Sami Arshak Yanikian: Debarment Order, 39245-39246 [2012-16156]
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39245
Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Notices
state child support enforcement
agencies with potential reprogramming
at varying times due to future changes
in either Part A or Part B, the
Administration for Children and
Families is resubmitting an unchanged
information collection package and
requesting an extension to the current
OMB approval of NMSN Part A to
synchronize with the expiration date of
NMSN Part B.
Respondents: State child support
enforcement agencies, employers, and
health plan administrators.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
National Medical Support Notice .....................................................................
54
97,775
0.17
897,574.50
mstockstill on DSK4VPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 897,574.50.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–16029 Filed 6–29–12; 8:45 am]
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Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0063]
Sami Arshak Yanikian: Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Sami Arshak Yanikian for 10 years 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. Yanikian
was convicted of two counts of
introducing unapproved new drugs into
interstate commerce, which relates to
the development or approval, including
the process for development or
approval, of drug products and to the
regulation of drug products under the
FD&C Act. In addition, the type of
conduct that served as the basis for Mr.
Yanikian’s convictions undermine the
process for the regulation of drugs. Mr.
Yanikian was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. Mr.
Yanikian failed to respond. Mr.
Yanikian’s failure to respond constitutes
a waiver of his right to a hearing
concerning this action.
DATES: This order is effective July 2,
2012.
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, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits FDA to debar an individual if it
finds that the individual has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product or otherwise relating
to the regulation of drug products under
the FD&C Act, and if FDA finds that the
type of conduct that served as the basis
for the conviction undermines the
process for the regulation of drugs.
On June 29, 2011, Mr. Yanikian was
found guilty of two counts of
introduction of an unapproved drug in
interstate commerce, in violation of
sections 301(d), 505(a), and 303(a)(1) of
the FD&C Act (21 U.S.C. 331(d), 355(a),
333(a)(1)) and of aiding and abetting, in
violation of 18 U.S.C. 2(b), and the U.S.
District Court for the Central District of
California entered judgment against Mr.
Yanikian for the misdemeanor offenses
of introduction of an unapproved drug
in interstate commerce and aiding and
abetting.
The FDA’s finding that debarment is
appropriate is based on the
misdemeanor convictions referenced
herein. The factual basis for the
conviction is as follows: On March 17,
2005, FDA sent Mr. Yanikian a warning
letter regarding his marketing and sale
of Novel natural formulation for atrial
fibrillation, Super Nasal Drops, and
Sams No Tinnitus Formulation. The
warning letter described the claims Mr.
Yanikian’s Web site was making
pertaining to these products and
informed him that his claims caused the
products to be ‘‘drugs’’ as defined by the
FD&C Act because they were intended
to cure, mitigate, treat, or prevent
disease. Mr. Yanikian was informed that
his products were ‘‘new drugs’’ and that
a new drug could not be introduced or
delivered for introduction into interstate
commerce unless an FDA-approved
application was in effect for it. The
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02JYN1
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39246
Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Notices
warning letter additionally noted that
none of the products described had an
approved application and that their
introduction or delivery for introduction
into interstate commerce violated
section 301(d) of the FD&C Act. Mr.
Yanikian was advised to immediately
correct the violations.
In response, on April 11, 2005, Mr.
Yanikian wrote a reply letter to FDA in
which he stated that the products were
mailed for sale outside the United States
to hospitals that deal with natural
health products. He further noted that
his products were not intended for sale
as over-the-counter or for single
individuals in the United States until
they were approved by FDA.
Despite knowing that he was not
allowed to sell these unapproved new
drugs in the United States without FDA
approval, and despite his repeated
representations to FDA that he was not
selling his products to customers in the
United States, Mr. Yanikian
subsequently sold his unapproved new
drug products to an undercover agent in
November 2005, and again in November
2006, in violation of sections 301(d),
505(a), and 303(a)(1) of the FD&C Act
and 18 U.S.C. 2(b).
As a result of his conviction, on April
3, 2012, FDA sent Mr. Yanikian a notice
by certified mail proposing to debar him
for 10 years from providing services in
any capacity to a person that has an
approved or pending drug product
application. FDA subsequently
confirmed that Mr. Yanikian personally
received the notice on April 11, 2012.
The proposal was based on a finding,
under section 306(b)(2)(B)(i)(I) of the
FD&C Act that Mr. Yanikian was
convicted of two counts of a
misdemeanor under Federal law. In the
notice, FDA found that the conduct
underlying these Federal misdemeanor
convictions relates to the development
or approval, including the process for
development or approval, of drug
products and relates to the regulation of
drug products under the FD&C Act and
undermines the process for the
regulation of drugs because the
introduction and causing the
introduction of unapproved new drugs
into interstate commerce are prohibited
by the FD&C Act. The proposal also
offered Mr. Yanikian 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. Mr. Yanikian
failed to respond within the timeframe
prescribed by regulation, and has
therefore waived his opportunity for a
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17:22 Jun 29, 2012
Jkt 226001
hearing and waived any contentions
concerning his debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(b)(2)(B)(i)(I)
of the FD&C Act under authority
delegated to him (Staff Manual Guide
1410.35), finds that Sami Arshak
Yanikian has been convicted of two
counts of a misdemeanor under Federal
law for conduct relating to the
development or approval, including the
process for development or approval, of
drug products and relating to the
regulation of drug products under the
FD&C Act, and that the type of conduct
that served as a basis for the conviction
undermines the process for the
regulation of drugs.
As a result of the foregoing finding,
Mr. Yanikian is debarred for 10 years
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 306(c)(1)(B),
(c)(2)(A)(iii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B),
(c)(2)(A)(iii), and 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 Mr. Yanikian, in any
capacity during Mr. Yanikian’s
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.
Yanikian 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). In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Mr. Yanikian during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Yanikian for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2012–
N–0063 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
PO 00000
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Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: June 15, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2012–16156 Filed 6–29–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
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Date: July 20, 2012.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
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Place: St. Gregory Hotel, 2033 M Street
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Contact Person: Mark P Rubert, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
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Date: July 20, 2012.
Time: 3 p.m. to 4 p.m.
Agenda: To review and evaluate grant
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Place: St. Gregory Hotel, 2033 M Street
NW., Washington, DC 20036.
Contact Person: Mark P Rubert, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@csr.nih.gov.
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Small Business.
Date: July 23, 2012.
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]]>Agencies
[Federal Register Volume 77, Number 127 (Monday, July 2, 2012)]
[Notices]
[Pages 39245-39246]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16156]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0063]
Sami Arshak Yanikian: 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) debarring
Sami Arshak Yanikian for 10 years 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. Yanikian was
convicted of two counts of introducing unapproved new drugs into
interstate commerce, which relates to the development or approval,
including the process for development or approval, of drug products and
to the regulation of drug products under the FD&C Act. In addition, the
type of conduct that served as the basis for Mr. Yanikian's convictions
undermine the process for the regulation of drugs. Mr. Yanikian was
given notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. Mr. Yanikian
failed to respond. Mr. Yanikian's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective July 2, 2012.
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, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the development or approval, including the
process for development or approval, of any drug product or otherwise
relating to the regulation of drug products under the FD&C Act, and if
FDA finds that the type of conduct that served as the basis for the
conviction undermines the process for the regulation of drugs.
On June 29, 2011, Mr. Yanikian was found guilty of two counts of
introduction of an unapproved drug in interstate commerce, in violation
of sections 301(d), 505(a), and 303(a)(1) of the FD&C Act (21 U.S.C.
331(d), 355(a), 333(a)(1)) and of aiding and abetting, in violation of
18 U.S.C. 2(b), and the U.S. District Court for the Central District of
California entered judgment against Mr. Yanikian for the misdemeanor
offenses of introduction of an unapproved drug in interstate commerce
and aiding and abetting.
The FDA's finding that debarment is appropriate is based on the
misdemeanor convictions referenced herein. The factual basis for the
conviction is as follows: On March 17, 2005, FDA sent Mr. Yanikian a
warning letter regarding his marketing and sale of Novel natural
formulation for atrial fibrillation, Super Nasal Drops, and Sams No
Tinnitus Formulation. The warning letter described the claims Mr.
Yanikian's Web site was making pertaining to these products and
informed him that his claims caused the products to be ``drugs'' as
defined by the FD&C Act because they were intended to cure, mitigate,
treat, or prevent disease. Mr. Yanikian was informed that his products
were ``new drugs'' and that a new drug could not be introduced or
delivered for introduction into interstate commerce unless an FDA-
approved application was in effect for it. The
[[Page 39246]]
warning letter additionally noted that none of the products described
had an approved application and that their introduction or delivery for
introduction into interstate commerce violated section 301(d) of the
FD&C Act. Mr. Yanikian was advised to immediately correct the
violations.
In response, on April 11, 2005, Mr. Yanikian wrote a reply letter
to FDA in which he stated that the products were mailed for sale
outside the United States to hospitals that deal with natural health
products. He further noted that his products were not intended for sale
as over-the-counter or for single individuals in the United States
until they were approved by FDA.
Despite knowing that he was not allowed to sell these unapproved
new drugs in the United States without FDA approval, and despite his
repeated representations to FDA that he was not selling his products to
customers in the United States, Mr. Yanikian subsequently sold his
unapproved new drug products to an undercover agent in November 2005,
and again in November 2006, in violation of sections 301(d), 505(a),
and 303(a)(1) of the FD&C Act and 18 U.S.C. 2(b).
As a result of his conviction, on April 3, 2012, FDA sent Mr.
Yanikian a notice by certified mail proposing to debar him for 10 years
from providing services in any capacity to a person that has an
approved or pending drug product application. FDA subsequently
confirmed that Mr. Yanikian personally received the notice on April 11,
2012. The proposal was based on a finding, under section
306(b)(2)(B)(i)(I) of the FD&C Act that Mr. Yanikian was convicted of
two counts of a misdemeanor under Federal law. In the notice, FDA found
that the conduct underlying these Federal misdemeanor convictions
relates to the development or approval, including the process for
development or approval, of drug products and relates to the regulation
of drug products under the FD&C Act and undermines the process for the
regulation of drugs because the introduction and causing the
introduction of unapproved new drugs into interstate commerce are
prohibited by the FD&C Act. The proposal also offered Mr. Yanikian 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. Mr. Yanikian failed to respond within the timeframe prescribed
by regulation, and has therefore waived his opportunity for a hearing
and waived any contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Sami Arshak Yanikian has been convicted of two counts of a
misdemeanor under Federal law for conduct relating to the development
or approval, including the process for development or approval, of drug
products and relating to the regulation of drug products under the FD&C
Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
As a result of the foregoing finding, Mr. Yanikian is debarred for
10 years 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 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 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 Mr. Yanikian, in any capacity during Mr.
Yanikian's 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. Yanikian
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). In addition, FDA will not accept or review any abbreviated new
drug applications submitted by or with the assistance of Mr. Yanikian
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Mr. Yanikian for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-0063 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.
Dated: June 15, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-16156 Filed 6-29-12; 8:45 am]
BILLING CODE 4160-01-P
