Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 Clinical Trial Optional) is sponsored by NIH National Institute of General Medical Sciences (NIGMS). Provides funding for institutions to develop innovative biomedical research centers, including those focused on women's health.

Expired PAR-22-250: Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 - Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

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 ( NIH ) Components of Participating Organizations National Institute of General Medical Sciences ( NIGMS ) Funding Opportunity Title Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 - Clinical Trial Optional) Notices of Special Interest associated with this funding opportunity April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 June 18, 2024 - Clarification of Data Management and Sharing Plan Instructions in PAR-22-250 Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 - Clinical Trial Optional) . See Notice NOT-GM-24-038 June 21, 2023 - Termination of the Requirement for COBRE, INBRE, IDeA-CTR, and NARCH Awards to Provide Supplemental Annual Reports through the Scientific Information Reporting System (SIRS).

See Notice NOT-GM-23-046 April 3, 2023 - Notice of Change to Institutional Eligibility Criteria in PAR-22-250 . See Notice NOT-GM-23-040 .

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 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The Centers of Biomedical Research Excellence (COBRE) program supports the establishment and development of innovative biomedical research centers at Institutional Development Award (IDeA)-eligible institutions through awards for three sequential five-year phases.

The purpose of the COBRE Phase 1 award is to build capacity in an area of biomedical research through the establishment of a center of excellence that helps develop a critical mass of investigators who are able to compete effectively for independent research funding and improve infrastructure in the center's area of research.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) 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.

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 1. Overview Information Part 2. Full Text of Announcement Section I.

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

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

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Authorized by the U.S. Congress in 1993, the National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program to build biomedical research capacity in the 23 U.S. states and Puerto Rico that had historically low NIH grant funding success rates.

IDeA funding programs collectively support biomedical research in basic, clinical, behavioral, and translational science in IDeA-eligible states by developing faculty investigators, providing research opportunities to students, and enhancing research infrastructure.

A key IDeA component is the Centers of Biomedical Research Excellence (COBRE) program that supports the establishment and development of innovative biomedical research centers of excellence at institutions through awards for three sequential five-year phases.

This Funding Opportunity Announcement (FOA) supports COBRE Phase 1 awards, which aim to enhance an institution's capacity in one area of biomedical research by developing a critical mass of investigators who can compete effectively for independent funding, as well as to improve the research infrastructure.

COBRE Phase 2 awards are intended to strengthen successful Centers through the continued development of investigators and further improvements in research infrastructure. Phase 3 awards provide resources to transition COBREs to self-sustaining research programs.

COBRE Phase 1 Program Description and Requirements Overall Plan (required): A COBRE Phase 1 award supports the establishment of a multi-component center of excellence in an area of biomedical research that aligns with the applicant institution’s strategic priorities for growing its research capacity.

The COBRE Phase 1 program aims to develop a critical mass of investigators who can compete effectively for independent, external research funding. To achieve this goal, the COBRE award supports a Center that provides research support and mentoring to faculty investigators and funding for their recruitment. Enhancements to the institution’s research infrastructure that facilitate the proposed research are also supported.

The Center’s scientific goals must be aligned with the applicant institution’s strategic priorities and cover a sufficiently broad scientific area to warrant the institution’s sustained support.

Applicant institutions should demonstrate their commitment to the COBRE program goals by investing in the recruitment and long-term support of the Center’s investigators and the infrastructure required to carry out the scientific research.

An established investigator with scientific expertise in the research area of the Center as well as mentoring and administrative experience is expected to lead the Center as the Program Director/Principal Investigator (PD/PI) of the award.

An Advisory Committee (AC) comprised of institutional leadership and external experts in the scientific area should provide advice and oversight on critical scientific activities and administrative decisions.

Applications proposing to establish a Center in a scientific area closely related to one previously supported by a COBRE award to the institution or in an area for which the institution already has a critical mass of funded investigators are of low programmatic priority. Required components of the Center include an Administrative Core and 3-5 Research Projects.

Optional components include Research Cores and an Alteration and Renovation Project. All proposed components must be integral to attaining the goals of the Center and are expected to interact with each other and with relevant existing programs at the institution to foster a collaborative research environment.

Administrative Core (required) : The Administrative Core implements the Center's overall plan, coordinates the Cores, Projects, AC, and mentoring activities, and carries out all responsibilities required of the COBRE award.

These include preparing accurate and timely program and financial reports, ensuring all Center activities are compliant with federal regulations, managing the Center's budget, organizing Center-wide scientific and career development activities such as seminar series, workshops, and retreats, and conducting annual performance evaluations of the Center.

The Administrative Core may also support an optional Pilot Project Program, which is intended primarily for developing future Research Project Leaders (RPLs). Research Projects (required) : A minimum of three and a maximum of five Research Projects related to the Center’s research area must be proposed.

Each Research Project should propose innovative science that has the potential to advance the field and jumpstart the research program of the Research Project Leader (RPL). RPLs must qualify either as NIH Early Stage Investigators (ESIs) or as New Investigators (NIs), and must hold faculty appointments (or equivalent at research institutes) and lead their own research programs (see Section III.

Eligibility Information for additional details). A senior faculty member is assigned to each RPL as a mentor to guide the RPL's research and professional development. Each Research Project is expected to be supported for 2-3 years.

RPL graduation from COBRE support with research publications and independent grant funding is a key measure of the Center's success. Upon graduation of an RPL, a replacement RPL should be selected to fill the vacancy. Applications proposing ESIs in the RPL role are strongly encouraged.

Research Core(s) (optional) : A Research Core may be requested if it is required to support the work of the Research Projects. The Research Core should also be made available to other investigators at the institution as well as those from other IDeA institutions. A Research Core should provide cutting-edge technologies and/or services that are not duplicative of existing services or facilities at the applicant institution.

Upgrading existing research facilities including those supported by other IDeA programs (e.g., INBRE, IDeA-CTR, and other COBREs) is strongly encouraged. Alteration and Renovation (optional) : Alteration and Renovation (A&R) costs to improve existing research laboratories or animal facilities are allowed if they are relevant to the scope of the proposed research. 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 Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed 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). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets must not exceed $1. 5 million in annual direct costs, excluding consortium facilities and administrative (F&A) costs. This FOA allows one-time funding of up to $300,000 in direct costs in the first year of the award for an Alteration and Renovation Project.

If Alteration and Renovation costs are requested, the total application budget for the first year must not exceed $1. 8 million in direct costs. The project period is limited to five years.

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 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) Eligibility is restricted to institutions that meet all of the following criteria: Are located in an IDeA-eligible state, commonwealth, or jurisdiction , which are Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming; and Award doctoral degrees in the health-related sciences or are independent biomedical research institutes/medical centers with ongoing biomedical research programs funded by the NIH or other federal agencies; and At the time of submission, (1) hold two or fewer active COBRE Phase 1 and/or Phase 2 awards, including those in no-cost extension, and (2) through subcontracts, hold five or fewer COBRE Research Projects and/or Cores from Phase 1 and Phase 2 COBREs awarded to other institutions.

Please note that COBRE Phase 3 - Transitional Centers awards and their research cores are not counted for these eligibility requirements and that applications will not be accepted from institutions that hold three active Phase 1 and/or Phase 2 COBRE awards, including those in no-cost extension. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

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

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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 full SAM and Grants. gov registrations; 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.

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

The PD(s)/PI(s) is expected to be an established biomedical research scientist with the mentoring and administrative experience necessary to lead the Center. At the time of submission, the COBRE PD/PI's primary appointment must be at the applicant institution.

The PD/PI must also hold, as PD/PI, at least one active, peer-reviewed and externally funded research grant in the scientific area of the COBRE that is awarded to the applicant institution. If a COBRE PD/PI’s qualifying research grant is a multiple PD/PI award to a different institution, the applicant institution must receive funds via subcontract toward supporting the COBRE PD/PI's research.

For multiple PD/PI COBRE applications, a non-contact PD(s)/PI(s) must also have at least one active, peer-reviewed and externally funded research grant in the scientific area of the COBRE that is awarded to the institution where they hold a primary appointment. A PD/PI may not simultaneously lead more than one IDeA (INBRE, IDeA-CTR, or other COBRE) program award.

Previous COBRE PD(s)/PI(s) of different COBRE Centers, except those who served in that capacity on an interim basis, are not eligible to lead a COBRE Phase 1 application. All investigators who intend to apply as PD(s)/PI(s) are encouraged to consult with the Scientific/Research Contact listed in Section VII prior to preparing an application.

Eligible Individuals (Research Project Leaders) RPLs must qualify either as NIH Early Stage Investigators (ESIs) or as New Investigators (NIs). They must also hold independent multi-year faculty appointments (or equivalent at research institutes) and be leading their own research programs. More than half the RPLs must hold primary appointments at the applicant institution.

An RPL with a primary appointment at another IDeA institution may be proposed, provided that institution, through subcontracts, holds four or fewer COBRE Research Projects and/or Cores from active Phase 1 and Phase 2 COBREs awarded to other institutions; note that subcontracts for Research Cores from Phase 3 COBREs are not included in this calculation.

An investigator cannot receive more than five years of support as a COBRE RPL in total, inclusive of any RPL support from another COBRE award. A COBRE RPL cannot receive simultaneous research support as a COBRE Pilot Project Leader (PPL).

Furthermore, a COBRE RPL or PPL cannot receive simultaneous research support as a project lead from any other IDeA parent award (e.g., COBRE, INBRE, IDeA-CTR), but may be eligible to serve as a project lead of a supplement to an IDeA award. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). One application per eligible institution is allowed for each submission due date. 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 FOA.

See your administrative office for instructions if you plan 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 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 staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information, prospective applicants are encouraged 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: National Institute of General Medical Sciences (NIGMS) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Research Strategy Page Limit Alteration and Renovation 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 application. When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424(R&R) Cover (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. Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) 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 FOA) for the entire application. Biographical Sketch: Each PD/PI should include a description of their mentoring and administrative experience in the Personal Statement of the Biographical Sketch.

Current and Pending Support Attachment : Include an attachment titled Current and Pending Support with the following information for each PD/PI’s current and pending research grants from both federal and non-federal sources, which is critical information for determining the PD/PI's eligibility and suitability to lead the proposed Center: Name of Recipient Institution Source of Support and Title of the Project (or Subproject) Role on the Project and Level of Effort (in calendar-months) Dates of Approved/Proposed Project Total Costs to the PD/PI’s laboratory for the period of performance A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. 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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component. Specific Aims: Provide Specific Aims for the Center.

Research Strategy: This section must include the following elements: A. Justification for Establishment of the Center Applicants should provide a strong rationale for establishing a Center in the chosen area of biomedical research.

Important information to include are: A description of the institution’s research base (e.g., the size of the biomedical research faculty, the total external biomedical research and infrastructure grant support, etc.). A description of the investigators with external research funding in the Center’s scientific area.

The goals of the proposed Center and their alignment with the institution’s strategic priorities for growing its research capacity. A description of how institutional commitments, including faculty recruitment plans, will ensure a timely and adequate supply of RPLs for the Center. B.

Organization and Management Plan The overall Organization and Management Plan for the Center should clearly convey the strategy for accomplishing the Center’s goals. It should include: A description of the Center’s components and how each contributes to the Center’s goals and will interact with one another. Include all of the Research Projects (RPs) proposed in the application, but do not describe potential future RPs.

A description of how Research Cores, if proposed, complement and interface with existing resources at the institution without being duplicative; include equipment, instrumentation, and cores supported by current or prior IDeA (e.g., COBRE, INBRE, IDeA-CTR) awards.

If an increase in the total number of RPs after Year 1 is proposed, provide a timeline and strategy for RPL recruitment and identify the target area(s) of RPL scientific expertise. If the COBRE focuses on community-engaged research, detailed plans that outline stakeholder input, community outreach and input into evaluation strategies and dissemination of the results must be provided. C .

Plan for an Advisory Committee An Advisory Committee (AC) composed of three external, nationally recognized scientists with expertise directly relevant to the scientific research area of the Center, one senior institutional official (e.g., Dean, Vice-President for Research), and one senior faculty member appointed by the senior institutional official must be assembled to advise the PD(s)/PI(s) after the proposed Center is funded.

An AC member may not serve as an RPL mentor, core director/advisor, or hold any other position in the Center.

Responsibilities of the AC include, but are not limited to, reviewing the annual evaluation of the Center provided by its Administrative Core, making recommendations to the PD/PI to improve the performance of the Center, and providing feedback to RPLs, their mentors, and the PD(s)/PI(s) regarding the RPLs' progress in research and career development.

If an RPL is delayed in meeting milestones, the AC should provide advice to the PI on ways to address the shortcomings. The AC also assesses proposals for replacement Research Projects when the need arises. If a Pilot Project Program is proposed, the AC will also assess applications for Pilot Projects.

NIGMS will only consider requests to appoint replacement RPLs and PPLs if the AC’s recommendations are included. The AC should meet at least twice per year. Plans for the AC should detail: A description of the qualities and scientific expertise desired for external AC members and the process for their selection.

External AC candidates should not be named or contacted prior to receiving the Notice of Award (NoA) for the application. The names and positions of the senior official and senior faculty member from the applicant institution. A description of how the AC will function.

Additional responsibilities, if any, that are proposed for the AC. The Center is required to assign a mentor to each RPL. The mentor should be an established investigator who is able to provide scientific advice and career guidance to the RPL.

If a suitable mentor at the applicant institution is not available, it is acceptable to enlist an appropriate mentor from another institution, including those located in non-IDeA states.

The Mentoring Plan should: Provide a description of how mentors are selected, including their qualifications to provide scientific advice and career development guidance to the RPLs, how mentors will be trained in mentoring best practices, and how mentor performance will be assessed. Describe how mentoring will be conducted. Include mentoring strategies for RPLs who fall short of meeting established milestones.

A description of the institution's research base, including the size of the biomedical research faculty and the total external biomedical research and infrastructure grant support.

A description of the commitment of resources and facilities to establish, sustain, and support the COBRE throughout the period of funding, including support to hire new faculty members, and to maintain the research, faculty, and infrastructure developed by the Center beyond the period of COBRE support.

A list of the titles and periods of support of current and prior COBRE awards received by the institution as well as each active subcontract it receives for a COBRE Research Project and/or Research Core from a Phase 1 or Phase 2 COBRE awarded to another institution.

If the application proposes subcontracts to another institution for RPLs and/or Research Cores, a letter of support with similar content from a senior official of the participating institution must be provided. Additional letters demonstrating state-level, regional, and/or local support for the Center may be included in this section only if they address a substantive and specific need.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 multiple components. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

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

SF424 (R&R) Cover (Administrative Core) Complete only the following fields: 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