[Federal Register Volume 63, Number 112 (Thursday, June 11, 1998)]
[Notices]
[Pages 32013-32014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0003]


Dulal C. Chatterji; 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 Dr. Dulal C. Chatterji, 308 
Dalton Dr., Raleigh, NC 27615. FDA bases this order on a finding that 
Dr. Chatterji provided substantial assistance in the investigations or 
prosecutions of offenses relating to a matter under FDA's jurisdiction, 
and that special termination of Dr. Chatterji's debarment serves the 
interest of justice and does not threaten the integrity of the drug 
approval process.

EFFECTIVE DATE: June 11, 1998.
ADDRESSES: Comments should reference Docket No. 96N-0003 and be sent 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:
    In a Federal Register notice dated January 22, 1997 (62 FR 3297), 
Dr. Dulal C. Chatterji, cofounder, part owner, vice-president for 
scientific affairs, and head of the research and development (R&D) 
division at the generic drug manufacturer Quad Pharmaceuticals, Inc. 
(Quad), 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)) and 201(dd) 
of the act (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 321(dd)). The 
effective date of the debarment was November 1, 1995, based on Dr. 
Chatterji's acquiescence to debarment. The debarment was based on FDA's 
finding that Dr. Chatterji 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 
under section 306 of the act. On April 7, 1997, Dr. Chatterji applied 
for special termination of debarment under section 306(d)(4) of the 
act, as amended by the Generic Drug Enforcement Act.
    Under section 306(d)(4)(C) and (d)(4)(D) of the act, FDA may limit 
the period of debarment of a permanently debarred individual if the 
agency finds that the debarred individual has provided substantial 
assistance in the investigation or prosecution of offenses described in 
paragraph (a) or (b) of section 306 of the act or relating to a matter 
under FDA's jurisdiction. If substantial assistance is found, the 
extent to which debarment may be terminated will depend upon the 
agency's assessment of whether termination will serve the interest of 
justice and 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 that an 
individual provided substantial assistance conclusive in most cases. 
Dr. Chatterji fully cooperated with the Department of Justice 
investigations and prosecutions of others within Quad for offenses 
related to matters under FDA jurisdiction, as substantiated by two 
letters received by FDA from the U.S. Attorney's Office for the 
District of Maryland. Accordingly, FDA finds that Dr. Chatterji 
provided substantial assistance as described under section 306(d)(4)(C) 
of the act.

[[Page 32014]]

     In determining whether termination of debarment serves the 
interest of justice and poses no threat to the integrity of the drug 
approval process, 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, 
despite the seriousness of the offense for which Dr. Chatterji was 
debarred, his conduct may have been an aberration, his character and 
scientific ability remain highly regarded by his professional peers, 
and that he may serve as a strong advocate for compliance with current 
good manufacturing practice regulations. For these reasons, the agency 
finds that termination of Dr. Chatterji'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. Chatterji'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 Dr. Dulal C. Chatterji'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. Chatterji's application, 
an informal hearing under section 306(d)(4)(C) of the act is 
unnecessary.
     As a result of the foregoing findings, Dr. Dulal C. Chatterji's 
debarment is terminated effective June 11, 1998 (section 306(d)(4)(C) 
and (d)(4)(D) of the act).

    Dated: June 5, 1998.
Michael A. Friedman,
Acting Commissioner of Food and Drugs.
[FR Doc. 98-15555 Filed 6-10-98; 8:45 am]
BILLING CODE 4160-01-F