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 Nutrition Obesity Research Centers (NORC) program is to bring together basic science, clinical, and translational investigators from relevant disciplines to enhance and extend the effectiveness of research related to nutritional sciences and/or obesity. The NIDDK-supported NORCs are part of an integrated program of nutritional sciences and obesity research.

A NORC must be an identifiable unit within a university or medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence in biomedical basic and clinical research in the areas of nutritional sciences and/or obesity is required. The research must be in the form of research project grants (e.g. R21,R01), program project grants (P01), Resource-Related Research Project Grant (R24), or other peer-reviewed research that is already funded by NIH, other Federal Agencies, or non-federal groups at the time of submission of the NORC grant application. It is required that at least 50% of the nutritional sciences and obesity or other related research comprising the research base be supported by Federal Agencies. Close cooperation, communication, and collaboration among all involved personnel of various professional disciplines are ultimate objectives.

Criteria for becoming a NORC 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 must be Center members. Designation as a Center member without the need for the use of core facilities must be well-justified.

NORC applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The Administrative Core is expected to ensure the coordination and integration of NORC components and activities. The Administrative Core should have a process to a) Assess the productivity, effectiveness, and appropriateness of Center activities; b) Determine criteria and selection process for Center membership; and, c) Foster collaborations and scientific opportunities among its members. All NORCs are required to maintain a website, with the administrative core taking primary responsibility for its creation and oversight, as well as for ensuring proper and seamless integration of the NORC website with the overall NORC program website, www.norccentral.org.

The NORC Director, who is the Program Director/Principal Investigator on the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrated proficiency in managing a large, multi-component project. The Director will be responsible for the organization and operation of the NORC and for communication with the NIDDK on scientific and operational matters. NORC Directors are required, and their administrators are strongly encouraged, to attend Center Director's meetings to be held at a location to be determined by the NIDDK. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the NORC and who will serve as Acting NORC Director in the absence of the Director. A process must be in place that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed.

NORCs are designed around Research Cores that provide shared, specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of research performed by NORC-affiliated investigators. It is appropriate and may be beneficial to have one or more central themes around which core NORC research investigations are focused. The goal of the NORC program is to make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in nutrition, obesity and other related research areas. Moreover, cores are intended to facilitate basic, clinical, and translational research in order to accomplish the stated goals of the individual NORC and of the NIDDK NORC program.

Each Research Core should provide state-of-the art services to multiple, funded research projects. Examples of biomedical research cores that would be considered responsive to this FOA may include, but are not limited to:

• Nutrigenomics
• Metabolomics
• Dietary and/or physical activity assessment
• Basic behavioral science
• Molecular biology
• Nutritional biochemistry
• Adipocyte biology
• Imaging
• Translational research (bench to bedside; bedside to community/practice)
• Clinical research
• Bioinformatics
• Biostatistics

These cores are not listed in any particular order, nor do they represent a comprehensive list of possibilities. In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institution(s). Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in nutrition, obesity and other related topic areas. Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure.

For all proposed cores, the need for core support from the NORC must be well-justified, with clear documentation of a broad user base of NIH-funded investigators pursuing research activities in NORC topic areas as well as nutrition and/or obesity researchers with other sources of peer-reviewed support. Participants in the NORC program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards (CTSAs) supported by the NIH (https://www.ctsacentral.org/), other related NIH Common Fund activities (http://commonfund.nih.gov/), and any related NIDDK-funded Center programs such as the Diabetes Research Centers Program (http://www.diabetescenters.org) and the Digestive Disease Research Centers program: http://www.niddk.nih.gov/research-funding/research-programs/Pages/digestive-disease-centers.aspx.

NORCs are encouraged to support clinical and/or translational research, and these efforts should be described in the 'Clinical Element' within the Administrative Core. A NORC's potential or past efforts to develop clinically-relevant specialized services that are applicable and useful for the NORC research base are an important aspect of the NORC program and will be evaluated. The relationship of the research themes to the clinical research component should be described.

NORCs may support clinical/translational research and services through a variety of approaches, as follows:

• a clinical biomedical research core, i.e., clinical research services are provided for and budgeted through stand-alone research core(s)
• the administrative core
• a combination of the above in a manner that best meets the needs of the NORC.

The clinical research services offered, the qualifications of the relevant personnel supported within overall NORC, as well as the number of physician scientists, and perhaps basic researchers, who will make use of available/relevant clinical research services should be addressed. Any efforts to encourage collaboration between NORC clinical and basic science investigators should be described in the Clinical Element. The pilot and feasibility (P and F) program and the Enrichment Program may also be included if they contribute to efforts to foster clinical research within the NORC.

The Pilot and Feasibility (P and F) program provides modest support for new initiatives or feasibility research studies. It is anticipated that up to $50,000 in direct costs per year for up to two years will be provided for the majority of approved P and F projects. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to obesity or nutritional sciences research, and at established investigators who wish to make a substantial change in the direction of their nutritional sciences or obesity-related research.

It is expected that the majority of P and F project investigators will fall into the new investigator category and only in exceptional circumstances will investigators in the third category be supported. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P and F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the NORC's External Advisory Board and the NIDDK. Efforts to increase the number of P and F awards and availability of funds for the program through the use of program income or alternative funding sources are particularly encouraged.

The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. The NORC enrichment program should be designed to advance translational research in nutrition and obesity and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between nutrition and obesity researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. In all cases, the enrichment program should further the overall aims and objectives of the NORC as well as its cores.

Creative new programs, not precluded by NIH or NIDDK policies, are encouraged. While NORCs may not support stipends for postdoctoral fellows, the environment fostered by the existence of the NORC 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.

Applicants are encouraged to consult with NIDDK staff concerning plans for the development of the NORC and the organization of the application.

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 an ongoing, strong base of nutrition and/or obesity-related research are eligible. At least 50% of the nutritional sciences and obesity or other related research comprising the research base must be supported with funds from Federal Agencies. In renewal applications, the NIH-supported research base may be less than 50% due, typically, to a growing number of investigators entering nutrition and/or obesity research from other fields. Each proposed core must be utilized by a minimum of two federally-funded investigators.

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.

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

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

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

The NORC Director, who is the Program Director/Principal Investigator of the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrated his/her proficiency in managing a large, multi-component program.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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
FAX: (301) 480-3505
Email: [email protected]

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
P and F (use for Pilot and Feasibility Program)	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:

• Center Overview: Required
  • Administrative Core: Required
  • Biomedical Research Cores: At least one required (note: Cores will be listed in the final application in the order in which they were entered in ASSIST)
• Pilot and Feasibility (P and F) 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(s) of the NORC and the need for a NORC to support the investigators in the research base. Include the number of NORC members and the overall direct costs present in the research base. Provide a brief overview of the research base as it relates to the theme(s) of the Center, as well as an overview of the biomedical research cores, and the pilot & feasibility and enrichment programs.

Project Narrative: In 1-3 sentences describe the relevance of the research to be supported and facilitated by NORC activities (core services, Clinical Element, P and F program, and Enrichment program) on public health.

Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the NORC will use or change existing access, space, and usage; include space maps as needed (see "Other Attachments") and letters of institutional commitment (see 'Letters of Support'). Scientific personnel and institutional resources capable of supporting the research base must be available.

Equipment: A general listing of major, shared pieces of equipment to be used by NORC members should be provided. Note: Specific research core facilities, equipment, and special resources should also be listed in each proposed biomedical research core component.

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

• Research Base Investigator Grant Support: List all Federal and non-federal grant support for the NORC research base investigators. Complete and organize alphabetically by the last name of the NORC research base investigator who is listed as the Program Director/Principal Investigator (PD/PI) on the grant. Include Supporting Organization/Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs, and any Other NIDDK Centers utilized (if the grant listed is also included in its research base). Applicants are strongly encouraged to use Table A (see: NORC Application Resources). The attachment should include, in order: Current Grant Support (Table A.1), Other Grant Support (Table A.2) and Pending Grant Support (Table A.3).
• Description of NORC Research Base Investigators: Please title this attachment Description of NORC Research Base Investigators and organize alphabetically by investigator's last name. Provide a narrative description of no more than one page per research base investigator; try to limit each to less than one page. 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 NORC core facilities. In the description of the research base, include ONLY those grants awarded, or subcontracted, to investigators at the applicant institution or consortium, not to investigators at other locations. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to research in nutrition, obesity and/or related conditions when this is not readily apparent from the project title of the grant.
• Biographical Sketches of NORC Research Base Investigators: Please title this attachment "NORC Research Base Biographical Sketches." Provide biographical sketches for all NORC members, as defined by the NORC within the application and organize them alphabetically by the last name of the Research Base Investigator. Provide biosketches for all research base investigators. Do not include duplicate biosketches for Senior/Key personnel.
• Core Use by NORC Research Base: Please title this attachment "NORC Research Base and Core Facility Use" and organize alphabetically by research base investigator (last name). List all NORC investigators including Membership Category (only if more than one category of Membership is designated by the NORC), and for each NORC research base investigator indicate those NORC Core Facilities that will be used. Applicants are strongly encouraged to use Table B, which is provided for applicant assistance (see: NORC Application Resources).
  
• NORC Collaborations: Please title this attachment NORC Collaborations and organize alphabetically by NORC Member (last name, first name). List all NORC Members. Provide primary Department Affiliation, key words for research interests, names of other NORC members who are collaborators (through publications, grants or research projects), and the number of collaborative publications (only those relevant to the NORC). Applicants are strongly encouraged to use Table C, which is provided for applicant assistance (see: NORC Application Resources).
  
• Optional: Please title this attachment "Relation to Overall NORC". Provide Charts and Tables related to the Institutional Commitment at the applicant institution, such as an organizational chart(s) to illustrate the structure, interactions, and leaders of the institution and the NORC.

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 NORC. A theme and set of goals must be developed and described in the application. Provide a written strategy for how the NORC will implement this vision and which future directions will likely be followed during the project period. The plan should outline the existing skills, technologies and scientific research base and other resources at the institution. This plan should delineate how the NORC will enhance ongoing projects, assist in the introduction of outstanding new projects, respond to future challenges and opportunities, and promote collaborations, advances in technology, and progress in nutrition/obesity research. Detail expected scientific outcomes including a description of anticipated impact on human disease(s) and public health.

Research Strategy:

Research Base:

The NORC grant provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting high quality research on nutrition, obesity and/or related conditions. Therefore, existence of a strong, substantial research base in this area is a fundamental requirement for, and the most important aspect of, the establishment of a NORC.

Appropriate presentation of the research base is very important since its assessment is a key emphasis in the evaluation of an application. Therefore, existence of a strong research capability in nutrition/obesity is fundamental to establishment of a new, or continuation of an existing NORC.

Applicants should indicate how the establishment of a NORC will provide added dimensions, such as greater focus and increased cooperation, communication and collaboration that would not likely occur without NORC resources. Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to supporting the center. Such commitment may be provided as dedicated space, staff recruitment, salary-support for investigators, dedicated or shared equipment, or other financial support for the proposed center.

A high level of integration and close collaboration among NORC personnel from diverse scientific disciplines is an important feature of a successful NORC. Accordingly, the applicant should clearly state considerations for NORC membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships.

Criteria for becoming a NORC member should be clearly defined. Each NORC, however, is expected to formulate these definitions based on its own situation. Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined in order to better organize and facilitate the focus of the NORC’s mission. Subsets of members based on their degree of participation or other quantitative measures are acceptable. Although not required, examples could include, but are not limited to, 'full', 'associate', or 'affiliate' members. Applicants should provide clear guidelines for a) how NORC membership is defined; b) the application and selection processes for NORC membership; and c) the obligations of NORC membership. Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in nutrition/obesity-related research, and the need for the use of core facilities. Research base investigators must be affiliated with NORC institution or consortium. Designation as a NORC member without the need for the use of core facilities must be well-justified.

Presentation of the research base in the application should include 'Other Attachments' as described above and a description of the nutrition/obesity and related research activities at the applicant institution and any collaborating institutions. This presentation should be organized into several areas of emphasis that demonstrate the research focus of the NORC. The research of each NORC member should be discussed and interrelationships of research being conducted by NORC 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; (b) uses and benefits of core services; and (c) plans to develop productive collaborations among NORC investigators.

Strategic Vision:

Theme Provide the central theme(s) of the NORC and the likely supported research, resources, and relevance to nutrition/obesity. The theme may be broad or focused, depending upon the goals of the NORC. For clearer presentation, it is recommended that NORC applicants subdivide the research base into areas of research emphasis or central research themes that link NORC members and their research programs.

Goals and Directions Describe the current and future directions for the NORC in the forthcoming project period. Indicate how the research supported by the NORC will impact the understanding of nutrition and/or obesity, its complications and, ultimately, public health. Describe the short, mid- and long-term goals and measures of success. Describe the likely advances expected in the field of nutrition/obesity and how these advances can be applied to human disease and public health. Describe any basic science work that has successfully been translated to the bedside or community or plans to enhance that translation in the next project period. Describe the expected, widely-applicable research tools and scientific advances that will emerge from the NORC’s emphasis. Document how the NORC will organize and lead the team towards these advances. Identify levels of risk for these goals, potential roadblocks to achieving them, and how the NORC might respond to these challenges. Renewal applications must also describe the accomplishments of the NORC in the preceding project period and how it intends to build upon its successes. These accomplishments should be presented, as appropriate in the areas of basic science, clinical research, public health, prevention, and translation.

Applicants should provide information on other programs supporting related resources at their institution, including CTSA(s) and other P30s, and describe the nature of synergy and integration between the NORC and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services, and resources will be avoided. Leveraging of existing resources that provide a range of services or efficiency that would not otherwise be available is also encouraged.

Integration of investigators of multiple skills and talents Outline steps the NORC will take to promote interdisciplinary studies and collaborations, especially among basic scientists and clinical researchers. Describe the types of initiatives that will stimulate the teams and attract high-caliber professionals. Indicate to what degree the high-risk/high-payoff research that may require long-term support will be implemented. Describe academic and research partnerships that will be pursued by the NORC to advance its goals and missions.

Building research capacity Provide details on the special talents and resources that will be drawn to and built upon at the NORC. Indicate how these talents will be harnessed and used to promote new collaborations and produce multidimensional teams to address more complex questions. Include a plan for bringing investigators into the NORC from within and outside the area of nutrition/obesity research at the NORC institution. For renewals, efforts to expand research services to the outside nutrition/obesity community may also be addressed in this context.

Provide a plan for on-going evaluation of the need for services and instrumentation of the NORC. Address the steps that will ensure that the NORC proceeds at the cutting edge of technology and concepts. It is expected that biomedical research cores needs may change. Include information on the process of re-evaluation of needs and implementation of changes.

Within this section, describe the research capacity and clearly identifiable major scientific focus in nutrition/obesity research. The NORC program should foster interdisciplinary cooperation among established investigators conducting high-quality research related to nutrition/obesity. Therefore, existence of a strong research capability in nutrition/obesity is fundamental to establishment of a new, or continuation of an existing NORC.

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

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

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

NORCs must document policies and procedures for ensuring continuing evolution of core services in response to changing needs of the research base. Over time, new technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.

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

For renewal applications: Describe progress and accomplishments in the research base; development of multidisciplinary, collaborative, and cooperative interrelationships; and any alterations in the original NORC design in order to meet the evolving needs of the research base. It is recognized that the research base and the field of obesity research likely evolves over time. Thus, any applicable changes to the biomedical cores and/or demands for new services relevant to the research base should also be described.

Progress Report Publication List (renewal applications only): In this attachment, list the titles and complete references to all appropriate publications and manuscripts accepted for publication, that have resulted from the project since it was last reviewed competitively. Identify the core(s) utilized in association with the publication. Applicants are strongly encouraged to use Table F, which is provided for applicant assistance with documenting the contribution of individual cores to peer-reviewed publications by the research base (see: NORC Application Resources). Only list publications once. Within individual biomedical research core descriptions, refer to publications associated within the core by number as listed in the table of publications. Use an asterisk to indicate any publication that fails to cite NORC grant support.

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

If collaborative linkages are being developed between the NORC and the local CTSA staff and/or research personnel, a letter of agreement from the CTSA PD(s)/PI(s) should be included. For any collaborative linkages between the CTSA and a specific Biomedical Research Core, the letter of support should be included within the specific Biomedical Research Core component of 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 component.

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)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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. The Center Director(s) (PD(s)/PI(s)) are responsible for the scientific and administrative leadership of the NORC. The Director should be an experienced and respected scientist with a proven track record for obtaining NIH funding. She/he must be able to coordinate, integrate, and provide guidance in the establishment of new programs in nutrition/obesity and related research. A process must also be in place that would be used to recommend a successor to the Director, if needed. The application should include a statement of willingness of the PD/PI, Associate NORC Director, or other key personnel to attend an annual meeting of NORC Directors.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the NORC and will serve as Acting Center Director in the absence of the Director. An administrative assistant may also be proposed.

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.

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.'

New applications should not name potential External Advisory committee members.

Budget (Administrative Core)

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

If applicable, this budget category should also include any salary support for key personnel, technicians, and/or supplies necessary for clinical research services, if they are provided through the Admin core, as applicable. Note that the Administrative Core does not have to provide or budget for services for clinical research if those services are provided (and budgeted for) elsewhere in the NORC. Centers may budget for services, including personnel, associated with the Clinical Element in the Administrative Core, if applicable.

Equipment: For renewal applications only, 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 NORC 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.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the NORC. Include travel costs for the Center Director(s), Associate Director, and others as appropriate (i.e. Core Directors) to attend the annual NORC Directors' meeting.

Supplies: Consumable supplies directly related to the operational aspects of the Administrative Core facilities are an allowable expense. Centers may budget for supplies necessary for any Clinical Element services/support within the Administrative Core, if applicable.

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

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 Direct Costs: Funds for supporting the institutional NORC website may be requested. Centers may budget for other costs as necessary to support Clinical Element services within the Administrative Core, if applicable.

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.

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 NORC and outline interactions of the Administrative Core with each of the other Cores and Programs (P and F, Clinical Element, and Enrichment). Provide an overview of how the Administrative Core will set the overall direction of the NORC and ensure optimal utilization of NORC resources.

Research Strategy: A NORC must be an identifiable organizational unit within a university medical center or a consortium of cooperating institutions including the university-affiliated NORC. The Administrative Core plays a key role in the coordination and functioning of the NORC.

Within the Research Strategy, the applicant should describe how the Administrative Core will take a leadership role in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the NORC. In addition, direct lines of communication between the Administrative Core and Biomedical Research Cores (as well as with the Clinical Element, the P and F program, and the Enrichment Program) should be delineated, as all of these cores/programs serve critical roles for NORC integration.

Effective development of the NORC programs requires close interaction between the NORC Director(s), Core/Program Leaders, appropriate institutional administrative personnel, and the members of the community in which the NORC is located. Therefore, each NORC applicant should establish an administrative structure that will permit the development of such interactions. Within this structure, each applicant institution must also establish a mechanism to oversee the use of funds for the proposed pilot and feasibility program. This mechanism must include the use of appropriate consultants for review from the scientific community outside the NORC institution.

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

• Coordination and integration of NORC components and activities.
• Assessment of productivity, effectiveness, and appropriateness of NORC activities/services and determination of NORC membership, assessment of scientific opportunities, and areas for collaboration among NORC members.
• Oversight and coordination of clinical research within the NORC, including provision of services, if applicable. See 'Clinical Element' below.
• Organization of NORC activities, such as retreats, 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 NORC facilities, publications, pilot and feasibility awards, and new grant applications resulting from preliminary data enabled by the NORC.
• Interactions with other NORC, the NIDDK, and other appropriate individuals, groups, or organizations.
• Maintenance of a NORC website, with the administrative core taking primary responsibility for its development and oversight.

The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). Renewal applications must document the functions and effectiveness of the External and Internal Advisory Committees.

For new NORC applications, Consultants who will serve on advisory committees should not be specifically identified in the application but the process by which they will be selected should be described. These same consultants may be utilized, if desired, for review of other activities of the NORC, such as the P and F program.

Clinical Element

NORCs are also expected to support and advance clinical and translational research in nutrition/obesity, to promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between nutrition/obesity researchers and investigators from other fields with relevant clinical research expertise.

Within the Administrative Core research strategy, applicants must describe how the NORC will support and contribute to clinical/translational research in a section entitled 'Clinical Element'. A NORC may propose to support clinical research services through any of the following:

• one or more Biomedical Research Core(s)
• the Administrative Core, or
• a combination of the above

If any clinical research services will be provided through the Administrative Core, the services offered, expertise of applicable personnel, and procedures for managing these services should be described in adequate detail (similar to the description of services within the biomedical research cores) in the 'Clinical Element'. Note that a NORC has the option, but is not required, to provide and support clinical research services through the Administrative Core.

Details about clinical research services provided through other components (biomedical research cores, P and F program, enrichment program, etc.) should not be duplicated. Rather, the 'Clinical Element' section should provide an overview of how, as applicable, the various components of the NORC will support clinical and/or translational research. Efforts to encourage collaboration and cross-talk between the NORC clinical and basic science investigators may be detailed in the 'Clinical Element' as well.

Examples of services that would fall within the 'Clinical Element' could be, but are not limited to, support for specific services relevant to clinical (human subjects) research in one or more biomedical research cores (such as human biospecimen analyses, dietary/physical assessment, behavioral sciences, bioinformatics, etc.); biostatistical consultation; assistance with clinical study design; fostering collaboration among researchers; aiding in recruitment of participants for clinical studies; providing data entry support for epidemiological studies; providing modest funding for tissue, DNA, or serum storage; or offering other human nutrition/obesity-related assessment methods. In addition, staff relevant to the services falling und the 'Clinical Element' category may aid investigators to effectively addressing NIH policies and reporting requirements concerning inclusion of women, children, and ethnic/minority participation in clinical studies; data and safety monitoring requirements; and educational requirements for the protection of human research participants. Services may also include training in clinical/translational research, if such programs exist within the NORC.

The types and quality of clinical research services offered; the qualifications of the clinical research support/key personnel across the entire NORC; and the number and quality of clinical investigators, and perhaps basic researchers, who will make use of available/relevant clinical research services are an important part of the Clinical Element and should be addressed.

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 component.

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. Separate core components should be created for each individual Biomedical Research Core proposed.

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)

Follow standard instructions.

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. 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.

NORCs are strongly encouraged to enter into cooperative arrangements with cores already established within their institution, or with other NORCs in close proximity, when the existing cores offer the services needed. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. However, it should be clear that the NORC cores can function independently. It may be advantageous for a NORC to provide support for appropriate personnel to work specifically for NORC members in an existing facility/core (e.g., transgenic animal core) at the institution. In this case, the designated NORC 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 in order 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: Please title this attachment "Core Facility Use" and for each Biomedical Research Core indicate the Core User, Funded Project that supports the Core use, Period of Core Use, services used, and estimated use and comments. Applicants are strongly encouraged to use Table D, which is provided for applicant assistance (see NORC Application Resources).

NORCs are encouraged, but not required, to offer services to the wider nutrition/obesity research community, as appropriate; however, outside users may not be NORC members, nor can they be counted as part of the research base (such as in Table A; NORC Application Resources and research base narratives.)

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, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field. A Director must be named for each core. Core Directors may be acknowledged experts with independently-funded research programs that will use the core services.

• In the additional Senior/Key Profiles section, list Senior/Key persons who are working in the component. Where appropriate, an established expert in the core activities could also be included as a consultant to the core.

Include only one 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 should only be provided once. Do not attach duplicate biosketches.

• 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 NORC 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. Salary support for technicians and other core personnel is allowable in accordance with the volume and type of work in the core. Stipends for research trainees are not available through the NORC. 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 service provided to NORC 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.

Supplies: Consumable supplies directly related to the operational aspects of the NORC 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.

Other Direct 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' on the PHS 398 Research Plan form.. Request costs relating to the clinical research efforts of NORC 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 NORC. The NORC 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 NORC.

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 NORC investigators versus other users. The budget justification for any maintenance/service contracts should document usage of the equipment by NORC 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.

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

Definition: A biomedical research core is a shared facility that provides a needed service to NORC investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores should be designed to furnish a group of investigators with materials, techniques, determinations, instrumentations, and/or quality control to enhance research and contribute to cost effectiveness. A recharge mechanism is acceptable to help defray costs to the NORC. If such a cost recovery system is developed, a detailed charge justification must be presented.

Participating NORC members must also be informed to include such costs with their full budget justifications in their applications for individual grant support. Cores may be proposed to support any research activity of the NORC, but usually fall into one of five categories: (1) provision of a technology that lends itself to automation or preparation in large batches; (2) complex instrumentation; (3) animal preparation, care and characterization; (4) clinical resources; and (5) service and training. Limited developmental research is also an appropriate function of a core facility. Such activities, however, must be directly related to enhancing the function or utility of the Core.

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

Proposed NORC cores may be an institutional shared research core. In such cases applicants must provide a rationale for using such institutional cores, such as:

• Support for the existing resource through the NORC will provide added value and access to the resource beyond that which would be provided by paying for the use of the resource through a fee-for-service process;
• The institutional/departmental core represents a unique resource which would not otherwise be available (e.g. is too costly, too labor-intensive, or too specialized to be available to individuals)
• The institutional/departmental core provides a service done more effectively (i.e. more inexpensively or by specially trained personnel or requiring specialized facilities) than would be feasible in individual cores, e.g. histology, animal facilities, and thus using the institutional/shared core avoids duplication and lowers cost for NORC-center members;
• The service/instrumentation/expertise in the centralized core can only exist with the participation of multiple centers and their user fees and NORC-center members need the service; instrumentation, and/or expertise in proportion to the buy-in from the center to which they belong.

As with other research cores, details about access and prioritization of NORC members to the shared research core(s) should be provided. Moreover, the applicant should document that the NORC will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.

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

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

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

Progress Report Publication List, for renewal applications only. Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented; refer to the numbers of publications supported by the core within the "Consolidated Publication List". Applicants are strongly encouraged to use the provided table: Table F, see NORC Application Resources. Do not duplicate publication lists in individual biomedical research cores.

Letters of Support: For Shared/National Research Cores/Resources, include any letters of support from partnering institutions. For any collaborative linkages between the CTSA and a specific Biomedical Research Core, a letter of support should be included within the specific Biomedical Research Core component of 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 component.

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 P and F . Applicants who also propose an optional, expanded NORC P and F program to a different institution(s) should create a second, separate 'Pilot & Feasibility Program' component.

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)

Follow standard instructions.

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. 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 Program component in order 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.

Pilot Project Outcomes (renewal applications only): Please title this attachment "Pilot Project Outcomes" and list all Pilot Projects supported in full, or in part, by the NORC. Provide information on the most recent 5 or, if applicable, 10-year period. Include the years funded, awardee, dates and amount of P and F funding, pilot project title, P and F award type (i.e. new investigator; established investigator), abstract and publications derived from pilot support, resulting grants funded or pending applications (including grant number/funding agency and project period), and whether the P and F awardee is still involved in nutrition/obesity research. Applicants are strongly encouraged to complete Table E, which is provided for applicant assistance (see: NORC Application Resources).

Pilot Project Descriptions (renewal applications only). Please title this pdf attachment "Pilot Project Descriptions". Provide narrative reports for each pilot and feasibility study conducted during the last 5 year project period, or, if applicable 10-year period. These narrative reports should be brief and contain (1) the name of the investigator, degree(s), professional career status at the time awarded, and current professional career status (if known); (2) an overview of the project including its significance and salient results; (3) a list of resulting publications; and (4) any peer-reviewed subsequent funding in the same or related area.

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

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, use Project Role of Other with Category of Pilot and Feasibility Program Director and provide a valid eRA Commons ID in the Credential field. The P and F program must have a Director who is an established investigator in nutrition/obesity research.
• In the additional Senior/Key Profiles section, list Senior/Key persons who are working in the component. There must also be a committee representing all the aspects of the NORC to assist the P and F Director in the management of the program.
• 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: This category should include salary support for key personnel, including the P and F Program Director, and other professional and administrative personnel. The P and F Program Director must devote a minimum of 0.6 person months to the Program to ensure adequate oversight. The salary amount charged to the NORC grant must be commensurate with the time spent on P and F Program activities and is subject to institutional and NIH salary policies. If requested, include the salary for the Named New Investigator. Support for this individual is limited to 2 years and cannot exceed $90,000 per year, additional appropriate fringe benefits, and 9.0 calendar 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 individual Pilot & Feasibility projects. Typically at least 20-25% of the overall NORC direct costs, exclusive of equipment, should be for support of P AND F projects.

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 aims of the Pilot and Feasibility Program.

Research Strategy: The Pilot and Feasibility Program provides modest research support for a limited time (usually one to two years) to enable eligible investigators to explore the feasibility of a concept related to the mission of the NORC and generate sufficient data to pursue it through other funding mechanisms. The pilot and feasibility studies are intended to: (1) provide initial support for new investigators; (2) allow exploration of possible innovative new leads or new directions for established investigators in nutrition/obesity and (3) stimulate investigators from other areas to lend their expertise to research in nutrition/obesity. Pilot and feasibility study support is not intended for large projects by established investigators that would otherwise 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.

Requirements: Each NORC must propose a minimum of 2 pilot and feasibility studies to be supported from NIDDK funds each year.

Pilot and Feasibility award eligibility and related guidelines: Investigators eligible for pilot and feasibility funding generally fall into three categories: (1) new investigators without current or past NIH research support as a program director/principal investigator (current or past support from other sources should have been modest); (2) established investigators who are new to the nutrition/obesity field and wish to apply their expertise to a problem in this area; and (3) established investigators in nutrition/obesity who propose testing innovative ideas that represent clear departure from ongoing research interests. It is expected that the majority of the investigators will fall into the first category. All eligible investigators, however, must have faculty appointments and be independent investigators. Postdoctoral fellows or their equivalent are not eligible. Each pilot and feasibility study proposal should state clearly the justification for eligibility of the investigator under one of the above three criteria.

A proposed pilot and feasibility study should present a testable hypothesis and clearly delineate the question being asked, detail the procedures and approaches to be followed, and discuss how the data will be analyzed. It must be on a topic related to the objectives of the NORC. Projects should be focused, since funding for these studies is modest (typically $50,000 or less in direct costs per year per project) and is usually limited to two years or less. Any one investigator is eligible only once for this P and F support, unless the additional proposed pilot and feasibility study constitutes a real departure from his/her ongoing research.

The application should clearly describe and justify the pool from which potential pilot and feasibility applications will be selected. This can be limited to investigators at the parent institution(s) or expanded to include investigators at other institutions with a well-defined affiliation with the NORC. Such an affiliation can occur either through a sub-contractual relationship for support of core resources, or through inclusion of funded projects at a collaborating institution in the research base utilizing the shared resources of the NORC. The mechanisms by which information on the availability of pilot and feasibility awards will be disseminated and by which applicants will apply and be selected for these awards must be described and will be an important element in the review of the pilot and feasibility component of the NORC.

Initial review and management of the pilot and feasibility program: By the very nature of this program, a significant responsibility for its management will be left to the NORC administration during the project periods.

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

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

(1) Maintain oversight and review of progress for ongoing pilot and feasibility studies;

(2) Make recommendations regarding termination or other actions to the NORC Executive Committee (or equivalent);

(3) Prepare and ensure appropriate distribution of announcements of the availability of pilot and feasibility funding;

(4) Arrange and preside over the scientific merit review of proposals. At least one reviewer from outside the parent institution must be used for each proposal. All reviewers should assign impact scores in accordance with the NIH system. Copies of all of the proposals with written documentation of their reviews, impact scores, and final action must be retained by the NORC. These records must be made available to reviewers if requested at the time of a renewal application;

(5) Maintain, insofar as is possible, a record of subsequent career events of each pilot and feasibility study recipient. This record must also be made available to reviewers at the time of the renewal application;

(6) Make recommendations to the NORC Executive Committee (or equivalent) for final decisions. A record of actions by this committee must be documented.

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

Pilot and feasibility program in new applications: Initial pilot and feasibility studies (as presented in 'Other Attachments' for new applications; see above) must have been reviewed by the NORC in the manner proposed for review of future studies so that only those considered to be the highest quality are included in the grant application. The amount of pilot and feasibility funds provided for the first year will be based on the review of the proposed studies. The budget for future years is recommended by the initial review group based on the quality of the proposed pilot and feasibility studies and the proposed method for management and review (as evidenced by this set of projects). Also considered will be the review group's evaluation of the future justification for continued pilot and feasibility support.

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

In general, a renewal application will include: (1) An historical overview; (2) A description of NORC management of the program; (3) A description of the method for solicitation for pilot and feasibility projects and the number of respondents received for each solicitation; (4) Information as described in 'Other Attachments' (see above); and (5) A statement of the benefits of the program to the NORC, as well as the contribution of the uniqueness of the NORC environment to the program. Some of these points are detailed in the following paragraphs.

The historical overview will cover the pilot and feasibility program since the inception of the NORC. The pilot and feasibility program director may wish to highlight certain studies or particular aspects of the past studies such as research advances, collaborations which resulted in lasting relationships, acquisition of new skills by the study recipient, or other significant outcomes. The relationship of the scope of the various studies to that of the NORC should be emphasized.

The description of NORC P and F program should present in detail the current system used to manage the pilot and feasibility program, including its integration with and relationship to the rest of the administrative structure. The use of outside consultants for review should be included in the discussion. Important features of the solicitation process should be provided including the distribution and the number of respondents.

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, 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 component.

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

Planned Enrollment Report (Pilot and Feasibility Program)

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

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

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

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)

Follow standard instructions:

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. 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 NORC-supported Enrichment Program activities, such as NORC retreats, symposia, workshops, meetings, specialized courses, seminar series, etc., illustrating the interactions among NORC members and other investigators. This should be loaded as a file in .pdf format titled "Enrichment Program" in Other Attachments.

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, 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 who 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 salary amount charged to the NORC 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, NORC 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. Limited travel support may also be requested to allow NORC investigators to learn new laboratory techniques, to develop new collaborations, or to engage in scientific information exchange.

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.

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: The NORC enrichment program should be designed to advance translational research in nutrition/obesity and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between nutrition/obesity researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops..

Training post-doctoral fellows to conduct research in nutrition/obesity is an associated activity of a NORC. While stipends for fellows cannot be funded from the NORC, the establishment of a NORC should provide an enhanced environment for research training.

Letters of Support: A letter(s) from the PD/PI of any related NIDDK-funded T32 and/or T35 institutional training grant(s) at the NORC institution may be included that describes interactions between the two programs.

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

Planned Enrollment Report (Pilot and Feasibility Program)

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

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at [email protected] 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 these P30 Center applications, reviewers will be asked to evaluate the following individual sections. The overall impact score is not the average of the scores for all these components.

• Overall research base, including the focus, quality of research, collaborations among members, relevance to the NORC's stated research focus, and, for renewal applications, the growth, re-focusing, or evolution of the research base.
• Each Biomedical Research Core, 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.
• Administrative Core, including committee structure, NORC membership criteria, and lines of communication. Evaluation of the enrichment component will include the quality of proposed activities and likelihood for promoting new scientific collaborations and directions/approaches.
• Clinical Element, including the quality of clinical research services, relevance to the research base, and likelihood of enhancing clinical research at the applicant institution(s).
• 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.
• Enrichment Program, including the quality of proposed activities and likelihood for promoting new scientific collaborations and directions/approaches.
• NORC Director (PD/PI), including leadership and commitment to the stated goals of the NORC.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What are the strengths of the Center's research base (its breadth and depth) and the relevance and interrelation of the separately funded research projects to the focus/theme(s) of the Center? Is there an existing strong, scientifically excellent research base in nutrition, obesity, and related conditions at the Center that would benefit by the services/programs supported through the Center? What is the likelihood that the Center will increase efficiency; promote new research directions and meaningful collaborations among Center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective? How will the Center enhance clinical/translational research at the Center?

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 Center? 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 Center program? 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 Pilot & Feasibility (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 nutrition/obesity, 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 for the research base? How well will the modes of operation, such as potential utilization, prioritization of requests for services, cost-recovery, and quality control monitoring serve the research base? Will the cores provide opportunities not otherwise available to the investigators through other available federally-funded and/or institutional resources; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches? Will the Center appropriately support and stimulate clinical/translational research? Are criteria for membership in the Center clear and appropriate? Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the Center, 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 Center?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of institutional commitment to the Center program, including lines of accountability, regarding management of the Center grant 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 Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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:

Overall:

• Does the Center show evidence of a stable (or growing) research base with strong and consistent record of scientific excellence and achievement reflected in an outstanding level of productivity and continuing success in securing peer-reviewed research funding?
• Does the Center show evidence of fostering multi-disciplinary collaborations among its Center investigators? Have such collaborations resulted in new research directions?

Administrative Core:

• Has the administrative structure proven effective?
• Has oversight of Center activities, including the P and F and Enrichment programs, been effective?
• Is/are the Center Director(s) appropriately qualified to lead the Center?

Clinical Element:

• Does the Center provide meaningful support for patient-oriented/human subjects research in a manner that fosters clinical/translational research?
• Are the services appropriate for the Center members/research base?

Biomedical Research Cores:

• Are the number and listing of Center investigators who have used the core and resultant key advances consistent with the level of core investment?
• Do the number and listing of investigators who have used the core multiple times indicate satisfaction and continuing need for core services?
• Are there sufficient numbers of users who are not core personnel or their collaborators?
• Are the number and listing of users who are not Center personnel or members consistent with the best utilization of the core by the community?
• Are the numbers of services/tests completed by each core indicative of a growing need and sufficient to justify continued support?
• Are the number and impact of research publications that acknowledge the Center sufficient to justify each core?
• Is there a significant fraction of papers that a) acknowledge the Center and b) do not have core personnel as co-authors?
• Are shared or institutional cores well-justified with clear added value beyond what a fee-for-service model would provide?
• Is the capacity of each core with current resources sufficient to serve the needs of the Center base?
• Does the Center provide evidence of ability to evolve cores to meet changing needs of the research base?
• Has the Center made efforts to expand access to outside users, as appropriate for the Center's cores and services?

Pilot and Feasibility Program:

• Are the numbers and types of P and F awards well-justified?
• Was the P and F program fully utilized during the previous project period?
• Were awards made to investigators who fully met the eligibility criteria for pilot and feasibility support?
• Has the P and F program led to publications of significant impact, subsequent independent R01 or other peer-reviewed support, and/or attracted new investigators into nutrition/obesity-related research?
• Are papers generated under these awards, projects successfully funded with independent grants, and key advances, as applicable, linked to these awards well-documented and consistent with the level of support provided?
• Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Enrichment Program:

• Has the Enrichment program fostered multidisciplinary approaches to nutrition/obesity research and to attract new investigators or investigators with relevant expertise to nutrition/obesity research?

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 Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:

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

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

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

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

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

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

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

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: [email protected]

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: [email protected]

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

Mary E. Evans, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4578
Email: [email protected]

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

Elizabeth Gutierrez

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8844
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.