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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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01/22/1997

[Federal Register: January 22, 1997 (Volume 62, Number 14)]

[Notices]              

[Page 3297]

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

[DOCID:fr22ja97-71]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 96N-0003]

 

Dulal C. Chatterji; Debarment Order

 

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) permanently

debarring Mr. Dulal C. Chatterji, 8025 Cobble Creek Circle, Potomac, MD

20854, from providing services in any capacity to a person that has an

approved or pending drug product application. FDA bases this order on a

finding that Mr. Chatterji was convicted of a felony under Federal law

for conduct relating to the regulation of a drug product under the act.

Mr. Chatterji has notified FDA that he acquiesces to debarment and,

therefore, has waived his opportunity for a hearing concerning this

action.

 

EFFECTIVE DATE: November 1, 1995.

 

ADDRESSES: Application for termination of debarment to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857.

 

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug

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

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

 

SUPPLEMENTARY INFORMATION:

 

I. Background

    

Mr. Dulal C. Chatterji, formerly vice-president for scientific

affairs and head of the research and development (R&D) division at Quad

Pharmaceuticals, Inc. (Quad), pled guilty to, and on May 12, 1994, was

sentenced for, obstructing an agency proceeding, a Federal felony under

18 U.S.C. 1505. The basis for this conviction was as follows:

 

In its new drug application (NDA) for colistimethate sodium, Quad

falsely represented to FDA that it had produced three sterile batches

of the drug. In fact, the firm had produced two nonsterile batches and

only one sterile batch. During a subsequent FDA audit of Quad's R&D

department, Mr. Chatterji directed that samples from the nonsterile

batches of colistimethate sodium be destroyed.

 

Mr. Chatterji is subject to debarment based on a finding, under

section 306(a) of the act (21 U.S.C. 355a(a)), that he was convicted of

a felony under Federal law for conduct relating to the regulation of a

drug product. Mr. Chatterji's conduct related to the regulation of a

drug product because, in causing the destruction of drug samples, he

obstructed FDA's investigation of fraudulent NDA data submitted by

Quad.

 

In a letter received by FDA on November 1, 1995, Mr. Chatterji

notified FDA of his acquiescence to debarment, as provided for in

section 306(c)(2)(B) of the act. A person subject to debarment is

entitled to an opportunity for an agency hearing on disputed issues of

material fact under section 306(i) of the act, but by acquiescing to

debarment, Mr. Chatterji waived his opportunity for a hearing and any

contentions concerning his debarment.

 

II. Findings and Order

    

Therefore, the Director, Center for Drug Evaluation and Research,

under section 306(a)(2)(B) of the act, and under authority delegated to

her (21 CFR 5.99), finds that Mr. Dulal C. Chatterji has been convicted

of a felony under Federal law for conduct relating to the regulation of

a drug product.

 

As a result of the foregoing findings and based on his

notification of acquiescence, Mr. Dulal C. Chatterji is permanently

debarred from providing services in any capacity to a person with an

approved or pending drug product application under section 505, 507,

512, or 802 of the act (21 U.S.C. 355, 357, 360b, or 382), or under

section 351 of the Public Health Service Act (42 U.S.C. 262), effective

November 1, 1995, the date of notification of acquiescence (sections

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

321(dd))). Any person with an approved or pending drug product

application who knowingly uses the services of Mr. Chatterji, in any

capacity, during his period of debarment, will be subject to civil

money penalties. If Mr. Chatterji, during his period of debarment,

provides services in any capacity to a person with an approved or

pending drug product application, he will be subject to civil money

penalties. In addition, FDA will not accept or review any abbreviated

new drug applications (ANDA's) submitted by or with the assistance of

Mr. Chatterji during his period of debarment.

 

Any application by Mr. Chatterji for termination of debarment under

section 306(d)(4) of the act should be identified with Docket No. 96N-

0003 and sent to the Dockets Management Branch (address above). All

such submissions are to be filed in four copies. The public

availability of information in these submissions is governed by 21 CFR

10.20(j). Publicly available submissions may be seen in the Dockets

Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    

Dated: January 7, 1997.

Janet Woodcock

Director, Center for Drug Evaluation and Research.

[FR Doc. 97-1477 Filed 1-21-97; 8:45 am]

BILLING CODE 4160-01-F