Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Notices 45423

of the Agency for Health Care Policy and

Research (AHCPR) Contracts Review

Committee, recommendations to the

Administrator, AHCPR, regarding the

technical merit of contract proposals

submitted in response to a specific Request

for Proposals regarding the Small Business

Innovation Research (SBIR) Program.

The purpose of this contract is to continue

the research that was initiated in Phase I of

these SBIR contracts.

Agenda: The Committee meeting will be

devoted entirely to the technical review and

evaluation of contract proposals submitted in

response to the above referenced Request for

Proposals. The Administrator, AHCPR, has

made a formal determination that this

meeting will not be open to the public. This

action is necessary to protect the free and full

exchange of views in the contract evaluation

process and safeguard confidential

proprietary information, and personal

information concerning individuals

associated with the proposals that may be

revealed during the meeting. This action is

taken in accordance with section 10(d) of the

Federal Advisory Committee Act, 5 U.S.C.,

Appendix 2, 5 U.S.C. 522(b)(c)(6), 41 CFR

101–6.1023 and Department procurement

regulations, 48 CFR 315.604(d).

Anyone wishing to obtain information

regarding this meeting should contact

Charles Darby, Center for Quality

Measurement and Improvement, Agency for

Health Care Policy and Research, 2101 East

Jefferson Street, Suite 502, Rockville,

Maryland 20852, 301/594–1349, X1316.

Dated: August 20, 1997.

John M. Eisenberg,

Administrator.

[FR Doc. 97–22785 Filed 8–26–97; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0071]

Amirul Islam; Final 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 Mr. Amirul Islam, 120 Adams

St., Deer Park, NY 11729, 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 Mr. Islam

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product under the

act. Mr. Islam has waived his

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: August 27, 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

Mr. Amirul Islam, a former vice

president of technical services for

Halsey Drug Co., Inc., (Halsey) and

supervisor of Halsey’s Quality Control

Laboratory, pled guilty to, and on

October 19, 1994, was sentenced for,

obstructing an agency proceeding, a

Federal felony under 18 U.S.C. 1505.

The basis for this conviction was as

follows: On or about August 29, 1989,

Mr. Islam gave FDA inspectors a raw

material inventory card for fenoprofen

calcium which he knew to be false. The

inventory card stated that Halsey had

received 50 kilograms of fenoprofen

calcium on September 11, 1987. In fact,

Halsey had received only half that

amount. Mr. Islam knew that the

purpose of the falsified inventory card

was to conceal from FDA the fact that

Halsey did not have enough raw

material from the September 11, 1987,

shipment to manufacture pilot batches

in the sizes represented in abbreviated

new drug applications (ANDA’s) for

fenoprofen calcium 200 milligram (mg)

capsules, fenoprofen calcium 300 mg

capsules, and fenoprofen calcium 600

mg tablets.

Mr. Islam is subject to debarment

based on a finding, under section 306(a)

of the act (21 U.S.C. 355a(a)), that he

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product. Mr. Islam’s

conduct related to the regulation of a

drug product because, in presenting

false raw material inventory records, he

obstructed FDA’s regulation of generic

drugs by representing that the ANDA’s

submitted by Halsey were true in all

material respects.

FDA initiated debarment proceedings

against Mr. Islam on or about May 15,

1995. A person subject to debarment is

entitled to an opportunity for an agency

hearing on disputed issues of material

fact under section 306(i) of the act, but

Mr. Islam waived his opportunity for a

hearing and any contentions concerning

his debarment by letter received by FDA

on April 22, 1997.

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 Mr. Amirul Islam

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 findings

and based on his notification of

acquiescence, Mr. Amirul Islam 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 August 27, 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 Mr.

Islam, in any capacity, during his 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 Mr. Islam,

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 civil money penalties (section

307(a)(7) of the act). In addition, FDA

will not accept or review any ANDA’s

or abbreviated antibiotic drug

applications submitted by or with the

assistance of Mr. Islam during his

period of debarment.

Any application by Mr. Islam for

termination of debarment under section

306(d) of the act should be identified

with Docket No. 95N–0071 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 19, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–22704 Filed 8–26–97; 8:45 am]

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