Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45667

through (h), 1003.21(a) through (d),

1003.22(a) and (b), 1003.30(a) and (b),

1003.31(a) and (b), 1004.2(a) through (i),

1004.3(a) through (i), 1004.4(a) through

(h) and 1005.21(a) through (c). Other

requirements are not included because

they constitute a disclosure of

information originally supplied by the

Federal Government to the recipient for

the purpose of disclosure to the public

(5 CFR 1320.3(c)(2)).

Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22857 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0221]

Benzodiazepines and Related

Substances; Criteria for Scheduling

Recommendations Under the

Controlled Substance Act; Notice of

Public Hearing Modification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) in conjunction

with other Federal agencies is

announcing that the part 15 public

hearing on benzodiazepines and related

substances originally scheduled for

September 11 and 12, 1997, will be held

only on September 11, 1997. The public

hearing will not continue to September

12, 1997. The decision to forego the

second day is based on the limited

number of respondents submitting

notices of participation in the hearing.

DATES: The hearing will be held on

Thursday September 11, 1997, from 9

a.m. to 4 p.m. The closing date for

comments will be October 17, 1997.

ADDRESSES: The public hearing will be

held at the Renaissance Hotel, 999

Ninth St. NW., Washington, DC.

Comments are to be sent to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Transcripts of the public hearing

may be requested in writing from the

Freedom of Information Office (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, rm. 12A–16, Rockville,

MD 20857, approximately 15 working

days after the hearing, at a cost of 10

cents per page. The transcript of the

public hearing, copies of data and

information submitted during the

hearing, and any written comments will

be available for review at the Dockets

Management Branch (address above)

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

through Friday.

FOR FURTHER INFORMATION CONTACT:

Nicholas P. Reuter, Office of Health

Affairs (HFY–20), Food and Drug

Administration, 5600 Fishers Lane, rm.

15–22, Rockville, MD 20857, 301–827–

1696, FAX 301–443– 0232, e-mail

‘‘nreuter@bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal

Register of June 19, 1997 (62 FR 33418),

FDA in conjunction with other Federal

agencies announced that it would

convene a part 15 public hearing on

benzodiazepines and related substances.

The public hearing was scheduled for

Thursday, September 11, 1997 and part

of Friday, September 12, 1997.

Persons who wished to participate in

the hearing were asked to file a notice

of participation with the Dockets

Management Branch (address above) on

or before August 14, 1997. In response

to that notice, eight individuals

representing various organizations

indicated their interest in participating

in the hearing. FDA, along with the

other participating agencies, have

determined that the number of

individuals indicating an interest in

participating in the hearing can be

accommodated in one full day and that

there is no need to continue the hearing

to the second day. Therefore, the public

hearing will be held at the address

above from approximately 9 a.m. until

4 p.m. on September 11, 1997.

Interested parties may still sign up to

participate in the hearing. The June 19,

1997, notice included a provision

whereby persons may give oral notice of

participation by calling Nicholas Reuter

(telephone number above) no later than

August 29, 1997. This notice extends

until September 3, 1997, the

opportunity to give oral notice of

participation. Those persons who give

oral notice of participation should also

submit written notice containing the

information described above to the

Dockets Management Branch by the

close of business September 8, 1997.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22935 Filed 8–25–97; 11:56 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0256]

Norma D. Banks; Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring Norma D. Banks, 3688 West

Minarets Ave., Fresno, CA 91331, from

providing services in any capacity to a

person that has an approved or pending

drug product application. FDA bases

this order on a finding that Ms. Banks

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product under the

act. Ms. Banks has failed to request a

hearing and, therefore, has waived her

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: August 28, 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:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Ms. Banks was employed by H. R.

Cenci Laboratories, Inc. (Cenci), as

Director of Quality Assurance and

Regulatory Affairs. In that capacity, on

November 17, 1993, she knowingly and

willfully made false, fictitious, and

fraudulent representations in a matter

within the jurisdiction of FDA.

Specifically, she misrepresented to

FDA’s Office of Generic Drugs

information contained in an annual

report that stability tests for three drug

products manufactured by H. R. Cenci

Laboratories, Inc. (i.e., promethazine

syrup with phenylephrine,

promethazine syrup with codeine, and

promethazine syrup with phenylephrine

and codeine), were uniformly passing,

when, in fact, several stability test

results were failing.

On January 25, 1996, the United

States District Court for the District of

Maryland entered judgment against Ms.
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