Data Management and Resource Repository (DMRR) on Extracellular RNA (U54 Clinical Trial Not Allowed)

Data Management and Resource Repository (DMRR) on Extracellular RNA (U54 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). Establishes a repository for data management and resources related to extracellular RNA to support the scientific community.

Expired RFA-RM-12-010: Data Management and Resource Repository (DMRR) on Extracellular RNA (U54) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative ( http://commonfund. nih. gov/ ) through the NIH Office of the Director, Office of Strategic Coordination ( http://dpcpsi.

nih. gov/osc/ ). The FOA will be administered by a trans-NIH team led by the National Institute on Drug Abuse (NIDA) ( http://www.

drugabuse. gov/ ) on behalf of the NIH Common Fund Program on Extracellular RNA http://commonfund. nih.

gov/exrna/ .) Funding Opportunity Title Data Management and Resource Repository (DMRR) on Extracellular RNA (U54) U54 Specialized Center- Cooperative Agreements August 06, 2018 - This RFA has been reissued as RFA-RM-18-026 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-RM-12-011 , U01 Research Project Cooperative Agreements RFA-RM-12-012 , U19 Research Program--Cooperative Agreements RFA-RM-12-013 , UH2 / UH3 Phase Innovation Awards Cooperative Agreement RFA-RM-12-014 , UH2 / UH3 Phase Innovation Awards Cooperative Agreement Only one application per institution is allowed as defined in Section III. 3.

Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this FOA is to identify and support a Data Management Resource/Repository (DMRR) for the Extracellular RNA (ExRNA) Communication Program (ERCP).

The overall programmatic goal of the DMRR is to integrate the efforts of all of the funded components of the ERCP and serve as a community-wide resource for ExRNA standards, protocols, and data through the development of an ExRNA Atlas. .

Letter of Intent Due Date AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description The concept that RNA molecules are secreted in the extracellular spaces and act as endocrine signals to alter the phenotypes of target cells, both locally and at distant sites, represents a novel paradigm in intercellular signaling.

Recent advances in RNA sequencing technologies have identified a large and diverse population of extracellular RNA (exRNA) including microRNA and long non-coding RNA (lncRNAs).

Given that approximately 60% - 80% of all protein encoding genes are regulated by microRNA and certain lncRNAs have been linked to regulation of the epigenome, extracellular delivery of these RNAs could have profound implications for a wide range of physiologic and pathologic processes.

In humans, exRNAs are found in all body fluids examined, including blood, saliva, urine, breast milk, cerebral spinal fluid (CSF), amniotic fluid, ascites, and pleural effusions. Recent reports in the literature suggest that exRNAs have both protective and pathogenic roles in a variety of human diseases.

Further, functional plant- and microbe-derived exRNAs have been identified in human serum and cells, suggesting that trans-kingdom exRNA communication could explain some associations between environmental exposures and health or disease. Taken together, the above findings highlight the transformative potential that secreted RNAs may have in the regulation of health and disease.

However, to realize the potential that exRNAs may have as health/disease indicators and/or as therapeutic molecules, fundamental principles of their biogenesis, distribution, uptake, and function need to be defined.

While exRNAs are known to be encapsulated in extracellular vesicles (EVs), recent studies have also demonstrated their presence in nuclease-resistant complexes with RNA-binding carrier proteins, such as HDL and Argonaut, in serum.

A better understanding of exRNA sorting to different secretory pathways, regulation of secretion, mechanisms of targeting, and effector function in target cells would generate opportunities to identify novel strategies for prognosis, diagnosis, and intervention of many diseases. The Common Fund Extracellular RNA Communication Program has been developed to address critical issues in this nascent field.

Both fundamental scientific discovery and innovative tools and technologies will be required to advance the field.

The key components (and associated FOAs) 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 developming 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).

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.

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

The purpose of this FOA is to identify and support a Data Management Resource/Repository (DMRR) for the ExRNA Communication Program (ERCP). The overall programmatic goal of the DMRR is to integrate the efforts of all of the funded components of the Extracellular RNA Communication Program and serve as a community-wide resource for ExRNA standards, protocols, and data through the development of an ExRNA Atlas.

The DMRR, other ECRP consortium members, and NIH staff will need to work closely together to accomplish many of these activities. Specifically, the DMRR will: 1. Develop a community resource website, the ExRNA Atlas, to provide user-friendly access to ExRNA data, standardized ExRNA protocols, and other useful tools and technologies generated by the ExRNA consortium.

2. Develop workshops and a community outreach strategy to further develop a cadre of ExRNA researchers, build community consensus as needed, and to disseminate ERCP protocols and resources to the broad scientific community. 3.

Coordinate the ERCP consortium by organizing steering committee meetings and grantees meetings. 4. Work with ERCP Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) so that all ERCP-generated data and metadata have standardized formats and quality metrics to ensure that the data are interoperable, transportable, and maximally useful to the public.

5. Facilitate data use by the scientific community by depositing datasets generated by the ERCP in appropriate public or controlled-access databases and providing user-friendly access. 6.

Provide software, "apps", or other user-friendly computational analysis tools to enable both na ve and experienced investigators to query, integrate, analyze, and model the data. 7.

Work closely with the ERCP consortium PD(s)/PI(s to analyze the data generated, to develop analysis strategies to integrate the ExRNA datasets in synergistic ways with other relevant datasets, and to share useful information and insights about ExRNA species and profiles to the larger biomedical research community.

The anticipated functions of the DMRR require an administrative core as well as three distinct stand-alone components in the areas of Scientific Outreach, Data Coordination, and Data Integration and Analysis. For all components and the core, applicants should indicate their successful past experience in this area and their plans to achieve the necessary functions for each component.

Details concerning the administrative core and three required Components are described below. Scientific Outreach Component (DMRR SOC) Development of the ExRNA Atlas will require the DMRR to work closely with the rest of the ERCP consortium PD(s)/PI(s) to obtain protocols, data, etc. to 1. provide the scientific community with user-friendly, publicly accessible ExRNA information, and 2.

make the scientific community aware that this information is available for their use. Applicants should describe any prior experience in successfully communicating scientific information to experts and non-experts and should describe their plans to address some of the anticipated activities of the DMRR SOC which include: 1.

Establish and maintain a public website which will The Atlas will describe subcellular production pathways, tissues of origin, principle binding partners and/or cofactors, principle cargo constituents, and potential cellular or pathway targets of specific ExRNA populations from normal human body fluids.

Included in the Atlas will be an "E-Manual" of validated and standardized Extracellular RNA protocols (isolation, manipulation, RNA-seq, etc) to be updated as protocols and technologies The Atlas will contain information about common reagents, useful separation biomarkers, quality control standards, standard cell line/producer line, gold standard reagents, etc to ensure lab-to-lab consistency in ExRNA The Atlas should provide access to videos and tutorials (generated by the DMRR in collaboration with the ERCP PIs) on ExRNA biology, the use of ExRNA datasets and protocols, and related issues to help educate the scientific and lay community on these topics.

The Atlas should provide user-friendly access to datasets generated by the consortium, provide ExRNA profiles/signatures of healthy individuals, provide access to ExRNA biomarker datasets, and provide access to other relevant available datasets generated by non-consortium researchers.

The Atlas will be the primary portal for the broad scientific community to access ERCP data prior to publication and should provide access to "apps" as well as more sophisticated tools to facilitate data mining by both novice and experienced researchers. The Atlas should provide access to useful software developed by the ERCP Consortium and other researchers.

The Atlas should describe all of the datasets available for the ERCP and have metadata-enabled querying of the data to identify data subsets of interest. Links should be provided to a description of the data including any metadata associated with an experiment. The Atlas should provide a method to freely download large datasets so that users can acquire and analyze all or large parts of the data.

The Atlas should support data retrieval for any ERCP data deposited in NCBI or other public databases. The Atlas should provide a genome browser view of the ExRNA data generated by the ERCP Consortium, and should strive to make the visualization of the data as intuitive and user-friendly as possible. The Atlas should improve during the course of the project.

Applicants should describe plans to solicit user feedback and otherwise evaluate the usability of the Atlas that serve the user communities, as well as to facilitate analysis of usage (quantitation of page views, FTP downloads, etc.). This plan should describe the frequency of these evaluations and how this information will be used to improve the utility of the Extracellular RNA Atlas 2.

Develop an outreach strategy to advertise available ERCP protocols and resources to the scientific community. The outreach strategy sponsorship of workshops open to scientists outside of the consortium to facilitate use of datasets. support of sessions at scientific meetings to advertise ERCP discoveries and resources.

establishment of a discussion forum to engage the scientific community interested in this topic. DMRR Data Coordination Component Development of the Extracellular RNA Atlas will require the DMRR to work closely with the rest of the ERCP consortium PD(s)/PI(s) to obtain protocols, metadata, data, etc. to provide the scientific community with user-friendly, publicly accessible ExRNA information.

The DMRR will need to work particularly closely with PD(s)/PI(s) generating developing reference profiles of ExRNAs in normal conditions ( RFA-RM-12-011 ) as well as PD(s)/PI(s) investigating ExRNAs as potential biomarkers for disease diagnosis and therapeutic outcomes ( RFA-RM-12-013 ). We anticipate that the majority of datasets handled by the DMRR will be RNA-seq, small RNA-seq, genotypic or related data.

However, the DMRR DCC should also indicate how it would accommodate proteomic, lipidomic, metabolomic, or other non-DNA/RNA based datasets.

Applicants should describe any experience in successfully leading the coordination of data intensive activities and high-throughput datasets such as those to be generated by the ERCP and should describe their plans addressing some of the anticipated activities of the DMRR DCC which establishing common ERCP consortial protocols for the characterization of body fluids from normal and diseased individuals and the generation of ExRNA datasets derived from these fluids working with ERCP members to establish the exact types and formats of data that will be transferred to the DMRR and develop data verification, validation and quality metrics pipelines.

working with ERCP members to define standard experimental metadata required to be submitted with each dataset, including common data elements such as clinical phenotypes and ExRNA-specific categories, using well-defined formats and associated controlled vocabularies. making all data and metadata submitted to the DMRR DCC rapidly available to the data producers and ultimately to the public through the DMRR website.

establishing a process for accepting or incorporating data sets produced outside the consortium to help maximize the value of all ExRNA developing a separate submission pipeline for ancillary data and information as needed, including information on reagents, standard protocols, and data generated as a result of technology development, platform characterization, studies to examine biological relevance, and ERCP creating an overall data coordination plan that maximizes data transportability and data interoperability, given the rapidly changing landscapes for data access and data integration.

working with ERCP PD(s)/PI(s) to establish a public data release policy congruent with that of a community resource project while simultaneously protecting human subjects. The DMRR will need to be flexible and responsive in following the evolving NIH policies on data sharing. working with ERCP consortium members to establish regular data freezes to quantify productivity and facilitate analysis activities.

establishing an export pipeline to permit timely transfer of ERCP data from consortium data freezes or publications to appropriate public repositories and community databases.

These repositories may include the Gene Expression Omnibus (GEO) at the National Center for Biotechnology Information (NCBI), dbGAP (in the case of control access datasets), ArrayExpress at the European Bioinformatics Institute (EBI), the UCSC Genome Browser at the University of California at Santa Cruz, and Ensembl at the EBI and the Wellcome Trust Sanger Institute.

Regardless of where datasets are deposited, the DMRR DCC will provide access to the ERCP-generated data and metadata for the duration of the ERCP. Data and metadata must be available in standard formats to facilitate additional analysis by members of ERCP consortium and the broader scientific The DMRR DCC must be able to provide links between the data in the public repositories and the data as they reside in the DMRR.

Submission of the data to public repositories and community databases must be no later than submission of a manuscript. working with the DMRR DAIC and DMRR SOC to provide a public website containing links to the data and metadata, including workflows used to generate each analysis, for all figures in the paper.

Data Integration and Analysis Component (DMRR DIAC) Development of the Extracellular RNA Atlas will require the DMRR to work closely with the rest of the ERCP consortium PD(s)/PI(s) to facilitate analysis of the data obtained by PD(s)/PI(s) within the project. The ERCP PD(s)/PI(s) will establish the overall data integration and analysis priorities for the consortium.

We expect that the DMRR DIAC will coordinate multiple teams for analyzing consortium data in different ways. The DMRR DIAC should plan to facilitate data analysis efforts of smaller projects and also provide substantial support for consortium-wide integrative analysis efforts.

We anticipate that the majority of datasets that will be analyzed will be RNA-seq, small RNA-seq or related datatypes, however other datatypes (e.g. proteomic, metabolomic, individual variation) may require analysis as well.

Applicants should describe any prior experience in successfully leading the analysis of large and disparate datasets as well as describe their plans to address some of the anticipated activities of the DMRR DIAC which include: developing analysis tools and strategies to address the extent to which ExRNAs may be transferred from food, the environment, and the developing analysis strategies to integrate the ExRNA datasets in synergistic ways with other relevant datasets (e.g. inter-individual variation, proteomic, metabolomic) as well as developing user-friendly analysis tools for the consortium and apps for investigators with limited experience in RNA data publishing integrative ExRNA consortium papers which might include analyses of classes of ExRNAs, cells or organisms of origin, relative abundance, and/or other properties including the use of ExRNA profiles/signatures as biomarkers generating comprehensive and accurate catalogs of ExRNAs for different body fluid and/or define biological roles for these ExRNAs facilitating interactions between ERCP Consortium members or outside investigators to identify any additional datasets from outside of the ERCP Consortium for use in integrative analyses possibly developing software relevant to the analysis of ExRNA datasets.

Any software proposed to be developed should be modular, open-source, and include appropriate documentation, so that it can work as a stand-alone package. Software should not duplicate existing software with similar features and should leverage existing software projects as much as possible. Software should use standard formats for data input and output, to facilitate its use and interoperability with other software.

performing analyses requested by ERCP consortium members or NIH staff to assess the quality and coverage of the ExRNA datasets. planing and implementing regular conference calls with ERCP consortium PD(s)/PI(s) to develop Data Analysis Working Groups to coordinate and facilitate integrative analysis of ExRNA consortium data.

coordinating with the DMRR DCC to provide support, including data transformations and preparation of data freezes, for any data analyses. providing resources and coordination activities that will enable the ERCP Consortium to share useful information about ExRNA species and profiles to the larger biomedical research community.

supporting activities that include but are not limited to developing uniform data processing pipelines to standardize the ExRNA data analyses, assessing the quality of the ExRNA data, and integrating datasets and The DMRR Administrative Core should include a DMRR administrator who will dedicate substantial effort to the administrative core activities and who will collaborate closely with the DMRR Director(s), NIH staff, and ERCP PD(s)/PI(s).

Applicants should describe their plans to address some of the anticipated critical activities of the DMRR Administrative Core which include: facilitating communication and interaction between DMRR DCC, DIAC, facilitating communication across the ERCP consortium including setting up teleconferences/ steering committee/workgroup meetings and providing internet-based resources such as mailing lists, a wiki, file sharing, or social media tools to share data and enable discussions within the Consortium.

organizing and supporting an annual ERCP consortium-wide grantees meeting. This meeting will have 50-100 attendees and take place in the Bethesda, MD area. All attendees will support their own travel and lodging through their funded grants.

providing NIH staff with quantitative updates on data deposition, data quality, and data usage statistics upon request. providing assurance of compliance with NIH policy requirements. DMRR Application Considerations There are a number of additional issues that applicants should consider when crafting their applications.

These include: All components and the administrative core should provide a list of the ultimate goals/deliverables that will be generated by the U54. Deliverables should be quantitative whenever possible and would include items such as 1. reaching consortium-wide consensus on protocols and data format for RNA sequence deposition into the data repository.

2. establishing a community website, 3. making available an E-Manual of protocols, 4.

organizing the first annual ERCP consortium-wide grantees meeting, 5. development of uniform metadata standards, 6. providing ERCP-specific and community access to ERCP-generated data, 7.

development of user-friendly tools for the novice user, 8. Development of an outreach strategy to advertise resources, 8. establishing a process for accepting or incorporating data generated from outside the consortium, 9.

Developing the Extracellular RNA Atlas (ERA). A timeline (Gantt chart) including milestones is required for all studies. Milestones are intermediate steps towards the completion of concrete goals.

They must include clear and quantitative criteria for success. Yearly quantitative milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years.

The application must include clearly-specified, well-defined milestones, quantitative go/no go decision points, and timelines for assessing progress. DMRR key personnel/consultants should demonstrate strong scientific expertise in the area of ExRNAs or RNA biology, and expertise in handling and analyzing RNA-seq data sets.

The effective management of the DMRR requires a significant commitment by the PD(s)/PI(s) and the leaders of the individual DMRR components. PD(s)/PI(s). Applicants should describe how s/he will manage the proposed project, who will oversee the day-to-day activities (e.g., a project manager if not the PD(s)/PI(s)) and how the management structure will support achievement of the proposed goals and milestones.

Applications which do not include a description of all three distinct stand-alone components (DMRR DCC, DMRR DIAC, and DMRR SOC) and an administrative core will be deemed by NIH staff to be NON-RESPONSIVE to this FOA and administratively withdrawn without review. It will be difficult to predict the exact volume and types of data that will be submitted over the lifetime of the ERCP Consortium.

Increasing efficiencies in generating data along with potential changes in technology platforms may dramatically alter the types and volume of data, while the addition of data from outside of the ERCP also may add additional data volume and complexity. Applicants should describe how they will prioritize their activities to ensure that the main goal of the DMRR, generation of the Extracellular RNA Atlas, will be achieved.

As the data storage, analysis, and dissemination needs of the ERCP Consortium change with time, components of the DMRR may be asked to implement modifications to their workflows as agreed upon by the ERCP Consortium.

All components of the DMRR should indicate their willingness to be flexible in their implementation of data coordination, analysis, and outreach After award selection but prior to funding, the prospective awardee(s) for the DMRR components will be asked to submit revised budgets and research plans for all proposed DMRR components and the administrative core.

A key component of this program is the formation of consortium partnerships amongst all awardees. Each Notice of Grant Award will require the execution of an Inter-Institutional Agreement by the grantee. A template for Inter-Institutional Agreements should serve as a guidance document to provide a framework under which consortium relationships are established.

This and other templates, such as for Confidential Disclosure Agreements (CDAs) and Collaborative Research Agreements (CRAs), have been developed by the NIH Office of Technology Transfer ).

By participating in the consortium, the awardees in regular (monthly) conference calls with all consortium members efforts with other awardees, in particular with the DMRR and present findings at annual workshops convened by the NIH through the DMRR publish findings in a timely manner yearly milestones as defined by investigators and NIH program at the time of with, cooperatively interact with, and actively seek input from NIH, sharing of data and biological specimens with academic, industry and government researchers is a critical feature of this program that is consistent with applicable laws, regulations, and policies.

All subjects must be properly consented to allow appropriate sample and data distribution to researchers in and designated NIH databases will be utilized for the banking and distribution of biological and clinical data. Project PD(s)/PI(s) will be expected to harmonize all data and resource generation with the Data Management and Resource Repository (DMRR).

The DMRR is expected to curate and disseminate information regarding critical reagents, and resources as well as promote and facilitate cross-project collaborations. Section II. Award Information Application Types Allowed Glossary and the PHS398 Application Guide provide details on these application Funds Available and Anticipated Number of Awards NIH Common Fund will commit at least $2.

5 M/year total costs for five years to support one award intended to be funded in 2013. Although the financial plans of the NIH provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations..

Application budgets are limited to $2M total costs and must reflect actual needs of the proposed project. The total award period requested for this FOA may not described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government including the U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award.

Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s)) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Section IV.

Application and Submission Information Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 2. Content and Form of Application Submission It is critical that applicants follow the instructions in Application Guide , except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity The letter of intent should be sent to: John Satterlee, Ph. D.

on behalf of the NIH Common Fund Extracellular RNA Working Group National Institute on Drug Abuse/NIH Division of Basic Neuroscience and Behavioral Research 6001 Executive Blvd. Rm 4101 (For Fedex Delivery the address is Rockville, MD 20852) Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail) Bethesda, MD 20817 (for express/courier service; non-USPS service) At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to: John Satterlee, Ph.

D. for the NIH Common Fund Extracellular National Institute on Drug Abuse/NIH Division of Basic Neuroscience and Behavioral Research 6001 Executive Blvd.

Rm 4101 (For Fedex Delivery the address is Rockville, MD 20852) All page limitations described in the PHS398 Application Guide and must be followed, with the following modifications: Research Strategy section is limited to 12 pages for EACH of the three components (Data Coordination, Data Analysis, and Scientific Outreach.