Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 44807 

agenda for the hearing and any other 

background materials will be made 

available 5 days before the hearing at 

https://www.fda.gov/NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm572528.htm. 

If you need special accommodations 

because of a disability, please contact 

the Office of Combination Products at 

301–796–8930 or combination@fda.gov 

at least 7 days before the hearing. 

Streaming Webcast of the Public 

Hearing: For those unable to attend in 

person, FDA will provide a live webcast 

of the hearing. To join the hearing via 

the webcast, please go to https://

www.fda.gov/NewsEvents/Meetings

ConferencesWorkshops/ 

ucm572528.htm. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A transcript will also be 

available in either hard copy or on CD– 

ROM, after submission of a Freedom of 

Information request. The Freedom of 

Information office address is available 

on the Agency’s Web site at https://

www.fda.gov. 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with 21 CFR 

part 15. The hearing will be conducted 

by a presiding officer, who will be 

accompanied by FDA senior 

management from the Office of the 

Commissioner, the Center for Drug 

Evaluation and Research, the Center for 

Devices and Radiological Health, and 

the Center for Biologics Evaluation and 

Research. Under § 15.30(f), the hearing 

is informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may pose questions; they may 

question any person during or at the 

conclusion of each presentation. Public 

hearings under part 15 are subject to 

FDA’s policy and procedures for 

electronic media coverage of FDA’s 

public administrative proceedings (21 

CFR part 10, subpart C). Under § 10.205, 

representatives of the media may be 

permitted, subject to certain limitations, 

to videotape, film, or otherwise record 

FDA’s public administrative 

proceedings, including presentations by 

participants. The hearing will be 

transcribed as stipulated in § 15.30(b) 

(see Transcripts). To the extent that the 

conditions for the hearing, as described 

in this notice, conflict with any 

provisions set out in part 15, this notice 

acts as a waiver of those provisions as 

specified in § 15.30(h). 

Dated: September 19, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20521 Filed 9–25–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

COMPETES Reauthorization Act 

Challenge Competition 

AGENCY: Health Resources and Services 

Administration, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration’s (HRSA’s) 

Maternal and Child Health Bureau 

(MCHB) announces a prize competition 

to support the development and testing 

of low-cost, scalable technology-based 

innovations to meet the needs of 

families and health care providers of 

children with special health care needs 

(CSHCN), particularly children with 

medical complexity (CMC), to improve 

the quality of care, patient 

empowerment, and family experiences 

while saving costs to the health care 

system. 

FOR FURTHER INFORMATION CONTACT: 

James Resnick, Office of the Associate 

Administrator, MCHB, JResnick@

hrsa.gov, (301) 443–3222, or Marie 

Mann, Division of Services for Children 

with Special Health Needs, MCHB, 

MMann@hrsa.gov, (301) 443–4925. 

SUPPLEMENTARY INFORMATION: On 

January 4, 2011, the America 

COMPETES Reauthorization Act of 2010 

was signed into law allowing the use of 

challenges and prize competitions 

increasing agencies’ ability to promote 

and harness innovation. Competitions 

run by the federal government result in 

a number of benefits to the public, 

including the following: 

(a) Increasing the number and 

diversity of the individuals, teams, and 

organizations that are addressing a 

particular problem or challenge of 

national significance; 

(b) Improving the skills of the 

participants in the competition; and 

(c) Directing attention to new market 

opportunities and stimulating private 

sector investment. 

This challenge structured in three 

phases, reach a diverse population of 

innovators and solvers, including 

coders, public health experts, 

individuals affiliated with academic 

institutions, research and development 

communities in the private sector, and 

others. All submissions will be 

evaluated and separate prizes will be 

awarded for each of the three phases 

below. 

Phase 1: Design 

Phase 2: Development and Small Scale 

Testing 

Phase 3: Scaling 

Estimated dates for each phase are as 

follows: 

Phase 1: Effective on January 22, 2018 

Phase 1 Submission Period Ends: April 

20, 2018, 11:59 p.m. ET 

Phase 1 Judging Period: April 21–May 

18, 2018 

Phase 1 Winners Announced: May 25, 

2018 

Phase 2 Begins: May 29, 2018 

Phase 2 Submission Period Ends: 

October 26, 2018 

Phase 2 Judging Period: October 29– 

November 20, 2018 

Phase 2 Winners Announced: December 

4, 2018 

Phase 3 Begins: December 7, 2018 

Phase 3 Submission Period Ends: May 

10, 2019 

Phase 3 Winner Announced: May 30, 

2019 

Subject of Challenge Competition 

MCHB is sponsoring the Making 

Technology Work for Care Planning and 

Coordination for Children with Special 

Health Care Needs Challenge. CSHCN, 

particularly CMC, often rely on multiple 

systems, services, and health 

professionals to maintain health and 

optimize well-being. Care coordination 

and care planning centered on the 

comprehensive needs of the child and 

family can lead to improved quality and 

experience of care, as well as more costeffective care. Even with the presence of 

care coordinators and the development 

of shared care plans, communication 

and collaboration gaps remain because 

care coordinators and the shared care 

plans often are specific to providers 

and/or systems. Families have 

expressed frustration about working 

with the multiple systems and the lack 

of communication and coordination 

between them. They try to address the 

gap by assuming responsibility for their 

children’s 24/7 care and care 

coordination. However, they often 

encounter numerous obstacles and 

barriers to fulfilling this role, including 

difficulty obtaining needed information 

or guidance from health professionals. 

They desire resources like electronic 

and informational tools to allow easy 

aggregation of information and sharing 

44808 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 

from multiple providers to meet these 

expectations and responsibilities. 

Health information technology can 

play a critical role in effecting care 

coordination and information sharing. 

Electronic tools can facilitate 

information sharing among families and 

their children’s health care teams. 

Electronic care plans integrated into an 

electronic health record have the 

potential to facilitate information 

sharing between providers and families, 

particularly when coupled with patient/ 

family portals. While electronic health 

records (EHR)-supported patient portals 

allow families access to the children’s 

medical records, the information 

‘‘pushed’’ to the patient/family portal 

reflects only care received from the 

specific providers or health systems. 

CSHCN and particularly CMC 

frequently receive care from multiple 

health systems and families must access 

multiple patient portals to obtain a full 

picture of the children’s health 

information. Often the most complete 

information on CMC reside with their 

parents/caregivers, and a common need 

identified by families of CMC is 

improved and ready access to essential 

information for managing care, 

especially in urgent and emergency 

situations. This is particularly critical 

for families of CMC who reside in 

isolated or rural communities where the 

local health system is not able to care 

for the children. 

Similarly, while a majority of child 

health professionals have adopted the 

EHR, a significant number do not have 

a fully functional EHR with added 

pediatric functionality. Lack of pediatric 

functionality requires that clinicians 

perform tasks outside the EHR or 

develop workarounds adding to 

workload and reducing productivity and 

efficiency. Clinicians report feeling 

overburdened and express frustration at 

not having adequate support for the 

increased demand to adopt processes for 

coordinating care and sharing 

information. For the time being, the 

primary ‘‘solution’’ for fragmented 

providers and systems communication 

and coordination has become the 

responsibility of the families of CSHCN 

and CMC, with their 3-ring binders that 

contain important information and care 

plans from the various providers and 

systems; these binders are cumbersome, 

and it is difficult and time-consuming to 

keep them current. 

MCHB seeks innovations to address 

how to make technology work to 

improve care coordination and planning 

for CSHCN, their families, and the child 

health professionals who care for them. 

The solution allows for the electronic 

exchange of the children’s shared plans 

of care across multiple providers and 

care sites and consolidation of health 

information in a single user interface 

that supports access anytime, anywhere, 

with families maintaining control over 

who can modify or see this critical 

information. Information from the care 

plans could be extracted, compiled, and 

aggregated on a mobile platform so 

families can have 24/7 access to such 

information, specifically the 

information that lets parents/caregivers 

know when they need to call their 

primary care and/or specialty care 

providers and for what reason (i.e., the 

information needed to manage 

emergencies). This responsive platform 

should have the potential to integrate 

with existing platforms. Additionally, 

the challenge will bring forth multiple 

solutions (products/services) that could 

better scale and enhance healthcare 

services and family experiences with 

care. 

Key design features of the innovations 

include: 

• Low-cost and scalable; 

• Intuitively designed with needs of 

families in mind and information 

organized in a manner that makes sense 

to them; 

• Control of the information resides 

with families; 

• Engages child health professionals; 

• Employs Office of the National 

Coordinator for Health Information 

Technology (ONC) certified standards, 

where appropriate; 

• Advanced security architecture— 

HIPPA enabled; and 

• Broadly applicable to CSHCN/CMC 

and not confined to a population of 

children with a specific condition. 

Eligibility Rules for Participating in the 

Competition 

To be eligible to win a prize under 

this challenge, an individual or entity— 

(1) Shall have registered to participate 

in the competition under the rules 

promulgated by HRSA and the U.S. 

Department of Health and Human 

Services (HHS). 

(2) Shall have complied with all the 

requirements under this section. 

(3) In the case of a private entity, shall 

be incorporated in and maintain a 

primary place of business in the United 

States, and in the case of an individual, 

whether participating singly or in a 

group, shall be a citizen or permanent 

resident of the United States. 

(4) May not be a federal entity or 

federal employee acting within the 

scope of their employment. 

(5) Shall not be an HHS employee 

working on their applications or 

submissions during assigned duty 

hours. 

(6) May not be employees of HRSA or 

any other company, organization, or 

individual involved with the design, 

production, execution, judging, or 

distribution of the Challenge and their 

immediate family (i.e., spouse, parents 

and step-parents, siblings and stepsiblings, and children and stepchildren) and household members (i.e., 

people who share the same residence at 

least 3 months out of the year). 

(7) In the case of a federal grantee, 

may not use federal funds to develop 

COMPETES Act challenge applications 

unless consistent with the purpose of 

their grant award. 

(8) In the case of a federal contractor, 

may not use federal funds from a 

contract to develop COMPETES Act 

challenge applications or to fund efforts 

in support of a COMPETES Act 

challenge submission. 

(9) Shall not be deemed ineligible 

because the individual or entity used 

federal facilities or consulted with 

federal employees during a competition 

if the facilities and employees are made 

equitably available to all individuals 

and entities participating in the 

competition. 

(10) Must agree to assume any and all 

risks and waive claims against the 

federal government and its related 

entities, except in the case of willful 

misconduct, for any injury, death, 

damage, or loss of property, revenue, or 

profits, whether direct, indirect, or 

consequential, arising from the 

participation in this prize contest, 

whether the injury, death, damage, or 

loss arises through negligence or 

otherwise. 

(11) Must also agree to indemnify the 

federal government against third party 

claims for damages arising from or 

related to competition activities. 

(12) Shall not be currently on the 

Excluded Parties List (https://

www.epls.gov/). 

Submission Requirements 

The Challenge has three phases. 

Phase 1—Design 

The first stage of the prize 

competition aims to attract a large set of 

ideas and innovators. The target product 

of the first stage will be the 

conceptualization of the most promising 

innovations to meet the care planning 

and coordination needs of families and 

health care providers of children with 

special health care needs (CSHCN), 

particularly children with medical 

complexity (CMC). 

The submissions should aim to 

demonstrate that the proposed 

intervention will be accessible across 

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 44809 

diverse backgrounds and easily 

implemented by users. 

The Phase 1 Submission shall 

include: 

1. A comprehensive description of the 

proposed intervention in five pages or 

less, including: 

a. A one-paragraph executive 

summary that clearly states the question 

to be solved; 

b. Background information linking the 

evidence to support the intervention; 

c. A descriptive analysis of how the 

applicant arrived at their idea; 

d. Descriptions of the methods and 

technologies involved in 

implementation of the intervention 

e. An assessment describing the 

applicant’s ability to execute the 

proposed solution in Phases 2 and 3. 

Phase 2—Development and Small Scale 

Testing 

The winners of Phase 1 of the prize 

competition will then advance to a 

second stage focused on prototyping the 

intervention, and testing the 

effectiveness of the intervention. Using 

support from the Phase 1 prize funding, 

intervention developers will test the 

efficacy of their models to show that the 

proposed intervention demonstrates an 

impact on the outcomes for CSHCN and 

their families. The applicants should 

demonstrate both the evidence base for 

the intervention and its usability. 

Mentors will be available to help 

participants design appropriate testing 

methodologies and learn more about the 

evidence base. 

Phase 3—Scaling 

The winners of Phase 2 will move to 

the final phase of the incentive prize, 

which will involve testing the most 

promising models at greater scale 

through rollout at the program or 

community level. This will test the 

scalability of the device at low-cost, the 

feasibility of implementation, and the 

impact on the intended outcomes. 

Registration Process for Participants 

Participants will be able to register 

and submit an entry at the Making 

Technology Work for Care Planning and 

Coordination for Children with Special 

Health Care Needs Challenge Web site. 

Participants can find out more 

information at https://

www.challenge.gov/list/. 

Prizes 

• Total: $375,000 in Prizes 

Æ Phase 1: 7–10 winners; up to a total 

of $100,000 in prizes 

Æ Phase 2: 3–5 winners; up to a total 

of $125,000 in prizes 

Æ Phase 3: 1 winner; up to a total of 

$150,000 prize 

Payment of the Prizes 

Prize payments will be paid by a 

contractor. Phase 1 winners may be 

expected to use a portion of the prize 

money for travel and lodging to attend 

a 2-day meeting in Washington, DC, to 

demonstrate their innovation to the 

judges. 

Prizes awarded under this 

competition will be paid by electronic 

funds transfer and may be subject to 

Federal income taxes. HHS will comply 

with the Internal Revenue Service 

withholding and reporting 

requirements, where applicable. 

Basis for Winner Selection 

A review panel composed of HHS 

employees and experts will judge 

challenge entries in compliance with 

the requirements of the COMPETES Act 

and HHS judging guidelines: http://

www.hhs.gov/idealab/wp-content/ 

uploads/2014/04/HHS-COMPETITIONJUDGING-GUIDELINES.pdf. 

The review panel will make selections 

based upon the following criteria: 

Phase 1 

In Phase 1, proposed interventions to 

be judged on the following criteria: 

Accessibility 

• Is the proposed intervention easily 

utilized by families of diverse economic, 

social, and cultural backgrounds? Is it 

functional across disciplines/users? 

Measurability 

• How easily will the proposed 

intervention be evaluated in order to 

determine its efficacy (in both lab 

testing and in the real world)? Is the 

proposed intervention measurable 

among various audiences? 

Sustainability 

• Does the proposed intervention 

compel users to utilize the technology 

often and/or for long periods of time 

(‘‘sticky’’)? Does it fit into daily life? Is 

it easy to use? 

Impact 

• Does the applicant present a theory 

or explanation of how the proposed 

intervention would inspire coordination 

and collaboration between families and 

providers? 

Phase 2 

In Phase 2, interventions will be 

judged on the following criteria: 

Impact 

• How did the intervention impact 

families and child health professionals? 

Were desired outcomes achieved? 

Evidence Base 

• Is the intervention grounded in 

existing science and patient/family/ 

clinician preferences? 

Sustainability 

• Was the intervention ‘‘sticky’’ 

among users? Did users want to 

continuously engage with the 

development, testing, and scaling of the 

innovation? 

Implementation 

• How feasible is the intervention? 

How much support for implementation 

will the intervention require (estimated 

financial and time commitment). 

Phase 3 

In Phase 3, interventions will be 

judged on the following criteria: 

Impact 

• How effective was the intervention 

when implemented at scale? Did the 

impacts from Phase 2 remain 

consistent? 

Implementation 

• How feasible was the intervention 

on a larger scale? How much support for 

implementation did the model require 

(financial and time commitment). How 

challenging was the actual program 

implementation? 

Scalability 

• How costly was the intervention in 

a real-world setting? How likely are cost 

efficiencies for program delivery at 

greater scale? Can the device be used in 

existing platforms? 

Additional Information 

General Conditions 

• HRSA reserves the right to cancel, 

suspend, and/or modify the contest, or 

any part of it, for any reason, at HRSA’s 

sole discretion. 

• The interventions submitted across 

all phases should not use the HHS or 

HRSA logos or official seals in the 

submission, and must not claim 

endorsement. 

Intellectual Property 

• Each entrant retains full ownership 

and title in and to their submission. 

Entrants expressly reserve all 

intellectual property rights not 

expressly granted under the challenge 

agreement. 

• By participating in the challenge, 

each entrant hereby irrevocably grants 

to HRSA a limited, non-exclusive, 

royalty-free, worldwide license and 

right to reproduce, publically perform, 

publically display, and use the 

submission for internal HHS business 

44810 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 

and to the extent necessary to 

administer the challenge, and to 

publically perform and publically 

display the submission, including, 

without limitation, for advertising and 

promotional purposes relating to the 

challenge. 

• Record Retention and FOIA: All 

materials submitted to HRSA as part of 

a submission become HRSA records and 

cannot be returned. Any confidential 

commercial information contained in a 

submission should be designated at the 

time of submission. Participants will be 

notified of any Freedom of Information 

Act requests for their submissions in 

accordance with 45 CFR 5.65. 

The statutory authority for this 

challenge competition is Section 105 of 

the America COMPETES 

Reauthorization Act of 2010 

(COMPETES Act, Pub. L. 111–358) as 

amended by section 401(b) of the 

American Innovation and 

Competitiveness Act, Public Law 114– 

329. 

Dated: September 19, 2017. 

George Sigounas, 

Administrator. 

[FR Doc. 2017–20536 Filed 9–25–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Challenge Competition: Using 

Technology to Prevent Childhood 

Obesity in Low-Income Families and 

Communities 

AGENCY: Health Resources and Services 

Administration, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration’s (HRSA’s) 

Maternal and Child Health Bureau 

(MCHB) announces a prize competition 

to support the development of low-cost, 

scalable technology-based innovations 

to promote healthy weight for lowincome children and families in the 

socio-cultural and environmental 

contexts of their communities. 

The statutory authority for this 

challenge competition is Section 105 of 

the America COMPETES 

Reauthorization Act of 2010. 

This challenge, structured in three 

phases, will reach a diverse population 

of innovators and problem solvers, 

including families, coders, public health 

experts, community leaders, individuals 

affiliated with academic institutions, 

research and development communities 

in the private sector, and others. 

All submissions will be evaluated and 

separate prizes will be awarded for each 

of the three phases below. 

Phase 1: Design 

Phase 2: Development and Small Scale 

Testing 

Phase 3: Scaling 

Estimated dates for each phase are as 

follows: 

Phase 1: Effective on January 2, 2018 

Phase 1 Submission Period Ends: 

January 31, 2018, 11:59 p.m. ET 

Phase 1 Judging Period: February 1- 

February 28, 2018 

Phase 1 Winners Announced: March 12, 

2018 

Phase 2 Begins: March 13, 2018 

Phase 2 Submission Period Ends: July 

11, 2018 

Phase 2 Judging Period: July 12-August 

12, 2018 

Phase 2 Winners Announced: August 

20, 2018 

Phase 3 Begins: August 21, 2018 

Phase 3 Submission Period Ends: 

February 21, 2019 

Phase 3 Winner Announced: March 1, 

2019 

FOR FURTHER INFORMATION CONTACT: 

Meredith Morrissette, Division of 

Maternal and Child Health Workforce 

Development, MCHB, MMorrissette@

hrsa.gov, (301) 443–6392, or James 

Resnick, Office of the Associate 

Administrator, MCHB, JResnick@

hrsa.gov, (301) 443–3222. 

SUPPLEMENTARY INFORMATION: On 

January 4, 2011, the America 

COMPETES Reauthorization Act of 2010 

was signed into law allowing the use of 

challenges and prize competitions 

increasing agencies’ ability to promote 

and harness innovation. Competitions 

run by the federal government result in 

a number of benefits to the public, 

including the following: 

(a) Increasing the number and 

diversity of the individuals, teams, and 

organizations that are addressing a 

particular problem or challenge of 

national significance; 

(b) Improving the skills of the 

participants in the competition; and 

(c) Directing attention to new market 

opportunities and stimulating private 

sector investment. 

Subject of Challenge Competition 

Secretary Price identified reducing 

childhood obesity as a priority for the 

Department of Health and Human 

Services (HHS), acknowledging this is a 

growing epidemic in the United States. 

Since 1980, childhood obesity rates for 

2- to 19-year-olds have tripled, with 

rates of obesity in 6- to 11-year-olds 

more than doubling, and rates of obesity 

in 12- to 19-year-olds quadrupling. 

While improved eating behaviors and 

increased physical activity play a large 

role in obesity prevention, additional 

public health factors such as limited 

access to affordable, healthy food 

options, social and cultural norms, and 

limited availability of safe places to play 

also impact childhood obesity rates. 

While existing apps and tools address 

individual behaviors, such as exercise 

and nutrition, their uptake in 

underserved communities is limited 

because they are not tailored to the 

needs, challenges, and barriers to 

healthy weight in these communities. 

The goal of this challenge is to make 

technology work for the family as a unit 

within the reality of their larger 

community environment. 

Addressing childhood obesity from a 

population-based, public health 

perspective as a complement to the 

individual clinical perspective requires 

innovative, community-based solutions 

and partnerships. A challenge will 

maximize competition and spur 

innovation for communities in a costeffective and accelerated timeframe. It 

will reach a broad stakeholder group 

and allow involvement of nontraditional partners who are 

knowledgeable about the strengths and 

challenges affecting the community, and 

who can bring new ideas towards 

addressing this issue. A challenge will 

provide support for the development of 

several innovative ideas through a payfor-results mechanism, ultimately 

leading to the development of multiple 

novel and scalable interventions. 

Potential areas of focus include, but 

are not limited to: 

• Promoting access to healthy, 

affordable food; 

• Supporting community-owned 

solutions that increase families’ 

knowledge and skills related to healthy 

eating and nutrition; 

• Finding innovative ways that 

increase physical activity, such as 

gamification, while accounting for 

environmental barriers to physical 

activity in underserved communities; 

and 

• Empowering families to achieve 

healthy eating practices, healthy 

lifestyles, and sustainable changes in 

the home environment, while 

accounting for limited access to healthy 

foods in under-resourced communities. 

Key design features of the innovations 

may address one or more of the 

following: 

• Be at low-cost to families and 

scalable;