65692 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

1https://www.cdc.gov/nchs/fastats/obesityoverweight.htm 

2https://www.niddk.nih.gov/health-information/ 

health-statistics/overweight-obesity. 

3http://healthgamesresearch.org/ourpublications/research-briefs/Game-Changer. 

4Shiyko, M., Hallinan, S., Seif El-Nasr, M., 

Subramanian, S., & Castaneda-Sceppa, C. (2016). 

Effects of Playing a Serious Computer Game on 

Body Mass Index and Nutrition Knowledge in 

Women. JMIR Serious Games, 4(1), e8. http://

doi.org/10.2196/games.4977. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Requirements and 

Registration for ‘‘Shape of Health: An 

Obesity Prevention Game’’ 

AGENCY: Office on Women’s Health, 

Office of the Assistant Secretary for 

Health, Department of Health and 

Human Services. 

Subject of Challenge Competition: 

The Office on Women’s Health (OWH) 

is seeking new ways to get health 

messages out to women and girls. 

According to the CDC, two out of every 

three women in the United States are 

overweight or obese.1 This extra weight 

can lead to many diseases, such as heart 

disease, diabetes, and many cancers. 

Obesity results from a combination of 

causes and contributing factors, 

including individual factors such as 

behavior and genetics. Some examples 

of behaviors that affect weight include 

diet, physical activity, inactivity, and 

stress. Improving behaviors in these 

areas can help women and girls 

maintain a healthy weight. 

Furthermore, American children 

today are increasingly unhealthy at 

earlier ages. According to the 2014 

National Health and Nutrition 

Examination Survey (NHANES), of girls 

ages 2–19, 16 percent were overweight 

and 17.1 percent were obese.2 Many 

children and teens do not eat properly 

or exercise enough and as a result, 

childhood obesity and diabetes are 

increasingly prevalent. Children with 

obesity may experience immediate 

health consequences that can lead to 

weight-related health problems in 

adulthood. In addition to physical 

health problems, overweight and obese 

children can be targets of social 

discrimination that can lead to low selfesteem and hinder social and academic 

functioning. 

Video games are a unique medium to 

boost knowledge and skills and can lead 

to behavior change through exploration 

of cause and effect in a virtual 

environment. According to a Robert 

Wood Johnson project called ‘‘Health 

Games Research,’’ it was found that 

digital games can be effective in 

improving children’s health in multiple 

health topics including physical fitness, 

health promotion, and disease 

management.3 Additional evidence 

suggests adult learning and behavior 

change is also possible through gaming. 

A study in JMIR Serious Games found 

that women with a higher baseline 

readiness to change experienced 

improvement in BMI and nutrition with 

game play.4

Your challenge with this competition 

is to create an interactive video game 

with focus on obesity prevention or 

weight control for women or girls. The 

game you create will be shared with the 

general public. The game must address 

an evidence-based obesity prevention or 

control strategy. You must show that the 

game is unlike currently available 

offerings. The game must be made 

publically available at no cost as either 

a web-based or mobile based game 

available on a widely accessible 

platform. 

For more information about obesity 

prevention or control strategies and 

guidelines view the CDC’s resource 

here: https://www.cdc.gov/obesity/ 

resources/strategies-guidelines.html. 

The competition has three phases. All 

eligible submissions will be evaluated 

and separate prizes will be awarded for 

each of the three phases. 

Registration Process for Participants 

Participants will be able to register 

and submit a submission on 

challenge.gov. Participants can find out 

more information at https://

www.challenge.gov. All submissions 

will be made through the challenge.gov 

website. 

Dates: Submissions will be accepted 

starting January 15, 2019. The 

submission period for Phase 1 will end 

on March 15, 2019. The Phase 2 (InPerson Presentation) submission period 

will be on a date TBD in 2019. The prize 

winners will be announced at the 

completion of each phase. 

Entries not in compliance with the 

submission requirements outlined 

below will be ineligible for further 

review and prize award. During the 

open submission period, participants 

must submit the following information 

to enter the Shape of Health 

competition: 

Phase 1 (Concept Development) 

The first stage of the competition aims 

to attract a large range of ideas and game 

developers. The target submission of the 

first stage will be the conceptualization 

of the most promising and/or unique 

game to help support behavior change 

around physical activity and/or 

nutrition to prevent obesity in women 

or girls. The submissions should aim to 

demonstrate that the proposed game 

will be accessible to the general public, 

developed from evidence-based 

prevention or control techniques, and 

engaging for women or girls. 

The Phase 1 Submission shall include 

a comprehensive description of the 

proposed game in 5 pages or less, 

including: 

1. A one-paragraph executive 

summary that clearly states how the 

game will target obesity prevention or 

control determinants and be developed 

for a women or girls audience; 

2. Link evidence to support the 

obesity determinant chosen and the 

theoretical basis for the game (will your 

game change behavior? improve 

knowledge? something novel? etc.); 

3. A descriptive overview of how the 

participant arrived at their idea, and 

why the approach is unlike anything 

already available; 

4. A draft storyboard of the game that 

describes the game components; and 

5. An assessment describing the 

participant’s ability to execute the 

proposed solution through Phase 2 and 

to completion. 

Your Shape of Health competition 

concept submission must be uploaded 

in challenge.gov. 

Participants may also choose to 

include additional determinants that 

contribute to obesity not discussed in 

the provided resources. If additional 

determinants are included, the 

participant should include a short 

description of how these determinants 

may contribute to obesity and how this 

game will addresses these determinants. 

Up to 10 selections will be made in 

Phase 1 to continue on to Phase 2. 

Phase 2 (In-Person Presentation) 

Phase 2 of the competition builds 

upon the work of Phase 1 and is focused 

on prototyping the game, and providing 

an in-person presentation to a panel of 

judges. The participants should 

demonstrate both the evidence base for 

the intervention and its viability. 

The in-person presentation must 

include a description of how the 

following components are incorporated 

into the game: 

• Relates to women or girls; 

• Targets a determinant of obesity; 

and 

• Engages the player 

Selected participants must build out 

the storyboard submitted in Phase 1 to 

become a visual presentation of game 

play. The visual presentation of game 

play must be recorded into a video and 

available through a private YouTube 

link. OWH expects that the participants 

provide an in-person presentation, 


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Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65693 

which includes a demonstration of the 

recorded presentation of game play. 

Submissions must be free of security 

threats and/or malware. Participants 

agree that HHS may conduct testing on 

the submission to determine whether 

malware or other security threats may 

be present. HHS may disqualify the 

submission if, in HHS’ judgment, the 

software may damage government or 

others’ equipment or operating 

environment or if the game, in HHS’ 

judgment, is inconsistent with HHS’ 

public health mission, utilizes software 

or other technologies without 

appropriate licenses, or any other reason 

deemed necessary. 

The expectation is that each team will 

use the prize money from Phase 1 for at 

least one person to travel to 

Washington, DC to deliver the in-person 

presentation. 

Up to 2 selections will be made in 

Phase 2 to continue on to Phase 3 

Phase 3 (Final Development) 

Phase 3 builds upon the work of 

Phase 2 and is focused on the final 

development of the proposed game and 

making it available to the general 

public. Entrants are required to ensure 

that proper obesity prevention or 

control determinants are included in the 

final game. Participants are encouraged 

to discuss the proper obesity prevention 

or control determinants with OWH in 

order to make sure that they are 

included in the final game. 

Basis upon Which Winners Will Be 

Selected: A panel composed of subjectmatter experts will judge eligible Shape 

of Health competition entries. The panel 

will make winner selections based upon 

the criteria outlined below and in 

compliance with the HHS Competition 

Judging Guidelines. 

One winner may be selected from 

each category (1 women’s health and 1 

girls’ health). 

Phase 1 Scoring Criteria 

All Criteria are scaled 1–5, with 1 

being the lowest score on each 

dimension and 5 being the highest score 

on each dimension. Scores are weighted 

by the proportion of each dimension 

and then aggregated to create a final 

score. 

1. Viability of storyboard (30%) 

1 = Storyboard is not likely to be 

developed into a working game/5= 

Storyboard is likely to be able to 

developed into a working game 

2. Application of research (20%) 

1 = Storyboard does not address 

evidence-based obesity prevention 

or control determinants/5 = 

Storyboard addresses evidencebased obesity prevention or control 

determinants 

3. Relevancy of storyboard (20%) 

1 = Storyboard does not address 

obesity from a women/girls’ health 

perspective/5 = Storyboard 

addresses obesity from a women/ 

girls’ health perspective 

4. Originality of storyboard (15%) 

1 = Storyboard does not take a novel 

approach/5 = Storyboard takes a 

novel approach 

5. Likelihood of adoption (15%) 

1 = Proposed game is not likely to be 

used by women/girls/5 = Proposed 

game is likely to be used by 

women/girls. 

Phase 2 Scoring Criteria 

All Criteria are scaled 1–5, with 1 

being the lowest score on each 

dimension and 5 being the highest score 

on each dimension. Scores are weighted 

by the proportion of each dimension 

and then aggregated to create a final 

score. Judging criteria for Phase 2 

include: 

1. Viability of game (30%) 

1 = Demo is not likely to be developed 

into a working game/5= Demo is 

likely to be developed into a 

working game 

2. Application of research (20%) 

1 = Game does not address evidencebased obesity prevention or control 

determinants/5 = Game addresses 

evidence-based obesity prevention 

or control determinants 

3. Relevancy of game (20%) 

1 = Game does not address obesity 

from an women/girls’ health 

perspective/5 = Game addresses 

obesity from a women/girls’ health 

perspective 

4. Originality of game (15%) 

1 = Game does not take a novel 

approach/5 = Game takes a novel 

approach35. Likelihood of adoption 

(15%) 

1 = Game is not likely to be used by 

women/girls/5 = Game is likely to 

be used by women/girls 

Phase 3 Scoring Criteria (Pass/Fail) 

The final prize money will be 

provided when the game: 

• Is complete; 

• includes the proper obesity 

prevention or control determinants; and 

• is available to the general public on 

a widely accessible platform. 

Amount of the Prize 

• In Phase 1 (Concept Development), 

participants will compete for a $20,000 

prize pot from which up to 10 

submissions may be selected to receive 

a $2,000 prize each. 

• In Phase 2 (In-person Demo), the 10 

participants from Phase 1 will compete 

for a $70,000 prize pot. The following 

prizes may be awarded: 

D Two First Place winners of $20,000 

(one girls’ health, one women’s 

health) 

D Two Second Place winners of 

$10,000 (one girls’ health, one 

women’s health) 

D Two Third Place winners of $5,000 

(one girls’ health, one women’s 

health) 

• In Phase 3 the First Place winners 

from Phase 2 may each be awarded an 

additional $55,000. 

• All winners will be notified via 

email. 

Eligibility Rules for Participating in 

the Competition: To be eligible to win 

a prize under this competition, an 

individual, group, or entity— 

(1) Shall have registered to participate 

in the competition under the rules 

promulgated by 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 (all non-HHS 

Federal employees must consult with 

their agency Ethics Official to determine 

whether the Federal ethics rules will 

limit or prohibit the acceptance of a 

COMPETES Act prize); 

(5) Shall not be a Federal employee 

working on their applications or 

submissions during assigned duty 

hours; 

(6) May not be an HHS employee; 

(7) May not be any other individual or 

entity associated with the development, 

evaluation, or administration of the 

Shape of Health competition or 

members of such persons’ immediate 

families (spouses, children, siblings, 

parents), and persons living in the same 

household as such persons, whether or 

not related; 

(8) A Federal grantee may not use 

Federal funds to develop submissions 

unless consistent with the purpose of 

their grant award; 

(9) 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; 

(10) Must be an individual or team 

comprised only of members 18 years of 

age or older; 

(11) Shall not be deemed ineligible 

because the individual or entity used 

federal facilities or consulted with 


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65694 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

federal employees during a competition 

if the facilities and employees are made 

equitably available to all individuals 

and entities participating in the 

competition; 

(12) Must provide a statement 

agreeing to indemnify the federal 

government against third party claims 

for damages arising from or related to 

competition activities; 

(13) Must provide a statement 

agreeing to assume 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 participation in this prize contest, 

whether the injury, death, damage, or 

loss arises through negligence or 

otherwise. 

(14) HHS has hereby waived the 

requirement for participants to obtain 

liability insurance in a specified amount 

for this competition. Participants are 

advised to consult with appropriate 

advisors to determine what amounts of 

insurance may be necessary for their 

own liability protection. 

(15) Shall not be currently on the 

Excluded Parties List (https://

www.epls.gov). 

Additional Requirements 

Entrants shall not use the OWH or 

HHS logos or official seals in their 

submissions, and must not claim 

endorsement. 

HHS reserves the right to cancel, 

suspend, and/or modify the Shape of 

Health competition, or any part of it, for 

any reason, at HHS’ sole discretion. 

Payment of the Prize: 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. 

Intellectual Property (IP) 

• Each entrant retains full ownership 

and title in and to their submission. 

Entrants expressly reserve all 

intellectual property rights not 

expressly granted under this publication 

notice. 

• By participating in the competition, 

each entrant hereby irrevocably grants 

to HHS 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 competition, and to 

publically perform and publically 

display the submission, including, 

without limitation, for advertising and 

promotional purposes relating to the 

competition. 

• Record Retention and FOIA: All 

materials submitted to HHS as part of a 

submission become HHS 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. 

SUPPLEMENTARY INFORMATION: 

Information on obesity prevention and 

control in women and girls can be found 

at: 

https://www.cdc.gov/obesity/ 

resources/strategies-guidelines.html 

https://www.womenshealth.gov/a-ztopics/overweight-obesity-and-weightloss 

https://www.girlshealth.gov/nutrition/ 

healthyweight/ 

Details on the Shape of Health 

competition may be found at 

challenge.gov. 

FOR FURTHER INFORMATION CONTACT: Ann 

Abercrombie at Ann.Abercrombie@

hhs.gov. 

Dated: November 28, 2018. 

Brett Giroir, 

ADM, Assistant Secretary for Health. 

[FR Doc. 2018–27653 Filed 12–20–18; 8:45 am] 

BILLING CODE 4150–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: ‘‘Multifunctional RNA 

Nanoparticles and Methods of Uses’’ 

and ‘‘RNA/DNA Hybrid Nanoparticles 

Modified With Single Stranded RNA 

Toeholds and Uses Thereof’’ 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Patent License to 

practice the inventions embodied in the 

Patent Applications listed in the 

Supplementary Information section of 

this notice to Sixfold Biosciences Inc., 

(‘‘Sixfold’’) of Walnut, California. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Cancer 

Institute’s Technology Transfer Center 

on or before January 7, 2019 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

an Exclusive Patent License should be 

directed to: Jasmine Yang, Sr. Licensing 

and Patenting Manager, NCI Technology 

Transfer Center, 9609 Medical Center 

Drive, RM 1E530 MSC 9702, Bethesda, 

MD 20892–9702 (for business mail), 

Rockville, MD 20850–9702 Telephone: 

(240)–276–5530; Facsimile: (240)-276– 

5504 Email: jasmine.yang@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

A. Multifunctional RNA Nanoparticles 

and Methods of Uses 

1. U.S. Provisional Patent Application 

(Application No. 61/878,758) filed 

September 17, 2013, HHS Reference 

No.: E–765–2013–0–US–01 

2. PCT Application (Application No. 

PCT/US2014/056007) filed 

September 17, 2014, HHS Reference 

No.: E–765–2013–0–US–02 

3. European Patent Application 

(Application No. 14780963.6) filed 

September 17, 2014, HHS Reference 

No.: E–765–2013–0–EP–03 

4. Australian Patent Application 

(Application No. 2014321443) filed 

September 17, 2014, HHS Reference 

No.: E–765–2013–0–AU–04 

5. Canadian Patent Application 

(Application No. 2,924,509) filed 

September 17, 2014, HHS Reference 

No.: E–765–2013–0–CA–05 

6. Japanese. Patent Application 

(Application No. 2016–543964) 

filed September 17, 2014, HHS 

Reference No.: E–765–2013–0–JP– 

05 

7. US Patent Application (Application 

No. 15/022,530) filed March 16, 

2016, HHS Reference No.: E–765– 

2013–0–US–07 

B. RNA/DNA Hybrid Nanoparticles 

Modified with Single Stranded RNA 

Toeholds and Uses Thereof 

1. U.S. Provisional Patent Application 

(Application No. 62/294,848) filed 

February 12, 2016, HHS Reference 

No.: E–078–2016–0–US–01 

2. PCT Application (Application No. 

PCT/US2017/017661) filed 

February 13, 2017, HHS Reference 

No.: E–078–2016–0–US–02 

3. US Patent Application (Application 

No. 16/076,878) filed August 9, 

2018, HHS Reference No.: E–078– 

2016–0–US–03 

4. European Patent Application 

(Application No. 17706653.7) filed 

September 12, 2018, HHS Reference 

No.: E–078–2016–0–EP–04 

The patent rights in these inventions 

have been assigned and/or exclusively 


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