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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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06/11/1998

[Federal Register: June 11, 1998 (Volume 63, Number 112)]

[Notices]              

[Page 32013-32014]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11jn98-85]

 

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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