Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components 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)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-RM-12-010

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

Number of Applications

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)

93.310   

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.  .

Key Dates
Posted Date

August 3, 2012

Letter of Intent Due Date

October 12, 2012

Application Due Date(s)

November 13, 2012

AIDS Application Due Date(s)

Not Applicable..

Scientific Merit Review

February - March 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

July 2013

Expiration Date

November 14, 2012

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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.

Table of Contents

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 Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

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.

Research Objectives

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 naïve 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.

DMRR 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 include an ExRNA Atlas.

2. Develop an outreach strategy to advertise available ERCP protocols and resources to the scientific community.  The outreach strategy should include:

DMRR Data Coordination Component (DMRR DCC)

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 include: 

DMRR 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: 

DMRR Administrative Core

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: 

Other 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 workflows.   

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. 

ExRNA Consortium Agreement

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 agree to:

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

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..

Award Budget

Application budgets are limited to $2M total costs and  must reflect actual needs of the proposed project.

Award Project Period

The total award period requested for this FOA may not exceed five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions   

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
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.

Required Registrations

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 registrations.

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 NIH support.

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.     

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

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 plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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
Bethesda, MD 20892
(For Fedex Delivery the address is Rockville, MD 20852)
Phone:  301-435-1020
Email:  satterleej@nida.nih.gov

Application Submission

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 RNA Working Group
National Institute on Drug Abuse/NIH
Division of Basic Neuroscience and Behavioral Research
6001 Executive Blvd. Rm 4101
Bethesda, MD 20892
(For Fedex Delivery the address is Rockville, MD 20852)
Phone:  301-435-1020
Email:  satterleej@nida.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and must be followed, with the following modifications:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Institutions

Not Applicable..

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applicants should include in their budgets sufficient travel-related funds to attend bi-annual workshops to be held in conjunction with investigators funded under this Common Fund initiative on Extracellular RNA.  The yearly travel budget for the bi-annual workshops to be held in the greater Washington, D.C. metro area is not to exceed $6,000. 

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Applications Involving the NIH Intramural Research Program

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 NIH Intramural Program.  NIH intramural scientists will participate in this program as PD(s)/PI(s) 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. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.   

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the proposed DMRR is fully successful in carrying out its plans, will it have a transformative effect  on this scientific field?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do project team members and/or associated collaborators have prior experience and/or necessary qualifications to successfully execute and implement the proposed DMRR components including, where appropriate, the ability to partner and collaborate with other scientists or organizations? Are the relationships of the key personnel to the applicant organization and, if applicable, to other partnering organizations (e.g., Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), academic laboratories, clinical sites and/or strategic partners) appropriate for the work?   Do DMRR key personnel/consultants demonstrate strong scientific expertise in the area of ExRNAs or RNA biology  Do the PD(s)/PI(s) and/or key personnel have demonstrated expertise or prior experience in successfully leading the coordination or analysis of intensive activities and high-throughput datasets?  Is there expertise in handling and analyzing RNA-seq data sets?  Are the leadership plans, experience, and levels of effort appropriate for managing a project of this magnitude?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the applicant propose innovative plans (e.g. outreach strategies, data coordination solutions, data analysis approaches) for advancing the DMRR components?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? How well do the proposed plans of the DMRR DCC, DIAC, SOC, and administrative core align with the anticipated critical activities of the DMRR?  How well will the approach proposed by the applicant enable the DMRR components 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?  How well thought out are the plans for each component?  Does the DMRR overall plan allow for data transportability and data interoperability in the future?  How well does the management structure support achievement of the proposed goals and milestones?  Is the proposed DMRR data release plan appropriate for a community resource project?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?Is the applicant organization concentrating on its core competencies in order to maximize its chances of success?  Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate achievement of the research goals? Does the project take advantage of the best available tools and resources available to the scientific community?  Do the letters of collaboration and institutional support show strong commitment to the project?      

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Aapplicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.   

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.   

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Intellectual Property

The NIH recognizes that intellectual property rights may play an important role in achieving the goals of this program. To this end, all awardees shall understand and acknowledge the following:

Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, reports to the NIH Common Fund Extracellular RNA Steering Committee, and other mechanisms.

Data

Awardees will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Publications

The Program Director/Principal Investigator (PD(s)/PI(s)) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD(s)/PI(s) and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Project Leaders and will require appropriate acknowledgement of NIH support. Timely publication of major findings is encouraged.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Common Fund Extracellular RNA Communication Project Scientists will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination.  However, the role of NIH Common Fund Extracellular RNA Project Scientists will be to facilitate and not to direct the activities. 

Each NIH Common Fund Extracellular RNA Project Scientist shall participate as a member of the NIH Common Fund Extracellular RNA Steering Committee

The Project Scientists will:

Areas of Joint Responsibility include:

A Steering Committee will serve as the main governing board of the Extracellular RNA

Communications Network.  The Steering Committee membership will include NIH Project Scientists and the PD(s)/PI(s) of each awarded cooperative agreement. The PD(s)/PI(s) of each award (or designee) will have one vote on the Steering Committee. The Project Scientists may vote, but the total votes will count as a maximum of one-third of the total number of votes.  The Steering Committee Chair will not be an NIH staff member. Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions. The Steering Committee will:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

External Scientic Consultants:

The External Scientific Consultants (ESC) will be responsible for reviewing and evaluating the progress of the ExRNA Communications Network toward meeting their individual and collective goals. The ESC will be appointed by and provide recommendations to the NIH about continued support of the components of the Network. The Consultant Panel is composed of four to six senior scientists with relevant expertise who are not PIs of a cooperative agreement involved in the Network. The membership of the ESC may be enlarged permanently, or on an ad hoc basis, as needed. 

The ESC will meet at least once a year. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the ESC to interact directly with the awardees. Annually, the ESC will provide comments regarding progress of the Consortium and on any changes that may be necessary to the NIH.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

John Satterlee, Ph.D.  for 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
Bethesda, MD 20892
(For Fedex Delivery the address is Rockville, MD 20852)
Phone:  301-435-1020
Email:  satterleej@nida.nih.gov

Peer Review Contact(s)

Richard Panniers, Ph.D.
Chief
Genes, Genomes and Genetics
Center for Scientific Review (CSR)
Phone: (301) 435-1741
Email: pannierr@csr.nih.gov

Financial/Grants Management Contact(s)

Cheryl Nathaniel
Grants Management Specialist
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd., MSC 9560
Bethesda, MD 20892-9560
Rockville, MD 20852 (Express Mail)
Phone: (202) 526-0108
Fax: (301) 594-6849
Email:  nathanic@nida.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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