Please note: The primary source of all information regarding PAR-19-099 and PAR-19-100 are the FOAs themselves and any notices linked therein.
Anticipated Announcement and Award Dates
- Summary Statement Release: applicants are expected to receive the summary statement via the eRA Commons approximately 30 days before the Advisory Council Review date. Please refer to Part 1 for dates for scientific merit review, advisory council review, and earliest start date.
- Clinical Trial Optional: please refer to the resource Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?
- “As detailed in NOT-TR-18-025, NCATS is limited to direct support of clinical trials through phase IIB with the exception of phase III (21 CFR definition) clinical trials for treatment of a rare disease or condition.” Please refer to the related notice NOT-TR-19-023 that indicates:
“For NCATS to support a phase III clinical trial activity for a rare disease or condition, all policy guidance and statutory requirements stated in NOT-TR-18-025 must be followed, including a ≥ 120 day public notice of NCATS' intent to fund the Phase III CT for a rare disease or condition and lack of a written credible response from any public or private organization that the organization has timely plans to conduct Phase III CTs of a similar nature.”
- Award budget: for PAR-19-099 (U01): the allowable budget request for clinical project and the prior approval requirement for requests of $500,000 or more for direct costs are no longer applicable. Please refer to the related notice NOT-TR-20-004 that indicates:
- “Application budgets need to reflect the actual needs of the proposed project and are limited to no more than $750,000/year in direct costs excluding consortium/contractual F&A costs. Any application that proposes more than $750,000/year in direct costs excluding consortium/contractual F&A costs for any budget period will be withdrawn prior to review and without consideration of funding.”
- “Removal of prior approval requirement for requests of $500,000 or more for direct costs in any year in Section IV of PAR-19-099”.
- An application must involve investigators who are supported by CTSA Program hub institutions: investigators do not need to be supported by the CTSA grant, but they must be employed by CTSA Program hub institutions including the recipients of the CTSA Program hub award, as well as any institutions listed as partners in the CTSA Program hub UL1 awards.
- A partner is defined based on the use of its NIH funding for the purpose of determining the maximum total award direct costs for the CTSA U54 application. Partners included in one CTSA U54 application may not be included as partners in another CTSA U54 application for the purposes of determining the maximum award direct costs. Please see the CTSA Program PAR-18-940 Application Information.
- Single-PD/PI model or Multi-PI/PD model: applicants should determine the leadership model that is best for the proposed project. Please see Multiple Principal Investigators for additional information.
- For PAR-19-099 (U01), the revised Eligible Applicants section has been effective as of February 21, 2019. Please refer to the related notice NOT-TR-19-016, that indicates:
- “Eligible Organizations: an application must involve investigators who are supported by CTSA Program hub institutions from at least three different and currently funded CTSA Program hubs as of the due date of the application or alternatively, an application may involve investigators from at least two different and currently funded CTSA Program hubs (of which one must be the contact PI on the application) and one or more currently funded NIH Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR) participating institution, as of the due date of the application. A CTSA Program hub is defined as a UL1 award with a linked KL2 award and an optional TL1 award. A hub that is in no-cost extension (NCE) status is not considered a currently funded CTSA Program hub (see https://ncats.nih.gov/ctsa/about/hubs). CTSA Program hub institutions include the recipients of the CTSA Program hub award, as well as any institutions listed as partners in the CTSA Program hub UL1 awards. An IDeA-CTR participating institution is defined as the lead institution of an IDeA-CTR award or any of the partner institutions of the IDeA-CTR award. An IDeA-CTR participating institution that is in no-cost extension (NCE) status is not considered “currently funded.”
Other Submission Requirements and Information
- Post submission materials: applicants are required to follow the instructions for post-submission materials as described in the policy.
- Please see the NIH Resubmission Applications guide.