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

Part 1. Overview Information
Part 2. Full Text of 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

The purpose of this Funding Opportunity Announcement (FOA) is to give laboratories specializing in cryoelectron microscopy (cryoEM) access to advanced cryoEM data collection.  It will support regional state-of-the-art data collection resources to serve cryoEM laboratories that do not have state-of-the-art equipment at their own institutions.  This FOA is a short-term initiative of restricted scope that addresses a specific immediate problem of access to expensive new technology for laboratories whose research is dependent upon cryoEM.  It is intended to support laboratories with an established independent specialization in cryoEM as reflected in publications and grants for established investigators, and publications for new investigators.

This FOA will support multi-institutional consortia that comprise a host institution and partner institutions.  A consortium will support surplus capacity for cryoEM data collection (infrastructure and services) at the host institution and make it available as a resource for participating cryoEM partner laboratories at the partner institutions.  Partner laboratories are only at the partner institutions; laboratories at the host institution are not supported by these consortia. In addition to the host institution, consortia must include a minimum of four partner institutions.  Award budgets will depend on the number and data collection needs of the participating cryoEM partner laboratories. The partner laboratories are headed by Partner Investigators; the Partner Investigators must be identified in the application as Senior/Key Personnel as described in Section IV, Part 2.

This FOA requires multiple Program Directors/Principal Investigators (PDs/PIs).  Each consortium will be directed by a team of multiple PDs/PIs, one representing each institution.  See Section III for FOA-specific eligibility information and Section VI for FOA-specific cooperative agreement information. When there is more than one participating cryoEM Partner Investigator at a partner institution, only one will serve as a PD/PI.

Consortia supported by these awards will provide access for cryoEM partner laboratories to resources and services at host institutions.  Projects will (a) contribute to the fixed costs of maintaining the host facility in proportion to the capacity dedicated by the host to the partners and (b) provide costs to support access by the partners.

The host institution should already have a modern high-performing cryoEM installation and proven capability for high-resolution data collection.  It should have sufficient capacity to accommodate the data collection needs not only of its own laboratories, but of the consortium partners as well.  Given that improvements in the quality and throughput of data collection by cryoEM installations with direct detection may exceed an order of magnitude, we anticipate that a host institution will be able to accommodate not only laboratories at the host institution, but additional users as well.  The host institution need not already have an electron detector; this FOA can help fund acquisition of direct detection equipment.

The only research activity directly supported by these consortia is the collection of cryoEM data and the initial stages of processing the raw images by the partner laboratories.  The partner laboratories will complete their analyses of partially processed data at their home institutions.

The purpose of consortium funding is to enable data collection by the partner laboratories.  Funding to the host institution is to enable it to support a resource for partners from non-host institutions.  Although this FOA does not support laboratories at the host institution, hosting a consortium may be advantageous for institutions that have surplus capacity for cryoEM data collection and need partners to share expenses for infrastructure.  Sharing of infrastructure expenses with a consortium may enable a host institution to support better infrastructure and services than it could afford without a partner.  

Since services at cryoEM installations are subject to interruptions by a variety of causes, NIGMS aims to achieve some redundancy of coverage with these consortia.  To ensure uninterrupted ability to collect data, eligible cryoEM investigators may participate in more than one consortium.  NIGMS staff will resolve issues with the assignment of partner laboratories between consortia after review. 

Awards will fund a specified fraction of the host institution's fixed expenses for operating the cryoEM installation, in return for its support of consortium investigators from the partner institutions.  Awards will fund travel, lodging, preparatory work, data collection, and data processing.  Awards can support service contracts, infrastructure expenses, personnel and operating expenses, consumables, repairs, software upgrades, data storage, and other expenses.  Awards can also support direct detection and other equipment where necessary (see Section II for budget limits).  Since the purpose of this FOA is access for partner laboratories, awards will provide all provisions for travel, lodging and laboratory facilities needed to make it affordable, practical, and productive for visiting consortium partners to utilize the facility.

In cases where the partner laboratories' needs for data collection exceed available resources, additional funds may be requested for equipment to expand existing capacity. See Award Budget Information in Section II.

Through the Revision option, consortia that were funded through RFA-GM-16-001 and RFA-GM-17-001 may request support to add new partner laboratories and institutions.  This option may also be used to request operating costs and/or equipment.  In accordance with the objectives of this FOA, the purpose of a Revision is either to add more partners to consortia, and/or to expand data collection capacity for the partners.

Research needs and activities that are not supported by this FOA include:

(a) Adoption of cryoEM by new users entering the cryoEM field.  Laboratories that do not already have an independent track record of specialization in cryoEM as an established research focus will not be supported by these consortia. 

(b) Research other than cryoEM data collection.  It is expected that direct electron detection will open numerous research opportunities, not only for structure analysis, but also for technical research and development.  Although the infrastructure provided by this FOA will enable such research, this FOA is intended only to support infrastructure and access, and not to directly fund research.  In this respect, it differs from resources that support research applications and technology development in addition to service and infrastructure.  Consortia are dedicated solely to the purpose of data collection by the cryoEM partner laboratories and should not include other research activities. 

(c)  Service for non-specialists.  These consortia differ from resources in which the host laboratory performs full service technical analysis for non-specialist collaborating laboratories.  They are dedicated solely to the purpose of data collection by the cryoEM partner laboratories and do not provide other services.

Applications that propose these activities will be deemed non-responsive and will not proceed to review.

This FOA specifies restrictions in purpose, eligibility and scientific scope, including kinds of laboratories, PDs/PIs, and activities supported. It also includes special application instructions (Section IV.2). Because of the restricted scope, special application instructions, and additional review criteria of this FOA, potential applicants are strongly advised to discuss their plans with the Scientific/Research contact listed in Section VII below.

A FAQ (Frequently Asked Questions) for this FOA is posted at http://www.nigms.nih.gov/Research/Pages/CryoEM-Consortia-RFA-GM-17-005.aspx.

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 including the NIH Intramural Program
• 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

In addition to the host institution, consortia must include a minimum of four partner institutions. 

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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.

This FOA requires multiple Program Directors/Principal Investigators, who must be designated in accordance with the instructions in the SF424 application guide.  There should only be only one PD/PI per partner institution (grantee organization).

Each PD/PI must head a laboratory with an established independent specialization in cryoEM as reflected in independent publications and grants for established investigators, and publications for new investigators.

Investigators (both PDs/PIs and partner laboratories) may participate in more than one application to this FOA.  CryoEM investigators who are not NIH or NIGMS grantees are welcome to apply to this FOA.  PDs/PIs of existing cryoEM centers and research resources are welcome to apply. 

Only cooperative agreements awarded under RFA-GM-16-001 and RFA-GM-17-001 are eligible for Revisions under this FOA.  The applicants must include all of the currently approved PDs/PIs of the consortium (i.e., the current roster of PDs/PIs after any post-award changes) and may include additional PDs/PIs.

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).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. 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 PDs/PIs
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Paula Flicker, Ph.D.
Telephone: 301-594-0828
Fax: 301-480-2004
Email: [email protected]

All page limitations 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 an application to this FOA.

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

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

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

Facilities & Other Resources:  Describe the capabilities of the host's microscope(s) and supporting facilities for high-resolution cryoEM data collection.  Describe laboratory facilities that will be available to visiting users.  Describe arrangements and costs of lodging and local transportation for visitors.

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

Partner Investigators: Every Partner Investigator must head a laboratory with an established independent specialization in cryoEM as reflected in independent publications and grants for established investigators, and publications for new investigators. Partner Investigators must be at partner institutions; investigators at the host institution may not be Partner Investigators.

Partner Investigators must either have the Project Role "PD/PI", or the Project Role Category "Partner Investigator". If there is only one Partner Investigator at a partner institution, that individual must be a PD/PI. If there is more than one Partner Investigator at a partner institution, one and only one must be a PD/PI; the others should be identified as "Other in the Project Role field and Partner Investigator in the Other Project Role Category.

Partner Investigators must commit effort to the project (see Budget instructions below). A biosketch must be included. The first sentence of the biosketch should identify the individual as a "cryoEM Partner Investigator." The biosketch must include the Partner Investigator's qualifications for membership in the consortium, referencing recent publications and grant support relevant to cryoEM.

Persons who are not PDs/PIs or Partner Investigators should only be included in Senior/Key Personnel if they have an essential role in the project that is described in the application and are committing effort to the project. They should be identified as "Other for the Project Role field. In the Other Project Role Category they should be identified with roles such as "Expert", "Collaborator", or "Consultant" that clearly distinguish them from the PDs/PIs and the Partner Investigators. A biosketch must be included.

The application should not include Project roles like "Co-PI", "Co-investigator", "Co-director", or variations on these titles that imply a PD/PI-like role. Project roles like "Facility Director" or "Manager" are acceptable for persons who will direct day-to-day operations but will not have a PD/PI role.

Persons who do not have specific roles in the project and are not committing effort, but are available for advice and consultation, may be included as Other Significant Contributors. For example, cryoEM experts at the host institution or elsewhere who will be available for consultation but have no effort committed to the project may be included as Other Significant Contributors.

Support personnel may be included in the budget justification but should not be listed in Senior/Key Personnel.

Previous experience with electron detectors and preliminary data from electron detectors are not required for the team, but teams should document their general qualifications and other experience relevant to adopting direct electron detection technology.  If teams lack direct experience with direct electron detection, they are advised to enlist expert consultants who can provide technical assistance.

All instructions in the SF424 (R&R) Application Guide must be followed. PDs/PIs and Partner Investigators who are not PDs/PIs must devote a minimum of 0.1 person month effort to the project.

Applications should request funds to support the travel, lodging and laboratory facilities needed to make it affordable, practical, and productive for visiting consortium partners to utilize the facility.

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

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

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

Research Strategy:  The purpose of a consortium is to support resources and services for cryoEM Partner Investigators (partner laboratories) who are not located at the host institution. The Research Strategy should address the purposes of these consortia as described in Section I and should not include other research. 

Specify the capabilities and services that will be made available to the partner laboratories.  Because the consortium will share facilities and services at the host institution with other users (for example, laboratories at the host institution), specify the fraction of resources, time, and effort that will be dedicated to consortium services.

Significance.  The Significance section should address the purpose and priorities of this FOA. 

Approach. Services.  Define the data collection capabilities that will be made available to the partner laboratories.  Describe the provisions and plans for processing of raw image data.  Describe how the microscope and supporting facilities for high-resolution cryoEM data collection will function.  Describe infrastructure support and services for users.  For each partner laboratory, describe the laboratory's scientific and administrative roles, interactions in the consortium, and how it will utilize the facilities. 

Resource Operations.  This FOA does not specify how awardees will organize or operate their resources.  Applicants must develop their own operating plans and describe them fully.  The Research Strategy should describe:  how communication will occur; how consortium personnel will be managed; resource allocation and scheduling; services and support; management of space and facilities for visiting users from the partner laboratories; orientation and assistance of users; coordination of this award with other support and research obligations of the host institution.  For each partner laboratory describe the number and duration of visits.  Estimate the expenses for users from the partner laboratories to visit the facility.  Describe how the needs and priorities of laboratories at the host institution will be balanced against those of the partner laboratories.

Describe how decisions will be made to drop and add Partner Investigators and partner institutions.  The plan should explain how the performance of the resource will be monitored and evaluated and how scientific directions will be set.

Technical Operations.  Describe establishment and operation of direct detection technology; performance standards and benchmarks; monitoring and maintaining instrument performance;   specimen preparation; data collection; computers and computation; software; data storage and transport.

Backup Plans.  Extended outages of facilities can unpredictably occur from fire, flood, earthquakes, accidents, theft, catastrophic equipment breakdowns and other causes.  The application should include plans for contingencies in which the host institution is unable to perform its functions for an extended period (months or longer).  They should include provisions for support (for example, alternative employment) of consortium personnel if they are unable to perform their 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 facilities.

Multiple PD/PI Leadership Plan: Explain how the interests of consortium users and laboratories at the host will be represented and reconciled by the leadership team.  If there is more than one Partner Investigator at an institution, explain how their interests will represented by one PD/PI on the leadership team. 

The sharing of management responsibilities by a team of PDs/PIs, rather than a single PD/PI, poses challenges for direction and management.  It is important that the applicants devise a robust and workable management scheme and describe it clearly and completely.  Useful guidance for management of projects by multiple investigators is posted on the NIH Multiple PD/PI webpages (http://www.grants.nih.gov/grants/multi_pi/).  Potential applicants are encouraged to consult the Institute Scientific/Research contacts listed in Section VII about their project management plans.

The PDs/PIs are solely responsible for project management.  Although the PDs/PIs may choose to appoint an advisory committee for their consortium, an advisory committee should be not used in lieu of the PDs/PIs for project management.  Plans for an advisory committee should not be included in the application.  Names of potential members of advisory groups or other persons who do not have a specific role in the project that is described in the application should not be included in the application, nor should they be contacted until the review process is completed.  For Revisions, if an advisory committee already exists, the members should be named; for resubmissions, if an advisory committee was proposed in the previous application and members were invited, they should be named.

Letters of Support:  Partner Investigators and senior/key personnel should not submit Letters of Support. Their participation should be explained in their biosketches and other parts of the application. Letters of support should be limited to: (i) persons who are named in the application and have a role in the project, for example expert consultants; and (ii) statements of commitment from institutional officials.  Statements of commitment from institutional officials should describe the extent of availability of facilities and services (percent time and effort) committed to the project.   Do not include letters from persons who do not have an assigned role in the project, for example, collaborators and users who are not consortium members.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The Resource Sharing Plan should explain how the project will follow all applicable NIH policies and guidance for sharing of resources and data.

Resources.  Applicants are expected to describe the major categories of resources likely to be produced and the plans for sharing them, as appropriate.  Where applicable, the plan should specifically address computer algorithms, and software (including source code).

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applicants are expected to identify data generated by the project that will be retained by the investigators but not be included in publications.  Applicants are expected to: Discuss the disposition (storage, disposal schedules) of raw high-throughput data; Identify categories of data that can be deposited in public databases and describe the plans for sharing them; and Identify categories of data for which public databases are not available, and describe the plans for sharing them as appropriate.  If data will be analyzed and retained, and the conclusions but not the data published, applicants are expected to describe the plans for sharing the unreduced data.  In all cases, applicants are expected to estimate the volume of data that will be retained.

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. The only appendices allowed for this FOA are vendor quotations.

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

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

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). 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.

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) 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. See Section III of this FOA for information on registration requirements.

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. 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 responsiveness by NIGMS. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

The requests by NIH intramural scientists will be limited to the incremental costs required for participation.   As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

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

For this particular announcement, note the following: The sole purpose of this FOA (described in in Part 2, Section 1, "Funding Opportunity Description") is to provide access to the cryoEM partner labs to state-of-the-art data collection capabilities and support.  The review criteria should be applied in the context of this purpose. 

This FOA is intended only to enable host institutions to house a shared resource that accommodates partner laboratories from non-host institutions.  Other than proportionate support (cost sharing) for the portion of host infrastructure dedicated to use by partner laboratories, this FOA is not intended to provide support to the host institution. 

This FOA is not intended to provide direct support for research activities, for example technology development or structure analyses.  Applicants were instructed to not include other research in their research plans.

For the Significance criterion, emphasis should be on the capabilities and accessibility of the infrastructure that will be supported.  Of particular importance are the expected benefits to the partner laboratories.  For the approach criterion, emphasis should be on the effectiveness of the plans for delivering affordable access and advanced technical performance for the partner laboratories, rather than on the research that will be conducted at the facilities.

Although direct electron detection technology is new, experience to date indicates that the technology can be readily adopted by cryoEM investigators who are experienced in electron microscopy and computation.  Hence, review emphasis should be on the qualifications of the investigators to master the needed proficiencies, rather than prior direct experience, preliminary data, and technical detail.

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 Consortium address the needs of the Partner Investigators that it will serve? Is the scope of activities proposed for the Consortium appropriate to meet those needs? Will successful completion of the aims bring the intended capabilities to the Partner Investigators?

Additional Questions: Will the proposed resource significantly improve access of the cryoEM partner laboratories to state-of-the-art data collection, including high performance direct electron detection?

Investigators

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Consortium? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research services? Do the investigators demonstrate significant experience with coordinating collaborative research? Do the PDs/PIs have appropriate expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Consortium?

Additional Questions: Are the Partner Investigators' inclusion and roles justified?  Do the personnel at the host institution and the Partner Investigators have a track record of achievement in cryoEM?  Do the quality and breadth of the investigators' publication records indicate that the consortium team will be able to develop the proficiencies needed to implement and utilize direct electron detection technology?  Will the investigators be able to fill their assigned roles and be resourceful enough to solve the kinds of problems expected to arise in the course of the research? 

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in providing research services to the Partner Investigators that the Consortium will serve? 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 organizational concepts, management strategies or instrumentation proposed?

Additional Questions: Does the resource open new areas of opportunity to the consortium members?  Will the resource offer the capabilities needed to make novel findings and new perspectives in structural biology? 

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Consortium? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is new, 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?

Additional Questions: Will access be affordable and practical for the partner laboratories?  Is travel supported?  Have practical benchmarks for technical performance and delivery of cryoEM services been set?  Are the plans for monitoring resource performance adequate?  If the applicants have not had extensive experience with direct electron detection, have they enlisted consultants and made provisions for getting any needed help?

Multiple PD/PI Leadership Plan. Are the PDs/PIs integrated into an effective team? Will the Multiple PD/PI Leadership Plan provide effective scientific direction? Is a robust framework for making decisions proposed? Are sound principles for scientific and budgetary decision making set forth? Have the applicants anticipated and addressed management issues and problems that may arise during the course of the project?

Environment

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

Additional Questions: Will the microscope installation and computing facilities at the host institution be able to deliver reliable high-resolution and high-throughput cryoEM data collection? Are accommodations for visiting consortium users (laboratory facilities and lodging) adequate?

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.

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 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 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 project. 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 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.

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 (GDS).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, 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.
• Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. 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. Relevance to the special purposes and priorities of this FOA as described in Section 1 ("Funding Opportunity Description") and the cost-effectiveness in providing access to cryoEM data collection capabilities to the partner laboratories at partner (non-host) institutions will be funding considerations.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PDs/PIs will have the primary responsibility for:

• The PDs/PIs will manage the project and have authority over the project's budget. The PDs/PIs will direct the project in accordance with the objectives of the FOA, the plans and other commitments in the application, and other agreements with NIH. Individual PDs/PIs are responsible for abiding by and implementing decisions made by the group.  The PDs/PIs will monitor performance in accordance with the scientific performance benchmarks in the Research Plan.  They should hold at least two official business meetings yearly.  These may be telephone conferences.
• All research publications supported by this grant must acknowledge its support by citing the grant number in the form "supported by NIGMS grant U24 GM000000".  The PDs/PIs should maintain a current listing of all publications supported by the grant, which includes the exact acknowledgement of support that appears in the paper.  This list should also explain the contributions of this grant to the publication.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• NIGMS staff (a Project Coordinator and a Program Officer) have substantial programmatic involvement in oversight of project management. 
• The NIGMS Project Coordinator  is the Institute point-of-contact for the PDs/PIs, except for special circumstances designated by NIGMS.  The Project Coordinator will attend all business meetings of the multi-PD/PI leadership team as a non-voting member and must be kept informed of all substantive deliberations and developments affecting the project.  The Project Coordinator will provide advice and guidance to ensure that the project adheres to the objectives of the FOA, the plans and other commitments in the application, the Terms and Conditions of Award, and other agreements with NIH.  The Project Coordinator will keep the PDs/PIs informed of any issues and concerns involving the project and provide advice on how to address them.
• Additionally, an NIGMS Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Officer will monitor the project on an ongoing basis and will formally evaluate the project on a yearly basis.  The yearly evaluation will be based on the non-competing application and progress report and recommendations of the Project Coordinator.  NIGMS will review the performance and utilization of the resource.  NIGMS will also monitor that project is being managed in accordance with the Research Plan and the directives of the PD/PI Leadership Team.  NIGMS must approve in advance (i) changes to the roster of PDs/PIs (ii) changes in the roster of partner laboratories, (iii) changes and exceptions to the plans and other commitments in the application, and other agreements with NIH, (iv) changes in the scientific scope of the project, (v) changes to the frequency of business meetings.
• Annual Review. NIGMS will make a yearly determination whether the investigators are working together effectively and successfully as a team to conduct the project.  As a team, the PDs/PIs are expected to consult with the partner laboratories and reach agreement about project management, including budgeting, personnel, and resource operations.  All participants are expected to abide by and support management decisions reached in accordance with the Multiple PD/PI Leadership Plan.  The Project Coordinator will consult yearly with the partner laboratories to assess performance.  If concerns are identified, the Project Coordinator will work with the PDs/PIs to develop plans to address them prior to the issuance of the continuation award.  If there are substantial changes in the roster or status of the partner laboratories, NIGMS may modify the budget and/or term of support.
• Special reviews. NIGMS does not anticipate conducting special or mid-course reviews of scientific progress beyond the normal yearly non-competing progress review.  However, if concerns are identified about the performance of the resource or the management of the project, NIGMS may conduct special reviews of the project as it deems necessary.  NIGMS may engage outside experts to assist in these reviews.  If concerns about the project arise and are not resolved, NIGMS may reduce or restrict the budget or reduce the term of support to phase out the project.
• The NIGMS Project Coordinator and the PDs/PIs will monitor the technical performance of the resource and the delivery of services.  In the event of long-term incapacitation of resource facilities, NIGMS may reduce the budget and/or term of support to phase out the project.

Areas of Joint Responsibility include:

• Before the initial award is made, NIGMS and the awardees may negotiate clarifications, changes, or additions to the plans and other commitments in the application, and other agreements with NIH.  Future changes to these plans may be made by the NIGMS and the PDs/PIs.  Changes will be documented by an exchange of correspondence and referenced in the Terms and Conditions of award.
• NIGMS and the PDs/PIs will agree on scientific performance benchmarks prior to award and document these by an exchange of correspondence and referenced in the Terms and Conditions of award.  These may be adjusted later by mutual agreement.

Dispute Resolution:

• Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the PDs/PIs chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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: http://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: 301-710-0267

Paula Flicker, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email: [email protected]

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3663
Email: [email protected]

Earl C. Melvin
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3912
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.