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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4291 

representative. No audiovisual 

presentations are permitted. For 

additional information or questions on 

public comments, please contact Lisa 

Vasquez, Maternal and Child Health 

Bureau, Health Resources and Services 

Administration; email: lvasquez@

hrsa.gov. 

Contact Person: Anyone interested in 

obtaining other relevant information 

should contact Debi Sarkar, Maternal 

and Child Health Bureau, Health 

Resources and Services Administration, 

Room 18A–19, Parklawn Building, 5600 

Fishers Lane, Rockville, Maryland 

20857; email: dsarkar@hrsa.gov. 

More information on the Advisory 

Committee is available at http://

www.hrsa.gov/advisorycommittees/

mchbadvisory/heritabledisorders. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2015–01351 Filed 1–26–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60 Day Comment 

Request; Evaluation of the NHLBI 

Proteomics Centers Program: 

Qualitative Interviews (NHLBI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To Submit Comments and for Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Pothur Srinivas, Ph.D., 

Project Officer/ICD Contact, Two 

Rockledge Center, 6701 Rockledge 

Drive, Room 10188, MSC 10193, 

Bethesda, MD 20892, or call non-tollfree number (301) 435–0550, or Email 

your request to: srinivap@nhlbi.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Evaluation of the 

NHLBI Proteomics Centers Program: 

Qualitative Interviews 0925–New, 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: The Proteomics Centers 

Program was established in 2010 with 

the goal of applying proteomic 

approaches to gain a better mechanistic 

understanding of the physiologic 

pathways underlying defined clinical 

conditions related to heart, lung, and 

blood diseases. The primary goal of the 

program is to help facilitate a better 

understanding of the underlying 

mechanisms in heart, lung, and blood 

diseases which could contribute to more 

effective diagnoses, risk stratification, 

intervention, and prevention. Given the 

rapid developments in proteomic 

technologies and approaches in the last 

five years, it is important to determine 

the extent to which the efforts of the 

centers have matured, leading to 

discovery of new targets for intervention 

and clinically actionable tool sets. An 

eighteen-month outcome evaluation will 

coincide with the completion of funding 

for the program. This information 

collection request is being made for one 

component of this evaluation: Semistructured interviews with key 

informants across four targeted groups, 

internal and external to the program. 

The results of the evaluation will help 

determine the extent to which these 

desired outcomes were achieved as well 

as to inform future of proteomics 

research funding and commitments by 

the NHLBI. The key informant 

interviews are necessary to understand 

the perspectives of internal and external 

program stakeholders as it relates to the 

success, limitations, and opportunities 

that can shape future research funding. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

48. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Principal investigators and key personnel ....................................................... 27 1 50/60 23 

External Proteomics investigators ................................................................... 9 1 50/60 8 

Trainees and junior investigators .................................................................... 20 1 50/60 17 

Dated: January 14, 2015. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2015–01421 Filed 1–26–15; 8:45 am] 

BILLING CODE 4140–01–P 


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