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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 11212-11213]

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

[DOCID:fr11mr97-116]

 

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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.

 

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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