1. Who retains the rights to any intellectual property generated by a proposal?

Management of intellectual property will be determined by the proposal applicant’s institutional policies.

2. Should I disclose any unprotected proprietary information in the submission?

Protecting proprietary information is the responsibility of the applicant and the applicant institution. Consistent with NIH policy, applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, identify the pages in the application that contain this information by marking those paragraphs or lines with an asterisk (*) at the beginning of the paragraph. Indicate at the beginning of the Research Plan which pages contain asterisks and a note stating: "The following sections marked with an asterisk contain proprietary/privileged information that [name of applicant] requests not be released to persons outside the Government, except for purposes of review and evaluation." When information in the application constitutes trade secrets or information that is commercial or financial, or information that is confidential or privileged, it is furnished to the Government in confidence with the understanding that the information shall be used or disclosed only for evaluation of this application. If a grant is awarded as a result of or in connection with the submission of this application, the Government shall have the right to use or disclose the information to the extent authorized by law.

3. Who can apply for Point of Care Technology Research Network grants?

Applications from all sources will be considered including domestic or foreign, public or private, nonprofit or for-profit. Details regarding specific requirements can be found in the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards. If the proposed work is to done outside of the US or by a foreign company, please provide a strong justification as to why the work cannot be done in the US or by a domestic company and realize that applications outside of the US may require additional regulatory review and oversight.

4. Are international laboratories outside of the United States eligible to participate?

If the proposed work is to be done outside of the US or by a foreign company, please provide a strong justification as to why the work cannot be done in the US or by a domestic company and realize that applications outside of the US may require additional regulatory review and oversight

5. When are pre-proposal applications due?

Expressions of Interest are due no later than 4:59pm EST on Monday, March 2, 2020. Late submissions will not be accepted.

6. How much funding is available? Do you give multi-year Grants?

CAPCaT awards are, in general, $100,000 direct costs for a twelve-month period. Additional indirect costs are provided at the performance sites’ Federally-negotiated rates. Only single period applications are accepted.

7. How many awards will be made?

CAPCaT plans to fund up to six awards for the 2020-21 cycle pending the receipt of meritorious applications. At least one project that incorporates complementary and integrative health approaches may be funded.

8. Where do I submit my EOI?

All expressions of interest must be submitted through the online submission site.

9. When will I be notified if my Expression of Interest has been selected for submission as a full proposal?

All applicants will be notified by April 1, 2020 as to whether they are invited to submit a full proposal. Invitations will be sent by email both to the PI and to the administrative contact listed in the Expression of Interest.

10. My Expression of Interest was accepted and I have been invited to submit a full proposal. Now what?

If you are invited to submit a full proposal, it must be submitted through the online submission site no later than 11:59pm EST September 1st, 2020. No material can be submitted directly to Center staff.

Follow the instructions on the online submission site. The application does not need to be completed all at once. The PI may log on as many times as he or she wishes until the deadline.

11. Who reviews the applications?

Proposals are peer-reviewed on a confidential basis. The review panels are made up of individuals with appropriate expertise in medical innovation from clinical, engineering, regulatory, technical, scientific and/or business perspectives. Full proposal applicants can suggest areas of expertise to be included on a given panel, though no assurance is given that suggested review domains will be utilized. Please do not recommend reviewers by name to avoid potential conflicts of interest.  However, applicants can provide names of potential reviewers whom they would prefer not be used, and every effort will be made to accommodate these requests. These requests should be included in a letter uploaded with the other supporting documents.

12. What are the review criteria?

Review criteria for CAPCaT are: 1) Significance: Does the project address an unmet medical need? 2) Scientific basis: Is there a strong scientific basis, including preliminary data, presented? 3) Responsiveness to the CAPCaT/NIH areas of interest: Is the project designed to accelerate the refinement and clinical testing of point of care technologies for heart, lung, blood, and sleep disorders? Is the project designed to improve the diagnosis, monitoring, and management of heart, lung, blood, and sleep disorders or other related symptoms by incorporating complementary and integrative health approaches? Does the project address one of the areas of special focus identified above? Does the technology under development include one of more of the desirable characteristics mentioned above that will accelerate rapid adoption into clinical practice? 4) Technology performance: Is the technology accurate, usable, and at a “late stage” of development (defined as ready for clinical validation or prototype refinement). Projects proposing prototype development or preclinical studies are not in scope. Later-stage technologies that are closer to market and deployment for use will be given priority. 5) Feasibility: Is it highly likely that the proposed science can be accomplished with the funding and time allotted? If appropriate, are all human subject regulatory procedures (approved IRB protocol, human subjects training complete, project registered as a clinical trial) complete so that the project can start in a timely way?  Is a data safety monitoring plan articulated? 6) Innovation: Does the proposed technology have the potential to transform patient outcomes or how patient care is delivered? (i.e., a new POC that enables diagnosis/treatment in the home of a patient who would otherwise have had to go to the clinic or hospital for the diagnosis/treatment?) 7) Technology Intellectual Property and Development Plan: Has the team developing the technology met with the appropriate bodies to secure intellectual property and designation as an investigational device? Has the team acquired a 510k exemption? Has a path to FDA approval or clearance been identified and is it clearly articulated? Is there a patent or license that has been submitted or secured in the US or overseas? 8) Consumer costs and commercialization strategy: What is the commercialization strategy? Does the strategy have the potential to reduce healthcare costs for patients and/or payors? 9) Environment: Do the study team and/or company have an environment that is conducive for success? Has there been outside investment in the company?

13. Who should I list as collaborators?

List only individuals who are considered key personnel or significant contributors to the work that will be performed, and who have agreed to their role. Avoid honorific collaborations. For all proposals, the review committee requires that investigators collaborate closely with clinicians and product development experts in the development of the proposal and the conduct of the work. The input of these collaborators must be clearly reflected throughout the application.

14. I am writing an Expression of Interest. May I include several references?

You can include as many references as you would like, but they must be included in the two-page limit.

15. Should I submit copies of relevant publications?

Please do not submit copies of relevant publications. Standard citation of publications is acceptable.

16. Will you accept a video showing how my system works?

Videos are not accepted.

17. What is an institutional sign off page?

It is the official sheet from your research administration office indicating that your full proposal has been approved by your institution’s sponsored research office. Be sure to ask your research administration office how much lead time they need to process this form in the event you are invited to submit a full proposal so that you can submit all your documents before the deadline. Signature from an authorized business official must be received prior to the proposal deadline.

18. Are there any budget restrictions or limitations?

Funding can support a full array of resources, including core user fees for services such as biostatistics consults or use of specialized lab facilities. Funds are typically used for student/postdoc support, reagent costs, and small equipment. Capital and non-capital equipment must be well justified to the purpose and exclusive need of the project. Alterations and renovations will not be supported.

19. Are indirect costs provided?

Indirect costs are provided at the performance sites’ Federally-negotiated rates.

20. When would I receive my funding?

The timeliness of your revisions to the administrative materials and obtaining any necessary protocol approvals will affect when you receive your award, which would not be sooner than November 1, 2020. If your work involves human subjects, data or tissue derived, or live animals, the necessary IRB and IACUC approvals must be received by the Center prior to the activation of your award.

21. What are my reporting responsibilities if I receive an award?

An annual progress report is required to be submitted by investigators in accordance with the terms and conditions of the award. Additional follow-up meetings and bi-weekly reports are required so that CAPCaT can follow the progress of your projects. Investigators will also use the POCTRN GAITS (Guidance and Impact Tracking System) system for project management and tracking.

22. Can applicants submit multiple applications to more than one POCTRN Center solicitation?

Applicants can submit Expressions of Interest to multiple research areas appropriate Center solicitations. Only one submission, if selected, will be allowed to move to the full proposal stage. This will be decided among the Center Leadership for the best fit within the goals of the POCTRN.