Lawrence B. Ryan: Final Debarment Order, 12482-12483 [2021-04375]
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12482
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
M. Ophthalmic
No new entries at this time.
N. Orthopedic
11–368 ................
11–369 ................
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total
Knee Tibial Components.
Standard Practice for Inspection of Spinal Implants Undergoing Testing ...............
ASTM F3334—19.
ASTM F3292—19.
O. Physical Medicine
No new entries at this time.
P. Radiology
12–331 ................
12–332 ................
12–333 ................
12–334 ................
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance
Imaging Systems.
Magnetic resonance equipment for medical imaging—Part 1: Determination of
essential image quality parameters.
Guidance on error and warning messages for software used in radiotherapy .......
Radiation therapy machine characterization ............................................................
NEMA Standards Publication MS 14–
2019.
IEC 62464–1 Edition 2.0 2018–12.
IEC TR 63183 Edition 1.0 2019–12.
AAMI RT3:2020.
Q. Software/Informatics
13–115 ................
Software and systems engineering—Software testing—Part 1: Concepts and definitions.
ISO/IEC/IEEE 29119–1
2013–09–01.
First
edition
R. Sterility
14–549 ................
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne
Ultrasound.
ASTM F3004—13e1.
S. Tissue Engineering
No new entries at this time.
1 All
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has
recognized by notice published in the
Federal Register or that FDA has
decided to recognize but for which
recognition is pending (because a
periodic notice has not yet appeared in
the Federal Register). FDA will
announce additional modifications and
revisions to the list of recognized
consensus standards, as needed, in the
Federal Register once a year, or more
often if necessary.
jbell on DSKJLSW7X2PROD with NOTICES
V. Recommendation of Standards for
Recognition by FDA
17:29 Mar 02, 2021
Jkt 253001
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04376 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1638]
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
VerDate Sep<11>2014
be considered, such recommendations
should contain, at a minimum, the
information listed on FDA’s website,
which is specifically available at https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process.
Lawrence B. Ryan: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00073
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Lawrence B.
Ryan 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. Ryan was convicted of
a felony under Federal law for conduct
that relates to the regulation of a drug
product under the FD&C Act. Mr. Ryan
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing to show
why he should not be debarred. As of
October 18, 2020 (30 days after receipt
of the notice), Mr. Ryan had not
responded. Mr. Ryan’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable March 3,
2021.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
SUMMARY:
E:\FR\FM\03MRN1.SGM
03MRN1
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, or at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, (ELEM–4029) Division
of Enforcement, 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(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual from
providing services in any capacity to a
person that has an approved or pending
drug product application 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 18, 2020, Mr. Ryan was convicted
as defined in section 306(l)(1) of the
FD&C Act when judgment was entered
against him in the U.S. District Court for
the Eastern District of Virginia, Norfolk
Division, after his plea of guilty to one
count of conspiracy to defraud the
United States in violation of 18 U.S.C.
371.
The factual basis for this conviction is
as follows: As contained in the
Statement of Facts in Mr. Ryan’s case,
filed on January 8, 2020, from October
2007, and continuing through
September 2010, Mr. Ryan, a physician,
authorized drug orders for RX Limited
(also known as RX Partners), an internet
pharmacy organization that facilitated
the unlawful distribution of prescription
drugs to consumers throughout the
United States. RX Limited had a
business model whereby it allowed
consumers to fill out a brief medical
questionnaire, select the type of drugs
the consumer desired, the desired drug
strength, and the desired drug quantity
and pay by credit card. RX Limited then
forwarded the order to a participating
physician for ‘‘approval.’’ The drugs
sold by RX Limited were dispensed
without a valid prescription because
there was no valid doctor-patient
relationship established between the
authorizing physicians and the
customers. Customers had no face-toface contact with the participating
physician and were not subject to any
mental or physical examinations.
The physicians authorizing the orders
for prescription drugs sold by RX
Limited did not take patient histories or
perform any diagnostic or laboratory
testing, did not check the accuracy of
the information customers provided
VerDate Sep<11>2014
17:29 Mar 02, 2021
Jkt 253001
(including their identities, ages, and
qualifying medical conditions), and did
not monitor, or provide any means to
monitor, medication response. After the
participating physician authorized the
prescription, RX Limited sent the order
to a fulfillment pharmacy, which
fulfilled the order and mailed the drugs
to the customer.
As a participating physician, Mr.
Ryan authorized more than 158,000
drug orders for well over 10 individual
RX Limited customers. Prescription
drugs distributed pursuant to these
orders included, FIORICET (and its
generic equivalents), Carisoprodol
(SOMA), Tramadol (ULTRAM),
VIAGRA, CIALIS, and XENICAL. RX
Limited paid Mr. Ryan $2.00 per drug
order he authorized. From October 2007
through September 2010, RX Limited
paid Mr. Ryan at least $316,153 for the
orders he authorized.
As a result of this conviction, FDA
sent Mr. Ryan by certified mail on
September 11, 2020, a notice 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 a finding, under section
306(a)(2)(B) of the FD&C Act, that Mr.
Ryan was convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. The proposal also offered Mr.
Ryan 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
an election not to use the opportunity
for a hearing and a waiver of any
contentions concerning this action. Mr.
Ryan received the proposal on
September 18, 2020. Mr. Ryan did not
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived his opportunity for a
hearing and 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Ryan, has
been convicted of a felony under
Federal law for conduct otherwise
relating to the regulation of a drug
product under the FD&C Act.
As a result of the foregoing finding,
Mr. Ryan, is permanently debarred from
providing services in any capacity to a
person with an approved or pending
drug product application, effective (see
DATES) (see sections 306(a)(2)(B) and
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
12483
(c)(2)(A)(ii) of the FD&C Act). 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. Ryan, 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. Ryan 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 application from Mr. Ryan during
his period of debarment, other than in
connection with an audit under section
306 of the FD&C Act (section
306(c)(1)(B)). Note that, for purposes of
section 306 of the FD&C Act, a ‘‘drug
product’’ is defined as a drug subject to
regulation under section 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) (see section 201(dd) of the FD&C
Act (21 U.S.C. 321(dd))).
Any application by Mr. Ryan for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2020–N–1638 and sent to the
Dockets Management Staff (see
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: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04375 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0008]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
SUMMARY:
E:\FR\FM\03MRN1.SGM
03MRN1
Agencies
[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12482-12483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04375]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1638]
Lawrence B. Ryan: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Lawrence B. Ryan 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. Ryan was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Ryan was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of October
18, 2020 (30 days after receipt of the notice), Mr. Ryan had not
responded. Mr. Ryan's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is applicable March 3, 2021.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers
[[Page 12483]]
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, (ELEM-4029) Division
of Enforcement, 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(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application 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 18, 2020, Mr. Ryan was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the Eastern
District of Virginia, Norfolk Division, after his plea of guilty to one
count of conspiracy to defraud the United States in violation of 18
U.S.C. 371.
The factual basis for this conviction is as follows: As contained
in the Statement of Facts in Mr. Ryan's case, filed on January 8, 2020,
from October 2007, and continuing through September 2010, Mr. Ryan, a
physician, authorized drug orders for RX Limited (also known as RX
Partners), an internet pharmacy organization that facilitated the
unlawful distribution of prescription drugs to consumers throughout the
United States. RX Limited had a business model whereby it allowed
consumers to fill out a brief medical questionnaire, select the type of
drugs the consumer desired, the desired drug strength, and the desired
drug quantity and pay by credit card. RX Limited then forwarded the
order to a participating physician for ``approval.'' The drugs sold by
RX Limited were dispensed without a valid prescription because there
was no valid doctor-patient relationship established between the
authorizing physicians and the customers. Customers had no face-to-face
contact with the participating physician and were not subject to any
mental or physical examinations.
The physicians authorizing the orders for prescription drugs sold
by RX Limited did not take patient histories or perform any diagnostic
or laboratory testing, did not check the accuracy of the information
customers provided (including their identities, ages, and qualifying
medical conditions), and did not monitor, or provide any means to
monitor, medication response. After the participating physician
authorized the prescription, RX Limited sent the order to a fulfillment
pharmacy, which fulfilled the order and mailed the drugs to the
customer.
As a participating physician, Mr. Ryan authorized more than 158,000
drug orders for well over 10 individual RX Limited customers.
Prescription drugs distributed pursuant to these orders included,
FIORICET (and its generic equivalents), Carisoprodol (SOMA), Tramadol
(ULTRAM), VIAGRA, CIALIS, and XENICAL. RX Limited paid Mr. Ryan $2.00
per drug order he authorized. From October 2007 through September 2010,
RX Limited paid Mr. Ryan at least $316,153 for the orders he
authorized.
As a result of this conviction, FDA sent Mr. Ryan by certified mail
on September 11, 2020, a notice 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 a finding,
under section 306(a)(2)(B) of the FD&C Act, that Mr. Ryan was convicted
of a felony under Federal law for conduct relating to the regulation of
a drug product under the FD&C Act. The proposal also offered Mr. Ryan
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 an election not to
use the opportunity for a hearing and a waiver of any contentions
concerning this action. Mr. Ryan received the proposal on September 18,
2020. Mr. Ryan did not request a hearing within the timeframe
prescribed by regulation and has, therefore, waived his opportunity for
a hearing and 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr. Ryan,
has been convicted of a felony under Federal law for conduct otherwise
relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Mr. Ryan, is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). 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. Ryan, 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. Ryan 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 application from Mr.
Ryan during his period of debarment, other than in connection with an
audit under section 306 of the FD&C Act (section 306(c)(1)(B)). Note
that, for purposes of section 306 of the FD&C Act, a ``drug product''
is defined as a drug subject to regulation under section 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) (see section 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))).
Any application by Mr. Ryan for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2020-N-1638 and sent to the Dockets Management Staff
(see 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: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04375 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P