[Federal Register Volume 62, Number 166 (Wednesday, August 27, 1997)]
[Notices]
[Page 45423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22704]


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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.

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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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