Talib Khan: Debarment Order, 39121-39122 [2015-16664]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2015–16646 Filed 7–7–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2103]
Talib Khan: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The U.S. Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Talib
Khan from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Mr. Khan was convicted of
two felonies under Federal law for
conduct relating to the regulation of a
drug product. Mr. Khan was given
notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Mr. Khan
failed to respond. Mr. Khan’s failure to
respond constitutes a waiver of his right
to a hearing concerning this action.
SUMMARY:
DATES:
This order is effective July 8,
2015.
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.
srobinson on DSK5SPTVN1PROD with NOTICES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kenny Shade (ELEM–4144), Division of
Enforcement, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:49 Jul 07, 2015
Jkt 235001
I. Background
Section 306(a)(2)(B) of the FD&C 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 relating to the regulation of any
drug product under the FD&C Act.
On March 11, 2014, the U.S. District
Court for the Eastern District of Virginia
entered judgment against Mr. Khan for
one count of conspiracy in violation of
18 U.S.C. 371, and one count of
introducing misbranded drugs into
interstate commerce, in violation of 21
U.S.C. 331(a) and 333(a)(2) and 18
U.S.C. 2.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for this conviction is as
follows: Mr. Khan was a cofounder and
co-owner of Gallant Pharma
International Inc. (Gallant Pharma),
between August 2009 and August 2013.
Gallant was a company dedicated to the
illegal importation and sale of
misbranded and non-FDA approved
chemotherapy drugs and injectable
cosmetic drugs and devices in the
United States.
As cofounder and co-owner of Gallant
Pharma, Mr. Khan was primarily
responsible for the international aspect
of the conspiracy, including: (1)
Determining which drugs and devices to
sell in the United States; (2) establishing
relationships with international
suppliers; (3) directing those suppliers
to send drugs and devices to
transshippers in Canada and the United
Kingdom; (4) arranging for
transshipment from Canada and the
United Kingdom to the United States;
(5) interviewing, hiring, and training
sales representatives in the United
States; (6) and paying suppliers, sales
representatives, and office employees
out of foreign bank accounts. Gallant
Pharma was not licensed as a
prescription drug wholesaler by the
Commonwealth of Virginia. Some of the
drugs and devices that Mr. Khan
acquired were not approved by the FDA
for use on patients in the United States.
Mr. Khan admitted that the drugs sold
by Gallant Pharma were prescription
only and were misbranded in that,
among other things, they did not bear
adequate directions for use and were not
subject to an exemption from that
requirement, and they were
accompanied by non-FDA approved
packaging and inserts. The drugs Mr.
Kahn’s company sold also lacked the
FDA-required pedigree, which protects
patient health by tracking each sale,
purchase, or trade of a drug from the
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
39121
time of manufacturing to delivery to the
patient, and some drug packaging and
inserts were written solely in languages
other than English.
Immediately after establishing Gallant
Pharma’s presence in the Eastern
District of Virginia, on or about
September 25, 2009, Mr. Khan received
a cease and desist letter from a law firm
on behalf of Medicis, the exclusive
authorized marketer of Restylane and
Perlane in the United States and
Canada. The letter informed Mr. Khan’s
company that its marketing of these
drugs violated the FD&C Act and could
subject Gallant Pharma to substantial
criminal and civil penalties. The letter
included Gallant Pharma’s marketing
materials, which falsely claimed that
Gallant Pharma had been ‘‘strictly
working with the current FDA rules and
regulations for almost 10 years.’’
Mr. Khan purchased drugs and
devices from suppliers in, among other
places, Turkey, Switzerland, the United
Kingdom, and the United Arab
Emirates. In or around March 2011, after
a coconspirator’s medical license had
expired, Mr. Khan altered the expiration
date on the medical license to make it
appear that the license was still valid.
On at least 18 occasions, Mr. Khan
personally completed false customs
declarations and thereby illegally
imported misbranded drugs and devices
from Canada to the Eastern District of
Virginia. Mr. Khan also personally
accepted and processed orders for
Gallant Pharma customers.
Between August 2009 and August
2013, Gallant Pharma received illegal
proceeds of at least $12,400,000 from
the sale of misbranded and non-FDA
approved drugs and devices in the
United States. Mr. Khan admitted that
he was an organizer or leader of this
criminal activity and he additionally
admitted that his actions were in all
respects knowing, voluntary, and
intentional, and did not occur by
accident, mistake, or for another
innocent reason.
As a result of his conviction, on
March 19, 2015, FDA sent Mr. Khan a
notice by certified mail proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on the finding, under section
306(a)(2)(B) of the FD&C Act, that Mr.
Khan was convicted of felonies under
Federal law for conduct related to the
regulation of a drug product. The
proposal also offered Mr. Khan an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
E:\FR\FM\08JYN1.SGM
08JYN1
39122
Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
srobinson on DSK5SPTVN1PROD with NOTICES
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. The
proposal was received on March 23,
2015. Mr. Khan failed to respond within
the timeframe prescribed by regulation
and has, therefore, waived his
opportunity for a hearing and has
waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(a)(2)(B) of the FD&C Act,
under authority delegated to him (Staff
Manual Guide 1410.35), finds that Talib
Khan has been convicted of felonies
under Federal law for conduct relating
to the regulation of a drug product.
As a result of the foregoing finding,
Talib Khan 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 FD&C
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 201(dd),
306(c)(1)(B), and 306(c)(2)(A)(ii) of the
FD&C Act, (21 U.S.C. 321(dd),
335a(c)(1)(B), and 335a(c)(2)(A)(ii)). 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 Talib Khan, in any
capacity during his debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Mr. Khan provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act (21 U.S.C. 335b(a)(7))). In
addition, FDA will not accept or review
any abbreviated new drug applications
from Talib Khan during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B))).
Any application by Mr. Khan for
special termination of debarment under
section 306(d)(4) of the FD&C Act (21
U.S.C. 335a(d)(4)) should be identified
with Docket No. FDA–2014–N–2103
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.
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VerDate Sep<11>2014
18:49 Jul 07, 2015
Jkt 235001
Dated: June 25, 2015.
Douglas Stearn,
Director, Division of Compliance Policy,
Office of Enforcement, Office of Regulatory
Affairs.
[FR Doc. 2015–16664 Filed 7–7–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than August 7, 2015.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 594–4306.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Maternal, Infant, and Childhood Home
Visiting (Home Visiting) Program Fiscal
Year (FY) 2015, FY2016, FY2017 NonCompeting Continuation Annual
Progress Report for Formula Grant.
OMB No.: 0915–0355—Extension.
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting (Home
Visiting) Program, administered by the
Health Resources and Services
Administration (HRSA) in close
partnership with the Administration for
Children and Families (ACF), supports
voluntary, evidence-based home visiting
services during pregnancy and to
parents with young children up to
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
kindergarten entry. The purpose of this
formula grant program is to: support the
delivery of coordinated and
comprehensive voluntary early
childhood home visiting program
services and effective implementation of
high-quality evidence-based practices.
The fifty states, District of Columbia,
and 5 territories and nonprofit
organizations that would provide
services in jurisdictions that have not
directly applied for or been approved
for a grant are eligible for formula grants
and submit non-competing continuation
progress reports annually. There are 56
jurisdictions eligible for formula awards
and 56 formula awards are issued
annually.
Need and Proposed Use of the
Information: This information collection
is needed for eligible entities to report
progress under the Home Visiting
Program annually. On March 23, 2010,
the President signed into law the Patient
Protection and Affordable Care Act
(ACA). Section 2951 of the ACA
amended Title V of the Social Security
Act by adding a new section, 511, which
authorized the creation of the Home
Visiting Program (https://
frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=111_cong_
bills&docid=f:h3590enr.txt.pdf, pages
216–225). A portion of funding under
this program is awarded to participating
states and eligible jurisdictions by
formula. The purpose of formula
funding is to support the delivery of
coordinated and comprehensive
voluntary early childhood home visiting
program services and effective
implementation of high-quality
evidence-based practices.
The information collected will be
used to review grantee progress on
proposed project plans sufficient to
permit project officers to assess whether
the project is performing adequately to
achieve the goals and objectives that
were previously approved. This report
will also provide implementation plans
for the upcoming year, which project
officers can use to assess to whether the
plan is consistent with the grant as
approved, and will result in
implementation of a high-quality project
that will complement the home visiting
program as a whole. Progress Reports
are submitted to project officers through
the Electronic HandBooks (EHB).
Failure to collect this information
would result in the inability of the
project officers to exercise due diligence
in monitoring and overseeing the use of
grant funds in keeping with legislative,
policy, and programmatic requirements.
Grantees are required to provide a
performance narrative with the
following sections: project identifier
E:\FR\FM\08JYN1.SGM
08JYN1
]]>Agencies
[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Notices]
[Pages 39121-39122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16664]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2103]
Talib Khan: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Talib Khan from providing services in
any capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Khan was
convicted of two felonies under Federal law for conduct relating to the
regulation of a drug product. Mr. Khan was given notice of the proposed
permanent debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. Mr. Khan failed to respond. Mr.
Khan's failure to respond constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective July 8, 2015.
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 (ELEM-4144), Division of
Enforcement, Office of Enforcement and Import Operations, Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C 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 relating
to the regulation of any drug product under the FD&C Act.
On March 11, 2014, the U.S. District Court for the Eastern District
of Virginia entered judgment against Mr. Khan for one count of
conspiracy in violation of 18 U.S.C. 371, and one count of introducing
misbranded drugs into interstate commerce, in violation of 21 U.S.C.
331(a) and 333(a)(2) and 18 U.S.C. 2.
FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein. The factual basis for this conviction is
as follows: Mr. Khan was a cofounder and co-owner of Gallant Pharma
International Inc. (Gallant Pharma), between August 2009 and August
2013. Gallant was a company dedicated to the illegal importation and
sale of misbranded and non-FDA approved chemotherapy drugs and
injectable cosmetic drugs and devices in the United States.
As cofounder and co-owner of Gallant Pharma, Mr. Khan was primarily
responsible for the international aspect of the conspiracy, including:
(1) Determining which drugs and devices to sell in the United States;
(2) establishing relationships with international suppliers; (3)
directing those suppliers to send drugs and devices to transshippers in
Canada and the United Kingdom; (4) arranging for transshipment from
Canada and the United Kingdom to the United States; (5) interviewing,
hiring, and training sales representatives in the United States; (6)
and paying suppliers, sales representatives, and office employees out
of foreign bank accounts. Gallant Pharma was not licensed as a
prescription drug wholesaler by the Commonwealth of Virginia. Some of
the drugs and devices that Mr. Khan acquired were not approved by the
FDA for use on patients in the United States. Mr. Khan admitted that
the drugs sold by Gallant Pharma were prescription only and were
misbranded in that, among other things, they did not bear adequate
directions for use and were not subject to an exemption from that
requirement, and they were accompanied by non-FDA approved packaging
and inserts. The drugs Mr. Kahn's company sold also lacked the FDA-
required pedigree, which protects patient health by tracking each sale,
purchase, or trade of a drug from the time of manufacturing to delivery
to the patient, and some drug packaging and inserts were written solely
in languages other than English.
Immediately after establishing Gallant Pharma's presence in the
Eastern District of Virginia, on or about September 25, 2009, Mr. Khan
received a cease and desist letter from a law firm on behalf of
Medicis, the exclusive authorized marketer of Restylane and Perlane in
the United States and Canada. The letter informed Mr. Khan's company
that its marketing of these drugs violated the FD&C Act and could
subject Gallant Pharma to substantial criminal and civil penalties. The
letter included Gallant Pharma's marketing materials, which falsely
claimed that Gallant Pharma had been ``strictly working with the
current FDA rules and regulations for almost 10 years.''
Mr. Khan purchased drugs and devices from suppliers in, among other
places, Turkey, Switzerland, the United Kingdom, and the United Arab
Emirates. In or around March 2011, after a coconspirator's medical
license had expired, Mr. Khan altered the expiration date on the
medical license to make it appear that the license was still valid.
On at least 18 occasions, Mr. Khan personally completed false
customs declarations and thereby illegally imported misbranded drugs
and devices from Canada to the Eastern District of Virginia. Mr. Khan
also personally accepted and processed orders for Gallant Pharma
customers.
Between August 2009 and August 2013, Gallant Pharma received
illegal proceeds of at least $12,400,000 from the sale of misbranded
and non-FDA approved drugs and devices in the United States. Mr. Khan
admitted that he was an organizer or leader of this criminal activity
and he additionally admitted that his actions were in all respects
knowing, voluntary, and intentional, and did not occur by accident,
mistake, or for another innocent reason.
As a result of his conviction, on March 19, 2015, FDA sent Mr. Khan
a notice by certified mail proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on the
finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Khan was
convicted of felonies under Federal law for conduct related to the
regulation of a drug product. The proposal also offered Mr. Khan an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
that failure to
[[Page 39122]]
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. The proposal was
received on March 23, 2015. Mr. Khan failed to respond within the
timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and has waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of
the FD&C Act, under authority delegated to him (Staff Manual Guide
1410.35), finds that Talib Khan has been convicted of felonies under
Federal law for conduct relating to the regulation of a drug product.
As a result of the foregoing finding, Talib Khan 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 FD&C 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 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the
FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(ii)).
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 Talib Khan, in any capacity during his
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Khan provides services
in any capacity to a person with an approved or pending drug product
application during his period of debarment he will be subject to civil
money penalties (section 307(a)(7) of the FD&C Act (21 U.S.C.
335b(a)(7))). In addition, FDA will not accept or review any
abbreviated new drug applications from Talib Khan during his period of
debarment (section 306(c)(1)(B) of the FD&C Act (21 U.S.C.
335a(c)(1)(B))).
Any application by Mr. Khan for special termination of debarment
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should
be identified with Docket No. FDA-2014-N-2103 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.
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 25, 2015.
Douglas Stearn,
Director, Division of Compliance Policy, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2015-16664 Filed 7-7-15; 8:45 am]
BILLING CODE 4164-01-P
