A challenge or prize competition is a type of project that allows the public to solve challenges presented by federal agencies and receive awards for the best solutions. The process boils down to three steps:
    1. Agency announces a prize competition and invites the public to solve it.
    2. Participants create and submit solutions to the problem.
    3. Agency evaluates solutions and awards prizes to the best ones.
 

In grants and contracts, an agency receives proposals to do tasks or research, chooses one or more entities to participate, and then pays the monetary award incrementally for the work to be done. In prize competitions, an agency generally selects a winner or winners based on the work that has already been done. In prize competitions, only the winner(s) receives an award.

Prize competitions define a smaller set of requirements, which allow participants to bring their creative solutions. This can be advantageous when a problem can be solved in many different ways, including ways that the agency is not even aware of. The open innovation approach can entice participation from those who may not have direct expertise in the problem subject matter area but can lend expertise from their diverse backgrounds.
 

 No, submissions that propose mRNA vaccine development will not be considered competitive.

Unless the RNA-based technology targets endogenous RNA, RNA-based technologies and therapeutics will not be considered competitive.

Yes, the expectation is that this Challenge would result in several validated RNA-targeting technologies that are publicly available.  Phase I, the current active Phase, is for planning a comprehensive RNA-targeting technology that can be elaborated into a working prototype in the second stage of the Challenge.

The expectation is that technologies developed in response to this Challenge will address an unmet need in the RNA-targeting space that is relevant across multiple human diseases.  Individual diseases can be used as proof of concept, but the final technology must be applicable across many diseases.

Participants, 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. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced.

Participants are permitted to submit more than one submission, as long as those submissions are scientifically distinct.

There is no exact number of expected participants on a team.  However, please keep in mind that submissions will be judged on the likelihood that a Participant, be it an individual or team, can carry out the development of the proposed technology.

Please consult with your ethics official to determine if and how you may participate in this Challenge.

As a participant, you can designate yourself or your employer as the recipient.  However, please keep in mind that the recipient of the prize must 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. 

Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to federal income taxes. The Department of Health and Human Services (HHS)/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Entities participating in this Challenge are encouraged, but not required, to request and obtain a free Unique Entity ID (UEI), if they have not already done so, via SAM.gov as this will expedite prize payment. Additional information can be found at  https://sam.gov/content/entity-registration.  If you have additional questions concerning applicable tax laws, please speak with an accountant.

The expectation is that this Challenge, at the end of Phase III, would result in several validated RNA-targeting technologies that are publicly available.  Production of a technology as a marketable product or as a free product meets this requirement – while technology is not required to be free access, it must be publicly available.  As stated in the Challenge (Participation Rule 7) - each Participant (whether participating as a Team or Entity) grants to the NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the submission on the web or elsewhere. Each Participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Participant’s rights to the federal government. To receive an award, Participants will not be required to transfer their intellectual property rights to NIH, but Participants must grant to the federal government the nonexclusive licenses recited herein.

Only the Title and Executive Summary from participant submission will be posted publicly, as stated in the Submission Requirements section of the Challenge - Title and Executive Summary, the latter of which should include a brief description of the technology and how it will help to develop novel RNA-targeted therapies across multiple diseases. Do not include any proprietary or confidential information in the Title and Executive Summary sections as they may be publicly shared if the Participant is selected to win a prize across any Phase of this Challenge (see Participation Rule 7).
 

No, the Challenge will accept many types of submissions to develop novel and innovative technologies that modulate RNAs in human disease, such as:
• Approaches to modify RNA-RNA binding protein (RBP) interactions to modulate splicing, stability or translation;
• Targeting long non-coding RNAs (lncRNAs) to regulate gene expression in cis or trans (nearby vs. distant genes, respectively);
• Novel assays to identify native RNA-RBP interactions and examine therapeutic effects;
• Design and validate screening libraries that are enriched with RNA-targeting small molecules;
• Approaches that modify aberrant RNA structures for therapeutic purposes.

These are only examples, and submissions need not be limited to the above. Only solutions that target endogenous RNA to treat disease will be considered competitive for this Challenge.
 

No, you cannot submit RNA-targeting technology that is already under development.  This Challenge functions to promote the development of NEW RNA-targeting technology, not support RNA-targeting technology already in process.

No, you do not have to be a winner in Phase I to submit to Phase II of the Challenge.  More details concerning submission to Phase II will be released when Phase II is announced.

Federal grantees and recipients of cooperative agreements or other transaction (OT) awards are eligible to participate in the Challenge but may not use Federal funds from a grant award, cooperative agreement, or OT award to develop their Challenge submission or to fund efforts in support of their Challenge submission unless use of such funds is consistent with the purpose, terms, and conditions of the grant award, cooperative agreement, or OT award. Each Participant (whether participating as a Team or Entity) intending to use Federal grant, cooperative agreement, or OT award funds must register for and participate in the Challenge as an entity on behalf of the awardee institution, organization, or entity. If a winning Participant uses Federal grant, cooperative agreement, or OT award funds to participate in the Challenge, the prize must be treated as program income for purposes of the original grant, cooperative agreement, or OT award in accordance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards [2 CFR § 200]. Participants using Federal grant, cooperative agreement, or OT award funds to participate and/or report prize funding as program income (for winning Participants) should coordinate with the awarding official at the federal awarding agency.

No, submissions to this Challenge do not count towards the NIH six application per year limit, as described in NOT-OD-25-132: Supporting Fairness and Originality in NIH Research Applications.

Applicants are not required to go through their university’s Authorized Organization Representative in order to participate in this challenge. However, if federal funds awarded to the university are used to develop the submission, the submission must be made in compliance with the university’s policies and procedures and with the terms and conditions of award that apply to the funds used to develop the submission.

That is correct. If the federal funds are awarded to the institution, the most common situation, a submission that uses those funds must be submitted on behalf of the institution.

From the rules on the challenge announcement: “Federal grantees and recipients of cooperative agreements or other transaction (OT) awards are eligible to participate in the Challenge but may not use Federal funds from a grant award, cooperative agreement, or OT award to develop their Challenge submission or to fund efforts in support of their Challenge submission unless use of such funds is consistent with the purpose, terms, and conditions of the grant award, cooperative agreement, or OT award. Each Participant (whether participating as a Team or Entity) intending to use Federal grant, cooperative agreement, or OT award funds must register for and participate in the Challenge as an entity on behalf of the awardee institution, organization, or entity. If a winning Participant uses Federal grant, cooperative agreement, or OT award funds to participate in the Challenge, the prize must be treated as program income for purposes of the original grant, cooperative agreement, or OT award in accordance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards [2 CFR § 200]. Participants using Federal grant, cooperative agreement, or OT award funds to participate and/or report prize funding as program income (for winning Participants) should coordinate with the awarding official at the federal awarding agency.”

This is not a standard scientific review process or peer review process. It's a two-stage process. First, the submissions will be evaluated by a panel of subject matter experts who will provide what's called an objective review as opposed to a peer review. Then the second stage will be by Federal employees who will assess programmatic fit and finalize the review results.

A budget is not required to be submitted for this challenge.

There are no restrictions on how the prize funds are used. One caveat is that if you actively use Federal funds from a Grant contract, property agreement, or other award to develop your submission to this challenge, then those funds must be treated as program income per grants policy or contract policy.

For Teams, a Team Captain will register and submit on behalf of the Team members. In the event of winning a cash prize, the Team Captain will be paid the prize in full. 
For Entities, each participating Entity is required to identify a Point of Contact who will register and submit on behalf of the Entity. In the event of winning a cash prize, the prize will be paid directly to the Entity, not to the Point of Contact. As stated in the Participation Rules, Participants intending to use Federal grant, cooperative agreement, or OT funds must register for and participate in the Challenge as an Entity on behalf of the awardee institution or organization. 

Note that in all instances, the receiver of the prize must be a citizen or permanent resident of the United States or, in the case of an Entity, must maintain a primary place of business in the United States.

Yes, technology that targets RNAs among different diseases within one broader disease area would be considered multiple disease and thus would be considered competitive. 

If you are a university/institute and submitting as an Entity, the point of contact must be an Authorized Organizational Representative (AOR) for that university/institute.