Key Dates
NOT-AI-22-061 - Notice of Intent to Publish a Funding Opportunity Announcement for Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC) (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 promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications establishing a Clinical Data and Safety Management Center (CDSMC). The CDSMC will provide a broad range of clinical support services, including data management and processing, safety and pharmacovigilance management and processing, and sample tracking systems or NIAID-funded clinical trials, integrated studies of underlying mechanisms, clinical studies (e.g., longitudinal studies, genetic studies), and studies to identify and validate surrogates/biomarkers of immune-mediated diseases in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation.
This is 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 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.
This Notice encourages investigators with expertise and insights in clinical data management and safety oversight to begin to consider applying for this new FOA.
The clinical trials supported by this initiative span three major disease areas of research: asthma and allergic diseases, autoimmune diseases, and transplantation research. Each clinical trial has integrated studies that examine the mechanisms that underly the study outcomes.
The CDSMC will provide administrative oversight for all work conducted including but not limited to:
- Developing and implementing a plan to monitor timelines and progress
- Providing budget and financial management
- Establishing a comprehensive risk-based approach to quality management
- Implementing a training and technical assistance program
- Developing a portal for the sharing and dissemination of study information and metric tracking
- Cataloging and updating Standard Operating Procedures for all facets of the CDSMC
TBD
$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
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:
Leighton Thomas
National Institute of Allergy and Infectious Diseases (NIAID)
240-627-3522
and Human Services (HHS)
