Part 1. Overview Information

Key Dates

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 Announcement

Section I. Funding Opportunity Description

Purpose

NIGMS will support mature synchrotron resources, which may include Macromolecular Crystallography (MX) and other synchrotron-based techniques that generate important structural biology data. These resources must provide state-of-the-art instrumentation along with user support and training. They must be accessible to all biomedical researchers whose projects are vetted through a peer review process. This limited competition announcement is intended to continue support of NIGMS-supported mature synchrotron resources.

Technology development for synchrotron-based structural biology has advanced at a rapid pace, dramatically increasing the speed, precision, throughput and user-friendliness of tools to the extent that they are now accessible to a wide breadth of biomedical researchers. Thus, it is no longer necessary for technology development to be the focus of most synchrotron-based resources for structural biology. Awards under this FOA will support synchrotron-based resources where the technologies are at an advanced, stable level, requiring minimal development to maintain that state. The focus will be on user access, user training and user support in data collection, processing and analysis.

Supported Activities

To maintain the structural biology beamline resources at a suitably advanced level, replacement of existing equipment and implementation of the latest instrumentation with minor technology development will be supported. Implementation can include incorporation or replacement of instrumentation, process refinement, methods improvement, and software development for optimal operations. Some engineering or development may be involved in the improvements.

Technology development that directly advances the service objectives for the proposed Technology Operations Cores may also be proposed. For example, staff may develop technology that is expected to improve their data collection capabilities during the approved project period. Longer-term technology development that will not directly advance the Resource objectives during the project period is outside of the scope of this FOA.

NIGMS offers research project grants (R01 and R21 activity codes) targeted for technology development in areas of the NIGMS mission. Potential applicants are encouraged to contact NIGMS staff about eligibility of projects for this FOA.

Support for the development and operation of X-ray beamlines for structural biology has long been provided through a variety of other mechanisms at NIH and NIGMS. Only those NIGMS-supported resources that offer access to mature technologies are encouraged to seek support under this FOA. Structural biology resources that fulfill an ongoing community need require stable support. Since funds are limited, NIGMS is able to fund only a limited number.

Funding through this FOA will support resource administration, technology implementation, service-related technology development and provision of service support for users, user training and outreach to the community about the capabilities and services offered by the resource as well as the science it enables. NIGMS Mature Synchrotron Resources will consist of one Administration component, one User Training and Outreach component, and one or more Technology Operations Cores. Each Technology Operations Core should describe the technology and capabilities available and plans for maintaining it over the 5-year grant cycle. It will be the responsibility of the applicant to demonstrate that the Resource proposed comprises well-established, mature technologies that meet ongoing biomedical research community needs.

Details pertaining to the support available through this FOA can be found in the Budget sections of the Administration, User Training and Outreach, and Technology Operations Core(s) components.

Project oversight should include monitoring the facility usage and user productivity. An External Advisory Committee for the Mature Synchrotron Resource is recommended.

NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from, research and enhancing public trust (see, e.g., Notice of NIH's Interest in Diversity, NOT-OD-20-031). To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional engagement.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• User access, user training and outreach opportunities designed to benefit early- and mid-career investigators.

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

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

This FOA is limited to applications requesting support for existing synchrotron Resources that are currently, or recently have been, supported by NIGMS funding. Resources whose funding ended more than 36 months ago are no longer eligible to submit an application to this FOA.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations

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

• 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
  • Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.

• eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) 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.

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. 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 SF424 (R&R) Application Guide.

PD(s)/PI(s) should possess the skills, knowledge and resources required to provide leadership to all key components of the resource, not only to individual select activities.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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).

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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

Note: Effective for due dates on or after January 25, 2023 a Data Management and Sharing Plan is not applicable for this FOA.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Overall Component

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)

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: The application should include a summary of the proposed work. State the proposed Resource’s broad, long-term objective; specific aims; and the significance to the field of biomedical research. Define the relevance of the Technology Operations Core(s) to the overall theme and goals of the program.

Project Narrative: Provide the Project Narrative for the entire application.

Other Attachments: The following attachments are required.

Publications Enabled by the Resource: Provide an attachment that lists publications demonstrating impact of the Resource on the biomedical user community. Label the list with the heading "Publications Enabled by the Resource." Organize publications authored by Resource users and published in the last three years under subheadings by primary technique being utilized (Macromolecular Crystallography, Small Angle X-ray Scattering, etc.). Headings should align with Technology Operations Cores. This attachment should be titled "Resource Enabled Publications".

Plan for Enhancing Diverse Perspectives (PEDP) (1 page maximum): The application 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 section. 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 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 for groups traditionally underrepresented in the biomedical workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure to support 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.
• 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.

This attachment should be titled Plan for Enhancing Diverse Perspectives .

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 FOA) for the entire application.

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

Budget (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)

Specific Aims: Describe the overall aims of the Resource.

Research Strategy: Describe the overall objectives of the Resource and discuss the importance of this particular Resource for biomedical research as well as its relationship to other similar resources within the US and the world.Note that a Resource is not required to be unique, although that may be an asset. Discuss how the proposed activities and components integrate to form a coherent Resource, while providing a brief summary of each component, including the Administration component.

Summarize evidence of the impact, high demand for and productivity of the Resource, for new applications over the last three years or for renewal applications over the current project period. Include relevant metrics such as the numbers of Protein Data Bank (PDB) submissions and publications enabled by the Resource through user service activities for each Technology Operations Core, annual service hours, number of unique users, number of user/group visits, etc., as appropriate. Provide evidence of past success of the Resource in providing needed expertise to the users. For this FOA, "Innovation" is defined as a coherent plan to ensure that independently funded investigators have access to biomedical technologies and expertise that are not widely available and will enable biomedical research.

Letters of Support: Include letters of support following instructions found in the SF424 (R&R) Application Guide. Include any letters describing institutional support here. Do not include letters from persons who do not have an assigned role in the Resource. For example, do not include letters from past users or potential users.

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.

Although the entire project is considered a resource, in the context of the Resource Sharing Plan the definition of resource includes any software, materials, protocols, instrument components or interfaces, data pipelines, workshop video archives, training tutorials, etc. that are developed by the Resource staff and can be disseminated to the greater research community. Dissemination can occur in many forms, such as free distribution, fee-for-service, or commercialization.

Provide the Resource Sharing Plan for the entire project here.

• Provide a software sharing plan if applicable. Indicate whether FAIR (Findable, Accessible, Interoperable, and Reusable) principles are applied, and whether the software is open source. Note that NIH encourages data management and sharing practices that are consistent with the FAIR data principles and reflective of practices within specific research communities.
• Provide a resource sharing plan for any other resources developed or to be developed by the project. For sharing that has been fully described in the application, summarize the plan here.
• Provide details of how the Resource will inform the user of: (1) the NIH policies regarding data sharing, (2) the NIH Public Access Policy for peer reviewed publications and (3) the requirement that the user acknowledge the Resource by grant number in any publications. Note that users, not the Resource, are responsible for sharing and long-term storage of data generated through their access of the Resource. As a condition of use of Resource services, users must agree to follow all applicable NIH policies for the sharing of their data, as appropriate.

Appendix: 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 multiple components.

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 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.

Administration

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 (Administration)

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 (Administration)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administration)

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

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

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

Other Attachments: Provide the following attachments:

User Forms (Required): Provide samples of any forms to be filled out by Resource users, both those used to apply for access to the Resource and those used to provide feedback afterward and accompanying instructions. Provide all forms in one PDF file named "UserForms".

External Advisory Committee report (Optional): Provide the latest report from the Resource Advisory Committee. Name the file "EACReport".

Project /Performance Site Location(s) (Administration)

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 (Administration)

• 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 (Administration)

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

Applicants are strongly encouraged to contact NIGMS Scientific/Research staff early in the process of developing an application to discuss the budget for the proposed Resource.

Plan for Enhancing Diverse Perspectives (PEDP) implementation costs: Budget request may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement).

Note the following budget restrictions: Funds may not be requested for alteration and renovation or the direct support for Resource users research projects.

Personnel: The support requested for each member of the Resource staff providing administrative support should be included here. The budget should include a detailed justification for key personnel associated with this component. The same personnel can be included in more than one component, as long as total effort for each individual does not exceed 100% in the cumulative Resource budget. A table of all staff, their roles, their level of effort in each component, and totals for each staff effort and component effort may be included in the budget justification, but is not required.

Supplies: Supplies related to the administration activities of the Resource are permitted and may include consumable laboratory research materials, office materials, and small equipment costing less than $5,000 (unless the institution has a lower limit).

Equipment and Service Contracts: Do not include equipment or service contracts here. Include requests in the appropriate Technology Operations Core(s).

Travel: Domestic and foreign travel support for Resource personnel are permitted, provided the travel is directly related to the activities of the Resource.

Funds to support travel by the appropriate personnel of the Resource for up to three program meetings in the course of the project period should be requested in the budget for the purpose of sharing information with other Mature Synchrotron Resource directors regarding user support, ideas to improve service and descriptions of new facility features. Request funds for travel to a biennial meeting of PD(s)/PI(s) in the second quarter of odd-numbered calendar years.

Note: If an annual meeting of an External Advisory Committee (EAC) is planned, funds for support of any EAC member travel should be requested in the Consultant Services category rather than the travel category of the budget.

Consultants: Consultants (including External Advisory Committee members) and any associated costs are permitted.

Budget Justification:, Provide detailed information about support received or anticipated from other entities. This could include co-funding by another government agency, user fees, or institutional support, for example.

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 (Administration)

Specific Aims: Concisely state the goals of the proposed Administration component.

Research Strategy: Describe, in separate sections, the:

• Resource organizational structure and staff responsibilities,
• Resource operating procedures,
• External Advisory Committee (EAC) composition and role, as appropriate,
• Biennial Mature Synchrotron Resources Meeting, and
• Plans for Collecting and Reporting Metrics.

Organizational Structure and Staff Responsibilities

Describe the Resource organizational structure. Indicate the relationship of the Resource to the administrative structure of the applicant institution. The PD(s)/PI(s), the Technology Operations Core Leaders and other key personnel should be appropriately trained for their respective roles and have a history of performing services for the scientific community at large. Describe how the PD(s)/PI(s) and the proposed Resource staff will be organized and how their effort will be distributed with respect to: Technology Operations Core user service and maintenance or upgrade projects, and Administration, User Training and Outreach activities. Describe how staff with appropriate skills and knowledge will be recruited and retained.

Resource Operating Procedures

The Resource should be operated in an efficient manner to provide the best quality user facility possible. It must be accessible to all biomedical researchers whose projects are vetted through a peer review process. Plans must assure that appropriate users will have fair access to the facilities and services.

Describe the Resource operating procedures. Discuss procedures to review requests for use of the equipment and facilities, and to schedule that use once it has been approved, including any General User Program processes. Describe criteria and processes for prioritizing and selecting user research projects. Describe remote/mail-in/fast-track/high-priority project scheduling processes. (Note: sample user forms should be provided in Other Attachments section of this component.) Briefly describe available experimental station(s) and respective workspace(s), which should be adequate and conducive to effective user access (note full descriptions of all capabilities should be provided under "Facilities and other Resources"). Describe processes for user-staff interactions. Describe processes for user Resource evaluation and feedback on user experience and explain how this information will be utilized. Describe criteria and processes for scheduling and use of non-user beam time, including maintenance and technology implementation time.

Long Dark Period Planning: Provide dates and durations of any anticipated extended periods when the synchrotron will not be available to users as a result of planned upgrades. Provide detailed plans of any necessary staff activities in support of the planned upgrades.

Contingency Planning: Extended facility outages can occur unpredictably due to fire, flood, earthquakes, accidents, theft, catastrophic equipment breakdowns and other causes. Include plans for contingencies in which the facility is unable to perform its functions for an extended period (months or longer). Include provisions for support (for example, alternative employment) of personnel if they are unable to perform resource support functions for an extended period. Institutional support in terms of backup and/or special insurance is an option, as are reciprocal arrangements with other Resources.

To sustain efficient management of the Resource, include a contingency plan in the event the PD(s)/PI(s) can no longer fulfill the obligation due to health, retirement, or other unforeseeable circumstances.

External Advisory Committee

An External Advisory Committee (EAC) for the Resource is recommended. The EAC is appointed by the PD(s)/PI(s) and advises the PD(s)/PI(s) on operations and future direction of the Resource, particularly in planning additional grant applications, maintaining state-of-the-art capabilities though new technology implementation, and in setting priorities for allocation of Resource facilities.

If the Resource has a standing EAC, list the current members and briefly describe their qualifications. If the Resource does not currently have an EAC, refrain from assembling one prior to or during application review, or approaching or identifying potential candidates. Instead, describe the plans for selecting members with regard to areas of expertise relevant to the Resource.

If any other local executive committees or other local committees for the Resource are proposed or already exist, describe their composition, function and meeting schedules in this section.

Mature Synchrotron Resources PD/PI Meeting

PD(s)/PI(s) in this Program should plan to organize and rotate hosting a biennial meeting of PDs/PIs and appropriate staff from the Mature Synchrotron Resources to discuss best practices, share technical information, and assess the current needs of the greater biomedical research user community for the technologies they are providing. Other investigators who operate and staff resources that may be eligible for the Mature Synchrotron Resource program should be encouraged to participate. The meeting host should include a virtual attendance option.

Plans for Collecting and Reporting Metrics

Tracking the demand for and utilization of the Resource is important for ongoing improvements in the short term and for gauging impact of usage on the scientific field in the long term. A reporting plan should be tailored to the Resource to best evaluate its productivity, availability, efficiency, and impact. Provide a plan for collecting and reporting data on an annual basis for these purposes, as most appropriate for the proposed Resource. Examples of anticipated types of data to collect and report are listed below.

Note: Provide here only the plan proposing the information to be collected in the future and reported in the Research Performance Progress Report by the Resource; do not provide the actual data for categories listed here in the application. Data demonstrating impact of the Resource on the research community should be included in the Overall section.

• Applications and Review:
  • Data relating to applications received, review evaluations and outcome for requests to use the Resource.
• Facilities Usage:
  • Beam time usage, including the total annual hours of beam time available at the facility, and aggregate information on hours dedicated toward maintenance, general user time, and any other usage.
  • For each Technology Operations Core a list of the unique users served, the institutional affiliation of each user, and compiled statistics showing the number of user groups accessing the Resource, the number of visits by each user and user group; and the user geographic distribution. A visit may be considered usage in person, by remote access, or as a mail-in sample with data collected by beamline staff. A breakdown of the statistics that reports visit type (in-person, remote, mail-in) and user geographic distribution.
  • The level of demand for each of the Technology Operations Cores in terms of number of user requests received and number granted access, and the total usage compared to available capacity.
  • Funding source(s) for each user group project and a compiled summary table of projects associated with each Technology Operations Core. If the funding source is NIH, report the grant number that supports the project.
• Research Outcomes:
  • Publications, PDB, and other database depositions by users. Software downloads, data uploads and downloads, and website metrics.
  • Several (3 or 4) science highlights that were enabled by data collected at the Resource that demonstrate the value and impact of the Resource.
  • Metrics regarding User Training and Outreach activities.
  • Activities related to the Plan to Enhance Diverse Perspectives such as efforts to provide training to individuals from underrepresented groups and outcomes from these efforts.
• User Feedback:
  • Feedback requests, feedback received, compiled statistics on requested information.

Letters of Support: Include letters of support following instructions SF424 (R&R) Application Guide. Do not include letters from persons who do not have an assigned role in the Resource. For example, do not include past users or potential users.

Resource Sharing Plan: While individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, this information should be included in the Overall component.

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 (Administration )

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.

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 SF424 (R&R) Application Guide must be followed.

Technology Operations Core

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 (Technology Operations 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 (Technology Operations Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technology Operations 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.

Other Attachments: The following information is required. Provide five representative user research projects, a summary table of the projects, and any references. Limit the length to no more than 1 page per project, excluding references and summary table. The examples should demonstrate the current capabilities the Resource can offer the biomedical research community, reflect the regional and/or national geographic distribution of user projects, and demonstrate the types of impactful research that will be enabled by the Resource. Examples of information to provide include:

• Project title
• Name of the investigator of the user research project
• Investigator's institutional affiliation
• Source of funding support for the project
• Project description/abstract indicating how the Resource facilities and staff expertise will be utilized

Formatting: Begin the section with a heading in the body of the text indicating User Research Projects followed by the name of the Technology Operations Core. Next provide a summary table of these representative projects, followed by the one-page project descriptions in the same order as they are listed in the summary table. Provide any references at the end of the section. Save the entire section in a single file named Users-(Technology Operations Core name). Note: the maximum number of characters for filenames is 50.

Project /Performance Site Location(s) (Technology Operations 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 (Technology Operations 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. Technology Operations Core Leads should be acknowledged experts in the technology provided by their respective Technology Operations Core(s). The PD(s)/PI(s) of the Resource may be the leader(s) of the Technology Operations Core(s).
• 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 (Technology Operations Core)

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

Applicants are strongly encouraged to contact program staff early in the process of developing an application to discuss the budget for the proposed Resource.

Plan for Enhancing Diverse Perspectives (PEDP) implementation costs: Budget request may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement).

Note the following budget restrictions: Funds may not be requested for alteration and renovation or direct support for Resource users' research projects.

Personnel: The support requested for each member of the Resource staff associated with the specific Technology Operations Core should be included here. The budget should include a detailed justification for key personnel associated with this component. The same personnel can be included in more than one component, as long as total effort for each individual does not exceed 100% in the cumulative Resource budget. A table of all staff, their roles, their level of effort in each component, and totals for each staff effort and component effort may be included in the budget justification, but is not required.

Each Technology Operations Core budget can cover salaries for PDs/PIs and Core Leads to the extent that they provide an essential Resource function.

The Technology Operations Cores may support technicians and engineers that have the appropriate scientific or engineering skills. Examples of appropriate skills could be operation and maintenance of the specialized shared instrumentation, implementation/support of customized algorithms, assembly of existing components for research platforms and implementation/support of open computational tools. Note: where appropriate, an established expert in the Technology Operations Core activities could also be included as a consultant.

Equipment: Major equipment requests are permitted and must be justified. Equipment associated with more than one Technology Operations Core should be described in both budgets and have costs split between them.

Price quotes should be included for equipment costing more than $25,000. Do not duplicate what is requested under other components.

Major equipment purchases (more than $500,000 over the course of the project period) often require support from other sources when the Mature Synchrotron Resources Program is unable to fund the entire request. Plans for such shared funding should be detailed in the application.

Service Contracts: Service Contracts for major equipment items are allowed.

Travel: Domestic and foreign travel support for Resource personnel are permitted, provided the travel is directly related to the activities of the Resource.

Supplies: Supplies related to the operation of the Resource are permitted and may include consumable laboratory research materials and small equipment costing less than $5,000 (unless the institution has a lower limit).

Consultants: Consultants fees and any associated costs are permitted.

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 (Technology Operations Core)

Specific Aims: Describe the goals of the proposed Technology Operations Core. Include explicit sub-aims for each planned improvement intended to maintain the facility at the state of the art.

Research Strategy: Technology Operations Cores should provide advanced technologies and services that are stable with regard to major developments and are appropriate for the anticipated research needs of the biomedical research user community they serve. The research strategy should describe plans to:

• provide user access to specific technologies made available by the Resource,
• provide routine maintenance of Resource technologies, and
• implement improvements to maintain the Resource as a state-of-the-art facility.

Each Resource must include at least one Technology Operations Core component. Each Technology Operations Core should be defined as relating to a specific synchrotron-based method that requires dedicated instrumentation, software, methods, and expertise and represents an important resource for biomedical researchers. It is expected that the Resource will actively recruit user research projects and will provide broad access to Resource capabilities, as described in detail in the User Training and Outreach and Administration components. Discuss the role and contributions of the leader(s) of the Technology Operations Core. Do not repeat information that is included in the biosketches.

User Support and Providing Access to the Resource

Discuss the technologies or tools (hardware, software, other specialized facilities, etc.) provided by this Technology Operations Core, and how they deliver important capabilities to their Research Users. Describe the experimental station user interfaces, which should be straightforward and user friendly.

Discuss the role and contribution of Resource staff providing support to users. Describe the types of user research projects that will have access to the Resource. (Note: Details for five representative user research projects should be included in the Other Attachments section of this component.) Provide the anticipated capacity and throughput of the Resource for the Technology Operations Core user projects.

Maintenance Activities

Describe plans for routine maintenance of the Technology Operations Core resources. Discuss the roles and contributions of Resource staff in providing maintenance activities. Describe operations during regularly-scheduled synchrotron downtime. Describe how resources are and will be maintained for continuous operation. Provide details of service contracts that provide emergency repair services, especially any components designed to minimize downtime.

Planned Improvements

While technology development is not a primary goal of the Resource, implementation of technologies that enhance the impact on the user community and improve the utility of the Technology Operations Core is an important activity of the Resource. Whenever possible, plans should be made to utilize open-source software and/or equipment that either can be obtained commercially or has been previously developed. If an element of the support provided by the Resource involves technology development (e.g., software, algorithm development, or hardware engineering), it should be well justified in that it is not a research project in itself, can be completed within the proposed project period, and has utility for the user community at the Resource. Planned improvements should be discussed with NIGMS Scientific/Research staff prior to submission to ensure they conform to the requirements of this FOA. All technology development should be disseminated to the greater user community through commercialization, open source platforms, peer reviewed publications, and/or engineering plans.

Provide any plans for implementing technology updates necessary for maintaining the Resource at the state of the art or to advance the service objectives of the Resource. Discuss the role and contribution of Resource staff in implementing improvements to this Technology Operations Core. For any improvements that involve extensive engineering, provide details of appropriate technical review boards or other expertise to be consulted to obtain adequate feedback through the development and implementation stages. For improvements that involve software development, describe plans to provide software portability when appropriate, to document, and to make it readily available to the user community.

Letters of Support: Include letters of support following instructions in the SF424 (R&R) Application Guide. Do not include letters from persons who do not have an assigned role in the Resource. For example, do not include past users or potential users.

Resource Sharing Plan: While individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, this information should be included in the Overall component.

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 (Technology Operations 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.

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 SF424 (R&R) Application Guide must be followed.

User Training and Outreach

When preparing your application, use Component Type Project .

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

SF424 (R&R) Cover (User Training and Outreach)

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 (User Training and Outreach)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (User Training and Outreach)

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) (User Training and Outreach)

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 (User Training and Outreach)

• 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 (User Training and Outreach)

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

Applicants are strongly encouraged to contact NIGMS Scientific/Research staff early in the process of developing an application to discuss the budget for the proposed Resource.

Plan for Enhancing Diverse Perspectives (PEDP) implementation costs: Budget request may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement).

Note the following budget restrictions: Resource users benefiting from training experience at this Resource may not be supported through this program: user trainee-related costs such as stipends, fringe benefit, travel, and room and board are not allowed.

Personnel: The support requested for each member of the Resource staff providing user training and/or outreach support should be included here. The budget should include a detailed justification for key personnel associated with this component. The same personnel can be included in more than one component, as long as total effort for each individual does not exceed 100% in the cumulative Resource budget. A table of all staff, their roles, their level of effort in each component, and totals for each staff effort and component effort may be included in the budget justification, but is not required.

Web Site:Costs for the development and maintenance of a web site for outreach to and training of the research community are allowed.

Supplies: Supplies related to User Training and Outreach activities of the Resource are permitted, and may include consumable laboratory research materials, office materials, and small equipment costing less than $5,000 (unless the institution has a lower limit).

Travel: Domestic and foreign travel support for Resource personnel are permitted, provided the travel is directly related to the activities of the Resource.

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 (User Training and Outreach)

Specific Aims: State concisely the goals of the proposed User Training and Outreach component.

Research Strategy: Describe, in separate sections:

• User Training Procedures and Activities, and
• Outreach Activities.

User Training Procedures and Activities

User Training should prepare biomedical researchers to effectively use and apply the Resource technologies and data collected to their own research. Researchers being trained may include graduate students, faculty members, and researchers from industry as is appropriate for the Mature Synchrotron Resource’s technology. Plans for individualized user training in the safe and effective operation of the available Resource facilities are required. A combination of one-on-one interactions with Resource staff, web-based manuals, and training modules or tutorials, etc., may be used. Broader training open to the greater research community through means such as seminars and lectures, workshops and short courses, or symposia offered independently or in conjunction with society meetings attended by the user community is optional, but encouraged.

Academic courses that are offered as part of the curriculum of the Resource’s institution, and not available to those outside the institution, should not be considered a component of the Resource’s user training mission and should not be included in this section; the training experience should not be a requirement for receipt of an academic degree.

Describe the individualized training of Resource users provided by staff for the safe and effective operation of the Resource’s technology. Describe any plans for development of new or modifications of existing online training materials such as manuals, training modules, and tutorials. Describe plans for broad-based training open to the greater research community, as applicable.

Outreach

Outreach activities should have three objectives: informing the scientific community about the technical capabilities of the Resource, promoting and enabling the broader use of those technologies, and actively recruiting new user research projects. A variety of approaches can be proposed to meet these goals. These approaches can include, but are not limited to: publishing articles, books, newsletters, annual reports, or special issues of technical journals; patenting; issuing press releases; presenting research results at meetings; conducting workshops and conferences; distributing software products; transferring technologies to other laboratories directly; and licensing technologies to industry. All Resource Outreach activities must acknowledge NIGMS grant support and cite the NIGMS grant number.

A robust web presence is required for every Mature Synchrotron Resource. Support for the Resource, including the NIGMS grant number, should be acknowledged on that web site. The web site should minimally provide information about:

• The Resource’s capabilities
• How to access the Resource
• A section of plain language information for the general public about the technologies
• Contact information
• How Resource users should cite the grant
• Links to online tutorials
• The availability of software, reagents, and other resources, as applicable
• A section on current newsworthy items directed to the general public
• An image gallery that features data and results

Describe the content of the proposed website or, if applicable, of an existing Resource website.

In Resources that are developing software, emphasis should be placed on producing portable, well-documented, user-friendly software, making it readily available to the user community, and providing user support. Describe outreach plans for disseminating software resources.

Letters of Support: Include letters of support following instructions in the SF424 (R&R) Application Guide. Do not include letters from persons who do not have an assigned role in the Resource. For example, do not include past users or potential users.

Resource Sharing Plan: While individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, this information should be included in the Overall component.

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 (User Training and Outreach )

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.

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 SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

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.

PD/PIs and appropriate staff are expected to attend a biennial Program meeting.

7. Other Submission Requirements and Information

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

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

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 Resource address the needs of the research community that it will serve? Is the scope of activities proposed for the Resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the Resource?

Will the proposed Resource have a significant influence on biomedical research in ways that would not otherwise be feasible?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Do the PD(s)/PI(s) have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in administering and managing facilities for synchrotron beamline based research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Resource 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 Resource? Are the PD(s)/PI(s), the Technology Operations Core Leaders and other key personnel appropriately trained for their respective roles? Are they able to devote adequate effort to the Resource activities?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise provided for the project?

Innovation

Does the application propose appropriate management, training and outreach strategies in coordinating the research Resource? Are the concepts, strategies, or instrumentation appropriate to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of existing technologies proposed?

For this FOA, "Innovation" is defined as a coherent plan to ensure that independently funded investigators have access to biomedical technologies and expertise that are not widely available and will enable biomedical research.

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research Resource? Will the investigators promote strategies to ensure a robust and accessible Resource, as appropriate for the relevant user community?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

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

Are the experimental station(s) and respective workspace(s) adequate and conducive to effective user access?

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity) contribute to the success of the project?

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.

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

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

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

Revisions

Not Applicable

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

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.

Scored Review Criteria - Administration, Technology Operations Core(s), and User Training and Outreach

Reviewers will consider the review criteria below in the determination of scientific merit and give a single separate score for each component (Administration, each Technology Operations Core and User Training and Outreach).

Administration

Are plans for the administration of the Resource appropriate? Is the user application process adequate and straightforward? Are there means to obtain access to the Resource technologies other than in person (e.g., remote access, mail-in access, etc.)? Are the instructions and materials provided for potential users (forms for accessing the Resource, evaluation forms, etc.) clear? Are the experimental station user interfaces straightforward and user-friendly? Are Resource users provided a means to submit feedback of their user experience at the Resource, and are plans for utilizing feedback appropriate? Is the Resource operating in an efficient manner to provide the best quality user facility possible? Are operating procedures in place to provide a safe and effective working environment for Resource users? Are appropriate contingency plans in place to reduce the impact of synchrotron dark periods, catastrophic equipment failures or other unanticipated outages? Is a sound plan in place for recruiting and retaining staff with the appropriate skills and knowledge? Is a sound plan in place for replacing staff who leave the resource, in order to minimize service disruptions?

Technology Operations Core(s)

Does the Technology Operations Core provide advanced technologies and services? Are the technologies and capabilities stable with regard to major developments? Are they appropriate for the anticipated research needs of the biomedical research user community?

Do the Resource users have a regional and/or national geographic distribution? Does the previous record of users demonstrate high demand for and productivity of a state-of-the-art research Technology Operations Core?

Are plans for the maintenance and operation of the Technology Operations Core adequate? Are appropriate plans in place to reduce the impact of equipment failures or outages?

Are appropriate upgrade plans presented to keep the Technology Operations Core functioning as a state-of-the art facility? Do the plans provided incorporate existing technology or off-the-shelf instrumentation (as opposed to new developments) whenever possible? If extensive engineering is involved, are appropriate technical review boards or other expertise consulted to provide adequate feedback through the development and implementation stages?

User Training and Outreach

Do the plans for user training ensure that Resource users can apply the Resource technologies effectively in their own research?

Are plans for outreach appropriate? Are sufficient activities planned to inform the scientific community about the technical capabilities of the Resource, promote and enable a broader use of the technologies, and actively recruit new user research projects from a diverse applicant pool? Do the plans assure that appropriate users will have fair access to the facilities and service?

Is a robust web presence described, or is one planned?

For Resources that are developing software, is the software portable when appropriate, well-documented, user-friendly, and readily available to the user community?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

• 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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.

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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.

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: Generaland 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:

• Federalwide Research Terms and Conditions
• 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, 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 45 CFR Part 75.205 and 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

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.

Tracking the demand for and utilization of the Resource is important for ongoing improvements in the short-term and for gauging impact of usage on the scientific field in the long-term. A reporting plan tailored to the Resource to best evaluate the productivity, availability, efficiency, and impact of the Resource is required. Report data on an annual basis to track the demand for and utilization of the Resource, as outlined in the Administration, Research Strategy's reporting plan. Sample data may include:

• Resource usage, including the total annual hours available at the facility, and aggregate information on hours dedicated toward maintenance, general user time, any other usage, and unused available time.
• For each Technology Operations Core, the user base. A list of the unique users served, the institutional affiliation of each user and compiled statistics showing the number of user groups accessing the Resource and the number of visits by each user and user group as well as geographic distribution information. A visit may be considered usage in person, by remote access, or as a mail-in sample with data collected by beamline staff. A breakdown of the statistics that reports visit type (in-person, remote, mail-in), and geographic distribution.
• The level of demand for each of the Technology Operations Cores in terms of number of user requests received and number granted access, and the total usage compared to available capacity.
• Funding source(s) for each user group project and a compiled summary table of projects associated with each technical capability. If the funding source is NIH, report the grant number that supports the project.
• Publications, PDB and other database depositions by users.
• Software downloads, data uploads and downloads, and website metrics.
• Several (3 or 4) science highlights that the resource enabled.
• Challenges to the resource, including but not limited to equipment failures, loss of key personnel, unexpected suspension of operations, etc., and solutions to these challenges.
• Metrics regarding user training and dissemination activities.
• Activities related to the Plan to Enhance Diverse Perspectives. For example, list efforts to provide training to individuals from underrepresented groups and outcomes from those efforts.

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 FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 (currently 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 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the Mature Synchrotron Resource program, employing the representative measures identified below. In assessing the effectiveness of research resource investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Investigator demographics
  • Institution types
  • Types and extents of resources provided
• Measures of resource utilization, such as:
  • Information about the size and characteristics of the userbase
  • Instrument time requested and fulfilled
  • Downloads and uploads of software or other research results
  • Publications citing use of the resource
  • Degree of dissemination of software, specimen, or reagent resources
• Indicators of research community outreach and engagement, such as:
  • Availability of user training materials
  • Evidence of activities to publicize services provided
  • Enhanced recruitment of researchers from underrepresented groups in biomedical research
  • Availability to users or other Resources of developed software and instrumentation technical design plans

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: http://grants.nih.gov/support/ (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: 301-480-7075

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

Thomas Cho, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Anne Gershenson, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

[email protected]
Center for Scientific Review (CSR)

Jennifer Billington
National Institute of General Medical Sciences (NIGMS)
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 45 CFR Part 75 and 2 CFR Part 200.