Mike's Blog

Normally, my May blog highlights events and activities that transpired during the annual ACTS meeting in the prior month. Unfortunately, travel restrictions (and yes, even local travel that requires registration fees is considered travel) precluded NCATS participation. At the same time, NIH staff have been overwhelmed with regular administrative and programmatic activities, and some modifications [to various and multiple processes] are slowly sorting themselves out. Grant awards have experienced some significant delays this year, but with the herculean support of grants management staff, program staff are now moving forward with their regular work.

Let’s begin with those looking to submit applications (for FY26). All CTSA NOFOs have now been edited to align with new agency priorities and are noted with a large banner at the top of the NOFO. We have shared examples of alternative language used in the UM1 NOFO with the CTSA administrators during their recent meeting. NIH did terminate NOFOs supporting diversity supplements so those are no longer available. As usual, regarding any questions, please contact your PO for your grant specific questions, and for general questions please contact the Agency Contacts from Section VII in the NOFOs. For those with grants under consideration for funding, we had the unique experience of January NCATS Council taking place in April – a 3-month delay! NCATS (and all NIH Institutes) is required to hold three Council rounds per year. NIH Advisory Councils are subject to the Federal Advisory Committee Act (FACA) and require public notification. With the NIH-wide communications pause initiated after the administration transition resulting in restrictions in submitting to the Federal Register, April 17 was the earliest date that NCATS could hold the January Council. NCATS gets to reprise this date shift as our ‘May’ Council will now likely occur sometime in June (getting better – 1 month delay!). For those with a grant undergoing review, study sections are also subject to FACA rules. All reviews that will go to ‘May’ Council for FY25 funding consideration have been conducted. For those submitting for FY26 funding consideration, NIH is centralizing reviews, inclusive of the CTSA applications, and applications are being transitioned to the Center for Scientific Review (CSR) (reference here). One recent reminder has been issued by NIH (NOT-OD-25-098) for application requirements for projects involving activities outside of the United States or partnerships with international collaborators that applications are required to include a foreign justification. Those applications without these justifications have been withdrawn by CSR.

When we have more information on CSR processes for clustering applications, we will let you know.

Lastly, regarding competing and noncompeting awards, delays have been unfortunate, but we now have a process in place for ensuring all awards are compliant with agency priorities and secretarial directives. Further, NIH has released a notice (NOT-OD-25-090) of a new Civil Rights term and condition for all NIH grants that the extramural community must be aware, and we encourage you to read. We are proceeding in order and the majority of 3/1 start dates have been processed. This batch assisted in working through our overall approach and process and subsequent rounds should find the experience smoother. Unfortunately, some grants have and will experience a haircut, but at least so far, the cuts have been modest. Competing and noncompeting awards are treated equally, and staff review what is currently provided for consideration (see note below about cutting and pasting from the previous year’s RPPR and the note above about alternative language used in the UM1 NOFO). Additionally, with the final approval for a full year continuing resolution (CR) on March 15 (NOT-OD-25-084), NCATS has updated its website to provide clarity on our intent to award all non-competing grants at 100% of the committed level minus any unallowable costs. Grants that were issued during the CR at 90% will be revised prior to the end of fiscal year.

Finally, to clear up some confusion following the April CTSA Program Webinar, while we have received numerous inquiries regarding changes to grant title, abstract, and aims, please do NOT request changes in your RPPR submission. Details, as well as a template for such a request can be found here. This does require prior approval, and we encourage you to wait for your PO and/or GMS to reach out to you (likely during JIT and/or prior to budget start date but do NOT submit this with your RPPR or in your RPPR!). Lastly, please avoid simply cutting and pasting from last year’s RPPR. C&P has never been appropriate, but with enhanced scrutiny it has become especially problematic. If there are no major/significant changes, then state that as such. Budget justifications will be required for any and all significant changes. ‘Fraud, waste, and abuse’ has been bandied about quite extensively. It should be noted that misrepresentation in an application or RPPR can be regarded as fraud. Refer to the April CTSA Program Webinar for specific examples of possible misrepresentation. Potential consequences can be severe.

NCATS has full confidence in the capabilities of CTSA investigators and their institutions to navigate this time of change. We fully expect the CTSA Program to emerge stronger and serve as an exemplar in turning science into health for everyone!

Business as usual is not a viable option.

-Rebecca Henderson