Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	Seeding Collaborations for Translational Research to Discover and Develop New Therapies for Diseases and Conditions within NIDDK's Mission (Revisions) (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	March 9, 2016 - Notice of Early Expiration of PAR-14-006. See Notice NOT-DK-16-010. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PAR-14-006
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
Funding Opportunity Purpose	The purpose of this funding opportunity announcement (FOA) is to seed collaborations that enable translational research for the discovery and development of therapies for diseases and conditions of interest to NIDDK. The FOA encourages collaborations through revisions to active NIDDK R01 research project grants. The revision allows the Program Director/Principal Investigator (PD/PI) to propose an expansion of the specific aims to develop collaborations and approaches that facilitate translational research on target identification, early-stage pharmacological validation of targets and pre-therapeutic leads, lead optimization, and limited pre-clinical development.

Posted Date	November 21, 2013
Open Date (Earliest Submission Date)	January 5, 2014
Letter of Intent Due Date(s)	30 days prior to Application Due Date
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	New Date March 8, 2016 per issuance of NOT-DK-16-010. (Original Expiration Date: January 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.

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

This Funding Opportunity Announcement (FOA) is intended to develop collaborations that stimulate research and development activities around target identification, early-stage pharmacological target validation, lead optimization, and pre-clinical development. This will be achieved through revision applications to active NIDDK R01 research project grants that allow the PD/PI to expand the scope of their aims by proposing a collaborative pilot studies to enable the discovery and development of novel therapies for diseases and conditions of interest to NIDDK.

Recent advances in genetics, the basic understanding of physiology, and the pathogenesis of disease coupled with technological advances in areas of bioinformatics, chemical biology, synthetic chemistry, and protein engineering provide a rich knowledge base and toolbox to identify and pursue new drug targets and therapeutic strategies for treating diseases. As part of its mission to reduce the burden of disease, NIDDK is committed to encouraging translation of basic discoveries into new treatments. The NIDDK is interested in translational research to discover and develop novel therapies for diseases and conditions relevant to its mission, which includes obesity, diabetes, diabetic complications, endocrine disease, digestive and liver diseases, nutrition, kidney and urological diseases, hematology, and inborn errors of metabolism. For additional information on disease areas of interest to the NIDDK, please see http://www2.niddk.nih.gov/Research/.

The process of identifying and validating drug targets, small molecule chemical scaffolds, or non-viral biologics for the treatment of human disease begins with a hypothesis and can be viewed as progressing along a continuum of increasing confidence leading to widespread acceptance of its use in patient populations. For the purposes of this FOA, these stages are defined as:

Target identification: The generation of scientific evidence that a target is exploitable and involved in some significant way with a disease process. For the purpose of this FOA, target identification refers to approaches that identify the molecular target and/or mechanism of action of a potential therapeutic candidate.

Early-stage pharmacological target validation: Is a process of pre-clinical hypothesis testing to generate data that, over time, increases confidence that pharmacological manipulation of a target may be clinically efficacious and safe. This process occurs prior to clinical testing of a new compound but should include the use of human-derived data, tissues, cells, and systems.

Lead optimization and pre-clinical development: Are processes by which additional alterations to a pre-therapeutic lead may be made in conjunction with pre-clinical assessments of its in vivo bioavailability, efficacy, and safety. The goal is to generate a lead clinical candidate and associated data packet which strongly supports regulatory approval for the initiation of clinical development.

This FOA is intended to develop collaborations that stimulate research and development activities around target identification, early-stage pharmacological target validation, lead optimization and pre-clinical development.

A critical barrier to translational research for therapeutic development is the need for collaborations involving investigators with disparate expertise to translate the basic understanding of disease mechanisms into a clinical application. This may include collaboration between investigators with expertise in basic biology of a disease or condition and investigators with expertise in chemical biology and/or high-throughput screening to identify novel small molecule lead compounds that modulate a target or phenotype of interest; collaborations with medicinal chemists to optimize lead candidates; collaborations with protein chemists, microbiologists, or bioengineers to advance development of protein/peptide-, microbial-, or cell-based therapeutic strategies; and collaborations with clinical investigators to integrate patient-derived biosamples and clinical data for identifying and validating the role of particular mechanisms and targets in human disease or condition that affects health.

The purpose of this funding opportunity announcement is to seed collaborations to enable translational research to discover and develop new therapies for diseases and conditions within NIDDK's mission. This funding opportunity announcement encourages revision applications from PD(s)/PI(s) who currently have active NIDDK R01 research project grants. The revision would allow the PD(s)/PI(s) to propose an expansion of the specific aims to seed collaborations that enable specific translational goals related to target identification, early-stage pharmacological target validation, lead optimization, or pre-clinical development (as defined above). Particular areas of interest include, but are not limited to:

• Collaborations to develop novel cell, tissue, or organismal phenotypic assays for chemical or genome-wide siRNA screening approaches;
• Collaborations to test small molecule chemical probes or pre-therapeutic leads (including peptide, protein, and microbe-based leads) in novel cell, tissue or animal models of a disease or condition;
• Collaborations to identify the molecular target and/or mechanism of action of potential therapeutic candidates;
• Collaborations to optimize the efficacy and/or delivery of a lead candidate through medicinal chemistry, protein engineering, or bioengineering approaches;
• Collaborations to overcome barriers to obtaining materials produced under current good manufacturing practices (cGMP);
• Collaborations to explore the absorption, distribution, metabolism, excretion, and toxicological (ADMET) properties of a potential pre-therapeutic agent; and
• Collaborations to prospectively-obtain and integrate patient-derived biosamples and clinical data for identifying and validating novel targets, mechanisms, or lead candidates using human samples.

Research focused on clinical development and testing of novel therapies in pilot clinical trials is not appropriate for this FOA.

Although the revision allows an expansion of the scope of the specific aims to develop collaborations for therapeutic-directed translational research, the translational research goals need to be related to the overarching goals or topic of the parent grant. The focus should remain on the disease or condition that is the focus of the parent grant, and include an extension of the targets and pathways under investigation. However, the revision may allow an expansion to include additional targets, pathways, and/or models (in the context of the same disease or condition) that complement those being investigated in the parent grant.

It is anticipated that the revision will allow the PD(s)/PI(s) and collaborator(s) to generate the necessary preliminary data needed to prepare an application in response to existing funding opportunity announcements for high throughput screening and molecular target validation (PA-13-364, PAR-12-058, PAR-13-007); pilot and feasibility clinical studies in diabetes and endocrine and metabolic diseases (PA-12-157); digestive diseases and nutrition (PA-12-139), or kidney or urologic diseases (PAR-11-352); ancillary studies to partner with ongoing NIDDK clinical consortia to leverage existing clinical infrastructure and study populations (PAR-12-265); or promoting R&D and commercialization through small business concerns (PA-13-234, PA-13-235).

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	Revisions from investigators with active NIDDK-funded R01 awards. Resubmissions of Revision applications previously submitted in response to this FOA. 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 limited to $75,000 direct costs per year, but need to reflect the actual needs of the proposed project.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed two years. Applicants may request support for up to 2 years, but activities proposed must be completed by the end of the parent grant award period.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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.

The parent project must be an active NIDDK R01 research project. The project period of the revision application may not extend beyond that of the parent award. Grants that are in a no-cost extension period will not be considered for support under this program.

All revision applications must be submitted by the same PD/PI (or Contact PD/PI for multi-PI grants) as listed on the current award.

It is anticipated that additional investigators with relevant expertise to enable the proposed area of therapeutic discovery and development will be named as key personnel with significant contributions on the revision application. In addition, collaborators should include relevant expertise across the entire therapeutic development pipeline to ensure that appropriate considerations are made to enable the therapeutic development process.

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

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Peter Perrin, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 6707 Democracy Boulevard, Rm 665
Bethesda, MD 20892
Telephone: 301-451-3759
Email: [email protected]

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

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.

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.

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. The PD/PI(s) must specify one or more investigators not previously associated with the project who have expertise in the proposed area of translational research for therapeutic discovery and development. At least one of these individuals must assume a senior/key personnel role within the context of the revision application. New personnel added to the revision application should include biosketches that demonstrate a track record of productive collaborations for applying their respective expertise to advance translational research, which may but need not include areas of research related to the parent grant. In this section, the PD/PI(s) and collaborators should include biosketches with Personal Statements that clearly state the intended commitment to develop a collaboration to enable translational research for therapeutic discovery and development related to the parent grant and developing subsequent collaborative grant applications in response to relevant NIH funding opportunity announcements. The PD(s)/PI(s) and proposed collaborators may have collaborated previously on other projects.

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants must use the same budget format as the parent award.

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

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

Specific Aims: The Specific Aims of the competing revision application should propose pilot studies involving new collaborations that integrate translational approaches for target identification, target validation, lead optimization, or limited pre-clinical development for clinical candidates. The proposed studies and collaborations should enable the translational of basic science advances into the discovery and development of new therapeutic strategies.

Research Strategy: The research strategy must include the unmodified approved Specific Aims of the parent grant along with a description of recent progress towards completing those aims. In addition, the Research Strategy should describe how the objectives of the revision application relate to the objectives of this FOA to seed collaborations to enable translational research for the discovery and development of new therapies in diabetes or digestive, kidney, urologic, or hematologic diseases. Recent progress on the parent grant should provide the justification for applying translational approaches to enable target identification, early-stage pharmacological target validation, lead optimization and pre-clinical development. In addition to describing the studies to be completed under the revised specific aims, the PD/PI should describe how the studies will be enabled by the proposed collaboration. A plan should be described for communication between investigators and integration of novel approaches into the parent grant. The collaboration should involve significant interactions between personnel from the parent grant and the proposed collaborators with expertise in therapeutic discovery and development.

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.

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

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.

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

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

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.

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.

This initiative is not subject to intergovernmental review.

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.

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.

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

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.

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).

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? Is a collaboration proposed with investigator(s) that have appropriate expertise to enable translational research towards proposed goals for therapeutic discovery or development? Do proposed collaborators have broad expertise of the entire therapeutic development process to ensure that later stage development considerations are incorporated early in the discovery process?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the proposed collaboration bring novel translational approaches for identifying and/or validating novel targets or disease mechanisms for potential therapeutic development?

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?

Do(es) the PD(s)/PI(s) provide a plan for interacting with the proposed collaborators to integrate translational approaches into the existing research plan? Is the proposed research plan likely to generate a sustained interaction between the PD(s)/PI(s) and the collaborator with expertise in target identification, early-stage pharmacological target validation, lead optimization and pre-clinical development? Is the proposed approach likely to generate preliminary data that may facilitate development of subsequent research project grant applications to further enable the stated goals in target identification, target validation, lead optimization, or pre-clinical development?

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?

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

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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 National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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

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.

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

eRA Service Desk (Questions regarding ASSIST, 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)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Peter Perrin, Ph.D
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3759
Email: [email protected]

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

Jennifer Cho
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-2978
Email: [email protected]

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.

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.