Inspections, Compliance, Enforcement, and Criminal Investigations

11/29/1994

[Federal Register: November 29, 1994]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0326]

Patrick T. Ryan;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. Patrick T. Ryan, 94 Alaeloa Mauka St., Lahaina, HI 96761, 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. Ryan was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Mr. Ryan has failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action.

EFFECTIVE DATE: December 29, 1994.

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: Tamar S. Nordenberg, Center for Drug Evaluation and Research (HFD-366), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION:

  1. Background

    On December 12, 1991, the United States District Court for the District of Oregon entered judgment against Mr. Patrick T. Ryan for the Federal felony offense of knowingly selling, purchasing, and trading drug samples as defined in, and in violation of, 21 U.S.C. 353(c)(1),331(t), and 333(b)(1).

    As a result of this conviction, FDA served Mr. Ryan by certified mail on October 12, 1993, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application, and offered him an opportunity for a hearing on the proposal. The proposal was based on a finding, under section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), that he was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Mr. Ryan did not request a hearing. His failure to request a hearing constitutes a waiver of his opportunity for a hearing and a waiver of any contentions concerning his debarment.

  2. Findings and Order

    Therefore, the Interim Deputy Commissioner for Operations, under section 306(a) of the act, and under authority delegated to her (21 CFR 5.20), finds that Mr. Patrick T. Ryan has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product (21 U.S.C. 335a(a)(2)(B)).

    As a result of the foregoing finding, Mr. Patrick T. Ryan is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 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 29, 1994 (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(ee)). Any person with an approved or pending drug product application who knowingly uses the services of Mr. Ryan, in any capacity, during his period of debarment, will be subject to civil money penalties. If Mr. Ryan, 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 submitted by or with the assistance of Mr. Ryan during his period of debarment.

    Any application by Mr. Ryan for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 93N- 0326 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: November 21, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-29383 Filed 11-28-94; 8:45 am]

BILLING CODE 4160-01-P

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