82 FR 44807 - COMPETES Reauthorization Act Challenge Competition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 185 (September 26, 2017)

Page Range		44807-44810
FR Document		2017-20536
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.
Federal Register, Volume 82 Issue 185 (Tuesday, September 26, 2017)
[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44807-44810]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20536]


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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.

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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, [email protected], (301) 443-3222, or Marie Mann, 
Division of Services for Children with Special Health Needs, MCHB, 
[email protected], (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 cost-effective 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

[[Page 44808]]

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 
step-siblings, and children and step-children) 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

[[Page 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
    [cir] Phase 1: 7-10 winners; up to a total of $100,000 in prizes
    [cir] Phase 2: 3-5 winners; up to a total of $125,000 in prizes
    [cir] 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-COMPETITION-JUDGING-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

[[Page 44810]]

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

agenda for the hearing and any other acts as a waiver of those provisions as coders, public health experts,
background materials will be made specified in § 15.30(h). individuals affiliated with academic
available 5 days before the hearing at Dated: September 19, 2017. institutions, research and development
https://www.fda.gov/NewsEvents/ Anna K. Abram, communities in the private sector, and
MeetingsConferencesWorkshops/ others. All submissions will be
Deputy Commissioner for Policy, Planning,
ucm572528.htm. Legislation, and Analysis. evaluated and separate prizes will be
If you need special accommodations awarded for each of the three phases
[FR Doc. 2017–20521 Filed 9–25–17; 8:45 am]
because of a disability, please contact below.
BILLING CODE 4164–01–P
the Office of Combination Products at Phase 1: Design
301–796–8930 or combination@fda.gov Phase 2: Development and Small Scale
at least 7 days before the hearing. Testing
Streaming Webcast of the Public DEPARTMENT OF HEALTH AND
HUMAN SERVICES Phase 3: Scaling
Hearing: For those unable to attend in Estimated dates for each phase are as
person, FDA will provide a live webcast Health Resources and Services follows:
of the hearing. To join the hearing via Administration
the webcast, please go to https:// Phase 1: Effective on January 22, 2018
www.fda.gov/NewsEvents/Meetings Phase 1 Submission Period Ends: April
COMPETES Reauthorization Act
ConferencesWorkshops/ 20, 2018, 11:59 p.m. ET
Challenge Competition
ucm572528.htm. Phase 1 Judging Period: April 21–May
Transcripts: Please be advised that as AGENCY: Health Resources and Services 18, 2018
soon as a transcript is available, it will Administration, Department of Health Phase 1 Winners Announced: May 25,
be accessible at https:// and Human Services. 2018
www.regulations.gov. It may be viewed ACTION: Notice. Phase 2 Begins: May 29, 2018
at the Dockets Management Staff (see Phase 2 Submission Period Ends:
SUMMARY: The Health Resources and October 26, 2018
ADDRESSES). A transcript will also be
Services Administration’s (HRSA’s) Phase 2 Judging Period: October 29–
available in either hard copy or on CD–
Maternal and Child Health Bureau November 20, 2018
ROM, after submission of a Freedom of
Information request. The Freedom of (MCHB) announces a prize competition Phase 2 Winners Announced: December
Information office address is available to support the development and testing 4, 2018
on the Agency’s Web site at https:// of low-cost, scalable technology-based Phase 3 Begins: December 7, 2018
www.fda.gov. innovations to meet the needs of Phase 3 Submission Period Ends: May
families and health care providers of 10, 2019
IV. Notice of Hearing Under 21 CFR children with special health care needs Phase 3 Winner Announced: May 30,
Part 15 (CSHCN), particularly children with 2019
The Commissioner of Food and Drugs medical complexity (CMC), to improve
the quality of care, patient Subject of Challenge Competition
is announcing that the public hearing
will be held in accordance with 21 CFR empowerment, and family experiences MCHB is sponsoring the Making
part 15. The hearing will be conducted while saving costs to the health care Technology Work for Care Planning and
by a presiding officer, who will be system. Coordination for Children with Special
accompanied by FDA senior FOR FURTHER INFORMATION CONTACT: Health Care Needs Challenge. CSHCN,
management from the Office of the James Resnick, Office of the Associate particularly CMC, often rely on multiple
Commissioner, the Center for Drug Administrator, MCHB, JResnick@ systems, services, and health
Evaluation and Research, the Center for hrsa.gov, (301) 443–3222, or Marie professionals to maintain health and
Devices and Radiological Health, and Mann, Division of Services for Children optimize well-being. Care coordination
the Center for Biologics Evaluation and with Special Health Needs, MCHB, and care planning centered on the
Research. Under § 15.30(f), the hearing MMann@hrsa.gov, (301) 443–4925. comprehensive needs of the child and
is informal and the rules of evidence do SUPPLEMENTARY INFORMATION: On family can lead to improved quality and
not apply. No participant may interrupt January 4, 2011, the America experience of care, as well as more cost-
the presentation of another participant. COMPETES Reauthorization Act of 2010 effective care. Even with the presence of
Only the presiding officer and panel was signed into law allowing the use of care coordinators and the development
members may pose questions; they may challenges and prize competitions of shared care plans, communication
question any person during or at the increasing agencies’ ability to promote and collaboration gaps remain because
conclusion of each presentation. Public and harness innovation. Competitions care coordinators and the shared care
hearings under part 15 are subject to run by the federal government result in plans often are specific to providers
FDA’s policy and procedures for a number of benefits to the public, and/or systems. Families have
electronic media coverage of FDA’s including the following: expressed frustration about working
public administrative proceedings (21 (a) Increasing the number and with the multiple systems and the lack
CFR part 10, subpart C). Under § 10.205, diversity of the individuals, teams, and of communication and coordination
representatives of the media may be organizations that are addressing a between them. They try to address the
permitted, subject to certain limitations, particular problem or challenge of gap by assuming responsibility for their
to videotape, film, or otherwise record national significance; children’s 24/7 care and care
FDA’s public administrative (b) Improving the skills of the coordination. However, they often
proceedings, including presentations by participants in the competition; and encounter numerous obstacles and
participants. The hearing will be (c) Directing attention to new market barriers to fulfilling this role, including
transcribed as stipulated in § 15.30(b) opportunities and stimulating private difficulty obtaining needed information
(see Transcripts). To the extent that the sector investment. or guidance from health professionals.
conditions for the hearing, as described This challenge structured in three They desire resources like electronic
in this notice, conflict with any phases, reach a diverse population of and informational tools to allow easy
provisions set out in part 15, this notice innovators and solvers, including aggregation of information and sharing

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		James Resnick, Office of the Associate Administrator, MCHB, [email protected], (301) 443-3222, or Marie Mann, Division of Services for Children with Special Health Needs, MCHB, [email protected], (301) 443-4925.
FR Citation		82 FR 44807
82 FR 44807 - COMPETES Reauthorization Act Challenge Competition

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 82, Issue 185 (September 26, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
