Key Dates
NOT-AI-22-063 - Notice of Intent to Publish a Funding Opportunity Announcement for National Institute of Allergy and Infectious Diseases (NIAID) Clinical Data and Safety Management Center (CDSMC) (U01 Clinical Trial Not Allowed)
NOT-AI-22-062 - Notice of Intent to Publish a Funding Opportunity Announcement for Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01 Clinical Trial Not Allowed)
National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Allergy and Infectious Diseases (NIAID) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for an Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC). The AA-SCCC will provide a broad range of support critical for design, development, execution, and analysis of clinical research in allergic diseases and asthma. The types of research for which support will be provided include clinical trials, integrated studies of underlying mechanisms, clinical studies (e.g., longitudinal observational studies, genetic studies, etc.), and studies to identify and validate surrogates/biomarkers.
This Notice is being provided to allow potential applicants more time to consider the requirements of the AA-SCCC and develop responsive applications.
The FOA is expected to be published in August 2022 with an expected application due date in November 2022.
This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.
The causes, pathogenesis, diagnosis, treatment, and prevention of allergic diseases and asthma are major areas of emphasis for NIAID. NIAID pursues research on allergic diseases and asthma by supporting investigator-initiated research projects and national networks of research centers. The major NIAID clinical research programs to be supported by the AA-SCCC include the Atopic Dermatitis Research Network (ADRN), Consortium for Food Allergy Research (CoFAR), Childhood Asthma in Urban Settings (CAUSE) Clinical Research Network, and Immune Tolerance Network (ITN). The AA-SCCC also may support investigator-initiated clinical trials (IICT) and other clinical trial/study activities funded by NIAID.
The AA-SCCC (the Center) will provide a broad range of support critical for the design, development, execution, and analysis of the clinical studies that are conducted by NIAID-sponsored clinical research programs in allergic diseases and asthma. The scope of clinical research to be supported by the Center includes: (i) clinical trials at all phases to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of underlying disease mechanisms or mechanisms of action of therapeutic modalities as integral components of clinical trials; (iii) observational clinical studies (e.g., longitudinal birth cohort studies, genetic studies, studies designed with the main purpose to assess mechanisms of disease etc.); and (iv) surrogate/biomarker studies. The scope of functions to be performed by the Center includes statistical design and analysis, protocol development, study initiation and management, and management of sample repositories. In addition, the AA-SCCC will be responsible for organizing and maintaining study management teams (SMTs) for every study in which it is involved and for the communication, collaboration, and assistance with: the NIAID-supported Clinical Data and Safety Monitoring Center (CDSMC); the Clinical Site Monitoring Center (CSMC); the NIAID Clinical Products Center (CPC); and with NIAID staff for planning, oversight, execution, and analysis of NIAID-supported research.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
$9,000,000
NIAID intends to fund one award
$9,000,000
93.855
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Please direct all inquiries to:
Gang Dong, M.D., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
240-627-3508
and Human Services (HHS)
