Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4289 

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. 

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 

21⁄2 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 $1,895 

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 

1The 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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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 

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 

(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 http://

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 

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 

http://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 http://

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 


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