Roy Tuccillo, Jr.: Final Debarment Order, 58108-58109 [2022-20709]
Download as PDF
<![CDATA[
58108
Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
other key stakeholders in the medical
device ecosystem to identify the barriers
that prevent product developers from
entering the pediatric device market as
well as the proper incentives that would
motivate them to innovate and sustain
within this market.
This survey is a followup to the
public meeting that FDA held in August
2018, entitled, ‘‘Pediatric Medical
Device Development.’’ As mandated by
section 502(d) of the FDA
Reauthorization Act of 2017 (Pub. L.
115–52) the meeting was convened to
address several topics, including
consideration of ways to: (1) increase
FDA assistance to medical device
manufacturers in developing devices for
pediatric populations that are approved
or cleared, and labeled, for their use and
(2) identify current barriers to pediatric
device development and incentives to
address such barriers.
Feedback from this meeting clarified
the need to better understand factors
influencing suboptimal engagement and
participation by diverse innovators in
the pediatric medical device space.
Information garnered from this survey
may help inform strategic plans to
optimize existing programs for the
needs of pediatric medical device
innovators and develop new programs
that will support sustained development
in this space.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours 2
Phone Survey ...................................
Online Survey ...................................
17
56
1
1
17
56
0.5 (30 minutes) ...............................
1 .......................................................
9
56
Total ...........................................
........................
........................
........................
...........................................................
65
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest hour.
lotter on DSK11XQN23PROD with NOTICES1
2 Rounded
The targeted groups for this collection
of information include representatives
from the medical device industry,
academia, recipients of funding under
section 305 of the Pediatric Medical
Device Safety and Improvement Act of
2007 (Pub. L. 110–85; 42 U.S.C. 282
note), and trade organizations, medical
provider organizations, organizations
and individuals involved with financing
and reimbursement associated with
medical devices, pediatric healthcare
leaders, clinicians who regularly use
medical devices in caring for children,
and organizations and individuals
representing patients and consumers.
Phone survey: Respondents
participating in the phone survey will
be executives from companies either
producing products in pediatrics or
from companies that produce products
that could be used in pediatrics.
Executives will be invited to engage in
the 30-minute phone survey.
Online survey: The 1-hour online
survey will be administered to leaders
within pediatric companies and key
decision makers in the pediatric
medical device industry (e.g., venture
capitalists, banking investors, leaders in
children’s hospitals and research
networks, and pediatric patient
advocates).
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20626 Filed 9–22–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:48 Sep 22, 2022
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0317]
Roy Tuccillo, Jr.: Final 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
Roy Tuccillo, Jr. for a period of 5 years
from importing articles of food or
offering such articles for importation
into the United States. FDA bases this
order on a finding that Mr. Tuccillo was
convicted of a felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food. Mr. Tuccillo was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of July 15, 2022 (30 days
after receipt of the notice), Mr. Tuccillo
has not responded. His failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable
September 23, 2022.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food.
On November 9, 2021, Mr. Tuccillo
was convicted as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S.
District Court for the Eastern District of
New York, when the court accepted his
plea of guilty and entered judgment
against him for the offense of conspiracy
to commit wire fraud in violation of 18
U.S.C. 371 and 1343.
FDA’s finding that the debarment is
appropriate is based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows: As stated in the indictment,
filed September 26, 2018, transcript of
guilty pleas, filed December 26, 2019,
and Magistrate Judge Steven Locke’s
report and recommendation, filed May
E:\FR\FM\23SEN1.SGM
23SEN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
10, 2020, all from Mr. Tuccillo’s case,
Mr. Tuccillo was the manager of Anchor
Foods, Inc. and Advanced Frozen
Foods, Inc. (collectively, ‘‘Anchor
Foods’’), responsible for the purchase,
sale, shipment, and storage of food
products, including octopus and squid,
by both businesses. Both Anchor Foods
companies were located in Westbury,
New York.
From on or about February 2011 and
continuing through January 2014, Mr.
Tuccillo knowingly and willfully
conspired with Anchor Foods, Roy
Tuccillo, Sr., and others to import giant
squid from Peru to Mr. Tuccillo’s
companies’ location in Westbury, New
York, and repackage and sell that squid
falsely labeled and identified as
‘‘octopus.’’ Mr. Tuccillo sold the falsely
labeled squid in interstate commerce to
grocery stores in New Jersey, Texas, and
Massachusetts. Mr. Tuccillo used email
and fax to sell and receive payments for
the squid falsely labeled as octopus. In
total, Anchor Foods made $1,128,388.50
worth of fraudulent sales of squid.
As a result of this conviction, FDA
sent Mr. Tuccillo, by certified mail on
June 6, 2022, a notice proposing to
debar him for a period of 5 years from
importing articles of food or offering
such articles for import into the United
States. The proposal was based on a
finding under section 306(b)(1)(C) of the
FD&C Act that Mr. Tuccillo’s felony
conviction of Conspiracy to Commit
Wire Fraud in violation of 18 U.S.C. 371
and 1343, constitutes conduct relating
to the importation into the United States
of an article of food because Mr.
Tuccillo knowingly and willfully
conspired with Anchor Foods, Roy
Tuccillo, Sr., and others to import giant
squid from Peru to his companies’
location in Westbury, New York, and
repackage and sell that squid falsely
labeled and identified as ‘‘octopus’’ in
interstate commerce, using email and
fax to sell and receive payments for the
falsely labeled squid. The proposal was
also based on a determination, after
consideration of the relevant factors set
forth in section 306(c)(3) of the FD&C
Act, that Mr. Tuccillo should be subject
to a 5-year period of debarment. The
proposal also offered Mr. Tuccillo 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.
Tuccillo failed to respond within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
VerDate Sep<11>2014
17:04 Sep 22, 2022
Jkt 256001
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Tuccillo
has been convicted of a felony count
under Federal law for conduct relating
to the importation into the United States
of an article of food and that he is
subject to a 5-year period of debarment.
As a result of the foregoing finding,
Mr. Tuccillo is debarred for a period of
5 years from importing articles of food
or offering such articles for import into
the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C
Act (21 U.S.C. 331(cc)), the importing or
offering for import into the United
States of an article of food by, with the
assistance of, or at the direction of Roy
Tuccillo, Jr., is a prohibited act.
Any application by Mr. Tuccillo for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2022–
N–0317 and sent to the Dockets
Management Staff (ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20.
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20709 Filed 9–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0316]
Roy Tuccillo, Sr.: Final 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 (FD&C Act) debarring Roy
Tuccillo, Sr. for a period of 5 years from
importing articles of food or offering
such articles for importation into the
United States. FDA bases this order on
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
58109
a finding that Mr. Tuccillo was
convicted of a felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food. Mr. Tuccillo was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of July 17, 2022 (30 days
after receipt of the notice), Mr. Tuccillo
has not responded. Mr. Tuccillo’s
failure to respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable
September 23, 2022.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food.
On November 9, 2021, Mr. Tuccillo
was convicted as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S.
District Court for the Eastern District of
New York, when the court accepted his
plea of guilty and entered judgment
against him for the offense of conspiracy
to commit wire fraud in violation of 18
U.S.C. 371 and 1343.
FDA’s finding that the debarment is
appropriate is based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows: as stated in the indictment,
filed September 26, 2018, transcript of
guilty pleas, filed December 26, 2019,
and Magistrate Judge Steven Locke’s
report and recommendation, filed May
10, 2020, all from Mr. Tuccillo’s case,
Mr. Tuccillo was the owner, president,
and chief operating officer of Anchor
Foods, Inc. and Advanced Frozen
Foods, Inc. (collectively, ‘‘Anchor
Foods’’), and had overall responsibility
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58108-58109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20709]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0317]
Roy Tuccillo, Jr.: Final 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
Roy Tuccillo, Jr. for a period of 5 years from importing articles of
food or offering such articles for importation into the United States.
FDA bases this order on a finding that Mr. Tuccillo was convicted of a
felony count under Federal law for conduct relating to the importation
into the United States of an article of food. Mr. Tuccillo was given
notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of July 15,
2022 (30 days after receipt of the notice), Mr. Tuccillo has not
responded. His failure to respond and request a hearing constitutes a
waiver of his right to a hearing concerning this matter.
DATES: This order is applicable September 23, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a felony for conduct relating to the
importation into the United States of any food.
On November 9, 2021, Mr. Tuccillo was convicted as defined in
section 306(l)(1)(A) of the FD&C Act, in the U.S. District Court for
the Eastern District of New York, when the court accepted his plea of
guilty and entered judgment against him for the offense of conspiracy
to commit wire fraud in violation of 18 U.S.C. 371 and 1343.
FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: As stated in the indictment, filed September
26, 2018, transcript of guilty pleas, filed December 26, 2019, and
Magistrate Judge Steven Locke's report and recommendation, filed May
[[Page 58109]]
10, 2020, all from Mr. Tuccillo's case, Mr. Tuccillo was the manager of
Anchor Foods, Inc. and Advanced Frozen Foods, Inc. (collectively,
``Anchor Foods''), responsible for the purchase, sale, shipment, and
storage of food products, including octopus and squid, by both
businesses. Both Anchor Foods companies were located in Westbury, New
York.
From on or about February 2011 and continuing through January 2014,
Mr. Tuccillo knowingly and willfully conspired with Anchor Foods, Roy
Tuccillo, Sr., and others to import giant squid from Peru to Mr.
Tuccillo's companies' location in Westbury, New York, and repackage and
sell that squid falsely labeled and identified as ``octopus.'' Mr.
Tuccillo sold the falsely labeled squid in interstate commerce to
grocery stores in New Jersey, Texas, and Massachusetts. Mr. Tuccillo
used email and fax to sell and receive payments for the squid falsely
labeled as octopus. In total, Anchor Foods made $1,128,388.50 worth of
fraudulent sales of squid.
As a result of this conviction, FDA sent Mr. Tuccillo, by certified
mail on June 6, 2022, a notice proposing to debar him for a period of 5
years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Tuccillo's felony
conviction of Conspiracy to Commit Wire Fraud in violation of 18 U.S.C.
371 and 1343, constitutes conduct relating to the importation into the
United States of an article of food because Mr. Tuccillo knowingly and
willfully conspired with Anchor Foods, Roy Tuccillo, Sr., and others to
import giant squid from Peru to his companies' location in Westbury,
New York, and repackage and sell that squid falsely labeled and
identified as ``octopus'' in interstate commerce, using email and fax
to sell and receive payments for the falsely labeled squid. The
proposal was also based on a determination, after consideration of the
relevant factors set forth in section 306(c)(3) of the FD&C Act, that
Mr. Tuccillo should be subject to a 5-year period of debarment. The
proposal also offered Mr. Tuccillo 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. Tuccillo 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 Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Tuccillo has been convicted of a felony count under Federal law for
conduct relating to the importation into the United States of an
article of food and that he is subject to a 5-year period of debarment.
As a result of the foregoing finding, Mr. Tuccillo is debarred for
a period of 5 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Roy
Tuccillo, Jr., is a prohibited act.
Any application by Mr. Tuccillo for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2022-N-0317 and sent to the Dockets Management Staff (ADDRESSES).
The public availability of information in these submissions is governed
by 21 CFR 10.20.
Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20709 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P
