15712 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices

Board of Governors of the Federal Reserve

System, March 27, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–8331 Filed 4-1-97; 8:45 am]

BILLING CODE 6210-01-F

Consumer Advisory Council; Notice of

Meeting of Consumer Advisory

Council

The Consumer Advisory Council will

meet on Thursday, April 17, 1997. The

meeting, which will be open to public

observation, will take place at the

Federal Reserve Board’s offices in

Washington, D.C., in Terrace Room E of

the Martin Building. The meeting will

begin at 9:00 a.m. and is expected to

continue until 4:00 p.m., with a lunch

break from 1:00 p.m. until 2:00 p.m. The

Martin Building is located on C Street,

Northwest, between 20th and 21st

Streets in Washington, D.C.

The Council’s function is to advise

the Board on the exercise of the Board’s

responsibilities under the Consumer

Credit Protection Act and on other

matters on which the Board seeks its

advice. Time permitting, the Council

will discuss the following topics:

Bank Regulatory Issues

The Bank Regulation Committee will

discuss the potential effects of bank

mergers and acquisitions on local

communities; and will also discuss

proposed interagency regulations to

implement section 109 of the RiegleNeal Interstate Banking and Branching

Efficiency Act of 1994, which among

other things provide guidance for

determining whether a bank is

reasonably helping to meet community

credit needs served by interstate

branches.

Electronic Banking and Electronic

Disclosures

The Depository and Delivery Systems,

Community Affairs and Housing, and

Consumer Credit Committees will

discuss recommendations for revisions

to consumer regulations such as

Regulations DD (Truth in Savings), E

(Electronic Fund Transfers), B (Equal

Credit Opportunity), and Z (Truth in

Lending) to allow required disclosures

and documentation to be provided to

consumers electronically. The

Depository and Delivery Systems

Committee will also discuss industry

and consumer issues involving

electronic and home banking, and a

Board report on the application of the

Electronic Fund Transfer Act to

electronic stored-value products.

Consumer Identifying Information

The Depository and Delivery Systems

Committee will discuss findings in a

Board report on the availability of

consumer identifying information and

financial fraud.

Recommendations To Simplify

Mortgage Lending Disclosures

The Consumer Credit Committee will

discuss possible recommendations for

statutory amendments that may be

required to simplify, consolidate, and

streamline the provisions of Regulations

Z (Truth in Lending Act) and X (RESPA)

affecting home mortgage lending.

Governor’s Report

Report by Federal Reserve Board

Member Laurence H. Meyer on

economic conditions, recent Board

initiatives, and issues of concern, with

an opportunity for questions from

Council members.

Members Forum

Presentation by individual Council

members on the economic conditions

present within their industries or local

economies.

Committee Reports

Committees will report on plans for

1997; in addition, the Consumer Credit

Committee will discuss some issues to

be addressed in Federal Reserve Board

hearings on home equity lending (which

will be held pursuant to the Home

Ownership Equity Protection Act of

1994).

Other matters previously considered

by the Council or initiated by Council

members also may be discussed.

Persons wishing to submit to the

Council their views regarding any of the

above topics may do so by sending

written statements to Deanna AdayKeller, Secretary, Consumer Advisory

Council, Division of Consumer and

Community Affairs, Board of Governors

of the Federal Reserve System,

Washington, D.C. 20551. Information

about this meeting may be obtained

from Ms. Aday-Keller, 202–452–6470.

Telecommunications Device for the Deaf

(TDD) users may contact Diane Jenkins,

202–452–3544.

Board of Governors of the Federal Reserve

System, March 28, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–8356 Filed 4–1–97; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Notice is hereby given that

the Office of Research Integrity (ORI)

has made a final finding of scientific

misconduct in the following case:

Enrico Portuese, University of

Pittsburgh

Based upon an investigation

conducted by the University of

Pittsburgh, information obtained by the

Office of Research Integrity (ORI) during

its oversight review, and Mr. Portuese’s

own admission, ORI found that Mr.

Portuese, a former graduate student in

the Department of Epidemiology,

Graduate School of Public Health,

University of Pittsburgh, engaged in

scientific misconduct by fabricating

research data in biomedical research

supported by two grants from the

National Institute of Diabetes and

Digestive and Kidney Disease (NIDDK),

National Institutes of Health (NIH).

Specifically, Mr. Portuese fabricated

data in a study of angiotensinconverting enzyme polymorphism and

complications from insulin-dependent

diabetes mellitus. These fabricated data

were included in an abstract that was

submitted to the American Diabetes

Association in January 1996; however,

the abstract was not accepted, presented

in public, or published.

In addition, Mr. Portuese fabricated

genetic data on lipoprotein lipase

polymorphisms as related to diabetes

complications and risk factors. These

fabricated data were included in tables

prepared by Mr. Portuese and presented

by him to his doctoral committee in

October 1996. None of the fabricated

data in question has been published,

presented at a scientific meeting, or

used in any grant applications.

Mr. Portuese has accepted the ORI

finding and has entered into a Voluntary

Exclusion Agreement with ORI in which

he has voluntarily agreed, for the three

(3) year period beginning March 25,

1997:

(1) To exclude himself from serving in

any advisory capacity to the Public

Health Service (PHS), including but not

limited to service on any PHS advisory

committee, board, and/or peer review

committee, or as a consultant; and

(2) That any institution that submits

an application for PHS support for a

research project on which Mr.

Portuese’s participation is proposed or
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices 15713

which uses him in any capacity on PHS

supported research must concurrently

submit a plan for supervision of his

duties. The supervisory plan must be

designed to ensure the scientific

integrity of Mr. Portuese’s research

contribution. The institution must

submit a copy of the supervisory plan to

ORI.

No scientific publications were

required to be corrected as part of this

Agreement.

FOR FURTHER INFORMATION CONTACT:

Acting Director, Division of Research

Investigations, Office of Research

Integrity, 5515 Security Lane, Suite 700,

Rockville, MD 20852, (301) 443–5330.

Chris B. Pascal,

Acting Director, Office of Research Integrity.

[FR Doc. 97–8347 Filed 4–1–97; 8:45 am]

BILLING CODE 4160–17–P

Food and Drug Administration

[Docket No. 94N–0011]

Barry D. Garfinkel; Denial of Hearing;

Final Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) denies Dr. Barry

D. Garfinkel’s request for a hearing and

issues a final order under the Federal

Food, Drug, and Cosmetic Act (the act)

permanently debarring Barry D.

Garfinkel, 2854 Glenhurst Ave., St.

Louis Park, MN 55416, from providing

services in any capacity to a person that

has an approved or pending drug

product application. FDA bases this

order on its finding that Dr. Garfinkel

was convicted of a felony under Federal

law for conduct relating to the

development or approval of a drug

product and for conduct relating to the

regulation of a drug product under the

act.

EFFECTIVE DATE: April 2, 1997.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 1451

Rockville Pike, Rockville, MD 20857,

301–594–2041.

SUPPLEMENTARY INFORMATION:

I. Background

On November 19, 1993, the United

States District Court for the District of

Minnesota entered judgment against

Barry D. Garfinkel for, among other

counts, 3 counts of making a false

statement in a matter within the

jurisdiction of FDA, a Federal felony

offense under 18 U.S.C. 1001. The basis

for this conviction was Dr. Garfinkel’s

falsification of reports to conceal his

failure to comply with the protocols of

a clinical study of the drug Anafranil.

Dr. Garfinkel’s conviction was affirmed

by the Eighth Circuit Court of Appeals

on July 13, 1994.

As a result of this conviction, FDA

served Dr. Garfinkel by certified mail on

February 7, 1995, a letter proposing to

issue an order under section 306(a) of

the act (21 U.S.C. 335a(a)) permanently

debarring him from providing services

in any capacity to a person that has an

approved or pending drug product

application and offering him an

opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(A) and

(a)(2)(B) of the act, that Dr. Garfinkel

was convicted of a felony under Federal

law for conduct relating to the

development, approval, and regulation

of a drug product. Dr. Garfinkel

requested a hearing in a letter dated

February 16, 1995. However, Dr.

Garfinkel has not submitted any

information or analyses to justify a

hearing. Dr. Garfinkel’s failure to raise

any issues of fact constitutes a waiver of

his opportunity for a hearing and a

waiver of any contentions concerning

his debarment (21 CFR 12.22).

II. Findings and Order

Therefore, the Deputy Commissioner

for Operations, under section 306(a) of

the act and under authority delegated to

him (21 CFR 5.20), finds that Barry D.

Garfinkel has been convicted of a felony

under Federal law for conduct relating

to the development or approval of a

drug product and for conduct relating to

regulation of a drug product (21 U.S.C.

335a(a)(2)(B)).

As a result of the foregoing finding,

Barry D. Garfinkel is permanently

debarred from providing services in any

capacity to a person with an approved

or pending drug product application

under sections 505, 507, 512, or 802 of

the act (21 U.S.C. 355, 357, 360b, or

382), or under section 351 of the Public

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

effective April 2, 1997 sections

306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd)

of the act (21 U.S.C. 321(dd)). Any

person with an approved or pending

drug product application who

knowingly uses the services of Dr.

Garfinkel, in any capacity, during his

period of debarment, will be subject to

a civil money penalty (section 307(a)(6)

of the act (21 U.S.C. 335b(a)(6))). If Dr.

Garfinkel, during his period of

debarment, provides services in any

capacity to a person with an approved

or pending drug product application, he

will be subject to a civil money penalty

(section 307(a)(7) of the act). In

addition, FDA will not accept or review

any abbreviated new drug applications

or abbreviated antibiotic drug

applications submitted by or with the

assistance of Dr. Garfinkel during his

period of debarment.

Dr. Garfinkel may file an application

to attempt to terminate his debarment

under section 306(d)(4)(A) of the act.

Any such application would be

reviewed under the criteria and

processes set forth in section

306(d)(4)(C) and (d)(4)(D) of the act.

Such an application should be

identified with Docket No. 94N–0011

and sent to the Dockets Management

Branch (address above). All such

submissions are to be filed in four

copies. The public availability of

information in these submissions is

governed by 21 CFR 10.20(j). Publicly

available submissions may be seen in

the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: March 24, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–8272 Filed 4–1–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0123]

Richard Wolf Medical Instruments

Corp.; Premarket Approval of the

Hulka Clip Tubal Occlusion Device

and Applicator System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Richard

Wolf Medical Instruments Corp.,

Vernon Hills, IL, for premarket

approval, under the Federal Food, Drug,

and Cosmetic Act (the act), of the Hulka

Clip Tubal Occlusion Device and

Applicator System. After reviewing the

recommendation of the Obstetrics and

Gynecology Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of September 5, 1996, of the

approval of the application.