[Federal Register Volume 62, Number 14 (Wednesday, January 22, 1997)]
[Notices]
[Page 3297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1477]
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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
