Federal Register / Vol. 62, No. 200 / Friday, October 17, 1997 / Notices 54117

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0070]

Hedviga Herman; 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 Ms. Hedviga Herman, 1326

42d St., Brooklyn, NY 11219, 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. Herman

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product under the

act. Ms. Herman has failed to request a

hearing and, therefore, has waived her

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: October 17, 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:

Christine F. Rogers, 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

On September 23, 1994, the United

States District Court for the District of

Maryland entered judgment against Ms.

Hedviga Herman for, among other

counts: (1) One count of introducing

adulterated drugs into interstate

commerce, a Federal felony offense

under 21 U.S.C. 331(a) and 333(a)(2); (2)

one count of introducing unapproved

new drugs into interstate commerce, a

Federal felony offense under 21 U.S.C.

331(d) and 333(a)(2); and (3) one count

of obstruction of an agency proceeding,

a Federal felony offense under 18 U.S.C.

1505.

As a result of these convictions, FDA

served Ms. Herman by certified mail on

February 20, 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 she

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product. Ms.

Herman was provided 30 days to file

objections and request a hearing. Ms.

Herman 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)(2)(B) of the act, and

under authority delegated to her (21

CFR 5.99), finds that Ms. Hedviga

Herman 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. Hedviga Herman 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 October 17, 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.

Herman, 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.

Herman, 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 submitted by or with the

assistance of Ms. Herman during her

period of debarment.

Any application by Ms. Herman for

termination of debarment under section

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

with Docket No. 95N–0070 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: October 1, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–27586 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0421]

Yoshitomi Fine Chemicals, Ltd.; Filing

of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Yoshitomi Fine Chemicals, Ltd.,

has filed a petition proposing that the

food additive regulations be amended to

provide for the safe use of Di-tertbutylcresyl phosphonite condensation

product with biphenyl for use as an

antioxidant and/or stabilizer for olefin

polymers intended for use in contact

with food.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

205), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7B4557) has been filed by

Yoshitomi Fine Chemicals, Ltd., 6–9

Hiranomachi 2-chome, Chuo-ku, Osaka

541, Japan. The petition proposes to

amend the food additive regulations in

§ 178.2010 Antioxidants and/or

stabilizers for polymers (21 CFR

178.2010) to provide for the safe use of

Di-tert-butylcresyl phosphonite

condensation product with

biphenyl,produced by the condensation

of 2,4-di-tert-butylcresol with the

Friedel-Crafts addition product of

phosphorous trichloride and

biphenyl,for use as an antioxidant and/

or stabilizer for olefin polymers

intended for use in contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.
54118 Federal Register / Vol. 62, No. 200 / Friday, October 17, 1997 / Notices

Dated: September 23, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–27532 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anti-Infective Drugs 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: Anti-Infective

Drugs 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 November 19 and 20, 1997, 8

a.m. to 5:30 p.m.; and November 21,

1997, 8 a.m. to 2 p.m.

Location: Holiday Inn, Versailles

Ballrooms III and IV, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Ermona B.

McGoodwin or Danyiel A. D’Antonio,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12530. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On November 19, 1997, the

committee will discuss issues relating to

the development of fluoroquinolones for

use in pediatric patients. On the

morning of November 20, 1997, the

committee will discuss new drug

application (NDA) 50–585/S046,

ceftriaxone sodium (Rocephin sterile

vials, Roche Laboratories) for single

dose intramuscular treatment of acute

otitis media. On the afternoon of

November 20, 1997, the committee will

discuss NDA 20–799, ofloxacin otic

(Floxin, Daiichi Pharmaceuticals) for

treatment of otitis externa, chronic

suppurative otitis media with perforated

tympanic membrane, and acute otitis

media in pediatric patients with

tympanostomy tubes. On November 21,

1997, the committee will discuss NDA

50–753, tobramycin solution for

inhalation (TOBI, PathoGenesis Corp.)

for the management of cystic fibrosis

patients.

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 November 12, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. on November 19 and

20, and between approximately 11 a.m.

and 12 m. on November 21. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before November 12,

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: October 9, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–27530 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Peripheral and Central Nervous

System Drugs 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: Peripheral and

Central Nervous System Drugs Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

regulatory issues.

Date and Time: The meeting will be

held on November 18 and 19, 1997, 8:30

a.m. to 5 p.m.

Location: Quality Hotel, Maryland

Ballroom, 8727 Colesville Rd., Silver

Spring, MD.

Contact Person: Ermona McGoodwin

or Danyiel D’Antonio, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12543.

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

Agenda: On November 18, 1997, the

Committee will discuss the evidence of

safety and effectiveness in new drug

application (NDA) 20–861, Prosynap

(lubeluzole injection, Janssen Research

Foundation) for the treatment of acute

ischemic stroke in adults. On November

19, 1997, the Committee will discuss the

evidence of safety and effectiveness in

NDA 20–764, Lamictal CD Chewable

Dispersible Tablets (lamotrigine, Glaxo

Wellcome) for the treatment of the

generalized seizures of Lennox-Gastaut

syndrome in pediatric and adult

patients.

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 November 12, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. on November 18, 1997,

and between 9 a.m. and 10 a.m. on

November 19, 1997. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 12, 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: October 9, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–27529 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee for

Pharmaceutical Science; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.