[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