45158 Federal Register / Vol. 62, No. 165 / Tuesday, August 26, 1997 / Rules and Regulations

provides for intramuscular use of

Adequan Canine (polysulfated

glycosaminoglycan) for dogs for control

of signs associated with noninfectious

degenerative and/or traumatic arthritis

of canine synovial joints. The drug is

limited to use by or on the order of a

licensed veterinarian. The NADA is

approved as of July 15, 1997, and the

regulations are amended in 21 CFR

522.1850 by adding new paragraph (d)

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)(ii) of the

Federal Food, Drug, and Cosmetic Act,

this approval qualifies for 3 years of

marketing exclusivity beginning July 15,

1997, because the application contains

substantial evidence of the effectiveness

of the drug involved, 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

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 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).

2. Section 522.1850 is amended by

adding new paragraph (d) to read as

follows:

§ 522.1850 Polysulfated

gylcosaminoglycan.

* * * * *

(d) Conditions of use—dogs—(1)

Indications for use. For control of signs

associated with noninfectious

degenerative and/or traumatic arthritis

of canine synovial joints.

(2) Dosage. 2 milligrams per pound of

body weight by intramuscular injection.

(3) Limitations. Administer

intramuscularly twice weekly for up to

4 weeks (maximum of 8 injections). Do

not exceed recommended dose or

regimen. Do not mix with other drugs or

solvents. Federal law restricts this drug

to use by or on the order of a licensed

veterinarian.

Dated: August 6, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–22623 Filed 8–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD11–97–006]

RIN 2115–AE46

Special Local Regulations;

Thunderboat Regatta

AGENCY: Coast Guard, DOT.

ACTION: Implementation of rule.

SUMMARY: This document implements

33 CFR 100.1101, ‘‘Southern California

annual marine events, for the ‘‘World

Series of Powerboat Racing’’ listed as

‘‘Thunderboat Regatta.’’

This event consists of circle races by

various classes of Hydroplane racing

boats and a separate but adjacent venue

for dragboat racing. These regulations

will be effective in an area of San

Diego’s Mission Bay known as Fiesta

Bay, as described in Table 1 of 33 CFR

100.1101. Implementation of 33 CFR

100.1101 is necessary to control vessel

traffic in the regulated areas during the

event to ensure the safety of participants

and spectators.

Pursuant to 33 CFR 100.1101(b)(3),

Commander, Coast Guard Activities San

Diego, is designated Patrol Commander

for this event; he has the authority to

delegate this responsibility to any

commissioned, warrant, or petty officer

of the Coast Guard.

EFFECTIVE DATE: This section becomes

effective at 8 a.m. PDT on September 12,

1997 and terminates at 5 p.m. PDT on

September 14, 1997 unless canceled

earlier by Commander, Coast Guard

Activities San Diego.

FOR FURTHER INFORMATION CONTACT:

QMC Michael C. Claeys, U.S. Coast

Guard Activities San Diego, California;

Tel: (619) 683–6309.

Discussion of Implementation. The

World Series of Powerboat Racing is

scheduled to occur on September 12, 13,

and 14, 1997. These Special Local

Regulations permit Coast Guard control

of vessel traffic in order to ensure the

safety of spectators and participant

vessels. In accordance with the

regulations in 33 CFR 100.1101, no

persons or vessels shall block, anchor,

or loiter in the regulated area; nor shall

any person or vessel transit through the

regulated area, or otherwise impede the

transit of participant or official patrol

vessels in the regulated area, unless

authorized by the Patrol Commander.

Dated: August 8, 1997.

J.M. MacDonald,

Captain, U.S. Coast Guard, Commander,

Eleventh Coast Guard District Acting.

[FR Doc. 97–22671 Filed 8–25–97; 8:45 am]

BILLING CODE 4910–14–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD01–97–083]

RIN 2115–AE46

Special Local Regulation: Fireworks

Displays Within the First Coast Guard

District

AGENCY: Coast Guard, DOT.

ACTION: Implementation of rule.

SUMMARY: This document provides

notice of the dates and times of the

special local regulations contained in 33

CFR 100.114, Fireworks Displays within

the First Coast Guard District. All

vessels will be restricted from entering

the area of navigable water within a 500

yard radius of the fireworks launch

platform for each event listed in the

table below. Implementation of these

regulations is necessary to control vessel

traffic within the regulated area to

ensure the safety of spectators.

EFFECTIVE DATE: The regulations in 33

CFR 100.114 are effective from one hour

before the scheduled start of the event

until thirty minutes after the last