Notice Number: NOT-HL-15-264

Key Dates
Release Date: June 30, 2015

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

This Notice is to inform potential applicants that the NHLBI is revising RFA-HL-16-015 "Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01)".

The following changes to this FOA are being made:

Part 2. Section IV. 2 Application and Submission Information

R&R or Modular Budget

CURRENT LANGUAGE
Applications should budget for the following:

• CRC PD(s)/PI(s) will be required to declare a minimum effort of 2.4 person-months (20 percent) effort per year.  Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 2.4 person months.   
• Research coordinator(s) not to exceed 6 months for IRB submission of protocol/consent, CRF development, Manual of Procedures development of single and multicenter protocols, and training
• Arrangement of logistical services for protocol-specific costs, including subcontracts and supplies
• Support for the activities as member(s) of the Steering Committee, including in-person travel to Bethesda, MD at least twice a year throughout the project period, including the launch meeting which has been scheduled for July 28-29, 2016, in order to develop the multicenter protocol.  

Multicenter Data Collection [Biospecimens & Cardiorespiratory Monitor Data (CRM)

Budgets must include $100,000 direct costs for DNA biospecimen and cardiorespiratory monitor data collection and transfer to the LDCC for the multicenter protocol and if awarded will be restricted and may be renegotiated based on performance, and will not be re-budgeted without NHLBI prior approval. This may include personnel costs including information technology support.

REVISED LANGUAGE
Applications should budget for the following:

• CRC PD(s)/PI(s) will be required to declare a minimum effort of 2.4 person-months (20 percent) effort per year.  Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 2.4 person months.   
• Research coordinator(s) not to exceed 6 person-months (50 percent effort) in the first year for IRB submission of protocol/consent, CRF development, Manual of Procedures development of single and multicenter protocols, and training.
• Arrangement of logistical services for protocol-specific costs, including subcontracts and supplies
• Support for the activities as member(s) of the Steering Committee, including in-person travel to Bethesda, MD at least twice a year throughout the project period, including the launch meeting which has been scheduled for July 28-29, 2016, in order to develop the multicenter protocol.  

Multicenter Data Collection [Biospecimens & Cardiorespiratory Monitor Data (CRM)]

Budgets must include $100,000 direct costs over years 2-5 for DNA biospecimen and cardiorespiratory monitor data collection and transfer to the LDCC for the multicenter protocol and if awarded will be restricted and may be renegotiated based on performance, and will not be re-budgeted without NHLBI prior approval. This may include personnel costs including information technology support.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Carol J. Blaisdell, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: blaisdellcj@nhlbi.nih.gov