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

Required Application Instructions

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

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

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

This Funding Opportunity Announcement (FOA) invites applications for grants to build research infrastructure by providing medical rehabilitation researchers with access to expertise, technologies, and resources from allied fields such as neuroscience, engineering, applied behavior, and the social sciences. Medical rehabilitation involves basic and clinical studies in the domains of pathophysiology, impairment, functional limitation, disability, and societal interaction. Increasingly, research breakthroughs and potential therapeutic strategies are the result of integrating expertise from allied fields as well as building up a core understanding of rehabilitative mechanisms, therapeutic strategies, and clinical outcomes. Access to technologies and approaches from allied fields is key to promoting multidisciplinary collaborations and developing research opportunities. Centralized research infrastructure will enhance the capability of medical rehabilitation investigators to understand mechanisms of functional recovery, develop therapeutic strategies, and improve the lives of people with disabilities.

The aim of this FOA is to create a national network of research cores that will provide the broader rehabilitation researcher community with access to state-of-the-art expertise in biomedical, behavioral, and/or psychosocial fields that is particularly relevant to current opportunities in medical rehabilitation research. Applicants should propose a program of research resources and collaborative opportunities in a specific content area. This may be accomplished by providing access to research resources and expertise through a combination of workshops, written material, websites, consultations, collaborations, and pilot funding. In addition, the research core may support activities related to technique development, adaptation, and validation. Although examples of relevant expertise and content are provided below, additional areas may be proposed provided they are timely and appropriate for promoting medical rehabilitation research and improving outcomes for people with disabilities. Renewal applications would be considered, however programs are discouraged from seeking a third cycle of funding without substantially changing their targeted research infrastructure focus and support strategies in response to the evolving needs of the research community.

The mission of the National Center for Medical Rehabilitation Resources (NCMRR) is to enhance the quality of life for people with disabilities through research (NCMRR website). The NCMRR provides support for scientists to conduct research on impairments and functional changes associated with chronic physical conditions as well as rehabilitative strategies to reduce disability, improve health, and increase participation. The NCMRR is also tasked with coordinating rehabilitation research activities with other NIH Institutes and Centers and other federal agencies.

The mission of the NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NINDS will fund or co-fund meritorious applications that seek to provide resources that address identified gaps in rehabilitation research and education pertinent to advancing the state of scientific knowledge, improving clinical trial design, enhancing recovery of function and/or improving quality of life for individuals with neurological disorders or disease.

The mission of the NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. This is achieved through: research and development of new biomedical imaging and bioengineering techniques and devices to fundamentally improve the detection, treatment, and prevention of disease; enhancing existing imaging and bioengineering modalities; supporting related research in the physical and mathematical sciences; encouraging research and development in multidisciplinary areas; supporting studies to assess the effectiveness and outcomes of new biologics, materials, processes, devices, and procedures; developing technologies for early disease detection and assessment of health status; and developing advanced imaging and engineering techniques for conducting biomedical research at multiple scales.

In the context of this FOA, medical rehabilitation includes support and treatment for chronic conditions such as stroke, brain or spinal cord injury, orthopedic and joint conditions, and developmental and degenerative disorders. Investigations supported by NCMRR and other NIH Institutes support research at various levels: reducing pathophysiology, minimizing physical impairments, enhancing functional recovery, promoting learning and adaptation, preventing secondary complications, reducing disability and societal barriers, and enhancing overall health and quality of life. Research across these domains requires the integration of biological, engineering, and socio-behavioral approaches to understand the basis of chronic conditions, potential secondary complications, restorative therapies, and the interaction of the individual with his/her environment. A multidisciplinary approach to these goals is fundamental to medical rehabilitation practice.

In 1999, the NCMRR solicited applications for four regional research networks to promote resources, information, and networking in order to expand the capabilities and numbers of investigators who pursue research in medical rehabilitation. In 2004, the program evolved to its current form with additional cofunding support from the NINDS and the NIBIB to focus on providing nationwide access to unique expertise and research resources. With renewal in 2009 and again in 2014, the program expanded into additional research domains to provide continued support for the broader rehabilitation researcher community. At this point, the new NIH P2C funding mechanism is being used to replace the R24 mechanism for multicomponent activities.

With the current FOA, we are particularly interested in supporting infrastructure programs in clinical trial design, engineering and the environment, individualized medical rehabilitation and dynamic reassessment, and applied behavioral supports for rehabilitation research and healthy outcomes. Additional areas may be proposed, provided they can be justified as unique, state-of-the-art, teachable, and specifically related to medical rehabilitation research.

1. Clinical Trial Design: Clinical Trials have a special role in documenting the impact and efficacy of therapeutic interventions. Nowhere is this more important that in the area of rehabilitation research where trials must define and operationalize the active ingredient(s), account for unique patient and environmental factors, consider appropriate and clinically-significant outcome measures, and document the impact on functional improvement and health care utilization. Moreover, the lessons learned from rehabilitation trials would also improve clinical trial design in other domains, especially with respect to translating clinical finding into real-world outcomes and seeking durable outcomes. The purpose of this center is not to generate more clinical trials but rather higher quality and more impactful studies that influence clinical practice and access to health-care resources

Opportunities and needs in clinical trial design include:

• Extending acute treatments to more diverse chronic patient populations;
• Supporting the development of more complex treatment packages that integrate activity, electrophysiology, assistive technologies and/or pharmacological therapies;
• Strategies to identify and operationalize the active ingredient in clinical treatments, especially those that involve more complex mixtures of treatment modalities; designing appropriate contrast conditions to isolate potential treatment effects;
• Targeting and recruiting the appropriate patient populations that maximize the potential for demonstrating efficacy but also provide some generalization to diverse clinical populations;
• Promoting the use of randomized clinical trial design and alternative trial designs such as mixed-trial design, adaptive trial design, small N studies, and practice-based trials to demonstrate efficacy in real-world settings;
• Support for appropriate pilot studies, early-stage proof-of-concept studies and futility studies; support for dosing studies to optimize delivery of therapy;
• Promoting access to NIH Clinical Trial and Translational Science Awards (CTSAs), clinical trial networks, and patient registries;
• Strategies to identify potential confounds and environmental factors that may influence patient outcome, and to account for these in clinical trial design;
• Maximize the use of behavioral and psychosocial strategies to support better trial design and understanding their potential impact on outcome variables;
• Strategies to promote access to patient populations and recruitment, as well subject support and enhancing treatment compliance;
• Statistical support for power calculations on patient heterogeneity, proposed effect size, and recruitment numbers; support for data analysis and dissemination;
• Promoting the use of appropriate outcome measures: matching outcomes to the level of intervention and treatment mechanism; outcome measures validated for that patient population; connecting to common data elements (CDEs) and person-centered outcome instruments such as PROMIS, NIH toolbox, NeuroQOL; outcomes that are clinically significant for people with disabilities and that could impact clinical practice.

2. Engineering and The Environment: Environmental factors are central to the success of rehabilitation treatments and supporting functional gains. The development of assistive technologies varies widely depending upon the needs of the individual, family resources, and the larger environment where the technology will be used. Moreover, the issues and constraints in a laboratory setting are very different from those present in a hospital, public community, or home setting. Environmental factors could be positive or negative, and it is important for clinical researchers to consider how these factors impact the lives and goals of people with disabilities. With the advent of low-cost sensors, wireless communication, and motion-analysis techniques, new opportunities exist for the use of smart rehabilitation systems that sense the environment, communicate with the individual and rehabilitation specialists, promote rehabilitative therapies, and support health and independence. Engineering strategies could be particularly useful in understanding environmental supports and barriers, modifying key environmental factors, and integrating assistive technologies. Setting up a dialogue among clinicians, engineers, and people with disabilities will be important in order to identify needs, opportunities, and promote solutions.

Opportunities and needs in engineering and the environment include:

• Create a collaborative platform on environmental factors and engineering strategies among clinicians, engineers, and people with disabilities in order to identify needs and opportunities, and to promote practical solutions;
• Provide clinical rehabilitation researchers with engineering strategies to support key environmental and human outcomes and to promote novel applications of rehabilitation engineering to support functional gains, especially outside the clinical setting; develop, apply, and validate rehabilitation engineering applications in real-world environments;
• Sensors, wireless communication, and motion-analysis techniques to document outcomes and explore how people function in home and community environments;
• Provide training and resources for rehabilitation researchers, clinicians, bioengineers, and people with disabilities to promote the dissemination, translation, commercialization, and implementation of rehabilitative applications;
• Promote telerehabilitation and decentralized support of rehabilitation technologies; create systems for the global exchange of technical, engineering, and clinical information and the distribution of technological devices, equipment, and support to individuals with disabilities in low-resource settings; also the use of cyberphysical systems and assistive robot technologies;
• Innovative engineering solutions to promote independence in diverse environments (e.g., home, community, school, workplace, and recreational environments);

3. Individualized Medical Rehabilitation and Dynamic Reassessment: The diagnosis, treatment, and management of chronic disabilities require a complex assessment of the physiological and psychosocial state of the individual; careful evaluation of personal goals, needs, and resources; and a thorough understanding of clinical opportunities, treatment strategies, psychosocial support, and assistive technologies. Moreover, this must be a dynamic plan that allows for the changing state of the individual, evolving environmental factors, and health-care constraints in order to optimize therapeutic treatments and functional progress. There is a need to promote integrated research strategies that support patient-centered outcomes, better integrate clinical management, constantly reevaluate therapeutic opportunities, and document positive outcomes and comparative effectiveness. The overall objective is to develop practices that identify which therapies work best for which patients and in what manner of delivery.

Opportunities and needs in individualized medical rehabilitation and dynamic reassessment include:

• Efficient and effective diagnostic and prognostic strategies for multidisciplinary, but cost-effective baseline and longitudinal patient assessment to determine the initial extent of pathophysiology, impairment, comorbidities, and risk for secondary conditions - as well as the potential for adaptation, recovery, and response to various therapeutic interventions. This assessment should also include a psychosocial evaluation of patient motivation, resiliency, and possible response to various therapeutic modalities and clinical support strategies;
• Improved evaluation and prioritization of patient goals, expectations, resources, and family/community supports, with the understanding of how this intersects with clinical management goals. Patient evaluations should be sensitive to gender, racial, and ethnic factors, which may influence patient attitudes and family and community support;
• Strategies to predict, diagnose, and treat comorbidities and secondary conditions that may arise during the course of treatment;
• Development of dynamic plans that allow for changing patient attitudes and goals and changes in family and caretaker support. For children, plans should also allow for rapidly changing physiological, behavioral, and emotional development; for elderly, plans should support aging with a disability
• Improved connection of individualized goals to standardized and validated patient- outcome instruments (e.g., PROMIS, NIH toolbox, NeuroQOL);
• The development and validation of surrogate measures of plasticity, adaptation, and recovery, especially those that provide early indications of patient response and functional improvement;
• Identification of genomic factors and molecular biomarkers that provide insight into possible differences in patient pathophysiology and response characteristics;
• The dissemination of treatment theory and clinical decision trees into clinical practice;
• Documenting how individualized medicine and dynamic reassessment impacts patient outcomes and health-care utilization.

4. Applied Behavioral Supports for Rehabilitation Research and Healthy Outcomes: Support of rehabilitative therapies and improved outcomes requires a sustained commitment from the subject. Various strategies grounded in applied behavior are key for connecting to patients and motivating them to support clinical treatments and health lifestyles. Successful treatment strategies require a rich understanding of patient attitudes, adjustments, and reactions, including the positive and negative spirals that link patient activities, functional change, and secondary consequences, and patient health. A better understanding of behavioral mechanisms would also enhance research studies and clinical trial design.

Opportunities and needs in applied behavioral supports for rehabilitation research and healthy outcomes include:

• Improved strategies for understanding patient attitudes, motivation, resiliency, and response to potential therapeutic modalities and clinical-support strategies. Also, how patient decisions are influenced by the quality of provider communication and health literacy;
• The role of modifiable lifestyle behaviors on the effectiveness of rehabilitation interventions, occurrence of secondary conditions, and health outcomes, especially the role of exercise, diet, and sleep;
• The impact of sociodemographic, racial/ethnic, and gender factors on the delivery of treatment and rehabilitative outcomes; this may include culturally-derived traditions and beliefs on what constitutes a disability and family/community responsibilities;
• The role of comorbidities and secondary symptoms (e.g., pain, cognitive impairment, depression, addiction) that impact behavioral domains, and importance of addressing these factors in effective rehabilitation programs;
• The ability of self-management strategies to help individuals better understand and manage their impairments and disabilities, cope with stressors, adhere to rehabilitation regimens, and avoid negative health spirals;
• Promoting technology for delivering rehabilitation interventions, telemedicine, and supporting independence; and the importance of tailoring the delivery of these technologies to the appropriate demographics (e.g., age group), socioeconomic background, and cultural context of the target audience;
• Improved understanding of the mechanisms and linkages of healthy behaviors, secondary factors, and negative and positive spirals that arise in people with disabilities;
• The impact of psychosocial issues associated with disabilities on treatment delivery and research design (e.g., social withdraw, loss of self-efficacy and self-esteem, lack of social support, difficulty in adjusting to a changed environment, depression and addiction);
• Unique behavioral, psychosocial, and developmental issues related to children; conversely, issues associated with aging with a disability;
• Challenges experienced by caregivers and family members of individuals with disabilities, including musculoskeletal injuries, general health, stress, and economic insecurity.

The purpose of the medical rehabilitation research infrastructure program is to provide researchers with access to specialized expertise and resources not typically available through their departments, institutions, and other professional associations. This includes the introduction from allied fields of cutting-edge technologies and approaches that are particularly timely for understanding physiological, behavioral, and psychosocial processes and for promoting rehabilitative outcomes. The emphasis should be on approaches that are relevant to current research opportunities in medical rehabilitation and those that can be transmitted through a concerted program of promotion, technology dissemination, and collaborative opportunities.

The NIH continues to encourage institutions to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds.

Applicants should propose a program of outreach, research resources, and collaborative opportunities in a specific content area that includes the following:

Promotion and Outreach: Workshops, and demonstrations may occur at the applicant institution, at national meetings and other public venues, or through virtual meeting technologies, as appropriate. When possible, activities should be available for remote viewing and archived for possible screening at a later date. In addition, the core has the responsibility to make its activities, resources, and opportunities known to the basic and clinical rehabilitation research community and allied fields. This may be accomplished through some combination of advertisements in professional journals, newsletters, and websites; contacts with relevant research departments and funded researchers; presentations at professional meetings; and other means, as appropriate. The program should develop a web portal that helps to promote outreach, with connection to archived research resources (e.g., research manuals, background information, reference articles, databases, and contact information, as appropriate).

Collaborative Opportunities: The core should provide consultative services, hands-on research experience, and opportunities for visiting rehabilitation researchers to work with experts at the grantee institution, as appropriate. There should be a formal plan for promoting, supporting, and prioritizing interactions. It is expected that the home institution of the visiting researcher would share substantial responsibility for financial support of the candidate's extended visit.

Techniques Development: Applicants may propose activities at the grantee institution to further develop, adapt, and/or validate core research techniques, tools or other resources. These activities must be focused on improving access, utility, and validity of these approaches for the medical rehabilitation research community.

Pilot Studies: Each infrastructure program must set aside funds to support small pilot research studies by qualified investigators (generally from other institutions) who are accessing core resources and have the potential to develop competitive rehabilitation research applications to the broader NIH (or equivalent). There should be a formal process to advertise, review, and prioritize pilot funding. Researchers associated with the infrastructure grant may be considered for pilot funding, but first priority should be researchers from other locations. The distribution of pilot funding will require negotiating with secondary institutions to transfer grant funds in the most efficient manner.

Administrative Oversight: The applicant should present a clear model of managerial oversight, responsibilities, and commitment to this program, which includes the role of key personnel and their expertise. The research core must develop formal plans for prioritization of resources, access guidelines, quality control, improved responsiveness to the research community, and documentation of overall-effectiveness and impact. Oversight must include the use of an external advisory board. In addition, rehabilitation infrastructure programs would be expected to collaborate with other infrastructure programs in the network as appropriate.

Collaboration with Other Institutions (optional): Collaborations may be used to provide access to additional expertise or resources essential for the proposed goals of the research core.

Frequently Asked Questions

An additional 'Frequently Asked Questions' site will be accessible at www.nichd.nih.gov/about/org/ncmrr/Pages/RehabInfrastructureRenewalFAQ.aspx

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

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

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

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

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ralph Nitkin, PhD
Telephone: 301-402-4206
Fax: 301-402-0832
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Promotion and Dissem: Use for Promotion and Dissemination	12
Collab Opportunities	6
Tech Development	6
Pilot Studies	6
Admin Oversight	12

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed. Note: Depending on the research domain and the strategies used, some of the components above may be described in significantly fewer pages than the maxima indicated above.

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

The application should consist of the following components:

• Overall: required
• Promotion and Dissemination: required; maximum of one
• Collab Opportunities: required; maximum of one
• Tech Development: required; maximum of one
• Pilot Studies: required; maximum of one
• Admin Oversight: required; maximum of one

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

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

Complete entire form.

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

Follow standard instructions.

Enter primary site only.

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

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

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

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

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

Specific Aims: Briefly state the proposed research domain(s), expertise, and key resources - as well as the specific strategies for promoting and teaching these opportunities to the larger research community.

Research Strategy: Discuss the philosophy, objectives, and potential impact of the proposed research core on medical rehabilitation research. Describe how it would build on resources and expertise of the applicant institution (and collaborative institutions, if appropriate). Provide some background on the broader field(s) of expertise involved, including recent advances, limitations, and overall impact on biomedical research. Make clear why this unique expertise would be particularly appropriate and timely for medical rehabilitation researchers. Describe the scope of the research core proposed, including the techniques, approaches, resources, and opportunities that it will provide to the rehabilitation community. Indicate which rehabilitation researchers would be the primary target(s) of this core and what sort of background would be required to take advantage of these opportunities. Indicate how readily this expertise or technology could eventually be franchised out to interested researchers and their departments.

The NIH continues to encourage institutions to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Within the context of providing research infrastructure to the broader community, discuss efforts to particularly promote diversity within the NIH-funded scientific workforce. Applicants should describe how they will identify and address barriers that may impede the participation of underrepresented racial and ethnic minorities, persons with disabilities and women in the proposed program. The program should discuss special efforts to connect to appropriate researchers and their mentors and even possible accommodations to support collaborative opportunities.

Letters of Support: Include here any letters of support for the proposed research program as a whole.

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 submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

Generally, Resource Sharing Plans are expected especially if the propose infrastructure program would be developing resources and materials useful for the larger rehabilitation research community.

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 preparing your application in ASSIST, use Component Type Promotion and Dissem .

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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

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

Specific Aims: Provide a brief outline of the range of activities proposed along with organizational structure and possible venues; also include strategies for promoting core expertise and resources into the research community.

Research Strategy: Describe the specific mix of, workshops, website interactions, and demonstrations proposed. For each activity, provide some detail on the proposed content, format, relevant expertise and resources, target audience, and planned venue. Discuss how often these activities will be offered and how they will be promoted, evaluated, and archived (if appropriate).

Briefly describe the target audience and potential secondary audiences for the range of research opportunities proposed. Discuss how the core would make its activities, resources, and opportunities known to the research communities and allied fields. For example, this may include some combination of advertisements in professional journals, newsletters, and websites; contacts with relevant research departments and funded researchers; presentations at professional meetings; and other means, as appropriate. Also, describe how the program would develop a web portal to promote outreach, with connection to archived research resources (e.g., research manuals, background information, reference articles, databases, and contact information, as appropriate). A particular effort should be made to promote research opportunities for individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences.

Letters of Support: Include any letters of support specific to this component.

• 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:

Generally, Resource Sharing Plans are expected for the package as a whole, but need not be discussed component by component in this FOA.

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.

Not Applicable

Not Applicable

When preparing your application in ASSIST, use Component Type Collab Opportunities .

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

SF424 (R&R) Cover (Collab Opportunities)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Collab Opportunities)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Collab Opportunities)

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

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

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

Project /Performance Site Location(s) (Collab Opportunities)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Collab Opportunities)

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Collab Opportunities)

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

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

PHS 398 Research Plan (Collab Opportunities)

Specific Aims: Briefly indicate the range of consultative and collaborative opportunities proposed and specific laboratories or resources that they would connect to.

Research Strategy: Discuss the range and depth of consultative services and logistical support that would be provided. Enumerate the laboratories, projects, and resources at the applicant institution (or at collaborative sites, if applicable) that could offer potential hands-on and other collaborative opportunities. Discuss how these interactions could be incentivized and sustained (i.e., potential benefits to the host laboratory that sponsors such interactions and the appropriate time commitments required). Discuss how the logistics of on-site collaborations might be negotiated with the home institution of the visiting researcher (the expectation is that the home institution of the visiting researcher would take substantial responsibility for financial support of the candidate's visit). There should be a formal plan for promoting, supporting, prioritizing, and evaluating collaborative interactions.

Letters of Support: Include any letters of support specific to this component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

Generally, Resource Sharing Plans are expected for the package as a whole, but need not be discussed component by component in this FOA.

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.

Planned Enrollment Report (Collab Opportunities)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Collab Opportunities)

Not Applicable

When preparing your application in ASSIST, use Component Type Tech Development.

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

SF424 (R&R) Cover (Tech Development)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Tech Development)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Tech Development)

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

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

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

Project /Performance Site Location(s) (Tech Development)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Tech Development)

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

Budget (Tech Development)

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

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

The Tech Development Core may include activities at the grantee institution to further develop, adapt, and/or validate core research techniques, tools or other resources. Up to $100,000 per year (direct costs) may be directed toward these activities provided they are focused on improving access, utility, and validity of these approaches for the medical rehabilitation research community.

PHS 398 Research Plan (Tech Development)

Specific Aims: Briefly describe overall strategies for techniques development in order to make the research core more responsive to the needs of the research community.

Research Strategy: Describe the state of the technologies and expertise proposed and whether further modification would be required and/or warranted during the course of the project. Discuss plans for technology development, assessment, access, adaptation, and validation in order to better serve the rehabilitation research community. This may include plans to modify technologies and resources to make them more appropriate for specific clinical conditions, populations (e.g., children or minorities), or other specialized research applications. Some validation studies may be appropriate, but direct support for large-scale studies and clinical trials are beyond the scope of these infrastructure grants and should be supported by other means.

Letters of Support: Include any letters of support that are specific to this component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

Generally, Resource Sharing Plans are expected for the package as a whole, but need not be discussed component by component in this FOA.

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.

Planned Enrollment Report (Tech Development)

Not Applicable

Not Applicable

When preparing your application in ASSIST, use Component Type Pilot Studies.

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

SF424 (R&R) Cover (Pilot Studies)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Pilot Studies)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Studies)

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

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

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

Project /Performance Site Location(s) (Pilot Studies)

List all performance sites that apply to the specific component. This would refer to the part of the applicant institution that administers the pilot program but not the potential institutions where the pilot funds would be used.

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

Research & Related Senior/Key Person Profile (Pilot Studies)

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

Budget (Pilot Studies)

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

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

Each infrastructure program may set aside funds up to $150,000 per year (direct costs) to support small pilot research studies by qualified investigators (generally from other institutions) who are accessing core resources and have the potential to develop competitive rehabilitation research applications to the broader NIH (or equivalent).

PHS 398 Research Plan (Pilot Studies)

Specific Aims: Briefly present a strategy for identifying, reviewing, prioritizing, and funding pilot research projects that arise from interactions with the research infrastructure core.

Research Strategy: Provide a formal plan to invite, review, and prioritize requests for pilot funding that arise from interactions with the research core. Include details on eligibility criteria, evaluation, and likelihood of leading to a competitive NIH (or equivalent) research application. Researchers associated with the infrastructure grant may be considered for pilot funding, but first priority should be researchers who come to the infrastructure network from external locations. Applicants are encouraged to provide pilot funding and other opportunities to qualified individuals who are currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds. The leveraging of pilot funding will require strategies for negotiating with secondary institutions to transfer grant funds in the most efficient manner.

Letters of Support: Include any letters of support that are specific to this component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

Generally, Resource Sharing Plans are expected for the package as a whole, but need not be discussed component by component in this FOA.

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.

Planned Enrollment Report (Pilot Studies)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Studies)

Not Applicable

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

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

SF424 (R&R) Cover (Admin Oversight)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Admin Oversight)

Enter Human Embryonic Stem Cells in each relevant component.

Not applicable.

Research & Related Other Project Information (Admin Oversight)

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

Not applicable.

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

Not applicable.

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

Project /Performance Site Location(s) (Admin Oversight)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Admin Oversight)

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

Budget (Admin Oversight)

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

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

PHS 398 Research Plan (Admin Oversight)

Specific Aims: Briefly present a strategy for administrative oversight, including roles, responsibilities, and procedures. This may include reference to quality control, responsiveness, and documenting impact on the research community. The plan should also incorporate an independent advisory board.

Research Strategy: Describe the administrative organization of the research infrastructure core. This should include descriptions of roles and responsibilities. There should be a formal plan to interface with the medical rehabilitation research community, promote access to resources, deal with competing demands on facilities, evaluate quality control, improve responsiveness, and document overall effectiveness and impact on medical rehabilitation. Include plans for an independent advisory board to provide guidance on resources and interactions with the medical rehabilitation community. New applications should not list specific advisory board members, but indicate the types of people who would be appropriate for these roles. Renewal applications should list advisory board members who participated previously. Rehabilitation infrastructure programs would be expected to collaborate with other infrastructure programs funded under this FOA, as appropriate; however this would depend on the range of programs that get funded under this FOA and their potential synergy.

Letters of Support: Include any letters of support that are specific to this component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

Generally, Resource Sharing Plans are expected for the package as a whole, but need not be discussed component by component in this FOA.

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.

Planned Enrollment Report (Admin Oversight)

Not Applicable

Not Applicable

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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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 NICHD 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.

For this particular announcement, reviewers will emphasize the ability of the applicant to provide access to unique resources and expertise that are particularly relevant to the broad field of medical rehabilitation research, including quality of the resources and expertise; unique nature of research opportunities and collaborations; proposed strategies for promoting, teaching, and supporting research opportunities; leveraging of resources; promotion of a diverse workforce; and administrative vision, management, and prioritization.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the infrastructure program 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 infrastructure program 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 program that by its nature is not innovative may be essential to advance a field.

Does the infrastructure program address an important problem or a critical barrier to progress in the field? If the aims of the infrastructure program 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?

How significant and unique are the proposed expertise and resources?

How appropriate is the proposed domain of research for the broader field of medical rehabilitation research?

Does the application provide access to unique expertise, resources, and opportunities that would not be readily available elsewhere or through other means? Are the proposed research domains/expertise particularly relevant to the broad field of rehabilitation research? Would access to the proposed research infrastructure advance some key aspects of rehabilitation research and provide opportunities for improved researcher applications?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the infrastructure program? 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 applicants have some history of supporting and incentivizing collaborative approaches and managing research priorities?

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?

Are there innovative strategies for promoting research opportunities to diverse communities? Are the applicants promoting remote learning and collaborative opportunities through the innovative use of the internet (e.g., webinars) and other social media approaches?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the infrastructure program? 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?

If the infrastructure program 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?

Would the program provide access to cutting-edge, state-of-the-art technologies and approaches?

Are there appropriate strategies for providing direct access to expertise and resources?

Is the proposed expertise "teachable" in a manner that would make it accessible to the accessing researchers?

Is the proposed research domain(s) clearly defined with access to the necessary expertise, teaching strategies, and collaborative opportunities?

Is there an active plan for understanding the needs of the research community, improving responsiveness, and prioritizing resources?

Is there a plan for evaluating the impact of the proposed infrastructure program on the rehabilitation research community?

Does the applicant propose appropriate strategies to promote and support diversity across the NIH-funded scientific workforce?

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?

Does the applicant institution (and collaborative sites) provide access to cutting-edge expertise, technology, and resources?

Does the applicant institution (and collaborators) have the necessary resources to promote and support research collaborations?

Does the applicant institution provide the necessary support for a rehabilitation research infrastructure program, including the leveraging of additional institutional resources where appropriate?

As applicable for the infrastructure program 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 infrastructure program 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

For Renewals, the committee will consider the progress made in the last funding period and the overall impact on the rehabilitation research field; this may include the following: the number of research contacts supported, the quality of research collaborations, successful use of pilot funding strategies, and the resulting number of research applications from infrastructure consumers to federal agencies and other funding sources. In addition, any infrastructure programs seeking renewal must demonstrate a continued need for research support in the proposed domain and a continuing commitment to improving research infrastructure support and responding to the needs of the research community.

Not Applicable

As applicable for the infrastructure program 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) Genome 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.

As applicable for the Research Infrastructure Program proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an impact score for Promotion and Dissemination, but will not give separate scores for these items.

• Given the expertise proposed, is the proposed mix of workshops, and/or demonstrations appropriate?
• Are there innovative strategies for promoting, conducting, archiving, and evaluating these opportunities?
• Are the proposed frequencies of offerings and venues appropriate?
• Are there sufficient expertise and administrative support for the proposed activities?
• Does the applicant have a good fix on their target audiences?
• Have they proposed an appropriate strategy to promote expertise to the broader rehabilitation research community?
• Do they incorporate creative use of promotional activities and networking opportunities?
• Would the proposed web portal provide a good connection to the breadth of opportunities and resources?
• Would the website provide access to a useful array of materials and/or references?
• Did the applicant make a particular effort to promote opportunities to individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences?

As applicable for the Research Infrastructure Program proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an impact score for Collab Opportunities, but will not give separate scores for these items.

• Does the applicant provide access to consultative resources and in a manner that would be useful to outside researchers?
• Given the research domain proposed, does the applicant institution provide the appropriate mix of collaborative opportunities and direct hands-on activities?
• Are the participating laboratories and other venues committed to supporting proposed consultations and collaborations?

As applicable for the Research Infrastructure Program proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an impact score for Tech Development, but will not give separate scores for these items.

• To what extent would the proposed technologies and expertise need to evolve and be optimized during the course of the grant?
• Does the applicant provide appropriate strategies to evaluate and be responsive to the needs of the research community?
• Are there appropriate strategies to modify and validate the application of the proposed technologies/expertise to specialized rehabilitative populations and other targeted applications?
• Would the proposed investment of funds in technology development benefit the broader rehabilitation research community?

As applicable for the Research Infrastructure Program proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an impact score for Pilot Studies, but will not give separate scores for these items.

• Does the applicant have an appropriate strategy for advertising the pilot study program and for reviewing and prioritizing requests?
• Has the applicant laid out appropriate criteria for prioritizing the outlay of pilot funding?
• Does the applicant have a strategy for following up and evaluating pilot funding investments?

As applicable for the Research Infrastructure Program proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an impact score for Admin Oversight, but will not give separate scores for these items.

• Does the applicant provide a solid organizational structure with clearly defined roles and appropriate personnel?
• Is there an appropriate plan for administrative oversight and prioritization of resources?
• Is there an appropriate evaluation plan to improve responsiveness and document effectiveness and impact?
• Are there appropriate plans to develop an effective advisory board?
• Would the proposed program have opportunities to interact with other rehabilitation infrastructure programs funded under this FOA?

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

As part of the scientific peer review, all applications:

• 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 score.
• 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Synergy with other meritorious infrastructure applications submitted to this FOA; thus it is possible that more than one application could be supported in one or more of the key domains.

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

Not Applicable

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

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 Center Telephone: 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)
Telephone: 301-710-0267
Email: [email protected]

Ralph Nitkin, PhD
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4206
Email: [email protected]

Daofen Chen, PT, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: [email protected]

Lyn Jakeman, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: [email protected]

Grace Peng, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
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 Parts 74 and 92.