61628 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

July 9, 1996 (61 FR 35949), FDA

provided for approval of five

supplemental NADA’s to reflect

compliance with the results of the NAS/

NRC DESI review of the products and

FDA’s conclusions based on that study.

In that document, FDA failed to reflect

that Hoffmann-La Roche is the sponsor

of the product codified in

§ 558.128(d)(2) (see 53 FR 31316,

August 18, 1988). The sponsor was the

subject of a change of sponsor from

American Cyanamid published in the

Federal Register of April 24, 1996 (61

FR 18081). At this time, the paragraph

is amended to reflect the correct

sponsor.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

human food safety data and information

submitted to support approval of this

supplement 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.

FDA 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.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.128 [Amended]

2. Section 558.128 Chlortetracycline is

amended in the table in paragraph (d)(1)

in entry (xi) in the column

‘‘Limitations’’ by adding after the

existing text the sentence ‘‘For sponsor

000004 zero withdrawal time.’’, in entry

(xii) for indication 1., in the column

‘‘Limitations’’ by adding after the phrase

‘‘for sponsor 048573;’’ the phrase ‘‘zero

withdrawal for sponsor 000004;’’, in

entry (xvii) for indication 1., in the

column ‘‘Limitations’’ by adding after

the existing text the sentence ‘‘For

sponsor 000004 zero withdrawal time.’’,

and in paragraph (d)(2) by adding after

the number ‘‘(2)’’ the phrase ‘‘For

sponsor 000004:’’ and removing the

phrase ‘‘discontinue use 4 days prior to

slaughter’’.

Dated: November 3, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–30405 Filed 11–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Office of Justice Programs

28 CFR Part 50

[OJP–1078]

RIN 1121–AA37

Young American Medals Program

AGENCY: Office of Justice Programs,

Justice.

ACTION: Final rule.

SUMMARY: The United States Department

of Justice, Office of Justice Programs

(OJP), is publishing this final rule to

implement the regulations for the Young

American Medals Program as authorized

by the Youth Medals Act. The final rule

provides an outline of the program and

criteria for the awarding of the Young

American Medals for Bravery and

Service.

DATES: This regulation is effective as of

November 19, 1997.

FOR FURTHER INFORMATION CONTACT:

Ellen Wesley at (202) 616–3558.

SUPPLEMENTARY INFORMATION: Congress

authorized the Department of Justice to

promulgate rules and regulations

establishing medals under the Youth

Medals Act, codified at 42 U.S.C,

§ 1921, et seq. The Act establishes two

medals to be awarded under different

criteria to persons eighteen years of age

or younger at the time of the occurrence.

The first, the Young American Medal for

Bravery, 42 U.S.C. § 1921, is awarded to

a person who has exhibited exceptional

courage, extraordinary decisiveness,

presence of mind, and unusual

swiftness of action, regardless of his or

her own personal safety. The second

medal, the Young American Medal for

Service, 42 U.S.C. § 1922, is awarded to

a person who has displayed outstanding

character and service.

The final rule sets forth eligibility

criteria and application and

presentation procedures for the medals.

The Young American Medals

Committee, part of the Office of the

Attorney General, is authorized to issue

regulations for the establishment of the

two medals, and pursuant to that

authority is issuing this final rule.

The interim rule with request for

comments was published on September

19, 1996. No comments were received

before November 18, 1996, the end of

the comment period. Accordingly, the

interim rule amending 28 CFR part 50

which was published at 61 FR 49259 on

September 19, 1996, is adopted as a

final rule without change.

Regulatory Flexibility Act

The Assistant Attorney General,

Office of Justice Programs, in

accordance with the Regulatory

Flexibility Act (5 U.S.C. § 605(b)), has

reviewed this final rule and, by

approving it, certifies that the final rule

will not have a significant economic

impact on a substantial number of small

entities. The Assistant Attorney General,

Office of Justice Program determined

that the: (1) Final rule provides the

outline of a program governing the

award of medals to individuals for

bravery or service; and (2) the award of

such medals imposes no requirements

on small businesses or on small entities.

Paperwork Reduction Act

No information requirements are

contained in this final rule.

Executive Order 12866

This final rule has been reviewed in

accordance with Executive Order 12866,

§ 1(b), Principles of Regulation. The

Office of Justice Programs has

determined that this Final Rule is not a

‘‘significant regulatory action’’ under

Executive Order 12866 § 3(f), Regulatory

Planning and Review, and accordingly

this Final Rule has not been reviewed

by OMB.

Executive Order 12612

This regulation will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on

distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Unfunded Mandates Reform Act of

1995

This rule will not result in the

expenditure by State, local and tribal

governments, in the aggregate, or by the

private section, of $100,000,000 or more

in any one year, and it will not

significantly or uniquely affect small

governments. Therefore, no actions were
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61629

deemed necessary under the provisions

of the Unfunded Mandates Reform Act

of 1995.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule is not a major rule as

defined by § 804 of the Small Business

Regulatory Enforcement Fairness Act of

1996. This rule will not result in an

annual effect on the economy of

$100,000,000 or more; a major increase

in cost or prices; or significant adverse

effects on competition, employment,

investment, productivity, innovation, or

on the ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

List of Subjects in 28 CFR Part 50

Medals.

PART 50—STATEMENTS OF POLICY

Accordingly, the Interim Rule

amending 28 CFR part 50 which was

published at 61 FR 49259 on September

19, 1996, is adopted as a final rule

without change.

Dated: November 14, 1997.

Laurie Robinson,

Assistant Attorney General, Office of Justice

Programs.

[FR Doc. 97–30402 Filed 11–18–97; 8:45 am]

BILLING CODE 4410–18–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD07–97–054]

RIN 2115–AE46

Special Local Regulations: City of

Pompano Annual Christmas Boat

Parade, Pompano Beach, Florida

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing temporary special local

regulations for the City of Pompano

Annual Christmas Boat Parade. This

event will be held Sunday, December

14, 1997, between 5 p.m. and 10 p.m.

Eastern Standard Time (EST). There will

be approximately 150 participants and

75 spectator craft. The resulting

congestion of navigable channels creates

an extra or unusual hazard in the

navigable waters. These regulations are

necessary to provide for the safety of life

of navigable waters during the event.

DATES: These regulations become

effective on December 14, 1997, from 5

p.m. to 10 p.m. EST.

FOR FURTHER INFORMATION CONTACT:

LTJG J. Delgado, Coast Guard Group

Miami, FL at (305) 535–4409.

SUPPLEMENTARY INFORMATION:

Background and Purpose

The City of Pompano Annual

Christmas Boat Parade is a nighttime

parade of approximately 150 pleasure

and fishing boats ranging in length from

23 feet to 125 feet decorated with

holiday lights. There will be

approximately 75 spectator craft. The

parade will form in the staging area at

Lake Santa Barbara then proceed north

up the Intracoastal Waterway (ICW) to

the Hillsboro Boulevard Bridge where

the parade will disband.

The regulated area will include the

Intracoastal Waterway from Pompano

Beach daybeacon 74 LLNR 47230 to

State Road 810 Bridge (ICW mile marker

1050). While the parade is transiting,

these regulations will prohibit

nonparticipating vessels from

approaching within 500 feet ahead of

the lead vessel in the parade to 500 feet

astern of the last participating vessel in

the parade to within 50 feet on either

side of the parade unless authorized by

the patrol commander. After the passage

of the parade participants, all vessels

will be allowed to resume normal

operations.

In accordance with 5 U.S.C. 553, a

notice of proposed rulemaking was not

published for this regulation and good

cause exists for making it effective in

less than 30 days after Federal Register

publication. Publishing an NPRM and

delaying its effective date would be

contrary to national safety interests

since immediate action is needed to

minimize potential danger to the public,

as the Coast Guard was only given

notice of the date of the parade less than

five weeks before the event.

Regulatory Evaluation

This proposal is not a significant

regulatory action under Section 3(f) of

the Executive Order 12866 and does not

require an assessment of the potential

costs and benefits under Section 6(a)(3)

of that Order. It has been exempted from

review 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

proposed rule to be so minimal that a

full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

Entry into the regulated area is

prohibited for only five hours on the

day of the event.

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’’ include small

businesses, not-for-profit organizations

that are independently owned and

operated and are not dominant in their

fields, and governmental jurisdictions

with populations of less than 50,000.

Therefore, the Coast Guard certifies

under 5 U.S.C 605(b) that this rule

would not have a significant economic

impact on a substantial number of small

entities as the regulations would only be

in effect for approximately five hours in

a limited area of the intracoastal

waterway.

Collection of Information

These proposed regulations contain

no collection of information

requirements under the Paperwork

Reduction Act (44 U.S.C. 3501 et seq.).

Federalism

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

the rulemaking does not have sufficient

Federalism implications to warrant the

preparation of a Federalism Assessment.

Environmental Assessment

The Coast Guard has considered the

environmental impact of this proposal

consistent with Section 2.B.2 of

Commandant Instruction M16475.1B. In

accordance with that section, this

proposed action has been

environmentally assessed (EA

completed), and the Coast Guard has

concluded that it will not significantly

affect the quality of the human

environment. An Environmental

Assessment and a Finding of No

Significant Impact have been prepared

and are available in the docket for

inspection or copying.

List of Subjects in 33 CFR Part 100

Marine safety, Navigation (water),

Reporting and recordkeeping

requirements, Waterways.

Temporary Regulations: In

consideration of the foregoing, the Coast

Guard amends part 100 of Title 33, Code

of Federal Regulations, as follows: