Rules and Regulations. Notice

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BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002N-0511] Thomas Ronald Theodore; Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. Thomas Ronald Theodore from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Mr. Theodore was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and his opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Theodore failed to request a hearing. Mr. Theodore's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective August 5, 2003. ADDRESSES: Submit applications for termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kathleen Swisher, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background On March 1, 2002, the U.S. District Court for the District of Massachusetts entered judgment against Mr. Theodore for nine counts of mail fraud, Federal felony offenses under 18 U.S.C. 1341. Mr. Theodore devised a scheme and artifice to defraud and to obtain money and property by means of false and fraudulent pretenses and representations. Mr. Theodore illegally arranged to ship an unapproved new drug identified as “LK-200” that had been manufactured in Woburn, MA, to the Bahamas, and then arranged to have the drug shipped from the Bahamas to pharmacists, physicians, and patients in the United States. As a result of this conviction, FDA sent to Mr. Theodore by certified mail on December 17, 2002, a notice proposing to permanently debar Mr. Theodore from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. The proposal also offered Mr. Theodore an opportunity for a hearing on the proposal. The proposal was based on a finding, under section 306(a)(2)(B) and (c)(2)(A)(ii) of the act (21 U.S.C. 335a(a)(2)(B) and (c)(2)(A)(ii)), that Mr. Theodore was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Mr. Theodore was provided 30 days to file objections and request a hearing. On January 3, 2003, FDA received from Mr. Theodore a response to the proposal to debar and notice of opportunity for hearing. Mr. Theodore did not request a hearing. Mr. Theodore argued that, although he was convicted of all felony counts, an appeal is pending. However, this argument fails under the applicability of conviction provision of section 306(l)(1)(A) of the act (21 U.S.C. 335a(l)(1)(A)). This law states that a person is considered to have been convicted of a criminal offense when a judgment of conviction has been entered against the person by a Federal or State court, regardless of whether there is an appeal pending. Therefore, Mr. Theodore's failure to request a hearing constitutes a waiver of his opportunity for a hearing and a waiver of any contentions concerning his debarment. In the event that the convictions that served as the basis for Mr. Theodore's debarment are reversed on appeal, the order of debarment shall be withdrawn. (See section 306(d)(3)(B)(i) of the act (21 U.S.C. 335a(d)(3)(B)(i)).) II. Findings and Order Therefore, the Director, Center for Biologics Evaluation and Research, under section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), and under authority delegated to the Director (21 CFR 5.34(a)), finds that Mr. Theodore 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 finding, Mr. Theodore is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application. A drug product means a drug, including a biological product, subject to regulation under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262). Any person with an approved or pending drug product application including, but not limited to, a biologics license application, who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Mr. Theodore, in any capacity, during Mr. Theodore's permanent debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Theodore, during his permanent debarment, provides services in any capacity to a person with an approved or pending drug product application including, but not limited to, a biologics license application, Mr. Theodore will be subject to civil money penalties (section 307(a)(7) of the act (21 U.S.C. 335b(a)(7))). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Mr. Theodore during Mr. Theodore's permanent debarment. Any application by Mr. Theodore for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 2002N-0511 and sent to the Division of Dockets Management (see ADDRESSES ). All such submissions are to be filed in four copies (§ 10.20(a) (21 CFR 10.20(a))). The public availability of information in these submissions is governed by § 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday (§ 10.20(j)(1)). Dated: July 23, 2003. Mark Elengold, Deputy Director for Operations, Center for Biologics Evaluation and Research. [FR Doc. 03-19806 Filed 8-4-03; 8:45 am]

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