[Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)]
[Notices]
[Pages 21255-21256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0359]


Craig H. Petrik; 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. Craig H. Petrik 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. Petrik 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 his proposed 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation, Mr. Petrik failed to request a hearing. Mr. 
Petrik's failure to request a hearing is deemed a waiver of his right 
to a hearing concerning this action.

DATES: This order is effective April 30, 2002.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, 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 January 19, 2001, the U.S. District Court for the Central 
District of California accepted a plea of guilty and entered a judgment 
against Mr. Petrik for one count of making a false statement to a 
government agency, a Federal felony under 18 U.S.C. 1001. As a result 
of this conviction, FDA sent a letter dated August 31, 2001, to Mr. 
Petrik proposing to issue an order to permanently debar him 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, and offering him 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. 
355a(a)(2)(B) and (c)(2)(A)(ii)), that he was convicted of a felony 
under Federal law for conduct relating to the regulation of a drug 
product. Mr. Petrik was provided 30 days to file objections and request 
a hearing. Mr. Petrik did not request a hearing. His failure to request 
a hearing constitutes a waiver of his right to a hearing concerning the 
proposed order.

II. Findings and Order

    Therefore, the Director, Center for Biologics 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. Craig H. Petrik 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. Craig H. Petrik 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 section 351 of the Public Health Service Act (42 
U.S.C. 262), effective April 30, 2002 (21 U.S.C. 335a(a)(2), (c)(1)(B), 
and (c)(2)(A)(ii), and 321(dd)). Any person with an approved or pending 
drug product application including, but not limited to, a biologics 
license application, who knowingly uses the services of Mr. Petrik, in 
any capacity, during his period of debarment, will be subject to civil 
money penalties (21 U.S.C. 335a(a)(6)). If Mr. Petrik, during his 
period of 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, he will be subject to 
civil money penalties (21 U.S.C. 335a(a)(7)).
    Any application by Mr. Petrik for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 01N-
0359 and sent to the Dockets Management Branch (see ADDRESSES). All 
such submissions are to be filed in four copies (Sec. 10.20(a) (21 CFR 
10.20(a))). The public availability of information in these submissions 
is governed by Sec. 10.20(j). Publicly available submissions may be 
seen in the Dockets Management Branch

[[Page 21256]]

between 9 a.m. and 4 p.m., Monday through Friday (Sec. 10.20(j)(1)).

    Dated: April 10, 2002.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 02-10562 Filed 4-29-02; 8:45 am]
BILLING CODE 4160-01-S