[Federal Register: April 30, 2002 (Volume 67, Number 83)]
[Notices]
[Page 21255-21256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap02-79]
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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
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