- What is meant by "Extracellular RNA"?
- What is the goal of the NIH Common Fund program on Extracellular RNA Communication?
- What consortial agreements are expected in the ERC Program?
- Who should we contact regarding organ/cell/disease-questions?
- What kind of research and technologies fall under this initiative?
- What role does the NIH have in this cooperative agreement?
- What are the points to consider when submitting an application in response to these FOAs?
- Do I have to submit a letter of intent? What should be in it? How should I send it?
- When is the receipt date for sending in an application?
- Can I submit more than one application in response to one or any of these FOAs?
- Will these FOAs be reissued?
- How will applications be reviewed?
- Will I have an opportunity to submit supplementary information before my application is reviewed?
- Will my application(s) be reviewed by experts in my field?
- What sort of milestones will be expected for these proposals?
- Who will develop the Milestones Funding Plan?
- How many meetings will project PIs/co-PIs be required to attend each year?
- Will site visits be conducted?
- Do I have to submit a detailed budget for the competing and noncompeting awards or can I use the modular format?
- I am an NIH intramural investigator. Am I eligible to apply?
- I am not a US citizen. Am I eligible to apply?
- My institution is not in the US. Am I eligible to apply?
- Can work be performed outside the US?
- Is it open to commercial, for-profit companies? Is there a benefit to having industry partners?
- What does NIH expect in the Intellectual Property Management Plan?
- Will work within this grant restrict or constrain further commercial efforts by my firm? What are the "terms" with regard to the promotion and use of any technology that my firm would bring to this project or develop?
- Can additional PIs be added during the course of the Project Period?
- Can changes be made to the Research Plan during the Project period as new information is obtained?
- What are the plans for data and resource sharing for this program?
- How can I locate potential collaborators interested in Extracellular RNA biology?
FAQs specific for RFA-RM-12-010 Data Management and Resource Repository (DMRR) on Extracellular RNA (U54)
- Is an applicant organization allowed to submit more than one application to RFA-RM-12-010 for the Data Management and Resource Repository (DMRR) on Extracellular RNA (U54)?
- Are foreign institutions eligible to apply to RFA-RM-12-010?
FAQs specific for RFA-RM-12-011 Reference Profiles of Human Extracellular RNA (U01)
- In preparing applications responsive to this FOA, what key elements should we consider?
- What kind of expertise is desirable for this FOA?
FAQs specific for RFA-RM-12-012 Extracellular RNA Biogenesis, Biodistribution, Uptake, and Effector Function (U19)
- Why does this FOA utilize the U19 mechanism?
- In preparing applications responsive to this FOA, what key elements should we consider?
- Is this FOA focused on the role of human exRNAs in health and disease?
FAQs specific for RFA-RM-12-013 Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3)
- Do I only need to submit the UH2 part of the application by the receipt date?
- What is the page limit for applications under this FOA?
- What is the allowable budget for each of the two phases?
- Will the NGA for the Phase 1 (UH2) include the future commitments for the Phase 2 (UH3)?
- Will this FOA cover the collection of human biospecimen?
- Does the biospecimen collection have to be from biofluids?
FAQs specific for RFA-RM-12-014 Clinical Utility of Extracellular RNA for Therapy Development (UH2/UH3)
- Do I only need to submit the UH2 part of the application by the receipt date?
- What is the page limit for applications under this FOA?
- What is the allowable budget for each of the two phases?
- Will the NGA for the Phase 1 (UH2) include the future commitments for the Phase 2 (UH3)?
- Will this RFA provide support for animal studies?
What is meant by "Extracellular RNA"?
Extracellular RNAs (exRNAs) for the purposes of these FOAs (RFA- RM-12-010, RFA-RM-12-011, RFA-RM-12-012, RFA-RM-12-013 and RFA-RM-12-014) are RNA molecules that are secreted in the extracellular space from a variety of cell types and act as endocrine signals to alter the phenotype of recipient cells. The cells of origin can be endogenous or from exogenous sources, i.e. derived from microbes living in our bodies or from food products, such as plants that we eat. exRNAs include microRNA, mRNA, and long non-coding RNA which are secreted and found in all body fluids examined, including blood, saliva, urine, breast milk, cerebral spinal fluid (CSF), amniotic fluid, ascites, and pleural effusions. When in circulation, exRNAs may be encapsulated in extracellular vesicles (EVs) or associated through nuclease-resistant complexes with RNA-binding carrier proteins, such as HDL, Argonaut, and Nucleophosmin 1.
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What is the goal of the NIH Common Fund program on Extracellular RNA Communication?
The Common Fund Extracellular RNA Communication (ERC) Program http://commonfund.nih.gov/exrna/ has been developed to address critical issues in exRNA research. Both fundamental scientific discovery and innovative tools and technologies will be required to advance the field. The key components that need attention include: (a) defining the fundamental principles of exRNA biogenesis, distribution, uptake, and function, developing the molecular tools, technologies, and imaging modalities to enable these studies (RFA-RM-12-012 ), (b) generating a reference catalog of exRNAs present in the body fluids of normal healthy individuals that would facilitate disease diagnosis and therapeutic outcomes (RFA-RM-12-011), (c) demonstrating the clinical utility of exRNAs as therapeutic agents and/or biomarkers and support the development of the scalable technologies required for these studies (RFA-RM-12-013 and RFA-RM-12-014); and (d) developing a community resource, the exRNA Atlas, to provide access to exRNA data, standardized exRNA protocols, and other useful tools and technologies generated by the exRNA consortium (RFA-RM-12-010).
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What consortial agreements are expected in the ERC Program?
Awards funded under these FOAs are anticipated to involve activities conducted by multidisciplinary teams of investigators. Awardees from all 5 initiatives will form a consortium, with the overarching goal of determining fundamental principles associated with exRNAs. Comparisons across studies will be essential to establish these cross-cutting principles so investigators must be willing to act as part of the consortium.
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Who should we contact regarding organ/cell/disease-questions?
The Scientific and Research contacts are indicated in each of the Funding Opportunity Announcements (FOAs). In addition, the Common Fund ERC Program is administered via a team of NIH program experts. The NIH ERC Program working group members and their affiliations are listed below and at the ERC Program URL: http://commonfund.nih.gov/Exrna/members.aspx.
- Alexandra Ainsztein, Ph.D., Division of Cell Biology and Biophysics, National Institute of General Medical Sciences (NIGMS) ainsztea@nigms.nih.gov
- Maureen Beanan, Ph.D., Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID) beananm@mail.nih.gov
- Philip J. Brooks, Ph.D., Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS) pjbrooks@mail.nih.gov
- Max Guo, Ph.D., Division of Aging Biology, National Institute on Aging (NIA) qmguo@mail.nih.gov
- T. Kevin Howcroft, Ph.D., Division of Cancer Biology, Cancer Immunology and Hematology Branch, National Cancer Institute (NCI) howcrofk@mail.nih.gov
- Patricia (Trish) Labosky, Ph.D., Office of Strategic Coordination, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director patricia.labosky@nih.gov
- George A. McKie, D.V.M., Ph.D., Cornea, Ocular Infection, Inflammation, and Immunology, National Eye Institute (NEI) mckiegeo@nei.nih.gov
- Suresh Mohla, Ph.D., Tumor Biology and Metastasis Branch (TBMB), National Cancer Institute (NCI) mohlas@mail.nih.gov
- Richard Panniers, Ph.D., Genes, Genomes and Genetics, Center for Scientific Review (CSR) pannierr@csr.nih.gov
- Matthew Reilly, Ph.D., Division of Neuroscience & Behavior, National Institute on Alcohol Abuse and Alcoholism (NIAAA) reillymt@mail.nih.gov
- John Satterlee, Ph.D., Epigenetics, Model Organism Genetics, Functional Genomics, National Institute on Drug Abuse (NIDA) satterleej@nida.nih.gov
- Pothur R. Srinivas, Ph.D., M.P.H., Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (NHLBI) satterleej@nida.nih.gov
- Robert Star, M.D., Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) starr@niddk.nih.gov
- Danilo A. Tagle, Ph.D., National Center for Advancing Translational Sciences (NCATS) danilo.tagle@nih.gov
- Xenia Tigno, Ph.D., M.S., Office of Extramural Programs, National Institute of Nursing Research (NINR) xenia.tigno@nih.gov
- Sundar Venkatachalam, Ph.D., Integrative Biology and Infectious Diseases Branch, National Institute of Dental and Craniofacial Research (NIDCR) sundar.venkatachalam@nih.gov
- Steven Zullo, Ph.D., Division of Discovery Science and Technology, National Institute of Biomedical Imaging and Bioengineering (NIBIB) Steven.Zullo@nih.gov
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What kind of research and technologies fall under this initiative?
Please see Section I under Research Objectives for each of the FOAs.
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What role does the NIH have in this cooperative agreement?
The role of NIH staff in this cooperative agreement is spelled out in Section VI of each FOA and will be defined further in the terms and conditions of award. In brief, the NIH ERC Program working group members will have substantial scientific and programmatic involvement during the project period of this award through technical assistance, advice and coordination. However, the role of NIH ERC Program working group members will be to facilitate and not to direct the activities.
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What are the points to consider when submitting an application in response to these FOAs?
The research supported through this initiative will recognize innovation that supports the development of new methods, models or technologies that will catalyze and facilitate exRNA research. In preparing applications responsive to these FOAs, please see Section V of RFA FOA regarding review criteria.
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Do I have to submit a letter of intent? What should be in it? How should I send it?
No. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH CSR to estimate the potential review workload and plan the review. Letters of intent can be e-mailed, faxed, or sent as hard copy (e-mail is preferred). There is no need to send hard copy of a letter that has already been sent via e-mail or fax. All letters of intent should be sent to contact person indicated on the FOA to which you are responding to.
Prospective applicants are asked to submit a letter of intent by October 13, 2012 that includes the following information:
- Descriptive title of proposed research
- Name, address, and telephone number of the Principal Investigator
- Names of other key personnel
- Participating institutions
- Number and title of the funding opportunity
- How much preliminary data is required?
Sufficient preliminary data should be provided to determine the feasibility of the proposed approach.
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When is the receipt date for sending in an application?
The application receipt date is November 13, 2012. This is the receipt date and not a postmarked date. The application must be received by the Division of Receive & Referral of CSR on or before that date. There is no extension to that deadline. If you have served recently as a reviewer or advisory council member, normally you get an extension to your own submission deadline; however, extensions do not apply for this FOA. The continuous submission policy does not apply to this FOA.
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Can I submit more than one application in response to one or any of these FOAs?
Yes, as long as they are non-overlapping and scientifically distinct. Applicants may be PIs, co-PIs or subcontracts on other projects, so long as there is no scientific overlap between projects. In addition, a PI should not exceed 100% effort on all funding he/she has. Applications that are non-responsive to the specific requirements of the FOAs will not be considered.
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Will these FOAs be reissued?
No.
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How will applications be reviewed?
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by a Special Emphasis Panel (SEP) convened by the Center for Scientific Review (CSR). Reviews most likely will take place during the months of February through March 2013. Questions regarding the review process can be directed to Dr. Richard Pannier at pannierr@csr.nih.gov.
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Will I have an opportunity to submit supplementary information before my application is reviewed?
No.
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Will my application(s) be reviewed by experts in my field?
Every effort will be made to ensure appropriate reviewer expertise; however, it is likely that not all of the reviewers assigned to your application will be considered experts in your specific field. We anticipate that investigators will submit applications on a wide range of topics. The SEP reviewers will be drawn from academia and industry, and have general expertise that is relevant to your application. It is extremely important to keep this in mind when you are writing your application. When describing what you want to do, avoid jargon, and use language that scientists in other fields can understand. You will also have to convince scientists in other fields that what you are proposing to do is exciting and exceptionally innovative or important to the field, and that the proposed research will have a profound impact. Please see Section V of FOA regarding review criteria.
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What sort of milestones will be expected for these proposals?
The use of milestones should provide clear indicators of a project's continued success or emergent difficulties. Milestones are different from specific aims. The milestones must provide objective and quantitative outcomes by which to justify advancing the project. The application must include a strong rationale for the choice of models, parameters, and quantitative go/no-go decisions to be made by NIH staff, based upon accepted practices in the specific field. Please see examples of milestones at the ERC Program URL http//:commonfund.nih.gov/exrna/milestones.aspx
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Who will develop the Milestones Funding Plan?
The applicant should provide the proposed milestones when the application is submitted. Subsequent to peer review and prior to award, these milestones will be incorporated into a Milestone Funding Plan, This is a negotiated process between the Program Director, the Principal Investigator and Business Official. Once the Milestones Funding Plan have been developed and approved, the business official should submit a signed copy of the milestones to the NIH Grants Management Office.
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How many meetings will project PIs/co-PIs be required to attend each year?
Project PIs/co-PIs should budget for semi-annual meetings during the course of the award. The yearly budget for the bi-annual workshops to be held in the greater Washington, D.C. metro area is not to exceed $6,000.
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Will site visits be conducted?
It is possible that site visits will be conducted on a periodic basis as part of monitoring the progress of awarded grants.
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Do I have to submit a detailed budget for the competing and noncompeting awards or can I use the modular format?
Applicants are asked to submit a detailed budget and justification. Please see Section V.1 for each FOA.
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I am an NIH intramural investigator. Am I eligible to apply?
Yes intramural investigators are eligible to apply. Please see special application instructions under Section IV.6. “Applications Involving the NIH Intramural Research Program” under each FOA.
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I am not a US citizen. Am I eligible to apply?
Yes, if your place of business/institution is located within the US.
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My institution is not in the US. Am I eligible to apply?
Investigators at non-US (foreign) institutions are eligible to apply except for RFA-RM-12-010. Applications from foreign institutions will be assessed by reviewers to whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources. Please see Section V. 1 for each FOA. Also refer to the Office of Extramural Research site http://grants.nih.gov/grants/oer.htm for general guidance on submitting NIH grant applications and http://grants.nih.gov/grants/foreign/ for elements of the NIH grants process specific to foreign applicants.
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Can work be performed outside the US?
Yes, as primary applicant institution or as a subcontract to the US-based institution. Justification for inclusion of work to be performed outside the US must be provided in the grant application and if selected for funding, foreign clearance will be required prior to release of a Notice of Grant Award (NoGA).
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Is it open to commercial, for-profit companies? Is there a benefit to having industry partners?
Yes, for-profit organizations are eligible to apply or serve as collaborators. The needs and scope of the proposed project should dictate and strongly justify the field of collaborators needed to accomplish the task. In general, the NIH encourages partnership with industry and a multidisciplinary team approach in accomplishing the goals of this FOA.
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What does NIH expect in the Intellectual Property Management Plan?
Details about intellectual property (IP) involved with the proposed cell source, devices, or anything that may hinder commercialization of the finished product. More details are presented in Section VI of the FOAs.
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Will work within this grant restrict or constrain further commercial efforts by my firm? What are the "terms" with regard to the promotion and use of any technology that my firm would bring to this project or develop?
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Please see Section IV.6 “Intellectual property management plan” of the FOA.
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Can additional PIs be added during the course of the Project Period?
Yes. Addition of new key personnel is subject to approval by NIH and should not result in any increase in the approved budget.
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Can changes be made to the Research Plan during the Project period as new information is obtained?
Since the awards are made as cooperative agreements, the NIH ERC Program working group through the Project Officer of the award will work with the investigators if minor changes to the research approach have to be made during the course of the project. However the research plan has to remain true to what was peer-reviewed.
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What are the plans for data and resource sharing for this program?
Awardees will be encouraged to publish and publicly release and disseminate results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community and NIH. Awardee will work collectively with the NIH to develop and implement an appropriate rapid data release policy that will be applicable to all awardees in the consortium.
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How can I locate potential collaborators interested in Extracellular RNA biology?
To facilitate collaborations and promote multidisciplinary approaches, the ERC program has launched a Web Collaboration Portal to help researchers find collaborators with complementary experience in Extracellular RNA biology. This portal will allow researchers to upload a research profile containing information about their expertise and research interests, and browse research profiles created by others. You can access the Web Collaboration Portal at http://commonfund.nih.gov/exrna/cwcp/index.aspx/. We hope this resource will allow investigators to identify colleagues with whom they would like to continue more extensive discussions outside of this portal. Participation in this Web Collaboration Portal is voluntary, and is NOT required to apply for these funding opportunities.
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FAQs specific for RFA-RM-12-010 Data Management and Resource Repository (DMRR) on Extracellular RNA (U54)
- Is an applicant organization allowed to submit more than one application to RFA-RM-12-010 for the Data Management and Resource Repository (DMRR) on Extracellular RNA (U54)?
Yes, more than one DMRR application from an applicant institution may be submitted, however each application must be scientifically distinct.
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- Are foreign institutions eligible to apply to RFA-RM-12-010?
No, however components of the DMRR could be at foreign institutions.
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FAQs specific for RFA-RM-12-011 Reference Profiles of Human Extracellular RNA (U01)
- In preparing applications responsive to this FOA, what key elements should we consider?
Application responsive to this RFA should strongly consider whether the human samples are of sufficient quality and representation to significantly contribute to understanding of human exRNA variability and similarity between individuals. An adequate description of the biofluid sample collection, storage conditions, sample preparation, consent language, etc should be provided in the application.
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- What kind of expertise is desirable for this FOA?
A multidisciplinary and collaborative team of investigators is strongly encouraged that have demonstrable experience and expertise in RNA sequencing methodologies, and in the annotation of RNA sequence data.
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FAQs specific for RFA-RM-12-012 Extracellular RNA Biogenesis, Biodistribution, Uptake, and Effector Function (U19)
- Why does this FOA utilize the U19 mechanism?
The U19 mechansim supports an overall research project consisting of multiple component sub-projects directed toward a specific major objective, theme, or program goal and requires a broad-based, multidisciplinary team-science approach.
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- In preparing applications responsive to this FOA, what key elements should we consider?
Applications should (a) involve multidisciplinary, collaborative teams of investigators; (b) propose transformative, high-impact studies connected by a unifying research theme that addresses the overarching goals of the FOA; and (c) develop enabling tools, technologies, and bioreagents required to increase the knowledge of how RNA are secreted.
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- Is this FOA focused on the role of human exRNAs in health and disease?
No. Research projects that propose the use of model organisms or non-mammalian systems to establish the fundamental principles governing exRNAs will be considered responsive. However, work in mammalian systems that validate results derived from less complex models is encouraged. Validation studies using human samples, although not required, is also encouraged.
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FAQs specific for RFA-RM-12-013 Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3)
- Do I only need to submit the UH2 part of the application by the receipt date?
Both the UH2 and UH3 phases must be submitted as a single application but the approach should be clearly organized into two stages: UH2 (phase 1) and UH3 (phase 2). A complete application package for this FOA to be submitted by the November 13, 2012 receipt date and should consists of both the UH2 and UH3 parts.
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- What is the page limit for applications under this FOA?
The UH2 and UH3 parts of the application are each limited to 12 pages. The 12 page Research Strategy section for the UH2 part should include milestones, timeline, and future plans. Under the UH3 part of the application, the 12 page Research Strategy section should have milestones including benchmarks for determining transition from the UH2 to the UH3 phase, timeline and future plans.
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- What is the allowable budget for each of the two phases?
Applicants may request up to $500,000 total costs for each year of the UH2 phase, and $1,000,000 total costs for each year of the UH3 phase.
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- Will the NGA for the Phase 1 (UH2) include the future commitments for the Phase 2 (UH3)?
No. An administrative review will be performed during the last half of terminal year for the UH2 phase and if it is determined that the milestones have been successfully met, the Notice of Grant Award (NoGA) will be revised to reflect the UH3 Phase to include funding for future years.
The UH2--Only 1-2 years of funding will be indicated on the NoGA. The UH3 will provide the remaining approved funding for future years. The maximum period of support for the combined UH2 and UH3 phases is 5 years
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- Will this FOA cover the collection of human biospecimen?
Studies using existing human biospecimen collections are strongly encouraged. However, additional collection may be proposed in order to perform confirmatory or validation studies.
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- Does the biospecimen collection have to be from biofluids?
The development of the biomarker has to be from exRNA obtained from biofluids. However confirmatory studies involving determination of cellular origin and/or target of the exRNA may involve tissue sources.
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FAQs specific for RFA-RM-12-014 Clinical Utility of Extracellular RNA for Therapy Development (UH2/UH3)
- Do I only need to submit the UH2 part of the application by the receipt date?
Both the UH2 and UH3 phases must be submitted as a single application but the approach should be clearly organized into two stages: UH2 (phase 1) and UH3 (phase 2). A complete application package for this FOA to be submitted by the November 13, 2012 receipt date and should consists of both the UH2 and UH3 parts.
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- What is the page limit for applications under this FOA?
The UH2 and UH3 parts of the application are each limited to 12 pages. The 12 page Research Strategy section for the UH2 part should include milestones, timeline, and future plans. Under the UH3 part of the application, the 12 page Research Strategy section should have milestones including benchmarks for determining transition from the UH2 to the UH3 phase, timeline and future plans.
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- What is the allowable budget for each of the two phases?
Applicants may request up to $500,000 total costs for each year of the UH2 phase, and $1,000,000 total costs for each year of the UH3 phase.
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- Will the NGA for the Phase 1 (UH2) include the future commitments for the Phase 2 (UH3)?
No. An administrative review will be performed during the last half of terminal year for the UH2 phase and if it is determined that the milestones have been successfully met, the Notice of Grant Award (NoGA) will be revised to reflect the UH3 Phase to include funding for future years.
The UH2--Only 2-3 years of funding will be indicated on the NoGA. The UH3 will provide the remaining approved funding for future years. The maximum period of support for the combined UH2 and UH3 phases is 5 years
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- Will this RFA provide support for animal studies?
Yes. It is anticipated that proof of concept and efficacy studies will be conducted on appropriate animal models of disease.
