Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional)

Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-AR-25-002: Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices.

Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Heart, Lung, and Blood Institute ( NHLBI ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Neurological Disorders and Funding Opportunity Title Senator Paul D.

Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional) August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 846, 93.

865, 93. 853, 93. 233, 93.

837, 93. 838, 93. 839, 93.

840 Notice of Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to publicize a competition for Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRCs). These Centers promote collaborative basic, translational, and clinical research and provide important resources that can be used by the national muscular dystrophy research communities.

The Centers also provide outstanding environments for the training of new researchers capable of addressing high priority objectives in muscular dystrophy research.

Center investigators are expected to participate in important community outreach efforts to increase awareness of their research activities among people with lived experiences and the advocacy communities and to incorporate community perspectives into the conduct of patient-centered research.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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 Announcement Section I.

Notice of 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 Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRCs). These Centers promote collaborative basic, translational, and clinical research and provide important resources that can be used by the national muscular dystrophy research community.

A goal of this Centers program is to support important and innovative research in the muscular dystrophies that is best pursued through an interdisciplinary and collaborative center environment and projects that may not be as effective if supported by "stand-alone" research project grants.

The Centers also provide outstanding environments for the training of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy.

Finally, Center investigators are expected to engage the patient and advocacy communities in conversations to increase awareness of research, encourage patient participation in research, and incorporate the perspectives of these communities in the conduct of patient-centered research.

The Muscular Dystrophy Community Assistance, Research, and Education Amendments of 2001 (the MD-CARE Act, Public Law 107-84) specified provisions for expanding and intensifying research on muscular dystrophy. One provision of the MD-CARE Act was that the NIH establish centers of excellence for research on muscular dystrophy. The Wellstone MDSRCs program was subsequently developed in honor of Senator Paul D.

Wellstone, a champion of muscular dystrophy research. Through open competitions and peer review of applications for awards, participating NIH institutes established three Centers in 2003 and three more in 2005 and have since sought to maintain six active centers.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Neurological Disorders and Stroke (NINDS) are committed to continuing and enhancing the tradition of scientific excellence that has been fostered in this centers program.

This Wellstone MDSRCs program was formally evaluated in 2018 by an external Working Group of the NIAMS Advisory Council, facilitated by NIH staff. The report from the Working Group was approved by the Council on February 5, 2019, and the Executive Summary is available at https://www. wellstonemdcenters.

nih. gov/sites/wellstone/files/WellstoneCenterEvalRptExecSumm-508. pdf .

Recommendations described in the report were incorporated into this funding opportunity announcement and informed other aspects of the program. Muscular dystrophy refers to a group of hereditary, progressive degenerative disorders causing weakness of the skeletal or voluntary muscles. There are many different forms of muscular dystrophy, which differ in their age of onset, severity, and pattern of muscles affected.

Most types of muscular dystrophy are not simply muscle disorders, but rather multi-system disorders with manifestations in a variety of body systems, including the heart, respiratory system, gastrointestinal system, endocrine glands, skin, eyes, brain, and other organ systems. The major forms of muscular dystrophy include congenital, Duchenne/Becker, Emery-Dreifuss, facioscapulohumeral, limb-girdle, myotonic, and oculopharyngeal.

Although some forms first become apparent in early childhood, others may not appear until middle age or later, but all have a significant clinical, economic, and psychosocial consequences.

Studies that are responsive to this NOFO must be focused on one or more type of muscular dystrophy including those conditions listed above or other inherited condition(s) that directly affect muscle, lead to progressive weakness and muscle degeneration, and have pathophysiological mechanisms and clinical manifestations similar to other muscular dystrophies.

Potential applicants are strongly encouraged to contact NIH program staff listed under Scientific/Research Contacts in section VII prior to developing an application if it is on a disease/condition not listed above or risk having the application withdrawn as non-responsive.

Knowledge needs regarding different muscular dystrophies are distributed across research spectrum from disease characterization, to therapy development, to conducting clinical trials, to incorporating approved therapies into the standard of care. Currently, therapeutic options to treat any of the muscular dystrophies are limited.

For some muscular dystrophies there remains a need for cohort studies to identify genetic mutations and characterize disease progression, as well as studies in cell and animal models to understand disease mechanisms. For other dystrophies there have been significant advances in the development of candidate therapeutics that address specific disease mechanisms, and several candidates are currently being tested in clinical trials.

In addition to the development of therapies that address "root" causes, research in optimizing symptomatic treatment such as respiratory support, nutrition, and physical therapy are critically important to improve quality of life and decrease associated morbidity.

In addition to the need for new disease- or symptom-modifying therapies, there are gaps in understanding how the muscular dystrophies affect the lives of patients and their families and interfere with social interactions, education, and workforce integration of those living with muscular dystrophies. There may also be missed opportunities for optimizing health care and improving accesses to care and services.

The Action Plan for the Muscular Dystrophies ( https://www. mdcc. nih.

gov/action-plan ), updated and approved in November 2015 by the interagency Muscular Dystrophy Coordinating Committee (MDCC) ( https://mdcc. nih. gov/index.

htm ), is a consensus document of high priority research objectives and other strategies to decrease the consequences of these diseases. This document was developed with input from patients, advocacy groups, Federal agencies, and basic-, translational- and clinical-scientists to guide the muscular dystrophy research field for years to decades.

Applicants to this NOFO are encouraged to consider this Action Plan when selecting research projects for their proposed Center. Cardiomyopathy and respiratory dysfunction in muscular dystrophies are clinically important but understudied. Patients often experience sleep disruptions due to decreased respiratory muscle function or other respiratory complications.

High priority research objectives related to cardiomyopathy, respiratory dysfunction, and disrupted sleep are included in the Action Plan, and applicants to this NOFO are encouraged to consider proposing projects that address these and other objectives.

NIAMS, NICHD, NHLBI, and NINDS seek to continue this MDSRC program to advance research in the muscular dystrophies leading to improved understanding of these diseases and to develop effective treatments and other strategies for reducing disease consequences.

Under this NOFO, each Center application must propose a clinical research project and at least one other project, which could include basic, preclinical translational, or clinical research. The research projects should be related to a common theme, be synergistic, and leverage the multidisciplinary and collaborative environment of this Center mechanism.

Awards are expected to contribute to the long-term goals of advancing understanding of the causes and natural history of the dystrophies, developing therapies and reducing the impact of one or more form(s) of muscular dystrophy, as well as the training, research resource sharing, and patient/community outreach goals described below.

Projects should be focused only on muscular dystrophy research and may include studies of the impact of these diseases on skeletal muscle, the heart, respiratory system, sleep, smooth muscle, the central nervous system, gut, or other organ systems as well as neuropsychological or neurobehavioral studies.

Areas of research can include, but are not limited to the following: Characterizing disease natural history or genotype/phenotype correlations Characterizing and/or validating molecular, biochemical, physiological, imaging, or other types of biomarkers for use in therapy development or clinical trials Developing and/or validating clinical outcome assessment measures, including patient-reported outcome (PRO) measures, or clinical scales for use in clinical trials Developing innovative translational products that can meaningfully impact patient outcomes Identifying new muscular dystrophy causing genetic mutations Identifying, characterizing and validating therapeutic targets Identifying and validating genetic or epigenetic modifiers of disease presentation or severity Engineering and characterizing new cell or animal models of disease to advance studies of pathophysiology or preclinical translation Screening, optimizing, and preclinical testing of candidate therapeutics Activities leading to investigational new drug (IND) or investigational device exemption (IDE) applications to the FDA Developing and/or validating epidemiological, behavioral, or health outcomes to assess patient- and family-centered outcomes with the eventual goal of reducing overall consequences of disease Optimizing symptom treatment such as respiratory support, nutritional support, and physical therapy to improve quality of life and decrease associated morbidity Conducting early-stage clinical trials (proof of concept trials, safety/tolerability, dose ranging studies, etc.) Phase 3/registration trials are not permitted.

These areas have been identified as high priority to muscular dystrophy research through NIH: Forms of muscular dystrophy for which the natural history and/or causes of disease remain understudied Understudied areas and complications of any dystrophy including Respiratory complications including sleep disturbances and related home care needs Viable cardiac outcome measures for the development of therapeutic agents to combat cardiomyopathy Co-morbid intellectual/cognitive, affective, or social processing deficits Strategies to improve the full and appropriate patient representation in all aspects of muscular dystrophy research MDSRC applicants are encouraged to consider projects that address the high priority areas described in the Action Plan for the Muscular Dystrophies ( https://www.

mdcc. nih. gov/sites/default/files/documents/2015_action_Plan_to_MDCC_508C_0.

pdf ). The research problems proposed should require substantial collaborative efforts to solve and thus are best carried out in a center setting. Collectively and in cooperation with the NIH, the MDSRCs form a coordinated national program.

Applicants are expected to emphasize new ideas, novel approaches, and state-of-the-art technologies to advance understanding of disease and develop effective treatments and other strategies to improve the lives of muscular dystrophy patients. Applications should include multidisciplinary collaborative efforts, especially those involving basic scientists and clinicians with appropriate expertise.

Center applications are encouraged to include investigators with significantly different and synergistic expertise such as muscle physiologists, neurologists and bioinformaticians or engineers. MDSRC applicants must also propose resource core facilities, training, and outreach activities that will enhance muscular dystrophy research on a national or international level.

General Description of MDSRC and Center Components The organizational structure of the proposed MDSRC should facilitate the flow of new scientific findings and technologies into translational and clinical research. Each center must include clinical research as defined below. Clinical research is research with human subjects that is: 1.

Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

Patient-oriented research includes: mechanisms of human disease therapeutic interventions development of new technologies 2. Epidemiological and behavioral studies. 3.

Outcomes research and health services research. Although guidance is provided in this NOFO for interventional clinical trials in MDSRCs, clinical trials using investigational drugs or biologics are NOT a required element of an MDSRC.

Each Center may also contain basic and/or translational studies research with an emphasis placed upon moving the research field forward toward novel or improved therapies or other strategies for reducing impact of the muscular dystrophies. A goal of this initiative is to support studies that lead to findings that are applicable to all people affected by the type(s) of muscular dystrophy being studied.

Therefore, it is important that the sex/gender, race, ethnicity and age of the participants appropriately represent the population of people living with the studied condition(s) in the United States. Applications may request personnel effort, support for study participant travel/meals, and other budget items within the overall budget cap to ensure that this goal of appropriate inclusion is met.

The minimal structural requirements of a Wellstone MDSRC under this NOFO are: Two or more projects involving collaborations of investigators.

At least one of these projects must address clinical research aims and must involve the direct interaction of Center investigators with MD patients; A Center Director and Co-Director responsible for scientific and administrative oversight of the Center; An Administrative Core that promotes a Center environment through enhanced communication and collaboration of investigators within and outside the Center.

The Administrative Core must also promote conversations with the patient/advocacy community to increase awareness of the research, promote enrollment of understudied populations in clinical studies with attention to sex/gender, race, and ethnicity, and incorporate the perspectives of patient/advocates in the research conducted by the Center.

The Administrative Core will establish a Center Advisory Committee including external scientific and lay members; A Shared Scientific Research Resource Core that is to be shared with the national muscular dystrophy research community and meets the needs of the community.

A Center can have other cores that are justified by the level of use within the Center but are not necessarily shared with researchers outside the Center; and A Training Core to promote training and career development of students and fellows associated with the Center, recruit new trainees, promote support through individual fellowships, organize training activities for the students and fellows in other Wellstone MDSRCs and across the entire muscular dystrophy research community.

Each of the proposed research projects should be best suited for a center environment rather than a collection of stand-alone grants and address problems that require a substantial collaborative research effort to solve.

Collectively, the projects should involve synergistic teams of researchers with complementary expertise such as basic and clinical, skeletal muscle and other organ systems, primary data collection and bioinformatics, etc. Collaborations should be developed to bring the best expertise to bear on a problem, whether the proposed collaborations are all on-site or utilize consortium agreements with off-site investigators at existing MDSRCs or off-site investigators not affiliated with an MDSRC.

Although a clinical project is required, this need not be a clinical intervention trial. See section IV. 2 for additional guidance on projects that propose a clinical trial.

Epidemiological, behavioral, and health outcomes research studies for the muscular dystrophies are also encouraged. The Center Director and Co-Director must develop and maintain a center environment that fosters traditional and novel approaches to multi-disciplinary research collaborations and training.

At least one Program Director/Principal Investigator of a scientific project must be an NIH-defined new investigator or an NIH experienced investigator who is new to muscular dystrophy research as demonstrated by funding history.

This includes, but is not limited to, having been a PI or MPI, primary recipient or subcontract, on a muscular dystrophy grant as determined by Research, Condition, and Disease Categories (RCDC) coding and/or PI or Co-PI of a muscular dystrophy grant supported by private funding, primary recipient or subcontract, research project or training/career development award.

The Center Director and Co-Director cannot serve as the Program Director/Principal Investigator of a project in another active MDSRC award. But, other than this restriction, collaborations among Centers are encouraged. The Administrative Core must provide for the integration and management of activities within the MDSRC.

The Administrative Core must also promote interactions and communications between the research and patient/advocacy communities on both a national and local level. Funded MDSRCs are expected to utilize the Administrative Core to establish and maintain a website to communicate the Center mission and the availability of training opportunities and specimens/data available through the Shared Scientific Research Resource Core.

Each Center must form an external Center Advisory Committee (CAC) with scientific, clinical, and patient advocate representation, composed of at least five members. The CAC should meet in-person or electronically approximately once a year, beginning in the first or second year of the Center award.

Applicants are encouraged to form the strongest teams to address the research questions, regardless of geography, and the Administrative Core must be responsible for coordinating communication among the Center sites and integrating participating researchers into a cohesive center environment, even if geographically dispersed.

To promote awareness of muscular dystrophy research and the Wellstone MDSRCs program in the patient/advocacy communities, the Administrative Core must develop activities or materials, such as seminars, web-based information, or lab tours involving patients and their families interacting with junior and senior investigators. Participation of patient advocacy groups in the planning and conduct of outreach activities is encouraged.

Shared Scientific Research Resource Core The shared Scientific Research Resource Core must be designed and managed to support the research of the MDSRC, as well as serving as a resource for the national and perhaps international muscular dystrophy research community. Applicants may wish to consult the Action Plan for the Muscular Dystrophies ( https://www. mdcc.

nih. gov/action-plan ) for consensus statements on infrastructure needs of the muscular dystrophy research community. Applicants are encouraged to propose a core that will provide services, specimens, or other resources that are rate limiting to the progress of muscular dystrophy research so that the core will help to accelerate research conducted by users within and outside the MDSRC.

As nationally recognized centers of excellence in muscular dystrophy research, the MDSRCs are expected to play a leadership role in training new researchers for the muscular dystrophy field, contributing to the development of future research leaders.

Each Center must include a Training Core to 1) enhance the training environments present in the participating labs and clinics and promote career advancement for students and fellows working on projects supported by the Center, 2) recruit trainees new to muscular dystrophy research, 3) encourage trainees to apply for individual fellowships or career development awards from public and private funding organizations to help prepare them for independent research careers, 4) organize research meetings for trainees across the network of Wellstone MDSRCs, and 5) organize training activities such as courses or webinars for the overall muscular dystrophy research community.

Leveraging of existing institutional training programs is encouraged, and support from the MDSRC should add value to existing programs by enhancing the focus on the muscular dystrophies and increasing the number of trainees.

This core may propose activities that enhance the training environment through specialized coursework, a seminar program, retreats for presentation of trainee research, journal clubs, or other activities that contribute to the preparation of junior investigators for careers in muscular dystrophy research.

Training activities must emphasize scientific rigor by providing guidance and assessing the implementation of strategies to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of results (see https://grants. nih. gov/policy/reproducibility/index.

htm ). Trainees should learn about the broad range of research conducted by investigators at their own and other Centers including preclinical translational research and clinical studies. Exposure to research at other Wellstone MDSRCs is also encouraged through exchange programs, short-term training opportunities, or visits to learn new research approaches.

Non-clinical students and postdocs should get exposure to clinical research and clinical research projects should involve medical students, clinical fellows, and residents.

NIH strongly encourages applicants to include a diverse group of scientists in their research and training programs, including individuals from groups underrepresented in the biomedical, clinical, behavioral, and social sciences (see NOT-OD-20-031 , Notice of NIH’s Interest in Diversity and NOT-OD-22-019 , see also Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

A Recruitment Plan to Enhance Diversity through this core must be included in the application.

The Wellstone Muscular Dystrophy Research Network Recipients of MDSRC awards will become part of a national program in muscular dystrophy and will be expected to participate in network activities, including meetings of the Steering Committee (composed of Center Directors and Co-Directors, and NIH staff) and a biennial centers meeting that rotates among the Wellstone Muscular Dystrophy Research Network sites.

For answers to common questions about the Wellstone Muscular Dystrophy Research Network and this NOFO, see: https://www. wellstonemdcenters. nih.

gov/addl_links. htm Applications Not Responsive to this NOFO Applications that do not include a PI or co-PI of a scientific project that is an NIH-defined New Investigator or an established NIH PI who is new to the muscular dystrophy field as reflected by funding history are not responsive to this NOFO. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to fund up to three awards, corresponding to a total of $4,800,000, for fiscal year 2025. Future year amounts will depend on annual appropriations. Applicants may request up to $1,000,000 direct costs/year (exclusive of facilities and administrative costs of subcontractors with collaborating organizations) for up to five years.

Applications may request up to five years of support. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information 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 (Other than Small Businesses) 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 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 Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

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. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; 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 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.

Eligible Individuals (Program Director/Principal Investigator) 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

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 How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2- Definitions of Terms.

3. Additional Information on Eligibility 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 per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

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 NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package 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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the How to Apply - 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 ,