Key Dates

NOT-HD-21-006 - Notice of Intent to Publish a Funding Opportunity Announcement for Autism Centers of Excellence: Networks (R01 Clinical Trial Optional)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

The purpose of this Notice is to announce the intention of NICHD, with NIDCD, NIEHS, NIMH, and NINDS, to issue a Funding Opportunity Announcement (FOA) to solicit new and renewal applications for autism centers of excellence (ACE) P50 Centers. This FOA will be a reissue of RFA-HD-17-009. A companion FOA will solicit applications for ACE Networks supported by the R01 activity code (see NOT-HD-21-006). An individual may serve as the Principal Investigator for an ACE Center or Network on only one application.

Investigators of current ACE Centers and others who believe that they have sufficient expertise and resources to coordinate and implement a center research program, are encouraged to begin consideration of applying for this initiative. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Summer with an expected application due date in Winter.

This FOA will utilize the P50 activity code. Details of the planned FOA are provided below.

Autism spectrum disorders (ASD), characterized by difficulties with social communication and stereotypic and repetitive patterns of behaviors, are complex and highly heterogeneous neurodevelopmental disorders with early childhood onset. The ACE Centers RFA will seek applications from institutions that support major multidisciplinary research programs of ASD research. An ACE Center application will include: 1) an administrative core; 2) a dissemination and outreach core; 3) a plan for recruiting study participants from underrepresented minority groups and disadvantaged background; and 4) a minimum of 3 and a maximum of 5 interdependent and interrelated research projects. Each ACE center must promote two-way communication between the investigators and the community of individuals with ASD and caregivers.

The purpose of ACE Centers is to support research that will lead to better understanding of the causes and mechanisms underlying ASD, improve the efficiency of methods of early identification and diagnosis, and/or examine innovative and cost-effective services for individuals with ASD across their lifespan.

Other areas of interest may include studies focusing on:

• Understudied subgroups within the ASD population (e.g., aging and older adults, minimally verbal individuals) or those with comorbid conditions (e.g., intellectual disabilities, epilepsy, sensorimotor, autonomic, or gastrointestinal issues)
• Identification of previously undiagnosed adults
• Development of new or validation of existing and commonly used measures or tools in ASD research for diverse subgroups within the ASD population (e.g., transition-age youth and adults, those with intellectual disabilities, under-represented minorities, and economically disadvantaged groups
• Unbiased and well-powered studies of the interplay of genetic and non-genetic (e.g., environmental and other modifiable exposures) risk and protective factors in the etiology or development of ASD

This ACE Centers RFA will support hypothesis-driven mechanistic clinical trial studies in basic and/or translational discovery research in healthy human participants and in the pathobiology and pathophysiology in human participants with ASD. The goal is to address basic questions and to interrogate concepts in biology, behavior, and pathophysiology that will provide insight into understanding ASD. Such studies may seek to understand a biological or behavioral process, or the mechanism of action of an intervention. This RFA supports biomarker studies that may provide information about physiological function, target engagement of novel therapeutics, and/or mechanisms of therapeutic responses. The submitted studies may be defined as clinical trials (as noted above) but should not seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions or treatments.

Potential applicants are encouraged to monitor the NIH Guide for Grants and Contracts for the publication of the FOA. There is no additional information that will be provided at this point.

Applications are not being solicited at this time. 

Please direct all inquiries to:

Alice Kau, Ph.D.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: 301-496-1383

Email: kaua@mail.nih.gov