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.