75N99223R0003 NITRO BAA Q_A 13 June.pdf

75N99223R0003 NITRO BAA Questions and Answers ü

Questions and Answers

Does my research apply broadly to and fit within the scope of the NITRO Technical Areas 1, 2, and/or 3?

The NITRO project team is unable to discuss concepts that a potential applicant is considering submitting to the BAA. We will evaluate and provide feedback on technical concepts once they have been officially submitted. The NITRO program anticipates that teaming will be necessary to accomplish our program goals and metrics. You can find more information about teaming on the NITRO teaming page, here: https://arpa-h.gov/engage/programs/nitro/teaming/. Additionally, the NITRO program anticipates considering a broad spectrum of applications across a range of development phases. The specifics about the NITRO program can be found in the BAA.

The NITRO BAA can be found here https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view. Please be sure to review the posting in it its entirety, including all the attachments at the bottom of the page. The submission process and other questions should all be answered by reviewing these materials.

I’m an OA patient, how can I get involved with the NITRO program?

ARPA-H does not conduct its own research. Instead, the agency funds research organizations such as universities and medical centers to conduct such work. If you have an interest in volunteering for studies, you could look for volunteer opportunities at hospitals, universities, or research institutions near you. For example, the National Institutes of Health maintains a webpage with information on volunteering: https://clinicaltrials.gov/. Thank you again for your interest, and we encourage you to stay up to date on the current state of the program at https://arpa-h.gov/engage/programs/nitro/.

Is attendance at Proposers’ Day required for submission of an Abstract or Full Proposal?

Participation in the NITRO Proposers’ Day is not a requirement for submission of an abstract, full proposal, or selection for funding.

Are Lightning Talks and Sidebars limited to in-person participants for Proposers’ Day?

Lightning Talks and Sidebar conversations are not limited to in-person participants; virtual participants were also selected.

Is there a limit for in-person registrants and virtual registrants for Proposers’ Day?

The in-person registration is limited to 2 individuals per institutional department, and 130 maximum in-person attendees. The virtual registration is not limited based on institutional department, and the maximum number of attendees is 3000.

I am confirmed for the in-person and virtual Proposers’ Day, what should I expect throughout the day regarding travel plans and watching the event virtually?

Proposers’ Day will be a full day of events with opening presentations from ARPA-H Directors to presentations on the specifics about the NITRO BAA from the Program Manager and Acquisitions.

The Proposers’ Day complete Schedule will be released no later than 6/14/23 to all confirmed registrants. At this time, please note the event will take place on Thursday, June 15, 2023, from 8:30AM to 6:00PM CDT.

If selected for a timeslot to present at Proposers’ Day, registrants will be notified no later than 6/14/23.

Registrants notified with selected timeslots will not need to upload slides at the time of Proposers’ Day (the ARPA-H team will handle all slides during the event to maintain schedule given time constraints). Registrants selected for a timeslot for a Sidebar conversation on Proposers’ Day were notified on 6/9/23.

https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view https://clinicaltrials.gov/ https://arpa-h.gov/engage/programs/nitro/

Due to the enormous interest in sidebars, ARPA-H will be scheduling additional sidebars on 6/20/23. ARPA-H will provide additional scheduling information to those who previously requested the sidebars in their registration for Proposers’ Day; information will be sent no later than 6/19/20. No additional requests for sidebars will be accepted.

I’ve run into an issue with Abstract or Proposal submission. Can the NITRO team help?

Please email NITRO@arpa-h.gov with more specific information about the issue and a team member will get back to you to resolve the issue.

What is the difference between an Abstract and a Full Proposal?

Please refer to the information on the solicitation for the NITRO BAA here:

https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view. Abstracts are limited to 6-pages to pitch the idea to the NITRO team. While not required, abstracts are intended to be an option for potential performers to receive a recommendation from ARPA-H (i.e., recommendation to submit or not submit a full proposal) prior to investing the effort required to submit a full proposal. Full Proposals are limited to 40-pages.

Can you meet with me to discuss the NITRO program?

The NITRO project team is unable to accommodate individual requests for calls or meetings to discuss concepts that a potential applicant is considering submitting to the BAA. We will evaluate and provide feedback on technical concepts once they have been officially submitted. Sidebar conversations serve as the opportunity to meet with the NITRO team to discuss your concepts and to answer any BAA specific questions.

When will my teaming information be posted on the teaming page, and can I change the teaming information after the initial submission?

The teaming information is reviewed and posted on a rolling basis. Submission of teaming information does not guarantee that the information will be posted on the NITRO Teaming Page. The NITRO team reviews the team profiles based on the completeness, relevance, and acceptability of the submitted information. Incomplete, non-relevant, and non-acceptable submissions will not be posted on the teaming page. If you wish to change your teaming information, please email NITRO@arpa-h.gov with the requested changes.

What is the timeline from abstract submission to invitation for full proposal?

Notification for full proposal recommendations will be sent out following the review of all submitted abstracts.

NITRO anticipates full proposal recommendations will be sent out no later than 07/05/2023. Please refer to the information on the solicitation for the NITRO BAA here:

https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view.

Is there a limit on the level of funding and are there mandatory requirements for the cost proposal?

The BAA does not include a funding limit for individual awards. Abstracts will be evaluated based on the criteria laid out in the solicitation, to develop novel techniques for the regeneration and reconstruction of intra-articular (IA) cartilage and subchondral (SC) bone, the two key tissue types in a joint, in osteoarthritis (OA) patients, and the cost realism of such development.

There is no statutory requirement for cost sharing under any OTs negotiated by ARPA-H. ARPA-H will consider proposals for cost sharing from Proposers. Ultimately award terms and conditions will be determined for each project considering all elements of the projects (e.g., Fixed support, Expenditure with cost share or Expenditure based with no cost share). Please refer to the solicitation for all the details:

https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view mailto:NITRO@arpa-h.gov https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view mailto:NITRO@arpa-h.gov https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view https://sam.gov/opp/0d6d0844c8c949f39819badf44197a98/view

Who is allowed to submit for Abstracts and Full proposals? Young Investigators? Industry? Academia?

We welcome investigators at all stages in both academia and industry. The NITRO program anticipates teaming will be necessary to accomplish our program goals and metrics. You can find more information about teaming on the NITRO teaming page, here: https://arpa-h.gov/engage/programs/nitro/teaming/.

Is a university, as an institution, limited to submitting one (1) proposal as a prime awardee?

A university, as an institution, is not limited to submitting one (1) proposal as a prime awardee. A department within an institution (e.g., a university) is limited to submitting one (1) proposal as a prime awardee.

If so, would the limitation apply to submission of abstracts or invited full proposals?

The limitation will only apply to full proposals, not abstracts.

Or for universities, should the term proposer be understood in reference to individual PIs, and thus multiple PIs at the same university could submit in parallel on behalf of independent teams?

Multiple PIs from different departments at the same institution may submit separate Abstracts or Full Proposals given that there is no overlap between the applications. Multiple PIs from the same department can submit an Abstract to the NITRO BAA; however, only one (1) Full Proposal will be considered from each department. It is possible that multiple Full Proposals could be accepted from different departments in the same institution, yet the teams must not overlap.

Are cover letters limited to one page? Are there margin formatting restrictions?

Please see the BAA for specific guidance related to these and other formatting questions.

https://arpa-h.gov/engage/programs/nitro/teaming/