Key Dates

NOT-HD-21-007 - Notice of Intent to Publish a Funding Opportunity Announcement for Autism Centers of Excellence: Centers (P50 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 an FOA to solicit new and renewal applications for autism centers of excellence (ACE) R01 Networks. This FOA will be a reissue of RFA-HD-17-008. A companion FOA will solicit applications for ACE Centers supported by the P50 activity code (see NOT-HD-21-007). An individual may serve as the Principal Investigator for an ACE Center or Network on only one application.

Investigators of current ACE Networks and others who believe that they have sufficient expertise and resources to coordinate and implement a multi-site 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 2021 with an expected application due date in Winter.

This FOA will utilize the R01 activity code. Each ACE network will submit one R01 application that includes subawards to the collaborating sites. 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 Networks FOA will seek applications from institutions that support major multi-site research programs of ASD research. An ACE Network application will include the following components: 1) administration and operation of the ACE network; 2) a plan for recruiting study participants from underrepresented minority groups and disadvantaged background; 3) dissemination of research information and outreach to the scientific and lay communities ; 4) research project(s) that requires multiple sites for optimal design and conduct of the study; and 5) a clearly defined data coordinating center which will operate independently from data collection sites. Each ACE network must promote two-way communication between the investigators and the community of individuals with ASD and caregivers.

The purpose of ACE Networks 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.

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 Networks FOA 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: [email protected]