[Federal Register Volume 74, Number 224 (Monday, November 23, 2009)]
[Notices]
[Pages 61150-61151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0281]


Niaja Kane: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) (the agency) is issuing 
an order under the Federal Food, Drug, and Cosmetic Act (the act) 
permanently debarring Niaja Kane from providing services in any 
capacity to a person that has an approved or pending drug product 
application. We base this order on a finding that Ms. Kane was 
convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the act. Ms. Kane was given notice 
of the proposed permanent debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation. As of September 
20, 2009, Ms. Kane failed to respond. Ms. Kane's failure to respond 
constitutes a waiver of her right to a hearing concerning this action.

DATES: This order is effective November 23, 2009.

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

FOR FURTHER INFORMATION CONTACT:  Kenny Shade, Office of Regulatory 
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6844.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)) requires 
debarment of an individual if FDA finds that the individual has been 
convicted of a felony under Federal law for conduct otherwise relating 
to the regulation of any drug product under the act.
    On January 22, 2007, the U.S. District Court for the Eastern 
District of Pennsylvania accepted Niaja Kane's guilty plea and entered 
judgment against her for trafficking in counterfeit goods in violation 
of 18 U.S.C. 2320(a), holding counterfeit drugs for sale with intent to 
defraud in violation of 21 U.S.C. 331(i)(3) and 333(a)(2), and 
attempted possession with intent to distribute a counterfeit controlled 
substance in violation of 21 U.S.C. 846. The actions underlying these 
convictions were associated with Ms. Kane's order of counterfeit 
Percocet[reg], Viagra[reg], and Cialis[reg] on or about February 28, 
2006. These drugs included approximately 2,040 tablets purporting to be 
Viagra[reg], 1,200 tablets purporting to be Cialis[reg], 2,333 tablets 
purporting to be Percocet[reg] 7.5 milligrams (mg), and 6,573 tablets 
purporting to be Percocet[reg] 10 mg. All of these drugs, without 
authorization, bore the trademark, trade name and identifying marks, 
imprints and other characteristics of the products they purported to 
be, thereby falsely purporting to be manufactured, processed, packed, 
or distributed by the legitimate holders of such trademarks. Ms. Kane 
intentionally trafficked and attempted to traffic in goods, all of 
which were counterfeit. She knowingly used on and in connection with 
such goods counterfeit marks, that is spurious marks identical to and 
substantially indistinguishable from shape and imprints found on the 
genuine products whose marks were in use and were registered for those 
products by those companies on the principal register of the United 
States Patent and Trademark Office. Ms. Kane also, with intent to 
defraud and mislead, willfully caused a drug to be a counterfeit drug 
and held for sale or dispensing the drugs referenced previously. With 
respect to the tablets purporting to be Percocet[reg], Ms. Kane 
knowingly and intentionally attempted to possess with intent to 
distribute or dispense a mixture and substance containing oxycodone, a 
Schedule II controlled substance contained in Percocet[reg], all of 
which without authorization bore the identifying marks of the 
manufacturer and distributor of the controlled substance, which did not 
manufacture or distribute such substances.
    As a result of these convictions, FDA sent Ms. Kane by certified 
mail on August 13, 2009, a notice proposing to permanently debar her 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(B) of the act that Niaja Kane was 
convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the act. The proposal also offered 
Ms. Kane an opportunity to request a hearing, providing her 30 days 
from the date of receipt of the letter in which to file the request, 
and advised her that failure to request a hearing constituted a waiver 
of the opportunity for a hearing and of any contentions concerning this 
action. Ms. Kane failed to respond within the timeframe prescribed by 
regulation and has, therefore, waived her opportunity for a hearing and 
waived any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the act, under 
authority delegated to the Acting Director (Staff Manual Guide 
1410.35), finds that Niaja Kane has been convicted of felonies under 
Federal law for conduct relating to the regulation of a drug product 
under the act.
    As a result of the foregoing finding, Ms. Kane is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under sections 505, 512, 
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) 
(see section 306(c)(1)(B) and (c)(2)(A)(ii), and section 201(dd) of the 
act (21 U.S.C. 321(dd)). Any person with an approved or pending drug 
product application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Niaja Kane, in any 
capacity, during Ms. Kane's debarment, will be subject to civil money 
penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Ms. 
Kane, during her period of debarment, provides services in any capacity 
to a person with an approved or pending drug product application, she 
will be subject to civil money penalties (section 307(a)(7) of the 
act). In addition, FDA will not accept or review any abbreviated new 
drug applications submitted by or with the assistance of Ms. Kane 
during her period of debarment (section 306(c)(1)(B) of the act).
    Any application by Ms. Kane for special termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
2009-N-0281 and sent to the Division of Dockets Management (see 
ADDRESSES). 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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.


[[Page 61151]]


    Dated: November 9, 2009.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-28083 Filed 11-20-09; 8:45 am]
BILLING CODE 4160-01-S