Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Rules and Regulations 66521

CAUTION: Do not interrupt the automatic

sequence of operation of the leading edge deice boots once it is turned ON. The system

should be turned OFF only after leaving the

icing conditions and after the protected

surfaces of the wing are free of ice.

(b) Within 10 months after the effective

date of this AD, install an ice detector in

accordance with EMBRAER Service Bulletin

No.: 120–30–0027, dated May 9, 1997.

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Atlanta

ACO. Operators shall submit their requests

through an appropriate FAA Principal

Operations Inspector, who may add

comments and then send it to the Manager,

Atlanta ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Atlanta ACO.

(d) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(e) The installation of the ice detector shall

be done in accordance with EMBRAER

Service Bulletin No. 120–30–0027, dated

May 9, 1997. This incorporation by reference

was approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from EMBRAER, Empresa Brasileira De

Aeronautica S/A, Sao Jose Dos Campos,

Brazil. Copies may be inspected at the FAA,

Transport Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(f) This amendment becomes effective on

January 23, 1998.

Issued in Renton, Washington, on

December 11, 1997.

Gilbert L. Thompson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–33000 Filed 12–18–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Part 4

[T.D. 98–3]

RIN 1515—AC27

Addition of Hong Kong to the List of

Nations Entitled to Special Tonnage

Tax Exemption

AGENCY: U.S. Customs Service,

Department of the Treasury.

ACTION: Final rule.

SUMMARY: Pursuant to information

provided by the Department of State, the

United States Customs Service has

found that Hong Kong does not impose

or levy any discriminating duties of

tonnage or imposts upon vessels wholly

belonging to citizens of the United

States, or upon the produce,

manufactures, or merchandise imported

in these vessels from the United States

or any foreign country and that,

accordingly, vessels of Hong Kong are

exempt from the payment of special

tonnage taxes and light money in ports

of the United States. This document

amends the Customs Regulations by

adding Hong Kong to the list of nations

whose vessels are exempt from the

payment of any higher tonnage duties

than are applicable to vessels of the

United States and from the payment of

light money.

EFFECTIVE DATE: The amendment to the

19 CFR 4.22 is effective on December

19, 1997. The exemption from special

tonnage tax and light money for vessels

registered in Hong Kong became

effective on July 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Craig Clark, Entry and Carrier Rulings

Branch (202) 927–2320.

SUPPLEMENTARY INFORMATION:

Background

Generally, the United States imposes

regular and special tonnage taxes, and a

duty of a specified amount per ton

denominated ‘‘light money’’, on all

foreign vessels which enter United

States ports (46 U.S.C. App. 121 and

128). Vessels of a foreign nation,

however, may be exempted from the

payment of such special tonnage taxes

and light money upon presentation of

satisfactory proof that no discriminatory

duties of tonnage or impost are imposed

by that foreign nation on United States

vessels or their cargoes (46 U.S.C. App.

141). The list of nations whose vessels

have been found to be reciprocally

exempt from the payment of any higher

tonnage duties than are applicable to

vessels of the United States and from

the payment of light money is found at

§ 4.22, Customs Regulations (19 CFR

4.22). Nations granted these commercial

privileges that subsequently impose

discriminatory duties are subject to

retaliatory suspension of the

commercial privileges (46 U.S.C. App.

141 and 142).

Treatment of Hong Kong

On July 1, 1997, Hong Kong became

a Special Administrative Region of the

People’s Republic of China. Before that

date, vessels from Hong Kong had an

exemption from special tonnage tax by

virtue of Hong Kong’s status as a British

colony.

The Department of State has

requested that Customs add Hong Kong

to the list of nations under § 4.22 in

order that vessels from Hong Kong

receive the same treatment as they did

prior to July 1, 1997. In addition, the

Department of State has submitted

information regarding the absence of

discriminatory duties of tonnage or

impost imposed on U.S. vessels in the

ports of Hong Kong.

The Department of State’s request is

consistent with the terms of section 2 of

the Act of October 5, 1992, referred to

as the United States-Hong Kong Policy

Act (Pub. L. 102–383, 106 Stat. 1448)

codified in title 22, United States Code,

section 5701, et seq., which embodies

the policy of the United States

applicable to dealing with Hong Kong

following reversion, including trade and

commerce matters. That law

demonstrates that dealings with Hong

Kong after June 30, 1997, are to be

conducted without change until and

unless the Administration (the

President) makes a determination that

different treatment is warranted.

Finding

Based on the request and information

submitted by the Department of State,

and based on 22 U.S.C. 5701, et seq., in

order that vessels from Hong Kong

remain exempt from the payment of

special tonnage tax following reversion,

the Customs Service has determined

that Hong Kong should be added to the

list of nations contained in 19 CFR 4.22,

effective July 1, 1997. The Customs

Regulations are amended accordingly.

Inapplicability of Public Notice and

Delayed Effective Date Requirements,

the Regulatory Flexibility Act, and

Executive Order 12866

Because this amendment merely

implements a statutory requirement and

confers a benefit upon the public,

pursuant to 5 U.S.C. 553(b)(B), notice

and public procedure are unnecessary;

further, for the same reasons, good cause

exists for dispensing with a delayed

effective date under 5 U.S.C. 553(d)(1)

and (3). Since this document is not

subject to the notice and public

procedure requirements of 5 U.S.C. 553,

it is not subject to the provisions of the

Regulatory Flexibility Act (5 U.S.C. 601

et seq.). Furthermore, this amendment

does not meet the criteria for a

‘‘significant regulatory action’’ as

specified in Executive Order 12866.

List of Subjects in 19 CFR Part 4

Cargo vessels, Customs duties and

inspection, Maritime carriers, Vessels.
66522 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Rules and Regulations

Amendment to the Regulations

Part 4, Customs Regulations (19 CFR

part 4), is amended as set forth below.

PART 4—VESSELS IN FOREIGN AND

DOMESTIC TRADES

1. The general authority for Part 4 and

relevant specific authority continue to

read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66,

1431, 1433, 1434, 1624; 46 U.S.C. App. 3, 91.

* * * * *

Section 4.22 also issued under 46

U.S.C. App. 121, 128, 141;

* * * * *

§ 4.22 [Amended]

2. Section 4.22 is amended by adding

‘‘Hong Kong’’ in appropriate

alphabetical order.

Dated: December 15, 1997

Harold M. Singer,

Chief, Regulations Branch.

[FR Doc. 97–33169 Filed 12–18–97; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 94N–0421]

Revocation of Regulation on Positron

Emission Tomography Drug Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; revocation.

SUMMARY: The Food and Drug

Administration (FDA) is revoking a

regulation on positron emission

tomography (PET) radiopharmaceutical

drug products. The regulation permits

FDA to approve requests from

manufacturers of PET drugs for

exceptions or alternatives to provisions

of the current good manufacturing

practice (CGMP) regulations. FDA is

taking this action in accordance with

provisions of the Food and Drug

Administration Modernization Act of

1997 (Modernization Act). Elsewhere in

this issue of the Federal Register, FDA

is publishing a notice revoking two

notices concerning certain guidance

documents on PET drugs and the

guidance documents to which the

notices relate.

EFFECTIVE DATE: December 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Brian L. Pendleton, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5649.

SUPPLEMENTARY INFORMATION: On

November 21, 1997, President Clinton

signed into law the Food and Drug

Administration Modernization Act of

1997 (Pub. L. 105–115). Section

121(c)(1)(A) of the Modernization Act

directs FDA to develop appropriate

procedures for the approval of PET

drugs as well as CGMP requirements for

such drugs, taking into account any

relevant differences between not-forprofit institutions that compound PET

drugs and commercial manufacturers.

FDA is to establish these procedures

and requirements not later than 2 years

after the date of enactment. In doing so,

the agency must consult with patient

advocacy groups, professional

associations, manufacturers, and

persons licensed to make or use PET

drugs.

Under section 121(c)(2) of the

Modernization Act, FDA cannot require

the submission of new drug applications

or abbreviated new drug applications for

compounded PET drugs that are not

adulterated under section 501(a)(2)(C) of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 351(a)(2)(C)) for a period

of 4 years after the date of enactment,

or 2 years after the date that the agency

adopts special approval procedures and

CGMP requirements for PET drugs,

whichever is longer.

Section 121(d) of the Modernization

Act requires FDA, within 30 days of

enactment, to publish in the Federal

Register a notice terminating the

application of FDA’s final rule,

published in the Federal Register of

April 22, 1997 (62 FR 19493), permitting

the agency to approve requests from

manufacturers of PET drug products for

exceptions or alternatives to provisions

of FDA’s CGMP regulations (21 CFR

211.1(d)). FDA already has received one

such request for an exception or

alternative to the CGMP requirements

for PET drugs in the form of a citizen

petition submitted by Case Western

Reserve University (CWRU) (Docket No.

97P–0198/CP1). As required by the

Modernization Act, the final rule on

exceptions and alternatives is hereby

revoked, which also renders the CWRU

citizen petition moot. The information

and views presented in the CWRU

citizen petition will be considered as a

part of the rulemaking proceeding to

establish appropriate CGMP

requirements for PET drugs under

section 121(c)(1)(A)(ii) of the

Modernization Act.

Section 121(d) of the Modernization

Act also directs FDA to terminate the

application of two notices concerning

certain guidance documents on PET

drugs. Elsewhere in this issue of the

Federal Register, FDA is publishing a

notice revoking these two notices and

the guidance documents to which the

notices relate.

The revocation of the final rule on

CGMP exceptions or alternatives for

PET drugs is effective December 21,

1997.

In accordance with section

121(c)(1)(A) of the Modernization Act,

FDA intends to begin the development

of new PET drug approval procedures

and CGMP requirements immediately

and will obtain appropriate public input

during this process.

List of Subjects in 21 CFR Part 211

Drugs, Labeling, Laboratories,

Packaging and containers.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 211 is

amended as follows:

PART 211—CURRENT GOOD

MANUFACTURING PRACTICE FOR

FINISHED PHARMACEUTICALS

1. The authority citation for 21 CFR

part 211 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 355,

356, 357, 360b, 371, 374.

§ 211.1 [Amended]

2. Section 211.1 Scope is amended by

removing paragraph (d).

Dated: December 16, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–33187 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Decoquinate and Bacitracin

Zinc

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

Alpharma Inc. The ANADA provides for

using approved decoquinate and

bacitracin zinc Type A medicated