80_FR_8358 80 FR 8327 - Food and Drug Administration/Xavier University Global Medical Device Conference; Public Conference

80 FR 8327 - Food and Drug Administration/Xavier University Global Medical Device Conference; Public Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

Page Range8327-8328
FR Document2015-03116

Federal Register, Volume 80 Issue 31 (Tuesday, February 17, 2015) 
[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8327-8328]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Food and Drug Administration/Xavier University Global Medical 
Device Conference; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    The Food and Drug Administration (FDA) Cincinnati District, in 
cosponsorship with Xavier University, is announcing a public conference 
entitled ``FDA/Xavier University Global Medical Device Conference 
(MedCon).'' This 3-day public conference includes presentations from 
key FDA officials and industry experts with small group breakout 
sessions. The conference is intended for companies of all sizes and 
employees at all levels.

DATES: Dates and Times: The public conference will be held on May 6, 
2015, from 8:30 a.m. to 5 p.m.; May 7, 2015, from 8:30 a.m. to 5 p.m.; 
and May 8, 2015, from 8:30 a.m. to 12:30 p.m.
    Location: The public conference will be held on the campus of 
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3016.
    Contact Persons: For information regarding this notice: Gina 
Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 
45237, 513-679-2700, FAX: 513-679-2771, email: 
[email protected].
    For information regarding the conference and registration: Mason 
Rick, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471, 
513-745-3016, email: [email protected], or visit http://www.XavierMedCon.com.
    Registration: There is a conference registration fee which covers 
the cost of the presentations, training materials, receptions, 
breakfasts, and lunches for the 3 days of the conference. Advanced 
registration begins February 6, 2015. Standard registration begins 
March 6, 2015. There will be onsite registration. The cost of 
registration is as follows:

[[Page 8328]]



                     Table 1--Registration Fees \1\
------------------------------------------------------------------------
                                    Advanced rate  (2/   Standard rate
           Attendee type             6/15 to 3/5/15)     (after 3/5/15)
------------------------------------------------------------------------
Industry..........................             $1,495             $1,695
Small Business (<100 Employees)...              1,000              1,200
Startup Manufacturer..............                250                300
Academic..........................                250                300
FDA/Government Employee...........               Free               Free
------------------------------------------------------------------------
\1\ The following forms of payment will be accepted: American Express,
  Visa, MasterCard, and company checks.

    To register online for the public conference, please visit the 
``Registration'' link on the conference Web site at http://www.XavierMedCon.com. FDA has verified the Web site address, but is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register.
    To register by mail, please send your name, title, firm name, 
address, telephone, email, and payment information for the fee to 
Xavier University, Attention: Mason Rick, 3800 Victory Pkwy., 
Cincinnati, OH 45207-5471. An email will be sent confirming your 
registration.
    Attendees are responsible for their own accommodations. The 
conference headquarters hotel is the Downtown Hilton Cincinnati 
Netherland Plaza, 35 West Fifth St., Cincinnati, OH 45202, 513-421-
9100. Special conference block rates are available through April 16, 
2015. To make reservations online, please visit the ``Venue/Logistics'' 
link at http://www.XavierMedCon.com.
    If you need special accommodations due to a disability, please 
contact Mason Rick (see Contact Persons) at least 7 days in advance of 
the conference.

SUPPLEMENTARY INFORMATION: The public conference helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health. The conference will provide those engaged in 
FDA-regulated medical devices (for humans) with information on the 
following topics:

 Center Director Corner: Strategic Priorities for 2015 and 
Beyond
 Office of Compliance Strategic Priorities
 Advancements in Medical Device Software Technology
 Understanding and Preparing for the Revision of ISO13485
 Update from FDA's Office of Combination Products
 Unique Device Identification--Implementation
 FDA Inspections and Insights
 Understanding the Current Activities of the International 
Medical Device Regulators Forum
 European Union Medical Device/In Vitro Diagnostics Regulation 
Review
 Update from the Office of Device Evaluation
 Regulatory Submissions and Strategies
 Complaints, Corrective and Preventive Actions, and Recalls
 Regulatory Challenges in Asia
 Action Plan Writing
 Lunch Networking by Topic

    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 (Public Law 
104-121) by providing outreach activities by Government agencies to 
small businesses.

    Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03116 Filed 2-13-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8327 always be published quickly enough to Procedure: Interested persons may Notice of this meeting is given under provide timely notice. Therefore, you present data, information, or views, the Federal Advisory Committee Act (5 should always check the Agency’s Web orally or in writing, on issues pending U.S.C. app. 2). site at http://www.fda.gov/Advisory before the committee. Written Dated: February 10, 2015. Committees/default.htm and scroll submissions may be made to the contact Leslie Kux, down to the appropriate advisory person on or before February 18, 2015. Associate Commissioner for Policy. committee meeting link, or call the Oral presentations from the public will [FR Doc. 2015–03155 Filed 2–13–15; 8:45 am] advisory committee information line to be scheduled between approximately 1 learn about possible modifications p.m. and 2 p.m. Those individuals BILLING CODE 4164–01–P before coming to the meeting. interested in making formal oral Agenda: On February 20, 2015, the presentations should notify the contact committee will discuss, make DEPARTMENT OF HEALTH AND person and submit a brief statement of recommendations, and vote on HUMAN SERVICES the general nature of the evidence or information regarding the premarket arguments they wish to present, the Food and Drug Administration approval application (PMA) for the names and addresses of proposed Superion InterSpinous Spacer device participants, and an indication of the [Docket No. FDA–2015–N–0001] sponsored by Vertiflex Inc. The approximate time requested to make proposed indication for use for the their presentation on or before February Food and Drug Administration/Xavier Superion InterSpinous Spacer device, as 13, 2015. Time allotted for each University Global Medical Device stated in the PMA, is as follows: The presentation may be limited. If the Conference; Public Conference Superion InterSpinous Spacer (the number of registrants requesting to Superion ISS) is intended to treat speak is greater than can be reasonably AGENCY: Food and Drug Administration, skeletally mature patients suffering from accommodated during the scheduled HHS. pain, numbness, and/or cramping in the open public hearing session, FDA may ACTION: Notice of public conference. legs (neurogenic intermittent conduct a lottery to determine the claudication) secondary to a diagnosis speakers for the scheduled open public The Food and Drug Administration of moderate lumbar spinal stenosis, hearing session. The contact person will (FDA) Cincinnati District, in with or without grade 1 notify interested persons regarding their cosponsorship with Xavier University, spondylolisthesis, confirmed by x ray, request to speak by February 17, 2015. is announcing a public conference magnetic resonance imaging, and/or Persons attending FDA’s advisory entitled ‘‘FDA/Xavier University Global computed tomography evidence of committee meetings are advised that the Medical Device Conference (MedCon).’’ thickened ligamentum flavum, Agency is not responsible for providing This 3-day public conference includes narrowed lateral recess, and/or central access to electrical outlets. presentations from key FDA officials canal or foraminal narrowing. The FDA welcomes the attendance of the and industry experts with small group Superion ISS is indicated for those public at its advisory committee breakout sessions. The conference is patients with impaired physical meetings and will make every effort to intended for companies of all sizes and function who experience relief in accommodate persons with physical employees at all levels. flexion from symptoms of leg/buttock/ disabilities or special needs. If you DATES: Dates and Times: The public groin pain, numbness, and/or cramping, require special accommodations due to conference will be held on May 6, 2015, with or without back pain. The a disability, please contact Anne Marie from 8:30 a.m. to 5 p.m.; May 7, 2015, Superion ISS may be implanted at one Williams at Annmarie.Williams@ from 8:30 a.m. to 5 p.m.; and May 8, or two adjacent lumbar (L) levels in fda.hhs.gov or 301–796–5966 at least 7 2015, from 8:30 a.m. to 12:30 p.m. patients in whom treatment is indicated days in advance of the meeting. Location: The public conference will at no more than two levels, from L1 to FDA is committed to the orderly be held on the campus of Xavier L5. conduct of its advisory committee University, 3800 Victory Pkwy., The meeting was originally scheduled meetings. Please visit our Web site at Cincinnati, OH 45207, 513–745–3016. for December 12, 2014. The meeting http://www.fda.gov/Advisory Contact Persons: For information date is being postponed from December Committees/AboutAdvisoryCommittees/ regarding this notice: Gina Brackett, 12, 2014, until February 20, 2015, due ucm111462.htm for procedures on Food and Drug Administration, 6751 to FDA needing additional time to public conduct during advisory Steger Dr., Cincinnati, OH 45237, 513– review information supplied by committee meetings. 679–2700, FAX: 513–679–2771, email: sponsor. FDA regrets that it was unable to gina.brackett@fda.hhs.gov. FDA intends to make background publish this notice 15 days prior to the For information regarding the material available to the public no later February 20, 2015, Orthopaedic and conference and registration: Mason than 2 business days before the meeting. Rehabilitation Panel of the Medical Rick, Xavier University, 3800 Victory If FDA is unable to post the background Devices Advisory Committee meeting. Pkwy., Cincinnati, OH 45207–5471, material on its Web site prior to the Because the Agency believes there is 513–745–3016, email: meeting, the background material will some urgency to bring these issues to rickm@xavier.edu, or visit http:// be made publicly available at the public discussion and qualified www.XavierMedCon.com. location of the advisory committee members of the Orthopaedic and Registration: There is a conference meeting, and the background material Rehabilitation Panel of the Medical registration fee which covers the cost of will be posted on FDA’s Web site after Devices Advisory Committee were the presentations, training materials, tkelley on DSK3SPTVN1PROD with NOTICES the meeting. Background material is available at this time, the Commissioner receptions, breakfasts, and lunches for available at http://www.fda.gov/ of Food and Drugs concluded that it was the 3 days of the conference. Advanced AdvisoryCommittees/Calendar/ in the public interest to hold this registration begins February 6, 2015. default.htm. Scroll down to the meeting even if there was not sufficient Standard registration begins March 6, appropriate advisory committee meeting time for the customary 15-day public 2015. There will be onsite registration. link. notice. The cost of registration is as follows: VerDate Sep<11>2014 16:51 Feb 13, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1

8328 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices TABLE 1—REGISTRATION FEES 1 Advanced rate Standard rate Attendee type (2/6/15 to 3/5/15) (after 3/5/15) Industry ........................................................................................................................................................ $1,495 $1,695 Small Business (<100 Employees) ............................................................................................................. 1,000 1,200 Startup Manufacturer ................................................................................................................................... 250 300 Academic ..................................................................................................................................................... 250 300 FDA/Government Employee ........................................................................................................................ Free Free 1 The following forms of payment will be accepted: American Express, Visa, MasterCard, and company checks. To register online for the public • European Union Medical Device/In Policy in Food, Drug, and Medical conference, please visit the Vitro Diagnostics Regulation Review Device Regulation.’’ The conference ‘‘Registration’’ link on the conference • Update from the Office of Device Web site is http://indy.afdo.org/. This Web site at http:// Evaluation conference is intended to provide www.XavierMedCon.com. FDA has • Regulatory Submissions and information about FDA food, drug, and verified the Web site address, but is not Strategies device regulation to the regulated responsible for subsequent changes to • Complaints, Corrective and industry. the Web site after this document Preventive Actions, and Recalls Date and Time: The public conference publishes in the Federal Register. • Regulatory Challenges in Asia will be held on June 20 to 24, 2015. To register by mail, please send your • Action Plan Writing Times will vary. name, title, firm name, address, • Lunch Networking by Topic Location: The conference will be held telephone, email, and payment FDA has made education of the drug at the Sheraton Indianapolis Hotel at information for the fee to Xavier and device manufacturing community a Keystone Crossing, Indianapolis, 8787 University, Attention: Mason Rick, 3800 high priority to help ensure the quality Keystone Crossing, Indianapolis, IN Victory Pkwy., Cincinnati, OH 45207– of FDA-regulated drugs and devices. 46240, 317–846–2700 or toll-free 888– 5471. An email will be sent confirming The conference helps to achieve 627–7814; www.sheratonindianapolis your registration. objectives set forth in section 406 of the keystonecrossing.com. Attendees are responsible for their Food and Drug Administration Attendees are responsible for their own accommodations. The conference Modernization Act of 1997 (21 U.S.C. own accommodations. To make headquarters hotel is the Downtown 393), which includes working closely reservations at the Sheraton Hilton Cincinnati Netherland Plaza, 35 with stakeholders and maximizing the Indianapolis Hotel at the reduced West Fifth St., Cincinnati, OH 45202, availability and clarity of information to conference rate, please call 303–295– 513–421–9100. Special conference block stakeholders and the public. The 1234 and mention ‘‘AFDO Conference’’ rates are available through April 16, conference also is consistent with the before May 20, 2015. All the hotel 2015. To make reservations online, Small Business Regulatory Enforcement information needed to call or reserve please visit the ‘‘Venue/Logistics’’ link Fairness Act of 1996 (Public Law 104– online is available at http:// at http://www.XavierMedCon.com. 121) by providing outreach activities by indy.afdo.org/hotel.html. If you need special accommodations Government agencies to small AFDO contact information: Randy due to a disability, please contact Mason businesses. Young, Association of Food and Drug Rick (see Contact Persons) at least 7 Dated: February 10, 2015. Officials, 2550 Kingston Rd., suite 311, days in advance of the conference. York, PA 17402, 717–757–2888, FAX: Leslie Kux, SUPPLEMENTARY INFORMATION: The 717–650–3650, email: ryoung@afdo.org. Associate Commissioner for Policy. Registration: You are encouraged to public conference helps fulfill the [FR Doc. 2015–03116 Filed 2–13–15; 8:45 am] register by May 20, 2015. The AFDO Department of Health and Human Services’ and FDA’s important mission BILLING CODE 4164–01–P registration fees cover the cost of to protect the public health. The facilities, materials, and breaks. Seats conference will provide those engaged are limited; therefore, please submit DEPARTMENT OF HEALTH AND your registration as soon as possible. in FDA-regulated medical devices (for HUMAN SERVICES humans) with information on the Course space will be filled in order of following topics: receipt of registration. Those accepted Food and Drug Administration • Center Director Corner: Strategic into the course will receive Priorities for 2015 and Beyond [Docket No. FDA–2015–N–0001] confirmation. Registration will close • Office of Compliance Strategic after the course is filled. Registration at In Motion: Science Transforming the site is not guaranteed but may be Priorities Policy in Food, Drug, and Medical • Advancements in Medical Device possible on a space available basis on Device Regulation the day of the conference beginning at Software Technology • Understanding and Preparing for the AGENCY: Food and Drug Administration, 8 a.m. The cost of registration follows: Revision of ISO13485 HHS. Cost of Registration: • Update from FDA’s Office of ACTION: Notice of public conference. Member—$475.00 tkelley on DSK3SPTVN1PROD with NOTICES Combination Products Non-Member—$575.00 • Unique Device Identification— The Food and Drug Administration *A $100 late fee will be added if Implementation (FDA) Detroit District Office, in payment is postmarked after June 1, • FDA Inspections and Insights cosponsorship with the Association of 2015. • Understanding the Current Activities Food and Drug Officials (AFDO), is If you need special accommodations of the International Medical Device announcing a public conference entitled due to a disability, please contact Randy Regulators Forum ‘‘In Motion: Science Transforming Young (see AFDO contact information) VerDate Sep<11>2014 16:51 Feb 13, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1


Document Created: 2015-12-18 13:19:56
Document Modified: 2015-12-18 13:19:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public conference.
DatesDates and Times: The public conference will be held on May 6, 2015, from 8:30 a.m. to 5 p.m.; May 7, 2015, from 8:30 a.m. to 5 p.m.; and May 8, 2015, from 8:30 a.m. to 12:30 p.m.
FR Citation80 FR 8327 
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