[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44818-44820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20539]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Challenge Competition: Improving Remote Monitoring of Pregnancy

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 improve the ability of prenatal care 
providers to monitor the health and wellbeing of pregnant women 
remotely, especially women who live in rural and medically-underserved 
areas who have limited access to on-site prenatal care.
    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; 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: Jessie Buerlein, MSW, Office of Policy 
and Planning, MCHB, <a href="/cdn-cgi/l/email-protection#1d575f68786f717874735d756f6e7c337a726b"><span class="__cf_email__" data-cfemail="58121a2d3d2a343d313618302a2b39763f372e">[email protected]</span></a>, (301) 443-8931, or James 
Resnick, Office of the Associate Administrator, MCHB, 
<a href="/cdn-cgi/l/email-protection#3b71695e48555258507b5349485a155c544d"><span class="__cf_email__" data-cfemail="357f6750465b5c565e755d4746541b525a43">[email protected]</span></a>, (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

    In recent years, technological advances have improved the ability 
of healthcare providers to monitor their patients from afar. For 
example, wearable biosensors provide for the remote monitoring of 
patients, athletes, premature infants, children, psychiatric patients, 
people who need long-term care, the elderly, and people in rural and 
medically underserved areas. Telemedicine is improving access for 
patients, while smartphone apps are improving patients' ability for 
self-care.
    At the same time, recent scientific advances around developmental 
origins of health and disease point to the important role that 
environmental exposures, nutrition, and stress play in maternal health 
and fetal programming. Remote, real-time, and more continuous 
monitoring of harmful environmental exposures, nutritional intake and 
energy expenditure, and stress and sleep, along with blood pressure, 
proteinuria, blood glucose, and fetal heart rate, has the potential to 
improve prenatal care quality and pregnancy outcomes while reducing 
healthcare costs.
    Recent trends in hospital closures in rural America also increase 
the need for technological innovations that support remote monitoring 
of pregnant women. Between 2004 and 2014, 179 rural counties (9 percent 
of all rural counties) lost access to in-county hospital obstetric 
services, and the percent of all rural counties in the U.S. that lacked 
hospital obstetric services increased from 45 to 54 percent, due to 
hospital and obstetric-unit closures.\1\ Many low-income women, in both 
rural and urban communities, do not access prenatal care. Fully 
conflicting priorities such as work, childcare, and transportation make 
it difficult to make the approximately 15 visits to their provider's 
office, which include critical medical assessments and instructions 
about self-care. This challenge is designed to make technology work for 
pregnant women, increase access, improve communications (between 
patients and providers and across providers), and empower pregnant 
women to take better care of themselves.
---------------------------------------------------------------------------

    \1\ http://rhrc.umn.edu/wp-content/files_mf/1491501904UMRHRCOBclosuresPolicyBrief.pdf.
---------------------------------------------------------------------------

    This challenge will support the development and testing of low-
cost, scalable technology-based innovations to improve the ability of 
prenatal care providers to monitor the health and wellbeing of pregnant 
women from afar (e.g., in their homes); utilizing technology to empower 
patients and providers with more complete and up-to-date information.
    Key design features of the innovations should include:

[[Page 44819]]

    <bullet> The innovation is low-cost to families and scalable;
    <bullet> The innovation is safe, accurate, and effective;
    <bullet> The innovation supports remote, real-time, and more 
continuous monitoring and early detection;
    <bullet> The innovation improves communication between patients and 
providers;
    <bullet> The innovation improves patient-centeredness of prenatal 
care;
    <bullet> What gets monitored is grounded in science (e.g., 
developmental origins of health and disease); and
    <bullet> The innovation empowers patients to use their own health 
data to improve behaviors.

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 improve 
the ability of prenatal care providers to monitor the health and 
wellbeing of pregnant women remotely, especially women who live in 
rural and medically underserved areas who have limited access to on-
site prenatal care.
    The submissions should aim to demonstrate that the proposed 
intervention will be accessible across 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; and
    e. An assessment describing the applicant's ability to execute the 
proposed solution in Phase 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 of interest for providers and pregnant women. 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 
Improving Remote Monitoring of Pregnancy Challenge Web site. 
Participants can find out more information at https://www.challenge.gov/list/.

Prizes

<bullet> 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 America 
COMPETES Act and HHS judging guidelines: http://www.hhs.gov/idealab/wp-content/uploads/2014/04/HHS-COMPETITION-JUDGING-GUIDELINES.pdf.

[[Page 44820]]

    The review panel will make selections based upon the following 
criteria:

Phase 1

Accessibility

    <bullet> Is the proposed intervention easily utilized by families 
of diverse economic, social, and cultural backgrounds? Is it functional 
across disciplines/users?

Measurability

    <bullet> 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

    <bullet> Does the proposed intervention compel users to utilize the 
technology often and/or for long periods of time? Does it fit into 
daily life? Is it fun to use?

Impact

    <bullet> Does the applicant present a theory or explanation of how 
the proposed intervention would result in concrete change?

Phase 2

Impact

    <bullet> How did the intervention impact outcomes for providers and 
patients? What did data show?

Evidence Base

    <bullet> Is the intervention grounded in existing science related 
to improving health care and related services for pregnant women?

Sustainability

    <bullet> Was the intervention compelling to users and did it 
encourage users to use the technology often? Did users want to 
continuously engage with the technology?

Implementation

    <bullet> How feasible is the intervention? How much support for 
implementation will the intervention require (estimated financial and 
time commitment)?

Phase 3

Impact

    <bullet> How effective was the intervention when implemented at 
scale? Did the impacts on users from Phase 2 remain consistent?

Implementation

    <bullet> 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

    <bullet> How costly was the intervention in a real-world setting? 
How likely are cost efficiencies for program delivery at greater scale? 
Can the technology be used in existing platforms?

Additional Information

    General Conditions:
    <bullet> 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.
    <bullet> 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

    <bullet> 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.
    <bullet> 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 
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.
    <bullet> 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.

    Dated: September 19, 2017.
George Sigounas,
Administrator.
[FR Doc. 2017-20539 Filed 9-25-17; 8:45 am]
BILLING CODE 4165-15-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>