Part 1. Overview Information

Key Dates

Dates in bold and italics reflect changes per NOT-DK-24-039.

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity (NOFO) invites applications for a Nutrition Obesity Research Center (NORC) Research Resource Center (RRC) grant proposing to manage common NORC activities with a goal of enhancing the rigor and reproducibility of nutrition and obesity research; providing support for the early-to-midcareer nutrition and obesity researchers from diverse backgrounds, including individuals from underrepresented groups (see, NOT-OD-20-031); managing an Opportunity Program; providing a Pilot and Feasibility Program; and supporting other related needs for the NORC program more broadly. The mission of the NORC program is to serve as a key component of the NIDDK-supported nation-wide effort to advance nutrition and obesity research across the research spectrum. The NORCs promote new discoveries and enhance scientific progress through support of cutting-edge basic, clinical, translational, and health disparities research in nutrition science and obesity with the ultimate goal of improving public health for all. 

The NORC program consists of 11 independent but highly collaborative P30 Centers across the United States. Each NORC is associated with an existing program of excellence in nutrition and obesity research as evidenced by a consistent and outstanding record of productivity and peer-reviewed research funding in those areas. NORC funding provides support for core facilities (shared resources), pilot and feasibility studies, and program enrichment activities. Except for pilot and feasibility studies, NORCs do not fund or otherwise support individual biomedical or behavioral research projects other than through core usage. Rather the goal of the NORC program is to bring together investigators from a variety of scientific disciplines in a manner that enhances and extends the effectiveness of their research and collaborative activities. More information about the NORC program can be found on www.NORCcentral.org and https://www.niddk.nih.gov/research-funding/research-programs/nutrition-obesity-research-centers.

The NORC Program is collectively pursuing the following goals:

• Attracting and retaining early-stage investigators and investigators new to nutrition/obesity research, including those from groups underrepresented in the biomedical research workforce;
• Enhancing nutrition and obesity research education and training opportunities, including career development and mentoring of early career scientists;
• Providing core services that leverage funding and unique expertise and advancing nutrition and obesity research methods and tools;
• Improving and sustaining rigor and reproducibility in nutrition and obesity research;
• Fostering interdisciplinary collaborations, especially in emerging areas of research, to catalyze new ideas and scientific approaches;
• Raising awareness and interest in fundamental and clinical nutrition and/or obesity research at the local, regional, and national level; and
• Promoting the dissemination and implementation   of scientific discoveries from bench to bedside to the community to improve public health.

The NORC RRC will be expected to facilitate and contribute to common activities and collaborations across the entire NORC program, to serve as a resource for projects related to career advancement and approaches, consistent with applicable law,  to  enhance the diversity and retention of the early career nutrition and obesity research workforce, and to assist with the identification and development of approaches to fill gaps in nutrition and obesity research methodologies. The NORC program will have an Executive Committee composed of selected NORC PIs/PDs and the RRC PIs/PDs. The NORC RRC will not conduct or otherwise support individual biomedical or behavioral research projects other than through a Pilot and Feasibility Program.  Please note that consistent with NIH practices and applicable law, funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a trainee, faculty candidate, or other program participant as an eligibility or selection criteria. 

RRC expectations will include but are not limited to:

• Providing valuable administrative support, facilitation, and project management to the entire Consortium, including organization of annual NORC meetings, facilitation of standing working groups or committees, and conduct of other activities, as needed;
• Assisting with efforts to synergize services and programs across the NORCs to reduce duplication, increase innovation, and expand access to services that may be of value to researchers outside the affiliated NORC institutions and collaborators; 
• Managing the NORC website and improving a central portal that successfully shares unique resources, tools, technologies, services available across the NORCs to the broader nutrition and obesity research community;
• Providing expertise and supporting research that addresses fundamental challenges in nutrition and obesity research, including health disparities and health equity research, dissemination and implementation, and community-engaged research;
• Assisting and supporting the NORC effort to provide training resources, mentoring, and other program support designed to advance the careers and to retain early-to-mid-career investigators, including scientists from groups underrepresented in the biomedical research workforce  (see NOT-OD-20-031); 
• Participating and assisting with the leadership of highly collaborative Consortium-wide working groups and committees;
• Implementing a NORC Opportunity Program, supported by appropriate oversight and rigorous external peer review, which will have a goal of addressing scientific gaps, rigor and reproducibility, data sharing, and promotion of collaboration across the fields of nutrition and obesity research;
• Managing a Pilot and Feasibility program available to external investigators in the nutrition and obesity research field(s); and
• Other activities as determined collaboratively with the NORC program as a whole.
   

Center Structure and Activities

The RRC should be composed of an Administrative Core, an Opportunity Program, and a Pilot and Feasibility Program. The RRC should encourage collaboration, development, and implementation of NORC-wide initiatives; promote a diverse and inclusive research training environment with equitable leadership training and opportunities);  enhance  the use of shared NORC resources; and collaboratively administer a Pilot and Feasibility Program. The structure may change as needed based on new scientific opportunities and partnerships.
 

Plan for Enhancing Diverse Perspectives (PEDP)

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. 

Administrative Core

A NORC RRC must include an Administrative Core, which will be responsible for oversight of the NORC RRC and facilitating productive collaborations between relevant NORC components and working groups or projects. The Administrative Core will be responsible for managing communications across the NORCs, coordinating Executive Committee activities, hosting the NORC website, organizing the annual NORC meeting as well as working group meetings, and providing appropriate oversight of the Opportunity Program and the Pilot and Feasibility Program. The NORC RRC will also be expected to provide expertise in mentorship and career development activities relevant to early career investigators, including those from underrepresented groups, and should have appropriate subject matter expertise in nutrition and obesity research, including health equity research, as necessary to collaborate with the NORC program.
 

RRC Director(s)

The RRC Director, who is the Program Director/Principal Investigator on the P2C 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 and participation in collaborative groups. The Director will be responsible for the organization and operation of the RRC, collaboration with the NORC Program, and for communication with the NIDDK on scientific and operational matters. The NORC RRC Director(s) is required to lead the organization of and attend NORC 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/mentoring 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 or Program Manager may also be proposed.
 

Opportunity Program

The opportunity Program will be available to support NORC-wide projects or programs intended for one of a select number of purposes, such as efforts to promote diversity, equity, inclusion, and accessibility in the research workforce, projects designed to improve rigor and reproducibility of nutrition and obesity research, mentorship and career development programming, or other purposes in accordance with broader nutrition/obesity research community's needs. Opportunity fund projects will arise from within NORC-led working groups and/or a collaborative group of NORCs. Prioritization procedures will be established by the NORC consortium with facilitation from the RRC. Projects emanating from working group recommendations will take precedence. Engagement of external input from scientific organizations relevant to nutrition and obesity research will be encouraged. Efforts to increase the number of opportunity program projects and availability of funds for the program from alternative funding sources are strongly encouraged. The RRC may be asked to assist with identification of additional funding sources to support the Opportunity Program and to help prepare or submit relevant applications to NIH or other organizations and Foundations.
 

Pilot and Feasibility (P and F) Program

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 will be directed at new and early stage investigators and investigator(s) who have had prior support as a PD/PI on a substantial independent research award and unless successful in securing a substantial research grant award from NIH or other relevant Federal agencies in the near future, will have no substantial research grant funding.

Efforts to increase the number of P and F awards and availability of funds for the program from alternative funding sources from the application institution/consortium and other relevant sources such as Federal agencies, scientific societies or other organizations, and/or Foundations are particularly encouraged. P and F grants must be awarded to investigators outside the actively-funded NORC institution(s)/consortium members and/or, in limited circumstances, investigators at the RRC institution(s).  The distribution of pilot funding will require negotiating with secondary institutions to transfer grant funds in the most efficient fiscal and administrative manner possible.

NIH Office of Dietary Supplements Research Interests

The Office of Dietary Supplements (ODS) advances and disseminates research on dietary supplements to foster knowledge and optimize health across the lifespan. Dietary supplement ingredients are defined as including vitamins, minerals, herbs and other botanicals, amino acids, and other dietary or bioactive substances, consumed as dietary supplements to promote health and prevent disease. For this NOFO, ODS is interested in interventional studies, including, but not limited to, those that advance the study of the biological effects of dietary supplements on appetite regulation, gut-brain and gut-muscle crosstalk in the context of eating behavior and obesity-related metabolic dysfunction, muscle anabolic resistance, obesity-mediated inflammation and its effects on gut barrier function, insulin sensitivity, and the potential for dietary supplements to augment gut transit time and nutrient uptake. ODS will prioritize studies that explore the biological effects of dietary supplements in diverse populations predisposed to obesity and associated metabolic dysfunction. Studies that advance the study of composition, quality, stability, safety, and efficacy of dietary supplements on obesity prevention will also be considered.

The ODS does not award grants and only accepts co-funding requests from NIH Institutes and Centers; therefore, applications submitted to this NOFO must be relevant to the objectives of the NOFO. For questions regarding funding priorities, please contact the NIDDK Scientific/Research Contact named in this NOFO. For additional information about ODS, please visit http://ods.od.nih.gov. 

NIH Office of Disease Prevention Research Interests

The NIH Office of Disease Prevention (ODP) is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP provides co-funding support for research that has strong implications for disease and injury prevention, health equity, and research that includes innovative and appropriate research design, measurements, and analysis methods. For this opportunity, ODP is interested in co-funding applications that include, but are not limited to, a) the development and implementation of preventive interventions that seek to strengthen overall health among populations that experience health disparities, b) nutrition or obesity research methods and tools, c) opportunities to enhance nutrition and obesity research education and training, or d) the design and/or analysis of studies to evaluate multi-level preventive interventions.

The ODP does not award grants and only accepts co-funding requests from NIH Institutes and Centers; therefore, applications submitted to this NOFO must be relevant to the objectives of the NOFO. For questions regarding funding priorities, please contact NIDDK Scientific/Research Contact named in this NOFO. For additional information about ODP, please refer to the ODP Strategic Plan or visit prevention.nih.gov.
 

Annual NORC Meeting

Every 12 months, all NORC Directors and administrators and the RRC are expected to attend a meeting to exchange information, develop trans-NORC programs, and interact with NIDDK senior staff.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Describe the goals of the RRC. Provide a brief overview of the structure of the RRC, including the administrative core, the Opportunity Program, and the Pilot and Feasibility Program. Describe how the RRC will promote and facilitate trans-NORC activities and share opportunities the research community and the goals of the NORC Program.

Project Narrative: In 1-3 sentences describe the relevance of the research to be supported and facilitated by NORC RRC, including the Administrative Core, Opportunity Program, and Pilot and Feasibility Program.

Facilities and Other Resources: Explain how the scientific and institutional environments at the applicant institution contribute to the probability of success for achieving the Specific Aims described in this application. Describe the organizational resources available to the RRC. Identify the facilities to be used, including dedicated space, computer facilities and resources, and other facilities. Relative proximity of resources and size and shape of dedicated space may be presented in either graphic or narrative form. Describe only those resources that are directly related to achieving the Specific Aims described in this application or that complement the proposed components. Provide any information describing the Other Resources available to the project and the extent to which they would be available to the project.

Other Attachments: The following attachments must be included with the NORC RRC Overview 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.

Statement of Willingness:

This statement should be provided as an PDF attachment and should be entitled “Willingness.”  It is expected that the PD(s)/PI(s), as well as the applicant institution, have a commitment to serve the objectives as outlined in this NOFO. Thus, applicant(s) should provide a statement indicating their willingness to:

• Cooperatively work with the NORC Program members to share all RRC resources and expertise with the NORC program and to participate in all NORC projects, working groups, activities, conference calls, and meetings, as needed during the award.
• Organize and facilitate the annual in-person NORC meeting and other working group/committee meetings, as appropriate.
• Actively seek input from the NORC program regarding resource or expertise needs that may arise during the performance of the project.
• Cooperatively work with the NORC program to administer the Opportunity Program, and
• Administer and provide appropriate oversight for a P&F program open to the broader nutrition and obesity research community.
   

Plan for Enhancing Diverse Perspectives

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.

The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy sections. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review.

Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop trans-disciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds 

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

 Note that Senior/Key Person biosketches should only be submitted once. Do not submit duplicate biosketches for Senior/Key Persons within other attachments.

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Introduction to Application: 

Specific Aims: Describe the broad long-term objectives of the proposed RRC. Provide a brief overview of the structure of the RRC. Outline the existing skills and technologies to be made available to the NORC Program as well as other resources at the institution(s) and summarize how the RRC will enhance ongoing NORC projects, assist in the development of new projects, respond to future opportunities, enhance diverse perspectives, and promote collaborations leading to advances in nutrition and obesity research.  

Research Strategy: The objectives of the RRC are to: (1) provide administrative support and assistance as needed for the NIDDK-funded NORC Program, (2) administer and manage an Opportunity Program to address gaps in nutrition and obesity research methods and promote collaboration among the NORCs, (3) serve as a resource for career development strategies for early career investigators, including scientists from groups underrepresented in the biomedical research workforce, and (4) administer and manage a national P and F program.

The Research Strategy should encompass the following information:

A. Evidence of capacity for leadership, administrative support, and project management to the entire Consortium and proposed approach to planning, organizing, and supporting meetings, education, and outreach activities to meet Consortium objectives. This should include:

• An overview of the RRC, its objectives, and how they are aligned with the objectives of the NORC program.
• An organizational chart of the RRC, identifying the proposed PD(s)/PI(s) and key personnel.
• A description of relevant expertise, experience, and accomplishments of the proposed key personnel in the successful planning, direction, and management of collaborative programs. It is expected that diverse scientific expertise and perspectives will be included at every level of RRC leadership.
• Evidence of knowledge and leadership in nutrition, obesity, and/or related research fields, such as but not limited to common comorbid conditions associated with obesity and nutrition and health disparities/health equity research.
• Strategies to maintain regular communication among Consortium members and to facilitate Consortium working groups.
• Plans to organize and hold at least one annual, face-to-face meeting of the NORC Program as well as one to two to-be-determined NORC-wide virtual working group meetings with Executive Committee oversight, and
• Plans to manage a NORC website including promotion of resources and services that are available to the research community.

B. Assist the NORC program in developing and sustaining collaborative efforts to expand and improve mentorship of the early career nutrition and obesity research workforce at the NORCs and the research community more broadly and to  s erve as a resource for the NORC program on effective career development strategies, mentoring, and support for diversity, equity, and inclusion across the early career nutrition and obesity workforce. Plans to manage any conflicts of interest within the NORC Program or between the member NORCs and the RRC, including any perceived conflicts of interest with key personnel, should be detailed. 

C. Plans to establish, manage, and promote a NORC Opportunity Program to address gaps and promote collaboration among  the fields of nutrition and obesity research. Specifically, the RRC will:

• Support the NORCs in identifying methodological gaps in nutrition/obesity research in an effort to improve rigor and reproducibility in nutrition and obesity research;
• Identify and assist with efforts to improve mentoring and career development of early career scientists from diverse backgrounds, including those from underrepresented  groups; and assisting in expanding access to the NORCs through varied approaches;
• Establish an administrative process to award RRC funds supporting common projects and track productivity of awards funded through the opportunity program; and
• Assist NORC members in securing additional support for collaborative NORC projects, as necessary, when opportunities arise.

D. Administer and manage a Pilot and Feasibility Program. 

Applicants must propose a plan and provide  implementation details designed to prevent and manage perceived or real conflicts of interest with key personnel (NORC Directors, Associate Directors, and Core Directors) and institutions involved in actively funded NORCs. Serving on a NORC External Advisory Board(s) is not considered a conflict of interest. A list of funded NORCs can be found on these websites: www.NORCcentral.org and the NIDDK NORC website. In addition, applicants should not appoint or name external members of Advisory Board(s), if proposed.  

Letters of Support: Include any letters of support for the proposed RRC by appropriate institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the RRC and its goals. The parent institution should provide assurance of its commitment to continuing support of the RRC in the event of a change in directorship and a well-defined plan for this eventuality should be in place and pertinent departments must show a strong commitment to supporting the RRC. Applications should not include Letters of Support from any existing NORC leadership members (Directors or Associate Directors, etc.) or key personnel.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type ‘Admin. Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ 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.
• In this component, also provide biographical sketches for any consultants. 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.' Applicants may choose to convene an External Advisory Committee (EAC) but should NOT provide names or biosketches for any External Advisory Committee members. Overall qualifications and areas of scientific expertise for the EAC members may be included.

Budget (Administrative Core)

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

Personnel: The RRC Director must devote a minimum of 1.8 person months to the RCC and at least 1.2 of those months must be within the Administrative Core to ensure adequate oversight of the RRC. In a multiple-PD/PI application, the combined effort of the PD(s)/PI(s) must be 1.8 person months. The RRC size and complexity will warrant inclusion of a Program Manager/Administrator, so salary support for this individual should be included in the Administrative Core.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the RRC.  Include travel costs for the RRC Director, Associate Director, and others as appropriate (i.e., Opportunity Program or P and F Directors) and Program Manager/Administrator to attend Nutrition Obesity Research Center meetings held every 12 months. Include costs of reserving a meeting room at a hotel sufficient to accommodate ~30-40 attendees for 1.5 days on an annual basis as well as relevant expenses for hosting virtual meetings.

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

Consultants: Include costs associated with any named consultants (consultant fees, per diem, virtual meetings, and travel) when their services are required by the RRC, such as members of an optional External Advisory Board. Applicants must also budget for two consultants to be appointed in collaboration with the NORC program over the entire project period. These consultants will include one mid-to senior career researcher and one early career researcher for activities related to career development. Do not name these consultants. Consultant costs may vary depending on the selected consultants' positions and institutions.

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 development/maintenance of the NORC website may be requested.  Include funds to support up to two Working Groups with monthly virtual executive committee meetings and quarterly virtual meetings for the full group. Funds may be requested for anticipated workshops, research fora, symposia, NORC retreats and seminar series.

PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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

PHS 398 Research Plan (Administrative Core)

Introduction to Application: Not applicable 

Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the RRC and outline interactions of the Administrative Core with the Opportunity Program Core and the P and F Program. Provide an overview of how the Administrative Core will set the overall direction of the RRC and assure optimal collaboration across the NORC Program.    

Research Strategy: The NORC RRC 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 will play a key role in the functioning of the NORC RRC. Within the Research Strategy, the applicant should describe how the Administrative Core will take a leadership role in encouraging collaboration, communication, and achievement of trans-NORC goals in achieving goals such as but not limited to the following: 

• Assistance with and integration of NORC components and activities;
• Leadership in the assessment of productivity, effectiveness, and appropriateness of NORC Program activities, assessment of scientific opportunities, and areas for collaboration across the NORC program;
• Interaction with the scientific and lay communities and the NIDDK in order to develop relevant goals for the NORC and with the scientific leadership of the NORC programs to enhance the visibility and effectiveness of the NORC as a focus for nutrition/obesity research;
• Organization of NORC program activities, including the annual NORC meeting and other committee meetings (to be held virtually) as appropriate;
• Recordkeeping including meeting summaries/minutes and measures of success including NORC-wide or working group publications, pilot and feasibility awards, and opportunity funds projects;
• Facilitating interactions with external scientific organizations, the NIDDK, and other appropriate individuals, groups, or organizations, as appropriate;
• Oversight of the RRC Opportunity Program and Pilot and Feasibility Program;
• Maintenance of a NORC website with the administrative core taking primary responsibility for its curation and oversight and likewise for ensuring proper and seamless integration of the institutional NORC website with the NIDDK NORC-wide program website (www.norccentral.org); and
• Other activities as determined by the NORC Program.

The final administrative structure of the RRC will be left largely to the discretion of the applicant institution; however, the RRC applicant should establish an administrative structure that will permit the development of appropriate interactions between RRC components and the NORC Program. Within this structure, the applicant institution must also establish a mechanism to oversee the use of funds for the proposed Pilot and Feasibility program.

In addition, direct lines of communication between the Administrative Core, Opportunity Program, and the P and F Program should be delineated, as all of these components will serve critical roles for NORC RRC 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.  The application should include a statement of willingness of the PD/PI, Associate or Program Director(s), or other key personnel to attend this annual meeting of NORC Program.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide,

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Opportunity Program

When preparing your application, use Component Type ‘Opportunity Program'

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Opportunity 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 (Opportunity Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Opportunity 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.

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

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

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

Personnel: This category should include salary support for key personnel, including the Opportunity Program Director, and other professional and administrative personnel. The Opportunity Program Director must devote a minimum of 0.6 person month to the Program to ensure adequate oversight.  The salary amount charged to the RRC Center grant must be commensurate with the time spent on the opportunity program activities and is subject to institutional and NIH salary policies.

Other Expenses: Request support for an Opportunity Program at $175,000  in year 1   (inclusive of all F&A costs) and $150,000 per year (inclusive of all F&A costs) for years 2-5,  which will support common NORC programs or collaborative projects such as development, refinement, or harmonization of nutrition and obesity research methods or tools; collaborative efforts to support the early career nutrition and obesity research workforce,  (e.g., mentorship and other career development strategies, etc.); or other projects designed to advance the NORC program and nutrition/obesity research more broadly. The RRC should not calculate F&As on the Opportunity Program set- aside. Rather, the RRC should budget for costs associated with the administration of the Opportunity Program (including key personnel). The RRC is also entitled to F&A costs on the first $25,000 of each sub-award made from the Opportunity Program. Please note that the F&A costs for the sub-award institution would be included in the total costs of each sub-award.

PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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

PHS 398 Research Plan (Opportunity Program)

Introduction to Application: Not applicable 

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

Research Strategy: Describe the overall goals and structure of the Opportunity Program. Provide an overview of the plan to manage and support collaborative development and prioritization of common NORC Projects or Programs. Provide an overview of the process to either award Opportunity Program funds to support the common projects and/or obtain additional funds from external sources to support those projects, i.e., assist with or submit grant applications or secure matching funds. Outline strategies to broadly focus on a) programming and other efforts to mentor and advance the career development of early career scientists conducting nutrition and obesity research with an emphasis on senior post-doctoral fellows and junior faculty/early-stage investigators, and b) approaches to improve upon or advance the rigor of nutrition and obesity research-related methods and tools; however, other potential activities may arise during the project period. Efforts related to enhancing diversity in the research workforce a, through means consistent with applicable law, are particularly encouraged. Provide examples of the research team’s prior experience with similar collaborative activities, including leadership roles. RRC applicants are not expected to propose common projects, but rather assist in the process of identifying, prioritizing, planning, and managing projects in collaboration with the NORC program leadership.  Please note that the race, ethnicity, or sex of members of the research team, faculty, key personnel, trainees or any other program participants, will not be considered in the application review process or when making funding decisions.

Letters of Support: Include any letters of support for the proposed Opportunity Program, as appropriate

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Opportunity Program)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Pilot and Feasibility Program

When preparing your application, use Component Type ‘P&F Program'

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (P and F Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (P and F 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.

Project /Performance Site Location(s) (P and F 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 (P and F Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ 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 (P and F Program)

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

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 RRC 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 of up to $50,000 in direct costs each per year for up to two years will be provided for the majority of approved P and F projects. P&F awards may provide salary support for the P&F recipients and other expenses as appropriate for individual projects. 

Request support of $125 ,000 (direct costs) in year 1 and a minimum of $100,000 per year (direct costs) for years 2-5 of the P&F program. Generally, the pilot funds will be distributed in the form of subcontracts to a third-party researcher's institution.

PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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.

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

PHS 398 Research Plan (P and F Program)

Introduction to Application: Not applicable 

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

Research Strategy: Provide a formal plan to solicit, review, and prioritize requests for pilot funding that arise from interactions with the research center. Include details on eligibility criteria, evaluation, and assessment of the likelihood of the proposed pilot study leading to a competitive NIH (or equivalent) research application. Researchers associated with the infrastructure grant may be considered for pilot funding, but first priority should be researchers who come to the infrastructure network from outside locations. The distribution of pilot funding will require strategies for negotiating with secondary institutions to transfer grant funds in the most fiscally and administratively efficient manner.

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. Projects may include clinical studies and clinical trials; however, projects that are considered to have greater than minimal risk to human participants must be well-justified and must obtain prior approval from the NIDDK Program Director. Greater than minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research risks are more than minimal risk, but not significantly greater. 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 the process for promoting and inviting applicants outside the applicant institution/consortium and the NORC program. 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. NORCs are expected to provide appropriate mentorship and career development for their early career P&F recipients. The approach to mentorship and career development should be described. 

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 the administrative framework for management of the Pilot and Feasibility program will be under the management of the RCC, there must also be a mechanism for consultation a committee consisting of representatives from the NORCs in the operation of the program. The major responsibilities of the RRC P and F Program Director 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 RRC must be used for each proposal.  All reviewers should assign impact scores in accordance with the NIH system.  Copies of all 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 and provide mentoring to P and F recipients, as applicable;
(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 RRC; and
(8) Maintain, insofar as it is possible, a record of subsequent career events of each pilot and feasibility study recipient.  

All applicants should describe how these requirements will be met and provide details on any prior experience managing a P and F program(s). The description of the management of the program should present in detail the proposed 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.

Oversight Plan for P&F Program involving HS research (required):

Although all P&F projects should be monitored for productivity, P&F projects involving Humans Subjects Research must develop a detailed, formal plan for assuring compliance with all relevant NIH regulations. The plans for implementation of this oversight plan must be included in the application, as appropriate for either clinical studies or clinical trials. Do not duplicate information already provided in the PHS Human Subjects Clinical Trial Information form.

The following elements or procedures are required as part of the oversight plan:

• Development and implementation of appropriate data and safety monitoring plans,
• Documentation of IRB approval,
• Registration of all clinical trials in clinicaltrials.gov,
• Development and monitoring of appropriate milestones,
• Oversight of participant recruitment and retention,
• Results reporting in https://clinicaltrials.gov/ , as appropriate, and
• Planning for dissemination of research results.

Letters of Support: Include any letters of support for the proposed Pilot and Feasibility Program, as appropriate

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (P and F Program)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - 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 NIDDK, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Use of Common Data Elements in NIH-funded Research

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular Notice of Funding Opportunity (NOFO), note the following:

Reviewers will be asked to evaluate the following individual sections.  The overall impact score is not the average for these components.

1. The Administrative Core, including committee structure, expertise and collaborative experience, capacity to achieve the goals of the administrative core, and lines of communication, and the RRC Director (PD/PI), including leadership and commitment to the stated goals of the RCC.
2. Opportunity Program, including evaluation of the leadership, organization, and collaborative process for identifying, prioritizing, and awarding/securing funds to support common programs; and
3. Pilot and Feasibility Program, including the Program's vision/mission statement and the organization of the overall process of solicitation, review, selection, and monitoring of P and F Projects.

The RRC Pilot and Feasibility Program will have the option to support Clinical Trials.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project 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 project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the research resource that it will administer? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program. .

Specific to this NOFO: How appropriately do the focus, relevance, interrelationships, quality, productivity, and, to some extent, the track record of the team, address the stated goals of the RRC? What is the likelihood that the RRC to promote new research opportunities and meaningful collaborations among NORC Programs; contribute to career development and mentoring efforts for nutrition and obesity researchers; and facilitate interactions and collaborations with the research community where appropriate and possible? How appropriate are the plans to facilitate communication, including organization of NORC meetings and working groups as well as management of the NORC website? How likely is the proposed P&F program to be able to attract and support new investigators through the P and F Program? Is the proposed plan for leadership and management of the Opportunity Program well-conceived and structured? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative basic and clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this NOFO: Have the RRC investigators responsible for the individual components proposed an effective strategy to interact with each other and the existing NORC Programs to contribute to the overall objectives of the RCC and the NORC Program? How appropriate are the RRC Director's and other key personnel’s administrative abilities and scientific expertise for effective management of the RRC? How strong is their commitment and their ability to devote adequate time for the effective management of the RRC?  How well qualified are the Opportunity Program and P&F Program Directors, as proposed, and how appropriate are their scientific expertise and administrative abilities? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application propose novel organizational concepts and management strategies in coordinating the Program the Center will serve? Are the concepts and strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, and management strategies proposed?

Specific to this NOFO: How innovative are the proposed strategies to lead collaborative NORC-wide discussions that successfully identify emerging areas of science; to advance mentorship and career development for early career investigatorsfrom diverse backgrounds, including scientists from groups underrepresented in the biomedical research workforce; and to meet other needs of the NORC and nutrition/obesity research community? How successfully is the RRC likely to be to encourage innovative ideas and expansion of opportunities to support the nutrition/obesity research community through their P and F Program? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this NOFO: To what extent will the RRC capabilities and activities as proposed benefit the NORC program and the research community? How appropriate is the administrative organization proposed for the following:

(a) facilitation of collaborative activities pursued by the NORC Program, including mechanisms for internal monitoring;
(b) organization of the in-person NORC annual meeting and (virtual) working group/committee meetings; 
(c) establishment and maintenance of internal communication and cooperation among the RRC team and the NORC Programs;
(d) management of the NORC website and other relevant promotional strategies; 
(e) mechanism for selecting and replacing professional or technical personnel within the RRC; management capabilities, including fiscal administration, procurement, and property; and (f) personnel management, planning, budgeting, and other appropriate capabilities?

How appropriate are the proposed strategies to manage real or perceived conflicts of interest? How well does the P and F Program's vision or mission statement reflect the RRC’s goals and inform the Program's processes? How appropriate and transparent are the processes for soliciting, evaluating, selecting, and providing oversight for P and F projects? Will the solicitation process likely reach the appropriate pool of potential candidates? Are the evaluation and selection processes free of bias and likely to lead to awards for strong applications? Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?  

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this NOFO: Is the institutional commitment to the RRC’s management and scientific impact sufficient? How strong is the potential for scientific interactions? To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Overall

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable 

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK, in accordance with NIH peer review policies and practices, 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 will receive a written critique.

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

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

In accordance with NIH policy http://grants.nih.gov/grants/policy/hs/index.htm and the NIH Guide Announcement NOT-OD-15-129, the awardee institution is responsible for ensuring that all awarded P and F projects follow all relevant regulations and policies for Human Subjects Research. The following elements or procedures must be included in the recipient institution's P&F program oversight plan, as appropriate for all HS research inclusive of both clinical studies and clinical trials:

• Development and implementation of appropriate data and safety monitoring plans
• Documentation of IRB approval
• Registration of all clinical trials in clinicaltrials.gov
• Development and monitoring of appropriate milestones
• Oversight of participant recruitment and retention
• Results reporting in clincaltrials.gov, as appropriate
• Planning for dissemination of research results

Prior Approval of Pilot Projects

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

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient 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, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Awardees will provide updates at least annually on implementation of the PEDP.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to  2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

Melissa C. Green Parker, Ph.D.
Office of Disease Prevention (ODP)
Phone: 301-480-1161
E-mail: [email protected]

Patricia A. Haggerty, Ph.D.
NIH Office of Dietary Supplements
Email:  [email protected]
Phone:  301-529-4884

Thomas Tatham, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-3993
Email: [email protected]

Angela Walters
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-6950
Email: [email protected]

Section VIII. Other Information

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 2 CFR Part 200.