Notice Number: NOT-HL-16-459
Key Dates
Release Date: October 27, 2016
NOT-HL-16-462
RFA-HL-17-009
Issued by
National Heart, Lung, and Blood Institute (NHLBI)
Purpose
The purpose of this Notice is to announce a change to the Application Due Date and to remove the requirement for the clinical consent as an attachment to the application for RFA-HL-17-009 Clinical Centers for the NHLBI’s Precision Interventions for Severe and/or Exacerbation Prone Asthma (PrecISE) Network (UG1) . A consent document is no longer required.
Part 1. Key Dates
Currently reads:
Open Date:November 20, 2016
Letter of Intent Due Date(s):November 20, 2016
Application Due Date: December 20, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
No late applications will be accepted for this Funding Opportunity Announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Expiration Date: December 21, 2016
Modified to read:
Open Date: November 28, 2016
Letter of Intent Due Date(s): November 28, 2016
Application Due Date: December 28, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
No late applications will be accepted for this Funding Opportunity Announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Expiration Date: December 29, 2016
Part 2. Section IV. Application and Submission Information
SF424(R&R) Other Project Information
Other Attachments
Currently reads:
Upload each attachment as a separate pdf file with the names specified below.
1. Protocol and Consent (required)
A single attachment must be included that contains the full protocol and template consent. This should be a single PDF file with the name "PrecISE protocol.pdf".
Modified to read:
1. Protocol (required)
A single attachment must be included that contains the full protocol. This should be a single PDF file with the name "PrecISE protocol.pdf".
The Clinical Protocol should not repeat information provided in the Research Strategy, and may not exceed 12 pages. It should provide detailed information about the patient phenotypes, predictive and monitoring biomarkers, proposed interventions, outcomes that will determine a participant’s continuation with a specific intervention or a change to a different intervention, and trial outcomes. Data, biospecimen collection and analysis plans, and subject visit schedule should be included. The underlying assumptions and statistical methodologies that are proposed to inform decision-making algorithms regarding therapeutic responsiveness and achievement of primary and secondary endpoints should be included. It is expected that information provided will inform the evaluation of feasibility and investigative team expertise and readiness to execute precision, adaptive clinical trials in severe and/or exacerbation prone asthma patients.
All other aspects of this FOA remain unchanged.
Inquiries
Please direct all inquiries to:
Patricia Noel, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: noelp@nih.gov
and Human Services (HHS)
