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

The human gastrointestinal tract and other body sites harbor trillions of microorganisms (including fungi and other eukaryotes, archaea, bacteria, and viruses), collectively referred to as the microbiota or microbiome. The genomes of the members of the microbial community collectively encode orders of magnitude more metabolic and other biochemical functions than the genome of the human host. Individuals harbor distinct microbiome compositions associated with phenotypes related to obesity and a variety of diseases affecting the gastrointestinal tract, pancreas and the hepatobiliary system. In addition, diet and drugs (especially antibiotics) significantly shape an individual’s microbiome, leading in turn to modulation of many host physiological functions, including gut barrier, nutrient absorption, and inflammation. Microbial metabolism yields bioactive compounds, which, by virtue of their ability to cross the gut barrier, impact a number of host functions and are thus implicated in a variety of pathophysiological processes in obesity, gastrointestinal diseases such as inflammatory bowel disease (IBD), and liver diseases such as Nonalcoholic Steatohepatitis (NASH).

Despite numerous associations of alterations in the microbiome with a range of diseases, and an increasing number of demonstrations of transmission of disease-related phenotypes by microbiota transplantation, there are only a small number of examples for which the mechanism by which an altered microbiome modulates host physiology has begun to be elucidated. For example, Bacteroides fragilis, a human commensal species, produces polysaccharide A, which protects the intestines of mice from inflammation. Butyrate produced by commensal Clostridia induces differentiation of Tregs, providing protection from inflammation by an independent mechanism. Taurocholic acid produced by Bilophila wadsworthia, whose growth is promoted by dietary milk fat, promotes colitis in mice,. There is a great need for studies to elucidate the mechanistic and functional basis of host-microbiome interactions in obesity and across the full range of diseases of the gastrointestinal tract, hepatobiliary system, and exocrine pancreas. In order to develop microbiome-based interventions for treatment and prevention of diseases, it will be necessary to identify the microbial strains, genetic pathways, proteins, and metabolites critical for modulating key aspects of host physiology and pathophysiology. It will similarly be important to identify the host physiological pathways which are modulated by factors contributed by the microbiota. There is also a need for better understanding of the effects of dietary components on the composition and activity of the microbiome, in order to define the role of nutrition in the pathophysiology of these diseases. The identification of individual microbial strains and metabolites which modulate host physiology will require the coordinated efforts of investigators with diverse sorts of expertise, such as clinical studies, microbiology, high-throughput generation of multi-omic data, data processing and analysis, and validating assay systems such as cultured cells and organoids, and gnotobiotic model organisms. This FOA accordingly uses the R24 mechanism to invite applications from multidisciplinary teams of investigators to create a community research resource of identified members of the microbiome and factors they elaborate which modulate human physiology or pathophysiology related to obesity, nutrition, or digestive, hepatobiliary, or exocrine pancreatic diseases. The elaborated factors can be macromolecules (proteins, RNA, or complex carbohydrates) or small molecules (metabolites). The resource must include the following elements:

• assembled partial or preferably complete genomic sequences of identified microbial strains,
• annotation of the genomic sequences with at least the genetic pathways for elaboration of key factors identified as modifying host physiology or pathophysiology
• cultures of these strains (when they can be cultured in pure form)
• cultures of mutants and engineered strains generated by the project
• chemical structures of key compounds elaborated by these strains with a demonstrated role in modulating host physiology or pathophysiology
• all -omic datasets used to identify and validate these strains and compounds
• software for any novel analytic methods developed and used in the course of the project.

The resource may also include additional elements such as (but not limited to) the following:

• research protocols
• samples of purified or synthesized compounds demonstrated to modulate host physiology or pathophysiology
• additional annotation of microbial genomic sequences beyond that specified by the second bullet in the preceding list
• annotation of host genomic sequences with genetic pathways whose functions are impacted by the microbes and compounds modulating host physiology or pathophysiology
• cell lines, model organisms, or reagents for other assays used to validate roles of key microbes and compounds in modulating host physiology or pathophysiology.

The resource must be made broadly available to the research community to enable the development of microbiome-based interventions for prevention and treatment of the diseases noted above.

The sequence of steps outlined below is an example of a discovery pipeline for creation of the resource, for illustrative purposes. Investigators may propose this sequence of steps, or another one, so long as the proposed sequence leads progressively to the validation of one or more factors elaborated by the microbiota.

• Recruitment of patients and collection of biological samples and clinical data
• Processing of samples to extract analytes (e.g., DNA, RNA, protein, metabolites)
• Generation of human and microbial multi-omic data (e.g., metagenomic, transcriptomic, proteomic, metabolomic)
• Analysis of data to identify microbes and molecules associated with changes in human physiology or pathophysiology
• Isolation of microbial strains and molecules associated with changes in human physiology or pathophysiology
• Elucidation of microbial genetic pathway(s) essential for elaboration of factor(s) modulating human physiology or pathophysiology
• Validation (demonstration of causal role) of microbial strains and molecules in modulating physiology or pathophysiology. The assays for validation may make use of primary cultured cells or tissues, engineered reporter cell lines, cultured organoids, gnotobiotic animals, or other experimental systems.

Applications on the following topics will be considered non-responsive to this FOA and will not be reviewed:

• Projects that explore the impact of the microbiome in areas other than obesity, digestive, liver, or exocrine pancreatic diseases, or nutrition.
• Projects on cancer (however, projects on some precancerous conditions may be considered responsive).
• Projects which are not based on a demonstrated association between an alteration of composition or activity of the human microbiota and some aspect of human health or disease. However, projects using animal models to validate candidate strains and molecules discovered from investigation of an association between an altered human microbiota and aspects of human health or disease will be considered responsive. Investigators seeking support for projects based on an association between an altered animal microbiota and aspects of animal physiology or pathophysiology may apply for a R01 award under the Parent R01 Program Announcement, PA-13-302, https://grants.nih.gov/grants/guide/pa-files/PA-13-302.html.

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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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. 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.

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.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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, including Supplemental Grant Application Instructions 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, preferably electronically, should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 7005
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-7797
Email: NIDDKletterofintent@mail.nih.gov

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

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.

Other Attachments: An attachment called "Team Science Justification and Organization" should be uploaded in Other Attachments. Although no specific page limitation applies to this section of the application, be succinct. Do not use this section to circumvent the page limits of the Research Strategy. The following points should be addressed in this attachment and are an important part of the application:

1) A description of the collaborative team aspect of the work proposed. The PD/PI(s) of an R24 grant may be located at one institution while other members of the collaborative team may be located at the same, affiliated, or other institutions. It is anticipated that members of the team may not already be interacting on this, or other, projects. Lines of communication and exchange of data should be clearly established. If some of the participating investigators are at the same institution, a rationale must be provided explaining how this grant will enhance integration and collaboration among those participants, beyond what would normally be expected of a group of investigators with shared interests at the same institution. Since the overall goal of the FOA is to create resources by bringing together investigators from varied disciplines to attack a complex problem in a coherent fashion, the justification for drawing investigators from varied disciplines should be well defined. How the team synergies will facilitate answering the complex problem should be clearly articulated. These activities should significantly enhance the investigators' existing capabilities and introduce new approaches to the research aims of the objective of the collaborative team.

2) A clear plan of operation should be provided for the administrative structure and proposed interactions among the investigators. The coordinated use of shared resources that could increase the efficiency of the entire team, as well as facilitate the use of new technologies and the pursuit of new lines of investigation should be defined. The plan for development and use of resources should help to promote the interdisciplinary and collaborative research around which the team has formed. The final administrative structure of the team will be left largely to the discretion of the applicant institution (subject to NIH peer review). However, NIH's experience has demonstrated that the effective development of a collaborative, interdisciplinary team such as this requires close interaction between the PD/PI (or multi-PDs/PIs), collaborating investigators, and appropriate institutional administrative personnel. It is expected that the PD/PI would provide a plan for the organization of collaborating investigators and institutions, including the need for electronic communication and/or travel. Depending on how the team is structured, the PD/PI(s) might need to develop policies and procedures for the operations of project resources. The allocation of resources to the development of new technologies in comparison to provision of services with existing technologies should be addressed.

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

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

Research patient care costs (both in-patient and out-patient expenses) will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities, such as CTSAs. Costs relating to the clinical research efforts of the investigators may be funded through this award, provided there is no overlap of funding. The award is not intended to be a facility for health care delivery; thus, only those patient costs directly related to research activities may be charged to the grant.

Domestic and foreign travel of project personnel directly related to the collaborative team activities of the award as well as travel of collaborative team members for attendance at annual meetings is allowable.

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, with the following additional instructions:

Research Strategy: A proposed project can either begin by establishing an association of an altered microbiota composition or activity with an alteration of some aspect of human physiology or pathophysiology, or can take a previously established association as its departure point. In the latter case, the application must cite or present evidence supporting the association. The applicants should delineate a clear pipeline of discovery from establishment of an association to identification and validation of one or more microbial factors and describe clearly how each step in the discovery process shall be accomplished.

Applications must describe a set of resources which will be developed for the use by the research community.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan and a Resource Sharing Plan, which, in addition to following the instructions in the SF424 (R&R) Application Guide, should specify plans for continued availability of the data and resources after the end of the project.

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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at NIDDKletterofintent@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

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.

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?

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?

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?

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?

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.

FOA-Specific Review Criteria

To what extent will the resources described in the application be useful to the broader research community for the purposes of advancing understanding of physiological or pathophysiological mechanisms, and/or developing interventions for prevention and treatment of disease?

Is the plan for sharing the resources likely to be effective in making them broadly accessible both while the project is ongoing and afterwards, in a manner which will advance the understanding of physiological or pathophysiological mechanisms, or the development of microbiome-based interventions for prevention or treatment of disease?

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.

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.

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.

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.

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.

Not Applicable

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.

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 NIDDK, 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.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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)
Finding Help Online: https://grants.nih.gov/support/index.html
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
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Robert W. Karp, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-8875
Email: karpr@mail.nih.gov

Paul Rushing, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8895
Email: rushingp@mail.nih.gov

Sharon Bourque
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8846
Email: bourques@mail.nih.gov

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