Food and Drug Administration/Xavier University PharmaLink Conference: Increasing Product Confidence, 4311-4312 [2016-01486]

Download as PDF Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices Dated: January 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01473 Filed 1–25–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Request for Nominations on the National Mammography Quality Assurance Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) for the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the NMQAAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by February 25, 2016, (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by February 25, 2016. ADDRESSES: All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent to Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 MD 20993–0002. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s Web site at https://www. fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5215, Silver Spring, MD 20993. 301–796–5960, FAX: 301– 847–8505, email: margaret.ames@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency request nominations for nonvoting industry representatives to the following committee: I. National Mammography Quality Assurance Advisory Committee The Committee shall advise the Food and Drug Administration on: (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 4311 candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the mammography manufacturing industry. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01487 Filed 1–25–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Food and Drug Administration/Xavier University PharmaLink Conference: Increasing Product Confidence AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier SUMMARY: E:\FR\FM\26JAN1.SGM 26JAN1 4312 Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES University, is announcing a public conference entitled ‘‘FDA/Xavier University PharmaLink Conference: Increasing Product Confidence’’. The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, featuring 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 dialogue, which has led to innovative initiatives. DATES: The public conference will be held on March 16, 2016, from 8:30 a.m. to 5 p.m.; March 17, 2016, from 8:30 a.m. to 5p.m.; and March 18, 2016, from 8:30 a.m. to 12:20 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 document: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East 7th St., Cincinnati, OH 45202; 513–246–4134, steven.eastham@ fda.hhs.gov. For information regarding the conference and registration: Mason Rick, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207–5471; 513–745–3016, rickm@xavier.edu. SUPPLEMENTARY INFORMATION: I. Background 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. II. Meeting Information A. Registration There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts and VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 • Medicines and Healthcare products Regulatory Agency (MHRA) Update: Strategic Priorities and Initiatives • Operating in India and Southeast Asia • Serialization TABLE 1—REGISTRATION FEES 1 • Integrity of Supply Standard • Office of Pharmaceutical Quality Attendee type rate Update • How to Measure Quality Culture Industry ......................................... $1,895 • Pharmaceutical Metrics and the Small Business (<100 employees) 1,295 Supplier ......................................... 600 Value Proposition • Office of Regulatory Affairs Update Start-up Manufacturer ................... 300 • The 21st Century Cures Act: Goals Academic ...................................... 300 Media ............................................ Free and Impact • International Conference on Government .................................. Free Harmonisation Q12: Technical and 1 The fourth registration from the same company is free; all four attendees must register at Regulatory Considerations for Pharmaceutical Product Lifecycle the same time. Management The following forms of payment will • Barriers to Quality and Supply be accepted: American Express, Visa, Chain Excellence Mastercard, and company checks. To • Proactive and Systematic Quality register online for the public conference, Implementation: Case Studies across please visit the ‘‘Registration’’ link on functional areas the conference Web site at https://www. • FDA and MHRA Investigator XavierPharmaLink.com. FDA has Insights verified the Web site address, but is not The conference includes: responsible for subsequent changes to • Networking by topic the Web site after this document • Case Studies publishes in the Federal Register. • Small Group Discussions • Action Plans To register by mail, please send your • Keynote dinner at Paul Brown name, title, firm name, address, Stadium (Home of the Cincinnati telephone number, email address, and Bengals) payment information to: Xavier The conference helps to achieve University, Attention: Mason Rick, 3800 objectives set forth in section 406 of the Victory Pkwy., Cincinnati, OH 45207– Food and Drug Administration 5471. An email will be sent confirming Modernization Act of 1997 (21 U.S.C. your registration. 393), which includes working closely Attendees are responsible for their with stakeholders and maximizing the own accommodations. The conference availability and clarity of information to headquarters hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 stakeholders and the public. The conference also is consistent with the West 5th St., Cincinnati, OH 45202, Small Business Regulatory Enforcement 513–421–9100. To make reservations Fairness Act of 1996 (Pub. L. 104–121) online, please visit the ‘‘Venue & by providing outreach activities by Logistics’’ link at https://www.Xavier PharmaLink.com. The hotel is expected Government Agencies to small businesses. to sell out during this timeframe, so early reservation in the conference Dated: January 21, 2016. room-block is encouraged. Leslie Kux, If you need special accommodations Associate Commissioner for Policy. due to a disability, please contact Mason [FR Doc. 2016–01486 Filed 1–25–16; 8:45 am] Rick (see FOR FURTHER INFORMATION BILLING CODE 4164–01–P CONTACT) at least 7 days in advance of the conference. DEPARTMENT OF HEALTH AND B. Purpose and Scope of Meeting HUMAN SERVICES The public conference helps fulfill the Health Resources and Services Department of Health and Human Administration Services and FDA’s important mission to protect the public health. The Advisory Committee on Heritable conference will engage those involved Disorders in Newborns and Children; in FDA-regulated global supply chain Notice of Meeting quality and management through the following topics: In accordance with section 10(a)(2) of • Office of Compliance Update the Federal Advisory Committee Act • Data Integrity (Public Law 92–463, codified at 5 U.S.C. lunches for the 2.5 days of the conference. There will be onsite registration. The cost of registration is as follows: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1

Agencies

[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4311-4312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01486]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration/Xavier University PharmaLink 
Conference: Increasing Product Confidence

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

[[Page 4312]]

University, is announcing a public conference entitled ``FDA/Xavier 
University PharmaLink Conference: Increasing Product Confidence''. The 
PharmaLink conference seeks solutions to important and complicated 
issues by aligning with the strategic priorities of FDA, featuring 
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 
dialogue, which has led to innovative initiatives.

DATES: The public conference will be held on March 16, 2016, from 8:30 
a.m. to 5 p.m.; March 17, 2016, from 8:30 a.m. to 5p.m.; and March 18, 
2016, from 8:30 a.m. to 12:20 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 
document: Steven Eastham, Food and Drug Administration, Cincinnati 
South Office, 36 East 7th St., Cincinnati, OH 45202; 513-246-4134, 
steven.eastham@fda.hhs.gov.
    For information regarding the conference and registration: Mason 
Rick, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471; 
513-745-3016, rickm@xavier.edu.

SUPPLEMENTARY INFORMATION:

I. Background

    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.

II. Meeting Information

A. Registration

    There is a registration fee. The conference registration fees cover 
the cost of the presentations, training materials, receptions, 
breakfasts and lunches for the 2.5 days of the conference. There will 
be onsite registration. The cost of registration is as follows:

                     Table 1--Registration Fees \1\
------------------------------------------------------------------------
                                                                Standard
                        Attendee type                             rate
------------------------------------------------------------------------
Industry.....................................................     $1,895
Small Business (<100 employees)..............................      1,295
Supplier.....................................................        600
Start-up Manufacturer........................................        300
Academic.....................................................        300
Media........................................................       Free
Government...................................................       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 number, email address, and payment information 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 headquarters hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 West 5th St., 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 sell 
out during this timeframe, so early reservation in the conference room-
block is encouraged.
    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.

B. Purpose and Scope of Meeting

    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:
     Office of Compliance Update
     Data Integrity
     Medicines and Healthcare products Regulatory Agency (MHRA) 
Update: Strategic Priorities and Initiatives
     Operating in India and Southeast Asia
     Serialization
     Integrity of Supply
     Office of Pharmaceutical Quality Update
     How to Measure Quality Culture
     Pharmaceutical Metrics and the Value Proposition
     Office of Regulatory Affairs Update
     The 21st Century Cures Act: Goals and Impact
     International Conference on Harmonisation Q12: Technical 
and Regulatory Considerations for Pharmaceutical Product Lifecycle 
Management
     Barriers to Quality and Supply Chain Excellence
     Proactive and Systematic Quality Implementation: Case 
Studies across functional areas
     FDA and MHRA Investigator Insights
    The conference includes:
     Networking by topic
     Case Studies
     Small Group Discussions
     Action Plans
     Keynote dinner at Paul Brown Stadium (Home of the 
Cincinnati Bengals)
    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, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01486 Filed 1-25-16; 8:45 am]
BILLING CODE 4164-01-P

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