81_FR_4933 81 FR 4915 - Food and Drug Administration/Xavier Medical Device Conference

81 FR 4915 - Food and Drug Administration/Xavier Medical Device Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

Page Range4915-4915
FR Document2016-01681

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

Federal Register, Volume 81 Issue 18 (Thursday, January 28, 2016) 
[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Page 4915]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01681]



[[Page 4915]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Food and Drug Administration/Xavier Medical Device Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

DATES: The public conference will be held on May 4, 2016, from 8:30 
a.m. to 5 p.m.; May 5, 2016, from 8:30 a.m. to 5 p.m.; and May 6, 2016, 
from 8:30 a.m. to 12:05 p.m.

ADDRESSES: The public conference will be held on the campus of Xavier 
University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3016.

FOR FURTHER INFORMATION CONTACT: 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, Program Manager, Xavier Health, Xavier 
University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471, 513-745-
3016, email: [email protected] or visit http://www.XavierMedCon.com.

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:

 Update from FDA's Office of Combination Products
 Center Director Corner: Strategic Priorities for 2016 and 
Beyond
 Office of Compliance Strategic Priorities
 Medical Device Innovation Consortium (MDIC)/Xavier University 
Medical Device Metrics Initiative
 Critical Thinking--Responding to FDA
 Working Through Challenges with Supplier Quality and Design--
What to Do and When
 FDA Inspections and Insights
 Canada's Changing Quality System Requirements
 European Medical Device Regulation Progress
 Update from the Office of Device Evaluation
 What to Expect with FDA's Program Alignment
 When to File a 510(k) for Modifications to Your Cleared Device
 Storing Clinical Data in the Cloud
 Regulatory Strategy for Innovation
 Internet and Social Media Concerns--FDA and Federal Trade 
Commission (FTC) Perspectives
 Navigating Japan's Regulatory Environment
 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 (Pub. L. 
104-121) by providing outreach activities by Government Agencies to 
small businesses.
    Registration: There is a registration fee. The conference 
registration fees cover the cost of the presentations, training 
materials, receptions, breakfasts, and lunches for the 3 days of the 
conference. Early registration rates end February 3, 2016. Advance 
registration rates end on March 3, 2016. Standard registration rates 
begin March 4, 2016. There will be onsite registration. The cost of 
registration is as follows:

                                         Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
                                                                Early rate     Advance rate  (2/   Standard rate
                       Attendee type                         (through 2/3/16)     4/16-3/3/16)    (after 3/3/16)
----------------------------------------------------------------------------------------------------------------
Industry..................................................             $1,195             $1,495          $1,695
Small Business (<100 employees)...........................                900              1,000           1,200
Start-up Manufacturer.....................................                200                250             300
Academic..................................................                200                250             300
FDA/Government Employee...................................               Free               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, Attn: 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 headquarter hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 W. 5th St., Cincinnati, OH 45202, 513-421-9100. 
Special conference block rates are available through April 11, 2016. 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 FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the conference.

    Dated: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01681 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4915 DEPARTMENT OF HEALTH AND information regarding the conference • Storing Clinical Data in the Cloud HUMAN SERVICES and registration: Mason Rick, Program • Regulatory Strategy for Innovation Manager, Xavier Health, Xavier • Internet and Social Media Concerns— Food and Drug Administration University, 3800 Victory Pkwy., FDA and Federal Trade Commission [Docket No. FDA–2016–N–0001] Cincinnati, OH 45207–5471, 513–745– (FTC) Perspectives 3016, email: rickm@xavier.edu or visit Food and Drug Administration/Xavier http://www.XavierMedCon.com. • Navigating Japan’s Regulatory Medical Device Conference Environment SUPPLEMENTARY INFORMATION: The public conference helps fulfill the • Action Plan Writing AGENCY: Food and Drug Administration, Department of Health and Human • Lunch Networking by Topic HHS. Services’ and FDA’s important mission FDA has made education of the drug ACTION: Notice of public conference. to protect the public health. The and device manufacturing community a SUMMARY: The Food and Drug conference will provide those engaged high priority to help ensure the quality Administration (FDA) Cincinnati in FDA-regulated medical devices (for of FDA-regulated drugs and devices. District, in co-sponsorship with Xavier humans) with information on the The conference helps to achieve University, is announcing a public following topics: objectives set forth in section 406 of the conference entitled ‘‘FDA/Xavier • Update from FDA’s Office of Food and Drug Administration Medical Device Conference (MedCon).’’ Combination Products Modernization Act of 1997 (21 U.S.C. This 3-day public conference includes • Center Director Corner: Strategic 393), which includes working closely presentations from key FDA officials Priorities for 2016 and Beyond with stakeholders and maximizing the and industry experts with small group • Office of Compliance Strategic availability and clarity of information to break-out sessions. The conference is Priorities stakeholders and the public. The intended for companies of all sizes and • Medical Device Innovation conference also is consistent with the employees at all levels. Consortium (MDIC)/Xavier University Small Business Regulatory Enforcement DATES: The public conference will be Medical Device Metrics Initiative Fairness Act of 1996 (Pub. L. 104–121) held on May 4, 2016, from 8:30 a.m. to • Critical Thinking—Responding to by providing outreach activities by 5 p.m.; May 5, 2016, from 8:30 a.m. to FDA Government Agencies to small • Working Through Challenges with 5 p.m.; and May 6, 2016, from 8:30 a.m. businesses. Supplier Quality and Design—What to 12:05 p.m. Registration: There is a registration to Do and When ADDRESSES: The public conference will • FDA Inspections and Insights fee. The conference registration fees be held on the campus of Xavier • Canada’s Changing Quality System cover the cost of the presentations, University, 3800 Victory Pkwy., Requirements training materials, receptions, Cincinnati, OH 45207, 513–745–3016. • European Medical Device Regulation breakfasts, and lunches for the 3 days of FOR FURTHER INFORMATION CONTACT: For Progress the conference. Early registration rates information regarding this notice: Gina • Update from the Office of Device end February 3, 2016. Advance Brackett, Food and Drug Evaluation registration rates end on March 3, 2016. Administration, 6751 Steger Dr., • What to Expect with FDA’s Program Standard registration rates begin March Cincinnati, OH 45237, 513–679–2700, Alignment 4, 2016. There will be onsite FAX: 513–679–2771, email: • When to File a 510(k) for registration. The cost of registration is as gina.brackett@fda.hhs.gov. For Modifications to Your Cleared Device follows: TABLE 1—REGISTRATION FEES 1 Early rate Advance rate Standard rate Attendee type (through 2/3/16) (2/4/16–3/3/16) (after 3/3/16) Industry ............................................................................................................................ $1,195 $1,495 $1,695 Small Business (<100 employees) .................................................................................. 900 1,000 1,200 Start-up Manufacturer ...................................................................................................... 200 250 300 Academic ......................................................................................................................... 200 250 300 FDA/Government Employee ............................................................................................ Free Free Free 1 The following forms of payment will be accepted: American Express, Visa, MasterCard, and company checks. To register online for the public Victory Pkwy., Cincinnati, OH 45207– If you need special accommodations conference, please visit the 5471. An email will be sent confirming due to a disability, please contact Mason ‘‘Registration’’ link on the conference your registration. Rick (see FOR FURTHER INFORMATION Web site at http:// Attendees are responsible for their CONTACT) at least 7 days in advance of www.XavierMedCon.com. FDA has own accommodations. The conference the conference. verified the Web site address, but is not headquarter hotel is the Downtown Dated: January 22, 2016. responsible for subsequent changes to Cincinnati Hilton Netherlands Plaza, 35 Leslie Kux, wgreen on DSK2VPTVN1PROD with NOTICES the Web site after this document W. 5th St., Cincinnati, OH 45202, 513– Associate Commissioner for Policy. publishes in the Federal Register. 421–9100. Special conference block [FR Doc. 2016–01681 Filed 1–27–16; 8:45 am] To register by mail, please send your rates are available through April 11, name, title, firm name, address, 2016. To make reservations online, BILLING CODE 4164–01–P telephone, email, and payment please visit the ‘‘Venue/Logistics’’ link information for the fee to Xavier at http://www.XavierMedCon.com. University, Attn: Mason Rick, 3800 VerDate Sep<11>2014 13:19 Jan 27, 2016 Jkt 238001 PO 00000 Frm 00009 Fmt 4703 Sfmt 9990 E:\FR\FM\28JAN1.SGM 28JAN1


Document Created: 2018-02-02 12:40:56
Document Modified: 2018-02-02 12:40:56
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.
DatesThe public conference will be held on May 4, 2016, from 8:30 a.m. to 5 p.m.; May 5, 2016, from 8:30 a.m. to 5 p.m.; and May 6, 2016, from 8:30 a.m. to 12:05 p.m.
ContactFor 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, Program Manager, Xavier Health, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471, 513-745- 3016, email: [email protected] or visit http://www.XavierMedCon.com.
FR Citation81 FR 4915 
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