Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: March 11, 1997 (Volume 62, Number 47)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0190]
Padam C. Bansal; Grant of Special Termination; Final Order
AGENCY: Food and Drug Administration, HHS.
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
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