Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Proposed Rules 59829

regulatory evaluation prepared for this

action has been placed in the Rules

Docket. A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend part

39 of the Federal Aviation Regulations

(14 CFR part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive

(AD) to read as follows:

Extra Flugzeugbau GMBH: Docket No. 97–

CE–93–AD.

Applicability: Models EA–300/S airplanes,

serial numbers 01 through 24, certificated in

any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (c) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required within the next 100

hours time-in-service (TIS) after the effective

date of this AD, unless already accomplished.

To prevent failure of the canopy while the

airplane is in flight due to cracked canopy

latches, which could result in loss of the

canopy and possible loss of control of the

airplane, accomplish the following:

(a) Modify all canopy latches or replace all

canopy latches with parts of improved

design, part number (P/N) PC–23303.8P1 for

both front latches and the rear right; and P/

N PC–23303.8P2 for the rear left. Accomplish

the modifications or replacements in

accordance with the Instructions section of

EXTRA Service Bulletin No. 300–3–94, dated

August 3, 1994.

(b) 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.

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Small Airplane

Directorate, FAA, 1201 Walnut, suite 900,

Kansas City, Missouri 64106. The request

shall be forwarded through an appropriate

FAA Maintenance Inspector, who may add

comments and then send it to the Manager,

Small Airplane Directorate.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(d) All persons affected by this directive

may obtain copies of the document referred

to herein upon request to EXTRA

Flugzeugbau GmbH, Flugplatz Dinslaken,

46569 Hunxe, Germany; or may examine this

document at the FAA, Central Region, Office

of the Regional Counsel, Room 1558, 601 E.

12th Street, Kansas City, Missouri 64106.

Note 3: The subject of this AD is addressed

in German AD No. 94–258, dated August 25,

1994.

Issued in Kansas City, Missouri, on

October 29, 1997.

Mary Ellen A. Schutt,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 97–29239 Filed 11–4–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF COMMERCE

International Trade Administration

15 CFR Part 303

DEPARTMENT OF THE INTERIOR

Office of Insular Affairs

[Docket No. 971021249–7249–01]

RIN 0625–AA50

Proposed Limit on Duty-Free Insular

Watches in Calendar Year 1998

AGENCIES: Import Administration,

International Trade Administration,

Department of Commerce; Office of

Insular Affairs, Department of the

Interior.

ACTION: Proposed rule and request for

comments.

SUMMARY: This action invites public

comment on a proposal to amend the

ITA regulations, which govern dutyexemption allocations and duty-refund

entitlements for watch producers in the

United States’ insular possessions (the

Virgin Islands, Guam and American

Samoa) and the Northern Mariana

Islands. The proposed amendments

would establish the total quantity and

respective territorial shares of insular

watches and watch movements which

would be allowed to enter the United

States free of duty during calendar year

1998 and make a minor adjustment to

the verification of shipments.

DATES: Comments must be received on

or before December 5, 1997.

ADDRESSES: Address written comments

to Faye Robinson, Program Manager,

Statutory Import Programs Staff, Room

4211, U.S. Department of Commerce,

Washington, D.C. 20230.

FOR FURTHER INFORMATION CONTACT:

Faye Robinson, (202) 482–3526, same

address as above.

SUPPLEMENTARY INFORMATION: The

insular possessions watch industry

provision in Section 110 of Public Law

97–446 (96 Stat. 2331) (1983) as

amended by Section 602 of Public Law

103–465 (108 Stat. 4991) (1994)

additional U.S. Note 5 to chapter 91 of

the HTS requires the Secretary of

Commerce and the Secretary of the

Interior, acting jointly, to establish a

limit on the quantity of watches and

watch movements which may be

entered free of duty during each

calendar year. The law also requires the

Secretaries to establish the shares of this

limited quantity which may be entered

from the Virgin Islands, Guam,

American Samoa and the Northern

Mariana Islands. Regulations on the

establishment of these quantities and

shares are contained in §§ 303.3 and

303.4 of title 15, Code of Federal

Regulations (15 CFR 303.3 and 303.4).

The Departments propose to establish

for calendar year 1998 a total quantity

and respective territorial shares as

shown in the following table:

Virgin Islands ........................... 2,600,000

Guam ........................................ 500,000

American Samoa ...................... 500,000

Northern Mariana Islands ....... 500,000

Compared to the total quantity

established for 1997 (61 FR 55883;

October 30, 1996), this amount would

be a decrease of 500,000 units. The

proposed Virgin Islands territorial share

would be reduced by 500,000 and the

shares for Guam, American Samoa and

the Northern Mariana Islands would not

change. The amount we proposed for

the Virgin Islands is more than

sufficient for the anticipated needs of all

the existing producers.

The proposed rule would also modify

§ 303.6(a). Currently, the Departments

are able to verify shipments through the

U.S. Customs Service. However, due to

informal entry procedures on some

shipments or other problems, Commerce

is occasionally unable to verify an entry.

We propose allowing producers to
59830 Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Proposed Rules

provide other means of verification

satisfactory to the Secretaries in these

situations.

The proposed rule does not contain

policies with Federalism implications

sufficient to warrant preparation of a

Federalism assessment under Executive

Order 12612.

Regulatory Flexibility Act. In

accordance with the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq., the

Assistant General Counsel for

Legislation and Regulation has certified

to the Chief Counsel, Small Business

Administration, that the proposed rule

will not have a significant economic

impact on a substantial number of small

entities. This is because the rulemaking

is primarily to make technical changes.

Paperwork Reduction Act. This

rulemaking involves information

collection activities subject to the

Paperwork Reduction Act of 1980, 44

U.S.C. 3501 et seq. which is currently

approved by the Office of Management

and Budget under control number 0625–

0134. The amendments would have no

effect on the information burden on the

public.

Notwithstanding any other provision

of the law, no person is required to

respond to, nor shall any person be

subject to a penalty for failure to comply

with a collection of information unless

it displays a currently valid OMB

Control Number.

It has been determined that the

proposed rulemaking is not significant

for purposes of Executive Order 12866.

List of Subjects in 15 CFR Part 303

Administrative practice and

procedure, American Samoa, Customs

duties and inspection, Guam, Imports,

Marketing quotas, Northern Mariana

Islands, Reporting and recordkeeping

requirements, Virgin Islands, Watches

and jewelry.

For reasons set forth above, we

propose to amend 15 CFR Part 303 as

follows:

PART 303—[AMENDED]

§ 303.6 [Amended]

1. Section 303.6(a) is amended by

adding to the second to last sentence ‘‘,

or verified by other means satisfactory

to the Secretaries,’’ after the words U.S.

Customs Service.

§ 303.14 [Amended]

2. Section 303.14(e) is amended by

removing ‘‘3,100,000’’ and adding

‘‘2,600,000’’ in its place.

Robert S. LaRussa,

Assistant Secretary for Import

Administration.

Allen Stayman,

Director, Office of Insular Affairs.

[FR Doc. 97–29198 Filed 11–4–97; 8:45 am]

BILLING CODE 3510–DS–M and 4310–93–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. 97N–0435]

Substantial Evidence of Effectiveness

of New Animal Drugs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA), as directed by

the Animal Drug Availability Act of

1996 (ADAA), is proposing to amend its

new animal drug regulations to further

define the term ‘‘substantial evidence.’’

The purpose of this proposed regulation

is to encourage the submission of new

animal drug applications (NADA’s) and

supplemental NADA’s for single

ingredient and combination new animal

drugs. The proposal also encourages

dose range labeling.

DATES: Submit written comments on the

proposed rule by February 3, 1998.

Submit written comments on the

information collection requirements by

December 5, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Submit

written comments on the information

collection requirements to the Office of

Management and Budget (OMB), New

Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503,

Attn.: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Herman M. Schoenemann, Center for

Veterinary Medicine (HFV–126), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1638.

SUPPLEMENTARY INFORMATION:

I. Background

Congress enacted the ADAA (Pub. L.

104–250) on October 9, 1996. The

purpose of the ADAA is to facilitate the

approval and marketing of new animal

drugs and medicated feeds. In

furtherance of this purpose, section 2(a)

of the ADAA amended section 512(d)(3)

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360b(d)(3)) to

revise the definition of ‘‘substantial

evidence.’’ Section 2(e) of the ADAA

directs FDA to issue proposed

regulations to further define the term

‘‘substantial evidence’’ in a manner that

encourages the submission of NADA’s

and supplemental NADA’s. Section 2(e)

also directs FDA to issue proposed

regulations to encourage dose range

labeling. This proposed regulation

further defines substantial evidence and

encourages dose range labeling.

Before FDA can approve a new animal

drug, FDA must find, among other

things, that there is substantial evidence

that the new animal drug is effective.

The demonstration of effectiveness

represents a significant component of

drug development time and cost such

that the amount and nature of the

evidence needed can be an important

determinant of whether and when new

animal drugs become available to the

public. The availability of certain

approved new animal drugs for use in

livestock, poultry, pets, and other

animals is vital to protecting the health

of animals and the health of humans

who consume the products of food

producing animals. The availability of

other approved new animal drugs is

vital to increasing the efficiency of food

production in the United States. Thus,

animal and human health and food

production are best served by the

development of substantial evidence of

effectiveness in an efficient manner. The

changes made to the definition of

‘‘substantial evidence’’ by the ADAA

and by the further definition of that

term in this proposed rule give FDA

greater flexibility to make case-specific

scientific determinations regarding the

number and types of adequate and wellcontrolled studies that will provide, in

an efficient manner, substantial

evidence that a new animal drug is

effective.

II. The Statutory Definition of

Substantial Evidence

The term ‘‘substantial evidence’’ as

defined in section 512(d)(3) of the act

refers to the number and types of

adequate and well-controlled studies

needed for a new animal drug to be

determined to be effective for the

intended uses under the conditions of

use prescribed, recommended, or

suggested (hereinafter suggested) in its

labeling or proposed labeling.