Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund

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 Diabetes and Digestive and Kidney Diseases (www.niddk.nih.gov) on behalf of the NIH.

Funding Opportunity Title

Limited Competition: Renewal Applications for Technology Development for New Affinity Reagents Against the Human Proteome (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-RM-14-002

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed as described in Section III. 3. Additional Information on Eligibility.

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

93.310  

Funding Opportunity Purpose

The NIH Common Fund Protein Capture Reagents Program (PCRP) aims to develop over time the capacity to generate a community resource of high quality renewable affinity reagents for all human proteins (see https://commonfund.nih.gov/proteincapture/). This Funding Opportunity Announcement (FOA) is a component of the PCRP, and it seeks renewal applications to cooperative agreements that were funded through RFA-RM-10-018.

Novel approaches for producing validated protein affinity reagents have been developed by the presently funded technology centers and have demonstrated potential for substantially reducing cost and increasing throughput. To determine if any of these approaches can be used in a large-scale proteome project, applicants funded through this FOA are expected to demonstrate scalability by generating affinity reagents recognizing at least three hundred human protein targets.    

Key Dates
Posted Date

February 12, 2014

Open Date (Earliest Submission Date)

March 25, 2014

Letter of Intent Due Date(s)

March 25, 2014

Application Due Date(s)

April 25, 2014, 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)

Not Applicable

Scientific Merit Review

June/July, 2014

Advisory Council Review

August 2014

Earliest Start Date

September 2014

Expiration Date

April 26, 2014

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

Background

Protein affinity reagents have been widely used in basic research and clinical applications.  For example, antibodies have been used to label and isolate individual proteins, complexes and groups of proteins, and whole cells; to localize and visualize, in a time resolved manner, individual proteins, complexes and groups of proteins in cells, tissues, organs, and whole organisms for analytical or diagnostic purposes, including clinical diagnostics; to determine the expression level of proteins in samples of interest, including biological fluids and tissue/cellular samples; to characterize the functional state of the protein as evidenced by its conformational status, post-translational modifications or macromolecular interactions, and biological effects; to manipulate the function of the target protein as a potential tool for mechanistic research; and to target specific proteins for therapeutic intervention.

Immunoglobulin G (IgG) antibodies are the most common protein affinity reagents, but several combinatorial display technologies exist where only a fragment of the whole IgG (e.g. the single chain Fv or the Fab) is used for capturing the protein target of interest.  Several other classes of molecules such as aptamers have also been used for generating high quality affinity reagents.  Recent improvements on the production of several types of synthetic and recombinant protein affinity reagents show great promise for substantially reducing cost and increasing throughput and applicability. However, the novel methods and approaches developed within the technology development component of the PCRP have been limited to the generation of a handful of reagents and have not demonstrated scalability. The overall scalability and cost determination in a production pipeline are still to be determined. The generation of hundreds or thousands of reagents in a pilot pipeline would allow an estimate of the cost for a proteome scale project.

Research Objectives and Scope

There are about 20,500 protein-coding human genes.  However, for a large portion of these genes there are few tools that enable the research community to directly characterize their encoded proteins, for example by identifying and quantifying them in mixtures, by localizing and visualizing them within cells and tissues, or for characterizing the molecular complexes in which they reside. The intent of this solicitation is to develop production pipelines for renewable and validated affinity reagents that can be generated at a cost and throughput that would enable the creation of a community resource of reagents against the human proteome. For this purpose this FOA solicits applications to generate affinity reagents against at least three hundred proteins at a cost below $3,500 per target. The cost and throughput of the production pipeline should be estimated from target selection to reagent validation and distribution. Specific quantifiable milestones should also be used for assessing the actual progress toward the final goal. The results from the projects funded through this initiative should demonstrate if the novel affinity reagents technologies and established pipelines can be used to generate at a reasonable cost a proteome scale resource of renewable and validated affinity reagents for the research community.

The challenge in developing a community resource of high quality renewable affinity reagents for all human proteins resides also in being able to develop a scalable approach that addresses all steps of the pipeline from antigen production to the validation and distribution of the produced affinity reagents.  This FOA seeks to meet this challenge by soliciting projects that can demonstrate the generation of affinity reagents against at least three hundred human proteins at a cost of about $3,500 per target (inclusive of antigen production, affinity reagents production, and their validation).

It is foreseeable that different technologies might be more successful on particular protein families thus more than one approach might be required to achieve the final goal of a proteome scale community resource of renewable affinity reagents. 

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Renewals to RFA-RM-10-018

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

Funds Available and Anticipated Number of Awards

The NIH Common Fund intends to commit $6,000,000 in FY 2014 to fund 2-4 awards.

Award Budget

Direct costs requested may not exceed $2,000,000 per year.

Award Project Period

The project period may not exceed two 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

Eligibility is limited to cooperative agreement awards that were funded through RFA-RM-10-018 "Technology Development for New Affinity Reagents Against the Human Proteome (U54)."

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 not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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)

Eligibility is limited to PD(s)/PI(s) of cooperative agreement awards that were funded through RFA-RM-10-018 "Technology Development for New Affinity Reagents Against the Human Proteome (U54)."

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

Only one application per institution (normally defined by having a unique DUNS number or NIH IPF number) is allowed.

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.

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:

Salvatore Sechi, Ph.D.
Senior Advisor for Proteomics and Systems Biology
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 797
Bethesda, MD 20892-5460
Telephone: 301-594-8814
Email: Sechi@NIH.GOV

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

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 PD/PI is expected to devote at least 2.5 person/months to this award.

The budget for the management plan should be specified and justified, including funds for coordination among components and travel (including travel for key personnel to Steering Committee meetings; and PCRP annual meetings.

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:

Specific Aims: The applicant should outline the new aim(s) and how the project proposed in the renewal application will achieve the objectives and scope of this FOA.  

Research Strategy: Applications should address all the points listed below.

A. Identification, prioritization, and acquisition of antigens

The selection of the targets (three hundred or more human proteins) is up to the applicants. However, for developing an efficient pipeline, and for maximizing the impact that the project might have on the scientific community, the applicants should consider focusing on functionally relevant human protein families (e.g. proteases, kinases, phosphatases, G-protein coupled receptors, glycosyltransferases) or topic (e.g. nuclear proteins, set of metabolic pathways, mitochondrial proteins) or subsets of proteins with few reliable and renewable affinity reagents available. Multiple targets may be selected for the same gene product. For example, the active and inactive forms of an enzyme or the phosphorylated and non-phosphorylated forms of a specific protein may be considered as separate targets. It should be noted that the NIH might provide a small list of antigens that all awardees will have to work on for comparing different technologies.

The applicants should present data indicating the feasibility of producing or acquiring the antigens needed in the project. If the applicants are planning to produce the antigens, preliminary data generating affinity reagents against these antigens should be presented. If the applicants are planning to acquire the antigens, a letter of commitment specifying cost, format, list of antigens, and timeline should be included in the application. Preliminary data generating affinity reagents using these antigens should also be presented.

The quantities needed for the development of the affinity reagents and for their validation should be considered when estimating cost per target.

The known or estimated success rates in antigen production and generation of affinity reagents against these antigens should be accounted for in the proposed plan and milestones. A contingency plan for reaching the proposed goal and milestones should also be described.

B. Production pipeline

The applicants should provide detailed plans for how they will develop a highly efficient, scalable production pipeline for renewable and validated affinity reagents against at least three hundred human protein targets.

Technical approach. The applicants should describe relevant results from the previously funded period for justifying the basic technical approach to making and selecting affinity reagents (e.g. recombinant antibodies, aptamers, etc.). This approach should be minimally justified in terms of: ability to be used in a high-throughput production pipeline; scalability; cost; technical and practical ability to obtain reagents against a large number of protein targets; ability to validate in a cost efficient manner using applications that are common for affinity reagents (e.g. Immunohistochemistry, Immunoprecipitation, Western Blot, Immunofluorescence); advantages compared to alternative approaches; and usability by the community (including advantages for distribution, availability of secondary reagents, ability to label the reagents for various applications, etc.).

Applicants should include other important information relating to the goal of successfully generating a useful resource. For example, how many affinity reagents should be generated per target in order to optimize utility to the community? NIH has been advised that a minimum of two reagents per target should be sought; however applicants should propose and justify a number balancing quality, scientific utility, and costs.

Pipeline development. The applicants should discuss how production will be assessed, what criteria will be applied to determining success at various stages, and also how the process will be monitored to identify any problems within the pipeline. Applicants should discuss routine pipeline quality control (e.g. quality control for reagents used in the process). Applicants should discuss how standard operating procedures will be developed. Applicants should discuss any laboratory information management systems or other informatics that will support their effort.

The applicants should discuss current state of commercial costs per typical renewable affinity reagent (e.g. mouse monoclonal) and per target.  The applicants should discuss their expected costs per reagent and per target at the start of their award and at the end of their two-year funded period.  A breakdown of costs for each stage of the process should be detailed (e.g. target selections, acquisition/production of antigens, validation, and distribution).  Applicants should specifically outline what is included, and not included, in cost estimates.  Applicants should discuss how their cost model might serve as the basis to compare other production platforms against; or suggest a useful cost model for comparative assessment of different platforms.

Applicants should discuss and justify any automation they will use in terms of how it will improve efficiency, cost, quality, or other aspects of production. However, in view of the short term of these awards, where expensive instrumentation might be required, leasing instrumentation or use of facility that can operate on a fee basis as an alternative to purchase is strongly encouraged.

Applicants should provide timelines and quantitative milestones for all critical stages of the pipeline development with particular emphasis on cost and quality.

C. Continuing improvements

The applicants should include a discussion of plans for improving the production pipeline within the proposed budget. Plans for improvements in cost or quality should be discussed, for example, by identifying and addressing important cost-drivers, by modifying protocols or methods, and by cost advantages of scale.

D. Initial characterization and validation

Applicants should propose and justify initial characterization for reagents, including stating criteria for success, based on the importance for assuring a high-quality resource of renewable affinity reagents. It is however expected that at minimum the affinity of the reagent to the target/antigen and the specificity within the context of one application are determined.

Applicants should clearly describe the validation method(s). Although the NIH encourages the generation of reagents that will have the broadest possible utility it is anticipated that particular affinity reagents will not perform optimally for all applications. The choice and number of applications against which the reagents are validated are left to the applicant. 

E. Ability to collaborate productively with other significant public efforts

The NIH acknowledges other international efforts to develop protein affinity reagents for the human proteome and believes these are collaborative opportunities with potentially mutual benefit towards developing a comprehensive resource. The applicants should briefly discuss any plan for present or future collaborations in this field.

F. An effective center management structure

The applicants should include an overall management plan for the center that addresses the following elements:

1) A description of the project leadership and key personnel, and their responsibilities. While it is up to the applicant to provide a specific management structure, this FOA will require dedicated specialized key personnel with appropriate levels of expertise and responsibility overseeing critical aspects of the project. It is expected that these individuals will need to dedicate a significant amount of effort in day-to-day management of the center. For example, the PD/PI may designate someone in the role of a scientific project manager to oversee daily operations. Alternately (or in addition) the PD/PI may choose dedicated experienced individuals to lead critical components of their pipeline. Such individuals are expected to have appropriate expertise in addition to scientific expertise, including knowledge of and experience in project management, ability to use project management tools, leadership skills, ability to maintain and communicate appropriate records, and ability to collaborate with all components of the proposed effort. The management leadership structure, and individuals identified to fulfill those roles, should be justified based on their appropriateness to the proposed effort.

2) A description of how the various elements of the project will be managed in an integrated way. This includes a description of how communications will be handled within the center, lines of authority, and how decisions will be made. It is critical to describe how any collaborations that are at another physical site will be managed and integrated (e.g. subcontracts).

It is highly likely that the formation of project sub-committees or working groups will be recommended by the steering committee to resolve program-wide issues (e.g., quality, validation, exchange of antigens/reagents, distribution). Management plans should anticipate the need for this level of collaborative activity among the program Research Network components.

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:

Applicants are expected to discuss how they will make available information about the antigens and affinity reagents (validation and characterization data)

Applicants are expected to discuss how they will make available protocols for validation and characterization.

Applicants are expected to discuss how any software tools developed within this award will be made available.

Applicants are expected to discuss how intellectual property will be managed. The NIH intends that the reagents be broadly available and distributed at minimal cost, and without undue intellectual property constraints. These features should enable creative scientists to develop downstream applications for the reagents. Applicants and their institutions should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov). In order to ensure that the further development of these reagents is not unduly impaired or impeded, applicants are expected to address how they will manage intellectual properties and also meet the goals of this funding initiative. It is strongly encouraged that distribution sites such as DNASU and DSHB, which distribute reagents and clones at a minimal cost, are used. Restrictive licensing and restrictive sharing practices for this program could substantially diminish the value and public benefit provided by this community resource project. Management practices that would prevent or block access to, or use of, these resources for research use will be considered to be hindering the goals of the program. Applicants are encouraged to clearly demonstrate in their Resource Sharing Plan how their strategies will achieve the desired public benefit and programmatic goals through effective sharing of resources generated under this award

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. 

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.

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?

Is there a high likelihood that the proposed center can produce high-quality affinity reagents to human proteins, based on the applicant’s past experience and the proposed future plans?

Is there a high likelihood that the applicants can accomplish this at levels of throughput, data quality, and cost within the scope and award period anticipated by this FOA?

Is there a high likelihood that the activities of the proposed center will provide useful information about how to pursue a larger-scale effort, for example by providing insight into bottlenecks, cost-drivers, and other significant aspects of scale?

Is there a high likelihood that the proposed project will demonstrate scalability?

Is there a high likelihood that the affinity reagents produced will be of a type that could be widely used by the community, considering all relevant factors such as quality, ability to be used in a range of applications (for example, ease of labeling, existence of secondary reagents)?

Is there a high likelihood that the center will make significant contributions to the state-of-the-art in the production of affinity reagents? 

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

Not Applicable

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

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)

Reviewers should consider and comment on, but not score, the aspects of the Resource Sharing Plan that pertain to overall consistency of the intention to create a readily distributable public resource, including licensing and intellectual property issues that need to be consistent with the goals of this FOA for a broadly available resource that is readily usable by the community, as outlined above.  

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:

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

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 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/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

NIH Cooperative Agreements are subject to terms and conditions in addition to, and not in lieu of, otherwise applicable U.S. Office of management and Budgets (OMB) Administrative Guidelines, U.S. Department of Health and Human Services (DHHS) 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 grants administration policies.

Each renewal made under this FOA will be subject to the same terms and conditions specified for the original U54 award. Applicants should consult the Notice of Award for their current U54 for the specifics of those terms and conditions.

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:

Defining the details for the center within the guidelines of this RFA and for performing the scientific activities. The PD/PI will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."

The PD/PI of a center will:

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

The Project Scientist(s) and the Program Director(s) will:

Areas of Joint Responsibility include:

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.

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)

Salvatore Sechi, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8814
Email: sechi@nih.gov

Peer Review Contact(s)

Joseph Mosca, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9465
Email: joseph.mosca@nih.gov

Financial/Grants Management Contact(s)

Craig E. Bagdon
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-2115
Email: Craig. Bagdon@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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