It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.

Background

Understanding and ameliorating autosomal dominant PKD are central to the mission of the NIDDK. The clinical course of this disease is highly variable; some patients develop only a modest number of renal cysts, while others develop a massive number of cysts and renal failure at an early age. The disease has extra-renal manifestations, including in liver and systemic vasculature, with variable penetrance. The common underlying mechanisms are unknown despite important advances in elucidating causative genetic defects.

In 1999, the NIDDK originally established the PKD Research and Translation Core Centers, which functioned as stand-alone centers that addressed the many gaps in our understanding of PKD. Examples of progress made by these centers include: improved animal models of disease due to increased understanding of the underlying molecular processes that result in cyst formation and growth; progress in understanding the role of the primary cilium in kidney tubule cyst formation and growth; progress in understanding the role of the primary cilium in kidney tubule cyst formation; and the development of prediction models based upon kidney imaging.

Despite this progress, many challenges remain in determining other genetic and pathophysiologic mechanisms of PKD that could potentially be targeted for therapeutic interventions. Recognizing the need for interdisciplinary, integrated approaches for identification of novel therapies, a FOA (RFA-DK-19-010) has been issued to support the PKD Research and Translational Core Centers (RTCCs) to support development of innovative research resources for the wider research community. Concomitantly, this FOA is issued to support a CCS to provide centralized administrative support to the RTCCs. The CCS is expected to work collaboratively with RTCCs as part of the PKD Research Consortium.

Objectives and Scope

The overall goal of the CCS is to organize and facilitate the activities of the PKD Research Consortium, under the direction of the PKD Research Consortium Steering Committee, to achieve the following objectives:

1) Facilitate sharing of resources and data within the PKD Research Consortium and with the wider PKD research community,

2) Develop a multipronged communication plan for disseminating the information about the research resources and methods offered through the RTCCs to the wider PKD research community,

3) Organize, support and facilitate the education and outreach activities of the PKD Research Consortium,

4) Develop, support and execute the Pilot and Feasibility Program to encourage new investigators in the PKD field,

5) Develop and manage a website for internal and external communication,

6) Plan, organize and support at least one annual face-to-face meeting for the PKD Research Consortium with a portion of the meeting open to the entire PKD research community,

7) Provide centralized administrative support, including coordination of Material Transfer Agreements across the Consortium,

8) Identify fixed and variable costs and establish procedures for negotiation of third party agreements or selection of subawards/subcontractors (i.e. clinical/research laboratories, biospecimen repositories, etc.), with involvement of NIDDK Technology Advancement Office, and develop processes to efficiently administer and manage same throughout the project, and

9) Schedule and coordinate web-based conference calls and webinars.

Project Organization

The PKD Research Consortium will consist of up to four RTCCs and a CCS. Each RTCC and the CCS will be led by their respective Directors. The RTCCs and the CCS will be considered equal partners in the Consortium with complementary roles. The coordinated efforts of the RTCCs and the CCS will be overseen by the PKD Research Consortium Steering Committee composed of RTCC Directors, the CCS Director and NIDDK program staff. All members of the Consortium will meet monthly via conference calls, and annually at a face-to face meeting in Bethesda, MD. The first meeting that will establish the goals of the Consortium will be held on September 14^th, 2020 in Bethesda, MD.

The NIDDK will utilize an External Experts Panel (EEP) to monitor research efforts and advise the Institute on the progress of the PKD Research Consortium. Applications for the RTCCs are solicited through a separate, companion FOA (RFA-DK-19-010). Investigators with appropriate expertise may apply to either or both RFA-DK-19-010 and RFA-DK-19-011. Potential applicants are encouraged to contact the Program Official named in Section VII to discuss their potential applications.

1. Eligible Applicants

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

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. 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.

The CCS Director is required to have an established record of external funding and research accomplishment but is not required to have a background in PKD research.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications  

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)

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

Letter of Intent  

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKletterofintent@mail.nih.gov

Other Attachments:

Statement of Willingness: Please title this attachment "Willingness to Participate" and provide a statement indicating a willingness to:

• Work with NIDDK and the PKD Research Consortium to participate in the initial and annual meetings thereafter during the course of the grant award;
• Cooperatively interact with NIDDK and PKD Research Consortium in support of the projects and activities;
• Work collaboratively with the RTCCs to develop and execute Material Transfer Agreements to permit sharing of resources, biological specimens and de-identified patient data;
• Actively seek input from NIDDK and the PKD Research Consortium regarding resource or expertise needs that may arise during the performance of the project; and
• Participate in monthly conference calls.

The CCS Director is required to have an established record of external funding and research accomplishment but is not required to have a background in PKD research.

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

The Director of the CCS will oversee all activities of the PKD Research Consortium. The minimum level of effort for the CCS Director is 1.2 person months (10% effort). An Associate Director may be named as well, but the total, combined Directorship efforts may not exceed 2.4 person months. The CCS may also include administrative assistant(s) and specialized support personnel (e.g. website developer) and must be fully justified.

The budget must include $400,000 direct costs per year to fund the Pilot and Feasibility Program. The Pilot and Feasibility projects, which may include voucher programs or full grants, are limited to $50,000 in direct costs per year up to two years. The budget must also include support for the annual PKD Research Consortium face-to-face meeting which will include an open enrichment meeting targeting the wider research community with a minimum of $20,000 of these direct costs specifically devoted to travel awards for junior investigators, investigators outside of the PKD research field and trainees. The Educational Enrichment Program may also support the activities outlined in Section I, including travel support of investigators to learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. Additionally, the budget must include funds to support travel of the CCS Director attend face-to-face meeting of the PKD Research Consortium, as outlined in Section VI.

Budget Justification: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For years 2-5 of support requested, justify any significant increase or decrease in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.

Specific Aims: The specific aims should reflect the integrated approach that clearly presents a pathway to reach the goal of the PKD Research Consortium.

Research Strategy: The overall goal of the CSS is to provide leadership, in collaboration with the RTCCs, in organizing and facilitating the activities of the PKD Research Consortium under the direction of the PKD Research Consortium Steering Committee. The CCS should provide a plan for administrative coordination of the Consortium activities, that will be executed in partnership with the RTCCs. Specifically, the CCS should describe a plan to:

• Organize and facilitate sharing of the PKD Research Consortium resources within and outside of the Consortium. An example of sharing may be, but is not limited to, external, centralized repository and distribution of cell lines to members of the Consortium and the wider research community.
• Devise an innovative and multipronged communication strategy to ensure that the resources of the PKD Research Consortium are widely known and effectively utilized within and outside the Consortium. The strategy may also include a plan to widely disseminate any publications arising from the Consortium investigators and opportunities for joint publications on behalf of the Consortium.
• Facilitate and promote educational and enrichment activities for the PKD Research Consortium. The Education and Enrichment Program should aim to expand the pool of investigators who utilize the PKD Research Consortium resources and are drawn into the field of PKD research. It is expected that this program would provide outreach to a larger research community and provide a means for inclusion of new disciplines into PKD research. The Educational Enrichment Program may also include, but is not limited to, web-based lecture series by experts with scientific backgrounds that are not traditionally involved in PKD research ; or workshops that educate RTCCs members and the wider research community on how to use available databases or resources.
• Manage the solicitation, review and selection of projects to be funded under the Pilot and Feasibility Program designed to increase the capacity of the PKD research community by leveraging resources supported by the PKD Research Consortium. Award subcontracts and provide fiscal oversight for Pilot and Feasibility Projects. The Pilot and Feasibility projects are limited to (a) junior investigators or (b) established investigators not previously involved in PKD research. The Pilot and Feasibility Program is not intended to support or supplement ongoing research of an established PKD investigator. It is expected that Pilot and Feasibility projects will generate preliminary data to support future research applications, such as NIH investigator-initiated R01s and may serve to pilot test high-risk/high-reward concepts. Basic, clinical and translational research projects are all encouraged. Pilot and Feasibility projects are limited to $50,000 direct costs per year for two years. Pilot and Feasibility project proposals will be assessed by independent content experts selected by the CCS Steering Committee. These experts will provide comments on scientific merit for submitted Pilot and Feasibility applications to the NIDDK. The PKD Research Consortium Steering Committee is responsible for making final award decisions based on review, the availability of funds, and the Consortium goals and interests.
• Develop an easily navigated website to highlight and update the available resources within the PKD Research Consortium and utilize all relevant avenues and modes of communication with the wider research community to ensure that a wide range of investigators are aware of and are encouraged to use the resources of the PKD Research Consortium. Develop a transparent method to track requests for models, cells, molecules, genes and data.
• The CCS should provide a plan to organize and support an annual, face-to-face meeting of the PKD Research Consortium. Part of this meeting is expected to be open to the wider PKD research community and focus on scientific advancements related to the field.
• The CCS is also expected to organize the monthly, web-based conference call of the PKD Research Consortium Steering Committee.
• Work with the RTCCs as they develop a unified approach to PKD patient evaluation, novel phenotyping, data collection, and data and image sharing to make the best use of human subjects.
   

Letters of Support: Include all assurance letters including institutional commitments and outside collaborations, if such plans are listed in application. The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources; collaboration or role in the project; potential or current user of a resource or service proposed in the application).

The following modifications also apply:

• All applications should include a Data Sharing Plan.
• All applications are expected to provide plans that address sharing and demonstrate commitment to making resources, models, reagents, tools and methods available to the PKD Research Consortium and the broader research community. The terms and timelines for sharing within the PKD Research Consortium, validation of models and methods and sharing with the broader research community will be established by the Steering Committee in a manner consistent with achieving the goals of the program and NIH policies. All participants are expected to adhere to these terms as a condition of award.
• Applicants are expected to register resources supported by this FOA with the NIDDK Information Network (dkNET) at https://dknet.org/ and use Research Resource Identifiers (RRID) assigned through dkNET in any publication supported by this FOA.

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Significance  

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

Does the proposed CCS address the needs of the PKD Research Consortium? Is the scope of activities proposed for the CCS appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the PKD Research Consortium? Does the application describe an outward focus of the CCS rather than merely an inward organization strategy?

Investigator(s)  

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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(s)/PI(s) have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing and coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; is their leadership approach, governance, and organizational structure appropriate for the CCS?

Innovation  

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

Does the application propose novel organizational concepts or management strategies in coordinating the PKD Research Consortium the CCS will serve?

Approach  

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the PKD Research Consortium the CCS will serve? Is there a clearly articulated plan to facilitate the sharing of PKD Research Consortium resources? Is the organization appropriate to address the need for collaboration within the PKD Research Consortium and with the outside research community? Are potential problems, alternative strategies, and benchmarks for success presented? Is an appropriate plan for work-flow and a well-established timeline proposed? Does the CCS have a plan to respond to those outside the PKD Research Consortium who request resources and methods? Does the applicant describe an innovative communication strategy for the PKD Research Consortium? Is the educational enrichment program appropriate for the needs of the PKD Research Consortium goals?

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 individuals of all ages (including children and older adults), 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?

Will the institutional environment in which the CCS will operate contribute to the probability of success in facilitating the PKD Research Consortium it serves? Are the institutional support and other resources available to the investigators adequate? Is the proposed team willing to work cooperatively with the NIDDK and the Consortium to further the overall goals of the PKD Research Consortium?

Protections for Human Subjects  

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan  

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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals  

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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  

Not applicable.

Revisions  

Not applicable.

Applications from Foreign Organizations  

Not applicable.

Select Agent Research  

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

Resource Sharing Plans  

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

Authentication of Key Biological and/or Chemical Resources:  

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support  

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

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

• Will receive a written critique.

Applications will be assigned 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
• Evidence that the applicant and investigators are committed to policies as established by the PKD Research Consortium Steering Committee including with regard to sharing of information and resources and cooperative interaction.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

1. Award Notices

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.

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Part 75, 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 PKD Research Consortium Steering Committee and attending the initial meeting which will serve as a planning meeting, the annual meeting, and monthly teleconference calls.
• Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee, and be responsible for close coordination and cooperation with the components of the PKD Research Consortium with NIH staff.
• Adhering to PHS policy for the distribution of unique research resources produced with PHS funding as described under Resource Sharing. The NIH Project Scientist, on behalf of the NIH, will have the same access, privileges and responsibilities regarding the collaborative data as other members of the Steering Committee.
• 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.
• 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.
• Any third-party (including industry, academia, and foundations) collaboration should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, Memorandum of Understanding, etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program and other staff (including Technology Advancement Office).
• Any involvement of a third party (including industry, academia, and foundations) in the study, including access to any study data or study results not already publicly available; using the name of the study; or the name of the NIH or NIDDK, is permitted only after written concurrence by the NIDDK Program staff who may consult with others at NIH including the NIDDK Technology Advancement Office.

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

• NIH Project Scientist(s) 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 Evaluation Panel (EEP), comprised of the NIDDK Project Scientist(s) and other NIH extramural staff with relevant scientific expertise or who manage research grant programs that relate scientifically to the goals of the PKD Research Consortium, and outside advisors selected by the NIDDK. The EEP will meet annually with the PKD Research Consortium Steering Committee to review and assess the Consortium and to advise NIDDK Project Staff of scientific developments and opportunities that may enhance the achievement of the PKD Research Consortium goals.
• NIDDK Project Scientist(s) will attend and participate as a voting member in all meetings of the Steering Committee and provide liaison between the Steering Committee and the EEP.
• NIDDK Project Scientist(s) will help the Steering Committee develop and draft operating policies.
• The NIDDK Project Officer will review the scientific progress of the PKD Research Consortium 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.

Areas of Joint Responsibility include:

• Steering Committee - The NIH Project Scientist, PIs from projects funded through this FOA and RFA-DK-19-010, 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 PKD Research 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 projects.
• The PIs and NIDDK Project Scientist(s) will each have one vote on the Steering Committee. 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 one face-to-face Steering Committee meeting annually, with the exception of year one, where there will be two. Additional periodic Steering Committee meetings will be held via web conferences. The first meeting will be held on September 14, 2020. At this initial meeting, the Steering Committee will be formed, and a chairperson selected from among the members. At this 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; and (b) agree upon the terms of the charter; and (c) devise a plan for working with the Central Coordinating Site to provide input into website design and database content.

Dispute Resolution

• Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CR Part 16.

3. Reporting

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Christine Maric-Bilkan, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-0486
Email: christine.maric-bilkan@nih.gov

Susan R. Mendley, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-1861
Email: susan.mendley@nih.gov

Xiaodu Guo, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4719
Email: guox@niddk.nih.gov

Krystle Nicholson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8860
Email: nicholsonk@niddk.nih.gov