Limited Competition: NIDDK Program Projects (P01 Clinical Trial Optional)

Limited Competition: NIDDK Program Projects (P01 Clinical Trial Optional) is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This Funding Opportunity Announcement (FOA) invites grant applications for investigator-initiated Research Program Project Grant (P01) renewal (Type 2) applications.

Expired PAR-20-075: Limited Competition: NIDDK Program Projects (P01 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health Components of Participating Organizations National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Funding Opportunity Title Competition: NIDDK Program Projects (P01 Clinical Trial Optional) P01 Research Program Projects February 28, 2023 - This PAR has been reissued as PAR-23-121 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

See Notice NOT-OD-21-169 . August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077 . Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.

Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Funding Opportunity Announcement Companion Funding Opportunity See Section III. 3.

Additional Information on Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose Announcement (FOA) invites submission of investigator-initiated Research Program Project Grant (P01) renewal (Type 2) applications.

The proposed programs should address scientific areas relevant to the NIDDK mission including diabetes, selected endocrine and metabolic diseases, obesity, digestive diseases and nutrition, and kidney, urologic and hematologic diseases, as well as new approaches to prevent, treat and cure these diseases, including clinical research. A description of NIDDK scientific program areas can be found at https://www. niddk.

nih. gov/about-niddk/research-areas . Letter of Intent Due Date(s) 30 days prior to the application March 18, 2020, thereafter Standard The first standard due date for this FOA is May 25, 2020.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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 All applications are due by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process October 2020, thereafter Standard Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information knowledge will come from both sole investigators following their vision and from teams of scientists sharing their expertise. Some complex biomedical problems require a multidisciplinary vantage point to discover an innovative solution.

This Funding Opportunity Announcement (FOA) invites grant applications for investigator-initiated Research Program Project Grant (P01) renewal (Type 2) applications. The P01 program project award supports research that has multiple distinct but synergistic projects built around a unifying central theme within the scientific mission of the NIDDK.

several grant mechanisms the NIDDK uses to foster multi-disciplinary, collaborative research projects. More information on and a comparison among these collaborative grant mechanisms supported by NIDDK can be found at: https://www. niddk.

nih. gov/research-funding/process/apply/funding-mechanisms/collaborative-grants-comparison . well-defined major objective is the foundation of a P01 program project.

Compared to the narrower thrust of a traditional R01 research project, a program project is directed toward a range of scientific questions that elucidate various aspects of the central theme. The interrelationships of research projects and collaborations among investigators will yield synergy and results beyond those achievable if each research project were to be pursued independently.

In addition, one or more shared research cores are required. and core leaders should be established investigators with strong records of innovative research and independent funding support. The participation of experts in several disciplines or in several areas of one discipline will greatly enhance the goals of the program project.

All investigators must contribute to, and share in, the responsibilities of fulfilling the program objectives.

program projects should advance the mission of the NIDDK to gain new knowledge relevant to understanding diabetes, selected endocrine and metabolic diseases, obesity, digestive diseases and nutrition, and kidney, urologic and hematologic diseases, and to develop new approaches to prevent, treat and cure these this FOA requires: a) a minimum of three inter-related and synergistic research projects that complement and contribute to a unifying central theme; and b) at least one research core facility that provides services to at least two research projects.

An administrative support core may also be proposed. The research projects and scientific and administrative cores are all under the leadership of an overall P01 leader responsible for program integration and management. allowed to submit each research project as an R01 application and as part of the program project for review in the same review cycle.

If such a project were to receive impact scores that merit funding of both the R01 and P01 applications, funding of the project in the program project will take precedence, and the R01 application will be inactivated administratively.

are strongly encouraged to contact NIDDK while they are still in the process of developing conceptual plans for an application and at least 3 months and preferably 6 months before the due date to discuss a potential application. The discussion could include the choice of activity code, relevance of the topic to the NIDDK mission and the scope and approach of the project.

NIDDK-supported P01s that are in their first project period (i.e., first five years of funding) are eligible for renewal through this funding opportunity. Awardees with a gap of greater than two years since the end of the initial project period are ineligible to apply. No resubmission applications or new applications will be accepted to this announcement.

VIII. Other Information for award authorities and regulations. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed NIDDK-supported P01s that are in their first project period (i.e., first five years of funding) are eligible for renewal through this funding opportunity. Awardees with a gap of greater than two years since the end of the initial project period are ineligible to apply. No resubmission applications or new applications will be accepted to this announcement.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

Anticipated Number of Awards contingent upon the NIDDK budget and the number of highly meritorious applications. A limited pool of funds for program projects and similar large grants makes these awards highly competitive. Applications should not request more than $6.

25 million in direct costs over 5 years. The indirect costs related to the subcontracts will be excluded from the requested direct cost levels prior to The maximum project period for NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher 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 Hispanic-serving Institutions Historically Black Colleges and Universities Tribally Controlled Colleges and Universities Alaska Native and Native Hawaiian Serving Asian American Native American Pacific Islander Serving 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 (Other than Small City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations.

The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) 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. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.

Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration, but 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 DUNS number and SAM registration in order to complete the Grants. gov registration.

Directors/Principal Investigators (PD(s)/PI(s)) 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 Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Only current NIDDK-supported P01 awardees who are in the first project period (i.e., first five years of funding) are eligible to submit a renewal (Type 2) application via this funding opportunity.

Awardees with a gap of greater than two years since the end of the initial project period are ineligible to apply. No resubmission applications or new applications will be accepted to this announcement. established research scientist who has the experience, ability, and time commitment to provide scientific leadership and to ensure quality control, effective administration and integration of all components of the program project.

Each research project should be led by an experienced investigator with an established record of productivity and independent funding. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information Applicant organizations may submit more than one application, provided that each application is scientifically The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will 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 An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). IV. Application and Submission Information 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system 2.

Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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 Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent, preferably electronically, should be sent to: Strategy/Program Plan Page Limits Core (Use for Research Cores) Additional page limits described in the SF424 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 the SF424 (R&R) Application Guide, and should be used for preparing a multi-component The application should consist of the following components: Administrative Core: Optional (Minimum: 0, Maximum: 1) Research Core: Required (Minimum: 1, Maximum: No maximum) Projects: Required (Minimum: 3, Maximum: No maximum) When preparing your application, use Component Type All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional SF424 (R&R) Cover (Overall) 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.

Project Information (Overall) Follow standard instructions. Facilities and Other Resources: Describe the features of the institutional environment that would facilitate effective implementation of the program project. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographic distribution of space and personnel, and consultative resources.

If the projects are not at the same location, describe the plans for communication and sharing of biologic material. Project/Performance Site Location(s) 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.

Senior/Key Person Profile (Overall) Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Include evidence that the PD/PI(s) has (have) a track record(s) of consistently producing highly significant research publications in one or more areas proposed in the program project and a track record of demonstrating the ability to effectively and productively manage a large, interdisciplinary project in the proposed research area.

Describe PD/PI commitment and ability to develop a well-defined central research focus and demonstrated ability in mounting similar programs. A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of 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 PHS 398 Research Plan (Overall) Specific Aims: Describe the specific aims of the overall program project.

Outline how the individual cores and projects will contribute Strategy: The overall research A. Program Background and Statement of Objectives: Present the background, rationale and hypotheses of the central scientific theme and the strategies to address specific questions and problems related to the central theme. Explain the strategy for achieving the objectives of the overall B.

Organization and Synergy of the Program Project: Describe the relationships among the projects and cores and their contribution to the overall program project theme and strategy and the cohesiveness and multidisciplinary scope of the program.

Describe the unique advantages that would be gained by the proposed program project, potential impact on the field, the scientific synergy among the projects and cores, and the means by which the projects collectively will achieve the stated objectives of the proposed research.

The overall scientific synergy (i.e., potential for scientific impact of the proposed program project as a whole to be greater than the sum of its component research projects and cores) should be addressed. Include in this description, the role of the research cores in promoting the collaboration among the projects and how proposed approaches in cores and projects are complementary.

For renewal (Type 2) applications, applicants should address progress and achievements specific to this program project during the past funding period, evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions of ongoing work, and previous performance and estimated use of the core(s).

In addition, a description of the collaboration among the projects and cores during the previous funding period must be included. Information about publications, conferences, etc. may be provided as evidence of collaboration. A justification for adding new projects or cores or for deleting components previously supported should also be included.

C. Relation of the Program Project to the Applicant Institution: Describe the relationships between the proposed program project and other existing research units at the applicant institution. List all NIDDK-supported Centers and Program Projects at the applicant institution and the relationship, if any, with the proposed Program Project.

Indicate if any of the proposed cores will expand cores already existing at the institution. Progress Report Publication List: Include a table of publications that directly resulted from the Program Project since it was last reviewed. The table should list the publications and note which Project(s) and Core(s) were directly involved in the research for each publication.

Protection of Human Subjects: Please specify which Projects and Cores will Vertebrate Animals: Please specify which Projects and Cores will utilize vertebrate animals. Letters of Support: Attach letters of support relevant to the program project as a whole e.g., letters of institutional support.

Letters of support relevant to specific projects or cores should be attached in their respective Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan for the entire Program Project.

The individual projects and cores can refer to this Data Sharing Plan. Other Resource Sharing Plans [Sharing Model Organisms and Genomic Data Sharing (GDS) Plan] should be addressed in the Research Plan forms for the individual projects and cores, as needed. Only limited items are allowed in the Appendix.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 SF424 (R&R) 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 Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed PHS Assignment Request Form (Overall) All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Admin All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, SF424 (R&R) Cover (Administrative Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Enter Human Embryonic Stem Cells in Project Information (Administrative Core) Human Subjects: Answer only the Are Human Subjects Involved?

and 'Is the Project Exempt from Federal regulations? questions. The Administrative Core should not involve Human Vertebrate Animals: Answer only the Are Vertebrate Animals Used?

question. The Administrative Core should not involve vertebrate animal Research. not complete.

It is not required for the Administrative Core. 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. 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 Core 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 (Administrative Core) Budget forms appropriate for the specific component will be included in the application package. Minimum expected levels of effort for management of the overall P01 application are three person months, either for a single PD/PI or an aggregate of three months with multiple PDs/PIs. This includes level of effort requested for all components of the P01 for which the PDs/PIs participate.

The Administrative Core may include limited funds for program enrichment activities such as seminars and research workshops, if they are directly related to the goals of the program project. The funds cannot be used for general departmental activities.

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 Specific Aims: Describe the specific aims of the Administrative Research Strategy: The research strategy should provide a strong justification for the inclusion of an administrative core and its benefit to the program project. It should also describe the process in place to recommend a successor to the PD/PI(s), should there be a need for a change in PD/PI.

If an administrative core is included, it could provide a support structure for activities such as: coordinate the research mission, monitor timeline for achieving research milestones, coordinate and integrate program project activities, implement a plan for regular evaluation of scientific Letters of Support: Attach letters of support relevant to the Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: The application can note that the Data Sharing Plan for the whole Program Project applies to the Administrative Core.

Other resource sharing plans are not relevant to the Administrative Core. Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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 SF424 (R&R) 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.

Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Research Core) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Research Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core) the Are Human Subjects Involved? and 'Is the Project Exempt from Federal Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) List all performance sites that apply to the specific 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 (Research Core) In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core 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 forms appropriate for the specific component will be included in the application package. Minimum expected level of effort is 1. 2 person months 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 (Research Core) the specific aims of the Research Core. core and the various services it would provide, as well as core management and any special arrangements such as cooperation with other cores.

The research strategy should also include a clear delineation of procedures, techniques, and quality control, and how core usage would be prioritized. If applicable, describe in detail statistical analyses and data management. Describe the role of the leaders of the Research Cores in developing the research directions of the Program Project.

The research strategy could also include plans for the development of new methods and innovative procedures essential to advancing the research goals of the Program Project. Research Core resources should not simply duplicate resources already available at the institution. The Research Core could be available to investigators outside the Program Project, but procedures for prioritization