Funding Opportunity Announcement (FOA) Number

RFA-DK-14-013

Companion Funding Opportunity

None

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

PKD is the fourth leading cause of chronic kidney disease (CKD) in America, affecting approximately 500,000 people. The disease presentation is highly variable, with some patients developing only a modest number of renal cysts during their lifetime without being aware of this disorder, while others develop a massive number of renal cysts and renal failure at an early age. It is also not unusual for cysts to develop in the liver and within the systemic vasculature. Evidence also indicates that in addition to documented cyst enlargement and interstitial fibrosis, apoptotic loss of non-cystic nephrons is a significant component of the pathology of PKD and may contribute to the progressive loss of renal function.

Much progress has been made since the initial solicitation for PKD centers in 1999. Examples 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 progress in understanding aneurysmal development in PKD. This solicitation from NIDDK allows for further enhancement of the PKD Centers program by allowing for regional, national and even international collaboration.

The NIDDK has also funded two complementary multicenter clinical studies. In 1999, the NIDDK funded the Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) to determine whether changes in anatomic characteristics of the kidneys of patients with PKD will be useful in providing surrogate measures for disease progression. This study is still active and preliminary findings from this group have, and will continue to inform the designs of clinical trials in patients with PKD in the near future. In 2001, the NIDDK established the PKD Clinical Trials Network to design and implement clinical trials to determine which pharmacologic agents might slow the progressive loss of function in PKD. The first large interventional clinical trial in this network, HALT-PKD, is a randomized trial of renin-angiotensin axis blockade in patients with PKD that will end in the Fall of 2014.

Despite the progress noted above, many challenges remain in determining other specific genetic and pathophysiologic mechanisms of PKD that could potentially be targeted for therapeutic interventions.

The goal of these PKD Research and Translation Core Centers is to provide resources for communication and collaboration between basic and clinical researchers in the field of polycystic kidney disease. Core Centers will work collaboratively to best serve the larger PKD community. Core Centers will collaboratively provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of research on PKD. Centers may be located in a single institution or in multiple institutions with complementary research bases.

A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center. Each core should provide services to multiple funded research projects. Centers may propose either Institutional Cores or Regional/National/International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level. The research base for cores that are used as a regional, national, or international resource should be considered the "extended research base". The extended research base for a regional, national or international core could include all investigators who might expect to use the core in some way. This might include investigators who would be expected to fully compensate the core service through a charge-back, and thus would not be obtaining direct financial assistance from the Center. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. The extended research base should be presented as a unique part of the core, in order to distinguish it from the local institutional research base.

Examples of types of biomedical core resources that would be considered responsive to this FOA include, but are not limited to, those listed below:

• Collection, analysis, storage and distribution of data and samples;
• Provision of specialized tools and technologies or access to specialized expertise;
• Development, standardization and distribution of reagents and/or protocols;
• Provision of technical assistance, training, and enrichment programs;
• Recruitment of patients and coordination of patient studies;
• Development, beta-testing and dissemination of specialty assays, methods, and services on an institutional level;
• Increase in interdisciplinary interactions at the institution through cross-project/laboratory exchange;
• Sharing of specialized tools, technologies and expertise between collaborating investigators.

In addition to biomedical cores, an administrative core must be described which will be responsible for the allocation of resources within the Center and the distribution of resources to Center participants. The Administrative Core will also be responsible for planning the Educational Enrichment Program consisting of a seminar series, guest lectures, and workshops, and convening a Committee to oversee the solicitation, review and selection of the pilot projects. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for Center members.

Each Core Center must develop a cohesive Pilot and Feasibility Program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of PKD research. A pilot and feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores. Pilot and Feasibility projects could include clinical projects to investigate basic research findings in a clinical setting.

The National Center for Advancing Translational Sciences (NCATS) currently supports 62 institutions via Clinical and Translational Science Awards (CTSA), which provide services and resources to enhance clinical research (http://www.ctsaweb.org ). Research Centers supported by the NIDDK are encouraged to collaborate with CTSAs to avoid duplication of effort and enhance utilization of services and resources.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent, preferably electronically, should be sent to:

Francisco Calvo, Ph.D.
Telephone: 301-594-8897
Fax: 301-480-4126
Email: calvof@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall (use for Center Overview)	12
Admin Core	12
Core (use for Biomedical Research Core)	12
PilotandFeasibility	12

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Center Overview: Required
• Administrative Core: Required
• Biomedical Research Cores: At least one required
• Pilot and Feasibility (P&F) Program: Required

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover Center Overview

Complete entire form.

PHS 398 Cover Page Supplement Center Overview

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Center Overview)

Follow standard instructions:

Project Summary/Abstract: Describe the scientific theme(s) of the PKD Research and Translation Center. Describe the need for a Center to support the investigators in the research base and the number of Center members. Provide a brief overview of the biomedical research cores and describe how they relate to the overall theme(s).

Project Narrative: In 13 sentences describe the relevance of the research to be supported and facilitated by Center activities on public health.

Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the Center will use or change existing access, space, and usage; include space maps as needed. Scientific personnel and institutional resources capable of supporting the research base must be available.

Other Attachments: Include the following "Other Attachments". The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments need to be in .pdf format.

Grant Support: Please title this attachment "Grant Support" and include all Federal and non-federal grant support for PKD Research and Translation Center members. Complete and organize alphabetically by the last name of the Center Investigator who is listed as the Project Director/Principal Investigator (PD/PI) on the grant. Include Supporting Organization/Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs, and Identify Other NIDDK Centers (if the grant listed is also included in its research base). The attachment should include, in order: Current Grant Support, Other Grant Support and Pending Grant Support. Tables are provided for applicant assistance with this requirement (see Illustration III in: http://www.niddk.nih.gov/research-funding/process/apply/about-funding-echanisms/P30/Documents/PKD%20Research%20Translation%20and%20Core%20Centers%20P30guidelines%20-%20Tables.pdf).

Biographical Sketches of Center Research Base Investigators: .Please title this attachment "Center Member Biographical Sketches." Provide biographical sketches for all Center members, as defined by the Center within the application, and organize them alphabetically by the last name of the Research Base Investigator. Do not include biographical sketches for Senior/Key Personnel since those are included with the appropriate component of the application and should not be duplicated here.

Description of Center Research Base Investigators: Please title this attachment Description of Center Research Base Investigators and organize alphabetically by Center Member (last name). Provide a narrative description of no more than one page per research base investigator. These narratives should include: the active grant number(s), title(s), and a few descriptive sentences of the investigator’s research projects, as well as a brief description regarding what aspect of the investigator’s research justifies the use of Center core facilities. In the description of the research base, include ONLY those grants awarded, or subcontracted, to investigators at the applicant institution or consortium, not to investigators at other locations. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to research in PKD when this is not readily apparent from the project title of the grant.

Optional: Please title this attachment "Relation to Overall Center". Provide Charts and Tables related to the Institutional Commitment at the applicant institution, such as an organizational chart(s) to illustrate the structure, interactions, and leaders of the institution and PKD Research and Translation Center.

Project/Performance Site Location(s) (Center Overview)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Center Overview)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Center Overview)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Center Overview)

Specific Aims: Describe the broad, long-term objectives of the proposed PKD Research and Translation Center. A strategic vision, theme and set of goals must be developed and described in the application. The plan should outline the existing skills and technologies available in the research base as well as other resources at the institution(s). This plan should delineate how the Center will enhance ongoing projects, assist in the development of new projects, respond to future opportunities, and promote collaborations toward developing new treatments for PKD.

Research Strategy: The Research Strategy should include the following sections.

Research Base:

The Center Core grant provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting high quality research on PKD. Therefore, existence of a strong, substantial research base in this area is a fundamental requirement for, and the most important aspect of, the establishment of a Center.

Applicants should include an overview of current research in PKD and related areas being conducted at their institution in sufficient detail to allow reviewers to judge its extent and the interrelationship of ongoing research. Applicants should indicate how the establishment of a Center will provide added dimensions, such as greater focus and increased cooperation, communication and collaboration that would not likely occur without Center resources.

A high level of integration and close collaboration among Center personnel from diverse scientific disciplines are important features of a successful PKD Research and Translation Center. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships. Criteria for becoming a PKD Research and Translation Center member should be clearly defined. Each Center, however, is expected to formulate these definitions based on its own situation. Center membership and affiliation are often open to those individuals who would like to promote the mission of the Center. Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined by the Center Director in order to better organize and facilitate the focus of the Center’s mission. Subsets of members based on their degree of participation or other quantitative measures are acceptable. Applicants should provide clear guidelines for a) how Center membership(s) is (are) defined; b) the application and selection processes for Center membership; and c) the obligations of Center membership. Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in PKD-related research, and the need for the use of core facilities. All research base investigators should be Center members. Designation as a Center member without the need for the use of core facilities must be well justified.

Presentation of the research base in the application should be done in two ways: (1) by completing a Table itemizing grant funding (see "Other Attachments" and (2) by a full narrative description of the PKD and related research activities at the applicant institution and any collaborating institutions. This presentation should be organized into several areas of emphasis that demonstrate the research focus of the Center. The research of each Center participant should be discussed and interrelationships of research being conducted by Center participants should be highlighted. Since most, if not all, of the research base will have undergone separate peer review, the quality of the individual funded projects is already established. The more important aspects are: (a) interactions and interrelationships of the research efforts; (b) uses and benefits of core services; and (c) plans to develop productive collaborations among Center investigators.

Strategic Vision:

Theme Provide the central theme(s) of the PKD Research and Translation Center and the likely supported research, resources, and relevance to PKD. The theme may be broad or focused, depending upon the goals of the Center. For clearer presentation, it is recommended that Center applicants subdivide the research base into areas of research emphasis or central research themes that link Center members and their research programs. Appropriate presentation of the research base is very important since its assessment is a primary emphasis in the evaluation of an application.

Goals and Directions Describe the current and future directions for the PKD Research and Translation Center in the forthcoming project period. How will the research supported by the Center impact the understanding of PKD and its complications? Describe any basic science work that has successfully been translated to the bedside or plans to enhance that translation in the next project period. Describe the expected, widely-applicable research tools and scientific advances that will emerge from the Center’s emphasis. Outline steps the PKD Research and Translation Center will take to promote interdisciplinary studies and collaborations, especially among basic scientists and clinical researchers. New areas of research need to be highlighted. Renewal applications must also describe the accomplishments of the Center in the preceding project period and how it intends to build upon its successes. These accomplishments should be presented, as appropriate in the areas of basic science and clinical research. The impact of Center-based science should be discussed in detail.

Biomedical Research Cores should be discussed and their role in the Strategic Vision described. Brief examples of ongoing or planned research should be discussed as appropriate with reference to the supporting Core.

Building research capacity Provide details on the special talents and resources that will be drawn to and built upon at the PKD Research and Translation Center. How will these talents be harnessed and used to promote new collaborations and produce multidimensional teams to address more complex questions? Include a plan for bringing investigators into the Center from within and outside the area of PKD research who might provide new technologies. What expertise will these individuals share with the Center? Describe academic and research partnerships that will be pursued by the PKD Research and Translation Center to advance its goals and missions.

Within this section, describe the research capacity and clearly identifiable major scientific focus in PKD research. The PKD Research and Translation Center grant mechanism fosters interdisciplinary cooperation among established investigators conducting high-quality research related to PKD. Therefore, existence of a strong research capability in PKD is fundamental to establishment of a new, or continuation of an existing, PKD Research and Translation Center.

Innovation:

Address how the PKD Research and Translation Center will not only evolve with the science conducted by the Center Investigators, but also challenge and seek to advance or change current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions. Explain how the synergy of the Center with the research base will lead to novel services and resources in the cores. Describe the potential for interdisciplinary collaborations among Center Investigators. For a Biomedical Research Core that by its nature is not innovative, describe how it is essential to advance the field.

Summarize the services and resources provided by the Center, and how they are managed and coordinated. Describe how the Center will address the scientific needs of the research base. Indicate if any of the proposed cores will utilize or expand cores already existing at the institution. Describe how the proposed Center will leverage existing resources and fill gaps in the services available. Also describe how the Center will enhance the research base through enrichment activities.

Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available. Furthermore, applicants should demonstrate that support for the existing resource through the PKD Research and Translation Center provides added value to the resource beyond that which would be provided by paying for use of the resource through a fee for service. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate.

For new applications: Emphasize the anticipated impact of the establishment of a PKD Research and Translation Center on the research base. Include an indication of how the establishment of a PKD Research and Translation Center will provide added dimensions and new opportunities for cystic disease and related research, along with increased cooperation, communication, and collaboration among investigators.

Progress Report Publications List: In this attachment, list the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the Center since it was last reviewed competitively. Consideration will be given to progress and accomplishments in the research base, to development of multidisciplinary, collaborative, and cooperative interrelationships, and to alteration in the original Center design in order to meet the evolving needs of the research base. This should be described in a narrative fashion and accompanied by the Consolidated Publications List (Illustration IV in:

http://www.niddk.nih.gov/research-funding/process/apply/about-funding-mechanisms/P30/Documents/PKD%20Research%20Translation%20and%20Core%20Centers%20P30guidelines%20-%20Tables.pdf) to assist applicants with documenting the contribution of individual cores to peer-reviewed publications by the research base. Since one of the objectives of the Center is to extend research relevant to PKD, new areas of research and acquisition of new funding should be indicated in the list of publications.

Letters of Support: Include any letters of support for the proposed Center by appropriate institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the PKD Research and Translation Center and its goals. The parent institution is expected to recognize the PKD Research and Translation Center as a formal organization and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the PKD Research and Translation Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing to Center members priority access to Institution’s and Center s facilities and services at minimal or reduced cost. Both the institution and pertinent departments must show a strong commitment to supporting the Center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Center Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each applicant institution specifies one or more Center Director(s) (PD(s)/PI(s)) to be responsible for the scientific and administrative leadership of the Center. If multiple Center Directors are proposed, the application must document their complementary expertise. The Director(s) should be an experienced and respected scientist with a proven track record for obtaining NIH funding. She/he must be able to coordinate, integrate, and provide guidance in the establishment of new programs in PKD and related research. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and will serve as Acting Center Director in the absence of the Director. A process must be described that would be used to recommend a successor to the Director, if needed.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: The Center Director must provide at least 1.2 person month effort on the Administrative Core and a total of 2.4 person months effort distributed among the Administrative and other components of the Center. In a multiple-PD/PI application, the combined effort of the PD/PI must equal 2.4 person months.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the PKD Research and Translational Center which should include travel for external advisors and guest speakers. Include travel costs for the Center Director and Associate Director (s) to attend the PKD Research and Translation Center Directors meetings in Bethesda, Maryland in years 2 and 4.

Other Expense: Funds for supporting a PKD Research and Translation Center website may be requested.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: The Administrative Core will set the overall direction for the Center. It will also be responsible for prioritization of Center resources, external review of Center functions and organizing enrichment activities.

Research Strategy: The PKD Research and Translation Center must be an identifiable organizational unit within a university medical center or a consortium of cooperating institutions including the university-affiliated Center. Such a Center will involve the interaction of broad and diverse elements; thus, lines of authority and approval by the appropriate institutional officials must be clearly specified. The Administrative Core plays a key role in the coordination and functioning of the Center.

Within the Research Strategy, the applicant should describe how the Administrative Core will take a leadership role in setting the overall direction of the Center. In addition, direct lines of communication between the Administrative Core and Biomedical Research Cores as well as with the P&F Program should be delineated, as all of these cores/programs serve critical roles for Center integration. Procedures for reviewing the utilization, quality and necessity of Core services must be described.

Centers need to develop policies and procedures for changes in core function over the life of the Center. These will allow Centers to adapt to the development of new technologies, existing technologies may no longer be needed, or economic changes such as commercial services may replace core services. Provide a plan to determine the need for services and instrumentation of the Center.

Applicants should describe any training opportunities afforded by the PKD Research and Translation Core Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on related T32 training programs at the Center institution(s), and describe how the PKD Center will help to integrate, facilitate and enhance activities of T32-supported trainees.

It is expected that organization of the Administrative Core will provide a supportive structure sufficient to ensure accomplishment of the following:

• Coordination and integration of the PKD Research and Translation Center components and activities
• Assessment of productivity, effectiveness, and appropriateness of the PKD Research and Translation Center activities, assessment of scientific opportunities, and areas for collaboration among Center members
• Develop criteria for Center membership and a process for reviewing and updating membership.
• Organization of PKD Research and Translation Center enrichment activities, such as retreats, invitation of consultants, meetings, and seminars
• Organization of the Internal and External Advisory Committees to coordinate and review Center activities
• Recordkeeping of meeting minutes and measures of success including: use of Center facilities, publications, pilot and feasibility awards, and new grant applications resulting from preliminary data enabled by the PKD Research and Translation Center.
• Interactions with other PKD Research and Translation Centers, the NIDDK, and other appropriate individuals, groups, or organizations.
• Maintenance of a Center website, with the administrative core taking primary responsibility for its curation and oversight.
• Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.

The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). New applications should not list members of the EAC but should describe what expertise is needed. Renewal applications must document the functions and effectiveness of the External and Internal Advisory Committees.

The final administrative structure of the Center will be left largely to the discretion of the applicant institution. However, past experience has demonstrated that the effective development of the Center programs requires close interaction between the Center Director, Core/Program Leaders, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located. Therefore, each Center applicant should establish an administrative structure that will permit the development of such interactions. The Administrative Core of each applicant institution is responsible for managing/overseeing all of the funds for the center and all of its components As part of the oversight for the P&F Program, this mechanism must include the use of appropriate consultants for review from the scientific community outside the Center institution.

Consultants who will serve on advisory committees should not be specifically identified in the application but the process by which they will be selected should be described. These same consultants may be utilized, if desired, for review of other activities of the Center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide,

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. Not Applicable

When preparing your application in ASSIST, use Component Type Core. Separate 'Core' components should be created for each individual Biomedical Research Core proposed including optional Regional/National Shared Resources Cores.

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

SF424 (R&R) Cover (Biomedical Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Biomedical Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Research Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Facilities and Other Resources: Particularly in initial applications, the description of the physical arrangements and instrumentation for the cores should be given special attention. Arrangements for sufficient space for core activities or for access to appropriate established facilities must be made. Centers are strongly encouraged to enter into cooperative arrangements with cores already established within their institution, or with other Centers in close proximity, when the existing cores offer the services needed. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. However, it should be clear that the PKD Research and Translation Center cores can function independently. It may be advantageous for a PKD Research and Translation Center to provide support for appropriate personnel to work specifically with Center members in an existing facility/core (e.g., transgenic animal core) at the institution. In this case, the designated PKD Research and Translation Center Core Director must work closely with the parent facility core Director to coordinate services, unless the same individual assumes both roles.

Other Attachments: Include the following "Other Attachments". The filename provided for each attachment will be the name used for bookmark in the application image. All Attachments should be in a pdf format.

Core Facility Use: Please title this attachment "Core Facility Use" and indicate each Core user, funded project that supports the Core use, period of Core use, services used and estimated use. Table Illustration V is provided for applicant assistance with this requirement:

http://www.niddk.nih.gov/research-funding/process/apply/about-funding-mechanisms/P30/Documents/PKD%20Research%20Translation%20and%20Core%20Centers%20P30guidelines%20-%20Tables.pdf

Project /Performance Site Location(s) (Biomedical Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Biomedical Research Core)

Each applicant institution specifies one or more Center Director(s) (PD(s)/PI(s)) to be responsible

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biomedical Research Core)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: A core Director must devote a minimum of 0.6 person months to the Core to ensure adequate oversight. A co-director or other professional or technical staff may be included. Stipends for graduate students and postdoctoral fellows are not appropriate for Biomedical Research Cores.

Equipment: If specialized equipment costing more than $5,000 is requested, the application must provide a clear justification based on the core services being provided to PKD Research and Translation Center investigators. Equipment may only be requested in the initial year of the project period.

Supplies: Consumable supplies directly related to the Core are an allowable expense.

Research Patient Care Costs: Research patient care costs are an allowable expense. If a Clinical and Translational Science Awards (CTSA) is being used a letter of agreement from the PD/PI of the CTSA is required. This letter in pdf format should be attached as a "Letter of support" for the appropriate Biomedical Research Core.

Other Expenses: Funds for equipment maintenance/service contracts may be requested, but should reflect an equivalent percentage of the service contract based on the overall use by the Center Investigators.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Biomedical Research Core)

Specific Aims: Clearly state the aims of the Biomedical Core.

Research Strategy: Cores may be based solely at the applicant institution or at multiple institutions through subcontracts. If subcontracts are to be utilized the applicant must clearly demonstrate how a cohesive and integrated operation will be ensured and describe the advantages of this approach to the performance of core functions. The Center may also provide resources for funded projects at collaborating institutions without a sub-contractual arrangement with the parent institution.

Definition: A biomedical research core is a shared facility that provides a needed service to Center investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores should be designed to furnish a group of investigators with materials, techniques, determinations, instrumentations, and/or quality control to enhance research and contribute to cost effectiveness. A recharge mechanism is acceptable to help defray costs to the Center. If such a cost recovery system is developed, a detailed charge justification must be presented. Participating Center members must also be informed to include such costs with their full budget justifications in their applications for individual grant support. Cores may be proposed to support any research activity of the Center, but usually fall into one of five categories: (1) provision of a technology that lends itself to automation or preparation in large batches; (2) complex instrumentation; (3) animal preparation, care and characterization; (4) clinical resources; and (5) service and training. Limited developmental research is also an appropriate function of a core facility. Such activities, however, must be directly related to enhancing the function or utility of the Core.

Proposed Center research cores may be an institutional shared research core. In such cases, the research core support provided by the PKD Research and Translation Center should be proportional to the use of the institutional research core by Center members. As with other research cores, details about access and prioritization of center members to the shared research core(s) should be provided. Moreover, the applicant should document that the PKD Research and Translation Center will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.

Regional/National/International Cores: Centers are encouraged to propose Cores that provide unique resources to a community outside the Institution. These could be on a regional level, a national level or an international level. A Regional/National/International Core may define its own research base which is expanded from that of the rest of the Center. It may include investigators that just use this resource or service but do not have a formal collaboration with other Center investigators.

Justification for proposing a core: The establishment and continued support of biomedical research cores within a Center are justified on the basis of use by independently funded Center investigators. The minimum requirement for establishing a core is significant usage by two or more investigators with independently-funded, peer-reviewed projects. While investigators holding awards from the Center Pilot and Feasibility Program are appropriate users of the core facilities, their use does not contribute to justification for establishment or continued support of a core. Additionally, the minimum of two independently funded users does not in itself provide sufficient justification. Core usage should be documented in the "Core Facility Use" attachment in Other Attachments above.

Recharge System: A recharge system may be developed to allow investigators to utilize any core. Recharge fees are allowable budgetary items in the investigators' individual research project grants. A system of payment management/accounting must be established such that it is clear to the individual users, the institutional business office, and the NIDDK what the recharge system covers and how funds recovered are being used. This will enable Center investigators to appropriately adjust the budgets on their own grants and ensure accountability.

Program Income: Centers are encouraged, where appropriate, to develop a program income (re-charge/fee-for-service) system for use of core services. Such a program income system would constitute a method of charging core users for their usage of equipment, time, supplies (such as reagents) and personnel providing the service. Program income must be re-invested into direct support of Center-related activities and/or expenses and may not generate a profit for the Center. Such income could be used to support, for example, the PKD Center operational expenses and/or efforts to expand access to core services or develop new technologies/services that are relevant to research base investigators. Re-charge/fee-for-service costs are allowable budgetary items in individual NIH research project grants. A system of payment management and accounting should be established such that it is clear to the individual users, the institutional business office, and the NIDDK what services or reagents, etc., the business plan/re-charge system covers, which users are affected and how prices will be set, how charges will be tracked and billed, and how funds recovered will be used. This will enable the PKD Center investigators to appropriately adjust the budgets on their own grants and ensure accountability. Changes to this plan should be reported in the annual progress report.

Management of the core and operational plan: The organization and proposed mode of operation of each core should be presented. Included should be a plan for prioritizing investigator use of the core as well as a definition of qualified users. If use by investigators outside the parent institution is proposed, the mechanism by which such investigators will apply and be evaluated and selected should be detailed. The definition of qualified users should not be too narrow. Some minor core use could serve to entice established investigators in other scientific disciplines into PKD research. Any proposed, ongoing or completed developmental efforts should be described. If the core is used to train investigators in special techniques, the mechanism for this training should be included.

Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the PKD Research and Translation Center and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Renewal applications: Information relative to cores in renewal applications should generally cover all of the same points as initial applications. In addition, past performance and accomplishments should be described and highlighted. The effect of the service provided by a core on investigator productivity and cost effectiveness should also be addressed. In renewal applications, any changes should be carefully documented.

Progress Report Publications List: Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented; list the number(s) of the relevant publication(s) from Illustration IV in http://www.niddk.nih.gov/research-funding/process/apply/about-funding-mechanisms/P30/Documents/PKD%20Research%20Translation%20and%20Core%20Centers%20P30guidelines%20-%20Tables.pdf.

Letters of Support: For Regional/National/International Cores, include letters of support from partnering institutions.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Biomedical Research Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Biomedical Research Core)

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

When preparing your application in ASSIST, use Component Type PilotandFeasibility.

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

SF424 (R&R) Cover (Pilot and Feasibility Program)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot and Feasibility Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot and Feasibility Program)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Other Attachments: Include the following "Other Attachments". The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments should be in .pdf format.

Pilot Project Outcomes (renewal applications only): Please title this attachment "Pilot Project Outcomes" and list all Pilot Projects supported in full, or in part, by the PKD Research and Translation Center. Provide information on the most recent 5 or, if applicable, 10-year period. Include the years funded, awardee, dates and amount of P&F funding, pilot project title, P&F award type (i.e. new investigator; established investigator), abstract and publications derived from pilot support, resulting grants funded or pending applications (including grant number/funding agency and project period), and whether the P&F awardee is still involved in PKD research. Table F is provided for applicant assistance with this requirement (see: http://www.niddk.nih.gov/research-funding/process/apply/about-funding-mechanisms/P30/Documents/PKD%20Research%20Translation%20and%20Core%20Centers%20P30guidelines%20-%20Tables.pdf).

Pilot Project Summary/Abstract (new applications only): Please title this attachment "Pilot Project Information" and provide a Project Summary/Abstract for each proposed pilot and feasibility project, as well as the biographical sketch of the investigator for each of the proposed pilot and feasibility projects.

Project /Performance Site Location(s) (Pilot and Feasibility Program)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot and Feasibility Program)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of P and F Program Director and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot and Feasibility Program)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: This category should include salary support for the P&F Program Director who must devote a minimum of 0.6 person months to ensure adequate oversight.

Other Expenses: Include funds to support individual Pilot & Feasibility projects. Each center must support a minimum of 2 P&F projects which can be up to $50,000 direct funds per year each. The applicant should provide details on how F&A costs for P&F projects with partnering institutions will be handled.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot and Feasibility Program)

Specific Aims: Clearly state the aims of the Pilot and Feasibility Program.

Research Strategy: A Pilot and Feasibility study provides modest research support for a limited time (one to two years) to enable eligible investigators to explore the feasibility of a concept related to the mission of the Center and generate sufficient data to pursue the project through other funding mechanisms. The pilot and feasibility studies are intended to: (1) provide initial support for new investigators; (2) allow exploration of possible innovative new leads or new directions for established investigators and (3) stimulate investigators from other areas to lend their expertise to research in this area. Pilot and feasibility study support is not intended for large projects by established investigators which would otherwise be submitted as separate research grant applications. Pilot and feasibility funds are also not intended to support or supplement ongoing funded research of an established investigator.

Requirements: Each Center must contain a pilot and feasibility program with a minimum of 2 projects. A maximum of 4 projects can be requested.

Eligibility and related guidelines: Investigators eligible for pilot and feasibility funding generally fall into three categories: (1) new investigators without current or past NIH research support (R01, P01) as a principal investigator (current or past support from other sources should have been modest); (2) established investigators with no previous work in PKD who wish to apply their expertise to a problem in this area; and (3) established investigators who propose testing innovative ideas that represent clear departure from ongoing research interests. It is expected that the majority of the investigators will fall into the first category. All eligible investigators, however, must have faculty appointments and be independent investigators. Postdoctoral fellows or their equivalents are not eligible. Each pilot and feasibility study proposal should state clearly the justification for eligibility of the investigator under one of the above three criteria.

A proposed pilot and feasibility study should present a testable hypothesis and clearly delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed. It must be on a topic related to the objectives of the Core Center. Projects should be focused, since funding for these studies is modest and is limited to two years or less. Any one investigator is eligible only once for this support, unless the additional proposed pilot and feasibility study constitutes a real departure from his/her ongoing research.

Pilot and Feasibility projects proposing clinical studies are encouraged. The National Center for Advancing Translational Sciences (NCATS) supports Clinical and Translational Science Awards (CTSA) nationwide, which provide services and resources to enhance clinical research (http://www.ctsaweb.org/ ). Research Centers supported by the NIDDK and other NIH Institutes and Centers are encouraged to collaborate with CTSAs to avoid duplication of effort and enhance utilization of services and resources.

Initial review and management of the pilot and feasibility program: By the very nature of this program, a significant responsibility for its management will be left to the P&F Program Director during the project periods. The application should clearly describe and justify the pool from which potential pilot and feasibility applications will be solicited. This can be limited to investigators at the parent institution or expanded to include investigators at institutions with well-defined affiliation with the Center. Such an affiliation can occur either through a subcontractual relationship for support of core resources or through inclusion of funded projects at a collaborating institution in the research base utilizing the shared resources of the Center. The mechanisms by which information on the availability of pilot and feasibility awards will be disseminated and by which applicants will apply and be selected for these awards must be described and will be an important element in the review of the pilot and feasibility component of the Center.

Since pilot and feasibility studies can be awarded for any period of time up to two years, studies end at various times. In addition, the studies may also be terminated by the Center administration before their approved time limit for various reasons: e.g., (1) the investigator may receive outside funding for the project; (2) the project was found not to be feasible; (3) the investigator may leave the Center institution; etc. When this occurs, the Center may make new awards for pilot and feasibility studies with the remaining funds.

While a Center's administrative framework for management of the pilot and feasibility program is basically left up to each Center (subject to NIH peer review), certain minimal requirements must be met. The program must have a director who is an established investigator in PKD research. There must also be a committee representing all the aspects of the Center which will assist the director in the management of the program. The major responsibilities of the director and the committee will be to:

• Maintain oversight and review of ongoing pilot and feasibility studies;
• Make recommendations regarding termination or other actions to the Center Executive Committee (or equivalent);
• Prepare and ensure appropriate distribution of announcements of the availability of pilot and feasibility funding;
• Arrange and preside over the scientific merit review of proposals. At least one reviewer from outside the parent institution must be used for each proposal. All reviewers should assign impact scores in accordance with the NIH system. Copies of all of the proposals with written documentation of their reviews, priority/impact scores, and final action must be retained by the Center;
• Maintain, insofar as is possible, a record of subsequent career events of each pilot and feasibility study recipient. This record must also be made available to reviewers at the time of the renewal application;
• Make recommendations to the Center Executive Committee (or equivalent) for final decisions. A record of actions by this committee must be documented.

All applicants should describe how these requirements will be met and have been met in the case of renewal applications. Also included should be an assessment of the relevancy of the proposed individual pilot and feasibility studies and of the program as a whole to research on PKD and to the specific goals and objectives of the individual Center and of the Center program generally.

Pilot and Feasibility program in new application: Applicants should provide (see "Other Attachments") an abstract for each proposed pilot and feasibility project, and the biographical sketch of the investigator of the proposed pilot and feasibility project; these pilot and feasibility proposals are reviewed for scientific merit and eligibility by the initial review group. These initial pilot and feasibility studies must have been reviewed by the Center in the manner proposed for review of future studies so that only those considered to be of the highest quality are included in the grant application. The amount of pilot and feasibility funds provided for the first year will be based on the review of the proposed studies. The budget for future years is recommended by the initial review group based on the quality of the proposed pilot and feasibility studies, and the proposed method for management and review (as evidenced by this set of projects). Also considered will be the review group's evaluation of the future justification for continued pilot and feasibility support.

Review of the pilot and feasibility program in renewal applications: After the initial review of pilot and feasibility proposals as described above, all responsibility for review and funding during the remainder of the project period will reside within the Center itself. This approach provides each Center with the needed flexibility for effective and efficient management of the program. In renewal applications, the review of this program will be based on the past track record, the management of the program, and an assessment of overall potential needs and opportunities.

In general, a renewal application will include: (1) a historical overview; (2) a description of Center management of the program; (3) a description of the method for solicitation for pilot and feasibility projects and the number of respondents received for each solicitation; and (4) a statement relating to benefits of the program to the Center as well as the contribution of the uniqueness of the Center environment to the program. These points are detailed in the following paragraphs.

The historical overview will cover the pilot and feasibility program since the inception of the Center. The pilot and feasibility program director may wish to highlight certain studies or certain aspects of the past studies. Collaborations which resulted in lasting relationships, acquisition of new skills by the study recipient, or other significant outcomes should be identified. The relationship of the scope of the various studies to that of the Center should be emphasized. Details such as back-up documentation (described earlier in relation to the arrangement of the pilot and feasibility program) should not be included., The description of center management of the program will present in detail the current system used to manage the pilot and feasibility program, including its integration with and relationship to the rest of the administrative structure. The use of outside consultants for review should be included in the discussion. Important features of the solicitation process should be provided including the distribution and the number of respondents.

Funding levels for the pilot and feasibility program on renewal applications: The format for renewal of pilot and feasibility programs will depend on whether the applicant is requesting: (1) a number of pilot projects less than or equal to that for the previous project period, or (2) an increase in the number of pilot projects.

If the applicant wishes to maintain the same number of pilot projects in a renewal application, the recommendation of the initial review group will be based on the overall performance of the center's pilot and feasibility program as documented in the application.

Conversely, should the applicant institution feel that an increased level of funding for the pilot and feasibility program is justified, new pilot and feasibility studies, over and above the number currently awarded, must be submitted with the renewal applications. These proposals would be reviewed by the initial review group in a fashion similar to the review of pilot and feasibility studies during the initial review. The initial review group would assess the new proposals, along with the overall performance of the program during the previous grant period to arrive at a recommendation for a possible increased pilot and feasibility funding level.

Letters of Support: Include any letters of support for the Pilot and Feasibility Program by the appropriate institutional official at partnering organizations if applicable. A letter from the PD/PI of any related NIH-funded T32 at the Center institution should be included that acknowledges and details how the PD/PI of the T32 intends to promote cohesive interactions between the two programs.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot and Feasibility Program)

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

PHS 398 Cumulative Inclusion Enrollment Report (Pilot and Feasibility Program)

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For these P30 Center applications, reviewers will be asked to evaluate the Overall Impact of the application and the following individual sections:

• Research Base
• Each Biomedical Research Core
• The Administrative Core
• Pilot and Feasibility
• Center Director(s) (PD/PI)

Each of the above will be evaluated on the strengths and weaknesses of the following: Overall evaluation, the utility of the Core to the Center Program, the quality of the facilities and services to be provided, the qualifications of the Core Director and other Personnel, and the utilization of the Core by members of the Center.

The overall impact score is not the average of the scores for all these components but will be graded as follows.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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? Do the proposed Cores fill a need in the PKD research community, and will they provide services that would otherwise be unavailable, or be more cost-effective if centralized? Will the Center increase efficiency, promote new research directions and collaborations, and prove cost effective? Will Core Centers work collaboratively to better serve the larger PKD community?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the proposed Center Director and Associate Director(s) have the appropriate administrative and leadership experience necessary to direct a multicomponent Center? Are the Core Directors well-qualified and appropriate? Have they demonstrated collaborative efforts outside their institution(s)? Do they propose to communicate their capabilities to the broader scientific community?

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? Have they proposed new methods of education and training with other NIH-funded entities within their institution(s) and outside, in the broader scientific community?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Are criteria for membership in the PKD Research and Translation Center clear and appropriate? Is the administrative structure appropriate to monitor Core usage, prioritization, and quality? Are the proposed Cores appropriate for the focus of the Center? Do they provide added value to what is available elsewhere within or outside their institution, and will they stimulate the development of new approaches? Is there an appropriate structure to solicit, award and monitor the pilot and feasibility studies? Is the business plan for each Core acceptable?

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? Is there evidence of institutional commitment to the Center program? Are there interactions among scientists from different departments and/or other Institutions? Are there established relationships with CTSAs or other Centers within or outside their institution?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

In addition, the committee will consider the following:

Does the Center show evidence of a stable or growing research base with a strong and consistent record of scientific excellence and achievement? Does the Center show evidence of continued success in securing peer-reviewed research funding related to the focus of the Center?

Does the Center show evidence of fostering multi-disciplinary collaborations among Center members? Has oversight of Center activities including the Enrichment Program been effective? Does the Center website provide appropriate information on Center activities and Core services? Are the number and impact of research publications that acknowledge the Center sufficient to justify continuation of each Core? Does the Center demonstrate the ability to evolve Cores to meet changing needs of the research community? Does the Core duplicate services that are provided elsewhere, inside or outside the institution? Are the number and types of P&F awards well justified? Does the data provided document the publications of all P&F projects completed in the last 5 years? Did the pilot and feasibility projects lead to independent grant funding and/or new Center members?

Revisions

Not Applicable

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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) 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.

Is the budget requested directly correlated to the breadth and quality of the PKD research base being served by the Center?

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Michael F. Flessner, MD, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7717
Email: flessnermf@mail.nih.gov

Francisco Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email: dianaly@mail.nih.gov

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.