58344 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

mile. The amendment at Dexter

Municipal Airport, MO, will provide

additional controlled airspace for

aircraft operation under IFR, include the

NDB and coordinates in the text header

and comply with the criteria of FAA

Order 7400.2D. The area will be

depicted on appropriate aeronautical

charts. Class E airspace areas extending

upward from 700 feet or more above the

surface of the earth are published in

paragraph 6005 of FAA Order 7400.9H,

dated September 1, 2000, and effective

September 16, 2000, which is

incorporated by reference in 14 CFR

71.1. The Class E airspace designation

listed in this document will be

published subsequently in the Order.

The Direct Final Rule Procedure

The FAA anticipates that this

regulation will not result in adverse or

negative comment and, therefore, is

issuing it as a direct final rule. Previous

actions of this nature have not been

controversial and have not resulted in

adverse comments or objections. The

amendment will enhance safety for all

flight operations by designating an area

where VFR pilots may anticipate the

presence of IFR aircraft at lower

altitudes, especially during inclement

weather conditions. A greater degree of

safety is achieved by depicting the area

on aeronautical charts. Unless a written

adverse or negative comment, or a

written notice of intent to submit an

adverse or negative comment is received

within the comment period, the

regulation will become effective on the

date specified above. After the close of

the comment period, the FAA will

publish a document in the Federal

Register indicating that no adverse or

negative comments were received and

confirming the date on which the final

rule will become effective. If the FAA

does receive, within the comment

period, an adverse or negative

comments, or written notice of intent to

submit such a comment, a document

withdrawing the direct final rule will be

published in the Federal Register, and

a notice of proposed rulemaking may be

published with a new comment period.

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 would be needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy-related

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. 00–ACE–31.’’ The postcard

will be date stamped and returned to the

commenter.

Agency Findings

The regulations adopted herein will

not have a substantial direct effect 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 does not

have federalism implications under

Executive Order 13132.

The FAA has determined that this

regulation is noncontroversial and

unlikely to result in adverse or negative

comments. For the reasons discussed in

the preamble, I certify that this

regulation (1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under Department of

Transportation (DOT) Regulatory

Policies and Procedures (44 FR 11034;

February 26, 1979); and (3) if

promulgated, 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.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

navigation (air).

Accordingly, 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 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 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.

* * * * *

ACE MO E5 Dexter, MO [Revised]

Dexter Municipal Airport, MO

(Lat 36°46′39′′ N., long. 89°56′28′′ W.)

Dexter NDB

(Lat 36°47′18′′ N., long. 89°56′27′′ W.)

That airspace extending upward from 700

feet above the surface within a 6.4-mile

radius of Dexter Municipal Airport and

within 2.6 miles each side of the 183° bearing

from the Dexter NDB extending from the 6.4-

mile radius to 7.4 miles south of the NDB.

* * * * *

Issued in Kansas City, MO, on September

20, 2000.

Herman J. Lyons, Jr.,

Manager, Air Traffic Division, Central Region.

[FR Doc. 00–24933 Filed 9–28–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 00–ACE–30]

Amendments to Class E Airspace;

Moberly, MO

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Direct final rule; request for

comments

SUMMARY: This action amends Class E

airspace area at Omar N. Bradley

Airport, Moberly, MO. A review of the

Class E airspace area for Omar N.

Bradley Airport indicates it does not

comply with the criteria for 700 feet

Above Ground Level (AGL) airspace

required for diverse departures as

specified in FAA Order 7400.2D. The

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58345

Class E airspace has been enlarged to

conform to the criteria of FAA Order

7400.2D.

In addition, the Nondirectional Radio

Beacon (NDB) Standard Instrument

Approach Procedures (SIAPs) have been

cancelled, therefore the extensions to

the southeast and northwest can be

eliminated.

The intended effect of this rule is to

provide additional controlled Class E

airspace for aircraft operating under

Instrument Flight Rules (IFR), eliminate

the extensions to the southeast and

northwest and comply with the criteria

of FAA Order 7400.2D.

DATES: Effective date: 0901 UTC,

January 25, 2001.

Comments for inclusion in the Rules

Docket must be received on or before

November 29, 2000.

ADDRESSES: Send comments regarding

the rule in triplicate to: Manager,

Operations and Airspace Branch, Air

Traffic Division, ACE–530, DOT

Regional Headquarters Building, Federal

Aviation Administration, Docket

Number 00–ACE–30, 901 Locust,

Kansas City, MO 64016.

The official docket may be examined

in the Office of the Regional Counsel for

the Central Region at the same address

between 9:00 a.m. and 3:00 p.m.,

Monday through Friday, except Federal

holidays.

An informal docket may also be

examined during normal business hours

in the Air Traffic Division at the same

address listed above.

FOR FURTHER INFORMATION CONTACT:

Brenda Mumper, Air Traffic Division,

Operations and Airspace Branch, ACE–

520A, DOT Regional Headquarters

Building, Federal Aviation

Administration, 901 Locust, Kansas

City, MO 64106; telephone: (816) 329–

2524.

SUPPLEMENTARY INFORMATION: This

amendment to 14 CFR 71 revises the

Class E airspace at Moberly, MO. A

review of the Class E aispace for Omar

N. Bradley Airport, MO, indicates it

does not meet the criteria for 700 feet

AGL airspace required for diverse

departures as specified in FAA Order

7400.2D. The criteria in FAA Order

7400.2D for an aircraft to reach 1200 feet

AGL is based on a standard climb

gradient of 200 feet per mile plus the

distance from the Airport Reference

Point (ARP) to the end of the outermost

runway. Any fractional part of a mile is

converted to the next higher tenth of a

mile. The amendment at Omar N.

Bradley Airport, MO, will provide

additional controlled airspace for

aircraft operating under IFR, eliminate

the extensions to the southeast and

northwest and comply with the criteria

of FAA Order 7400.2D. The area will be

depicted on appropriate aeronautical

charts. Class E airspace areas extending

upward from 700 feet or more above the

surface of the earth are published in

paragraph 6005 of FAA Order 7400.9H,

dated September 1, 2000, and effective

September 16, 2000, which is

incorporated by reference in 14 CFR

71.1. The Class E airspace designation

listed in this document will be

published subsequently in the Order.

The Direct Final Rule Procedure

The FAA anticipates that this

regulation will not result in adverse or

negative comment and, therefore, is

issuing it as a direct final rule. Previous

actions of this nature have not been

controversial and have not resulted in

adverse comments or objections. The

amendment will enhance safety for all

flight operations by designating an area

where VFR pilots may anticipate the

presence of IFR aircraft at lower

altitudes, especially during inclement

weather conditions. A greater degree of

safety is achieved by depicting the area

on aeronautical charts. Unless a written

adverse or negative comment, or a

written notice of intent to submit an

adverse or negative comment is received

within the comment period, the

regulation will become effective on the

date specified above. After the close of

the comment period, the FAA will

publish a document in the Federal

Register indicating that no adverse or

negative comments were received and

confirming the date on which the final

rule will become effective. If the FAA

does receive, within the comment

period, an adverse or negative comment,

or written notice of intent to submit

such a comment, a document

withdrawing the direct final rule will be

published in the Federal Register, and

a notice of proposed rulemaking may be

published with a new comment period.

Comment 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 would be needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy-related

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 their 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. 00–ACE–30.’’

The postcard will be date stamped and

returned to the commenter.

Agency Findings

The regulations adopted herein will

not have a substantial direct effect 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 does not

have federalism implications under

Executive Order 13132.

The FAA has determined that this

regulation is noncontroversial and

unlikely to result in adverse or negative

comments. For the reasons discussed in

the preamble, I certify that this

regulation (1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under Department of

Transportation (DOT) Regulatory

Policies and Procedures (44 FR 11034,

February 26, 1979); and (3) if

promulgated, 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.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

Accordingly, the Federal Aviation

Administration amends 14 CFR part 71

as follows:

58346 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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 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 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.

* * * * *

ACE MO E5 Moberly, MO [Revised]

Moberly, Omar N. Bradley Airport, MO

(Lat 39°27′50′′ N., long. 92°25′40′′ W.)

That airspace extending upward from 700

feet above the surface within a 6.5-mile

radius of Omar N. Bradley Airport.

* * * * *

Issued in Kansas City, MO, on September

20, 2000.

Herman J. Lyons, Jr.,

Manager, Air Traffic Division, Central Region.

[FR Doc. 00–24932 Filed 9–28–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0044]

RIN 0910–AB97

Regulations on Statements Made for

Dietary Supplements Concerning the

Effect of the Product on the Structure

or Function of the Body; Partial Stay of

Compliance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; partial stay of

compliance.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

partial stay of compliance for the final

rule defining the types of statements

that can be made concerning the effect

of a dietary supplement on the structure

or function of the body for certain

dietary supplement products. Dietary

supplement products that were labeled,

or for which labeling had been printed,

on or before January 6, 2000, the

publication date of the final rule, are

eligible for the stay. This action is in

response to two petitions for stay and

reconsideration.

DATES: This rule is effective October 30,

2000. Submit written comments by

October 30, 2000. Submit written

comments on the information collection

provisions of this final rule by October

10, 2000. Notifications of products that

are eligible for the stay of compliance

may be submitted to FDA at any time

following the effective date of this rule;

it is to manufacturers’ advantage to

submit such notifications as soon as

possible, as only products for which

FDA has received a notification qualify

for the stay.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

written comments on the information

collection provisions of this final rule to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget (OMB), 725 K St. NW., rm.

10235, Washington, DC 20503, Attn:

Desk Officer for FDA. Send notifications

of products that are eligible for the stay

of compliance to Food and Drug

Administration, Office of Nutritional

Products, Labeling, and Dietary

Supplements, Division of Compliance

and Enforcement (HFS–810), 200 C St.

SW., Washington, DC 20204.

FOR FURTHER INFORMATION CONTACT:

Robert J. Moore, Office of Nutritional

Products, Labeling, and Dietary

Supplements (HFS–800), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4605.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of January 6,

2000 (65 FR 1000), FDA published a

final rule entitled ‘‘Regulations on

Statements Made for Dietary

Supplements Concerning the Effect of

the Product on the Structure or

Function of the Body’’ (hereinafter

referred to as ‘‘the final rule’’). In the

final rule, FDA established regulations

to define the types of statements that

may be made without prior FDA review

about the effects of dietary supplements

on the structure or function of the body

(structure/function claims), and to

distinguish these claims from claims

that a product treats, prevents, cures,

diagnoses, or mitigates disease (disease

claims).

In the preamble to the final rule, FDA

stated that the final rule would become

effective on February 7, 2000,

approximately 30 days after publication.

FDA also stated that any product that is

marketed for the first time after

publication of the final rule, and any

new claims made for an existing

product for the first time after the

publication of the final rule, would be

expected to be in compliance as of the

effective date, February 7, 2000.

However, small businesses that

marketed a product as of January 6,

2000, the date of publication of the final

rule, would have an additional 17

months (until July 7, 2001) to bring

existing claims (i.e., claims already in

the product’s labeling on January 6,

2000) for those products into

compliance. For all other products that

were on the market as of January 6,

2000, FDA allowed an additional 11

months beyond the effective date (until

January 7, 2001) to bring existing claims

for those products into compliance.

II. Petitions for Reconsideration and

Stay of Action

FDA received one petition under

§ 10.35 (21 CFR 10.35) for stay of the 30-

day effective date and one petition

under 21 CFR 10.33 for stay and

reconsideration of part of the

implementation plan in the final rule. A

petition for stay submitted jointly by the

Council for Responsible Nutrition (CRN)

and the Consumer Healthcare Products

Association (CHPA) (Docket No. 99N–

0044/PSA1) (Ref. 1) (hereinafter referred

to as the ‘‘joint petition’’) requested that

FDA stay its 30-day effective date for

‘‘pipeline’’ products, i.e., products that

were labeled, or for which labeling had

been printed, but that had not yet been

marketed when the final rule was

published on January 6, 2000. The joint

petition requested that such products be

given the 11 or 17 months for

compliance afforded to products that

were being marketed as of the

publication date of the final rule. The

joint petition stated that in the nearly 2

years between publication of the

proposed and final rules, dietary

supplement manufacturers and

distributors had relied on the criteria

and examples of acceptable structure/

function claims in the proposed rule to

develop marketing strategies,

manufacture products, and design and

produce labeling. The petition stated

that in many cases, this reliance had

involved a significant investment of

resources.

The joint petition further stated that

the implementation of the final rule will

involve, among other things, package

redesign, redesign of websites and