[Federal Register Volume 62, Number 47 (Tuesday, March 11, 1997)]
[Notices]
[Pages 11212-11213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6066]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0252]


Atul Shah; Grant of Special Termination; Final Order Terminating 
Debarment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order under the Federal Food, Drug, and Cosmetic Act (the act) granting 
special termination of the debarment of Dr. Atul Shah, 20 Hampton 
Hollow Dr., Perrineville, NJ 08535. FDA bases this order on a finding 
that Dr. Shah has

[[Page 11213]]

provided substantial assistance in the investigations or prosecutions 
of offenses relating to a matter under FDA's jurisdiction, and that 
special termination of Dr. Shah's debarment serves the interest of 
justice and does not threaten the integrity of the drug approval 
process.

EFFECTIVE DATE: March 11, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Comments should be identified with the docket 
number found in brackets in the heading of this document.

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 a Federal Register notice dated December 
5, 1994 (59 FR 62399), Dr. Atul Shah, the former Director of Analytical 
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 (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. Shah 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 March 30, 1995, Dr. Shah 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.
    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: (1) The debarred individual has provided substantial 
assistance in the investigation or prosecution of offenses described in 
section 306(a) or (b) 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 Dr. 
Shah's 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. At Dr. Shah's sentencing, the Assistant U.S. 
Attorney prosecuting Dr. Shah, recommended a reduced sentence based on 
Dr. Shah's ``substantial assistance'' to the Government in its 
investigation. Accordingly, FDA finds that Dr. Shah 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. Atul 
Shah 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. Shah's period of 
debarment, which commenced on December 5, 1994, 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. Atul Shah'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. Shah's application, an 
informal hearing under section 306(d)(4)(C) of the act is unnecessary.
     As a result of the foregoing findings, Dr. Atul Shah's debarment 
is terminated, effective (insert date of publication in the Federal 
Register) (21 U.S.C. 335a(d)(4)(C) and (d)(4)(D)).

    Dated: February 27, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-6066 Filed 3-10-97; 8:45 am]
BILLING CODE 4160-01-F