[Federal Register Volume 63, Number 176 (Friday, September 11, 1998)]
[Notices]
[Pages 48733-48734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0253]


Mark Perkal; 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 Mark Perkal, Israel. FDA bases 
this order on a finding that Dr. Perkal provided substantial assistance 
in the investigations or prosecutions of offenses relating to a matter 
under FDA's jurisdiction and that special termination of Dr. Perkal's 
debarment serves the interest of justice and does not threaten the 
integrity of the drug approval process.

EFFECTIVE DATE: September 11, 1998.
ADDRESSES:  Comments should reference Docket No. 93N-0253 and be sent 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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:
    In a Federal Register notice dated November 29, 1993 (58 FR 62676), 
Mark Perkal, the former Executive Vice President and Chief Scientific 
Officer of PharmaKinetics Laboratories, Inc., was permanently debarred 
from providing services in any capacity to a person with an approved or 
pending drug product application (21 U.S.C. 335a(c)(1)(B) and 
(c)(2)(A)(ii) and 21 U.S.C. 321(dd)). The debarment was based on FDA's 
finding that Dr. Perkal 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 April 14, 1995, Dr. Perkal applied for special 
termination of debarment under section 306(d)(4) of the act (21 U.S.C. 
335a(d)(4)), as amended by the Generic Drug Enforcement Act (GDEA).
    Under section 306(d)(4)(C) and (d)(4)(D) of the act, FDA may limit 
the period of debarment of a permanently

[[Page 48734]]

debarred individual if the agency finds that: (1) The debarred 
individual has provided substantial assistance in the investigation or 
prosecution of offenses described in subsections (a) or (b) of section 
306 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. Dr. Perkal cooperated with the Department of 
Justice investigations and prosecutions of others, as substantiated by 
the testimony of the Assistant U.S. Attorney at Dr. Perkal's 
sentencing. Accordingly, FDA finds that Dr. Perkal 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 
Dr. Perkal 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 and scientific ability are highly regarded by 
his professional peers. The evidence presented supports the conclusion 
that the conduct upon which Dr. Perkal's debarment was based is 
unlikely to recur. For these reasons, the agency finds that termination 
of Dr. Perkal's debarment serves the interest of justice and will not 
pose a threat to the integrity of the drug approval process.
    Under section 306(d)(4)(D) 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. Dr. Perkal's period of 
debarment has lasted more than 1 year. Accordingly, the Deputy 
Commissioner for Operations, under section 306(d)(4) of the act and 
under authority delegated to him (21 CFR 5.20), finds that Mark 
Perkal'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 Deputy 
Commissioner for Operations further finds that because the agency is 
granting Dr. Perkal's application, an informal hearing under section 
306(d)(4)(C) of the act is unnecessary.
    As a result of the foregoing findings, Dr. Mark Perkal's debarment 
is terminated effective September 11, 1998 (21 U.S.C. 335a(d)(4)(C) and 
(d)(4)(D)).

    Dated: September 2, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-24375 Filed 9-10-98; 8:45 am]
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