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-2015-N-0001]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice of public conference.
 SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship 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, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialog that has led to innovative initiatives. *Dates and Times:*
                         The public conference will be held on March 25, 2015, from 8:30 a.m. to 5 p.m.; March 26, 2015, from 8:30 a.m. to 5 p.m.; and March 27, 2015, from 8:30 a.m. to 12:45 p.m. *Location:*
                         The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or 513-745-3020. *Contact Persons: For information regarding this notice:*
                         Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East 7th Street, Cincinnati, OH 45202, 513-246-4134, email: 
                        *steven.eastham@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.* *Registration:*
                         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
                        1/2
                         days of the conference. There will be onsite registration. The cost of registration is as follows: Table 1—Registration Fees 1
Attendee type
Early rate
                             (on or before 1/24/15)
Advanced rate
                             (1/25/15 to 2/24/15)
Standard rate
                             (after 2/24/15)Industry
$1,295
$1,695
$1,895Small Business (<100 employees)
995
1,195
1,295Startup Manufacturer
200
250
300Academic
200
250
300Media
Free
Free
FreeGovernment
Free
Free
Free1
                         The fourth registration from the same company is free—all four attendees must register at the same time.
 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.XavierPharmaLink.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 and fax numbers, 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 headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, 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 sellout during this timeframe, so early reservation in the conference room-block is encouraged. If you need special accommodations due to a disability, please contact Marla Phillips (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 engage those involved in FDA-regulated global supply chain quality and management through the following topics: Major Changes at FDA Affecting You
                FDA-Driven Initiatives through Food and Drug Administration Safety and Innovation Act Implementation
                Held at the Border? Understand Why
                Toyota Production System—Cultural Requirements
                Barriers to Quality and Supply Chain Excellence
                Establishing Good Supply Practices
                Medicines and Healthcare Products Regulatory Agency Perspective on Global Supply Chain Challenges
                Systematic Approach to Managing Your Global Supply Chain
                Deep Dive Lunch Session—Clinically Relevant Metrics
                Deep Dive Lunch Session—Data Integrity: How To Verify You Are Okay
                Deep Dive Lunch Session—Integrity of Supply Workshop
                Nobel Prize-Based Alignment Optimization( print page 4290)
                Quality Metrics Beyond Compliance To Drive Strategic Value
                Risk Categorization of Your Company
                Challenges That Lie Outside U.S. Borders
                Global Supply Chain Risk Management Case Studies
                FDA Investigator Insights The conference includes: Networking by topic
                Case studies
                Small group discussions
                Action plans
                Keynote dinner at the Newport Aquarium The most pressing challenges of the global pharmaceutical industry require solutions which are inspired by collaboration to ensure the ongoing health and safety of patients. These challenges include designing products with the patient in mind, building quality into the product from the onset, 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. Dated: January 21, 2015. Leslie Kux, Associate Comissioner for Policy.


[FR Doc. 2015-01418 Filed 1-26-15; 8:45 am] BILLING CODE 4164-01-P