46874 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

Larry Tonish, Airspace Specialist,

Airspace Branch, AWP–520, Air Traffic

Division, Western-Pacific Region,

Federal Aviation Administration, 15000

Aviation Boulevard, Lawndale,

California 90261, telephone (310) 725–

6531.

SUPPLEMENTARY INFORMATION:

History

On June 9, 1997, the FAA proposed to

amend part 71 of the Federal Aviation

Regulations (14 CFR part 71) by

amending the Class E airspace areas at

Mammoth Lakes, CA (62 FR 31374). The

development of a GPS SIAP at

Mammoth Lakes Airport has made this

action necessary. The intended effect of

this action is to provide adequate

airspace for aircraft executing the GPS

RWY 27 SIAP to Mammoth Lakes

Airport, Mammoth Lakes, CA.

Interested parties were invited to

participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments to the proposal were

received. Class E airspace designations

are published in Paragraph 6005 of FAA

Order 7400.9D, dated September 4,

1996, and effective September 16, 1996,

which is incorporated by reference in 14

CFR 71.1. Class E airspace designations

listed in this document will be

published subsequently in the Order.

The Rule

This amendment to part 71 of the

Federal Aviation Regulations (14 CFR

part 71) amends the Class E airspace

area at Mammoth Lakes, CA. The

development of a GPS SIAP at

Mammoth Lakes Airport has made this

action necessary. The intended effect of

this action is to provide adequate

controlled airspace for aircraft executing

the GPS RWY 27 SIAP at Mammoth

Lakes Airport, Mammoth Lakes, CA.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, 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)

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact 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

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—[AMENDED]

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 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AWP CA E5 Mammoth Lakes, CA [Revised]

Mammoth Lakes Airport, CA

(Lat. 37°37′26′′ N, long. 118°50′19′′ W)

That airspace extending upward from 700

feet above the surface within a 6.6-mile

radius of the Mammoth Lakes Airport. That

airspace extending upward from 1,200 feet

above the surface within the area bounded by

a line beginning a lat. 37°49′00′′ N, long.

119°00′00′′ W; to lat. 37°49′00′′ N, long.

119°13′00′′ W; to lat. 38°11′00′′ N, long.

119°13′00′′ W; to lat. 38°11′00′′ N, long.

118°27′00′′ W; to lat. 37°30′00′′ N, long.

118°27′00′′ W; to lat. 37°30′00′′ N, 119°00′00′′

W, thence to the point of beginning.

* * * * *

Issued in Los Angeles, California, on

August 12, 1997.

Sonja P. Keller,

Acting Manager, Air Traffic Division WesternPacific Region.

[FR Doc. 97–23604 Filed 9–4–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 97–ASO–11]

Establishment of Class E Airspace;

Sebastian, FL

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This amendment establishes

Class E airspace at Sebastian, FL. A

Global Positioning System (GPS)

Runway (RWY) 4 Standard Instrument

Approach Procedure (SIAP) has been

developed for Sebastian Municipal

Airport. Controlled airspace extending

upward from 700 feet Above Ground

Level (AGL) is needed to accommodate

the SIAP and for Instrument Flight

Rules (IFR) operations at the airport.

The operating status of the airport will

change from Visual Flight Rules (VFR)

to include IFR operations concurrent

with publication of the SIAP.

EFFECTIVE DATE: 0901 UTC, November 6,

1997.

FOR FURTHER INFORMATION CONTACT:

Nancy B. Shelton, Airspace Branch, Air

Traffic Division, Federal Aviation

Administration, P.O. Box 20636,

Atlanta, Georgia 30320; telephone (404)

305–5581.

SUPPLEMENTARY INFORMATION:

History

On May 14, 1997, the FAA proposed

to amend part 71 of the Federal Aviation

Regulations (14 CFR part 71) by

establishing Class E airspace at

Sebastian, FL, (62 FR 26458). This

action will provide adequate Class E

airspace for IFR operations at Sebastian

Municipal Airport. Designations for

Class E airspace extending upward from

700 feet or more above the surface are

published in Paragraph 6005 of FAA

Order 7400.9D dated September 4, 1996,

and effective September 16, 1996, which

is incorporated by reference in CFR part

71.1. The Class E airspace designation

listed in this document will be

published subsequently in the Order.

Interested parties were invited to

participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments objecting to the proposal

were received.

The Rule

This amendment to part 71 of the

Federal Aviation Regulations (14 CFR

part 71) establishes Class E airspace at

Sebastian, FL, to accommodate a GPS

RWY 4 SIAP and for IFR operations at

Sebastian Municipal Airport. The

operating status of the airport will be

changed from VFR to include IFR

operations concurrent with publication

of the SIAP.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. It, therefore, (1) is not a

‘‘significant regulatory action’’ under
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46875

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact 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

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFR

Part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120, EO 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 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ASO FL E5 Sebastian, FL [New]

Sebastian Municipal Airport, FL

(Lat. 27°48′46′′ N, long. 80°29′44′′ W)

That airspace extending upward from 700

feet above the surface within a 6.5-mile

radius of Sebastian Municipal Airport,

excluding that airspace within the Vero

Beach, FL, Class E airspace area.

* * * * *

Issued in College Park, Georgia, on August

6, 1997.

Nancy B. Shelton,

Manager, Air Traffic Division, Southern

Region.

[FR Doc. 97–23603 Filed 9–4–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. 95N–0138]

Disqualification of a Clinical

Investigator

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

investigational new drug regulation that

provides for disqualification of clinical

investigators who submit false

information. The revision is intended to

clarify the agency’s authority to reach

sponsor-investigators under the

regulation.

EFFECTIVE DATE: November 4, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas C. Kuchenberg, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1046.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is amending the regulations

governing the disqualification of clinical

investigators to clarify that § 312.70 (21

CFR 312.70) reaches sponsorinvestigators.

Part 312 (21 CFR part 312) requires

sponsors to monitor the progress of

clinical investigations, to review and

evaluate evidence relating to the safety

and effectiveness of the drug under

investigation, and to report to FDA

information based on these monitoring

and review activities. Clinical

investigators conduct clinical trials on

new drugs and submit the resulting data

to individual or corporate sponsors.

Data generated by the clinical

investigators are the subject of the

reports submitted by sponsors to FDA.

In the Federal Register of February

16, 1996 (61 FR 6177), FDA proposed

amending § 312.70 by adding language

that would clarify that FDA can

disqualify clinical investigators,

including sponsor-investigators, for

submitting to sponsors or to FDA false

information in any required report.

Under current § 312.70(b), the agency

may disqualify an investigator who has

‘‘deliberately or repeatedly submitted

false information to the sponsor in any

required report.’’ However, unlike

investigators, sponsor-investigators,

who both directly conduct

investigations and report data to FDA,

submit information directly to FDA and

not to a separate sponsor. Because

§ 312.3(b) specifically states that the

‘‘requirements applicable to a sponsorinvestigator under this part include both

those applicable to an investigator and

a sponsor,’’ § 312.70(b) encompasses the

disqualification of sponsorinvestigators. This has been the agency’s

long-standing interpretation for clinical

investigator disqualifications for drugs,

animal drugs, and devices. However, for

clarity, the agency is amending this

regulation to make specific reference to

FDA and to sponsor-investigators. FDA

also intends in the near future to review

and harmonize the clinical investigator

disqualification provisions under device

and animal drug regulations (21 CFR

812.119 and 511.1(c)) with the changes

made in this final rule.

II. Comments on the Proposed Rule

FDA received one comment on the

proposed rule. The comment

commended FDA for the proposed

amendment to § 312.70, stating that it is

imperative that data supporting the

safety and efficacy of pharmaceuticals

be accurate and reliable. The comment

noted that it was in the best interest of

patients, investigators, pharmaceutical

companies, and the Government that

FDA be able to assure the integrity of

data. The comment also expressed

support for the disqualification of a

clinical investigator who has

deliberately or repeatedly supplied false

information to a sponsor or to FDA.

FDA welcomes comments and

suggestions from all persons interested

in protecting the integrity of clinical

data. The deliberate submission of false

information by those directly

responsible for administering or

dispensing an investigational new drug

subverts the integrity of the review

process. At worst, such actions may

endanger public health and safety and,

at a minimum, will challenge public

confidence in a review process that is

conducted with honesty by the vast

majority of investigators and sponsorinvestigators.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) 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.

IV. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866