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.
15714 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices

DATES: Petitions for administrative

review by May 2, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Colin M. Pollard, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1180.

SUPPLEMENTARY INFORMATION: On

December 30, 1987, Richard Wolf

Medical Instruments Corp., Vernon

Hills, IL 60061, submitted to CDRH an

application for premarket approval of

the Hulka Clip Tubal Occlusion

Device and Applicator System. The

device is a contraceptive tubal occlusion

device and is indicated for female

sterilization (permanent contraception)

by occluding the fallopian tubes.

On May 25, 1988, the Obstetrics and

Gynecology Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application subject to the submission of

the data from the long-term animal

carcinogenic studies demonstrating the

safety of the device materials. On

September 5, 1996, CDRH approved the

application by a letter to the applicant

from the Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of review to be used,

the persons who may participate in the

review, the time and place where the

review will occur, and other details.

Petitioners may, at any time on or

before May 2, 1997 file with the Dockets

Management Branch (address above)

two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: March 7, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–8274 Filed 4–1–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0121]

Medtronic, Inc.; Premarket Approval of

the Legend Plus Pacing System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Medtronic, Inc., Minneapolis, MN, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the Legend Plus Pacing System.

After reviewing the recommendation of

the Circulatory System Devices Panel,

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of February 7, 1997,

of the approval of the application.

DATES: Petitions for administrative

review by May 2, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Mitchell J. Shein, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8517.

SUPPLEMENTARY INFORMATION: On July

21, 1993, Medtronic, Inc., Minneapolis,

MN 55432, submitted to CDRH an

application for premarket approval of

the Legend Plus Pacing System. The

device consists of the following

components: The Legend Plus Pulse

Generator Models 8446 and 8448; the

Model 9790 and 9790C Programmers

with the Model 9891 Baseline Software

and the Model 9807 Software. The

device system includes implantable

pulse generators and associated

programming hardware and software

and is indicated for permanent

ventricular or atrial pacing applications.

Their use is indicated in the treatment

of patients who may benefit from a

pacing rate that changes in response to

activity.

Ventricular indications include: (1)

Chronic atrial flutter or fibrillation with

slow ventricular response; (2) sinus

node dysfunction or sick sinus

syndrome (e.g., sinus bradycardia, sinus

arrest and/or exit block, bradycardiatachycardia syndrome, chronotropic

insufficiency, etc.,); and (3) AV block.

Atrial indications include: Sinus node

dysfunction or sick sinus syndrome

(e.g., sinus bradycardia, sinus arrest

and/or exit block, bradycardiatachycardia syndrome, etc.,) with intact

AV conduction.

On May 9, 1995, the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application. On February 7, 1997, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested