policies and Procedures

This final rule has been evaluated in

accordance with the existing policies

and procedures and is considered to be

not significant under both Executive

Order 12866 and DOT Regulatory

Policies and Procedures. The final rule

is exempt from review by the Office of

Management and Budget (OMB) in

accordance with the provisions of

Executive Order 12866, because it is

limited to the adoption of statutory

language, without interpretation. This

final rule amends the regulations

implementing the civil penalty

provisions to comply with AIR–21 and

reviews the civil penalties unaffected by

the recent statutory amendments to

determine if inflation adjustments are

necessary in accordance with Federal

Civil Penalties Inflation Adjustment Act

and the Debt Collection Improvement

Act. This rule simply adjusts or sets

penalties for those who violate the

regulations. As a result, we have

determined that there are no economic

consequences flowing from this rule.

61090 Federal Register / Vol. 65, No. 200 / Monday, October 16, 2000 / Rules and Regulations

Indeed, to avoid any costs, regulated

entities need only comply with the law.

Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980

requires an assessment of the impacts of

proposed and final rule on small

entities. An agency must prepare a

regulatory flexibility analysis that is

consistent with the Regulatory

Flexibility Act (5 U.S.C. 601–612),

unless the agency can certify that a

regulation will not have a significant

economic impact on a substantial

number of small entities. This rule

imposes no substantive burden and

merely amends the existing penalties for

those who engage in prohibited conduct

to reflect statutory changes. The civil

penalties will affect only those who

engage in conduct prohibited by statute

or related regulations. Those who

comply with the law will not be affected

by the civil penalties. Accordingly, the

Office of the Secretary certifies that this

action will not have a significant

economic impact on a substantial

number of small entities.

Paperwork Reduction Act

This final rule imposes no new

reporting or record keeping

requirements necessitating clearance by

OMB.

List of Subjects in 14 CFR Part 383

Administrative practice and

procedure, Penalties.

Accordingly, the Department of

Transportation revises Part 383 of Title

14, as set forth below:

PART 383—CIVIL PENALTIES

Sec.

§ 383.1 Basis and purpose.

§ 383.2 Amount of penalty.

Authority: Secs. 222, 706, 707(b), Pub. L.

106–181, 114 Stat. 61; Pub. L. 101–410, 104

Stat. 890, as amended by sec. 31001, Pub. L.

104–134, 110 Stat. 1321.

§ 383.1 Basis and purpose.

(a) Basis. This part implements the

civil penalty provisions of the Wendell

H. Ford Aviation Investment and

Reform Act for the 21st Century (AIR 21,

Pub. L. 106–181; 114 Stat. 61; April 5,

2000, sections 222, 706, 707(b)), and the

Federal Civil Penalties Inflation

Adjustment Act of 1990 (Pub. L. 101–

410), as amended by the Debt Collection

Improvement Act of 1996 (Pub. L. 104–

134, section 31001). The Debt Collection

Improvement Act requires each agency

head to adjust by regulation each civil

monetary penalty provided by law by

the inflation adjustment described

under section 5 of the Federal Civil

Penalties Inflation Adjustment Act. We

have applied these guidelines to the

civil penalty amounts that were not

affected by AIR 21 and, taking into

account the inflation that has occurred

since the most recent adjustment, have

found that no further adjustment is

warranted as of June 2000.

(b) Purpose. This part states the civil

penalty amounts with respect to

violations of 49 U.S.C. 40127, 41705 and

41712 and other civil penalties provided

in 49 U.S.C. 46301 (a)(1) for violations

covered by this chapter.

§ 383.2 Amount of penalty.

A person is liable to the United States

Government for a civil penalty of not

more than $10,000 for each violation of

49 U.S.C. 41705 and a civil penalty of

not more than $2,500 for each violation

of 49 U.S.C. 40127 or 41712. For other

violations of this chapter within the

scope of 49 U.S.C. 46301, the civil

penalty amount is $1,100.

* * * * *

Issued this 20th day of September, 2000, at

Washington, D.C.

Rodney E. Slater,

Secretary of Transportation.

[FR Doc. 00–26197 Filed 10–13–00; 8:45 am]

BILLING CODE 4910–62–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Levamisole

Phosphate Injection

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 Agri

Laboratories, Ltd. The ANADA provides

for use of levamisole phosphate solution

by subcutaneous injection for the

treatment of various species of

gastrointestinal parasites in cattle.

DATES: This rule is effective October 16,

2000.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Agri

Laboratories, Ltd., P.O. Box 3103, St.

Joseph, MO 64503, filed ANADA 200–

271 for LEVAMISOLE PHOSPHATE

Injectable Solution, 13.65%. The

ANADA provides for use of levamisole

phosphate solution by subcutaneous

injection for the treatment of various

species of gastrointestinal parasites in

cattle. The ANADA is approved as a

generic copy of Schering-Plough Animal

Health’s NADA 126–742 for

LEVASOLE Injection. ANADA 200–

271 is approved as of September 7,

2000, and the regulations are amended

in 21 CFR 522.1244 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

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 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.1244 [Amended]

2. Section 522.1244 Levamisole

phosphate injection is amended in

paragraph (b) by removing ‘‘No.

000061’’ and by adding in its place

‘‘Nos. 000061 and 057561’’.