Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain, 4289-4290 [2015-01418]

Download as PDF Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices II. Goals and Objectives • To provide a forum for open discussion between industry, academia, other stakeholders, and FDA around proposed changes to the Food-Effect Guidance. • To seek feedback from industry, academia, and other stakeholders on FDA’s proposals and to seek any additional input that will benefit decision making on a guidance revision on the topic. Dated: January 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–01409 Filed 1–26–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–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. 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., SUMMARY: 4289 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 21⁄2 days of the conference. There will be onsite registration. The cost of registration is as follows: TABLE 1—REGISTRATION FEES 1 Early rate (on or before 1/24/15) Attendee type Industry .................................................................................................... Small Business (<100 employees) .......................................................... Startup Manufacturer ............................................................................... Academic ................................................................................................. Media ....................................................................................................... Government ............................................................................................. asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 The Advanced rate (1/25/15 to 2/24/15) $1,295 995 200 200 Free Free $1,695 1,195 250 250 Free Free Standard rate (after 2/24/15) $1,895 1,295 300 300 Free Free 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 https:// 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 VerDate Sep<11>2014 18:01 Jan 26, 2015 Jkt 235001 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 https:// 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 • 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 E:\FR\FM\27JAN1.SGM 27JAN1 4290 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices • 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Discretionary Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act VerDate Sep<11>2014 18:01 Jan 26, 2015 Jkt 235001 (Pub. L. 92–463, codified at 5 U.S.C. App.), notice is hereby given of the following meeting: Name: Discretionary Advisory Committee on Heritable Disorders in Newborns and Children. Dates and Times: February 12, 2015, 8:30 a.m. to 5:00 p.m.; February 13, 2015, 9:00 a.m. to 4:00 p.m. Place: Webinar and In-Person, National Institutes of Health, 5635 Fishers Lane, Rockville, Maryland 20857. Status: The meeting will be open to the public with attendance limited to space availability. Participants also have the option of viewing the meeting via webinar. Whether attending in-person or via webinar, all participants must register for the meeting. The registration link will be made available at https:// www.hrsa.gov/advisorycommittees/ mchbadvisory/heritabledisorders/. The registration deadline is Friday, January 30, 2015, 11:59 p.m. Eastern Time. Purpose: The Discretionary Advisory Committee on Heritable Disorders in Newborns and Children (Committee), as authorized by Public Health Service Act (PHS), 42 U.S.C. 217a: Advisory councils or committees, was established to advise the Secretary of the Department of Health and Human Services about the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. In addition, the Committee’s recommendations regarding additional conditions/ inherited disorders for screening that have been adopted by the Secretary are included in the Recommended Uniform Screening Panel (RUSP) and constitute part of the comprehensive guidelines supported by the Health Resources and Services Administration. Pursuant to section 2713 of the Public Health Service Act, codified at 42 U.S.C. 300gg–13, non-grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without charging a co-payment, co-insurance, or deductible for plan years (i.e., policy years) beginning on or after the date that is 1 year from the Secretary’s adoption of the condition for screening. Agenda: The meeting will include: (1) A final report on the Mucopolysaccharidosis 1 (MPS 1) Condition Nomination for inclusion on the Recommended Uniform Screening Panel (RUSP), (2) a final report on the Laboratory Procedures and Standards Subcommittee’s Timely Newborn Screening Project, (3) a presentation PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 from the U.S. Preventive Services Task Force on the transfer of newborn screening topics (sickle cell disease, phenylketonuira, congenital hypothyroidism) to the Committee, (4) update on the condition review of Adrenoleukodystrophy (ALD), (5) update from the Pilot Study Workgroup and discussion on the different mechanisms and challenges for implementing pilot studies, (6) presentation on analyzing costs when implementing screening for a new condition, (7) presentation by the Newborn Screening Translational Research Network Long-term Follow-up Project, and (8) updates on priority projects from the Committee’s subcommittees on Laboratory Standards and Procedures, Follow-up and Treatment, and Education and Training. The Committee is expected to vote on whether or not to recommend to the Secretary the addition of MPS 1 to the RUSP. Tentatively, the Committee is expected to review and/or vote on the final recommendations on timely newborn screening. Agenda items are subject to change as necessary or appropriate. The agenda, webinar information, Committee Roster, Charter, presentations, and other meeting materials will be located on the Advisory Committee’s Web site at https://www.hrsa.gov/ advisorycommittees/mchbadvisory/ heritabledisorders. Public Comments: Members of the public may present oral comments and/ or submit written comments. Comments are part of the official Committee record. The public comment period is tentatively scheduled for both days of the meeting. Advance registration is required to present oral comments and/ or submit written comments. Registration information will be on the Committee Web site at https:// www.hrsa.gov/advisorycommittees/ mchbadvisory/heritabledisorders. The registration deadline is Friday, January 30, 2015, 11:59 p.m. Eastern Time. Written comments must be received by the deadline in order to be included in the February meeting briefing book. Written comments should identify the individual’s name, address, email, telephone number, professional or business affiliation, type of expertise (i.e., parent, researcher, clinician, public health, etc.), and the topic/subject matter of comments. To ensure that all individuals who have registered to make oral comments can be accommodated, the allocated time may be limited. Individuals who are associated with groups or have similar interests may be requested to combine their comments and present them through a single E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4289-4290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01418]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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 
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\
----------------------------------------------------------------------------------------------------------------
                                                  Early rate (on or   Advanced rate (1/25/  Standard rate (after
                 Attendee type                     before 1/24/15)       15 to 2/24/15)           2/24/15)
----------------------------------------------------------------------------------------------------------------
Industry......................................                $1,295                $1,695                $1,895
Small Business (<100 employees)...............                   995                 1,195                 1,295
Startup Manufacturer..........................                   200                   250                   300
Academic......................................                   200                   250                   300
Media.........................................                  Free                  Free                  Free
Government....................................                  Free                  Free                  Free
----------------------------------------------------------------------------------------------------------------
\1\ 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 https://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 https://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

[[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
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