Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	A GenitoUrinary Development Molecular Anatomy Project (GUDMAP) (U01)
Activity Code	U01
Announcement Type	Reissue of PAR-04-042
Related Notices	July 23, 2015 - This RFA has been reissued as RFA-DK-15-015. July 23, 2015 - This RFA has been reissued as RFA-DK-15-014. November 26, 2012 - This RFA has been reissued as RFA-DK-12-024.
Funding Opportunity Announcement (FOA) Number	RFA-DK-11-001
Companion FOA	None
Number of Applications	10-15 Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
FOA Purpose	Through the efforts of the GUDMAP consortium, substantial progress has been made in establishing a molecular anatomy atlas of the developing murine kidney. This has provided a significant resource in support of research in kidney development, repair and regeneration. However, there remain significant gaps within the atlas in the areas of the developing lower urinary tract (ureter, bladder, urethra, sphincter, and prostate) and the developing vascular and nervous system associated with the organs of the urinary tract. To address these deficiencies, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Cooperative Agreement Research Projects (U01) that focus on defining the molecular anatomy of the developing murine lower urinary tract, or the innervation and vasculature of the lower urinary tract organs. These applications will be considered as part of a continuing GUDMAP effort.

Posted Date	January 27, 2011
Letter of Intent Due Date	March 10, 2011
Application Due Date(s)	April 7, 2011
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July, 2011
Advisory Council Review	October, 2011
Earliest Start Date(s)	December, 2011
Expiration Date	April 8, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

Background

The genitourinary (GU) tract encompasses organ systems and structures commonly involved in congenital birth defects, and emerging data suggest that the prevalence of some of these birth defects (e.g., hypospadias and cryptorchidism) is increasing. Understanding the developmental basis for these defects is only the first step in developing successful therapeutic strategies to reduce or eliminate the defects.

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 neighbor.

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 to (1) develop a low resolution gene expression atlas of all genes expressed within the developing murine GU 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.

Through the efforts of the GUDMAP consortium, substantial advances have been made in establishing a molecular anatomy atlas of the developing murine kidney. Molecular markers have now been identified for physiologically or anatomically defined cell types within the kidney and for developmental established functional domains and 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, because 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.

There are, however, considerable gaps within the atlas for the other organs of the urinary tract, as well as for the vasculature and innervation associated with urinary tract, including the kidney. There is a paucity of cell-specific markers for key lineages, an incomplete understanding of the normal innervation and vasculature of the major organs of the urinary tract, and an absence of knowledge regarding the three dimensional cellular structure of the major organs of the lower urinary tract (ureter, bladder, urethra, sphincters, and prostate) and the morphogenetic events that occur during organogenesis.

GUDMAP Atlas Projects and the Ontology Team

This FOA invites applications for Atlas Projects and for the Ontology Team that will work together as a consortium with the GUDMAP Website/Database Center (RFA-DK-10-005). The GUDMAP Website/Database Center will oversee the continued production of an integrated, continuously updated database, and the incorporation of data generated by the continuing GUDMAP Atlas Projects. The Ontology Team will ensure that these data are accurately annotated and easily accessible to the entire research community. Applicants should propose either an Atlas project or an Ontology Team project in their application and indicate clearly which activity is being proposed. Because these are distinct research activities, investigators interested in both project types should submit two separate applications. Combined applications for an Atlas Project and Ontology Team will not be accepted.

GUDMAP Atlas projects

GUDMAP Atlas projects will focus on defining the molecular anatomy of the developing murine lower urinary tract. Projects studying the innervation and vasculature of the major organs of the lower urinary tract may include the kidney, however, projects that focus solely on the kidney will be considered unresponsive. The goals of each of the applications for GUDMAP Atlas Projects are expected to vary, depending upon the objectives they are designed to address; however, projects must be focused on the organs of the lower urinary tract (e.g., ureter, bladder, urethra, sphincters, prostate). Studies of the vasculature or innervation may also include the kidney but cannot be solely focused on the kidney. Examples of the types of projects that may be supported include, but are not limited to:

• Large scale spatial analyses of gene/protein expression 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 provide near-genome-wide analyses of gene expression in the relevant organs and associated nervous or vascular systems at a single time during development, expanding to a second time point if possible.
• Low resolution analyses of 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. This type of approach may be especially suited for the urologic organs, for which studies examining gene expression at multiple developmental stages are particularly lacking.
• 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.
• Analysis of gene expression programs in critical cell types using state of the art technology (i.e., NexGen RNA 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.

It is expected that novel tools may need to be developed to allow these studies to be conducted. This FOA will support GUDMAP Atlas projects for the development of these tools, with the understanding that they will be rapidly shared, prior to publication, with the general research community.

Ontology Team

It is expected that the successful application for the Ontology Team will lead the development and monitoring of the ontology to ensure the global integrity of all components of the urogenital tract, and to ensure the utility of the GUDMAP website for all researchers working across all urogenital tract organs. The Ontology Team will also facilitate and help coordinate efforts with the GUDMAP Website/Database Center and 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.

It is expected that these studies 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 are also unsuitable for this solicitation.

GUDMAP Structure and Organization

The GUDMAP Atlas Projects and the Ontology Team will work together with the GUDMAP Website/Database Center as a consortium. The GUDMAP consortium is designed to serve as a resource to the research community, so all of these components must be well integrated, coordinated, and materials freely shared beyond the consortium members. All applicants for this FOA are expected to indicate their willingness to participate as active members of the GUDMAP consortium (see Cooperative Agreement Terms and Conditions of Award) and to work together to establish database vocabularies, annotation criteria, and to provide feedback regarding the utility of the GUDMAP database and the ease of use of the GUDMAP website. Applicants are also expected to indicate their willingness to distribute research tools to the wider community, including probe sets, antibody libraries, transgenic or knock-in mouse strains, cell lines, and other reagents, and to describe their willingness to submit data generated through this project to the GUDMAP database prior to publications. It is expected that data will be released to the database as soon as they are validated (see Special Instructions for Appendix under Research Plan).

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 Principal Investigator(s), in consultation with NIH 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.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIDDK intends to commit $1,000,000 in total cost to support 2-3 atlas project awards and one ontology team award in FY2011. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. The direct costs are expected to be in the range of $100,000-$200,000 per year for a five-year period.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 5 years..

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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

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 Organizations)

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
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]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
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 PHS398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Investigators who have generated GUDMAP data as part of a subcontract may submit within the Progress Report within the Research Strategy section. Please use the instructions provided for Progress Report for Renewal/Revision Applications. Provide the beginning and ending dates for the period covered. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Applicants are expected to include in the appendix a plan addressing if, or how, they will exercise their intellectual property rights while making available to the broader scientific community patentable research resources, consistent with achieving the goals of this program. These plans must be consistent with the applicant’s institution’s policies for intellectual property.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide,

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants must indicate their willingness to be part of a GUDMAP consortium and be willing to participate in the Steering Committee for this consortium, which will meet monthly through telephone conference calls, semi-annually in person, and may meet additionally in subcommittees (see Cooperative Agreement Terms and Conditions of Award). GUDMAP consortium participants are expected to discuss progress toward each project, quality assurance, and activities involved in coordination of projects, data and reagent sharing, and means of informing the research community of progress (see Cooperative Agreement Terms and Conditions of Award). The GUDMAP Atlas Project participants are expected to work together and in coordination with the GUDMAP Ontology Team and the GUDMAP Website/Database Center to establish database vocabularies and annotation criteria and to provide feedback regarding ease of use and database utility. This consortium is expected to serve as a resource to the community, so the consortium members must maintain resource generation as the primary objective for their participation in this consortium. Applicants must indicate their willingness to distribute research tools to the wider community, including probe sets, antibody libraries, transgenic or knock-in mouse strains, cell lines, and other reagents, and describe their willingness to submit data generated through this project to the GUDMAP database prior to publication. It is expected that data will be released to the database as soon as they are validated.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

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.

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/priority score to reflect their assessment of the likelihood for the atlas project or ontology team 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 or team 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, an atlas project or ontology team project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

For Atlas Project applications, 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?

For Ontology Team Project applications, does the application describe significant leadership activities and strategies that will ensure global integrity of the GUDMAP projects? Does the application propose valuable modifications and improvements to the GUDMAP website/database in order to improve accessibility and utility?

Investigator(s)

Are the PD/PIs, 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?

For Atlas Project applications, 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?

For Ontology Team Project applications, do the PD/PIs have prior experience in the development and modification of ontology for components of the urogenital tract?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project or team proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Interactions:

Are there adequate plans for effective interaction and coordination among Consortium components and the NIH? Do the investigators state their willingness to collaborate extensively and share information fully? Do the investigators state their willingness 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?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

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

Revisions

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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/priority score.
• Will receive a written critique.

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; and
• 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 business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

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:

• 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.
• 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. The NIH Project Scientist, on behalf of the NIH, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.
• Establishing written milestones for the project, in negotiation with NIDDK Project Staff within the first three months of the award period.
• The PI is expected to put 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.
• Add any additional bulleted information. 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 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 the GUDMAP and to advise NIDDK Project Staff 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 GUDMAP database/website, access 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-10-005, and voluntary representatives from the previously funded GUDMAP atlas projects funded under PAR-04-042 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 and RFA-DK-10-005, 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, both in the Washington, DC area. The first meeting will be a Planning Meeting on October 13-14, 2011. 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; the NIH Project Scientist on subcommittees as they deem appropriate.
• Each full member will have one vote. 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 Project Staff 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 composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

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

Dr. Francisco O. Calvo
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone: (301) 594-8897
Email: [email protected]

Charlette Kenley
National Institute of Diabetes and Digestive and Kidney Diseases
Phone: (301)594- 8847()
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 Parts 74 and 92.