This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

14633

Vol. 62, No. 59

Thursday, March 27, 1997

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Airspace Docket No. 97–AWP–4]

Adding Controlling Agency to

Restricted Areas: R–2530 Sierra Army

Depot, CA; R–4802 Lone Rock, NV; and

R–4811 Hawthorne, NV

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action adds ‘‘FAA,

Oakland Air Route Traffic Control

Center (ARTCC)’’ as the controlling

agency for Restricted Areas 2530 (R–

2530), Sierra Army Depot, CA; R–4802,

Lone Rock, NV; and R–4811,

Hawthorne, NV, to support the

provisions of the Open Skies Treaty.

This is an administrative change,

therefore, there are no changes to the

boundaries, designated altitudes, times

of designation, or activities conducted

within the affected restricted area.

EFFECTIVE DATE: 0901 UTC, May 22,

1997.

FOR FURTHER INFORMATION CONTACT:

William C. Nelson, Airspace and Rules

Division, ATA–400, Office of Air Traffic

Airspace Management, Federal Aviation

Administration, 800 Independence

Avenue, SW., Washington, DC 20591;

telephone: (202) 267–8783.

SUPPLEMENTARY INFORMATION:

The Rule

This amendment to part 73 of the

Federal Aviation Regulations (14 CFR

part 73) adds ‘‘FAA, Oakland ARTCC’’

as the controlling agency for R–2530

Sierra Army Depot, CA, R–4802 Lone

Rock, NV, and R–4811 Hawthorne, NV,

to support the provisions of the Open

Skies Treaty. This amendment is an

administrative change, therefore, there

are no changes to the boundaries,

designated altitudes, times of

designation, or activities conducted

within the affected restricted area.

Because this action is a minor technical

amendment in which the public is not

particularly interested, I find that notice

and public procedure under 5 U.S.C.

553(b) are unnecessary. Sections 73.25

and 73.48 of part 73 of the Federal

Aviation Regulations were republished

in FAA Order 7400.8D dated July 11,

1996.

The FAA has determined that this

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 will not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

Environmental Review

This action adds a controlling agency

to the specified restricted areas. There

are no changes to the boundaries,

designated altitudes, times of

designation, or activities conducted

within the affected restricted areas.

Accordingly, this action is not subject to

environmental assessments and

procedures as set forth in FAA Order

1050.1D, ‘‘Policies and Procedures for

Considering Environmental Impacts’’

and the National Environmental Policy

Act of 1969.

List of Subjects in 14 CFR Part 73

Airspace, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 73 as follows:

PART 73—[AMENDED]

1. The authority citation for part 73

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.

§ 73.25 [Amended]

2. Section 73.25 is amended as

follows:

R–2530 Sierra Army Depot, CA

[Amended]

By adding the following controlling

agency: ‘‘Controlling agency. FAA,

Oakland ARTCC.’’

§ 73.48 [Amended]

3. Section 73.48 is amended as

follows:

R–4802 Lone Rock, NV [Amended]

By adding the following controlling

agency: ‘‘Controlling agency. FAA,

Oakland ARTCC.’’

R–4811 Hawthorne, NV [Amended]

By adding the following controlling

agency: ‘‘Controlling agency. FAA,

Oakland ARTCC.’’

Issued in Washington, DC, on March 19,

1997.

Jeff Griffith,

Program Director for Air Traffic Airspace

Management.

[FR Doc. 97–7825 Filed 3–26–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ivermectin

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 Merck

Research Laboratories, Division of

Merck & Co., Inc. The supplemental

NADA provides for persistent control of

gastrointestinal roundworms and

lungworms following use of ivermectin

injection for cattle for treatment and

control of certain harmful

gastrointestinal roundworms,
14634 Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Rules and Regulations

lungworms, grubs, lice, and mange

mites infections.

EFFECTIVE DATE: March 27, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Merck

Research Laboratories, Division of

Merck & Co., Inc., P.O. Box 2000,

Rahway, NJ 07065, is sponsor of NADA

128–409, which provides for the use of

Ivomec Injection (1% ivermectin) for

cattle for the treatment and control of

gastrointestinal roundworm, lungworm,

grub, lice, and mange mite infections.

The supplement provides for control of

infections of Dictyocaulus viviparus and

Ostertagia ostertagi for 21 days after

treatment, and Haemonchus placei,

Trichostrongylus axei, Cooperia

punctata, C. oncophora, and

Oesophagostomum radiatum for 14

days after treatment. The supplement is

approved as of February 24, 1997, and

the regulations are amended in 21 CFR

522.1192(d)(2)(ii) 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, 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), approval of

this supplement qualifies for 3 years of

marketing exclusivity beginning

February 24, 1997, because the

supplement contains substantial

evidence of effectiveness of the drug

involved, any studies of animal safety

or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval of the

supplement and conducted or

sponsored by the applicant. Exclusivity

applies only to the additional

indications.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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 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: Sec. 512 of the Federal Food,

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

§ 522.1192 [Amended]

2. Section 522.1192 Ivermectin

injection is amended in paragraph

(d)(2)(ii) by adding to the end of the

paragraph the sentence ‘‘It is also used

to control infections of D. viparus and

O. ostertagi for 21 days after treatment,

and H. placei, T. axei, C. punctata, C.

oncophora, and Oesophagostomum

radiatum for 14 days after treatment.’’

Dated: March 17, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–7789 Filed 3–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD8–95–026]

Drawbirdge Operation Regulation;

Bonfouca Bayou, LA

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is revising

the regulation governing the operation

of the swing span drawbridge across

Bonfouca Bayou, mile 7.0, at Slidell, St.

Tammany Parish, Louisiana. A notice of

proposed rulemaking was published on

May 1, 1996, and a supplemental notice

of proposed rulemaking (SNPRM) was

published on December 27, 1996,

because of comment received. This final

rule maintains the operating times

published in the SPRM to which no

comments were received.

DATES: This regulation becomes

effective on April 28, 1997.

FOR FURTHER INFORMATION CONTACT:

Mr. Phil Johnson, Bridge Administration

Branch, Eighth Coast Guard District,

telephone (504) 589–2965.

SUPPLEMENTARY INFORMATION:

Regulatory History

The Coast Guard published a notice of

proposed rulemaking [61 FR 19223] on

Wednesday, May 1, 1996. Comments

received prompted the Coat Guard to

reevaluate the proposed rule. Mariners

and business owners, located upstream

of the bridge commented on the

proposal, stating that their business

would suffer if vessels were not

permitted to transit above the periods of

three continuous hours. Additionally,

local commercial marine interests

requested that the draw open on

demand from 9 p.m. to 5 a.m. if at least

4 hours advance notice is given, in lieu

of 12 hours notice. Subsequently, a

notice of supplemental proposed

rulemaking along with a notice of

temporary deviation was published

Friday, December 27, 1996 [61 FR

68198] incorporating changes in the

proposed rule. No comments were

received on the latter notice.

Accordingly, the Coast Guard will

maintain the operating times as noted in

the notice of supplemental proposed

rulemaking.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential cost

and benefits under section 6(a)(3) of that

order. It has not been reviewed by the

Office of Management and Budget under

that order. It is not significant under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, 1979). The

Coast Guard expects the economic

impact of this rule to be so minimal that

a full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.) the Coast Guard

must consider whether this rule will

have a significant economic impact on

a substantial number of small entities.

‘‘Small entities’’ may include (1) small

businesses and non-for-profit

organizations that are independently

owned and operated and are not

dominant in their field and (2)

governmental jurisdictions with

populations of less than 50,000.

Since this final rule was revised in

response to comments, concerns and

suggestions of local mariners and

maritime business interests, the

economic impact of this final rule is

expected to be minimal. Therefore, the

Coast Guard certifies under 5 U.S.C.