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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FR DATE:10/09/2003

[Federal Register: October 9, 2003 (Volume 68, Number 196)]

[Notices]               
[Page 58352-58353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc03-92]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1995N-0071]

 
Amirul Islam; Grant of Special Termination; Final Order 
Terminating Debarment

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) granting 
special termination of the debarment of Amirul Islam. FDA bases this 
order on a finding that Mr. Islam provided substantial assistance in 
the investigations or prosecutions of offenses relating to a matter 
under FDA's jurisdiction and that special termination of Mr. Islam's 
debarment serves the interest of justice and does not threaten the 
integrity of the drug approval process.

DATES: This order is effective October 9, 2003.

ADDRESSES: Comments should reference Docket No. 1995N-0071 and be sent 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nicole K. Mueller, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In a Federal Register notice dated August 
27, 1997 (62 FR 45423), Amirul Islam, the former vice president of 
technical services for Halsey Drug Co. Inc. (Halsey), and supervisor of 
Halsey's Quality Control Laboratory, was permanently debarred from 
providing services in any capacity to a person with an approved or 
pending drug product application under sections 306(c)(1)(B) and 
(c)(2)(A)(ii) of the act (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 
section 201(dd) of the act (21 U.S.C. 321(dd))). The debarment was 
based on FDA's finding that Mr. Islam was convicted of a felony under 
Federal law for conduct relating to the development or approval of any 
drug product, or otherwise relating to the regulation of a drug product 
(21 U.S.C. 335a(a)(2)). On December 12, 1997, Mr. Islam applied for 
special termination of debarment under section 306(d)(4)(a) of the act, 
as amended by the Generic Drug Enforcement Act (GDEA).
    Under section 306(d)(4)(C) and (D) of the act, FDA may limit the 
period of debarment of a permanently debarred individual if the agency 
finds that: (1) The debarred individual has provided substantial 
assistance in the investigation or prosecution of offenses described in 
section 306(a) or (b) of the act or relating to a matter under FDA's 
jurisdiction, (2) termination of the debarment serves the interest of 
justice, and (3) termination of the debarment does not threaten the 
integrity of the drug approval process. Special termination of 
debarment is discretionary with FDA.
    FDA considers a determination by the Department of Justice 
concerning the substantial assistance of a debarred individual 
conclusive in most cases. Mr. Islam cooperated with the Department of 
Justice investigations and prosecutions of others, as substantiated by 
the letters submitted to the agency by the Assistant U.S. Attorney who 
prosecuted Mr. Islam's case. Accordingly, FDA finds that Mr. Islam 
provided substantial assistance as required by section 306(d)(4)(C) of 
the act.
    The additional requisite showings that termination of debarment 
serves the interest of justice and poses no threat to the integrity of 
the drug approval process are difficult standards to satisfy. In 
determining whether these have been met, the agency weighs the 
significance of all favorable and unfavorable factors in light of the 
remedial, public health-related purposes underlying debarment. 
Termination of debarment will not be granted unless, weighing all 
favorable and unfavorable information, there is a high level of 
assurance that the conduct that formed the basis for the debarment has 
not recurred and will not recur, and that the individual will not 
otherwise pose a threat to the integrity of the drug approval process.
    The evidence presented to FDA in support of termination shows that 
Mr. Islam was convicted for a first offense, that he has no prior or 
subsequent convictions for conduct described under the GDEA and has 
committed no other wrongful acts affecting the drug approval process, 
and that his character

[[Page 58353]]

and scientific ability are highly regarded by his professional peers. 
The evidence presented supports the conclusion that the conduct upon 
which Mr. Islam's debarment was based is unlikely to recur. For these 
reasons, the agency finds that termination of Mr. Islam's debarment 
serves the interest of justice and will not pose a threat to the 
integrity of the drug approval process. FDA's analysis in reaching this 
conclusion is contained in the docket.
    Under section 306(d)(4)(D)(ii) of the act, the period of debarment 
of an individual who qualifies for special termination may be limited 
to less than permanent but to no less than 1 year. Mr. Islam's period 
of debarment has lasted more than 1 year. Accordingly, the Associate 
Commissioner for Regulatory Affairs, under section 306(d)(4) of the act 
and under authority delegated to him (21 CFR 5.20), finds that Amirul 
Islam's application for special termination of debarment should be 
granted, and that the period of debarment should terminate immediately, 
thereby allowing him to provide services in any capacity to a person 
with an approved or pending drug product application. The Associate 
Commissioner for Regulatory Affairs further finds that because Mr. 
Islam has waived his right to a hearing, and the agency is granting Mr. 
Islam's application, an informal hearing under section 306(d)(4)(C) of 
the act is unnecessary.
    As a result of the foregoing findings, Amirul Islam's debarment is 
terminated effective October 9, 2003 (21 U.S.C. 335a(d)(4)(C) and 
(d)(4)(D)).

    Dated: October 1, 2003.
John Marzilli,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 03-25594 Filed 10-8-03; 8:45 am]

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