Frequently Asked Questions for Somatic Cell Genome Editing FOAs

We appreciate your interest in the Somatic Cell Genome Editing funding opportunities and hope that you and your team will choose to submit an application. This list of frequently asked questions will be updated periodically as new questions from potential applicants are received.

Will the applicant webinar be posted online afterward?

Would you please verify when the NIH application deadline is?

Are multi-PI applications allowed?

What would be the eligibility rules regarding foreign researchers and institutions?

Can NIH intramural investigators apply to any of the funding announcements?

What are “U” grants and how are they different from R01s?

What is the maximum amount of direct costs available for each application?

Do I have to abide by the timeline outlined in the FOA?

Can I be a PI on an application for one FOA (for example, the genome editor development) and also be a PI or multi-PI on an application submitted to another FOA, for example the in vivo delivery?

The funding announcements state that there will be data sharing among the consortium members and to the public through the DCC. Will my institution be able to protect its intellectual property developed through these cooperative agreements?

Can my project focus on more than one type of cell/tissue?

Can a reviewer submit a proposal to a particular funding announcement and still participate as a reviewer?

Will the applications submitted to all the FOAs be reviewed in one study section?

Can I submit just the UG3 portion to RFA-RM-18-016?

I’m interested in using genome editing to treat disease X. Can I propose the use of a disease-specific animal model as proof of concept studies in my application? Or do I have to use the reporter animals generated in the Consortium?

Does the platform being developed under RFA-RM-18-015 need to focus on a cell/tissue type from a specific organ/system?

Do I have to incorporate a computational or bioinformatics approach into my project for RFA-RM-18-015?

If my application is fundable, will it be subject to Special Council Review (SCR) if I already have over $1M awarded in direct costs?

Can NIH provide additional guidance on including milestones in the application?

I am a young investigator, will applying for these RFAs make me lose ESI?

If it is expected that sex differences would not impact the effectiveness of my proposed delivery technology, can I propose to use animals of a single sex?

For RFA-RM-18-016, can you propose to subcontract any large animal studies in the UH3 phase with a collaborating center? If so, would I need a fully executed subcontract agreement in place, or is it sufficient to submit a signed letter of collaboration with a budget from the proposed large animal site?

Questions Generated from the Applicant Informational Webinar:

What resources are available to craft a competitive proposal?

What are examples of other Consortia that have multiple components?

How will data and resource sharing be addressed for the program?

Will there be annual consortium meetings?

Do small businesses qualify?

Are applications that have collaborations preferred or are individual applications acceptable?

What info should be included in Letters of Intent?

Will I receive feedback on a Letter of Intent?

Is it necessary to include both rats and mice in the Small Animal Testing Center (RFA-RM-18-012)?

For RFA-RM-18-013, does “large animals” include dogs or cats?

Is RFA-RM-18-015 (Biological Systems) only looking for proposals which focus on human cells?

How much proof-of-concept and expertise is needed in actual genome editing for the Delivery Initiative (RFA-RM-18-016)?

For RFA-RM-18-016, can you clarify what tissue types are of interest? Is ex vivo or in vivo preferred?

For RFA-RM-18-016, how should the UG3/UH3 transition be discussed in the application?

For RFA-RM-18-016, is it possible to propose gene editor delivery in a disease model and use the same model in the UH3 portion of the study?

For the UH3 phase of RFA-RM-18-016, what should be the primary focus that is included in the application?

How much proof-of-concept is expected for applications which are proposing novel approaches to gene editing delivery technologies (RFA-RM-18-016)?

Is the first phase (UG3) of RFA-RM-18-016 focused only on delivery to small animals?

For RFA-RM-18-016, should the budget for the UH3 portion of the award be included?

For RFA-RM-18-016, can the UH3 phase include GMP manufacturing and GLP studies?

For RFA-RM-18-016, if engineered variants of AAVs are proposed as a delivery system, would the proposal be considered responsive?

Can an application propose to create new editors for germline cells (RFA-RM-18-017)?

Does RFA-RM-18-017 allow the use of a modular budget since the cap is $250K?

The Data Coordination Center (DCC; RFA-RM-18-018) has a large budget, what are expected expenses?

This page last reviewed on March 23, 2018