80 FR 35652 - Mirwaiss Aminzada: Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 119 (June 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 119 (June 22, 2015)
| Page Range | 35652-35653 | |
| FR Document | 2015-15162 |
[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)] [Notices] [Pages 35652-35653] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15162] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0097] Mirwaiss Aminzada: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Mirwaiss Aminzada 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. Aminzada was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Mr. Aminzada was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Aminzada failed to request a hearing. Mr. Aminzada's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective June 22, 2015. ADDRESSES: Submit applications for 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), Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive, 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 June 10, 2014, the U.S. District Court for the Eastern District of Virginia entered judgment against Mr. Aminzada for one count of introducing misbranded drugs into interstate commerce with intent to defraud or mislead, in violation of sections 301(a) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)). FDA's finding that debarment is appropriate is based on the felony conviction referenced herein. The [[Page 35653]] factual basis for this conviction is as follows: Between around August 2009 and August 2013, Mr. Aminzada owned and operated several companies dedicated to international sales, including Royal Canadian Imports (headquartered in Canada), and Essa Gulf Trading (headquartered in Dubai, United Arab Emirates). Between approximately August 2009 and August 2012, Mr. Aminzada sold misbranded chemotherapy drugs and injectable cosmetic drugs to Gallant Pharma International, Inc. (Gallant Pharma) for resale in the United States. Neither of Mr. Aminzada's companies were licensed as a prescription drug wholesaler anywhere in the United States. Mr. Aminzada admitted that the drugs he sold to Gallant Pharma for resale in the United States were prescription only, and that many of the drugs were misbranded in that the drugs did not bear adequate directions for use and were not subject to an exemption from that requirement, and were accompanied by non-FDA approved packaging and inserts, which were sometimes written in foreign languages. The drugs Mr. Aminzada sold to Gallant Pharma also lacked the FDA-required pedigree, which protects patients' health by tracking each sale, purchase, or trade of a drug from the time of manufacturing to delivery to the patient. Between August 2009 and August 2012, Mr. Aminzada received at least $586,798 in wire transfers from Gallant Pharma, representing revenues from sales of such drugs to Gallant Pharma. Mr. Aminzada admitted that his actions were in all respect knowing, voluntary, intentional, and did not occur by accident, mistake, or for another innocent reason. As a result of his conviction, on March 9, 2015, FDA sent Mr. Aminzada 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. Aminzada was convicted of a felony under Federal law for conduct related to the regulation of a drug product. FDA determined that Mr. Aminzada's felony conviction was related to the regulation of drug products because the conduct underlying his conviction undermined FDA's regulatory oversight over drug products marketed in the United States by intentionally introducing into interstate commerce drug products that did not bear adequate directions for use and were not subject to an exemption from that requirement, and which, among other things, were accompanied by non-FDA approved packaging and inserts. The proposal also offered Mr. Aminzada 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 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 16, 2015. Mr. Aminzada 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 the Director (Staff Manual Guide 1410.35), finds that Mirwaiss Aminzada has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Section 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 335a(c)(2)(A)(ii)) requires that Mr. Aminzada's debarment be permanent. As a result of the foregoing findings, Mirwaiss Aminzada 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 sections 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 Mirwaiss Aminzada, 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. Aminzada 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 submitted by or with the assistance of Mirwaiss Aminzada during his period of debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A))). Any application by Mr. Aminzada 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-2015-N-0097 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 16, 2015. Douglass Stearn, Director, Division of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2015-15162 Filed 6-19-15; 8:45 am] BILLING CODE 4164-01-P
![35652 Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices
Department of Health and Human negotiates regulatory policy positions DEPARTMENT OF HEALTH AND
Services, Administration for Children with the Department and the Executive HUMAN SERVICES
and Families (ACF), as follows: Chapter Branch; and provides guidance to ACF
KT, as last amended, 65 FR 30413–14, program and staff components on policy Food and Drug Administration
May 11, 2000. and programmatic matters related to the [Docket No. FDA–2015–N–0097]
I. Under Chapter KT, Office of regulatory development process.
Legislative Affairs and Budget, delete Mirwaiss Aminzada: Debarment Order
KT.00 Mission in its entirety and The Division manages all Government
replace with the following: Accountability Office (GAO) AGENCY: Food and Drug Administration,
engagements with ACF; coordinates HHS.
KT.00 MISSION. The Office of
Legislative Affairs and Budget (OLAB) entrance and exit conferences within ACTION: Notice.
provides leadership in the development ACF; ensures GAO requests for
information are fulfilled; and SUMMARY: The Food and Drug
of legislation, budget, and policy,
coordinates ACF comments on GAO Administration (FDA) is issuing an
ensuring consistency in these areas
draft reports and Statements of Action order under the Federal Food, Drug, and
among ACF program and staff offices,
on GAO’s recommendations. Cosmetic Act (the FD&C Act)
and with ACF and the Department’s
permanently debarring Mirwaiss
vision and goals. It advises the Assistant The Division facilitates OIG Aminzada from providing services in
Secretary for Children and Families on engagements relating to the management any capacity to a person that has an
all policy and programmatic matters of ACF programs, to include, but not be approved or pending drug product
that substantially impact the agency’s limited to, audits to determine whether application. FDA bases this order on a
legislative program, budget an ACF program office met its statutory finding that Mr. Aminzada was
development, budget execution, and requirements; audits to determine convicted of a felony under Federal law
regulatory agenda. The Office serves as whether an ACF program office for conduct relating to the regulation of
the primary contact for the Department, complied with internal policies and a drug product. Mr. Aminzada was
the Executive Branch, and the Congress procedures; evaluations of an ACF given notice of the proposed permanent
on all legislative, budget development
program for efficiency and effectiveness; debarment and an opportunity to
and execution, and regulatory activities.
and evaluation of both ACF request a hearing within the timeframe
The Office serves as the ACF liaison to
management and selected grantees’ prescribed by regulation. Mr. Aminzada
the Government Accountability Office
management of their grants. failed to request a hearing. Mr.
and to the Office of Inspector General
Aminzada’s failure to request a hearing
(OIG) for OIG engagements relating to III. Continuation of Policy. Except as constitutes a waiver of his right to a
the management of ACF programs. inconsistent with this realignment, all hearing concerning this action.
II. Under Chapter KT, Office of statements of policy and interpretations
DATES: This order is effective June 22,
Legislative Affairs and Budget, delete with respect to organizational 2015.
KT.20, Functions, Paragraph B, in its components affected by this notice
entirety and replace with the following: within ACF, heretofore issued and in ADDRESSES: Submit applications for
B. The Division of Legislative and effect on this date of this realignment termination of debarment to the
Regulatory Affairs serves as the focal are continued in full force and effect. Division of Dockets Management (HFA–
point for congressional liaison in ACF; 305), Food and Drug Administration,
IV. Delegation of Authority. All 5630 Fishers Lane, Rm. 1061, Rockville,
provides guidance to the Assistant
delegations and redelegations of MD 20852.
Secretary for Children and Families and
authority made to officials and FOR FURTHER INFORMATION CONTACT:
senior ACF staff on congressional
activities and relations; manages the employees of affected organizational Kenny Shade (ELEM–4144), Office of
preparation of testimony and briefings components will continue in them or Regulatory Affairs, Food and Drug
for programmatic and budget-related their successors pending further Administration, 12420 Parklawn Drive,
hearings; negotiates clearance of redelegations, provided they are Rockville, MD 20857, 301–796–4640.
testimony; monitors hearings and other consistent with this realignment. SUPPLEMENTARY INFORMATION:
congressional activities that affect ACF V. Funds, Personnel, and Equipment.
programs; and responds to I. Background
Transfer of organizations and functions
congressional inquiries. affected by this realignment shall be Section 306(a)(2)(B) of the FD&C Act
The Division manages the ACF accompanied in each instance by direct (21 U.S.C. 335a(a)(2)(B)) requires
legislative planning cycle and the and support funds, positions, personnel, debarment of an individual if FDA finds
development of Reports to Congress; records, equipment, supplies, and other that the individual has been convicted
reviews and analyzes a wide range of resources. of a felony under Federal law for
congressional policy documents conduct relating to the regulation of any
including: legislative proposals, This realignment will be effective drug product under the FD&C Act.
pending legislation, and bill reports; upon date of signature. On June 10, 2014, the U.S. District
solicits and synthesizes internal ACF Dated: June 12, 2015. Court for the Eastern District of Virginia
comments on such documents; entered judgment against Mr. Aminzada
Mark H. Greenberg,
negotiates legislative policy positions for one count of introducing misbranded
with the Department and the Executive Acting Assistant Secretary for Children and drugs into interstate commerce with
Families.
tkelley on DSK3SPTVN1PROD with NOTICES
Branch; and reviews other policy intent to defraud or mislead, in
significant documents to ensure [FR Doc. 2015–15237 Filed 6–19–15; 8:45 am] violation of sections 301(a) and
consistency with statutory and BILLING CODE 4184–34–P 303(a)(2) of the FD&C Act (21 U.S.C.
congressional intent and the agency 331(a) and 333(a)(2)).
legislative agenda. FDA’s finding that debarment is
The Division manages the ACF appropriate is based on the felony
regulatory development process; conviction referenced herein. The
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![Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices 35653
factual basis for this conviction is as by non-FDA approved packaging and section 306(d)(4) of the FD&C Act (21
follows: Between around August 2009 inserts. The proposal also offered Mr. U.S.C. 335a(d)(4)) should be identified
and August 2013, Mr. Aminzada owned Aminzada an opportunity to request a with Docket No. FDA–2015–N–0097
and operated several companies hearing, providing him 30 days from the and sent to the Division of Dockets
dedicated to international sales, date of receipt of the letter in which to Management (see ADDRESSES). All such
including Royal Canadian Imports file the request, and advised him that submissions are to be filed in four
(headquartered in Canada), and Essa failure to request a hearing constituted copies. The public availability of
Gulf Trading (headquartered in Dubai, a waiver of the opportunity for a hearing information in these submissions is
United Arab Emirates). and of any contentions concerning this governed by 21 CFR 10.20.
Between approximately August 2009 action. The proposal was received on Publicly available submissions may
and August 2012, Mr. Aminzada sold March 16, 2015. Mr. Aminzada failed to be seen in the Division of Dockets
misbranded chemotherapy drugs and respond within the timeframe Management between 9 a.m. and 4 p.m.,
injectable cosmetic drugs to Gallant prescribed by regulation and has, Monday through Friday.
Pharma International, Inc. (Gallant therefore, waived his opportunity for a Dated: June 16, 2015.
Pharma) for resale in the United States. hearing and has waived any contentions
Douglass Stearn,
Neither of Mr. Aminzada’s companies concerning his debarment (21 CFR part
were licensed as a prescription drug Director, Division of Compliance Policy,
12).
Office of Enforcement, Office of Regulatory
wholesaler anywhere in the United
II. Findings and Order Affairs.
States. Mr. Aminzada admitted that the
Therefore, the Director, Office of [FR Doc. 2015–15162 Filed 6–19–15; 8:45 am]
drugs he sold to Gallant Pharma for
resale in the United States were Enforcement and Import Operations, BILLING CODE 4164–01–P
prescription only, and that many of the Office of Regulatory Affairs, under
drugs were misbranded in that the drugs section 306(a)(2)(B) of the FD&C Act,
did not bear adequate directions for use under authority delegated to the DEPARTMENT OF HEALTH AND
and were not subject to an exemption Director (Staff Manual Guide 1410.35), HUMAN SERVICES
from that requirement, and were finds that Mirwaiss Aminzada has been
Food and Drug Administration
accompanied by non-FDA approved convicted of a felony under Federal law
packaging and inserts, which were for conduct relating to the regulation of [Docket No. FDA–2014–N–2101]
sometimes written in foreign languages. a drug product. Section 306(c)(2)(A)(ii)
The drugs Mr. Aminzada sold to Gallant of the FD&C Act (21 U.S.C. Anoushirvan Sarraf: Debarment Order
Pharma also lacked the FDA-required 335a(c)(2)(A)(ii)) requires that Mr. AGENCY: Food and Drug Administration,
pedigree, which protects patients’ Aminzada’s debarment be permanent. HHS.
health by tracking each sale, purchase, As a result of the foregoing findings,
ACTION: Notice.
or trade of a drug from the time of Mirwaiss Aminzada is permanently
manufacturing to delivery to the patient. debarred from providing services in any SUMMARY: The Food and Drug
Between August 2009 and August 2012, capacity to a person with an approved Administration (FDA) is issuing an
Mr. Aminzada received at least or pending drug product application order under the Federal Food, Drug, and
$586,798 in wire transfers from Gallant under sections 505, 512, or 802 of the Cosmetic Act (the FD&C Act)
Pharma, representing revenues from FD&C Act (21 U.S.C. 355, 360b, or 382), permanently debarring Anoushirvan
sales of such drugs to Gallant Pharma. or under section 351 of the Public Sarraf from providing services in any
Mr. Aminzada admitted that his actions Health Service Act (42 U.S.C. 262), capacity to a person that has an
were in all respect knowing, voluntary, effective (see DATES) (see sections approved or pending drug product
intentional, and did not occur by 201(dd), 306(c)(1)(B), and application. FDA bases this order on a
accident, mistake, or for another 306(c)(2)(A)(ii) of the FD&C Act, (21 finding that Dr. Sarraf was convicted of
innocent reason. U.S.C. 321(dd), 335a(c)(1)(B), and seven felonies under Federal law for
As a result of his conviction, on 335a(c)(2)(A)(ii)). Any person with an conduct relating to the regulation of a
March 9, 2015, FDA sent Mr. Aminzada approved or pending drug product drug product. Dr. Sarraf was given
a notice by certified mail proposing to application who knowingly employs or notice of the proposed permanent
permanently debar him from providing retains as a consultant or contractor, or debarment and an opportunity to
services in any capacity to a person that otherwise uses the services of Mirwaiss request a hearing within the timeframe
has an approved or pending drug Aminzada, in any capacity during his prescribed by regulation. Dr. Sarraf
product application. The proposal was debarment, will be subject to civil failed to request a hearing. Dr. Sarraf’s
based on the finding, under section money penalties (section 307(a)(6) of the failure to request a hearing constitutes a
306(a)(2)(B) of the FD&C Act, that Mr. FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. waiver of his right to a hearing
Aminzada was convicted of a felony Aminzada provides services in any concerning this action.
under Federal law for conduct related to capacity to a person with an approved
DATES: This order is effective June 22,
the regulation of a drug product. FDA or pending drug product application
2015.
determined that Mr. Aminzada’s felony during his period of debarment he will
conviction was related to the regulation be subject to civil money penalties ADDRESSES: Submit applications for
of drug products because the conduct (section 307(a)(7) of the FD&C Act (21 termination of debarment to the
underlying his conviction undermined U.S.C. 335b(a)(7))). In addition, FDA Division of Dockets Management (HFA–
FDA’s regulatory oversight over drug will not accept or review any 305), Food and Drug Administration,
tkelley on DSK3SPTVN1PROD with NOTICES
products marketed in the United States abbreviated new drug applications 5630 Fishers Lane, Rm. 1061, Rockville,
by intentionally introducing into submitted by or with the assistance of MD 20852.
interstate commerce drug products that Mirwaiss Aminzada during his period of FOR FURTHER INFORMATION CONTACT:
did not bear adequate directions for use debarment (section 306(c)(1)(A) of the Kenny Shade (ELEM–4144) Office of
and were not subject to an exemption FD&C Act (21 U.S.C. 335a(c)(1)(A))). Regulatory Affairs, Food and Drug
from that requirement, and which, Any application by Mr. Aminzada for Administration, 12420 Parklawn Drive,
among other things, were accompanied special termination of debarment under Rockville, MD 20857, 301–796–4640.
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Document Created: 2018-02-22 11:14:02
Document Modified: 2018-02-22 11:14:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This order is effective June 22, 2015. | |
| Contact | Kenny Shade (ELEM-4144), Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive, Rockville, MD 20857, 301-796-4640. | |
| FR Citation | 80 FR 35652 |
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