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.

To accomplish this mission, the Nutrition Obesity Research Centers:

• Create an environment that supports important and innovative research;
• Attract and retain early stage investigators and investigators new to nutrition and obesity research;
• Provide core services that leverage funding and unique expertise;
• Foster interdisciplinary collaborations, especially in emerging areas of research, to catalyze new ideas and scientific approaches;
• Raise awareness and interest in fundamental and clinical nutrition and obesity research at their institutions, as well as locally, regionally, and nationally;
• Promote the translation of scientific discoveries from bench to bedside to community in order to improve public health;
• Enhance nutrition and obesity research education and training opportunities for patients, students, scientists, and clinicians.

One of the primary objectives of the Centers is to bring together investigators from a variety of scientific disciplines in a manner that will enhance and extend the effectiveness of their research. In addition to collaborations between scientists within an institution, Centers may also foster interactions and collaborations between investigators at multiple institutions to promote a multifaceted approach to a common goal. 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. Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in nutrition, obesity and related research areas. The biomedical research base will be given emphasis in the peer review process.

The research must be in the form of research project grants (e.g. R21, R01), program project grants (P01), RC2 interdisciplinary science, 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 NORC-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.

The organization and structure of the Nutrition Obesity Research Center should reflect the goals of the Center, encourage collaboration, develop and implement Nutrition Obesity Research Center-wide initiatives, and promote the use of shared resources and Pilot and Feasibility Program funds. The structure can change as needed based on new scientific opportunities and partnerships. This major underpinning of the Nutrition Obesity Research Center allows for modifications of programmatic and scientific activities and areas of support to fully capitalize on the most exciting research opportunities in nutrition, obesity and related research areas.

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.

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 overall 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.

Justification for proposing a core: The establishment and continued support of biomedical research cores within a Center are justified on the basis of use by independently-funded Center investigators. The minimum requirement for establishing a core is significant usage by two or more investigators with independently-funded, peer-reviewed projects. While investigators holding awards from the Center pilot and feasibility program are appropriate users of the core facilities, their use does not contribute to justification for establishment or continued support of a core. Additionally, the minimum of two independently-funded users does not in itself provide sufficient justification.

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.

For all proposed cores, the need for core support from the NORC must be well-justified with 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. The relevance and utilization of the core services by the research base will be emphasized during the review process. The NORC program and cores are encouraged to become synergistic with but not duplicative of other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes 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. When proposed core services are already available through the research institution (e.g. via an institutional core), there must be compelling justification for their support through the Nutrition Obesity Research Center. 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.

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.

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, or
• 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 the 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 Center may request 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.

Cooperation, Coordination and Integration: Applicants from institutions with an NIH Clinical and Translational Science Award (CTSA) program (https://www.ctsacentral.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs with the Nutrition Obesity Research Center. Nutrition Obesity Research Center directors should also be willing to collaborate with other NIDDK-funded Nutrition Obesity Research Centers.

Center Evolution: It is anticipated that advances in research, development of new research technologies/methods, and growth of the Center's research base will require existing Centers to evolve over time. Centers are encouraged to develop a plan to continuously evaluate and respond to the changing needs of their research base members by adding, eliminating, or expanding cores/core services during the life course of the Center.

Applicants are encouraged to consult with NIDDK staff concerning plans for the development of the Nutrition Obesity Research Center and the organization of the application.

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

See Section VIII. Other Information for award authorities and regulations.

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

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

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

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

Because a Nutrition Obesity Research Center has a large and complex administrative structure, the PD/PI must have strong leadership abilities and demonstrated proficiency in managing large, multi-component programs. The Nutrition Obesity Research Center PD(s)/PI(s) must also be willing to participate in annual meetings of the Center Directors.

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.

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

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

Successful Nutrition Obesity Research Center applications require an existing program of excellence in biomedical research in the area of nutrition and/or obesity, its complications, and related research. To justify Center support, the Nutrition Obesity Research Center must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as nutrition/obesity investigators with other sources of peer-reviewed support.

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, including Supplemental Grant Application Instructions 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, plan the review, and assess conflicts of interest of potential reviewers.

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:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 7005
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-7797
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall (use for Center Overview)	12
Admin Core (use for Administrative Core)	12
Core (use for each Biomedical Research Core)	12
P and F Program (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
• 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

Center Overview 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.

Complete entire form.

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

Follow standard instructions.

Project Summary/Abstract: Describe the scientific theme(s) of the Nutrition Obesity Research Center and the need for a Center to support the investigators in the research base. Include the number of Center 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 Center activities (Core services; Pilot and Feasibility, and Enrichment programs) on public health.

Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the Center will use or change existing access, space, and usage; include space maps as needed. Scientific personnel and institutional resources capable of supporting the research base must be available. Applicants should address how the institution and pertinent departments will commit to supporting the center, such as through dedicated space, staff recruitment, salary-support for investigators, pilot and feasibility program funding, dedicated or shared equipment, or other financial support for the proposed center

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

Other Attachments: The following attachments should be included with the Center Overview 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 need to be in .pdf format.

Grant Support: Please title this attachment "Grant Support" and 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 identify any Other NIDDK Centers utilized (if the grant listed is also included in the other Center(s) 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) for nutrition and obesity-related research project grants, Other Grant Support (Table A.2) and Pending Grant Support (Table A.3). The 'Current Grant Support' table should include research project grants relevant to nutrition and obesity research which are considered to be potential or likely users of the core services. 'Other Grant Support' should include infrastructure/services grants (other Centers or CTSA awards), training (such as T- or F-awards) grants, and other such grants that support nutrition/obesity research but would not be direct users of the core services.

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 which have already been provided under the Senior/Key Personnel profile for the Center Overview. -

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.

Core Use by Center Members: Please title this attachment "Core Use by NORC Center Members" 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 such as an organizational chart(s) to illustrate the structure, interactions, and leaders of the institution and the NORC.

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.

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.

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.

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. Provide the central theme(s) of the NORC. The theme may be broad or focused, depending upon the goals of the Center. However, it should also be cohesive and well-articulated in order to ensure a NORC with components that will substantially advance a defined area of nutrition/obesity-related science. Outline the existing skills and technologies available in the research base as well as other resources at the institution(s) and summarize how the Center will enhance ongoing projects, assist in the development of new projects, respond to future opportunities, and promote collaborations leading to advances in nutrition and obesity research.

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, applicants should demonstrate the existence of a strong, substantial research base in nutrition and obesity and how that research base will benefit from the establishment of a new or continuation of an existing NORC. The scientific personnel capable of supporting the research base should be described.

Provide a full narrative description of the nutrition/obesity and related research activities at the applicant institution and any collaborating institutions. 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.

Membership: A high level of integration and close collaboration among NORC members from diverse scientific disciplines is an important feature of a successful Center.

Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined by the Center Director in order to better organize and facilitate the focus of the Center’s mission. Subsets of members based on their degree of participation or other quantitative measures are acceptable. Applicants should provide clear guidelines for a) how Center membership(s) is (are) defined; b) the application and selection processes for Center membership; and c) the obligations of Center membership. Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in nutrition/obesity-related research, and the need for the use of core facilities.

Strategic Vision:

Theme The focus of the NORC may be broad or focused, depending upon the goals of the Center. It is recommended that Center applicants divide the research base into areas of research emphasis or central research themes that link Center members and their research programs.

Goals and Directions Describe the current and future directions for the Nutrition Obesity Research Center 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.

Biomedical Research Cores are to be discussed within the Strategic Vision. Summarize the services and resources provided by the NORC. Describe how the research cores will address the scientific needs of the research base. .

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. Applicants are encouraged to leverage existing resources to enhance efficiency, broaden access or broaden the range of services. However, it is important to clearly describe how redundancies of effort, services, and resources will be avoided.

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. Applicants should describe any academic and research partnerships that have been or will be pursued in order to advance the NORC's 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.

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. 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. Provide a plan for on-going evaluation of the need for services and instrumentation of the NORC and implementation of changes. Centers should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies.

Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available. For NORCs supporting or joining institutional/shared cores or core services, applicants should clearly describe how the support provided by the NORC adds value to the resource beyond that which would be provided through a fee for service structure.

For renewal applications: Briefly describe progress in the research base during the previous project period, including 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. These accomplishments should be presented, as appropriate in the areas of basic science, clinical research, public health, prevention, and translation. 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 able 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 Center by appropriate institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the Nutrition Obesity Research Center and its goals. The parent institution is expected to recognize the Nutrition Obesity Research Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the Nutrition Obesity Research Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing to Center members priority access to Institution’s and Center’s facilities and services at minimal or reduced cost. Both the institution and pertinent departments must show a strong commitment to supporting the Center.

If collaborative linkages are being developed between the Nutrition Obesity Research Center 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 as provided in the SF424 (R&R) Application Guide.

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

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

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.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Center Director(s) and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Center 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 and obesity-related research.
• 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 provide names or biosketches for External Advisory Committee members.

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

Personnel: The Center Director must devote a minimum of 2.4 person months to the Center, and at least 1.2 of those months must be within the Administrative Core to ensure adequate oversight of the Center. If a multiple-PD/PI application, the combined effort of the PD(s)/PI(s) must be 2.4 person months. Most Centers find that the size and complexity of a Nutrition Obesity Research Center warrant inclusion of a program administrator, so salary support for this individual should be included in the Administrative Core. Again, where possible and applicable, Nutrition Obesity Research Centers are encouraged to leverage administrative resources in other NIH funded centers (e.g. Centers for Diabetes Translation Research, Diabetes Research Centers, and Clinical and Translational Science Awards) to maximize efficiency of resources.

Equipment: If pieces of specialized equipment, or computers, costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on core service provided to Nutrition Obesity Research Center 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. Equipment may only be requested in the initial budget period.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the Nutrition Obesity Research Center. Include travel costs for the Center Director, Associate Director, and others as appropriate (i.e. Core Directors) to attend Nutrition Obesity Research Center Directors' meetings held every 12-18 months.

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

Consultants: Include costs associated with consultants (consultant fees, per diem, teleconferences and travel) when their services are required by the Nutrition Obesity Research Center, 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 Expenses: Funds for supporting the institutional Nutrition Obesity Research Center website may be requested.

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

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

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

Within the Research Strategy, the applicant should describe how the Administrative Core will take a leadership role in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the Center. In addition, direct lines of communication between the Administrative Core, Biomedical Research Cores, the P and F Program and the Enrichment Programs should be delineated, as all of these cores/programs serve critical roles for Center integration. A process must be in place, and should be described in the application, that would be used to recommend a successor to the Director, if needed.

It is expected that the organization of the Administrative Core should encompass a supportive structure sufficient to accomplish the following: coordinating and integrating the Center components and activities; reviewing the utilization and quality of core resources; interacting with the scientific and lay communities and the NIDDK in order to develop relevant goals for the Center; and interacting with the administrative and scientific leadership at the applicant institution(s) to enhance the visibility and effectiveness of the Center as a focus for nutrition and obesity research. The application should include a statement of willingness of the PD/PI, Associate Center Director, or other key personnel to attend this annual meeting of Nutrition Obesity Research Center Directors.

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

• Coordination and integration of Nutrition Obesity Research Center components and activities.
• Assessment of productivity, effectiveness, and appropriateness of Nutrition Obesity Research Center activities and determination of Nutrition Obesity Research Center membership, assessment of scientific opportunities, and areas for collaboration among Nutrition Obesity Research Center members.
• Organization of Nutrition Obesity Research Center 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 Nutrition Obesity Research Center facilities, publications, pilot and feasibility awards, and new grant applications resulting from preliminary data enabled by the Nutrition Obesity Research Center.
• Interactions with other Nutrition Obesity Research Centers, the NIDDK, and other appropriate individuals, groups, or organizations.
• Maintenance of a Center website, with the administrative core taking primary responsibility for its curation and oversight.

Clinical Element (required)- Provide an overview of how the NORC will support and encourage clinical/translational research. Clinical/translational services may be provided within the Administrative Core, a Biomedical Research Core(s), or a combination thereof. A summary of the services, relevant personnel, 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. Refer to, but do not duplicate, information provided within biomedical research cores that have a clinical/translational research focus.

Center Evolution - Applicants must document policies and procedures for ensuring continuing evolution of Center activities, such as core services, in response to changing needs Centers should address how the administrative core manages the allocation of resources to development of new technologies versus provision of services with existing technologies.

The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). New applications should NOT list members of the EAC but should describe what expertise is needed and the process by which they will be selected should be described. Renewal applications should provide information on membership of the IAC/EAC and must document the functions and effectiveness of the External and Internal Advisory Committees.

The final administrative structure of the Center will be left largely to the discretion of the applicant institution. However, past experience has demonstrated that the effective development of the Center programs requires close interaction between the Center director, Core/Program Leaders, appropriate institutional administrative personnel, and the members of the community in which the Center is located. Therefore, each Center applicant should establish an administrative structure that will permit the development of such interactions. 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 Center institution. These same consultants may be utilized, if desired, for review of other activities of the Center.

Letters of Support: Include any letters of support for the proposed Core, as appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Generally, Resource Sharing Plans 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.

PHS Inclusion Enrollment Report (Administrative Core)

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

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

A biomedical research core is a shared facility that provides a needed service to Center investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively. A Core 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 Core may be proposed to support any research activity of the Center, but usually fall into one of five categories: (1) provision of a technology that lends itself to automation or preparation in large batches; (2) complex instrumentation; (3) animal preparation, care and characterization; (4) clinical resources; and (5) service and training. Limited developmental research is also an appropriate function of a core facility. Such activities, however, must be directly related to enhancing the function or utility of the Core.

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

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Biomedical Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Research Core)

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

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

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

Facilities and Other Resources: 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.

Other Attachments: The following attachment should be included in order to aid in the review of applications. The filename provided for the attachment will be the name used for the bookmark in the application image. The attachment should be in .pdf format.

Core Facility Use: Please title this attachment "Core Facility Use" and, indicate the Core User, Funded Project that supports the Core use, Period of Core Use, services used, and estimated use and comments. An example of Table D is provided at this link NORC Application Resources for applicant assistance with this requirement.

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

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Where appropriate, an established expert in the core activities may also be included as a consultant to the core.

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 1 person month to the Core to ensure adequate oversight. The salary amount charged to the Nutrition Obesity Research Center 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 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 are allowable in accordance with the volume and type of work in the core. Stipends (and tuition) for research trainees (e.g. graduate students, postdoctoral fellows) are not available through the Center. Such funding must be sought through other grant mechanisms.

Equipment: If specialized equipment costing more than $5,000 per piece is 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 Nutrition Obesity Research Center 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. Equipment may only be requested in the initial year of the proposed project period.

Travel: Funds for Center investigators/faculty to attend national or international scientific meetings or workshops may not be requested. If well-justified and related directly to Core activities/functions, limited travel funds for Core professional staff may be requested to support travel to national scientific meetings/workshops.

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

Research Patient Care Costs: Research patient care costs (both in-patient and out-patient) are an allowable expense. Attempts should be made to utilize existing clinical facilities, such as those supported by Clinical and Translational Science Awards (CTSAs) and individually supported beds. Request costs relating to the clinical research efforts of Nutrition Obesity Research Center investigators ONLY if there is no overlap with other funding. Costs already budgeted in individual projects should be appropriately reduced if such costs are to be transferred to the Center. The Nutrition Obesity Research Center is not intended to be a facility for health care delivery. Thus, only those patient costs directly related to research activities may be charged to the Center.

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

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

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

PHS 398 Research Plan (Biomedical Research Core)

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

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

Research Strategy:

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

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

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

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

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

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

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

Any Core with only a minimum number of users must develop plans to broaden the number of Core users. Such plans are particularly important for any Core that, while not extensively used, is considered essential by the NORC administration. Describe any plans to use the Core for limited developmental research, including the relevance of this research to Core services, effectiveness, and adaptability.

Since NORCs are strongly encouraged to enter into cooperative arrangements with established cores at the applicant institution or at other NORCs offering a similar type of service, describe the nature of any cooperative arrangements, access, fee-schedules, the prioritization plan, and the methods to monitor use under these circumstances. It may be advantageous for a 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. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. Therefore, financial justification such as comparative costs of other sources of proposed core services as well as plans for cost recovery from users should be detailed.

Because cooperation between NORCs is also encouraged, but not required, any plans to work with one or more other established NORCs may be provided. Benefits might include, but are not limited to, cost savings, ability to provide additional or improved services, or enhanced productivity by Center members.

Program Income: Centers are also encouraged, where appropriate, to develop a program income (via re-charge/fee-for-service) process associated with the use of core services. Program income must be re-invested into direct support of Center-related activities and/or expenses and may not generate a profit for the Center.

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

Progress Report Publications List: Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented by listing the number(s) of the relevant publication(s) from Table F, which was attached in the Center Overview component. Do not duplicate publication lists for each Biomedical Research Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

PHS Inclusion Enrollment Report (Biomedical Research Core)

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

When preparing your application in ASSIST, use Component Type P and F Program

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

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

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

Other Attachments: The following attachments should be included 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 Nutrition Obesity Research Center. 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 and brief description, P and F award type (i.e. new investigator; established investigator), numbers of abstracts 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 and/or obesity research. Applicants may choose to use Table E which is provided at this link NORC Application Resources for applicant assistance with this requirement.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of P and F Program Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot & 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 month to the Program to ensure adequate oversight. The salary amount charged to the Nutrition Obesity Research Center grant must be commensurate with the time spent on P and F Program activities and is subject to institutional and NIH salary policies.

Other Expenses: Include funds to support individual Pilot and Feasibility projects. Typically at least 20-25% of the overall Center direct costs, exclusive of equipment, should be for support of P and F projects. 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. However, a limited number of P and F applications may be selected for support as enhanced P and F awards with prior NIDDK approval. Enhanced P and F awards require prior approval from NIDDK and will be selected from worthy proposals in the following three project categories: clinical and translational research awards, clinical and basic research innovative partnership awards, or technology research and development awards. These enhanced awards may be funded at up to $100,000 direct costs per year and for up to two years. 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.

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 & 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 Describe the overall goals and structure of the Pilot and Feasibility Program. Requirements: Each Center must propose a minimum of 2 pilot and feasibility studies to be supported from NIDDK funds each year.

P and F 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 PD/PI (current or past support from other sources should have been modest); (2) established investigators with no previous work in nutrition/obesity who 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. P and F awards are not intended to serve as 'bridge' funding for established nutrition/obesity researchers who may be experiencing a gap in research funding.

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 Center. Projects should be focused, since funding for these studies is modest. Individual investigators are 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 or expanded to include investigators at institutions with a well-defined affiliation with the Center. 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 Center. The mechanisms by which information on the availability of pilot and feasibility awards will be disseminated and by which applicants will apply and be selected for these awards must be described and will be an important element in the review of the pilot and feasibility component of the Center.

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

While a Center's administrative framework for management of the pilot and feasibility program is basically left up to each Center (subject to NIH peer review), certain minimal requirements must be met. There must also be a committee representing all the aspects of the Center 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) Prepare and ensure appropriate distribution of announcements of the availability of pilot and feasibility funding;

(2) 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 Center;

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

(4) Make recommendations to the Center for final funding decisions. A record of actions by this committee must be documented;

(6) Develop and maintain a mechanism for the oversight and review of ongoing P and F projects; this is especially important as a requirement for a second year of P and F support;

(7) Make recommendations regarding termination or other actions to the Center; and

(8) 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.

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 relevance of the proposed individual pilot and feasibility studies and of the program as a whole to research on nutrition and obesity and to the specific goals and objectives of the individual Center and of the Center program generally.

Pilot and feasibility program in new applications: Provide relevant information on proposed and funded projects, as applicable. These should be the best applications received by the NORC and should be reviewed in the manner proposed for all future P and F applications.

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

The description of the management of the 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.

The historical overview should cover the pilot and feasibility program since the inception of the Center. The pilot and feasibility program director may wish to highlight certain studies or 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 Center should be emphasized.

Progress Report Publications List: Productivity and accomplishments of the P and F Program as demonstrated by peer-reviewed research publications supported by the Center should be documented by listing the number(s) of the relevant publication(s) from Table F, which was attached in the Center Overview component. Do not replicate publication lists in the Pilot and Feasibility Program section.

Letters of Support: Include any letters of support for the Pilot and 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 as provided in the SF424 (R&R) Application Guide.

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

PHS Inclusion Enrollment Report (Pilot & Feasibility Program)

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

When preparing your application in ASSIST, use Component Type Enrichment Program

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

SF424 (R&R) Cover (Enrichment Program)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Enrichment Program)

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

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

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

Other Attachments (renewal applications only; optional): If not already described, additional critical documentation of Center-supported Enrichment Program activities, such as agendas/flyers for Nutrition Obesity Research Center retreats, symposia, workshops, meetings, specialized courses, seminar series, etc., illustrating the interactions among Center members and other investigators, as well as other educational opportunities may be included in the application. This should be loaded as a file in .pdf format titled "Enrichment Program".

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Enrichment Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Enrichment Program Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Enrichment Program)

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

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

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

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

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

Travel: Travel funds to support visiting scientists under the auspices of the Enrichment Program may be requested.

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 Nutrition Obesity Research Center enrichment program should be designed to advance translational research in nutrition and obesity and to promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between nutrition and obesity researchers/investigators from other fields with relevant expertise.

The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Applicants should describe any educational opportunities afforded by the Nutrition Obesity Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional educational environment. Specifically, Center applicants should provide information on nutrition/obesity-related NIDDK or other NIH Institute T32 programs at the Center institution(s), and describe how the Nutrition Obesity Center will help to integrate, facilitate and enhance activities of any T32-supported trainees, if appropriate.

Training postdoctoral fellows to conduct research in nutrition and obesity is an associated activity of a Center. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for educational and enrichment opportunities. Funding for fellowships may be sought from other sources, such as NIH NRSA institutional training grants (e.g. T32, T35), individual fellowships (e.g. F30, F32), and other organizations such as private foundations and commercial companies.

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 Center institution should be included that acknowledges and details how the PD/PI of the T32 training grant intends to promote cohesive interactions between the two programs. Such letters should also briefly describe how any trainees supported by NIDDK-funded T32 or T35 training grants, coordinate with Center activities related to the proposed Enrichment Program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

PHS Inclusion Enrollment Report (Enrichment Program)

Not Applicable

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

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

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: https://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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

Reviewers will be asked to evaluate the following individual sections:

• Research Base, including the focus, quality of research, collaborations among members, relevance to the Center's stated research focus, and, for renewal applications, the growth, re-focusing, or evolution of the research base.
• Each Biomedical Research Core, including the potential of the core to empower nutrition obesity research by promoting new research directions and creating nutrition/obesity-specific research opportunities that are not available through commercial or institutional resources; the documented need for and use of 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, Center membership criteria, and lines of communication.
• Pilot and Feasibility Program, including the organization of the overall process of solicitation, review, and monitoring of P and F projects, and for renewal applications the quality, appropriateness and outcomes of supported P and F projects.
• Enrichment Program, including the quality of proposed activities and likelihood for promoting new scientific collaborations and directions/approaches.
• Nutrition Obesity Research Center Director (PD/PI), including leadership and commitment to the stated goals of the Nutrition Obesity Research Center as well as the succession plan, if applicable.

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.

Does the Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 a strong, scientifically excellent existing research base in nutrition and obesity at the Center that would benefit by the services/programs supported through the Nutrition Obesity Research Center? What is the likelihood that the Nutrition Obesity Research 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?

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 components (Core Directors, P&F Program Director, etc.) willing to interact with each other and contribute to the overall objectives of the Nutrition Obesity Research 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?

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? Do the Cores provide new methods, techniques, and/or resources that are not available through commercial or existing institutional resources? Do the Cores demonstrate the ability to adapt when needed to support investigators in emerging areas of nutrition/obesity and its complications, and related research, as appropriate to the purpose of the Core and the research supported by the Center? Is the process by which individual Pilot and Feasibility applications are evaluated and selected for funding appropriate? Does the Center appear to encourage high-risk , innovative ideas through their P and F program?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? How appropriate and relevant are the proposed cores and the modes of operation, including utilization, prioritization of requests for services, cost-recovery, and quality control monitoring? 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? If proposed, is support through an institutional biomedical research core well-justified, and would it provide added value and access to the resource beyond that which would be accomplished with a fee-for-service process? Is there any role for the research cores in supporting either new investigators or established investigators moving into nutrition and obesity research? Are criteria for membership in the Nutrition Obesity Research Center clear and appropriate? Is appropriate administrative structure 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?

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.

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.

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

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

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.

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.

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

Research Base: 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?

Biomedical Research Cores: 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 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 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? Is the capacity of each core with current resources sufficient to serve the needs of the Center community? Does the Center provide evidence of ability to evolve cores to meet changing needs of the research community? Does the Center provide evidence of Program Income and/or sufficient institutional support? If applicable, has the national/regional shared resource core been effective as well as beneficial to both the Center members and partnering institution(s)?

Administrative Core: Has the administrative structure proven effective? Has oversight of Center activities, including the P and F and Enrichment programs, been effective? - Does the Center website show evidence of continuing maintenance and a high level of quality and usability?

Pilot and Feasibility Program: Are the numbers and types of P and F awards well-justified and related to the goals of the Center? Was the P and F program fully utilized during the previous project period? Were awards made to investigators who fully met the eligibility criteria (as described in the FOA) for pilot and feasibility support? Are data provided to document the outcome of all P and F projects completed in the last five years, including those that failed to lead to further funding? 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 research papers generated under these awards, projects successfully funded with independent grants, and key advances linked to these awards well-documented and consistent with the level of support provided? If applicable, has the national/regional P and F program been effective as well as beneficial to both the Center and partnering institution(s)?

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?

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.

Not Applicable

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).

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

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIDDK 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 . 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Awardee-selected projects that involve greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

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

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Thomas Tatham, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-3993
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 Part 75.