Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)

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 NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).  The FOA will be administered by the National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov) on behalf of the NIH.

Funding Opportunity Title

Accelerating the Integration and Translation of Technologies to Characterize Biological Processes at the Single Cell Level (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-RM-11-015

Companion FOA

U01 RFA-RM-11-013; R21 RFA-RM-11-014

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.310

FOA Purpose

This NIH Funding Opportunity Announcement (FOA), supported by funds from the NIH Common Fund, invites applications for R01 awards that will accelerate the translation of promising technologies for single cell analysis from prototype into practice, by taking them through the downstream development and validation process and establishing them as robust, well-characterized tools ready to transform our understanding of cell-level heterogeneity in a wide variety of clinical and research settings. Awards will focus on supporting multidisciplinary teams that apply an integrative, quantitative approach to developing these technologies so they fulfill a critical unmet need by offering compelling advantages to end-users, but can be applied to multiple types of cell populations. It is expected that applications will have well-defined goal(s) with intermediate quantitative milestones.

Key Dates
Posted Date

November 23, 2011

Open Date (Earliest Submission Date)

December 23, 2011

Letter of Intent Due Date

December 23, 2011

Application Due Date(s)

January 23, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2012

Advisory Council Review

August, 2012

Earliest Start Date(s)

September, 2012

Expiration Date

January 24, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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

Purpose

The goal of this FOA is to accelerate the translation of promising technologies for single cell analysis from prototype into practice, by taking them through the downstream development and validation process and establishing them as robust, well-characterized tools ready to transform our understanding of cell-level heterogeneity in a wide variety of clinical and research settings.

The purpose of this FOA is to solicit applications that propose to validate and translate innovative technologies which have been demonstrated to have the potential to provide comprehensive analyses of individual cells within an in situ population. The projects will be designed to fulfill a defined critical unmet need of researchers by providing, for example: 1) a groundbreaking clinical diagnostic device; 2) significantly higher sensitivity and specificity over existing approaches for detecting rare events, rare cells and for handling dilute or small volume samples; 3) order of magnitude improvements in the operating parameters, analysis and usability of existing approaches to establish them as methods of choice; 4) and/or innovative adaptation of techniques used exclusively with fixed cells or cell culture to analysis of live cells in situ.

Background

This initiative is part of the Single Cell Analysis Program (SCAP) and is funded through the NIH Common Fund (See http://nihroadmap.nih.gov/), which supports cross-cutting programs that are expected to have exceptionally high impact. Common Fund initiatives address key roadblocks in biomedical research that impede basic scientific discovery and its translation into improved human health. In addition, these programs capitalize on emerging opportunities to catalyze progress across multiple biomedical fields.

Single cell analysis has recently emerged as an important field of research because technologies have improved in sensitivity and throughput sufficiently to begin measuring and understanding heterogeneity in complex biological systems and correlating it with changes in biological function and disease processes. By profiling individual cells it is possible to resolve rare cells, transient cell states, and the influence of organization and environment on such cells and states, which cannot be described by ensemble measurements. The long-term goal of the SCAP is to accelerate this move towards personalizing health to the cellular level by understanding the link between cell heterogeneity, tissue function and emergence of disease through the discovery, development and translation of innovative approaches which will dramatically change the way cells are characterized.

The SCAP will focus on supporting work which will systematically measure, analyze and model cell-to-cell variation, and identify crucial differences and rare biological states, which may have important functional consequences. To robustly and systematically describe cell level heterogeneity, projects are expected to take a multiplexed approach with minimal perturbation, which can be applied reproducibly to any complex tissue. Technologies and methods must also be capable of capturing spatiotemporal information to understand the organization, evolution and response of cell states as part of a functional population. In addition, the SCAP emphasizes the application of these technologies to in situ populations of cells from multicellular organisms to link cell state measurements with complex, functional tissues which can inform our understanding of disease processes.

The SCAP has been designed as a five-year program with several components: (1) the collection, analysis and sharing of comprehensive expression datasets to understand the role of heterogeneity in tissues and systemically and identify critical parameters and states; (2)  the discovery of new, innovative tools for spatiotemporal imaging, manipulation, analysis and modeling of a biologically relevant population of cells with minimal perturbation; (3) milestone-driven validation and translation of technologies for characterizing single cells in situ meeting the needs of end-users; and (4) development and coordination of a multidisciplinary research community through workshops and other collective endeavors. Further details can be found on the Program’s website (http://commonfund.nih.gov/singlecell/).

Objectives

To accelerate the translation of promising technologies from prototype into practice, a key objective is to improve upon basic technical innovations that have already been demonstrated in principle and which have the potential to be robust, well-characterized technological solutions to the analyses of single cells in situ. Preliminary results should indicate that the proposed solution would offer significant advantages to at least one group of end-users. The proposed project is expected to overcome barriers to in situ measurement of human or animal cells and adoption of the technique into routine use. Investigators are asked to quantify the expected in situ performance measures and to benchmark them against current state-of-the-art approaches when describing these significant advantages. Validation of expected performance must be demonstrated using sufficiently large, functional, in situ populations of human or model animal cells.

Another key objective of this FOA is to support multidisciplinary teams who will develop innovative solutions to address critical unmet needs of clinical and scientific users. These teams must bring together the necessary biological, clinical, physical, computational, and engineering expertise with end-users and the necessary resources to realize the milestones which will guide the project. An application may involve strategic partnerships with companies or other organizations to assess user needs, for validation or for dissemination. As part of clear leadership and project plans, each partner is expected to provide substantive contributions to intellectual or technical aspects of the project that are clearly differentiated from simple contractual arrangements. It is recognized that the maximum project period supported by this FOA may not be sufficient for complete translation of some solutions, and in this case investigators are asked to briefly project their chosen milestones in a framework of larger milestones towards the final goal of their work. Milestones should describe projected specific, measureable and achievable progress throughout the project period which can be used as an indicator of success towards an end-goal such as entry into clinical testing or product launch.

A third key objective of this FOA is to enable the comprehensive analysis of cell state by clinicians and/or researchers. Technologies should collect a sufficient number of autonomous parameters in parallel to uniquely describe multiple cell states and tissue-level functions with minimal perturbation and with high spatiotemporal accuracy and specificity. Technologies should also be broadly applicable to other populations of cells and projects may include development or adaptation of appropriate data analysis techniques where appropriate for use by multiple end-users. Investigators are expected to submit appropriate resource sharing plans, and should describe in detail how resources and data generated under the grant would be shared and how technologies would be disseminated, consistent with achieving the goals of the program. The annual SCAP workshop will be also used to build synergy.

To meet these key objectives, investigators must justify the unmet need which the technology fulfills, give details of the major tasks in further developing, validating and translating this technology. They must also describe sufficient proof of principle data to justify further developing this technology towards a realistic end-goal. Detailed instructions are described in Section IV. 6. Other Submission Requirements.

Applications which focus on the validation and translation of technologies which have recently been demonstrated in principle with single cell organisms or in vitro and have the potential to transform our understanding of heterogeneity and the link with tissue-level function are encouraged. In addition, integrated and automated solutions for multiplexed analysis of autonomous cell characteristics and components with the potential to improve performance by an order of magnitude are encouraged. Applications to develop technologies and analytical methods for classes of cellular components which have not yet been measured at the single cell level are also encouraged. Applications which seek to establish proof-of-concept are encouraged to respond to a companion FOA RFA-RM-11-014 and those seeking to primarily use transcriptional analysis to respond to another companion FOA RFA-RM-11-013. Applications focused on improvements of current technologies which will not lead to a foundational change in the methods employed by end-users, are focused on in vitro analysis or which are validated using single cell organisms will be considered unresponsive.

Examples of technology translation supported by this FOA may include (but are not limited to):

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (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. NIH intends to fund an estimated 3-5 awards.

The total amount of funds available for these awards is approximately $4,000,000 in FY 2012.

Award Budget

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Applications are limited to a maximum of $750,000 annual direct costs.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 5 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 must complete the following registrations as described in the SF 424 (R&R) 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 least 4-6 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 SF 424 (R&R) Application Guide.

Each PD(s)/PI(s) is expected to devote a minimum of 3.0 person months (25% effort) to the project..

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. 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.

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 very strongly encouraged to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Richard Conroy, Ph.D.
Program Director
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Democracy Plaza II, Suite 200
Bethesda, MD 20892-5469
Tel: 301-402-1486
Fax: 301-480-1614
Email: Richard.Conroy@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following modification:

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.

Foreign Institutions

Foreign (non-US) 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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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 Central Contractor Registration (CCR). 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 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/PIs in accord with the Terms and Conditions provided in this FOA.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

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.

Additional Information

The following exceptions to the general R01 instructions will apply for this FOA:

Public Health Relevance Statement: Investigators should clearly articulate how addressing the needs of end-users through the validation and translation of technology will improve public health. The statement should highlight how understanding will be transformed and the size and nature of the communities affected.

Biosketches: PD(s)/PI(s) should cite relevant details that illustrate their ability to validate and translate technologies and lead multidisciplinary teams.  In their personal statements, investigators are asked to briefly summarize achievements in both single cell analysis and goal-directed, needs-driven research.

Budget: PD(s)/PI(s) should include attendance at the annual workshop as part of their project budget.

Research Strategy: The 12 page research strategy should clearly address:

Leadership Plan: A one page description of the leadership plan, describing the structure, budget allocation and responsibilities of each component of the team, communication plans, intellectual property management and processes for resolving conflicts and scientific direction should be included as an attachment entitled “Leadership Plan” under Other Project Information Component. Multiple PD(s)/PI(s) applications should address these same elements as part of their Multiple PD(s)/PI(s) Leadership Plan. Each PD/PI is expected to devote a minimum of 3.0 person months (25% effort) to the project.

Resource Sharing Plan: To accelerate the field of single cell analysis, grantees are expected to participate actively and openly in annual workshops. In addition to attending the annual workshop, investigators should describe how information will be rapidly disseminated and unique resources shared to advance biomedical research, consistent with achieving the goals of the program. Details of the kinds of resources to be developed including data, model organisms and genome-wide association studies, what format these resources would be disseminated in and how they would be shared should be included in the plan. The plan should also include plans for sharing raw (unreduced) data with other researchers who may wish to analyze it independently. Substantial information sharing is critical to the overall program, though it is understood that some information developed under the grants will be proprietary and cannot be shared immediately without damaging the commercialization potential of the scientific discovery or there may be other cases in which protection of human subjects need to be abided by . Investigators are expected to be aware of and abide by all applicable NIH guidance for sharing of research resources and data, consistent with existing laws, regulations, and policies. Please see: http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. The adequacy of  resource sharing plans will be considered by program staff of the funding organization when making recommendations about funding applications.

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.

For this announcement, note the following:

Reviewers should note that this FOA focuses on tool validation and translation and  so should expect sufficient proof-of-principle data to assess whether the proposed quantitative milestones are reasonable. Furthermore, the reviewers should understand and accept that later milestones may extend beyond the project period. Therefore, reviewers should balance the significance and innovation afforded by the long-term goal with the feasibility and approach of the milestones proposed within the project period.

Overall Impact

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

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(s)/PI(s), 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 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?

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/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 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/priority 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 (CSR), 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 in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications 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 National Advisory Council for Biomedical Imaging and Bioengineering. 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

Not Applicable.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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

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)

Richard Conroy, Ph.D.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Democracy Plaza II, Suite 200
Bethesda, MD 20892-5469
Tel: 301-402-1486
Fax: 301-480-1614
Email: Richard.Conroy@mail.nih.gov

Peer Review Contact(s)

David Balasundaram, Ph.D.
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892-7854
Telephone: (301) 435-1022
Email: balasundaramd@csr.nih.gov

Financial/Grants Management Contact(s)

Katie Ellis
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
6707 Democracy Blvd. Suite 900
Bethesda, MD  20892-5469
Phone: 301-496-8521
Fax: 301-480-4974
Email:  kellis@mail.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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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