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Notice of Special Interest: Advancing Research in Gastrointestinal Dysfunction in People with Neurodevelopmental Disorders

Notice of Special Interest
Wednesday, July 14, 2021
Wednesday, July 17, 2024
NOT-NS-22-003

Funding Opportunity Purpose

Gastrointestinal (GI) complications in children and adults with neurodevelopmental disorders have drawn attention to gaps in understanding their causes and treatment. GI dysfunction is particularly common in individuals with neurodevelopmental disorders such as autism, Fragile X syndrome, and Rett syndrome, as well as chromosomal disorders such as Down syndrome. GI disorders in these conditions can include gut malformations present at birth (such as pyloric stenosis or Hirschsprung disease) but also functional issues such as feeding problems, gastro-esophageal reflux disease (GERD), cyclic vomiting, delayed gastric emptying, diarrhea, bloating, celiac disease, irritable bowel symptoms, and constipation leading to encopresis, incontinence, and stool impaction. These GI issues may be associated with severe nutritional deficiencies, weight loss, and failure to thrive. GI symptoms are reported in between 23-70% of individuals with autism, a rate ~ 8 times higher than in the general population, with similar rates in individuals with other less common forms of intellectual and developmental disabilities (IDD) (Holingue et al., Autism Res 2018:11:24-36). Unfortunately, mechanisms to accurately diagnose GI conditions in this population are limited, and tailored treatments to address them are almost nonexistent, particularly since clinical trials for IDD populations are rare.

PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA
Thursday, July 8, 2021
Wednesday, April 6, 2022
R43/R44
PA-21-259

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small businesses to submit Small Business Innovation Research (SBIR) grant applications. United States small businesses that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. This Parent Funding Opportunity Announcement does not accept clinical trials.

Notice of Special Interest: Alzheimers-Focused Administrative Supplements for NIH Grants that are Not Focused on Alzheimers Disease

Notice of Special Interest
Friday, June 25, 2021
Saturday, October 2, 2021
333
NOT-AG-21-018

Funding Opportunity Purpose

The participating Institutes and Centers (ICs) are inviting applications to expand existing awards that are not currently focused on Alzheimers disease and its related dementias--frontotemporal dementia, Lewy body dementia, vascular cognitive impairment with dementia, and multiple etiology dementias--to allow the research to develop such a focus.

Role of Adaptive Immunity in Etiology of Alzheimers Disease and Alzheimers Disease-Related Dementias (R01 Clinical Trial Optional)

RFA
Wednesday, June 16, 2021
Friday, October 29, 2021
R01
RFA-AG-22-017

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) aims to explore the role of adaptive immunity in Alzheimers disease and Alzheimers disease-related dementias (AD/ADRD). Specifically, the FOA seeks an understanding of brain immune surveillance, the generation of CNS-directed immune responses in neurodegenerative disorders, and the functional role of adaptive immunity in AD/ADRD onset and progression.

HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)

RFA
Tuesday, June 8, 2021
Heal
Wednesday, October 11, 2023
RFA-NS-21-029
Rebecca A. Roof

Funding Opportunity Purpose

Reissue of RFA-NS-21-016: The goal of this funding opportunity announcement (FOA) is to solicit Initial Analgesic Development R61 applications that propose 2-year exploratory/planning awards that are expected to enable a future application for RFA-NS-21-015 HEAL Initiative: Team Research - for Initial Translational Efforts in Non-addictive Analgesic Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed). Thus, the limited scope of aims and approach of these applications are expected to establish a strong research team, feasibility, validity, or other technically qualifying results that support, enable, and/or lay the groundwork for a subsequent Team Research U19 application. These R61 awards will support the building of a research team to collect initial data and recruit additional collaborators. The proposal must include a plan for developing a strong research team, as well as a strategy to collect preliminary data linking putative therapeutic targets to the proposed pain indication and supporting the hypothesis that altering target activity will produce desirable outcomes for the disease.

Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) (D43 Clinical Trial Optional)

PAR
Monday, May 24, 2021
Friday, July 14, 2023
PAR-21-230

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages applications for the Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) D43 program for institutional research training programs in low-and middle-income countries (LMICs, as defined by the World Bank classification system). Applications may be for collaborations between institutions in the U.S and an eligible LMIC or may involve just LMIC institutions if there is a previous track record of externally funded research and/or research training programs by the lead LMIC institution. The proposed institutional research training program is expected to sustainably strengthen the NCD research capacity of the LMIC institutions, and to train in-country experts to develop and conduct research on NCDs across the lifespan, with the long-range goal of developing and implementing evidence-based interventions relevant to their countries. The main focus of research training covered in the application must be relevant to the interests of at least one of the participating NIH ICs as stated by each in this FOA. Other NCD topics may be included as secondary and complementary focus areas. This Funding Opportunity Announcement (FOA) allows support of trainees as the lead investigator of an independent clinical trial; or a separate ancillary study to an existing trial; or to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

NeuroNEXT Clinical Trials (U01 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Wednesday, March 6, 2024
U01
PAR-21-223
Codrin Lungu

Funding Opportunity Purpose

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Saturday, April 6, 2024
U44
PAR-21-224
Codrin Lungu

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
Clinical Trials Research
Saturday, April 6, 2024
U44
PAR-21-224
Codrin Lungu

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).

Notice of Special Interest (NOSI): Administrative Supplements to Promote Diversity for NINDS Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) Awardees

Notice of Special Interest
Thursday, April 22, 2021
Sunday, March 31, 2024
333
NOT-NS-21-047

Funding Opportunity Purpose

The purpose of this NOSI is to encourage eligible NINDS awardees in the Alzheimers Disease and Alzheimers Disease-Related Dementias (AD/ADRD) research community to apply for administrative supplements in response to PA-21-071, "Research Supplements to Promote Diversity in Health-Related Research," or any reissues of this announcement through the expiration date of this Notice. The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031 for details) and encourages institutions to diversify their student populations by enhancing the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Goal 1 of The National Plan to Address Alzheimers Disease is to prevent and effectively treat AD/ADRD by 2025. This initiative addresses the critical need to increase the number of health professionals who are trained to meet the expanding demand for cognitive impairment and dementia diagnosis, care, and clinical research to meet Goal 1.

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