20588 Federal Register / Vol. 66, No. 79 / Tuesday, April 24, 2001 / Rules and Regulations

Comments Invited

Although this action is in the form of

a final rule and was not preceded by a

notice of proposed rulemaking,

comments are invited on this rule.

Interested persons are invited to

comment on this rule by submitting

such written data, views, or arguments

as they may desire. Communications

should identify the Rules Docket

number and be submitted in triplicate to

the address specified under the caption

ADDRESSES. All communications

received on or before the closing date

for comments will be considered, and

this rule may be amended or withdrawn

in light of the comments received.

Factual information that supports the

commenter’s ideas and suggestions is

extremely helpful in evaluating the

effectiveness of this action and

determining whether additional

rulemaking action is needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the rule that might suggest a need to

modify the rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this

action will be filed in the Rules Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket No. 2001–ASW–08.’’ The

postcard will be date stamped and

returned to the commenter.

Agency Findings

The regulations adopted herein will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, it is

determined that this final rule will not

have federalism implications under

Executive Order 13132.

Further, the FAA has determined that

this regulation is noncontroversial and

unlikely to result in adverse or negative

comments and only involves an

established body of technical

regulations that require frequent and

routine amendments to keep them

operationally current. Therefore, I

certify that this regulation (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)

will not have a significant economic

impact, positive or negative, on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. Since this rule involves

routine matters that will only affect air

traffic procedures and air navigation, it

does not warrant preparation of a

Regulatory Flexibility Analysis because

the anticipated impact is so minimal.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me, the Federal

Aviation Administration amends 14

CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for 14 CFR

part 71 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.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, is

amended as follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ASW NM E5 Farmington, NM [REVISED]

Farmington, Four Corners Regional Airport,

NM

(Lat. 36°44′29′′N., long. 108°13′48′′W.)

Farmington VORTAC

(Lat. 36°44′54′′N., long. 108°05′56′′W.)

That airspace extending upward from

700 feet above the surface within a 6.7-

mile radius of Four Corners Regional

Airport, and within 2.4 miles each side

of the 086° radial of the Farmington

VORTAC extending from the 6.7-mile

radius to 13.4 miles east of the airport

and within 1.6 miles each side of the

266° radial of the Farmington VORTAC

extending from the 6.7-mile radius to

11.9 miles west of the airport; and that

airspace extending from 1,200 feet

above the surface bounded by a line

extending from lat. 37°04′00′′N., long.

108°56′54′′W.; to lat. 37°04′00′′N., long.

108°27′03′′W.; thence clockwise within

a 25.5-mile radius of the Farmington

VORTAC to lat. 37°00′00′′N., long.

107°40′18′′W.; to lat. 37°00′00′′N., long.

107°12′58′′W.; thence clockwise within

a 45.1-mile radius of the Farmington

VORTAC to point of beginning;

excluding that airspace within the

Durango, CO, Class E airspace area and

that airspace within and underlying the

Crownpoint, NM, Class E airspace area.

* * * * *

Issued in Fort Worth, TX, on April 6, 2001.

Robert N. Stevens,

Acting Manager, Air Traffic Division,

Southwest Region.

[FR Doc. 01–10131 Filed 4–23–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Part 159

[T.D. 01–24]

RIN 1515–AC30

Foreign Repairs to American Vessels;

Correction

AGENCY: U.S. Customs Service,

Department of the Treasury.

ACTION: Final rule; correction.

SUMMARY: This document contains a

correction to the final regulations (T.D.

01–24), which were published in the

Federal Register on Monday, March 26,

2001. The regulations related to the

requirements regarding the declaration,

entry, assessment of duty and

processing of petitions for relief from

duty for vessels of the United States

which undergo foreign shipyard

operations.

EFFECTIVE DATE: April 25, 2001.

FOR FURTHER INFORMATION CONTACT:

Russell A. Berger, Regulations Branch,

(202–927–1605).

SUPPLEMENTARY INFORMATION:

Background

The final regulations regarding foreign

repairs to American vessels were

published as T.D. 01–24 in the Federal

Register (66 FR 16392) on Monday,

March 26, 2001. In particular, these

final regulations set forth the

requirements regarding the declaration,

entry, assessment of duty and

processing of petitions for relief from

duty for vessels of the United States

which undergo foreign shipyard

operations. The final rule document

contained an error which could prove to

Federal Register / Vol. 66, No. 79 / Tuesday, April 24, 2001 / Rules and Regulations 20589

be misleading and is in need of

clarification.

Need for Correction

Specifically, the final rule document

amended the authority citation for part

159, Customs Regulations (19 CFR part

159), by moving specific authority

citations for certain regulatory sections

in the part to the authority citation

section set forth at the beginning of the

part from parenthetical references set

forth immediately following the text of

the particular sections. However, it has

come to Customs attention that these

same changes relating to the authority

citation for part 159 were previously

made in an interim rule document that

was published in the Federal Register

(64 FR 56433) on October 20, 1999, as

T.D. 99–75.

Correction of Publication

Accordingly, the publication on

March 26, 2001, of the final regulations

concerning foreign repairs to American

vessels (T.D. 01–24) (FR Doc. 01–7325)

is corrected as follows:

1. On page 16399, in the third

column, under the heading, ‘‘PART

159—LIQUIDATION OF DUTIES’’,

correct amendatory instruction number

1 to read: ‘‘The authority citation for

part 159 continues to read as follows:’’

2. On page 16400, in the first column,

under the heading, ‘‘PART 159—

LIQUIDATION OF DUTIES’’, remove

amendatory instruction number 2.

3. On page 16400, in the first and

second columns, again under the

heading, ‘‘PART 159—LIQUIDATION

OF DUTIES’’, renumber amendatory

instruction numbers 3, 4 and 5 as

amendatory instruction numbers 2, 3,

and 4, respectively.

Dated: April 19, 2001.

Harold M. Singer,

Chief, Regulations Branch.

[FR Doc. 01–10163 Filed 4–23–01; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50 and 56

[Docket No. 00N–0074]

RIN 0910–AC07

Additional Safeguards for Children in

Clinical Investigations of FDARegulated Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Interim rule; opportunity for

public comment.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

interim rule to amend its regulations to

provide additional safeguards for

children enrolled in clinical

investigations of FDA-regulated

products. This interim rule is intended

to bring FDA regulations into

compliance with provisions of the

Children’s Health Act of 2000 (the

Children’s Health Act), which requires

that within 6 months of its enactment

all research involving children that is

conducted, supported, or regulated by

the Department of Health and Human

Services (HHS) be in compliance with

HHS regulations providing additional

protections for children involved as

subjects in research. To comply with

this congressionally mandated

timeframe and for other reasons

described in this document, FDA is

publishing this regulation as an interim

rule.

FDA is requiring additional

safeguards to protect children because

of expected increases in the enrollment

of children in clinical investigations as

a result of recent pediatric initiatives.

These initiatives include FDA’s 1998

pediatric rule (the 1998 pediatric rule)

and the pediatric provisions of the Food

and Drug Administration Modernization

Act of 1997 (the Modernization Act).

DATES: This interim rule is effective

April 30, 2001. Submit written

comments by July 23, 2001. Submit

written comments on the information

collection requirements by May 24,

2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20857. Submit

written comments on the information

collection provisions to the Office of

Information and Regulatory Affairs,

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:

Carol Drew, Center for Drug Evaluation

and Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–2041.

SUPPLEMENTARY INFORMATION:

I. Background

FDA’s authority includes regulation of

safety and effectiveness testing in

humans of certain FDA-regulated

products. FDA-regulated products

include human drug and biological

products, medical device products, and

dietary supplements, nutritional, food

additive, and foods. This rule covers

safety and effectiveness testing of FDAregulated products in children. FDA

expects an increase in testing of drug

and biological products in children as a

result of recent initiatives in pediatric

research.

A. Recent Initiatives in Pediatric

Research

The 1998 pediatric rule (63 FR 66632,

December 2, 1998) requires

manufacturers to assess the safety and

effectiveness of certain drug and

biological products in pediatric patients.

In the preamble to the 1998 pediatric

rule, FDA stated that many drug and

biological products marketed in the

United States that are or could be used

in children are inadequately labeled for

use in pediatric patients or specific

pediatric subgroups. FDA concluded

that the absence of pediatric labeling

information for these drug and

biological products posed significant

risks for children.

The 1998 pediatric rule establishes a

presumption that certain drug and

biological products will be studied in

pediatric patients. The 1998 pediatric

rule also authorizes FDA to require

pediatric studies of those marketed drug

and biological products that: (1) Are

used in a substantial number of

pediatric patients for the labeled

indications, and where the absence of

adequate labeling could pose significant

risks to pediatric patients; or (2) would

provide a meaningful therapeutic

benefit over existing treatments for

pediatric patients for one or more of the

claimed indications, and the absence of

adequate labeling could pose significant

risks to pediatric patients.

The Modernization Act (Public Law

105–115) established economic

incentives for manufacturers to conduct

pediatric studies on drugs for which

exclusivity or patent protection is

available under the Drug Price

Competition and Patent Term

Restoration Act (Public Law 98–417) or

the Orphan Drug Act (Public Law 97–

414). These provisions attach 6 months

of marketing exclusivity to any existing

exclusivity or patent protection on a

drug for which FDA has requested

pediatric studies and the manufacturer

has conducted such studies in

accordance with the requirements of the

Modernization Act.

As of October 1, 2000, FDA had

received 194 proposed pediatric study

requests under the exclusivity

provisions of the Modernization Act and

had issued 157 Written Requests for

pediatric studies. A Written Request is