Notice of Intent to Publish a Funding Opportunity Announcement for Transplantation Statistical and Clinical Coordinating Center (T-SCCC) U01 Clinical Trial Not Allowed
Notice Number:
NOT-AI-22-062

Key Dates

Release Date:
July 21, 2022
Estimated Publication Date of Funding Opportunity Announcement:
August 30, 2022
First Estimated Application Due Date:
November 30, 2022
Earliest Estimated Award Date:
April 30, 2023
Earliest Estimated Start Date:
April 30, 2023
Related Announcements

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-22-063 - 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)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) to provide a broad range of support critical for the design, development, execution, and analysis of clinical research carried out by multiple NIAID-supported programs in transplantation.

This Notice is being provided to allow potential applicants sufficient time to develop responsive applications. The FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The purpose of the FOA is to solicit applications for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC), which will support transplant clinical research conducted by NIAID. The awardee will provide a broad range of support critical for the design, development, implementation, and analysis of clinical research carried out by multiple NIAID-supported programs in transplantation. The scope of support to be provided includes statistical design and analysis, protocol development, final analysis of study findings, establishment and maintenance of a biospecimen tracking database, and support for the mechanistic studies by providing biospecimen labeling, shipping, and kits and/or bulk supplies for specimen collection. Additional critical infrastructure for NIAID supported clinical trials, including data management, regulatory support, clinical site monitoring, and drug labelling and distribution, will be managed by other separately funded entities. The T-SCCC will coordinate with these other entities, especially the Clinical Data Safety Monitoring Center (CDSMC), to ensure comprehensive, efficient, and seamless support for NIAID clinical research. The types of research for which support will be provided include clinical trials and other types of clinical studies (e.g., longitudinal studies, genetic studies, etc., and studies to identify and validate surrogates/biomarkers), with integrated studies of underlying immunologic mechanisms. Current ongoing work supporting within-scope functions will transfer at the time of award to the T-SCCC grantee.

Funding Information

TBD

Estimated Total Funding

$9,000,000

Expected Number of Awards

NIAID intends to fund one award

Estimated Award Ceiling

$9,000,000

Primary Assistance Listing Number(s)

93.855

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
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. 

Inquiries

Please direct all inquiries to:

Deborah Hayes, MS

National Institute of Allergy and Infectious Diseases (NIAID)

240-627-3496