45668 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

Banks for one count of knowingly and

willfully making false, fictitious, and

fraudulent statements and

representations to a Federal agency as to

material facts, a Federal felony under 18

U.S.C. 1001.

As a result of this conviction, FDA

served Ms. Banks by certified mail on

September 26, 1996, a notice proposing

to permanently debar her from

providing services in any capacity to a

person that has an approved or pending

drug product application, and offered

her an opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of

the act (21 U.S.C. 335a(a)(2)(B)), that

Ms. Banks was convicted of a felony

under Federal law for conduct relating

to the regulation of a drug product. Ms.

Banks did not request a hearing. Her

failure to request a hearing constitutes a

waiver of her opportunity for a hearing

and a waiver of any contentions

concerning her debarment.

II. Findings and Order

Therefore, the Director, Center for

Drug Evaluation and Research, under

section 306(a) of the act, and under

authority delegated to her (21 CFR

5.99(b)), finds that Ms. Norma D. Banks

has been convicted of a felony under

Federal law for conduct relating to the

regulation of a drug product.

As a result of the foregoing finding,

Ms. Norma D. Banks is permanently

debarred from providing services in any

capacity to a person with an approved

or pending drug product application

under section 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 August 28, 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 Ms.

Banks in any capacity, during her

period of debarment, will be subject to

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

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

Banks, during her period of debarment,

provides services in any capacity to a

person with an approved or pending

drug product application, she will be

subject to civil money penalties (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

Ms. Banks during her period of

debarment.

Any application by Ms. Banks for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 96N–0256 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: August 12, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–22856 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0298]

Distributor Medical Device Reporting;

Draft Compliance Policy Guide;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft Compliance Policy

Guide (CPG) entitled ‘‘Distributor

Medical Device Reporting.’’ The

purpose of the CPG is to provide

guidance concerning the interpretation

and applicability of some of the

provisions in the Medical Device

Distributor Reporting Regulation. FDA

believes that the following guidance

will improve the administration and

efficiency of medical device distributor

reporting as well as the quality of

information received.

DATES: Written comments on the draft

CPG may be submitted by November 26,

1997.

ADDRESSES: Submit written requests for

single copies of the draft CPG to the

Division of Small Manufacturers

Assistance (DSMA), Center for Devices

and Radiological Health (CDRH) (HFZ–

220), Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850,

301–443–6597 or outside MD 1–800–

638–2041. Send two self-addressed

adhesive labels to assist that office in

processing your requests, or FAX your

request to 301–443–8818. Facsimiles of

the draft CPG are available from DSMA.

To receive the draft CPG on your fax

machine, call the CDRH Facts-OnDemand system at 1–800–899–0381 or

301–827–0111 from a touch tone

telephone. At the first voice prompt

press ‘‘1’’ to access DSMA Facts, at the

second voice prompt press ‘‘2’’ and then

enter the document number, ‘‘120’’

followed by the pound sign, ‘‘#’’. Follow

the remaining voice prompts to

complete the request. Submit written

comments on the draft CPG to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Chester T. Reynolds, Office of

Compliance (HFZ–300), Center for

Devices and Radiological Health, Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

4618, ext. 114.

SUPPLEMENTARY INFORMATION:

I. Background

Distributors of devices have been

required, by statute, to report device

related deaths, serious illnesses, serious

injuries and malfunctions to FDA and

the manufacturers of the devices since

May 28, 1992. The regulations that

implemented the statutory provisions

can be found in parts 804 and 807 (21

CFR parts 804 and 807).

Since 1993, FDA has received

thousands of Medical Device Reports

(MDR’s) submitted in response to part

804. As a result of this experience, FDA

has developed a draft CPG to provide

guidance concerning the interpretation

and applicability of some of the

provisions of the Distributor Medical

Device Reporting Regulation. For

practical purposes, FDA intends to

interpret the reporting standards for

both domestic distributors and

importers to be the same. In exercising

its enforcement discretion, the agency

does not plan to initiate regulatory

action involving distributor

requirements for staff training and

education. Additionally, FDA

encourages distributors to voluntarily

use the reporting form MEDWATCH

FDA Form 3500A. The agency believes

that using this form will reduce the

paperwork and level of effort for

distributors, manufacturers, and FDA.

This draft guidance document

represents the agency’s current thinking

on distributor medical device reporting.

It does not create or confer any rights for

or on any person and does not operate

to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

II. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft
Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45669

CPG entitled ‘‘Distributor Medical

Device Reporting.’’ Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The agency

will review all comments, but in issuing

a final CPG, need not specifically

address every comment. The agency

will make changes to the CPG in

response to comments, as appropriate. A

copy of the draft CPG and received

comments may be seen in the office

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

Monday through Friday.

III. Electronic Access

Copies of the draft CPG may also be

downloaded to a personal computer

with access to the World Wide Web

(www). The Office of Regulatory Affairs

(ORA) and CDRH Home Pages include

the draft CPG and may be accessed at

‘‘http://www.fda.gov/ora’’ or ‘‘http://

www.fda.gov/cdrh’’ respectively. The

draft CPG will be available on the

Compliance References or Compliance

Information pages for ORA and CDRH

respectively.

Dated: August 15, 1997.

Gary Dykstra,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 97–22702 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Food Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 25 and 26, 1997,

8:30 a.m. to 5 p.m.

Location: Holiday Inn—Eisenhower

Metro Center, Eisenhower Station

Ballroom, 2460 Eisenhower Ave.,

Alexandria, VA.

Contact Person: Lynn A. Larsen,

Center for Food Safety and Applied

Nutrition (HFS–5), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4727,

or Catherine M. DeRoever, Advisory

Committee Staff (HFS–22), 202–205–

4251, FAX 202–205–4970, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 10564.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will be

conducting an informational meeting

during which it will be receiving

updates on past issues that were

referred to the committee and on other

activities related to food safety. There

will also be briefings by the current

working groups formed to discuss the

Final Report from the Keystone National

Policy Dialogue on Food, Nutrition, and

Health, as well as simultaneous working

group sessions. Two working groups are

expected to have work products for

committee discussion.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by September 17, 1997. Oral

presentations from the public will be

scheduled between approximately 4

p.m. and 5 p.m. on September 25, 1997.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before September 17,

1997, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: August 21, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–22854 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Mammography Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Mammography

Workshop. The topics to be discussed

are: Update on the Mammography

Quality Standards Act (MQSA), State

regulations on mammography, the

medical physicist’s responsibilities,

FDA’s MQSA compliance, the

radiographic processor, and preparation

for the MQSA inspection.

Date and Time: The public workshop

will be held on Tuesday, September 23,

1997, 8:30 a.m. to 5 p.m.; registration, 8

a.m. to 8:30 a.m. Registration will close

on September 16, 1997.

Location: The public workshop will

be held at the Medical Forum Bldg., 950

22d St. North, Birmingham, AL 35203,

205–458–8800.

Contact: Ralph T. Trout, Food and

Drug Administration (HFR–SE19), 60

Eighth St. NE., Atlanta, GA 30309, 404–

347–4001, ext. 5248, FAX 404–347–

4349.

Registration: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

Tuesday, September 16, 1997. Space is

limited, therefore interested parties are

encouraged to register early.

If you need special accommodations

due to a disability, please contact Ralph

T. Trout at least 7 days in advance.

SUPPLEMENTARY INFORMATION: This

workshop is being sponsored by FDA’s

Southeast Region and the radiological

health programs of the States of the

Southeast Region. These States are

Alabama, Florida, Georgia, Louisiana,

Mississippi, North Carolina, South

Carolina, and Tennessee, and the

Commonwealth of Puerto Rico and the

Virgin Islands. The purpose of this

workshop is to provide mammography

facilities with an update on MQSA and

technical training in the area of

mammography.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22980 Filed 8–25–97; 4:44 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medicated Feed Good Manufacturing

Practices (GMP’s) Training Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Office of

Regulatory Affairs (ORA), Pacific Region

is announcing a training workshop to