We appreciate your interest in the Extracellular RNA Communication Program 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. For information from a recently held technical webinar, Download slides here. 

What is the NIH Common Fund?

  • The NIH Common Fund, managed by the Office of Strategic Coordination in the Office of the Director, supports cross-cutting trans-NIH programs that require participation by multiple Institutes and Centers. Common Fund programs are intended to be transformative, catalytic, synergistic, cross-cutting, and unique. This program is funded as a short-term, goal-driven strategic investment, with deliverables intended to catalyze research across multiple biomedical research disciplines. More information can be found at http://www.commonfund.nih.gov.

Will the applicant webinar be posted online afterward?

  • No. However this list of common FAQs will be updated to reflect questions asked during the webinar. Applicants are encouraged to send in additional questions to: exrnacommunication@mail.nih.gov or the specific FOA scientific/research contact.

Would you please verify when the NIH application deadline is?

  • Proposals are due October 23, 2018 at 5 PM local time of applicant’s organization.

When are LOIs due and are they required?

  • September 23, 2018. A letter of intent is not required but is encouraged. A LOI is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

Are multi-PI applications allowed?

  • Yes.

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

  • All funding opportunities except RFA-RM-18-026 accept foreign applicants and foreign components. For additional information please see Section III.1 Eligible Applicants in each FOA.

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

  • Yes, intramural PIs are eligible to apply for all funding opportunities except RFA-RM-18-026.

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

  • The FOAs use the cooperative agreement funding mechanism. A cooperative agreement supports discrete, specified, circumscribed projects to be performed by investigators in an area representing their specific interest and competencies and is used when substantial NIH programmatic involvement is anticipated.

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

  • RFA-RM-18-026: Application direct cost budgets are not limited but need to reflect the actual needs of the proposed project.
  • RFA-RM-18-027: application budgets should not exceed $300,000 direct costs per year for the UG3 Phase (FY2019 and FY2020) and $650,000 direct costs per year for the UH3 Phase (FY2021 and FY2022).
  • RFA-RM-18-028: application budgets should not exceed $300,000 direct costs per year for the UG3 Phase (FY2019 and FY2020) and $650,000 direct costs per year for the UH3 Phase (FY2021 and FY2022).

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

  • Milestones must be completed within the timeframe outlined in the FOA. However, milestones may be completed early.

Can I be a PI on an application for one FOA and also be a PI or multi-PI on an application submitted to another FOA?

  • These are separate FOAs. An investigator can be PI on one application and a PI or multi-PI on a second separate application.

What are the plans for data and resource sharing for this program?

  • The Steering Committee along with input from the NIH will discuss and set the guidelines. However, applicants are expect to comply with all existing NIH policies.

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

  • No. Applications will be reviewed by a Special Emphasis Panel for each funding opportunity, and reviewers may not have an application among those being reviewed.

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

  • No. These are separate FOAs. Separate Special Emphasis Panels will be convened for each FOA.

Can I submit just the UG3 portion to RFA-RM-18-027 or RFA-RM-18-028?

  • No, only applications for the combined mechanism (UG3/UH3) will be deemed responsive to this FOA.

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

  • No. The exRNA funding announcements (RFAs) will not require SCR. For more information please see NOT-OD-12-140.

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

  • Milestones should be scientifically justified and well defined for each year of the project and be based on the proposed specific aims. Whenever feasible, milestones should provide quantitative benchmarks for comprehensively assessing the annual progress of the project. Milestones must not be simply a restatement of the specific aims. The specific aims describe the research goals of the project. Rather, the milestones should provide the means for assessing the progress made towards each aim and offer a timeline and a “pathway” for the testing of a discovery concept or development of a technology.

How do I know if I am proposing a technology/strategy that is not an incremental advance?

  • For RFA-RM-18-027 and RFA-RM-18-028, you must justify how your proposed technology/strategy will improve the state of the art by proposing a method that has previously not been possible or will dramatically improve (by at least 5-fold) our current abilities to increased purity, increased speed, or decreased cost. 

 

 

Questions Generated from the Applicant Informational Webinar:

Will webinar slides be available later?

  • Yes, they are posted on Extracellular RNA Common Fund website

 

Who is eligible to apply for RFA-RM-18-026 (Data Management and Resource Repository)?

  • This is a limited competition RFA. Eligibility is limited to the awardee of RFA-RM-12-010.

Who is eligible to apply for RFA-RM-18-027 and -028?

  • Any independent investigator is eligible to apply to this funding opportunity. It is important that the applicant demonstrates a strong scientific background and expertise in exRNA and extracellular vesicle fields and has appropriate institutional support.  See Section III of the RFAs for eligibility information.

 

Are intramural applicants eligible to apply to RFA-RM-18-027 and -028?

  • Yes, intramural applications are accepted, see Section IV.7 of the RFAs. The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
  • If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

                                                     

Do applications for both RFA-RM-18-027 and -028 require an industry partner?

  • Applicants should include multidisciplinary team with expertise appropriate for the proposed technology. It is not a requirement to include an industry partner. However, industry is not excluded from either RFA-RM-18-027 or -028; biotech companies are welcome to apply independently to these FOAs.

 

For RFA-RM-18-027 and -028, how many PIs can be listed on any given application?

  • There is no limit to the number of PIs; however, institutions/organizations proposing multiple PDs/PIs, should read over the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

 

For RFA-RM-18-027 and -028, does an applicant need to identify a group who will independently validate the developed technology?

  • No. Predetermined partnerships are not required. However, applicants are expected to mention possible ways to collaborate in their application.

 

For RFA-RM-18-027 and -028, are collaborators allowed on applications?

  • Yes, multidisciplinary applications are encouraged. The required 10% set-aside funds in years 2-4 can be applied towards future collaborations within the Consortium.

 

For RFA-RM-18-027 and -028, how should the required 10% set-aside funds be spent, will it be internally between co-PIs, within the Consortium, or outside the Consortium?

  • Funds should be allocated with the goal to foster collaborations within or outside of the Consortium with other investigators and subject to approval by NIH.

 

For RFA-RM-18-027 and -028, will the 10% collaboration fund be a milestone for the proposed project?

  • Yes, applicants should propose to collaborate with others in starting in Year 2. Collaboration should be listed as a milestone in the application, which may be subject to approval by the NIH to ensure that collaborations yield appropriate validation of the proposed technology.

 

For RFA-RM-18-027 and -028, how should the 10% collaboration fund be listed on the budget and is it subject to indirect costs?

  • Applicants should provide a detailed R&R budget with their application. The 10% collaboration fund should be 10% of requested direct costs. Yes, this budget item is subject to indirect costs.

 

For RFA-RM-18-027 and -028, is there a particular biofluid that would be considered preferable for a successful application?

  • No, any biofluid can be proposed but the choice should be scientifically justified and relevant to the proposed technology.

 

For RFA-RM-18-027 and -028, how far along in the technology development process should applicants be in order to propose the technology?

  • The technology should be sufficiently mature such that preliminary data can be included in the application. Like any NIH application reviewers will consider feasibility in their critiques.

How would an application for RFA-RM-18-028 differ from a proposal geared towards RFA-RM-18-027, is the difference in approach mainly geared towards isolation of single EVs in addition to cell of origin?

  • RFA-RM-18-027 is focused primarily on developing innovative separation technologies/strategies to isolate pure populations of exRNA carrier molecules (EVs and EV subsets, RNPs, LPPs) from bulk biofluids and analyses of their associated cargo, whereas RFA-RM-18-028 is primarily focused on EVs and single EV isolation technologies/procedures and analysis of single EV cargo.

For both RFA-RM-18-027 and -028, can the proposed technologies integrate different platforms to cover the expertise of different PIs?

  • Yes, investigators’ expertise should complement each other and be directly related to the proposed technology.

 

For both RFA-RM-18-027 and -028, should applications focus on technology development or the function of exRNA or EV?

  • Applications should emphasize developing enabling and transformative exRNA carrier separation and single EV isolation technologies, and characterization of exRNA and associated cargo elements through genomic, proteomic, and lipidomic approaches.  Functional studies, while permitted, are secondary to the technology development.

 

For both RFA-RM-18-027 and 028, do proposed technologies need to have the capabilities to be adapted to all biofluids?

  •  A strong application would proposed technologies that would be generalizable to all biofluids.  However, applicants are not expected to propose evaluating each proposed technology/protocol comprehensively against all biofluid categories.

 

For both RFA-RM-18-027 and -028, should applications include details of making a reference dataset for healthy or diseased individuals?

  • Applications should focus on collecting biofluid samples from the most appropriate source for the technology being developed. Applicants are encouraged to use data currently available on the exRNA Atlas to determine the contribution of each carrier subclass (RFA-RM-18-027) or subpopulation (RFA-RM-18-028) to the bulk exRNA recovered from each biofluid.

 

For RFA-RM-18-028, can applications propose to also characterize proteins, lipids, and other metabolites associated with EVs, or should applications focus solely on RNA content?

  • The Extracellular RNA program’s main focus is on the RNA itself. If it will enhance the goal of addressing exRNA communication, an applicant can propose to include –omic analysis of other EV-associated content.

 

For RFA-RM-18-028, can a proposed single EV technology start from the pre-screening of bulk EV subpopulations?

  • Yes, applicants can propose to analyze subpopulations in the UG3 phase, and work towards the end goal of analyzing single EVs in the UH3 phase.

 

For RFA-RM-18-028, single vesicle analysis may produce large datasets that require companion analytical tools to infer cell of origin - should such analytical methods be proposed alongside the single vesicle isolation tools development?

  • Yes, it is acceptable to propose developing analytical tools for dataset deconvolution. The Data Management and Resource Repository (DMRR; RFA-RM-18-026) will not provide new analytical capabilities, and all analysis must be completed by the grantees.

 

For RFA-RM-18-028, should applications focus on identifying specific exRNA sequences at the single-EV level, or will characterization (number, size, type RNA, and proteins) of the single EV be sufficient?

  • Proposed technologies should address how subpopulations are different from each other in terms of cell of origin and trafficking to target cells. If biophysical attributes are needed to further define these subpopulations, the technology can incorporate those.

For RFA-RM-18-028, does “cGMP” mean that proposed technologies must enable isolated EVs to be left intact for therapeutic purposes, or can EVs be lysed to analyze their content?

  • The goal of RFA-RM-18-028 in the UH3 is to generate enabling technologies to characterize EV subpopulation, how they are trafficked, and how donor and recipient cells are communicating on a large scale.  However, an ancillary goal of the RFA is to generate protocols that would be amenable to cGMP for the delivery to EVs to recipient cells. Isolation of EVs for therapeutic purposes is not within the scope of the current RFA, but it is anticipated that proposed technologies will enable these other types of downstream use of the isolated vesicles.

This page last reviewed on September 17, 2018