Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain, 11043-11044 [2017-03176]
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–03234 Filed 2–16–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Food and Drug Administration/Xavier
University PharmaLink Conference—
Leadership in a Global Supply Chain
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Cincinnati
District, in co-sponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University PharmaLink Conference:
Leadership in a Global Supply Chain.’’
The PharmaLink conference seeks
solutions to important and complicated
issues by aligning with the strategic
priorities of FDA, and includes
presentations from key FDA officials
and industry experts.
DATES: The public conference will be
held on March 15, 2017, from 8:30 a.m.
to 5 p.m.; March 16, 2017, from 8:30
a.m. to 5 p.m.; and March 17, 2017, from
8:30 a.m. to 12:20 p.m. The conference
is preceded by a Welcome Reception on
March 14, 2017, from 5 p.m. to 7 p.m.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207, 513–745–3073 or
513–745–3483.
FOR FURTHER INFORMATION CONTACT:
For information regarding this notice:
Nicholas Paulin, Food and Drug
Administration, Cincinnati South
Office, 36 East 7th St., Cincinnati, OH
45202, 513–246–4134, email:
nicholas.paulin@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH 45207–
5471, 513–745–3073, email:
phillipsm4@xavier.edu.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
I. Background
The public conference helps fulfill the
Department of Health and Human
VerDate Sep<11>2014
17:38 Feb 16, 2017
Jkt 241001
Services’ and FDA’s important mission
to protect the public health. The most
pressing challenges of the global
pharmaceutical industry require
solutions which are inspired by
collaboration to ensure the on-going
health and safety of patients. These
challenges include designing products
with the patient in mind, building
quality into the product from the
starting point, selecting the right
suppliers, and considering total product
lifecycle systems. Meeting these
challenges requires vigilance,
innovation, supply chain strategy,
relationship management, proactive
change management, and a commitment
to doing the job right the first time. FDA
has made education of the drug and
device manufacturing community a high
priority to help ensure the quality of
FDA-regulated drugs and devices.
The conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121)
by providing outreach activities by
Government Agencies to small
businesses.
The conference includes the
following:
• Welcome Reception at the Hilton
Netherland Plaza.
• Lunch Networking by Topic.
• The Solution ‘‘Xchange’’.
• Case Studies and Small Group
Discussions.
• Action Plans.
II. Topics for Discussion at the Public
Conference
The public conference will engage
those involved in FDA-regulated global
supply chain quality and management
through the following topics:
• FDA Metrics Program—Path
Forward to Reduce Risks Within FDA
and Across Industry.
• Predictive Capabilities Through a
Living Metrics Model.
• How Big Data and Artificial
Intelligence Can Enhance Your
Proactive Risk Monitoring Programs.
• Connecting Culture to Performance.
• Data Integrity—Detection and
Successful Practices.
• Building a Bridge Across
Generations.
• Good Supply Practices (GSPs)—
Paradigm Shifting Solutions.
• How to Develop and Execute a
Robust Risk-Based Due Diligence Plan.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
11043
• Maximizing Post-Merger Success.
• Your Company Bought a New
Business—Now What?
• Supply Chains in China—Strategies
for Regulatory Success.
• Top 3 Challenges for Successful
Serialization Implementation Across
Your Supply Chain.
• Strategic Direction of the Food &
Drug Administration, Center for Drug
Evaluation and Research (CDER), Office
of Manufacturing Quality.
• Office of Regulatory Affairs Key
Initiatives.
• FDA Investigator Case Study
Insights.
III. Registration for the Public
Conference
Registration: To register online for the
public conference, please visit the
‘‘Registration’’ link on the conference
Web site at https://
www.XavierPharmaLink.com. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone. FDA has verified the Web
site address in this document, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, email, and
payment information for the fee to
Xavier University, Attention: Marla
Phillips, 3800 Victory Pkwy.,
Cincinnati, OH 45207–5471. An email
will be sent confirming your
registration.
If you need special accommodations
due to a disability, please contact Marla
Phillips (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the conference.
There is a registration fee. The
conference registration fees cover the
cost of the presentations, training
materials, receptions, breakfasts,
lunches, and dinners for the 2.5 days of
the conference, including the Welcome
Reception that precedes the conference.
There will be onsite registration if space
is available. The cost of registration is as
follows:
TABLE 1—REGISTRATION FEES 1
Attendee type
Industry .....................................
Small Business (<100 employees) .......................................
Start-up Manufacturer ...............
Academic ..................................
Media ........................................
E:\FR\FM\17FEN1.SGM
17FEN1
Standard
rate
$1,895
1,295
300
300
Free
11044
Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
TABLE 1—REGISTRATION FEES 1—
Continued
Standard
rate
Attendee type
Government ..............................
Free
1 The
fourth registration from the same company is free. Payment for the three paying
registrants must be made prior to registering
the fourth person free.
The following forms of payment will be
accepted: American Express, Visa,
Mastercard, and company checks.
Attendees are responsible for their
own accommodations. The conference
headquarter hotel is the Downtown
Cincinnati Hilton Netherlands Plaza, 35
West 5th St., Cincinnati, OH 45202,
513–421–9100. To make reservations
online, please visit the ‘‘Venue &
Logistics’’ link at https://www.Xavier
PharmaLink.com. The hotel is expected
to sell out during this timeframe, so
early reservation in the conference
room-block is encouraged.
Dated: February 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03176 Filed 2–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2191]
Raymond Sean Brown: 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 Dr.
Raymond Sean Brown 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 Dr. Brown was
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act. Dr.
Brown was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Dr. Brown failed to request a hearing.
Dr. Brown’s failure to request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective February
17, 2017.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:38 Feb 16, 2017
Jkt 241001
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:
ADDRESSES:
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
April 2, 2015, the U.S. District Court for
the Eastern District of Tennessee
entered judgment against Dr. Brown for
one count of receiving and distributing
misbranded drugs in interstate
commerce with intent to defraud and
mislead in violation of section 301(a) of
the FD&C Act (21 U.S.C. 331(c)), which
according to section 303(a)(2) of the
FD&C Act (21 U.S.C. 333(a)(2))
constitutes a felony.
FDA’s finding that the debarment is
appropriate based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows: Dr. Brown was a licensed
medical doctor in the state of Tennessee
with a practice address listed in
Cleveland, TN. The Tennessee
Department of Health also lists Bradley
PM&R as a licensed health care facility.
Dr. Brown was the medical director of
Bradley PM&R, and Dr. Brown’s medical
practice was listed at the same address.
As a part of the treatment of patients for
pain management, Bradley PM&R
purchased assorted prescription drugs,
including Botulinum Toxin Type A,
also known as Botox
Onabotulinumtoxin A (hereinafter
referred to as ‘‘Botox’’), which was
prescribed by Dr. Brown and was
administered and dispensed through
Bradley PM&R. Prior to 2009, Botox®/
Botox® Cosmetic, a product
manufactured by Allergan, Inc., was the
only Botulinum Toxin Type A product
licensed by FDA for use in humans for
any indication, including pain
management.
Axon Medical Supplies was a
business operating in Surry, BC,
Canada. Axon offered for sale to
physicians and other health care
providers in the United States drugs that
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
had been obtained from foreign sources
and that had not been approved by FDA
for distribution or use in the United
States.
From May 2008 until December 2012,
Dr. Brown received $7,482,968 in
reimbursement from Medicare for Botox
injections alone, with none of these
payments resulting from properly
payable claims for FDA approved Botox
injections.
Beginning in or about January 2007
and continuing through in or about
December 2012, Dr. Brown ordered 254
vials (25,400 units) of Botox from Axon
Medical Supplies that were misbranded
within the meaning of the FD&C Act in
that the drug’s labeling failed to bear
adequate directions for use and all
words, statements, or other information
required by or under authority of the
FD&C Act to appear on the label and
labeling were not present, in fact many
of the words were not in the English
language. These misbranded drugs were
sent to Bradley PM&R clinic and Dr.
Brown injected these drugs into his
patients, while purporting them to be
FDA-approved drugs.
Dr. Brown billed Medicare for all of
these Botox units as if they were FDAapproved drugs. Dr. Brown also
provided diluted Botox injections and
billed as if they were full doses. Dr.
Brown billed Medicare for an additional
15,865 vials that he did not inject into
patients. Dr. Brown admitted that he
received the Botox in interstate
commerce for delivery that was
misbranded and he acted with intent to
defraud and/or mislead. Dr. Brown’s
conduct constituted a violation of
section 303(c) of the FD&C Act, which
according to section 303(a)(2)
constitutes a felony.
As a result of this conviction, FDA
sent Dr. Brown by certified mail on
October 28, 2016, 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 Dr.
Brown was convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. FDA determined that Dr.
Brown’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—Dr.
Brown knowingly received and
distributed misbranded drugs in
interstate commerce with intent to
defraud and mislead. The proposal also
offered Dr. Brown an opportunity to
E:\FR\FM\17FEN1.SGM
17FEN1
Agencies
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11043-11044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03176]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Food and Drug Administration/Xavier University PharmaLink
Conference--Leadership in a Global Supply Chain
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
co-sponsorship with Xavier University, is announcing a public
conference entitled ``FDA/Xavier University PharmaLink Conference:
Leadership in a Global Supply Chain.'' The PharmaLink conference seeks
solutions to important and complicated issues by aligning with the
strategic priorities of FDA, and includes presentations from key FDA
officials and industry experts.
DATES: The public conference will be held on March 15, 2017, from 8:30
a.m. to 5 p.m.; March 16, 2017, from 8:30 a.m. to 5 p.m.; and March 17,
2017, from 8:30 a.m. to 12:20 p.m. The conference is preceded by a
Welcome Reception on March 14, 2017, from 5 p.m. to 7 p.m. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public conference will be held on the campus of Xavier
University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or
513-745-3483.
FOR FURTHER INFORMATION CONTACT:
For information regarding this notice: Nicholas Paulin, Food and
Drug Administration, Cincinnati South Office, 36 East 7th St.,
Cincinnati, OH 45202, 513-246-4134, email: nicholas.paulin@fda.hhs.gov.
For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-
5471, 513-745-3073, email: phillipsm4@xavier.edu.
SUPPLEMENTARY INFORMATION:
I. Background
The public conference helps fulfill the Department of Health and
Human Services' and FDA's important mission to protect the public
health. The most pressing challenges of the global pharmaceutical
industry require solutions which are inspired by collaboration to
ensure the on-going health and safety of patients. These challenges
include designing products with the patient in mind, building quality
into the product from the starting point, selecting the right
suppliers, and considering total product lifecycle systems. Meeting
these challenges requires vigilance, innovation, supply chain strategy,
relationship management, proactive change management, and a commitment
to doing the job right the first time. FDA has made education of the
drug and device manufacturing community a high priority to help ensure
the quality of FDA-regulated drugs and devices.
The conference helps to achieve objectives set forth in section 406
of the Food and Drug Administration Modernization Act of 1997 (21
U.S.C. 393), which includes working closely with stakeholders and
maximizing the availability and clarity of information to stakeholders
and the public. The conference also is consistent with the Small
Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121)
by providing outreach activities by Government Agencies to small
businesses.
The conference includes the following:
Welcome Reception at the Hilton Netherland Plaza.
Lunch Networking by Topic.
The Solution ``Xchange''.
Case Studies and Small Group Discussions.
Action Plans.
II. Topics for Discussion at the Public Conference
The public conference will engage those involved in FDA-regulated
global supply chain quality and management through the following
topics:
FDA Metrics Program--Path Forward to Reduce Risks Within
FDA and Across Industry.
Predictive Capabilities Through a Living Metrics Model.
How Big Data and Artificial Intelligence Can Enhance Your
Proactive Risk Monitoring Programs.
Connecting Culture to Performance.
Data Integrity--Detection and Successful Practices.
Building a Bridge Across Generations.
Good Supply Practices (GSPs)--Paradigm Shifting Solutions.
How to Develop and Execute a Robust Risk-Based Due
Diligence Plan.
Maximizing Post-Merger Success.
Your Company Bought a New Business--Now What?
Supply Chains in China--Strategies for Regulatory Success.
Top 3 Challenges for Successful Serialization
Implementation Across Your Supply Chain.
Strategic Direction of the Food & Drug Administration,
Center for Drug Evaluation and Research (CDER), Office of Manufacturing
Quality.
Office of Regulatory Affairs Key Initiatives.
FDA Investigator Case Study Insights.
III. Registration for the Public Conference
Registration: To register online for the public conference, please
visit the ``Registration'' link on the conference Web site at https://www.XavierPharmaLink.com. Please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone. FDA has verified the Web site address in this document,
as of the date this document publishes in the Federal Register, but Web
sites are subject to change over time.
To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Marla Phillips, 3800 Victory
Pkwy., Cincinnati, OH 45207-5471. An email will be sent confirming your
registration.
If you need special accommodations due to a disability, please
contact Marla Phillips (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the conference.
There is a registration fee. The conference registration fees cover
the cost of the presentations, training materials, receptions,
breakfasts, lunches, and dinners for the 2.5 days of the conference,
including the Welcome Reception that precedes the conference. There
will be onsite registration if space is available. The cost of
registration is as follows:
Table 1--Registration Fees \1\
------------------------------------------------------------------------
Standard
Attendee type rate
------------------------------------------------------------------------
Industry................................................... $1,895
Small Business (<100 employees)............................ 1,295
Start-up Manufacturer...................................... 300
Academic................................................... 300
Media...................................................... Free
[[Page 11044]]
Government................................................. Free
------------------------------------------------------------------------
\1\ The fourth registration from the same company is free. Payment for
the three paying registrants must be made prior to registering the
fourth person free.
The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.
Attendees are responsible for their own accommodations. The
conference headquarter hotel is the Downtown Cincinnati Hilton
Netherlands Plaza, 35 West 5th St., Cincinnati, OH 45202, 513-421-9100.
To make reservations online, please visit the ``Venue & Logistics''
link at https://www.XavierPharmaLink.com. The hotel is expected to sell
out during this timeframe, so early reservation in the conference room-
block is encouraged.
Dated: February 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03176 Filed 2-16-17; 8:45 am]
BILLING CODE 4164-01-P