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). 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

Translating laboratory and clinical discoveries into interventions that improve human health is a complex process that typically takes years of effort. Multi-site clinical trials are a critical step in the translation pathway that allows preventive, diagnostic, or therapeutic interventions to benefit individual and public health. These trials may require substantial sample sizes to credibly test hypotheses. However, such trials often experience delays or even fail entirely due to challenges in recruiting participants. Such challenges are a multi-faceted problem with scientific, psychological, sociological, economic, political, and ethical dimensions. Addressing these challenges therefore requires a multi-faceted and out of the box approach, rather than small changes only to the status quo. Participant recruitment may benefit from innovation in the following areas:

• Access to data on the availability of potential participants rather than reliance on clinician estimates.
• Data that provide sufficient detail to take into account the specific entry criteria of a given protocol.
• Recruitment strategies that employ innovative approaches from other fields such as communications.
• Sharing of recruitment strategies, materials, and associated outcomes among participating research sites or between projects for ongoing innovation and improvement so that best practices can be developed and disseminated.
• Engagement of relevant stakeholders (e.g. potential participants and referring clinicians) early in the recruitment process.
• Reducing burden on participants, and making referrals easy for busy clinicians who may have many priorities competing for their time.
• Reframing proposed solutions to recruitment challenges as testable scientific hypotheses to allow for data-driven process selection.

This FOA is intended to develop and implement innovative informatics-driven approaches as well as the ethics and policy frameworks that will accelerate the design, conduct, and completion of multi-site clinical trials by establishing Clinical and Translational Science Award (CTSA) Recruitment Innovation Centers (RICs).

The goal of this initiative is to improve research participant recruitment in the planning and implementation phase of clinical trials.

In the planning phase of a clinical trial, the RICs will rapidly provide investigators and funders with estimates of the availability of candidate participants meeting the study’s entry criteria. Such estimates will be based on de-identified, aggregate data derived from the electronic health record (EHR) at individual sites and across the CTSA consortium.

In the implementation phase of a clinical trial, the RICs will support investigators through innovative strategies for enrolling research participants in a timely manner.

The Recruitment Innovation Centers that NCATS seeks to fund under this FOA will work together to harmonize approaches to research participant recruitment across the CTSA network. They will develop innovative solutions, demonstrate how these can be successfully applied to accelerate research participant recruitment, and over time establish best practices that can be generalized to a broad range of research studies. This initiative is aligned with NCATS recently enunciated goal of building CTSA network capacity. The RICs will work under joint governance with each other, with the Trial Innovation Centers (TICs) that NCATS is planning to establish to improve the implementation of multi-site studies, as well as with the CTSA hubs where liaison personnel will be introduced in parallel.

The main focus of this initiative is to improve recruitment into trials. However, there may be observational studies that could benefit from innovations in recruitment so that the term multi-site trial in this FOA is used in a broad sense for interventional and also observational research studies. Single-site or small multi-site studies are not the main focus. However, it is anticipated that the new tools and approaches created will be generalizable to widely benefit trials, and ultimately patients.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

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

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.

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 must download 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.

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. 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:

Petra Kaufmann, M.D., M.Sc.
Telephone: 301-435-0178
Fax: 301-480-3661
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions:

For this specific FOA, the Research Strategy section is limited to 30 pages.

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.

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.

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:

Specific aims: Applicants should describe their overall vision for a RIC and their specific aims in establishing and running innovative centers that can improve participant recruitment into multi-site clinical trials, a critical factor in translational research success. Specifically, applicants should address both the planning and implementation phases of multi-site clinical trials and include informatics, operational, ethics, and policy solutions. Applicants should also describe their vision for collaborating with the different units of the CTSA network and with other stakeholders in the clinical research enterprise.

Research Strategy:

Team: Applicants should describe how they will assemble a team of investigators who together have experience in clinical trials, research informatics, health information technology (IT), communications, regulatory knowledge, ethics and engagement of participant communities.

Informatics: Applicants should describe how they will integrate the electronic health record (EHR) with research systems; describe any experience they may have in using the EHR for recruitment or research; how they will deal with IT heterogeneity across the CTSA hubs and their spokes (such as affiliated hospitals or clinics); and propose innovative approaches that will allow researchers to rapidly access information across the CTSA network on the estimated number of potential research participants who meet the entry criteria of a given trial protocol.

Recruitment Tools and Methods: Applicants should describe how they will interact with trial investigators, funders, and most importantly with the broader patient community in the planning and implementation of multi-site research studies across a broad range of diverse populations. They should describe how they will use informatics approaches to rapidly estimate participant availability. They should outline how they will use innovative tools and methods to recruit research participants, such as social media; mobile technology; visual, video or multi-media recruitment materials; and how they will design recruitment strategies and materials at the RIC, adapt these to the participating CTSA hubs, track success, continuously improve and disseminate the tools and methods. Further, applicants should describe innovative strategies for engaging research participants as active partners in the research enterprise and how they will include relevant communities across the entire lifecycle of a project so that they can test the hypothesis that such partnerships do accelerate participant recruitment within the community of interest, in order to ascertain which methods are most successful in accelerating recruitment.

Specifically, applicants should describe how they might minimize the burden on participants who are interested in information or access to the trials. Applicants should also describe how they will develop and test innovative outside of the box recruitment strategies and how they will actively work with potential research participants and other relevant stakeholder communities, such as clinicians, patients, or community organizations, as applicable, to develop novel recruitment materials or media.

Applicants should also outline how they will raise awareness of a trial among clinicians, and how they might obtain feedback and foster engagement. They should outline how they might minimize the burden on clinicians in recruiting research participants, or how they might develop alternative approaches to offer research opportunities to potential participants via the local trial investigator, CTSA research unit, or academic-community partnership organizations, for example.

Applicants should also explain how they might address recruitment shortfalls. Applicants should summarize any prior experience they may have in developing and implementing recruitment strategies. Applicants should also describe how they will develop innovative and flexible solutions that can be adapted to the policies, guidelines, and culture at the participating CTSA hubs.

Participant and Community Input: Applicants should discuss strategies to ensure adequate representation of under-represented populations in clinical research, such as children, the elderly, or minority populations. This could be advanced through innovative strategies, for example in working with patient advocacy groups or academic-community partnership organizations.

Ethics and Policy: Applicants should describe how they will work with the CTSA hubs to develop generalizable solutions to recruiting participants that can be flexibly adapted to local guidelines and policies; and how they will work with their partners in the CTSA consortium to promote innovations while maintaining ethical standards, and while safeguarding privacy and autonomy.

Partnership and Governance: Applicants should propose how they will work with recruitment liaison units to be introduced at the CTSA hubs, taking into account different policy frameworks and research cultures that may exist at the sites, such as opt-in or opt-out choices for individuals to be contacted with research opportunities. Applicants should indicate how they will develop feasible and adaptable solutions, and efficient means of communication and coordination with the hubs.

Applicants should describe their plan to work with the other partners in the CTSA network under a common governance structure to be developed by NCATS. They should plan on developing (within the first six months of award) joint standard operating procedures to enable the RICs to collaborate closely and efficiently. They should also plan on developing joint standard operating procedures with the Trial Innovation Centers (TICs) and the CTSA hubs, delineating the scope of work for each party. Applicants should plan on participating in at least two annual in-person meetings with the leadership of all RICs and TICs and NCATS staff, and on regular telephone calls.

Metrics and Evaluation: Applicants should describe their approach to recruitment as a scientific problem, requiring the usual sequence of historical analysis, hypothesis formulation, intervention, measurement, and development of next steps based on data generated. Data on recruitment hypotheses, methods and results, including the use of common metrics for the CTSA network to be developed by NCATS, will be essential. Applicants may suggest metrics to be used.

Capacity: Applicants should provide an estimate of the capacity they are planning to create, for example by indicating the average number of participant recruitment feasibility analyses they anticipate being able to provide per month, as well as the number of trial recruitment strategies they would be able to design and implement per year.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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

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

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 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.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are the proposed plans likely to improve patient recruitment into clinical trials?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the proposed principal investigator and the leadership team collectively have experience in multi-site clinical trials and innovative informatics, health IT, communications, community engagement, participant recruitment, ethics, and regulatory knowledge to facilitate recruitment? Do the applicants provide evidence of collaborative skills necessary to interact productively with partners in the CTSA network, with investigators and funders, and with other stakeholders?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Do the applicants propose innovative approaches to participant recruitment? Is the innovation likely to create successful and generalizable solutions for participant recruitment?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Informatics: Does the approach address the utilization of EHR-based data across multiple sites with various technical capabilities? Does it appear technically feasible and likely to be successful?

Research Tools and Methods: Will the proposed solution increase the likelihood of successful participant recruitment? Is there a plan to address recruitment shortfalls? Is there a plan to track and evaluate the success of novel recruitment strategies and materials such that improvements can be made and best practices implemented?

Participant and Community Input: Are there adequate plans to engage research participants as active partners in the research enterprise and to include relevant communities, including under-represented communities such as children, the elderly, and minority populations?

Ethics and Policy: Are the plans appropriate to accommodate current ethics and policy frameworks, and to aim for innovation and harmonization with CTSA hubs, their partners, and other CTSA network resources?

Partnership and Governance: Do the plans to interact with NCATS, the CTSA hubs, other CTSA network resources including the Innovation Centers, the NIH ICs, and external partners indicate willingness to collaborate under a joint governance structure? Are there plans to develop joint standard operating procedures (SOPs) across the Recruitment Innovation Centers (RICs) within the first 6 months of the award?

Metrics and Evaluation: Do the applicants describe their approach to recruitment as a scientific problem amenable to hypothesis-based testing? Do the applicants propose a sound strategy to track and collect metrics?

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

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of adequate institutional support, from both the academic and hospital side of the institution, to suggest that the applicants will have appropriate access and resources?

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Not Applicable

Not Applicable

Not Applicable

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

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 NCATS, 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact scores.
• 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 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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NCATS Advisory 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.

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.

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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 RIC PD(s)/PI(s) will have the primary responsibility for:

Overseeing all operations of the RIC according to the plan outlined in the grant application, with modification as needed per NCATS including, but not limited to, collaboration with other CTSA network partners under standard governance, to safeguarding of human subjects, their data, and their privacy.

• Defining research objectives and approaches and for providing overall scientific and administrative leadership for the Research Project.
• Collaborating with other CTSA Innovation Centers in developing joint Standard Operating Procedures, as needed, subject to NCATS review.
• Obtaining prior written approval of the NCATS Grants Management Specialist in consultation with the NCATS Program Officer for any change in any of the key personnel identified in the Notice of Grant Award.

NIH staff has substantial programmatic involvement that ensures the success of the project, as described below:

The NIH Project Scientist (PS) will:

• Provide substantial programmatic involvement that that ensures the success of the project.
• Provide cooperation or coordination with, or assistance to, awardees in performing project activities, e.g., coordination with NIH ICs and other stakeholders.
• Participate on executive and operations committees as a voting member or in other functions responsible for helping to guide the course of long-term projects or activities; e.g., annual meetings.
• Have no involvement in normal program stewardship.
• Not attend peer review meetings of renewal or revision applications unless an NCATS waiver is obtained per NCATS procedures for management of concern about bias.

Additionally, an NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The NIH Program Official stewardship includes:

• Enforcement of general statutory, regulatory, or policy requirements.
• Approval of awardee plans prior to award and review of performance after completion.
• Evaluation of progress by reviews of technical or fiscal reports, by program visits, or with external consultants, to determine that performance is consistent with objectives, terms and conditions of the award.
• Technical assistance requested by awardees, or correcting programmatic or financial deficiencies in awardee performance.
• Scientific and technical discussions with awardees, or actions to facilitate or expedite interactions between awardees; e.g., organizing and holding meetings of investigators.

Areas of Joint Responsibility include:

[For those activities for which milestones are appropriate, e.g. hypothesis-driven testing of an innovative recruitment strategy prior to implementation, such milestones will be negotiated between NCATS Program Official and the PD/PI.]

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 Steering Committee 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Mary Purucker, M.D., PhD
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0741
Email: [email protected]

Hua-Chuan Sim, M.D.
National Library of Medicine (NLM)
Telephone: 301-594-4882
Email: [email protected]

Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-312-3745
Email: [email protected]

Melissa Austin Williams, MPA
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-402-7183
Email: [email protected]

Dwight Mowery
National Library of Medicine (NLM)
Telephone: 301-496-4221
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 74 and 92.