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

There are important clinical implications to research on early development. Abnormalities in embryonic development that result in birth defects are likely to involve the disruption of many cellular signaling cascades that would usually direct normal embryonic development. Many of the same signaling networks become dysfunctional later in life and result in adult disease. Furthermore, embryonic developmental factors are emerging as important participants in adult regenerative and repair processes. Thus, a comprehensive understanding of how organs develop in the embryo is necessary to effectively interrogate maladaptive processes and understand regeneration. Successful development of cell therapies to replace or repair damaged tissue will require knowledge of the catalog of cell types for each organ; the genes that mark these cells, as well as those that are required for their function; the regulatory factors that induce or maintain the various cell types; and the developmental and anatomic relationships of each cell type to its neighbors.

As a result, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) sponsored the GenitoUrinary (GU) Development Molecular Anatomy Project (GUDMAP) in 2002 and in 2011 NIDDK renewed GUDMAP to continue efforts to (1) develop a low resolution gene expression atlas of all genes expressed within the developing murine urinary tract, (2) perform high resolution anatomic gene expression studies using available or newly generated molecular tools, and (3) produce an integrated, continuously updated database that provides the entire research community with access to the data as it is generated.

The GUDMAP consortium has generated a murine molecular atlas of the urogenital tract in the developing embryo. The GUDMAP website allows access to the database of gene expression for the developing urogenital tract as generated by the GUDMAP consortium. To date the database contains >460 microarray CEL files and >10,700 whole-mount or section in situ hybridizations representing 3,692 genes from 11 laboratories, 33 characterized transgenic lines, 194 RNA seq samples and 194 single cell samples. In situ hybridization samples are annotated in detail against a standard anatomical ontology developed by the GUDMAP consortium that is regularly updated as the data reveals new genetic sub-compartments. Complementing the emerging sub-compartments are the transcriptional profile datasets collected from these sub-compartments by laser capture micro-dissection, translating ribosome affinity purification (TRAP) and single cell analysis.

Molecular markers have now been identified for physiologically or anatomically defined cell types within the murine kidney and for developmental functional domains. These data are helping to reveal the genesis of kidney structure at the molecular and cellular level. This fundamental description of the kidney provides a significant resource to support research in kidney repair and regeneration, including stem cell research, where the design of novel therapies relies on knowledge of the cell types within an organ to determine whether putative therapies are effective at regenerating them or restoring their functionality. The amount of data now present in the database has reached the stage where analyses are increasingly informative and are readily used by the research community.

Despite these advances, there still remain gaps within the atlas for the major organs of the lower urinary tract. There is a paucity of cell-specific markers for key lineages and an absence of knowledge regarding the three dimensional cellular structure and the morphogenetic events that occur during organogenesis. In addition, there is an incomplete understanding of the normal innervation and vasculature of the major organs of the urinary tract, including the kidney.

This current GUDMAP effort will build upon the existing database and website infrastructure, and will retain the basic long-term objectives of GUDMAP: the establishment of a comprehensive understanding of urinary tract tissue development and maturation to inform the study of tissue maturation and aging, organ dysgenesis and disease, and ultimately organ repair and regeneration.

This FOA invites applications for Atlas Projects that will work together as a consortium with the GUDMAP Human Tissue Core (RFA-DK-15-016) and the GUDMAP Database/Website Project, which hitherto will be referred to as the data coordinating center (RFA-DK-15-015). The GUDMAP data coordinating center will oversee the incorporation of data generated by the GUDMAP Atlas Projects, and serve as the public face of the consortium through the GUDMAP website, and as the administrative core. The GUDMAP Human Tissue Core will identify and manage tissue source sites to collect, process, deposit and distribute human tissue samples to the GUDMAP Atlas Projects.

The GUDMAP Atlas projects are limited to either human or murine studies. Human GUDMAP Atlas projects are restricted to normal developing tissues of the kidney or lower urinary tract. Studies should take advantage of the GUDMAP framework and be designed to allow mouse/human comparisons through the establishment of common anchor/marker genes and tissue-specific developmental landmarks. It is also expected that the human atlas will inform the development of animal models of human developmental defects and diseases of urogenital tract, although the generation of new murine disease models will not be part of this FOA.

Murine studies may include the molecular anatomy of the innervation and vasculature of the kidney, as well as lower urinary tract organs. Furthermore, murine studies may include the interrogation of well-chosen sets of murine developmental diseases or defects (e.g., congenital anomalies of the kidney and urinary tract) to validate (or invalidate) murine pre-clinical models.

Specific examples of the types of projects that may be supported include, but are not limited to:

• Human: Large-scale spatial analyses of gene/protein expression of embryonic samples utilizing whole-mount in situ hybridization, or other in situ approaches, or using libraries of antibodies. It is expected that this type of approach will take advantage of the mouse atlas to provide the framework to develop distinct gene expression signatures in cell types of relevant organs at a single time during development, expanding to a second time point if possible. These studies should inform the development of murine developmental defects or disease model.
• Human: Broad chromatin and transcriptional profiling of human developing tissue as informed by the mouse atlas to identify and enrich regionally groups of cells to define compartments and sub-compartments and to establish key genetic markers, i.e., anchor genes.
• Human: Low resolution (e.g. whole-mount) analyses of human gene expression through developmental time, using high throughput strategies, but focusing on a restricted set of genes. This approach may be suited to study the expression of a given class of gene products, e.g., transmembrane proteins. These studies should inform the development of murine developmental defects or disease models.
• Murine preclinical disease models: Gene expression during the disease progression to validate (or invalidate) pre-clinical models
• High resolution, three-dimensional analyses of a set of genes or gene products using, for example, tagged gene constructs, antibodies, or section in situ hybridization. Various types of imaging may be useful, including confocal microscopy, optical tomography, micro-MRI, or light microscopy. The goal is to produce three dimensional representations of gene expression patterns and relate them to functional, anatomical, or molecular hallmarks.
• Large-scale spatial analyses of murine gene/protein expression utilizing whole-mount in situ hybridization, or other in situ approaches, or using libraries of antibodies to provide near-genome-wide analyses of gene expression in the nervous or vascular system of appropriate organ at a single time during development, expanding to a second time point if possible.
• Analysis of gene expression programs in critical cell types using state of the art technology (i.e., NexGen sequencing, TRAP, etc) to establish a set of novel cell type specific molecular markers. Labeled cells/tissues may be generated via knock-ins, transgenic, or other methods.

The goal of this FOA is to advance a comprehensive understanding of urinary tract tissue development and maturation to inform the study of tissue maturation and aging, organ dysgenesis and disease, and ultimately organ repair and regeneration and to support the novel tools that may be needed to allow these studies to be conducted. This FOA will support GUDMAP Atlas projects for the development of these tools, with the requirement that these tools be shared, prior to publication, with the general research community.

It is expected that the successful applicants will actively participate in the development and monitoring of the ontology relevant to their project to ensure the integrity of ontology for all the tissues of the urogenital tract, and to ensure the utility of the GUDMAP database for all researchers working across all urogenital tract organs. Successful applicants will also facilitate and coordinate efforts with the GUDMAP database coordinating center, GUDMAP Human Tissue Core and individual GUDMAP Atlas Projects to (a) improve the quality of the existing data within the GUDMAP database and thereby enhance the utility of the GUDMAP website for the research community, (b) extend the data content of the GUDMAP database by way of the presentation of bioinformatics results from existing analyses, and (c) improve the accessibility and utility of the GUDMAP website to end users. As a member of the GUDMAP Consortium it is expected that individuals will closely interact and share resources with the (Re)Building a Kidney consortium (RFA-DK-14-010 and RFA-DK-14-009).

The goals of the Atlas Projects are to generate data which will be very effective at generating new hypotheses. For example, discovery of sequential activation of gene expression in identical patterns might suggest a regulatory relationship between the first and subsequent genes. Hypothesis generation is a goal of this FOA. However, experiments to test these hypotheses are more suitable for investigator-initiated R01 applications and are beyond the scope of this FOA. Such applications will be considered non-responsive. Likewise, projects designed to test hypotheses based on previously generated data will also be considered non-responsive.

The GUDMAP consortium is designed to serve as a resource to the research community, therefore the GUDMAP Atlas Projects (RFA-DK-15-014), GUDMAP Database/Website Project (RFA-DK-15-015) and the GUDMAP Human Tissue Core (RFA-DK-15-016) must be well integrated, coordinated, and willing to share materials freely within the consortium. All participants are required to agree to participate as active members of the GUDMAP consortium (see Cooperative Agreement Terms and Conditions of Award) and as appropriate to work together (1) to establish database vocabularies, annotation criteria, (2) to coordinate human tissue acquisition and distribution, and (3) to provide feedback regarding the utility of the GUDMAP database and the ease of use of the GUDMAP website. Atlas Project participants are required to distribute all GUDMAP generated research tools (i.e., probe sets, antibody libraries, transgenic or knock-in mouse strains, cell lines, and other reagents) and data to the wider community upon validation and prior to publications.

During the course of the funding period, technologies will improve, and the rate of progress and focus of work supported by the cooperative agreement might change. It is expected that the Program Directors/Principal Investigators, in consultation with NIDDK program staff, the Steering Committee, and the External Advisory Board will make any necessary adjustments to accommodate the changing research environment, in order to remain focused on overall consortium goals; to maintain excellent coordination with the other projects; and to incorporate new technological advances. As a member of the GUDMAP Consortium, it is expected that individuals will closely interact and share resources as appropriate with the (Re)Building a Kidney Consortium (RFA-DK-14-010 and RFA-DK-14-009) as appropriate and consistent with achieving the goals of this program.

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. 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 should be sent should be sent electronically to:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817
Telephone: 301- 594-8897
Email: [email protected]

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.

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

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

There will be bi-annual meetings of the Consortium. The initial meeting will be held in Bethesda June 20-21, 2016 and subsequent meeting will be held at GUDMAP sites. Applicants should request a budget for costs of the PD/PI and other essential members of the Atlas project to attend these meetings.

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: Investigators who have generated GUDMAP data as part of a subcontract may submit these data in the Preliminary Studies for New Applications section within the Research Strategy.

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 statement that all data, tools and materials will be rapidly shared, prior to publication, with the general research community
• Applicants are expected to include a plan addressing if, or how, they will exercise their intellectual property rights while making available to the broader scientific community patentable research resources as appropriate and consistent with achieving the goals of this program. These plans must be fully supported by the applicant's institution.

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.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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.

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.

For this particular announcement, note the following:

In addition to standard review criteria, all applications will be judged on the documented ability of the investigators to meet the research objectives of the FOA.

This current GUDMAP effort will build upon the existing database and website infrastructure, and will retain the basic long-term objectives of GUDMAP: the establishment of a comprehensive understanding of urinary tract tissue development and maturation to inform the study of tissue maturation and aging, organ dysgenesis and disease, and ultimately organ repair and regeneration.

It is expected that the proposed studies will be very effective at generating hypotheses. Hypothesis generation is a goal of the initiative, not hypothesis testing.

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?

Where applicable: Will the generated human data provide distinct gene expression signatures in cell types of relevant organs and help inform the development of murine models of human developmental defects or diseases? Do the genes chosen for high resolution analysis mark distinct cell populations? Can the expression of these genes be correlated to anatomic landmarks? Are the gene sets chosen for high throughput studies well justified? Will the tools to be generated be useful for the community?

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?

Do the PD/PIs and other key personnel have a demonstrated track record of accomplishments indicating that they are capable of carrying out the proposed work and working as part of a consortium?

Is there evidence that the investigators will collaborate extensively and share information fully within the consortium? Is there evidence that the investigators will facilitate and coordinate efforts with the GUDMAP database coordinating center, and GUDMAP Human Tissue Core (where appropriate)? Do the investigators have appropriate experience and training to participate in the development and monitoring of the ontology relevant to their project?

Is there evidence that the investigators will abide by the priorities and policies agreed upon by the Steering Committee?

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?

Where applicable: Does the Human GUDMAP Atlas project take advantage of the GUDMAP murine atlas and facilitate the generation of anchor genes and developmental landmarks that can be used for comparison with the developing murine organ? Is there an overall strategy to develop the ontology and annotation for murine Atlas Projects that focuses on the innervation and vasculature of the major organs of the urinary tract? Are the murine pre-clinical models well thought out and do they take advantage of the GUDMAP murine atlas?

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.

Interactions

Are there adequate plans for effective interaction and coordination among Consortium components and the NIH? Do the investigators agree to to collaborate extensively and share information fully? Do the investigators agree to to abide by the priorities and policies agreed upon by the Steering Committee? Have the applicants proposed sound strategies for communication within the GUDMAP consortium and with the NIH

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.

Not Applicable

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

Not Applicable

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.

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.

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.
• Compliance with resource sharing policies and the evidence for willingness to work cooperatively.
• Degree of originality and innovation.
• Creativity of the approaches and technologies.
• Likelihood for substantial contribution by the applicants to a successful collaborative effort.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (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 grant administration policies.

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:

• All aspects of the scientific activities, including defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
• Collaborating with other investigators in the program for protocol development, sample, reagents and data sharing as appropriate, data quality control, and data organization
• Accountability towards the applicant organization officials and to the NIDDK for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award.
• Serving as a voting member of the Steering Committee and will attend the Planning Meeting and a Steering Committee meeting in the first year, two Steering Committee meetings a year in subsequent years and monthly teleconference calls.
• Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and subcommittees, and be responsible for close coordination and cooperation with the components of the GUDMAP consortium and with NIH staff.
• Adhering to PHS policy for the distribution of unique research resources produced with PHS funding as described under Special Requirements.
• Establishing written milestones for the project, in negotiation with NIDDK Project Staff prior to funding.
• Release all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NIDDK, for the conduct of research at no charge other than the costs of reproduction and distribution, consistent with achieving the goals of this program initiative.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. However, the dominant role and prime responsibility for the project as a whole resides with the awardees, although specific tasks and activities in carrying out the studies will be shared by awardees and the NIDDK.
• NIDDK will designate a Project Officer and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement.
• NIDDK will form an External Advisory Committee (EAC), comprised of the NIDDK Project Scientist and other NIH extramural staff with relevant scientific expertise or who manage research grant programs that relate scientifically to the goals of the GUDMAP projects, and outside advisors selected by the NIDDK. The EAC will meet annually with the GUDMAP Steering Committee to review and assess GUDMAP and to advise NIDDK of scientific developments and opportunities that may enhance the achievement of the GUDMAP goals.
• The NIDDK Project Scientist will attend and participate as a voting member in all meetings of the Steering Committee, and provide liaison between the Steering Committee and the External Advisory Committee.
• The NIDDK Project Scientist will help the Steering Committee develop and draft operating policies.
• The NIDDK Project Officer will review the scientific progress of the individual GUDMAP components, for compliance with operating policies developed by the Steering Committee, and may recommend to the NIDDK to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.
• An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Officer may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

• Steering Committee - The NIH Project Scientist, PIs from the project funded through this FOA and RFA-DK-15-015, and RFA-DK-15-016 and voluntary representatives from the previously funded GUDMAP atlas projects funded under RFA-DK-11-001 will be responsible for forming a Steering Committee as defined below. An arbitration system, as detailed below, will be available to resolve disagreements among members of the Steering Committee. The Steering Committee will be the main governing board of the GUDMAP consortium. It will develop collaborative protocols, identify technological impediments to success and strategies to overcome them, develop shared software tools for disseminating information about the projects, and identify opportunities for sharing techniques and tools that might be developed in future GUDMAP atlas projects.
• The Steering Committee will be composed of the PIs from the project funded through this FOA, RFA-DK-15-015, and RFA-DK-15-016, representatives from the previously funded GUDMAP projects, and the NIDDK Project Scientist. The representatives and the PIs will each have one vote. The NIDDK Project Scientist for this project will have one vote. The Steering Committee will select a chairperson who will be someone other than an NIH staff member.
• The Steering Committee may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the scientific or consumer expertise of the Steering Committee when necessary.
• There will be two Steering Committee meetings annually. The first meeting will be a Planning Meeting to be held in the Washington, DC area on June 20-21, 2016. At the Planning Meeting, the Steering Committee will be formed and a chairperson selected from among the members. At the Planning Meeting, the Steering Committee may: (a) draft a charter to detail policies and procedures, a process for monitoring compliance with the policies and procedures, and a process for recommending that the NIH Project Administrators act on evidence of non-compliance of any Consortium component with Steering Committee policies; (b) agree upon the terms of the charter; and (c) devise a plan for working with the GUDMAP database developers to provide ongoing input into database and website design.
• At the second and subsequent meetings, the Steering Committee will refine the GUDMAP scientific objectives and implementation as necessary, consistent with data produced by former and possible future GUDMAP atlas projects and from other laboratories.
• The Steering Committee will plan workshops, to which non-GUDMAP participants will also be invited, to inform the research community of the progress made toward development of the atlas, and to inform the research community of any technological advances related to the implementation of the GUDMAP website/database. The NIDDK Project Scientist, the External Advisory Committee, and other NIH staff as appropriate will provide the Steering Committee with advice on participants for the workshops and symposia.
• The Steering Committee may establish subcommittees as it deems appropriate.
• Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
• The EAC will meet annually with the GUDMAP Steering Committee to review and assess the progress of the GUDMAP consortium and to advise NIDDK of scientific developments and opportunities that may enhance the achievement of the GUDMAP goals.

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 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.

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Deborah K. Hoshizaki, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7712
Email: [email protected]

Dr. Xiaodu Guo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4719
Email: [email protected]

Charlette Kenley
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8847
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 Part 75.