Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2016-N-0001]
 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 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: *gina.brackett@fda.hhs.gov. 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: *rickm@xavier.edu* 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
Attendee type
Early rate  (through 2/3/16)
Advance rate  (2/4/16-3/3/16)
Standard rate (after 3/3/16)Industry
$1,195
$1,495
$1,695Small Business (<100 employees)
900
1,000
1,200Start-up Manufacturer
200
250
300Academic
200
250
300FDA/Government Employee
Free
Free
Free1 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