[Federal Register Volume 59, Number 228 (Tuesday, November 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29383]
[[Page Unknown]]
[Federal Register: November 29, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0326]
Patrick T. Ryan; 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. 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:
I. 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.
III. 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
