[Federal Register Volume 59, Number 250 (Friday, December 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32140]


[[Page Unknown]]

[Federal Register: December 30, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0462]

 

Abu Quamruzzaman; 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 section 306(a)(2) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 335a(a)(2)) permanently debarring Mr. Abu 
Quamruzzaman, 178-10 Wexford Ter., Jamaica, NY 11432, 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. 
Quamruzzaman was convicted of a felony under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of a drug product; and relating to the 
regulation of a drug product under the act. Mr. Quamruzzaman has 
notified FDA that he acquiesces to debarment and, therefore, has waived 
his opportunity for a hearing concerning this action.

EFFECTIVE DATE: November 18, 1993.

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: Tamar S. Nordenberg, Center for Drug 
Evaluation and Research (HFD-366), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    Mr. Abu Quamruzzaman, a former Vice President of Quality Affairs of 
Biopharmaceutics, Inc. (Biopharmaceutics), pled guilty and was 
sentenced on October 14, 1993, for making a false statement in a matter 
within the jurisdiction of a Federal agency, a Federal felony offense 
under 18 U.S.C. 1001. The basis for this conviction was Mr. 
Quamruzzaman's material false statements made in an abbreviated 
antibiotic drug application, prepared by him for submission to FDA, for 
Biopharmaceutics' product Clindamycin Hydrochloride 150-milligram 
capsules. The material falsehoods included misrepresentations (1) about 
the batches from which samples were submitted for human bioequivalency 
testing and stability testing and (2) about in-process tests that were 
not conducted during the manufacturing process as required, but rather 
were conducted later using product samples stored in bulk.
    Mr. Abu Quamruzzaman is subject to debarment based on a finding, 
under section 306(a) of the act, that he was convicted of a felony 
under Federal law for conduct relating to the development, approval, 
and regulation of a drug product. In a letter dated November 18, 1993, 
Mr. Quamruzzaman notified FDA of his acquiescence to debarment, as 
provided for in section 306(c)(2)(B) of the act. While 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, Mr. 
Quamruzzaman, by acquiescing to debarment, waived his right to an 
opportunity for a hearing and any contentions concerning his debarment.

II. Findings and Order

    Therefore, the Interim Deputy Commissioner for Operations, under 
section 306(a) of the act, and under authority delegated to her (21 CFR 
5.20), finds that Mr. Abu Quamruzzaman has been convicted of a felony 
under Federal law for conduct relating to the development or approval, 
including the process for development or approval, of a drug product 
(21 U.S.C. 335a(a)(2)(A)); and relating to the regulation of a drug 
product (21 U.S.C. 335a(a)(2)(B)).
    As a result of the foregoing findings and based on his notification 
of acquiescence, Mr. Abu Quamruzzaman 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 November 18, 1993, 
the date of notification of acquiescence (21 U.S.C. 335a(c)(1)(B) and 
(c)(2)(A)(ii) and 21 U.S.C. 321(ee)). Any person with an approved or 
pending drug product application who knowingly uses the services of Mr. 
Quamruzzaman, in any capacity, during his period of debarment, will be 
subject to civil money penalties. If Mr. Quamruzzaman, 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. In addition, FDA will not accept or review any 
abbreviated new drug applications submitted by or with the assistance 
of Mr. Quamruzzaman during his period of debarment.
    Any application by Mr. Quamruzzaman for termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
93N-0462 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: December 20, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-32140 Filed 12-29-94; 8:45 am]
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