Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)
National Human Genome Research Institute (NHGRI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
Office of Behavioral and Social Sciences Research (OBSSR)
National Cancer Institute (NCI)

Funding Opportunity Title

Extended Development, Hardening and Dissemination of Technologies in Biomedical Computing, Informatics and Big Data Science (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • July 30, 2014 - Notice of Modification of Allowable Budgets for Data Deposition in PA-14-156. See Notice NOT-GM-14-125.
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • March 24, 2014 - See Notice NOT-CA-14-041. Notice of National Cancer Institute (NCI) Participation.

Funding Opportunity Announcement (FOA) Number

PA-14-156

Companion Funding Opportunity

PA-14-155, R01 Research Project Grant
PA-14-154, R43/R44- Small Business Innovation Research - Phase I, Phase II, and Fast Track
PA-14-157, R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859, 93.273, 93.361, 97.853, 93.286, 93.865, , 93.846, 93.172, 93.113, 93.242, 93.279, 93.393, 93.394, 93.395, 93.396, 93.399

Funding Opportunity Purpose

The goal of this program announcement is to support the extended development, maintenance, testing, evaluation, hardening and dissemination of existing biomedical software. The NIH is interested in promoting a broad base of research and development of technologies in biomedical computing, informatics, and Big Data Science that will support rapid progress in areas of scientific opportunity in biomedical research. It is expected that this research and development is conducted in the context of important biomedical and behavioral research problems and that domain researchers are consulted to make sure that the software is relevant to users. As such, applications are intended to develop enabling technologies that could apply to the interests of most NIH Institutes and Centers and range from basic biomedicine and including research to all relevant organ systems and diseases. Major themes of research include collaborative environments; data integration; analysis and modeling methodologies; and novel computer science and statistical approaches.  New opportunities are also emerging as large and complex data sets are becoming increasingly available to the research community.  The proposed work should apply best practices and proven methods for software design, construction, and implementation to extend the applicability of existing technologies in biomedical computing, informatics and big data science to a broader biomedical research community.

Key Dates
Posted Date

March 14, 2014

Open Date (Earliest Submission Date)

May 5, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

May 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) 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. 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.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the 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

This Funding Opportunity Announcement (FOA) is aimed at satisfying one of the needs created by the parallel achievements and increased interdependence of the biomedical, computational, and big data science communities. This interdependence offers an unprecedented opportunity for sophisticated approaches to computer-enabled research in the biomedical sciences. The purpose of this FOA is to ensure the availability, continued usefulness (through extended development), and software hardening of existing technologies in biomedical computing, informatics and big data science. This FOA is coordinated by the NIH Big Data Initiative (BD2K) and the Biomedical Information Science and Technology Initiative (BISTI) committees. Through this and related opportunities, Institutes and Centers at the NIH offer support for: fundamental research (e.g., methodologies and approaches) in biomedical computing, informatics, and Big Data science; continued development, maintenance and hardening of software, tools and related resources; and applications of computational technologies to a particular domain area(s) in biomedical research. Information on these programs and related funding opportunities from participating Institutes and Centers of NIH can be found at http://www.bd2k.nih.gov and http://www.bisti.nih.gov/. Note that in this document, the term “biomedical” will be used in the broadest sense to include biological, biomedical, behavioral, social, environmental, and clinical studies that relate to understanding health and disease. Applicants are reminded to carefully check that the proposed research lies in the mission of the participant Institutes and Centers of the initiative.

In addition to applications for funding continued development and maintenance of software that have been accepted under previous BISTI funding opportunity announcements, this announcement acknowledges new opportunities are also emerging as large and complex data sets are becoming increasingly available to the research community. While the biomedical research enterprise is producing increasingly large amounts of digital data, it has not yet fully capitalized on the transformative opportunities that these data provide.  As stated by the Data and Informatics Working Group (DIWG) of the Advisory Committee to the NIH Director, "Colossal changes in biomedical research technologies and methods have shifted the bottleneck in scientific productivity from data production to data management, communication, and interpretation." (http://acd.od.nih.gov/Data%20and%20Informatics%20Working%20Group%20Report.pdf).  In this context, the term "Big Data Science" is meant to capture the opportunities and address the challenges facing all biomedical researchers in releasing, accessing, managing, analyzing, and integrating datasets of diverse data types.  Such data types may include imaging, phenotypic, molecular (including –omics), physiological, anatomical, clinical, behavioral, environmental, and many other types of biological and biomedical data.  They may also include data generated for other purposes (e.g., social media, search histories, and cell phone data). 

Applications under this program announcement can seek support to continue development and maintenance of Big Data Science software.  A number of features of the improved software are listed below. Any of these improvements should benefit the existing user community and/or have potential for attracting more users.

First, contemporary software must be easy to modify and extend, and must be fully documented. Users who experience problems with software should be able to correct the problem with minimal effort and a mechanism must exist for incorporating these corrections into the software. As the needs of a community of users change, the software that supports their research efforts must be adaptable as well. The ability of software to be repaired and to evolve is particularly important because the scientific discovery process is open-ended and ever-changing.

Second, interoperability among different software packages or among software and existing databases is a major challenge. Applications with the goal of extending interoperability are welcomed under this program announcement. Portability to different types of hardware is a related area of challenge. Applications with the goal of improving software so that it operates on a variety of platforms employing different operating systems are also encouraged.

Finally, an important goal of the BD2K and BISTI Initiatives is to promote a culture where a large body of annotated and shareable data is available online to the broad biomedical research community. The development and use of data and metadata standards are critical for achieving this goal. The NIH has a number of efforts to stimulate the creation and support of community-based approaches to develop such standards. Investigators may participate in the development of data standards, and may serve as early testers and adopters of community-developed standards. The application should include a plan for how the proposed R01 will manage data and metadata standards and formats.  Applicants should, as appropriate, i) engage with community-based standard and format development activities, and ii) apply community-based standards and formats to the data and metadata that the R01 is using for its research.

In the context of the research and development to extend, harden and disseminate established software, investigators may target one or multiple of the following four themes of biomedical computing, informatics, and Big Data science that will enable progress in biomedical research.

1. Collaborative environments and technologies: An applicant continues the development and maintenance of environments and technologies for Big Data science and gaining access to and using Big Data and tools. Examples include, but are not limited to:

2. Data integration: An applicant may propose to continue the development and maintenance of efficient and effective ways to create connections across data types (i.e., unimodal or multimodal data integration). Examples of data types that could be addressed include, but are not limited to:

3. Analysis and modeling methodologies: An applicant may propose to continue the development and maintenance of approaches for modeling, simulation, or analysis to produce useful biomedical information in ways that current methods cannot provide. Examples include, but are not limited to:

The research and development to extend, harden and disseminate established software should take place in the context of biomedical and behavioral research that is of interest across most NIH Institutes and Centers from basic biomedicine to research in all relevant organ systems and diseases. These projects do not require substantial innovation as the main purpose of this initiative is to support existing software and make it more useful to the user community.  Therefore, it is important to obtain testimonials from the user community, e.g., letters of support, as to the potential for the project, along with other preliminary results provided by the applicants. The applicant should address the intended use of the technology, identify the technology development needs that s/he proposes to address, and how these needs are related to important biomedical, translational, or clinical research problems. Applicants will be expected to demonstrate appropriate understanding and adequate expertise in the relevant areas of both biomedical research and computational science and technology.

Through separate funding opportunity announcements of similar scientific scope, participating Institutes and Centers invite applications for early stage development in biomedical computing, informatics, and Big Data science (R01) PA-14-155, as well as small business innovation research (SBIR) PA-14-154 and small business technology transfer research (STTR) PA-14-157 . Some NIH Institutes and Centers may have other grant mechanisms that could apply to biomedical computing projects. Applicants are encouraged to visit the BD2K and BISTI web sites for these and other relevant funding opportunities: http://www.bd2k.nih.gov/opportunities, and http://www.bisti.nih.gov/bistic_funding.cfm.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

Project periods are limited to 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 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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

The applicant may not request funds for large-scale data production or acquisition; however, a limited amount of funds may be requested for the production or acquisition of test datasets that are necessary for the proposed work. The development of comprehensive central databases for particular data types is not within the scope of this FOA.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: Applications will be expected to address the generalizability of the software, the scientific validation of implementations, and self-evaluation according to the following guidelines:

Generalizable, scalable, extensible, and interoperable: Given the expanding needs in biomedical research for advances in a variety of areas of biomedical computing and informatics, the technologies proposed under this announcement should address a significant biocomputational research question and, as appropriate, should be generalizable, scalable, extensible, and interoperable.  The applicant should also provide plans for the dissemination of products of the project, including software, tools and related resources, to the relevant research and user communities. The extended development work proposed should be forward-thinking, fill a critical gap, address an area of need or projected need, and seek to exceed the current state of the art.

Scientific Validation: Each application should contain a brief plan for validation of the scientific software, tools and related resources.  This plan should provide the organizing principles by which scientific validation will be conducted. 

User input: Projects should include plans for how end user input will be obtained. Users may be basic or translational biomedical researchers, experimental scientists, behavioral scientists, social scientists, clinicians, software developers, or computational scientists.

Evaluation: The application should include a plan for evaluating the quality and utility of the new software, tools and related resources being developed through this initiative.  Criteria for evaluation of products may include adequacy, trustworthiness, authenticity, integrity, availability, documentation, and transparency. Specific examples of evaluative information could include, as appropriate, the quality of publications citing uses, tracking the number of users, background/training of the users, requests for services, successful use of the products, number of students, use of training materials, the ability to extend the utility of tools through collaborations with other investigators, etc. The research community being served will have expectations that could be documented through mechanisms such as user feedback, letters of support, etc. Quantifiable measures of results and success are important and should be built in as:

Methods for assessment, such as user registration, should not be so onerous that they compromise the use of the investigator’s resources.

Use of Common Data Elements in NIH-funded Research: NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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 SF424 (R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

A software dissemination plan, with appropriate timelines, is expected to be included in the application. There is no prescribed single license for software produced through grants responding to this announcement. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

2. The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4. The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

5. To further enhance the potential impact of their software, applicants may consider proposing a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This application for funding may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

Reviewers will provide an overall impact 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

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?  

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

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?   

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

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?   

Additional Review Criteria

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

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 score.

Applications from Foreign Organizations

Reviewers will assess 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.

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) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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/PI 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, SAM 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

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

David Balshaw, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Email: 919-541-2448
Email: Balshaw@niehs.nih.gov

Vivien Bonazzi, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-8276
Email: bonazziv@mail.nih.gov

Regina Bures, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485
Email: buresrm@mail.nih.gov

German Cavelier, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: gcavelier@mail.nih.gov

John A. Matochik, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:  301-451-7319
Email:  jmatochi@mail.nih.gov

Augie Diana, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: (301) 402-6423
Email: dianaa@mail.nih.gov

Gayle Lester, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3511
Email: lester1@mail.nih.gov

Yuan Liu, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0012
Email: liuyuan@mail.nih.gov

Peter Lyster, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: lysterp@mail.nih.gov

Vinay Pai, Ph.D.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: paiv@mail.nih.gov

Joni L. Rutter, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0298
Email: jrutter@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196
Email: aldersoc@nida.nih.gov

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: burgle@nigms.nih.gov

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: chickc@mail.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Rebecca D Claycamp, MS, CRA
National Institute of Mental Health (NIMH)
Telephone: 301.443.2811
Email: rclaycam@mail.nih.gov

Maxine Davis
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-7359
Email: davisma@ninds.nih.gov

Judy Fox
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0606
Email: jfox@mail.nih.gov

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: (301) 402-6959 
Email: sintj@mail.nih.gov

James Huff
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: huffj@mail.nih.gov

Melinda B. Nelson
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-5278
Email: melinda.nelson@nih.gov

James Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1403
Email: williamsjr@niehs.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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