NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Synchrotron radiation is invaluable for structural biology research. To ensure that NIH-supported investigators have access to synchrotron beamlines for structural biology, 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 the support of mature NIGMS-supported synchrotron resources.

MX is the most commonly used synchrotron biology technique, with more than 90% of all macromolecular structures that are represented in the Protein Data Bank solved using synchrotron data. Most MX beamline resources rely on automation and user-friendly software that can guide strategic data collection, processing and even interpretation. They provide established technologies, requiring minimal development to maintain excellence. Other synchrotron-based techniques that provide important structural biology data may also be at a state of maturity such that they do not require further technology development before they can be made available to researchers at beamline resources. Examples include, but are not limited to, synchrotron-based solution scattering and spectroscopy.

NIGMS currently supports a number of synchrotron-based resources that have technology development as the focus. Over the last few decades, technology development for 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 user access, training and support in data collection, processing and analysis.

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. While the distinction between new development and upgrades that maintain current best practices may not always be clear, this FOA does not encourage or intend to support new technology development; other funding opportunities should be sought for such endeavors. Potential applicants are encouraged to contact NIGMS staff about this or any other issue.

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 mature technologies are encouraged to seek support under this FOA. Because structural biology resources fulfill an ongoing community need requiring stable support, NIGMS is able to fund only a limited number.

Funding through this FOA will support resource administration, technology implementation 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 Resources will consist of one Administration component, one User Training and Outreach component and one or more Technology Operations Cores. Each Technology Operations Core describes 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 is indeed comprised of well-established, mature technologies.

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.

Programmatic oversight should include monitoring the usage of the facility and productivity of the users. An external advisory committee for each Mature Synchrotron Resource is recommended.

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

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

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

This FOA is limited to applications requesting support for existing synchrotron resources that are currently, or recently have been, supported by NIGMS funding.

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

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

Applicant Organizations

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

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

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

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

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

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

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

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

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. This means that the NIH will not accept:

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity
• The letter of intent should be sent to:

Mary Ann Wu, Ph. D.
Telephone: 301-435-0787
Fax: 301-480-0884
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administration)	12
Project (Use for User Training and Outreach)	6
Core (Use for Technology Operations Cores)	12

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

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

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Administration: required; maximum of 1
• User Training and Outreach: required; maximum of 1
• Technology Operations Core(s): required, no maximum

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

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

Complete entire form.

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

Follow standard instructions.

Project Summary/Abstract: The application should include a succinct project 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:

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.).

Enter primary site only.

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

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

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

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

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

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

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 to biomedical research as well as its relationship to other similar resources within the US and 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 over the last 3 years, e.g., numbers of PDB submissions and publications enabled by the Resource through collaboration or service activities, service hours, number of users, etc., specified for each Technology Operations Core. 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 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

Other Attachments: Provide the following attachments:

User Forms: samples of any forms to be filled out by Resource users, both to apply for access to the Resource and to provide feedback afterward.

List all performance sites that apply to the specific component.

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

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

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

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.

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.

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 is 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.

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. The funds will be restricted for this purpose, and may not be re-budgeted without prior approval by program staff.

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

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

Specific Aims: State concisely 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, and
• Plans for Collecting and Reporting Metrics

Organizational Structure and Staff Responsibilities

Describe the organizational structure of the Resource. Indicate the relationship of the Resource to the administrative structure of the grantee institution. The PD(s)/PI(s), the Technology Operations Core Leaders and other key personnel should be appropriately trained for their respective roles, able to devote adequate effort to the Resource activities, 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 with respect to: Technology Operations Core user service and maintenance or upgrade projects, and Administration, User Training and Outreach activities

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. Include a description of how users are to acknowledge support provided by the Resource in any resulting publications and how they are instructed to do so. Describe processes for user Resource evaluation and feedback of user experience. Describe criteria and processes for scheduling and use of non-user beam time, including maintenance and technology implementation time.

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, one should not be constituted prior to or during the review of the application, and potential candidates should not be approached or discussed. 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 schedule in this section.

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 the productivity, availability, efficiency, and impact of the Resource. Provide a plan for collecting and reporting data on an annual basis for these purposes, as most appropriate for the proposed Resource. Examples of some 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 by the Resource; do not provide the data listed here in the application. Data demonstrating impact of the Resource on the research community should be included in the Overall section.)

• 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, the number of user groups accessing the Resource and the number of visits by each group. A visit may be considered usage in person, by remote access, or as a mail-in sample with data collected by beamline staff.
• The level of demand for each of the Technology Operations Cores in terms of number of user requests received and number granted access.
• 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
• Publications and PDB entries enabled by the resource.
• 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 dissemination activities.
• Workforce diversity is an important value of NIGMS, so a description of how the Resource plans to provide user training to individuals from underrepresented groups is encouraged (see https://www.nigms.nih.gov/Training/Diversity/Pages/Approaches.aspx for more information on how NIH defines underrepresented groups).

Letters of Support: Include letters of support following instructions found in the 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Administration)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

User Training and Outreach

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

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

Complete only the following fields:

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

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.

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.

Web Site: Costs for the development and maintenance of a web site 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 is 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)

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

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

Research Strategy: Describe, in separate sections, the:

• 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 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 collaborators and 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 web page or if applicable, of an existing Resource web page and provide a URL.

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. NIGMS encourages sharing of source code, consistent with the NIH data-sharing policy. Although software is not required to be open source, if a restrictive license will be used to distribute the software, written justification is required in the application.

Letters of Support: Include letters of support following instructions found in the 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (User Training and Outreach)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

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

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: User Research Projects

Provide five representative user research projects, a summary table 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 collaborating investigator of the user research project
• Institution of the collaborating investigator
• Source of funding support
• 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 Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (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. Note that funds may not be requested for alteration and renovation, or direct support for 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

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). 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. The funds will be restricted for this purpose, and may not be re-budgeted without prior approval by program staff.

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)

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

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 appropriate for the anticipated research needs of the biomedical research user community which 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 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).

Maintenance Activities

Describe plans for routine maintenance of the Technology Operations Core resources. Discuss the role and contribution of Resource staff in providing maintenance activities. Provide contingency plans for unexpected shut-downs or equipment failures. Describe operations during 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 and has utility for the user community at the Resource. Planned improvements should be discussed with Program 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 open source platforms, peer reviewed publications, and/or engineering plans.

Provide any plans for implementing technology needed to maintain the Resource at the state of the art. 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 found in the 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Technology Operations Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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.

Applicants are required to follow our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Resource 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 Resource 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 Resource 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?

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

Investigator(s)

Are the PD(s)/PI(s) and other personnel well-suited to their roles in the Resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in 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? If needed, does the applicant have experience overseeing selection and management of subawards?

For this FOA: Are the PD(s)/PI(s) well qualified to effectively administer 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? Do they have a history of performing services for the scientific community at large?

Innovation

Does the application propose novel management, training and outreach strategies in coordinating the research Resource? Are the concepts, strategies, or instrumentation novel 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 unbiased scientific approach across the Resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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?

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

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

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

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

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

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

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the Resource. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Not Applicable

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

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

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

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

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

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 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? Is the resource operating in an efficient manner to provide the best quality user facility possible?

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 that 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? Do the plans assure that appropriate users will have fair access to the facilities and service?

Is there a robust web presence, 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?

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 contingency plans in place to reduce the impact of equipment failures or outages? Are operating procedures in place to provide a safe and effective working environment for resource users?

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 reviews boards or other expertise consulted to provide adequate feedback through the development and implementation stages?

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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:

• 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, the number of user groups accessing the Resource and the number of visits by each group. A visit may be considered usage in person, by remote access, or as a mail-in sample with data collected by beamline staff.
• The level of demand for each of the Technology Operations Cores in terms of number of user requests received and number granted access.
• 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
• Publications and PDB entries enabled by the resource.
• 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 dissemination activities.
• Workforce diversity is an important value of NIGMS, so a description of how the Resource plans to provide training to individuals from underrepresented groups is encouraged (see https://www.nigms.nih.gov/Training/Diversity/Pages/Approaches.aspx for more information on how NIH defines underrepresented groups).

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Mary Ann Wu, Ph. D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-435-0787
Email: [email protected]

Ray Jacobson, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-996-7702
Email: [email protected]

Lori Burge
National Institute of General Medical Sciences (NIGMS))
Telephone: 301-451-3781
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.