42902 Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Rules and Regulations

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 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—[AMENDED]

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 the Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6005 Class E airspace area

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AWP CA E5 Salyer Farms, CA [Revised]

Salyer Farms Airport, CA

(Lat. 36°05′20′′ N, long. 119°32′33′′ W)

Salyer Farms RBN

(Lat. 36°05′05′′ N, long. 119°32′43′′ W)

El Rico Airport, CA

(Lat. 36°02′45′′ N, long. 119°38′48′′ W)

That airspace extending upward from 700

feet above the surface within a 6.6-mile

radius of Salyer Farms Airport and within 2

miles each side of the 151° bearing from the

Salyer Farms Radio Beacon extending from

the 6.6-miles radius to 8.3 miles southeast of

the Salyer Farms Radio Beacon, excluding

that airspace with a 1-mile radius of El Rico

Airport.

* * * * *

Issued in Lost Angeles, California on July

17, 1997.

Sabra W. Kaulia,

Assistant Manager, Air Traffic Division,

Western-Pacific Region.

[FR Doc. 97–21042 Filed 8–8–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Moxidectin Gel

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 new animal drug

application (NADA) filed by Fort Dodge

Animal Health. The NADA provides for

oral use of moxidectin gel for horses and

ponies for treatment and control of

infections of certain gastrointestinal

parasites.

EFFECTIVE DATE: August 11, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Fort

Dodge Animal Health, Division of

American Home Products Corp., 800

Fifth Street NW., P.O. Box 518, Fort

Dodge, IA 50501, filed original NADA

141–087 that provides for use of

QuestTM moxidectin 2 percent oral gel

in horses and ponies at 0.4 milligram

moxidectin per kilogram of body weight

for treatment and control of infections of

certain large strongyles, small strongyles

(adult and larvae), encysted

cyathostomes, ascarids, pinworms,

hairworms, large-mouth stomach

worms, and horse stomach bots, and for

supression of small strongyle egg

production for 84 days. The NADA is

approved as of July 11, 1997, and the

regulations are amended by adding new

21 CFR 520.1452 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.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act,

this approval qualifies for 3 years of

marketing exclusivity beginning July 11,

1997, because the application contains

substantial evidence of the effectiveness

of the drug involved, any studies of

animal safety or, in the case of foodproducing animals, human food safety

studies (other than bioequivalence or

residue studies) required for approval of

the application and conducted or

sponsored by the applicant.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. New § 520.1452 is added to read as

follows:

§ 520.1452 Moxidectin gel.

(a) Specifications. The gel contains 2

percent moxidectin (20 milligrams per

milliliter).

(b) Sponsor. See No. 000856 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount.

0.4 milligram moxidectin per kilogram

(2.2 pounds) of body weight.

(2) Indications for use. Horses and

ponies for treatment and control of large

strongyles (Strongylus vulgaris (adults

and L4/L5 arterial stages), S. edentatus

(adult and tissue stages),

Triodontophorus brevicauda (adults), T.

serratus (adults)); small strongyles

(Cyathostomum spp. (adults),

Cylicocyclus spp. (adults),

Cylicostephanus spp. (adults),

Gyalocephalus capitatus (adults),

undifferentiated lumenal larvae);

encysted cyathostomes (late L3 and L4

mucosal cyathostome larvae); ascarids

(Parascaris equorum (adults and L4

larval stages)); pinworms (Oxyuris equi

(adults and L4 larval stages)), hairworms

(Trichostrongylus axei (adults)), large-
Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Rules and Regulations 42903

mouth stomach worms (Habronema

muscae (adults)), and horse stomach

bots (Gasterophilus intestinalis (2nd and

3rd instars)). One dose also supresses

small strongyle egg production for 84

days.

(3) Limitations. For horses and ponies

including breeding mares and stallions.

Not for use in horses and ponies

intended for food. Consult your

veterinarian for assistance in the

diagnosis, treatment, and control of

parasitism.

Dated: August 1, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–21086 Filed 8–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Part 772

[FHWA Docket No. 96–26: FHWA–97–2348]

RIN 2125–AD97

Procedures for Abatement of Highway

Traffic Noise and Construction Noise

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Final rule.

SUMMARY: The FHWA is adopting, as

final, a current interim final rule that

revises the FHWA regulation that allows

Federal participation for Type II noise

abatement projects—that is, proposed

Federal or Federal-aid highway projects

for noise abatement on an existing

highway. This final rule restricts

Federal participation for Type II projects

to those that were approved before the

date of enactment of the National

Highway System Designation Act of

1995 (NHS) (Pub. L. 104–59, 109 Stat.

605) or are proposed along lands that

were developed or were under

substantial construction before approval

of the acquisition of the rights-of-way

for, or construction of, an existing

highway.

EFFECTIVE DATE: September 30, 1996.

FOR FURTHER INFORMATION CONTACT: Mr.

Robert Armstrong, Office of

Environment and Planning, (202) 366–

2073, or Mr. Robert Black, Office of the

Chief Counsel, (202) 366–1359, Federal

Highway Administration, 400 Seventh

Street, SW., Washington, DC 20590.

SUPPLEMENTARY INFORMATION: On August

29, 1996, the FHWA published an

interim final rule along with a request

for comments in the Federal Register

(61 FR 45319) as a means of

implementing changes in 23 CFR part

772 for Type II project eligibility. The

interim rule prohibits Federal

participation in Type II projects unless

development predated the existence of

any highway.

Discussion of Comments

The public comment period for the

interim final rule closed on November

27, 1996. The FHWA received two

comments from the Illinois Department

of Transportation. The response

concerning this interim final rule is

available for review at the U.S. DOT

Dockets, Room PL–401, 400 Seventh

Street, SW., Washington, DC 20590.

The first comment noted that the

FHWA went beyond the changes called

for by the NHS Act by indicating that

‘‘[n]oise abatement measures will not be

approved at locations where such

measures were previously determined

not to be reasonable and feasible for a

Type I project.’’ The comment stated

that there is no basis in the NHS

legislation for this change and

questioned the appropriateness of ruling

out the possibility of FHWA

participation in a Type II project on this

basis.

It was the intent of the NHS

legislation to prohibit Federal

participation in the construction of

Type II noise barriers in instances where

proper consideration has not been given

to highway traffic noise concerns and

issues during the local growth and

development process, i.e., growth and

development has occurred after a

highway was constructed and has

created unmitigated traffic noise

impacts. This intent was meant to limit

Federal expenditures for Type II noise

barriers.

The questioned statement is meant to

place increased emphasis on the

importance of noise-compatible land

use planning at the State and local level.

Highway traffic noise should be reduced

through a program of shared

responsibility. Thus, the FHWA

encourages State and local governments

to practice compatible land use

planning and control in the vicinity of

highways. Local governments should

use their power to regulate land

development in such a way that either

noise-sensitive land uses are prohibited

from being located adjacent to a

highway, or developments are planned,

designed, and constructed to minimize

noise impacts. The challenged statement

has been left unchanged.

The second comment noted that,

while the NHS legislation specifically

refers to limiting Federal participation

in the construction of Type II noise

barriers, revised § 772.13 limits Federal

participation in ‘‘noise abatement

measures,’’ a broader term that exceeds

the clear language of the NHS

legislation. As was the case above, the

wording ‘‘noise abatement measures’’ in

revised § 772.13 was used to meet the

intent of the NHS legislation to

generally prohibit Federal Type II

expenditures in instances where proper

consideration has not been given to

highway traffic noise concerns and

issues during the local growth and

development process. Therefore, no

change has been made in the final rule.

Rulemaking Analyses and Notices

Executive Order 12866 (Regulatory

Planning and Review) and DOT

Regulatory Policies and Procedures

The FHWA has determined that this

action is not a significant regulatory

action within the meaning of Executive

Order 12866 or significant within the

Department of Transportation

Regulatory Policies and Procedures. The

amendment clarifies some of the

requirements for Federal participation

in noise abatement projects for the 17

States that have constructed at least one

Type II noise barrier. It is anticipated

that the economic impact of the

rulemaking will be minimal; therefore, a

full regulatory evaluation is not

required.

Regulatory Flexibility Act

In compliance with the Regulatory

Flexibility Act (5 U.S.C. 601–612), the

FHWA has evaluated the effects of this

rule on small entities. Based on the

evaluation, the FHWA hereby certifies

that this action will not have a

significant economic impact on a

substantial number of small entities.

The amendment deals only with the

eligibility of certain State highway noise

abatement projects for Federal

participation. As such, it affects only

State highway agencies and not small

entities.

Executive Order 12612 (Federalism

Assessment)

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

this action does not have sufficient

federalism implications to warrant the

preparation of a federalism assessment.

It does not impose any new obligation

or requirement on a State. It does not

affect the amount of Federal

transportation funds that go to a State.

A State is not required to have a Type

II Noise Program. A State may still

expend its own funds on a noise

abatement project.