[Federal Register Volume 65, Number 114 (Tuesday, June 13, 2000)]
[Notices]
[Pages 37154-37155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 92N-0412]


Rajaram K. Matkari; Conviction Reversal; 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 an order, 
under the Federal Food, Drug, and Cosmetic Act (the act), terminating 
the debarment of Rajaram K. Matkari, 1304 Riverglen Way, Berthoud, CO 
80513. FDA is issuing this order because the U.S. District Court for 
the District of Maryland issued a Writ of Error Coram Nobis, reversing 
Mr. Matkari's conviction and Mr. Matkari applied for termination of his 
debarment on this basis.

EFFECTIVE DATE: June 13, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments are to be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Leanne Cusumano, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 20, 1993 (58 FR 54156), Rajaram K. Matkari was 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application (sections 
306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (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 Mr. Matkari was convicted of a felony 
under Federal law for conduct relating to the development or approval 
of a drug product, or otherwise relating to the regulation of a drug 
product (section 306(a)(2)(A) and (a)(2)(B) of the act). Mr. Matkari, 
the former Vice President for Regulatory Affairs and Product 
Development of Pharmaceutical Basics, Inc. (PBI), pled guilty to and 
was sentenced on July 28, 1989, for giving an unlawful gratuity, a 
felony offense under 18 U.S.C. 201(c)(1)(A). The basis for this 
conviction was Mr. Matkari's payment of approximately $2,000 to an FDA 
chemistry review branch chief who was responsible for supervising the 
chemists who reviewed PBI's applications to determine whether those 
applications met certain statutory standards for approval.
    On February 22, 2000, the U.S. District Court for the District of 
Maryland issued an order granting Mr. Matkari's petition for a Writ of 
Error Coram Nobis in his criminal case. A copy of the court's order is 
available in Docket No. 92N-0412. By this order, the court reversed Mr. 
Matkari's conviction. On April 18, 2000, Mr. Matkari petitioned for 
termination of debarment under section 306(d)(3)(B)(i) of the act, as 
amended by the Generic Drug Enforcement Act. Section 306(d)(3)(B)(i) of 
the act states that ``If the conviction which served as the basis for 
the debarment of an individual under subsection (a)(2) * * * is 
reversed, the Secretary shall withdraw the order of debarment.''
    Accordingly, the Senior Associate Commissioner for Policy, 
Planning, and Legislation, under section 306(d)(3)(B)(i) of the act and 
under authority delegated to him (21 CFR 5.20), is issuing this order 
withdrawing the order of permanent debarment of Rajaram K. Matkari, 
thereby allowing him to provide services in any capacity to a person 
with an approved or pending drug product application. Rajaram K. 
Matkari's debarment is terminated

[[Page 37155]]

effective June 13, 2000, (section 306(d)(3)(B)(i) of the act).

    Dated: June 6, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-14806 Filed 6-12-00; 8:45 am]
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