Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36609 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Christian Hussong, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 3283, Silver Spring, 

MD 20993–0002, 240–402–2246, or ELP 

Management, ELP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is responsible for ensuring the 

safety and effectiveness of medical 

devices marketed in the United States. 

Additionally, CDRH assures patients 

and providers have timely and 

continued access to high-quality, safe 

and effective medical devices. 

Continuing our 2016 and 2017 priorities 

of Partnering with Patients and 

Promoting a Culture of Quality and 

Organizational Excellence, adding our 

2018–2020 Strategic Priorities of 

Simplicity, Collaborative Communities 

and Employee Engagement, 

Opportunity, and Success, overlaid by 

our constant strive for patient safety and 

innovation highlights our need to 

understand the perspective of our 

stakeholders. The Center encourages 

applicants to consider including 

opportunities to discuss innovation, 

patient perspective, patient safety, 

incorporating quality system design and 

management, simplification principles, 

and utilization of collaborative 

communities in their proposal(s) as they 

contribute to the success of the device 

development life cycle. 

CDRH is committed to advancing 

regulatory science, providing industry 

with predictable, consistent, 

transparent, and efficient regulatory 

pathways, and helping to ensure 

consumer confidence in medical 

devices marketed in the United States 

and throughout the world. The ELP is 

intended to provide CDRH and other 

FDA staff with an opportunity to 

understand the laboratory and 

manufacturing practices, quality system 

management, patient perspective/input, 

simplification principles, and other 

challenges and how they impact the 

medical device development life cycle. 

ELP is a collaborative effort to enhance 

communication with our stakeholders to 

facilitate medical device reviews. The 

Center is committed to understanding 

current industry practices, innovative 

technologies, regulatory impacts and 

needs, and how patient perspective/ 

input, safety and quality systems 

management advance the development 

and evaluation of medical devices, and 

monitoring the performance of marketed 

devices. 

These formal training visits are not 

intended for FDA to inspect, assess, 

judge, or perform a regulatory function 

(e.g., compliance inspection), but rather, 

they are an opportunity to provide 

CDRH and other FDA staff a better 

understanding of the products they 

review, and how they are developed. 

Additionally, it is to understand 

challenges related to quality systems 

development and management and 

simplification in processes, patient 

preferences and safety, in the product 

life cycle, and how medical devices fit 

into the larger health care system. CDRH 

is formally requesting participation from 

industry, academia, and clinical 

facilities, medical device incubators and 

accelerators, health technology 

assessment groups, and those that have 

previously participated in the ELP or 

other FDA site visit programs. 

Additional information regarding the 

CDRH ELP, including current areas of 

interest, submission dates, a sample site 

visit request, and an example of a site 

visit agenda, is available on CDRH’s 

website at: https://www.fda.gov/ 

scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. 

II. CDRH ELP 

A. Areas of Interest 

In the ELP training program, groups of 

CDRH and other FDA staff will observe 

operations in the areas of research, 

device development, Digital Health, 

incorporating patient information and 

reimbursement, manufacturing, quality 

management principles, and health care 

facilities. The areas of interest for visits 

include various topics identified by 

managers at CDRH and other areas 

within FDA. These areas of interest are 

listed on the ELP website and are 

intended to be updated quarterly. 

To submit a proposal addressing one 

of the Center’s areas of interest, visit the 

link for the table of areas of interest at: 

https://www.fda.gov/ScienceResearch/ 

ScienceCareerOpportunities/ 

UCM380676.htm. 

Once you have determined an area of 

interest to address in your ELP proposal, 

follow the instructions in section III to 

complete the site visit request template 

and agenda provided at: https://

www.fda.gov/downloads/ 

ScienceResearch/ScienceCareer

Opportunities/UCM392988.pdf and at: 

https://www.fda.gov/downloads/ 

ScienceResearch/ScienceCareer

Opportunities/UCM487190.pdf. 

Submit all proposals at ELP@

fda.hhs.gov within the dates provided at 

the ELP website at: https://www.fda.gov/ 

scienceresearch/sciencecareer

opportunities/ucm380676.htm. 

B. Site Selection 

CDRH and FDA will be responsible 

for its own staff travel expenses 

associated with the site visits. CDRH 

and FDA will not provide funds to 

support the training provided by the site 

to the ELP. Selection of potential 

facilities will be based on CDRH and 

FDA’s priorities for staff training and 

resources available to fund this 

program. In addition to logistical and 

other resource factors, all sites must 

have a successful compliance record 

with FDA or another Agency with 

which FDA has a memorandum of 

understanding (if applicable). If a site 

visit involves a visit to a separate 

physical location of another firm under 

contract with the site, that firm must 

agree to participate in the ELP and must 

also have a satisfactory compliance 

history, and must be listed in the 

proposal along with a Facility 

Establishment Identifier number, if 

applicable. 

III. Request To Participate 

Information regarding the CDRH ELP, 

including a sample request and an 

example of a site visit agenda, and 

submission dates is available on CDRH’s 

website at: https://www.fda.gov/ 

scienceresearch/sciencecareer

opportunities/ucm380676.htm. 

Proposals to participate should be 

submitted at ELP@fda.hhs.gov, within 

the dates provided at the ELP website at: 

https://www.fda.gov/scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16177 Filed 7–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Meeting of the 

Secretary’s Advisory Committee on 

National Health Promotion and Disease 

Prevention Objectives for 2030 

AGENCY: Office of the Secretary, Office 

of the Assistant Secretary for Health, 

Office of Disease Prevention and Health 

Promotion, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

announces the next meeting of the 


daltland on DSKBBV9HB2PROD with NOTICES
36610 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

Secretary’s Advisory Committee on 

National Health Promotion and Disease 

Prevention Objectives for 2030 

(Committee). The meeting is open to the 

public and will be held in the 

Washington, DC metropolitan area. The 

Committee is working to accomplish its 

mission to provide independent advice 

to the Secretary of the U.S. Department 

of Health and Human Services or a 

designated representative for the 

implementation of Healthy People 2030. 

DATES: The Committee will meet on 

September 6, 2018, from 8:30 a.m. to 

5:00 p.m. Eastern Time (ET), and 

September 7, 2018, from 8:30 a.m. to 

3:00 p.m. ET. 

ADDRESSES: The meeting will be held at 

the 20 F Street Conference Center, 

located at 20th F Street NW, 

Washington, DC 20001. To register to 

attend the meeting, please visit the 

Healthy People website at https://

www.healthypeople.gov. 

FOR FURTHER INFORMATION CONTACT: 

Emmeline Ochiai, Designated Federal 

Officer, Secretary’s Advisory Committee 

on National Health Promotion and 

Disease Prevention Objectives for 2030, 

U.S. Department of Health and Human 

Services, Office of the Assistant 

Secretary for Health, Office of Disease 

Prevention and Health Promotion, 1101 

Wootton Parkway, Room LL–100, 

Rockville, MD 20852, (240) 453–8255 

(telephone), (240) 453–8281 (fax). 

Additional information is available on 

the Healthy People website at https://

www.healthypeople.gov. 

SUPPLEMENTARY INFORMATION: 

Appointed Committee Members: The 

names and biographies of the appointed 

Committee members are available at 

https://www.healthypeople.gov/2020/ 

about/history-development/healthypeople-2030-advisory-committee. 

Purpose of Meeting: In accordance 

with Federal Advisory Committee Act 

and to promote transparency of the 

process, deliberations of the Committee 

will occur in a public forum. At this 

meeting, the Committee will continue 

its deliberations from the last public 

meeting. 

Background: The Committee, a federal 

advisory committee, is charged with 

issuing recommendations for the 

Secretary regarding the implementation 

of national health promotion and 

disease prevention objectives for 2030. 

The Committee will discuss the nation’s 

health promotion and disease 

prevention objectives and will provide 

recommendations to improve health 

status and reduce health risks for the 

nation by the year 2030. The Committee 

will develop recommendations for 

implementing Healthy People 2030, 

including recommendations for 

engaging stakeholders in the 

implementation and achievement of the 

objectives. Through the Healthy People 

initiative, HHS leverages scientific 

insights and lessons from the past 

decade and new knowledge of current 

data, trends, and innovations to develop 

the next iteration of national health 

promotion and disease prevention 

objectives to improve the health of the 

nation. Healthy People provides 

science-based, 10-year national 

objectives for promoting health and 

preventing disease. Since 1979, Healthy 

People has set and monitored national 

health objectives that meet a broad 

range of health needs, encourage 

collaboration across sectors, guide 

individuals toward making informed 

health decisions, and measure the 

impact of our prevention and health 

promotion activities. 

Meeting Agenda: The meeting agenda 

is available at the Healthy People 

website at http://

www.healthypeople.gov. The Committee 

will develop further its 

recommendations regarding: 

Stakeholder engagement; the roles of 

health equity, complex systems science 

and modeling, and summary measures 

in Healthy People 2030; and activities 

for implementing Healthy People 2030. 

Public Participation at Meeting: 

Members of the public are invited to 

attend the Committee meeting. There 

will be no opportunity for oral public 

comments during the Committee 

meeting. However, written comments 

are welcome throughout the entire 

development process of the national 

health promotion and disease 

prevention objectives for 2030 and may 

be emailed to HP2030@hhs.gov. To 

attend the Committee meeting, 

individuals must pre-register at the 

Healthy People website at http://

www.healthypeople.gov. Registrations 

must be completed by 5:00 p.m. E.T., on 

August 31, 2018. Space for the meeting 

is limited and registration will be 

accepted until maximum room capacity 

is reached. A waiting list will be 

maintained should registrations exceed 

room capacity. Individuals on the 

waiting list will be contacted as 

additional space for the meeting 

becomes available. Registration 

questions may be directed to 

HealthyPeople@norc.org. 

Authority: 42 U.S.C. 217a. The 

Secretary’s Advisory Committee on 

National Health Promotion and Disease 

Prevention Objectives for 2030 is 

governed by provisions of the Federal 

Advisory Committee Act (FACA), Public 

Law 92–463, as amended (5 U.S.C., 

App.) which sets forth standards for the 

formation and use of federal advisory 

committees. 

Dated: July 25, 2018. 

Donald Wright, 

Deputy Assistant Secretary for Health, 

(Disease Prevention and Health Promotion). 

[FR Doc. 2018–16238 Filed 7–27–18; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–7006–N–13] 

60-Day Notice of Proposed Information 

Collection: Voucher Management 

System (VMS), Section 8 Budget and 

Financial Forms 

AGENCY: Office of the Assistant 

Secretary for Public and Indian 

Housing, PIH, HUD. 

ACTION: Notice. 

SUMMARY: HUD is seeking approval from 

the Office of Management and Budget 

(OMB) for the information collection 

described below. In accordance with the 

Paperwork Reduction Act, HUD is 

requesting comment from all interested 

parties on the proposed collection of 

information. The purpose of this notice 

is to allow for 60 days of public 

comment. 

DATES: Comments Due Date: September 

28, 2018. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

Control Number and should be sent to: 

Colette Pollard, Reports Management 

Officer, QDAM, Department of Housing 

and Urban Development, 451 7th Street 

SW, Room 4176, Washington, DC 

20410–5000; telephone 202–402–3400 

(this is not a toll-free number) or email 

at Colette.Pollard@hud.gov for a copy of 

the proposed forms or other available 

information. Persons with hearing or 

speech impairments may access this 

number through TTY by calling the tollfree Federal Relay Service at (800) 877– 

8339. 

FOR FURTHER INFORMATION CONTACT: 

Arlette Mussington, Office of Policy, 

Programs and Legislative Initiatives, 

PIH, Department of Housing and Urban 

Development, 451 7th Street SW, 

(L’Enfant Plaza, Room 2206), 

Washington, DC 20410; telephone 202– 

402–4109, (this is not a toll-free 

number). Persons with hearing or 

speech impairments may access this 

number via TTY by calling the Federal 

Information Relay Service at (800) 877– 


daltland on DSKBBV9HB2PROD with NOTICES