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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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04/30/2002

[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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