82 FR 44818 - Challenge Competition: Improving Remote Monitoring of Pregnancy
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 185 (September 26, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 185 (September 26, 2017)
| Page Range | 44818-44820 | |
| FR Document | 2017-20539 |
[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)] [Notices] [Pages 44818-44820] From the Federal Register Online [www.thefederalregister.org] [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, [email protected], (301) 443-8931, or James Resnick, Office of the Associate Administrator, MCHB, [email protected], (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]]The innovation is low-cost to families and scalable; The innovation is safe, accurate, and effective; The innovation supports remote, real-time, and more continuous monitoring and early detection; The innovation improves communication between patients and providers; The innovation improves patient-centeredness of prenatal care; What gets monitored is grounded in science (e.g., developmental origins of health and disease); and 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 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 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? Does it fit into daily life? Is it fun to use? Impact Does the applicant present a theory or explanation of how the proposed intervention would result in concrete change? Phase 2 Impact How did the intervention impact outcomes for providers and patients? What did data show? Evidence Base Is the intervention grounded in existing science related to improving health care and related services for pregnant women? Sustainability 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 How feasible is the intervention? How much support for implementation will the intervention require (estimated financial and time commitment)? Phase 3 Impact How effective was the intervention when implemented at scale? Did the impacts on users 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 technology 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 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. Dated: September 19, 2017. George Sigounas, Administrator. [FR Doc. 2017-20539 Filed 9-25-17; 8:45 am] BILLING CODE 4165-15-P
![44818 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices
Court of Federal Claims No: 17–1159V the America COMPETES healthcare providers to monitor their
82. Sandra Blevins, New York, New Reauthorization Act of 2010. patients from afar. For example,
York This challenge, structured in three wearable biosensors provide for the
Court of Federal Claims No: 17–1161V phases, will reach a diverse population remote monitoring of patients, athletes,
83. Michele Harding on behalf of W. J. of innovators and problem solvers premature infants, children, psychiatric
H., Madison, Wisconsin including families, coders, public health patients, people who need long-term
Court of Federal Claims No: 17–1164V experts, community leaders, individuals care, the elderly, and people in rural
84. Jody Larsen, Seattle, Washington affiliated with academic institutions, and medically underserved areas.
Court of Federal Claims No: 17–1165V research and development communities Telemedicine is improving access for
85. Alexis Garner on behalf of K. T. G., in the private sector, and others. patients, while smartphone apps are
Hyattsville, Maryland All submissions will be evaluated; improving patients’ ability for self-care.
Court of Federal Claims No: 17–1166V separate prizes will be awarded for each At the same time, recent scientific
86. Elvira Cruz, Englewood, New Jersey of the three phases below. advances around developmental origins
Court of Federal Claims No: 17–1167V Phase 1: Design of health and disease point to the
87. Rasheedah Smith, Lawrenceville, Phase 2: Development and Small Scale important role that environmental
Georgia Testing exposures, nutrition, and stress play in
Court of Federal Claims No: 17–1169V Phase 3: Scaling maternal health and fetal programming.
88. Carol Clark, Boston, Massachusetts Estimated dates for each phase are as Remote, real-time, and more continuous
Court of Federal Claims No: 17–1170V follows: monitoring of harmful environmental
89. Lesa Marie Bowman-Harris, Salem, Phase 1: Effective on January 2, 2018 exposures, nutritional intake and energy
Oregon Phase 1 Submission Period Ends: expenditure, and stress and sleep, along
Court of Federal Claims No: 17–1172V January 31, 2018, 11:59 p.m. ET with blood pressure, proteinuria, blood
90. Jennifer Claypool, Dayton, Nevada Phase 1 Judging Period: February 1– glucose, and fetal heart rate, has the
Court of Federal Claims No: 17–1176V February 28, 2018 potential to improve prenatal care
91. Theresa Anderson, White Plains, Phase 1 Winners Announced: March 12, quality and pregnancy outcomes while
New York 2018 reducing healthcare costs.
Court of Federal Claims No: 17–1178V Phase 2 Begins: March 13, 2018
Phase 2 Submission Period Ends: July Recent trends in hospital closures in
92. Maureen C. Clavio, Orland Park, rural America also increase the need for
Illinois 11, 2018
Phase 2 Judging Period: July 12–August technological innovations that support
Court of Federal Claims No: 17–1179V remote monitoring of pregnant women.
93. Ellen Honea, Beverly Hills, 12, 2018
Phase 2 Winners Announced: August Between 2004 and 2014, 179 rural
California counties (9 percent of all rural counties)
20, 2018
Court of Federal Claims No: 17–1180V Phase 3 Begins: August 21, 2018 lost access to in-county hospital
94. Jared Sipes, Jacksonville, North Phase 3 Submission Period Ends: obstetric services, and the percent of all
Carolina February 21, 2019 rural counties in the U.S. that lacked
Court of Federal Claims No: 17–1181V Phase 3 Winner Announced: March 1, hospital obstetric services increased
[FR Doc. 2017–20540 Filed 9–25–17; 8:45 am] 2019 from 45 to 54 percent, due to hospital
BILLING CODE 4165–15–P FOR FURTHER INFORMATION CONTACT: and obstetric-unit closures.1 Many low-
Jessie Buerlein, MSW, Office of Policy income women, in both rural and urban
and Planning, MCHB, JBuerlein@ communities, do not access prenatal
DEPARTMENT OF HEALTH AND hrsa.gov, (301) 443–8931, or James care. Fully conflicting priorities such as
HUMAN SERVICES Resnick, Office of the Associate work, childcare, and transportation
Administrator, MCHB, JResnick@ make it difficult to make the
Health Resources and Services approximately 15 visits to their
Administration hrsa.gov, (301) 443–3222.
provider’s office, which include critical
SUPPLEMENTARY INFORMATION: On
medical assessments and instructions
Challenge Competition: Improving January 4, 2011, the America
about self-care. This challenge is
Remote Monitoring of Pregnancy COMPETES Reauthorization Act of 2010
designed to make technology work for
was signed into law allowing the use of
AGENCY: Health Resources and Services pregnant women, increase access,
challenges and prize competitions
Administration, Department of Health improve communications (between
increasing agencies’ ability to promote
and Human Services. patients and providers and across
and harness innovation. Competitions
ACTION: Notice. providers), and empower pregnant
run by the federal government result in
women to take better care of themselves.
a number of benefits to the public,
SUMMARY: The Health Resources and including the following: This challenge will support the
Services Administration’s (HRSA’s) (a) Increasing the number and development and testing of low-cost,
Maternal and Child Health Bureau diversity of the individuals, teams, and scalable technology-based innovations
(MCHB) announces a prize competition organizations that are addressing a to improve the ability of prenatal care
to support the development and testing particular problem or challenge of providers to monitor the health and
of low-cost, scalable technology-based national significance; wellbeing of pregnant women from afar
innovations to improve the ability of (b) Improving the skills of the (e.g., in their homes); utilizing
prenatal care providers to monitor the participants in the competition; and technology to empower patients and
health and wellbeing of pregnant (c) Directing attention to new market providers with more complete and up-
women remotely, especially women opportunities and stimulating private to-date information.
who live in rural and medically- sector investment. Key design features of the innovations
underserved areas who have limited should include:
access to on-site prenatal care. Subject of Challenge Competition
The statutory authority for this In recent years, technological 1 http://rhrc.umn.edu/wp-content/files_mf/
challenge competition is Section 105 of advances have improved the ability of 1491501904UMRHRCOBclosuresPolicyBrief.pdf.
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![44820 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices
The review panel will make selections Scalability DEPARTMENT OF HEALTH AND
based upon the following criteria: HUMAN SERVICES
• How costly was the intervention in
Phase 1 a real-world setting? How likely are cost Health Resources and Services
Accessibility efficiencies for program delivery at Administration
• Is the proposed intervention easily greater scale? Can the technology be
used in existing platforms? Notice of Non-Competitive,
utilized by families of diverse economic, Supplemental Funding Award for Ryan
social, and cultural backgrounds? Is it Additional Information White HIV/AIDS Program, Special
functional across disciplines/users?
Projects of National Significance
General Conditions:
Measurability
• HRSA reserves the right to cancel, AGENCY: Health Resources and Services
• How easily will the proposed Administration (HRSA), HHS.
suspend, and/or modify the contest, or
intervention be evaluated in order to ACTION: Notice.
determine its efficacy (in both lab any part of it, for any reason, at HRSA’s
testing and in the real world)? Is the sole discretion.
SUMMARY: This non-competitive award
proposed intervention measurable • The interventions submitted across will provide Secretary’s Minority AIDS
among various audiences? all phases should not use the HHS or Initiative Fund (SMAIF) supplemental
Sustainability HRSA logos or official seals in the funding to the Jurisdictional Approach
submission, and must not claim to Curing Hepatitis C among HIV/HCV
• Does the proposed intervention endorsement. Coinfected People of Color—Evaluation
compel users to utilize the technology and Technical Assistance Center
often and/or for long periods of time? Intellectual Property
(ETAC), RAND Corporation. This
Does it fit into daily life? Is it fun to use? supplemental funding will allow RAND
• Each entrant retains full ownership
Impact and title in and to their submission. Corporation to provide evaluation and
• Does the applicant present a theory Entrants expressly reserve all technical assistance to cooperative
or explanation of how the proposed intellectual property rights not agreement recipients and subrecipient
intervention would result in concrete expressly granted under the challenge clinical sites under HRSA–17–047
change? Curing Hepatitis C among People of
agreement.
Color Living with HIV.
Phase 2 • By participating in the challenge, SUPPLEMENTARY INFORMATION:
each entrant hereby irrevocably grants Intended Recipient of the Award:
Impact
to HRSA a limited, non-exclusive, RAND Corporation (U90HA30519).
• How did the intervention impact royalty-free, worldwide license and Amount of Non-Competitive Award:
outcomes for providers and patients? right to reproduce, publically perform, Up to $250,000 per year for 3 years
What did data show? publically display, and use the (pending availability of future year
Evidence Base submission for internal HHS business funding).
• Is the intervention grounded in and to the extent necessary to Period of Funding: September 30,
existing science related to improving administer the challenge, and to 2017, through September 29, 2020.
health care and related services for publically perform and publically CFDA Number: No. 93.928.
pregnant women? display the submission, including, Authority: The Consolidated
without limitation, for advertising and Appropriations Act, 2017 (Pub. L. 115–
Sustainability promotional purposes relating to the 31), Division H, Title II.
• Was the intervention compelling to challenge. Justification: In fiscal year (FY) 2016,
users and did it encourage users to use the SMAIF Curing Hepatitis C among
• Record Retention and FOIA: All People of Color Living with HIV
the technology often? Did users want to
materials submitted to HRSA as part of initiative was launched through three
continuously engage with the
a submission become HRSA records and funding opportunities: (1) Jurisdictional
technology?
cannot be returned. Any confidential Approach to Curing Hepatitis C among
Implementation commercial information contained in a HIV/HCV Co-infected People of Color—
• How feasible is the intervention? submission should be designated at the Jurisdictional Sites (HRSA–16–189) and
How much support for implementation time of submission. Participants will be (2) Jurisdictional Approach to Curing
will the intervention require (estimated notified of any Freedom of Information Hepatitis C among HIV/HCV Coinfected
financial and time commitment)? Act requests for their submissions in People of Color—State Health
accordance with 45 CFR 5.65. Departments Coordinating Center
Phase 3
Dated: September 19, 2017. (HRSA–16–195) to provide HIV primary
Impact medical care to low income, uninsured,
George Sigounas,
• How effective was the intervention and underserved people living with
Administrator. both HIV and hepatitis C virus (HCV);
when implemented at scale? Did the
[FR Doc. 2017–20539 Filed 9–25–17; 8:45 am] and (3) Jurisdictional Approach to
impacts on users from Phase 2 remain
consistent? BILLING CODE 4165–15–P Curing Hepatitis C among HIV/HCV
Coinfected People of Color—ETAC
Implementation (HRSA–16–188) to provide evaluation
• How feasible was the intervention and technical assistance to the funded
on a larger scale? How much support for sites. In FY17, HRSA–17–047 was
implementation did the model require announced to improve HCV prevention
(financial and time commitment)? How and care; improve coordination to
challenging was the actual program linkage and retention in care; and
implementation? enhance capacity of health department
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Document Created: 2017-09-26 02:49:02
Document Modified: 2017-09-26 02:49:02
| 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 | Jessie Buerlein, MSW, Office of Policy and Planning, MCHB, [email protected], (301) 443-8931, or James Resnick, Office of the Associate Administrator, MCHB, [email protected], (301) 443-3222. | |
| FR Citation | 82 FR 44818 |
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