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
46876 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

and the Regulatory Flexibility Act (5

U.S.C. 601–612). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this regulation does

not impose reporting, recordkeeping, or

other economic burdens, the agency

certifies that the final rule will not have

a significant economic impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

List of Subjects in 21 CFR Part 312

Drugs, Exports, Imports,

Investigations, Labeling, Medical

research, Reporting and recordkeeping

requirements, Safety.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 312 is

amended as follows:

PART 312—INVESTIGATIONAL NEW

DRUG APPLICATION

1. The authority citation for 21 CFR

part 312 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 353, 355, 356, 357, 371); sec. 351 of the

Public Health Service Act (42 U.S.C. 262).

2. Section 312.70 is amended by

revising the first sentences of

paragraphs (a) and (b) to read as follows:

§ 312.70 Disqualification of a clinical

investigator.

(a) If FDA has information indicating

that an investigator (including a

sponsor-investigator) has repeatedly or

deliberately failed to comply with the

requirements of this part, part 50, or

part 56 of this chapter, or has submitted

to FDA or to the sponsor false

information in any required report, the

Center for Drug Evaluation and Research

or the Center for Biologics Evaluation

and Research will furnish the

investigator written notice of the matter

complained of and offer the investigator

an opportunity to explain the matter in

writing, or, at the option of the

investigator, in an informal conference.

* * *

(b) After evaluating all available

information, including any explanation

presented by the investigator, if the

Commissioner determines that the

investigator has repeatedly or

deliberately failed to comply with the

requirements of this part, part 50, or

part 56 of this chapter, or has

deliberately or repeatedly submitted

false information to FDA or to the

sponsor in any required report, the

Commissioner will notify the

investigator and the sponsor of any

investigation in which the investigator

has been named as a participant that the

investigator is not entitled to receive

investigational drugs. * * *

* * * * *

Dated: August 29, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23587 Filed 9–4–97; 8:45 am]

BILLING CODE 4160–01–F

UNITED STATES INFORMATION

AGENCY

22 CFR 514

Exchange Visitor Program

AGENCY: United States Information

Agency.

ACTION: Final rule.

SUMMARY: The Agency adopts as final

and without change the interim final

rule governing au pair program

participation adopted June 27, 1997.

DATES: This rule is effective September

5, 1997.

FOR FURTHER INFORMATION CONTACT:

Exchange Visitor Program Services,

Program Designation Branch, United

States Information Agency, 301 4th

Street, SW., Washington DC 20547;

Telephone (202) 401–9810.

SUPPLEMENTARY INFORMATION: The

Agency adopted an interim final rule

governing au pair program participation

on June 27, 1997 (62 FR 34632.) This

interim final rule amended existing au

pair program regulations adopted

February 15, 1995 (60 FR 8547.)

Specifically, the interim rule further

defined the selection and screening

requirements for au pair participants

and required that participants actually

attend rather than merely enroll for six

hours of academic credit. Further, the

number of hours that au pair may

provide child care services was limited

to no more than 10 hours per day and

forty-five hours in any given week.

The Agency provided for a thirty day

public comment period which ended

July 27, 1997 and received forty-one

comments. The Agency reviewed those

comments and found that all comments

received objected to the educational

program component, the wage to be

paid to the au pair participant, or the

limitation on the number of hours an au

pair participant may work. Due to the

Agency’s past review of these three

specific areas of the au pair program, the

Agency has determined that it is

appropriate to adopt the interim final

regulation as final and without

modification notwithstanding these

comments from interested members of

the public.

List of Subjects in 22 CFR Part 514

Cultural exchange programs.

Dated: August 29, 1997.

Les Jin,

General Counsel.

PART 514—EXCHANGE VISITOR

PROGRAM

Accordingly, the interim rule

amending 22 CFR part 514 which was

published at 62 FR 34633 on June 27,

1997 is adopted as a final rule without

change.

[FR Doc. 97–23624 Filed 9–4–97; 8:45 am]

BILLING CODE 8230–01–M

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8722]

RIN 1545–AV33

Guidance Regarding Claims for Certain

Income Tax Convention Benefits;

Correction

AGENCY: Internal Revenue Service,

Treasury.

ACTION: Correction to temporary

regulations.

SUMMARY: This document contains

corrections to temporary regulations (TD

8722) which were published in the

Federal Register on Wednesday, July 2,

1997 (62 FR 35673). The temporary

regulations relate to the eligibility for

benefits under income tax treaties for

payments to entities.

EFFECTIVE DATE: July 2, 1997.