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

The objective of the Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) is to bring together, on a cooperative basis, basic science and clinical investigators to enhance the effectiveness of their research related to digestive and/or liver diseases and their complications. DDRCCs are meant to improve communication among investigators and to integrate, coordinate, and foster interdisciplinary research involving the etiology, treatment, and prevention of digestive and/or liver diseases. To accomplish this, the DDRCC supports a group of established investigators actively conducting programs of important, high-quality research that relates to a common theme in digestive diseases (DD) or liver diseases research. Thus, the purpose of a DDRCC is to provide the capability for accomplishments greater than those that would be possible by individual research project grant support alone. Applicants should consult with NIDDK staff concerning plans for the development of the DDRCC and the organization of the application.

A DDRCC must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence in biomedical research as evidenced by productivity and peer-reviewed research funding in the area of digestive and/or liver diseases is a prerequisite for applying. The currently funded research base provides the major support for the investigators, i.e. Center members, who would benefit from a Center's shared resources. The research base includes only currently funded, peer reviewed research grants awarded to the applicant institution/consortium. These may be Federal or privately funded research awards or Research Career Development Awards. Training grants, education grants, and fellowship awards are not considered part of the research base funding. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considerations in judging the adequacy of the research base.

The absolute level of research base support must be sufficient to warrant the addition of a Center, typically at least $3 million a year. Since Facilities and Administration costs vary considerably between institutions, these should not be included in the calculation of the research base. Although collaborations with investigators outside the applicant institution/consortium are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium.

A DDRCC must have a central research focus or theme. The central focus must be a gastrointestinal/liver disease, group of diseases, or functional studies relating to digestive or liver diseases. Examples of a gastrointestinal disease-related central focus include, but are not restricted to, inflammatory bowel disease, functional bowel disorders, pancreatic disease, liver disease, pediatric gastrointestinal disease, and AIDS-related gastrointestinal disease. Examples of functional studies appropriate for a central focus include, but are not restricted to, gastrointestinal motility, actions of gastrointestinal hormones, role of the gastrointestinal tract in obesity, gastrointestinal physiology, or gene therapy for digestive or liver diseases.

To revitalize the DDRCC program, NIDDK is encouraging our existing, competing Centers to focus their efforts. NIDDK has not increased the direct cost cap for DDRCCs in recent years and thus more focused DDRCCs are necessary so as not to dilute the effectiveness of the limited Center support available. Therefore, it is not necessary for each competing Center to show growth in their research base when they have made the strategic decision to focus their research base (i.e. Center membership) rather than continuously expand. Due to NIDDK’s policies, therefore, a flat or even slightly reduced research base in a renewal application is acceptable. When a reduction results in a more thematically focused DDRCC, with added benefit to Center members, this is a positive as long as the funds requested are well-justified.

NIDDK has also instituted a policy that overlaps in the research base among DK-funded Centers should not inappropriately inflate the research base of any Center.

Non-research base investigators at the applicant institution or elsewhere may be encouraged to make use of the core facilities, collaborate with Center members, and participate in enrichment activities when space, time, and funds permit.

Criteria for becoming a DDRCC member must be clearly defined. Subsets of members based on their degree of participation or other quantitative measures are acceptable. Suitable criteria include peer-reviewed independent funding, participation in DD-related research, and 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.

Biomedical Research Cores

The DDRCCs are based on the core concept. Cores are defined as shared resources that foster productivity and benefit a group of investigators working to accomplish the stated goals of the Center. Cores should provide specialized technical resources, services, and/or expertise that enhance the efficiency and productivity of Center members. The proposed core services should be ones that are not readily available, or are not cost-effective when supplied from commercial sources, or which are technically challenging or require specialized expertise, equipment or infrastructure. Each proposed core must be utilized by a minimum of two Center members.

When appropriate, core staff should provide instruction for investigators, laboratory personnel, or fellows to learn, and then become proficient in, technologies that will become part of the repertoire of the user's laboratory. Teaching new or complex techniques and methodologies is an important function of a core.

Proposed cores may be part of institutional shared research cores, such as a centralized animal facility. In such cases, the support provided by the DDRCC should be proportional to the use of the institutional core by DDRCC members.

In addition to providing products or services, a Core must ensure appropriate quality control and maintain a record of use. Limited developmental research is also an appropriate function of a core facility as long as it is directly related to enhancing the function or usefulness of the core and is not an undertaking that should more appropriately be funded through other mechanisms. Plans for responding to the changing needs of the Center members should also be a part of each core.

Two to five biomedical research cores are usually included in a Center. Examples of core services/resources include, but are not limited to: imaging facilities; transgenic or gnotobiotic animal units; and membrane, cell, or tissue preparation and/or storage facilities.

NIDDK encourages, but does not require, our Centers to interact with the broader research community, serving as resources to support research of importance to the NIDDK. Therefore, core usage by (1) Members of other DDRCCs; (2) Members of other DK-funded Centers; and (3) Non-Center members, both locally and nationally, is encouraged when core capacity allows and institutional policies can be accommodated.

Administrative Core

Each Center must include an Administrative Core responsible for allocation and oversight of Center resources. The Administrative Core personnel provide support for the required External Advisory Committee and internal committee structure of the Center. Maintaining a Center website, providing editorial services, serving as the first point of contact for Center members, and potential members, as well as maintaining lines of communications among Center members, staff, and Institutional officials are all functions of the Administrative Core.

Clinical Element or Clinical Component

Since the NIDDK is interested in translating work supported by the DDRCCs into practical therapies for digestive and liver diseases, the clinical element or Clinical Component can serve as a resource, a focal point, and a facilitator for this function. Investigators, therefore, need not be funded directly for clinical studies to use the services or expertise nor to justify the existence of this unit. Providing the capability for translating basic research findings into a clinical setting is the ultimate goal of the clinical element or Clinical Component for those Centers wishing to build this part of their research base.

A clinical element may exist as a part of a Core, usually the Administrative Core. Alternatively, a separate, full-fledged Clinical Component is also an option, if the requirements for it can be met. Besides leading to a better understanding of the etiology and natural history of disease, a clinical element or Clinical Component might provide biostatistics support; help with clinical study design; foster collaboration among researchers; aid in recruitment of subjects for clinical studies; support epidemiological studies in areas of digestive and/or liver diseases; or provide modest funding for tissue, DNA, or serum storage. In addition, a Clinical element or Clinical Component may help Center members to effectively address NIH policies concerning women, children, and ethnic minority population participation in clinical studies.

Pilot and Feasibility Program (P and F Program)

The P and F Program provides modest support (typically $10,000 to $50,000 per year) for new initiatives or feasibility research studies. P and F Programs are intended to provide support for investigators to collect preliminary data sufficient to support a grant application for independent research support and/or to test a novel, even high risk, hypothesis. P and F studies may (1) provide support for new investigators; (2) encourage investigators from other areas of biomedical research to use their expertise for DD research; and (3) allow established DD-investigators to explore innovative new ideas that represent a significant departure from their ongoing, funded projects. It is expected that the emphasis of a strong P and F Program will be on the first of the above categories of applicant.

Pilot and feasibility support is not intended for large projects by established investigators that should be submitted as separate research grant applications, nor is it intended to provide bridging support. Pilot and feasibility funds are also not intended to support or supplement ongoing funded research of an investigator.

Named New Investigator (optional)

Each DDRCC may request salary support for a P and F Project recipient whom they designate a Named New Investigator (NNI). The individual selected must be named in the application and be a junior investigator and a permanent resident or US citizen. Individuals are eligible only once for this support. Subsequent candidates for this position are nominated by the Center and reviewed by its External Advisory Board. Appointment of the NNI is contingent upon the concurrence of the External Advisory Board and the NIDDK DDRCC program director.

Enrichment Program

Support for an Enrichment Program is available. Support for visiting scientists, seminars, and research fora are appropriate items for inclusion in an Enrichment Program as well as any appropriate, innovative means to support the goals of the Center, e.g. short-courses, mini-sabbaticals, etc. Also, limited travel support may be requested to allow DDRCC investigators to present scientific findings, to learn new laboratory techniques, to develop new collaborations, or to engage in scientific information exchange. In all cases, the Enrichment Program should further the overall aims and objectives of the DDRCC as well as its cores. Creative new programs, not precluded by NIH or NIDDK policies, are encouraged.

While DDRCCs cannot support stipends for postdoctoral fellows, the environment fostered by the existence of the Center with its core facilities in conjunction with the Enrichment Program educational opportunities should serve to foster the careers of postdoctoral fellows and junior faculty, including K-awardees.

DDRCC Directors' Meeting

Every 12-18 months, all DDRC Directors and Center administrators are expected to attend a meeting at one of the DDRCCs to exchange information, highlight the host Center, and interact with NIDDK senior staff.

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)
• 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

Only institutions at which there is a strong ongoing base of digestive and/or liver diseases-relevant research that relates to the proposed theme of the Center are eligible. At least 50 percent of the already funded research base in a new application must be supported by the NIDDK. In renewal applications, the NIDDK-supported research base may be less than 50 percent due, typically, to a growing number of investigators entering digestive or liver disease research from other fields.

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 not 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.

Because a DDRCC has a large and complex administrative structure, the Program Director(s)/Principal Investigator(s) must have strong leadership abilities and demonstrated proficiency in managing large, multi-component projects. The DDRCC PD(s)/PI(s) must also be willing to participate in meetings of the Center Directors and Administrators every 12 - 18 months.

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for 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 O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
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 Cores)	12
Clinical Component	6
PilotandFeasibility	12
Enrichment Program	6

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:

• Overall (Center Overview): Required
  • Administrative Core: Required
  • Biomedical Research Cores: Required; minimum of 2
• Clinical Component: Optional
• Pilot and Feasibility Program: Required
• Enrichment 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 of the DDRCC and the need for a Core Center to support the investigators in the research base. Include the number of Center members and the overall total direct costs present in the digestive and/or liver research base. Provide a brief overview of the research base as it relates to the theme of the Center as well as an overview of the biomedical research cores, and P and F, enrichment, and, if requested, clinical component.

Project Narrative: In 1-3 sentences describe the relevance of the research to be supported and facilitated by Center Activities (Core services, P and F, and enrichment programs) 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: The following "Other Attachments" should be included with the Overall Component to aid in the review of applications. 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 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 Digestive Diseases Grant Support (Table A.1), Other Digestive Diseases Grant Support (Table A.2) and Pending Digestive Diseases Grant Support (Table A.3). Tables A.1, A.2 and A.3 are provided for applicant assistance with this requirement (see: RFA-DK-14-012 Resource page).

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 digestive disease/liver research, and to the theme of the DDRCC, when this is not readily apparent from the project title of the grant.

Core Use by Center Members: Please title this attachment "Core Use by Center Members" and organize alphabetically by Center Member (last name, first name). List all DDRCC Members including Membership Category (only if more than one category of Membership is designated by the Center), and for each Center Member indicate those Center Core Facilities that will be used. Table B is provided for applicant assistance with this requirement (see: RFA-DK-14-012 Resource page).

For renewal applications: Provide an additional Table B with the same information for the "Actual Core Use by Center Members".

Center Collaborations: Please title this attachment Center Collaborations and organize alphabetically by Center Member (last name, first name). List all Center Members. Provide primary Department Affiliation, key words for research interests, names of other Center members who are collaborators (through publications, grants or research projects), and the number of collaborative publications (only those relevant to the DDRCC). Table C is provided for applicant assistance with this requirement (see: RFA-DK-14-012 Resource page.)

Optional: Provide Charts and Tables to illustrate the structure, interactions, and leaders of the institution and the DDRCC. Title this attachment "Relation to Overall 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)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the broad long-term objectives of the proposed DDRCC. Provide the central theme(s) of the DDRCC. The theme may be broad or focused, depending upon the goals of the Center. Outline the existing skills and technologies available in the research base as well as other resources at the institution(s) and summarize how the Center will enhance ongoing projects, assist in the development of new projects, respond to future opportunities, and promote collaborations leading to advances in digestive and liver diseases research.

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 digestive and/or liver diseases. Therefore, existence of a strong, substantial research base in the thematic focus areas(s) of the DDRCC is a fundamental requirement for the establishment of a Center.

Applicants should include an overview of current research in digestive and/or liver diseases related areas being conducted at their institution in sufficient detail to allow reviewers to judge the extent and the interrelationship of ongoing research. It is recommended that the DDRCC research base be sub-divided into areas of research emphasis or research themes that link Center members and their research programs. 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.

Presentation of the research base in the application should be done in two ways: (1) by completing a Table (see "Other Attachments") like the one shown in "Grant Support"; Table A: (RFA-DK-14-012 Resource page) itemizing grant funding and (2) by a full narrative description of the digestive diseases research activities at the applicant institution and any collaborating institutions in the context of the theme(s) of the Center. The research of each DDRCC member should be discussed and interrelationships of research being conducted by the members 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 as well as relevance to the theme of the DDRCC; (b) uses and benefits of core services; and (c) plans to develop productive collaborations among Center investigators.

Membership: A high level of integration and close collaboration among DDRCC members from diverse scientific disciplines is an important feature of a successful 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 DD-related research, and the need for the use of core facilities. All research base investigators must be Center members. Designation as a Center member without the need for the use of core facilities must be well justified.

Center Organization: Summarize the services, resources, and expertise provided by the proposed Biomedical Research Cores, emphasizing the support they will provide for the thematic areas of the research base. Point out novel services and resources available in the cores and describe the potential for interdisciplinary collaborations among Center Investigators.

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. Leveraging existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available.

Provide a plan to determine the need for new services or instrumentation of the DDRCC members. Discuss how the Center will ensure that Center members are able to take advantage of cutting edge technology and how services no longer required, or no longer cost-effective, will be phased out. Include information on the process of re-evaluating the needs of Center members and how evolving needs will be met.

Also describe how the Center will enhance the research base and foster the careers of its junior investigators through enrichment activities and the use of Core services/expertise.

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

For renewal applications: Briefly discuss the progress and accomplishments of the research base as influenced by the DDRCC; the development of multidisciplinary, collaborative, and cooperative interrelationships among Center members; and indicate any alteration in the original Center design that was instigated to meet the evolving needs of the research base. This should be described in a narrative fashion.

Progress Report Publication List: List publications related to or derived from DDRCC support or assistance. Include PMCIDs. Table F ( RFA-DK-14-012 Resource page) is provided for assistance with this list. The Core most significantly contributing to the work should be assigned 'primary' (P) status. All other contributing Cores are designated 'secondary' (S). Group publications by Core used, so that the number of publications (not the list of publications) that resulted from the use of each Core can be cited in each Core narrative write-up. Portions of this this table should NOT be duplicated in each Core, but the absolute number of publications from this main list should be cited.

Letters of Support: Include any letters of support for the proposed DDRCC from appropriate institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the DDRCC and its goals. The parent institution is expected to recognize the Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, staff recruitment, salary support for investigators or technical personnel, dedicated or shared equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the DDRCC in the event of a change in directorship. A well-defined plan for this eventuality should be in place.

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.

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.
  • One or more Associate Directors should be named to assist the Center Director and serve as Acting Center Director in the Center Director's absence.
  • In this component, also provide biographical sketches for any consultants. For renewal applications only, provide biographical sketches for the members of the External Advisory committee. In the additional Senior/Key Profiles section, list these Senior/Key persons in the Project Role of 'Other' with Category of 'Consultant,' or 'Advisory Committee Member'

Budget (Administrative Core)

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

Personnel: The Center Director must devote a minimum of 2.4 person months to the Center, and at least 1.2 of those months must be within the Administrative Core to ensure adequate oversight of the Center. If a multiple-PD/PI application, the combined effort of the PD(s)/PIs must be 2.4 person months. Most Centers find that the size and complexity of a DDRCC warrant inclusion of a full-time program administrator, so salary support for this individual should be included in the Administrative Core.

Equipment: If pieces of specialized equipment, or computers, costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on core service provided to DDRCC investigators. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. This includes all equipment in future budget years as well as the initial budget period.

Supplies: Consumable supplies directly related to the operational aspects of the Administrative Core facilities are an allowable expense.

Alterations and Renovations: Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested. Cosmetic renovations are not appropriate.

Other Expenses: Support for development/maintenance of the Center's website may be requested as well as funds for supporting regional Center meetings, if appropriate.

Consultants: Include costs associated with consultants (consultant fees, per diem, and travel) when their services are required by the DDRCC, such as the members of the External Advisory Board.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the DDRCC. Include travel costs for the DDRCC Director, Center administrator, and others as appropriate (i.e. co-Director, core Directors) to attend the DDRCC Directors' meeting.

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)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the DDRCC and outline plans for oversight/coordination of the biomedical research Cores, enrichment activities, and the P and F Program

Research Strategy: The Administrative Core is key to the coordination and functioning of the Center. Therefore, describe the administrative structure of the DDRCC, including: chain-of-command; committee structures (e.g. Internal Advisory Committee, P and F review committee, other oversight or management committees, and the required External Advisory Committee); and Core, Enrichment Program, and Clinical element (if included) management.

The DDRCC Director, who is the PD(s)/PI(s) of the application, should be assisted by one or more Associate Directors who will be involved in the administrative, scientific, or enrichment efforts of the Center and who will serve as Acting Center Director in the absence of the Director. Include a brief narrative describing the qualifications of the Director and Associate Director(s). A process must be in place to recommend a successor to the Director, if a successor becomes necessary.

The relationship of the DDRCC to the institution and the reporting lines of the DDRCC Director to appropriate institutional officials may be presented in diagrammatic form, but also provide a brief explanation in narrative form.

Include a description of the mechanism for monitoring budgetary overlap between the research projects included in the research base and the funds for the core facilities of the DDRCC, describing a mechanism to monitor the budgetary adjustments made necessary by the use of Core services. This will ensure that DDRCC investigators using Cores are able to provide a satisfactory explanation of their relationship to the DDRCC and their inclusion of charge-back fees for Core use in their individual grant budgets.

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 DDRCC components and activities.
• Assessment of productivity, effectiveness, and appropriateness of Center activities and determination of Center membership, assessment of scientific opportunities, and areas for collaboration among DDRCC members.
• Organization of Center activities, such as retreats, symposia, invitation of consultants, meetings, and focus groups.
• Organization of the Internal and External Advisory Committees.
• Recordkeeping of meeting minutes and measures of success including: use of Core facilities, publications, P and F awards, and new grant applications resulting from preliminary data enabled by the DDRCC.
• Interactions with other DDRCCs, 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.

For new applications: List the areas of expertise to be included on the External Advisory Board, not the names of the individuals whom you plan to recruit to serve in this capacity.

For renewal applications: List the current External Advisory Board members, and include their Biosketches in the application.

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, with the following modification:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.

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.

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

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. When proposing the use of a shared facility, details about access, fee-schedules, and prioritization of Center members' use of the shared facility must be described. It may be advantageous for a DDDRCC to provide support for appropriate personnel to work specifically for Center members in an existing facility/core (e.g., transgenic animal core) at the institution. In that case, the designated DDRCC Core Director must work closely with the parent facility Core Director to coordinate services, unless the same individual assumes both roles.

Other Attachments: The following "Other Attachments" should be included within each Biomedical Research Core component to aid in the review of applications. 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.

Core Facility Use: For all applications, please title this attachment "Core Facility Use" and indicate the Core User, Funded Project that supports the Core use, Period of Core Use, Services to be used, and Estimated Use and comments. Table D is provided for applicant assistance with this requirement: (RFA-DK-14-012 Resource page)

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)

• 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.

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.

Personnel: This category should include salary support for key personnel, including the Core Director, co-Director, and other professional and technical personnel. The Core Director must devote a minimum of 0.6 person months to the Core to ensure adequate oversight. The salary amount charged to the DDRCC grant must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies. A Core Director with requisite expertise may devote a greater effort to the core, and with exceptionally strong justification could devote up to 12 person months. In instances where a junior scientist (who may or may not be a part of the research base) with appropriate expertise will devote a significant effort to the Core and a more senior, established expert assumes the role of Core Director, a title of core manager or core technical director might be appropriate for the junior scientist. Salary support for technicians and other core personnel are allowable in accordance with the volume and type of work in the core. Stipends for research trainees are not available through the Center. Such funding must be sought through other grant mechanisms.

Equipment: If pieces of specialized equipment costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on core services provided to DDRCC investigators.

Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. This includes, when possible, all equipment in future budget years, in addition to the initial budget period.

Supplies: Consumable supplies directly related to the operational aspects of the core facilities are an allowable expense. This includes office materials as well as laboratory supplies. The supply budgets of separately funded individual research projects must be appropriately reduced to reflect such support, thus eliminating duplication.

Research Patient Care Costs: Research patient care costs (both in-patient and out-patient) are an allowable expense. Attempts should be made to utilize existing clinical facilities, such as those supported by Clinical and Translational Science Awards (CTSAs) and individually supported beds. If the CTSA is to be used, include a letter of agreement from the PD/PI of the CTSA; such a letter (in .pdf format) may be attached as a 'Letter of support' for the appropriate Biomedical Research Core(s).

Request costs relating to the clinical research efforts of DDRCC investigators ONLY if there is no overlap with other funding. Costs already budgeted in individual projects should be appropriately reduced if such costs are to be transferred to the Center. The DDRCC is not intended to be a facility for health care delivery. Thus, only those patient costs directly related to research activities may be charged to the Center.

Other Expenses: Funds for equipment maintenance/service contracts may be requested, but should reflect only an equivalent percentage of the service contract based on the overall use of the specified equipment by Center investigators versus other users. The budget justification for any maintenance/service contracts should document use of the equipment by Center members. Only in very rare cases should full support for a maintenance/service contract be requested, and strong justification must be provided in such cases.

Alterations and Renovations: Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested. Cosmetic renovations are not appropriate.

Consultants: Include costs associated with consultants (e.g. consultant fees, per diem, teleconferences, and travel) when their services are required by the core.

Travel: Include the costs of domestic and foreign travel for core personnel only if the travel is directly related to the activities of the DDRCC.

PHS 398 Research Plan (Biomedical Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

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

Research Strategy: Provide the rationale for establishing or continuing the core, the facilities to be used, and the activities of the core. Cores may be proposed to support any research activity of the Center. The description of each Core should indicate how it will support the Center’s research effort in a cost-effective manner.

Include a definition of qualified users and provide a list of research base investigators who will use the core, including the expected extent of their proposed use. Each proposed Core must be utilized by a minimum of two federally funded investigators who are Center members. Emphasize the anticipated benefits that investigators will derive from using core facilities. Criteria for use and for prioritization must be included in the application.

Present the organization and proposed mode of operation of each core. As appropriate to the core, a charge-back system may be developed to allow investigators to utilize its services. Financial justification such as comparative costs of other sources of proposed core services as well as plans for cost recovery, i.e. charge-back fees, from users should be detailed.

Charge-back 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 charge-back 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.

Each core must have an operational plan which must include methods to:

• Assure quality control
• Prioritize investigator use
• Monitor core use
• Adapt to new technology and to the needs of the DDRCC members.

Limited use of cores by investigators in other fields who are not Center members is encouraged, as is use by trainees, students, and junior faculty, but rules to regulate this use should be defined. If the core is used for training, the approach to and extent of training being performed in the Core should be detailed. Training is an appropriate and worthwhile activity of a Core and is encouraged.

Any Core with a minimum number of users must develop plans to broaden the number of Core users. Such plans are particularly important for any Core that, while not extensively used, is considered essential by the DDRCC administration.

Describe any plans to use the Core for limited developmental research, including the relevance of this research to Core services, effectiveness, and adaptability.

Since DDRCCs are strongly encouraged to enter into cooperative arrangements with established cores at the applicant institution or at other DDRCCs offering a similar type of service, describe the nature of any cooperative arrangements, access, fee-schedules, the prioritization plan, and the methods to monitor use under these circumstances. It may be advantageous for a DDRCC to provide support for appropriate personnel to work specifically for DDRCC members in an existing facility/core (e.g. transgenic animal core) at the institution. In this case, the designated DDRCC core Director must work closely with the parent facility core Director to coordinate services, unless the same individual assumes both roles. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. Therefore, financial justification such as comparative costs of other sources of proposed core services as well as plans for cost recovery from users should be detailed.

A well-qualified Core Director must be named for each Core. Core Directors should be acknowledged experts with independently funded research programs who will themselves use the core services. Therefore, the percent effort for the Director requested from the DDRCC will be relatively low, typically 0.6 to 2.4 person months of effort. While it is expected that all Core Directors and co-Directors will be Center members, occasionally experts in the specialty area required by the Core who are not part of the research base may be appropriate. Sufficient and compelling reasons must be given for appointing any Core Director/co-Director who is not a Center member.

For 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 and any changes in services provided should be carefully documented. Any Core usage by (1) Members of other DDRCCs; (2) Members of other DK-funded Centers; and (3) Non-Center members, both locally and nationally, should be documented.

Also, for renewal applications, include information on past use of the core services for which further funding is not being requested, as well as a brief explanation of the reasons for deleting the services, combining facilities, or creating new Cores.

Progress Report Publications List: Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented by listing the numbers of the relevant publications from Table F (RFA-DK-14-012 Resource page), which was attached in the 'Center Overview' component . The DDRCC should have been credited as a resource in all publications. This acknowledgement provides evidence to the study section, and the NIDDK, of Core use. Do not duplicate Table F in each Core.

Letters of Support: For any collaborative links between the CTSA and a specific Biomedical Research Core, a letter of support should be included within the relevant Core. Also, provide letters to address the career potential of, and institutional commitment to, junior scientists who serve as core managers/technical directors.

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.

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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 Clinical Component.

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

SF424 (R&R) Cover (Clinical Component)

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 (Clinical Component)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Component)

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) (Clinical Component)

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 (Clinical Component)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Clinical Component 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 (Clinical Component)

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

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.

Personnel: This category should include salary support for key personnel, including statistical support, patient coordinators, database managers, and other staff necessary for the functioning of the Clinical Component.

Equipment: If pieces of specialized equipment costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on the service provided to DDRCC investigators. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. This includes all equipment in future budget years as well as the initial budget period.

Supplies: Consumable supplies directly related to the operational aspects of the clinical Component are an allowable expense. This includes office materials as well as laboratory supplies. The supply budgets of separately funded individual research projects must be appropriately reduced to reflect such support, thus eliminating duplication.

Research Patient Care Costs: Research patient care costs (both in-patient and out-patient) are an allowable expense. Attempts should be made to utilize existing clinical facilities, such as those in supported by Clinical and Translational Science Awards (CTSAs) and individually supported beds.

Consultants: Include costs associated with consultants (consultant fees, per diem, and travel) when their services are required by the clinical component.

Travel: Include the costs of domestic and foreign travel for clinical component personnel only if the travel is directly related to the activities of the DDRCC.

PHS 398 Research Plan (Clinical Component)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state the aims of the Clinical Component.

Research Strategy: Describe the services to be provided by the Clinical Component as well as the potential number of users, including the rationale for establishing this Component and how it will be used to translate the work of the DDRCC research base investigators into practical therapies for digestive diseases. Center members need not already be funded for translational work to take advantage of the services of the clinical Component.

For renewal applications: Include a description of past use of the Clinical Component, highlighting benefits to the Center members as well as any changes to the services provided.

Letters of Support: If a CTSA will be involved in the Clinical Component, include a letter from the CTSA Director and relevant staff.

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

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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 (Clinical Component)

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 (Clinical Component)

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: The following "Other Attachments" should be included with the Pilot and Feasibility component to aid in the review of applications.

Pilot Project Outcomes (for renewal applications only): Please title this attachment "Pilot Project Outcomes" and list all P and F Projects supported in the most recent 5 or, if applicable, 10-year period. Include the dates and amount of the award, the title of the project, category of P and F recipient, subsequent funding, and whether the recipient is still involved in GI research. Table E is provided for applicant assistance with this requirement (see: RFA-DK-14-012 Resource page)

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.

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.

Personnel: Include salary support for the P and F Program director, who must devote sufficient effort to manage and provide oversight, typically 0.6 to 1person months. If requested, include the salary for the Named New Investigator. Support for this individual is limited to 3 years and cannot exceed $90,000 per year, additional appropriate fringe benefits, and 9.6 person months effort. The Pilot and Feasibility project summary/abstract of the Named New Investigator must be included in the P and F Program component (see "Other Attachments" for the P and F Program).

Other Expenses: Include funds to support the number of P and F projects requested. These funds are capped at $150,000 direct costs per year for the program.

Consultants: Include costs associated with consultants (e.g. consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Pilot and Feasibility Program, such as any external reviewers for P and F applications.

PHS 398 Research Plan (Pilot and Feasibility Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

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

Research Strategy: Describe the management plans for the P and F Program, including both internal and external review mechanisms along with an outline of the plans for future years of the P and F Program. While the management of the P and F Program is left to the discretion of the DDRCC, it must include the elements listed below.

• A mechanism must be established to advertise the availability of P and F funds.
• A mechanism for the scientific merit review of P and F projects must be established. At least one reviewer from outside the DDRCC must be used to evaluate each application. Details of handling the review will be left to the DDRCC, although all reviewers should assign impact scores in accordance with the NIH system. Copies of all of the projects with written documentation of the reviews, priority scores, and final action should be retained by the DDRCC. These records should be available to outside reviewers and NIH staff, if requested.
• A mechanism for making recommendations to the DDRCC Director for funding decisions should be outlined.
• A mechanism for the oversight and review of ongoing P and F projects should be developed as a requirement for a second or third year of funding.
• A mechanism to terminate P and F projects must be established. Studies may be terminated by the DDRCC administration before their approved time limit for various reasons such as (1) the investigator receives outside funding for the project; (2) the project was found not to be feasible; or (3) the investigator left the DDRCC institution. When a project is terminated, the DDRCC may use the unspent funds to either make new awards for P and F projects or to supplement ongoing P and F projects.
• A plan for tracking the success of the P and F Program should be established. A record of scientific publications, abstracts, and grant applications submitted/funded, as well as information on whether the investigator remains in DD-related research is important. Staff of the NIDDK uses this record to determine whether the P and F Program is a useful component of the Center which serves to encourage investigators to remain in DD-related research.

Each DDRCC is strongly encouraged to involve the External Advisory Board in the management of the P and F Program. P and F grant recipients are encouraged to collaborate or consult with any biostatistics component supported by the DDRCC or otherwise available at the applicant institution and to utilize the core facilities or the clinical component of the DDRCC.

Clearly indicate the Named New Investigator, if such a position is being requested, and how he/she was selected. Each DDRCC may request salary support for a P and F project recipient whom they designate a Named New Investigator (NNI).

Within the page limit, include a 1 page synopsis for each of 4 P and F project applications.

Each synopsis should include:

• budget and number of years requested
• eligibility of the P and F project (how it fits with the DDRCC's goals)
• name, department affiliation, and eligibility category of the P and F investigator
• proposed Core use
• abstract of the project.

The budget for the P and F Program as a whole is recommended by the initial review group based on the quality of the submitted P and F application synopses and the proposed method for management and review (as evidenced by this set of projects).

For new applications: These should be the best applications received by the DDRCC and reviewed in the manner proposed for all future P and F applications.

For renewal applications, these should be from the most recent group of funded projects.

Letters of Support: Include any letters of support for the Pilot & Feasibility Program by appropriate institutional officials at partnering organizations (other than the parent institution), if applicable.

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.

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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 (Core or Project Name)

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 Enrichment Program.

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

SF424 (R&R) Cover (Enrichment 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 (Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Enrichment 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 (renewal applications only; optional): Information related to the Center-supported Enrichment Program activities, such as Center retreats, symposia, workshops, meetings, specialized courses, seminar series, etc., illustrating the interactions among Center members and other investigators, as well as other training and educational opportunities may be included in the application. This should be loaded as a single, combined file in .pdf format titled "Enrichment Program".

Project /Performance Site Location(s) (Enrichment 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 (Enrichment Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Enrichment 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 (Enrichment Program)

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

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.

Personnel: This category should include salary support for key personnel, including the Enrichment Program Director and any other professional and administrative personnel. The Enrichment Program Director must devote a minimum of 0.6 calendar months to ensure adequate oversight of the Program. The salary amount charged to the DDRCC grant must be commensurate with the time spent on Program activities and is subject to institutional and NIH salary policies.

Other Expenses: Include funds to support Enrichment Program activities such as workshops, research fora, symposia, Center retreats and seminar series. Funds for Enrichment Program- associated activities such as the printing and distribution/mailing of brochures, programs, and meeting materials, as well as posters and other advertisement materials, may be requested.

Consultants: Include costs associated with consultants (e.g. consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Enrichment Program.

Travel: Travel funds to support visiting scientists under the auspices of the Enrichment Program may be requested as well as funds to support Center member travel for special programs. Also, limited travel support may be requested to allow DDRCC investigators to present scientific findings, to learn new laboratory techniques, to develop new collaborations, or to engage in scientific information exchange.

PHS 398 Research Plan (Enrichment Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state the aims of the Enrichment Program.

Research Strategy: Describe plans for the enrichment program in as much detail as possible, including anticipated benefits to Center members and how the program will assist investigators, trainees, and junior faculty to accomplish the goals of the DDRCC.

The Enrichment program will typically support seminars, short-courses, workshops, research and career development fora, mini-sabbaticals, etc., but any appropriate, innovative means to support the goals of the DDRCC may be proposed. Creative new programs, not precluded by NIH or NIDDK policies, are encouraged.

While DDRCCs cannot support stipends for postdoctoral fellows, the environment fostered by the existence of the Center with its core facilities in conjunction with the Enrichment Program educational opportunities should serve to foster the careers of postdoctoral fellows and junior faculty, including K-awardees.

For renewal applications: Describe the existing Enrichment Program, including its value to the DDRCC members and how the program has been adapted to the needs of the members. Describe future plans for the Enrichment Program.

Letters of Support: Supporting letters may be provided, as appropriate.

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

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.

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 NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

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

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

For this particular announcement, note the following:

Reviewers will be asked to evaluate the following individual sections, and the Scientific Review Officer will record these scores. The overall impact score is not the average of the scores for all these components.

• Research base, including the focus, quality of research, collaborations among members, relevance to the Center's stated research focus, and, for renewal applications, the maintenance, growth, re-focusing, or evolution of the research base.
• Each Biomedical Research Core, as well as the Clinical Component (if requested), including the documented need for the proposed services; number of users; qualifications of personnel; management, including prioritization and responsiveness to the needs of the users; quality control management; and any appropriate developmental work.
• The Administrative Core, including committee structure, Center membership criteria, and lines of communication.
• Pilot and Feasibility Program, including the organization of the overall process of solicitation, review, and monitoring of P and F Projects, and, for renewal applications the quality, appropriateness and outcomes of supported P and F Projects. The Named New Investigator, if requested, will also enter into this evaluation.
• The Enrichment Program, including the quality of proposed activities and likelihood for promoting new scientific collaborations and directions/approaches.
• Center Director (PD/PI), including leadership and commitment to the stated goals of the DDRCC.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the DDRCC 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?

What are the strengths of the Center's research base (its breadth and depth)? Do the focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity of the research base support the stated theme of the Center? Will the research base investigators benefit from the services/programs supported by the DDRCC? What is the likelihood that the DDRDC will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective?

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?

Are the Center investigators responsible for the individual research projects willing to interact with each other and contribute to the overall objectives of the DDRCC? What are the scientific and administrative leadership abilities of the proposed Center Director and Associate Director(s) and their commitment and ability to devote adequate time to the effective management of the DDRCC? Are the Core Directors well-qualified and appropriate? If requested, does the Named New Investigator appear well qualified and appropriate for support?

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?

Are the P and F applicants eligible and does the selection process by which the individual studies were selected appear appropriate? Does the Center appear to encourage high-risk , innovative ideas through their P and F Program? Do the Cores provide new methods, techniques, and/or resources and demonstrate the ability to adapt when needed to support investigators in emerging areas of digestive and/or liver diseases research, as appropriate to the purpose of the Core and the research supported by the Center?

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?

How appropriate and relevant are the proposed Cores and their modes of operation (such as prioritization of requests for services)? Will at least two funded investigators who are Center members use each Core? Will the Cores provide opportunities not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches? Are the criteria for membership in the DDRCC clear and appropriate? Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the DDRCC, including mechanisms for internal monitoring;(b) establishment and maintenance of internal communication and cooperation among the Center investigators;(c) mechanism for selecting and replacing professional or technical personnel within the Cores;(d) mechanism for reviewing the use of, and administering funds for, the P and F Program;(e) management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities? Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to the stated goals of the DDRCC?

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 institutional commitment to the DDRCC, including lines of accountability and the institution's contribution to the management capabilities of the Center? Is there clear potential for interaction with scientists from other departments and institutions?

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

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 Center 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

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.

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

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 Disease Advisory Council. 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.

If requested, the awardee-selected Named New Investigator requires prior approval by the NIDDK program officer.

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 Grey, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-640-0121
Email: GreyMJ@mail.nih.gov

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

Karin Mastrangelo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-443-3603
Email: mastangelokj@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.