82 FR 11043 - Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 32 (February 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 32 (February 17, 2017)
| Page Range | 11043-11044 | |
| FR Document | 2017-03176 |
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)] [Notices] [Pages 11043-11044] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207- 5471, 513-745-3073, email: [email protected]. 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 http://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 http://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
![Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices 11043
Dated: February 14, 2017. Services’ and FDA’s important mission • Maximizing Post-Merger Success.
William N. Parham, III, to protect the public health. The most • Your Company Bought a New
Director, Paperwork Reduction Staff, Office pressing challenges of the global Business—Now What?
of Strategic Operations and Regulatory pharmaceutical industry require • Supply Chains in China—Strategies
Affairs. solutions which are inspired by for Regulatory Success.
[FR Doc. 2017–03234 Filed 2–16–17; 8:45 am] collaboration to ensure the on-going • Top 3 Challenges for Successful
BILLING CODE 4120–01–P health and safety of patients. These Serialization Implementation Across
challenges include designing products Your Supply Chain.
with the patient in mind, building
DEPARTMENT OF HEALTH AND quality into the product from the • Strategic Direction of the Food &
HUMAN SERVICES starting point, selecting the right Drug Administration, Center for Drug
suppliers, and considering total product Evaluation and Research (CDER), Office
Food and Drug Administration lifecycle systems. Meeting these of Manufacturing Quality.
[Docket No. FDA–2017–N–0001] challenges requires vigilance, • Office of Regulatory Affairs Key
innovation, supply chain strategy, Initiatives.
Food and Drug Administration/Xavier relationship management, proactive • FDA Investigator Case Study
University PharmaLink Conference— change management, and a commitment Insights.
Leadership in a Global Supply Chain to doing the job right the first time. FDA III. Registration for the Public
AGENCY: Food and Drug Administration, has made education of the drug and Conference
HHS. device manufacturing community a high
priority to help ensure the quality of Registration: To register online for the
ACTION: Notice of public conference. public conference, please visit the
FDA-regulated drugs and devices.
SUMMARY: The Food and Drug The conference helps to achieve ‘‘Registration’’ link on the conference
Administration (FDA) Cincinnati objectives set forth in section 406 of the Web site at http://
District, in co-sponsorship with Xavier Food and Drug Administration www.XavierPharmaLink.com. Please
University, is announcing a public Modernization Act of 1997 (21 U.S.C. provide complete contact information
conference entitled ‘‘FDA/Xavier 393), which includes working closely for each attendee, including name, title,
University PharmaLink Conference: with stakeholders and maximizing the affiliation, address, email, and
Leadership in a Global Supply Chain.’’ availability and clarity of information to telephone. FDA has verified the Web
The PharmaLink conference seeks stakeholders and the public. The site address in this document, as of the
solutions to important and complicated conference also is consistent with the date this document publishes in the
issues by aligning with the strategic Small Business Regulatory Enforcement Federal Register, but Web sites are
priorities of FDA, and includes Fairness Act of 1996 (Pub. L. 104–121) subject to change over time.
presentations from key FDA officials by providing outreach activities by To register by mail, please send your
and industry experts. Government Agencies to small name, title, firm name, address,
DATES: The public conference will be businesses. telephone and fax numbers, email, and
held on March 15, 2017, from 8:30 a.m. The conference includes the payment information for the fee to
to 5 p.m.; March 16, 2017, from 8:30 following: Xavier University, Attention: Marla
a.m. to 5 p.m.; and March 17, 2017, from • Welcome Reception at the Hilton Phillips, 3800 Victory Pkwy.,
8:30 a.m. to 12:20 p.m. The conference Netherland Plaza. Cincinnati, OH 45207–5471. An email
is preceded by a Welcome Reception on • Lunch Networking by Topic. will be sent confirming your
March 14, 2017, from 5 p.m. to 7 p.m. • The Solution ‘‘Xchange’’. registration.
See the SUPPLEMENTARY INFORMATION • Case Studies and Small Group If you need special accommodations
section for registration date and Discussions. due to a disability, please contact Marla
information. • Action Plans.
Phillips (see FOR FURTHER INFORMATION
ADDRESSES: The public conference will II. Topics for Discussion at the Public CONTACT) at least 7 days in advance of
be held on the campus of Xavier Conference the conference.
University, 3800 Victory Pkwy., The public conference will engage There is a registration fee. The
Cincinnati, OH 45207, 513–745–3073 or those involved in FDA-regulated global conference registration fees cover the
513–745–3483. supply chain quality and management cost of the presentations, training
FOR FURTHER INFORMATION CONTACT: through the following topics: materials, receptions, breakfasts,
For information regarding this notice: • FDA Metrics Program—Path lunches, and dinners for the 2.5 days of
Nicholas Paulin, Food and Drug Forward to Reduce Risks Within FDA the conference, including the Welcome
Administration, Cincinnati South and Across Industry. Reception that precedes the conference.
Office, 36 East 7th St., Cincinnati, OH • Predictive Capabilities Through a There will be onsite registration if space
45202, 513–246–4134, email: Living Metrics Model. is available. The cost of registration is as
nicholas.paulin@fda.hhs.gov. • How Big Data and Artificial follows:
For information regarding the Intelligence Can Enhance Your
conference and registration: Marla Proactive Risk Monitoring Programs. TABLE 1—REGISTRATION FEES 1
Phillips, Xavier University, 3800 • Connecting Culture to Performance.
Victory Pkwy., Cincinnati, OH 45207– • Data Integrity—Detection and Standard
mstockstill on DSK3G9T082PROD with NOTICES
Attendee type
5471, 513–745–3073, email: Successful Practices. rate
phillipsm4@xavier.edu. • Building a Bridge Across Industry ..................................... $1,895
SUPPLEMENTARY INFORMATION: Generations. Small Business (<100 employ-
• Good Supply Practices (GSPs)— ees) ....................................... 1,295
I. Background Paradigm Shifting Solutions. Start-up Manufacturer ............... 300
The public conference helps fulfill the • How to Develop and Execute a Academic .................................. 300
Department of Health and Human Robust Risk-Based Due Diligence Plan. Media ........................................ Free
VerDate Sep<11>2014 17:38 Feb 16, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1](https://thefederalregister.org/doc/82_FR_11075/page/1.svg)
![11044 Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
TABLE 1—REGISTRATION FEES 1— ADDRESSES: Submit applications for had been obtained from foreign sources
Continued special termination of debarment to the and that had not been approved by FDA
Division of Dockets Management (HFA– for distribution or use in the United
Standard 305), Food and Drug Administration, States.
Attendee type rate 5630 Fishers Lane, Rm. 1061, Rockville, From May 2008 until December 2012,
MD 20852. Dr. Brown received $7,482,968 in
Government .............................. Free reimbursement from Medicare for Botox
FOR FURTHER INFORMATION CONTACT:
1 The fourth registration from the same com- Kenny Shade (ELEM–4144), Division of injections alone, with none of these
pany is free. Payment for the three paying Enforcement, Office of Enforcement and payments resulting from properly
registrants must be made prior to registering payable claims for FDA approved Botox
the fourth person free. Import Operations, Office of Regulatory
Affairs, Food and Drug Administration, injections.
The following forms of payment will be 12420 Parklawn Dr., Rockville, MD Beginning in or about January 2007
accepted: American Express, Visa, 20857, 301–796–4640. and continuing through in or about
Mastercard, and company checks. December 2012, Dr. Brown ordered 254
Attendees are responsible for their SUPPLEMENTARY INFORMATION: vials (25,400 units) of Botox from Axon
own accommodations. The conference I. Background Medical Supplies that were misbranded
headquarter hotel is the Downtown within the meaning of the FD&C Act in
Cincinnati Hilton Netherlands Plaza, 35 Section 306(a)(2)(B) of the FD&C Act that the drug’s labeling failed to bear
West 5th St., Cincinnati, OH 45202, (21 U.S.C. 335a(a)(2)(B)) requires adequate directions for use and all
513–421–9100. To make reservations debarment of an individual if FDA finds words, statements, or other information
online, please visit the ‘‘Venue & that the individual has been convicted required by or under authority of the
Logistics’’ link at http://www.Xavier of a felony under Federal law for FD&C Act to appear on the label and
PharmaLink.com. The hotel is expected conduct relating to the regulation of any labeling were not present, in fact many
to sell out during this timeframe, so drug product under the FD&C Act. On of the words were not in the English
early reservation in the conference April 2, 2015, the U.S. District Court for language. These misbranded drugs were
room-block is encouraged. the Eastern District of Tennessee sent to Bradley PM&R clinic and Dr.
entered judgment against Dr. Brown for Brown injected these drugs into his
Dated: February 13, 2017. one count of receiving and distributing
Leslie Kux, patients, while purporting them to be
misbranded drugs in interstate FDA-approved drugs.
Associate Commissioner for Policy. commerce with intent to defraud and Dr. Brown billed Medicare for all of
[FR Doc. 2017–03176 Filed 2–16–17; 8:45 am] mislead in violation of section 301(a) of these Botox units as if they were FDA-
BILLING CODE 4164–01–P the FD&C Act (21 U.S.C. 331(c)), which approved drugs. Dr. Brown also
according to section 303(a)(2) of the provided diluted Botox injections and
FD&C Act (21 U.S.C. 333(a)(2)) billed as if they were full doses. Dr.
DEPARTMENT OF HEALTH AND constitutes a felony. Brown billed Medicare for an additional
HUMAN SERVICES FDA’s finding that the debarment is 15,865 vials that he did not inject into
appropriate based on the felony patients. Dr. Brown admitted that he
Food and Drug Administration conviction referenced herein. The received the Botox in interstate
[Docket No. FDA–2016–N–2191] factual basis for this conviction is as commerce for delivery that was
follows: Dr. Brown was a licensed misbranded and he acted with intent to
Raymond Sean Brown: Debarment medical doctor in the state of Tennessee defraud and/or mislead. Dr. Brown’s
Order with a practice address listed in conduct constituted a violation of
AGENCY: Food and Drug Administration, Cleveland, TN. The Tennessee section 303(c) of the FD&C Act, which
HHS. Department of Health also lists Bradley according to section 303(a)(2)
ACTION: Notice. PM&R as a licensed health care facility. constitutes a felony.
Dr. Brown was the medical director of As a result of this conviction, FDA
SUMMARY: The U.S. Food and Drug Bradley PM&R, and Dr. Brown’s medical sent Dr. Brown by certified mail on
Administration (FDA or Agency) is practice was listed at the same address. October 28, 2016, a notice proposing to
issuing an order under the Federal As a part of the treatment of patients for permanently debar him from providing
Food, Drug, and Cosmetic Act (the pain management, Bradley PM&R services in any capacity to a person that
FD&C Act) permanently debarring Dr. purchased assorted prescription drugs, has an approved or pending drug
Raymond Sean Brown from providing including Botulinum Toxin Type A, product application. The proposal was
services in any capacity to a person that also known as Botox based on a finding, under section
has an approved or pending drug Onabotulinumtoxin A (hereinafter 306(a)(2)(B) of the FD&C Act, that Dr.
product application. FDA bases this referred to as ‘‘Botox’’), which was Brown was convicted of a felony under
order on a finding that Dr. Brown was prescribed by Dr. Brown and was Federal law for conduct relating to the
convicted of a felony under Federal law administered and dispensed through regulation of a drug product under the
for conduct relating to the regulation of Bradley PM&R. Prior to 2009, Botox®/ FD&C Act. FDA determined that Dr.
a drug product under the FD&C Act. Dr. Botox® Cosmetic, a product Brown’s felony conviction was related
Brown was given notice of the proposed manufactured by Allergan, Inc., was the to the regulation of drug products
permanent debarment and an only Botulinum Toxin Type A product because the conduct underlying his
opportunity to request a hearing within licensed by FDA for use in humans for conviction undermined FDA’s
mstockstill on DSK3G9T082PROD with NOTICES
the timeframe prescribed by regulation. any indication, including pain regulatory oversight over drug products
Dr. Brown failed to request a hearing. management. marketed in the United States—Dr.
Dr. Brown’s failure to request a hearing Axon Medical Supplies was a Brown knowingly received and
constitutes a waiver of his right to a business operating in Surry, BC, distributed misbranded drugs in
hearing concerning this action. Canada. Axon offered for sale to interstate commerce with intent to
DATES: This order is effective February physicians and other health care defraud and mislead. The proposal also
17, 2017. providers in the United States drugs that offered Dr. Brown an opportunity to
VerDate Sep<11>2014 17:38 Feb 16, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1](https://thefederalregister.org/doc/82_FR_11075/page/2.svg)
Document Created: 2017-02-17 00:28:31
Document Modified: 2017-02-17 00:28:31
| 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 of public conference. | |
| 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. | |
| 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: [email protected] | |
| FR Citation | 82 FR 11043 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR