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

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

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

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the National Center for Medical Rehabilitation Research (NCMRR), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute on Deafness and other Communication Disorders (NIDCD), the National Center for Complementary and Integrative Health (NCCIH), and the National Institute of Nursing Research (NINR) invite 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 an understanding of rehabilitative mechanisms, therapeutic opportunities, and clinical outcomes. 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. This FOA represents the fourth renewal of this highly successful and evolving research infrastructure program.

The aim of this FOA is to create a national network of research centers that will provide the broader rehabilitation research community with access to state-of-the-art collateral 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 mentored collaborative opportunities in a specific content area. This may be accomplished through a combination of didactic interactions (workshops, courses, written material, and websites), consultations, mentored collaborations, and pilot funding. In addition, the research center may support local institutional 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.

In addition, an infrastructure applicant may also propose to take on the overarching role of a network coordinating center to promote the overall infrastructure program, including the development of a web portal, coordinate trans-center activities, and document infrastructure outcomes and impact.

The mission of the NCMRR (located within the NICHD) is to enhance the quality of life for people with disabilities through research (NCMRR website at www.nichd.nih.gov/about/ncmrr/ncmrr.htm). 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. Of special interest are applications that seek to address resource gaps leading to interventions that can eventually be tested in NINDS supported clinical trial funding announcements or clinical trial networks.

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.

The mission of NIDCD is to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. The institute also conducts and supports research and research training related to disease prevention and health promotion; addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders; and supports efforts to create devices which substitute for lost and impaired sensory and communication function.

The National Center for Complementary and Integrative Health (NCCIH) will support research on optimization of nonpharmacological therapies for acute or chronic pain conditions, including chronic low back pain, that are treated with complementary and integrative health approaches. Examples of complementary and integrative health approaches relevant to this FOA include, but are not restricted to, natural products (e.g., herbs, prebiotic, probiotics, and selective medical diets, and mind and body practices (e.g., acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), and music/art therapies.

The mission of NINR is to promote and improve the health of individuals, families, and communities. To achieve this mission, NINR supports and conducts clinical and basic research and research training on health and illness, research that spans and integrates the behavioral and biological sciences, and that develops the scientific basis for clinical practice.

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, developmental and degenerative disorders, cardiovascular and pulmonary rehabilitation, and support for cancer survivors. Investigations supported by NCMRR/NICHD and other NIH Institutes explore 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 for people dealing with chronic conditions. 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.

With the current renewal, the highest priority will be given to applications that address research gaps in the current NIH rehabilitation research portfolio, as highlighted below. Additional areas may be proposed, provided they can be justified as unique, state-of-the-art, teachable, and specifically relate to the 2016 NIH Research Plan on Rehabilitation Research: https://www.nichd.nih.gov/sites/default/files/publications/pubs/Documents/NIH_ResearchPlan_Rehabilitation.pdf

1. Pediatric Rehabilitation

An analysis of the NIH rehabilitation portfolio points to a particular need to promote research in pediatric rehabilitation. There is a growing recognition that the interaction of normal development and aberrant plasticity poses unique challenges for rehabilitation and promoting function. There is a critical need to involve families and caregivers in treatment delivery, and to provide developmentally appropriate care and support. For children, rehabilitation may require unique approaches, implementation strategies, delivery models, or other considerations given the developmental stage of the individual, extent of disability and comorbidities, family resources, social context, and environmental challenges. The infrastructure center should also support the recruitment, support, and protection of children and their families in rehabilitation research studies.

2. Personalized Medicine Approaches

Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual differences in genes, premorbid health, environment, lifestyle, and other personal factors. The heterogeneity of contributing conditions, unique physiological and psychosocial interactions, comorbidities and secondary conditions, complex interactions with environment, and consideration of longer-term trajectories, provides a special application of personalized medicine to identify the unique needs, supports, and optimal treatment strategies for persons with disabilities. Special consideration should also be given to coping with chronic pain, sleep disturbances, reduced cardiovascular function, and cognitive or behavioral impairments - and their impact on functional capacity and overall disability. At the tissue level, regenerative medicine provides a special link between individualized cellular strategies (e.g., stem cell therapy or tissue engineering) and activity-mediated processes to support tissue function. There is a need to promote personalized medicine to determine the key factors and mechanisms that drive treatment approaches for specific patient populations, develop appropriate surrogate markers and outcome measures, manage secondary conditions, and optimize evolving health outcomes.

3. Family, Caregiver, and Community Support

Each person with a disability lives within the context of a community that may include family, social group, or other supports. The interplay of individuals and their environments is a key priority area for rehabilitation research across the NIH. There is also a need to focus on the caregivers of individuals with disabilities to examine the stressors, challenges, and benefits experienced by the caregivers well as the impact of these factors on their health and indirectly on the health and outcomes of the care recipient. The proposed center should promote individuals with disabilities, caregivers, and care providers as active members of the rehabilitation team, in order to facilitate adherence and assistance within facility or home-based care, and in setting treatment goals to optimize outcomes. Within the community, there is a need to identify the environmental barriers that may impede rehabilitation adherence or efficacy of a rehabilitation intervention and the broader issues of health disparities. People with disabilities represent diverse racial and ethnic populations, socioeconomic levels, gender identities, and communities with different levels of access to rehabilitation services and supports. The infrastructure center should promote research into how contextual factors impact diagnosis, treatment, and support of people with disabilities. Providing the research community with tools and methods to understand how these family, caregiver, and community factors impact rehabilitation efficacy and effectiveness is a critical gap.

4. Implementation and Dissemination Research

Dissemination research is the scientific study of targeted distribution of information and intervention materials to appropriate public-health or clinical-practice audiences. The intent is to understand how best to spread and sustain knowledge and the associated evidence-based interventions. Implementation research is the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings in order to improve patient outcomes and benefit population health. This area of research requires interdisciplinary collaboration across a broad range of fields and involvement of stakeholders including consumers of services and their families. Special consideration for underrepresented populations in biomedical research should be encouraged. This proposed center should promote the use of sound methodologic approaches to yield evidence on the outcomes, costs, and unanticipated consequences of rehabilitation interventions. To the extent possible, the center should encourage the use of health economics to justify the investment and benefits of rehabilitation interventions, supports and delivery methods. The center should also provide consideration of the context and environment in which the research will occur. Promotion of harmonized and/or standardized measures and stakeholder relevant outcomes of research would be a priority for this center.

5. Clinical Trial Design and Combinatorial Therapies

Clinical trials have a special role in documenting the efficacy and impact of therapeutic interventions and supports. The goal of a center in this domain would be to improve the quality and impact of research trials in order to influence clinical practice. Rehabilitation treatments increasingly rely on the integration of combinatorial approaches, involving biologics, regenerative medicine techniques, electrophysiological stimulation, pharmacotherapies, robotics, and/or activity-mediated and behavioral approaches. Special strategies are needed to integrate and optimize multifactorial dosing regimens and determine potential interactions, both in the short-term and long-term. A research infrastructure center in this domain would promote research designs to explore the integrations of treatments, possible synergistic interactions or negative side-effects, and their overall impact on functional outcomes, secondary conditions, and sustained health. Aside from randomized control trial design, the center should promote the use of alternative trial designs, such as pilot studies, early-stage proof-of-concept studies and futility studies, small N studies, mixed-trial design, adaptive trial design, and practice-based trials to demonstrate efficacy in real-world settings. The center should also promote access to resources for recruitment, leveraging existing clinical trial networks, or other NIH resources (e.g., Clinical Trial Translational Science Awards, NINDS StrokeNet, and NINDS NeuroNext).

6. Technology to Track Real-World Outcomes

Technology plays a significant role in rehabilitation in the context of diagnostics, treatment delivery, assistive technologies, compliance, assessment, and self-management. To best harness technology in the laboratory and various treatment settings, an infrastructure center in this domain would promote interdisciplinary collaborations among health disciplines and with colleagues in bioengineering, computer science, math, statistics, and especially the end-users of this technology. Noninvasive sensors and mobile health applications can be used to monitor disease progression and treatment response, provide outcome data, monitor compliance, and further engage patient populations. The center should not focus on the development of devices per se, but rather to integrate these approaches into rehabilitative supports and treatments, promote the development of rigorous and reproducible data, and validate their use in clinical and real-world settings.

The purpose of the medical rehabilitation research infrastructure center 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 promote current research opportunities in medical rehabilitation and those that can be transmitted through a concerted program of didactic and mentored collaborative interactions. Applicants should propose a coherent program of outreach, research resources, and mentored collaborative opportunities in a specific content area through the following core activities:

Didactic Interactions: Courses, 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 made available for remote viewing and archived for possible screening at a later date.

Mentored Collaborative Opportunities: The center should provide mentored consultative services, hands-on research experiences, and opportunities for visiting rehabilitation researchers to work with experts at the grantee institution, as appropriate for the research domains proposed. There should be a formal plan for promoting, supporting, and prioritizing interactions with outside researchers. 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: Research centers may propose local institutional activities to further develop, adapt, and/or validate center 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.

Pilot Studies: Each infrastructure center may set aside funds up to $150,000 per year (direct costs) to support small pilot research studies by qualified investigators who are accessing center resources and have the potential to develop competitive rehabilitation research applications to the broader NIH (other federal agencies). There should be a formal process to solicit, review, and prioritize pilot funding proposals. Researchers associated with the infrastructure center itself 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 fiscal and administrative manner.

Promoting Center Expertise: The center has the responsibility to make its activities, resources, and opportunities known to the broader basic and clinical rehabilitation research communities. 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 center should develop a web portal that helps to promote access with connection to archived research resources (e.g., research manuals, background information, reference articles, databases, and contact information, as appropriate).

Administrative Oversight: The applicant should present a clear model of managerial oversight, responsibilities, and commitment to this center, which includes the role of key personnel and their expertise. The research center 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. In addition, rehabilitation infrastructure centers would be expected to collaborate with other funded infrastructure centers in the network as appropriate.

Center Collaboration with Other Institutions (optional): To meet their infrastructure mission, collaborations with other institutions may be proposed to provide access to additional expertise or essential resources.

Coordinating Center (optional): In addition to proposing an infrastructure center, the applicant may propose to take on the additional role of serving as the coordinating center across all the RFA-funded rehabilitation infrastructure centers. Responsibilities for the coordinating center include: developing and maintaining a central web portal, coordinating the promotion of the overall infrastructure program to the research community in various settings, coordinate trans-center activities, hosting and archiving periodic teleconferences among the infrastructure PIs and senior staff, and documenting overall infrastructure outcome data with respect to how this program advances research and the goals of the NIH. Up to $250,000 per year (direct costs) may be requested to take on the additional responsibility of serving as the Coordinating Center.

Workforce Diversity: While not a specific core activity, the NIH continues to encourage institutions to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences; this includes: 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 the P2C application, 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.

A special interactive webinar will be scheduled and later archived for potential applicants. In addition, a webpage of frequently asked questions (FAQs) will be posted. Updates on both the webinar and the FAQs will be available at https://www.nichd.nih.gov/grants-contracts/FOAs-notices/rehabinfrastructure ]

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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, Ph.D.
Telephone: 301-402-4206
Fax: 301-402-0832
Email: RN21E@NIH.GOV

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Didactic Interaction (use for Didactic Interactions)	6
Collab Opportunities (use for Mentored Collaborative Opportunities)	6
Tech Development (use for Technology Development)	6
Pilot Studies	6
Promo Ctr Expertise (use for Promoting Center Expertise)	6
Admin Oversight (use for Administrative Oversight)	12
Collab w/ Other Inst (use for Center Collaborations with Other Institutions)	12
Coordinating Center	6

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 infrastructure application, some of the components above may be described in significantly less pages than 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)
• Didactic Interactions (required; 1 minimum, 1 maximum)
• Mentored Collaborative Opportunities (required; 1 minimum, 1 maximum)
• Technology Development (required; 1 minimum, 1 maximum)
• Pilot Studies (required; 1 minimum, 1 maximum)
• Promoting Center Expertise (required; 1 minimum, 1 maximum)
• Administrative Oversight (required; 1 minimum, 1 maximum)
• Center Collaborations with Other Institutions (optional; 0 minimum, 1 maximum)
• Coordinating Center (optional; 0 minimum, 1 maximum)

When preparing your application, use Component Type Overall .

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

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 these opportunities to the larger research community.

Research Strategy: Discuss the philosophy, objectives, and potential impact of the proposed infrastructure center on medical rehabilitation research. Describe how it builds on resources and expertise of the applicant institution (and collaborative institutions, if proposed). 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 center 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 center and what sort of background would be required to take advantage of these opportunities. Indicate how readily this expertise or technology could eventually be translated to or franchised out to interested researchers and their departments.

Letters of Support: Include here any letters of support for the proposed research center as a whole; letters of support specific to individual cores should be included with the appropriate 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:

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• NICHD Data and Specimen Hub - DASH is a centralized resource for researchers to store and access data from NICHD-funded research studies to use for secondary research.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type Didactic Interaction.

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

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

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 possible venues.

Research Strategy: Describe the specific mix of courses, workshops, webinars, 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 (as appropriate).

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:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Didactic Interactions)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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 (Mentored Collaborative 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 (Mentored Collaborative Opportunities)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Mentored Collaborative 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) (Mentored Collaborative 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 (Mentored Collaborative 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 (Mentored Collaborative 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 (Mentored Collaborative Opportunities)

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

Research Strategy: Discuss laboratories and projects at the applicant (or collaborative) institution that could offer potential hands-on and other mentored collaborative opportunities. Consider how these interactions would be incentivized and sustained (i.e., potential benefits to the host laboratory that sponsors such interactions and the appropriate time and resource commitments required). Discuss how the logistics of on-site mentored 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, and prioritizing the on-site 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 as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Only limited items are allowed in the appendix.

PHS Human Subjects and Clinical Trials Information (Mentored Collaborative Opportunities)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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 (Techniques 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 (Techniques Development)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Techniques 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) (Techniques 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 (Techniques Development)

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

Budget (Techniques Development)

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

Up to $100,000 per year (direct costs) may be budgeted for techniques development.

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 (Techniques Development)

Specific Aims: Briefly describe overall strategies for techniques development to better serve the research community.

Research Strategy: Describe the state of the technologies and expertise proposed and whether further enhancements would be required and/or warranted during the course of the project. Discuss plans for technology development, access, adaptation, and validation 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 applications. Some validation studies may be appropriate, but 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 as provided in the SF424 (R&R) Application Guide. The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Only limited items are allowed in the appendix.

PHS Human Subjects and Clinical Trials Information (Mentored Collaborative Opportunities)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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.

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

Budget (Pilot Studies)

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

Up to $150,000 per year (direct costs) may be budgeted for supporting pilot studies. Generally, the pilot funds will be distributed in the form of subcontracts to the third-party researcher's institution.

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 (Pilot Studies)

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

Research Strategy: Provide a formal plan to solicit, review, and prioritize requests for pilot funding that arise from interactions with the research center. Include details on eligibility criteria, evaluation, and assessment of the likelihood of the proposed pilot study 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 outside locations. The distribution of pilot funding will require strategies for negotiating with secondary institutions to transfer grant funds in the most fiscally and administratively 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 as provided in the SF424 (R&R) Application Guide. The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Only limited items are allowed in the appendix.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Promo Ctr Expertise .

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

SF424 (R&R) Cover (Promoting Center Expertise)

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 (Promoting Center Expertise)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Promoting Center Expertise)

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) (Promoting Center Expertise)

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 (Promoting Center Expertise)

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

Budget (Promoting Center Expertise)

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 (Promoting Center Expertise)

Specific Aims: Briefly describe overall strategies for promoting center expertise into the research community.

Research Strategy: Describe how the center would make its activities, resources, and opportunities known to basic and clinical rehabilitation research communities and allied fields. Highlight innovative strategies for promoting research opportunities to diverse communities. 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 center 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).

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 as provided in the SF424 (R&R) Application Guide. The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Only limited items are allowed in the appendix.

PHS Human Subjects and Clinical Trials Information (Promoting Center Expertise)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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 (Administrative 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 (Administrative Oversight)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Oversight)

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) (Administrative 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 (Administrative Oversight)

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

Budget (Administrative 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 (Administrative 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 center. This should include descriptions of roles, responsibilities, and qualifications. 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, didactic interactions, and interactions with the medical rehabilitation community. Do not propose the actual advisory board members at this time but rather indicate the types of expertise or perspectives that would be appropriate the board. Rehabilitation infrastructure centers would be expected to collaborate with other infrastructure centers funded under this FOA, as appropriate; however, this would depend on the actual research domains 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 as provided in the SF424 (R&R) Application Guide. The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Only limited items are allowed in the appendix.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Collab w/ Other Inst .

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

SF424 (R&R) Cover (Center Collaborations with Other Institutions)

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 (Center Collaborations with Other Institutions)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Center Collaborations with Other Institutions)

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) (Center Collaborations with Other Institutions)

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 (Center Collaborations with Other Institutions)

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

Budget (Center Collaborations with Other Institutions)

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 (Center Collaborations with Other Institutions)

Specific Aims: If appropriate, briefly present proposed collaborations with the center and other institutions. Discuss complementary expertise and resources they would provide.

Research Strategy: If appropriate, collaborations to other institutions may be proposed, provided that they provide complementary expertise and resources that are essential to the goals of the research infrastructure center. Logistical issues for such proposed collaborations should be discussed. The collaborating institutions must demonstrate a clear commitment to the proposed research infrastructure center as detailed in letters of support. Where possible, evidence of previous collaborations among the key researchers and their institutions should be provided. Collaborations with secondary sites are generally funded through subcontracts and proposed cost-benefits should be considered.

Letters of Support: Include any letters of support from colleagues at secondary institutions including appropriate administrative officials.

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. The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html)..

Appendix: Only limited items are allowed in the appendix.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Coordinating Center .

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

SF424 (R&R) Cover (Coordinating Center)

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 (Coordinating Center)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Coordinating Center)

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) (Coordinating Center)

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 (Coordinating Center)

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

Budget (Coordinating Center)

Up to an additional $250,000 per year (direct costs) may be requested to take on the responsibilities of serving as the Coordinating Center. 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 (Coordinating Center)

Specific Aims: In addition to proposing the infrastructure center, an applicant may propose to take on the additional role of serving as the coordinating center across all the funded P2C rehabilitation infrastructure center. However, this responsibility is optional and is not a necessary part of a the P2C application.

If interested in assuming the additional responsibilities of coordinating activities, briefly discuss how you would meet the specific goals of developing and maintaining the central web portal, promoting the overall infrastructure program to the research community in various settings, promoting and coordinating trans-center activities, hosting and documenting periodic teleconferences among the infrastructure centers PIs and staff, and documenting overall infrastructure outcome data with respect to supporting the research community and the goals of the NIH.

Research Strategy: Provide details on the operation of a centralized web portal that will provide the research community with access to the overall rehabilitation infrastructure network and direct them to the appropriate centers and resources. Discuss how you would promote the overall infrastructure program to appropriate research communities and individual investigators especially through presentations and booths at national research meetings. Provide strategies to coordinate/integrate activities and promote best practices across the infrastructure program. Discuss a model for hosting and archiving periodic (e.g., quarterly) teleconferences and occasional direct meetings among the funded infrastructure centers (PIs and their senior staff). Provide a framework for gathering outcomes data on the role of the infrastructure program in supporting mentored research collaborations and the potential value-added of the research infrastructure program.

Letters of Support: Include any letters of support from colleagues at secondary institutions including appropriate administrative officials.

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. The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Only limited items are allowed in the appendix.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 the NICHD, 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 EHayunga@mail.nih.gov 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 the policy. Any instructions provided here are in addition to the instructions in the policy.

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

For this particular announcement, applications will be reviewed on their ability to provide access to unique resources and expertise that are particularly relevant to the broad field of medical rehabilitation research. Thus, criteria include: quality of the resources and expertise; unique nature of research opportunities and mentored collaborations; proposed strategies for promoting, teaching, and supporting research opportunities; leveraging of resources; administrative vision, management, and prioritization; and, promotion of a diverse workforce.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

Significance

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

Does the proposed center 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 and timely 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the infrastructure center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing rehabilitation research? Do the investigators demonstrate significant experience with coordinating collaborative basic, clinical, and translation research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the infrastructure Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Do the applicants have some history of supporting and incentivizing collaborative approaches and managing research priorities?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research resource the infrastructure center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Are there innovative strategies for promoting research opportunities to diverse communities?

Are the applicants promoting remote learning and mentored collaborative opportunities through the innovative use of the internet (e.g., webinars) and other social media approaches?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the infrastructure will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the infrastructure center? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Is the proposed research domain(s) clearly defined with access to the necessary expertise, teaching strategies, and mentored 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 center on the rehabilitation research community?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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

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

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

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

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the infrastructure center 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of thene 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 peer-review committee will consider the progress made in the last funding period and the overall impact on the rehabilitation research field. Relevant outcomes may include the following: the number of research contacts supported, the quality of mentored 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 centers 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. However, centers are greatly discouraged from seeking a third cycle of funding without substantially changing their targeted research infrastructure focus and support strategies.

Not applicable.

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

Not applicable.

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

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

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

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

Review Criteria for Mentored Collaborative Opportunities

As applicable for the Research Infrastructure Center 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 in a manner that would be useful to outside researchers?
• Given the research domain proposed, does the applicant institution provide the appropriate mix of mentored collaborative opportunities and direct hands-on activities?
• Are the participating laboratories and other venues committed to supporting proposed consultations and mentored collaborations?
• Would the website provide access to a useful array of materials and/or references?

As applicable for the Research Infrastructure Center proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an impact score for Technology 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?

Review Criteria for Pilot Studies

As applicable for the Research Infrastructure Center 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?

Review Criteria for Promoting Center Expertise

As applicable for the Research Infrastructure Center proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an impact score for Promoting Center Expertise 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 the impact of these opportunities?
• Are the frequencies of the offerings and venues appropriate?
• Is 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?
• Would the proposed center web portal provide a good indication of 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?

Review Criteria for Administrative Oversight

As applicable for the Research Infrastructure Center 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 and utilize the advisory board?
• Would the proposed center seek opportunities to interact with other rehabilitation infrastructure centers funded under this FOA?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NICHD 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 National Advisory Child Health and Human Development (NACHHD) 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.
• Synergy with other meritorious research infrastructure proposals submitted to this FOA; thus it is possible that more than one proposal 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

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

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.

The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Ralph Nitkin, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-402-4206
Email: rn21e@nih.gov

Merav Sabri, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-496-2583
Email: merav.sabri@nih.gov

Daofen Chen, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: daofen.chen@nih.gov

Tiffani Lash, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: tiffani.lash@nih.gov

eila Selimovic, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8859
Email: seila.selimovic@nih.gov

Lana Shekim, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: shekiml@nidcd.nih.gov

Lois A. Tully, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5968
Email: tullyla@mail.nih.gov

Sherry Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3415
Email: duperes@mail.nih.gov

Bryan Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

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

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