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