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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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03/11/1997

[Federal Register: March 11, 1997 (Volume 62, Number 47)]

[Notices]              

[Page 11212]

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

[DOCID:fr11mr97-115]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N-0190]

 

Padam C. Bansal; 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. Padam C. Bansal, 9 Powelson

Lane, Bridgewater, NJ 08807. FDA bases this order on a finding that Dr.

Bansal has provided substantial assistance in the investigations or

prosecutions of offenses relating to a matter under FDA's jurisdiction,

and that special termination of Dr. Bansal's debarment serves the

interest of justice and does not threaten the integrity of the drug

approval process.

 

EFFECTIVE DATE: March 11, 1997.

 

ADDRESSES: Comments should reference Docket No. 93N-0190 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: Diane Sullivan-Ford, Center for Drug

Evaluation and Research (HFD-7), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-594-2041.

 

SUPPLEMENTARY INFORMATION: In the Federal Register of November 29, 1993

(58 FR 62674), Dr. Padam C. Bansal, the former Director of Research and

Development at Par Pharmaceutical, Inc. (Par), 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),

(c)(2)(A)(ii), and 201(dd) of the act (21 U.S.C. 335a(c)(1)(B),

(c)(2)(A)(ii), and 321(dd)). The debarment was based on FDA's finding

that Dr. Bansal 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 (section

306(a)(2) of the act). On December 29, 1993, Dr. Bansal 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) 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

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. Bansal fully cooperated with the

Department of Justice investigations and prosecutions of others within

Par, as substantiated by two letters received by FDA from the Maryland

U.S. Attorney's Office. Accordingly, FDA finds that Dr. Bansal provided

substantial assistance as required by section 306(d)(4)(C) of the act.

 

The additional requisite showings, i.e., 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.

 

Based on a thorough analysis of the available evidence, Dr. Padam

C. Bansal has demonstrated that termination of his 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. Bansal'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. Padam C.

Bansal'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. Bansal's application, an informal hearing under section

306(d)(4)(C) of the act is unnecessary.

 

As a result of the foregoing findings, Dr. Padam C. Bansal's

debarment is terminated, effective (insert date of publication in the

Federal Register) (section 306(d)(4)(C) and (D) of the act).

    

Dated: February 27, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97-5964 Filed 3-10-97; 8:45 am]

BILLING CODE 4160-01-F