[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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