I’m writing this the week before the new fiscal year is scheduled to begin. The USG has its own unique way of telling time and the fiscal year always begins on October 1st. In the absence of a full year’s budget which consists of twelve separate appropriation bills, Congress can pass a continuing resolution (CR) which keeps the government ‘open’ and operating at last year’s budget levels with the additional caveat that ‘new’ activities planned for the new fiscal year (FY26 for now) cannot move forward. One additional aspect of a CR is that the budget during the CR is only the amount for that period of the time the CR is in effect. In other words, if a seven-day CR were passed, then NCATS would have access to only get 7/365 of last year’s budget for that time period.&nbsp;In spite of the current Congressional makeup, simple majority does not always rule.&nbsp;The Senate requires a 60 vote threshold for passage and thus with the current makeup, some degree of bipartisan agreement is required. The House has passed its version of a ‘clean’ CR, but the vote on that CR failed in the Senate. At the same time, an alternative CR was offered in the Senate and that failed as well. The House is not due back in town until October 1st, so the only available option is for the Senate to adopt the House version early next week to avoid a shutdown. It is anticipated that the Senate will have this opportunity. There have been rumors of some sort of grand bargain being worked out, but as Congress tends towards last-minute cliffhangers, things typically remain uncertain until the last possible minute. &nbsp;If the USG were to shut down, staff come into work on the first day of the new fiscal year to effect an orderly shutdown of operations. This mostly entails setting an automatic reply to incoming emails (as well as voicemail if applicable) referencing the situation and directing emergency situations to a specific email address. In the case of the CTSA program, this will be me. CCOS organized meetings will proceed, but DCI staff will not be participating. Actions such as prior approval review will not take place.We are hoping for the best but are planning for the worst.&nbsp;The budget is like a mythical bean bag.&nbsp;Congress votes mythical beans into it, then reaches in and tries to pull real ones out.— Will Rodgers

By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation

Familiar Territory

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As FY25 comes to a close, most people at NIH are simply hoping to catch their breath before we learn what awaits us in FY26. The budget is (as typical) still pretty murky. The president has submitted a budget request which included an overall 40% reduction in total NIH funding as well as a reorganization plan. Bear in mind that Congress merely regards the President’s Budget as a suggestion. What we’ve seen with Congressional hearings on the budget have been uniformly uninformative. Little has emerged from the House. On the Senate side, <a href="https://www.appropriations.senate.gov/imo/media/doc/fy26_lhhs_senate_bill_summary.pdf" target="_blank" rel="noopener noreferrer">the Appropriations Committee did vote out their bill</a> giving NIH a $400M increase relative to FY25. There is also language specifically rejecting a 15% indirect cost rate as well as any NIH reorganization. This bill still requires full Senate approval and then will need to be reconciled with whatever comes from the House, so there is still a long way to go. And then there is still the possibility of a shutdown if the House and Senate cannot come to agreement.&nbsp;As far as grants go, the CTSA Program has been quite successful in achieving alignment with agency priorities for nearly 200 distinct grant actions. There may be a few more over the next couple of weeks as we await final decisions on certain contract actions. Overall, there were 61 hub awards with an average ‘haircut’ of only 2.27%. Over one third had no cuts at all and only 15% experienced cuts of over 5%.&nbsp;We have received all necessary approvals for the Fall Program meeting with the NIH Director as our keynote speaker. As a reminder, due to our inability to support CTSA activities at the spring ACTS meeting, the Enterprise Committees and other groups will be also meeting during this time. Hopefully, the arrangements with the hotel will be finalized by the time you read this.&nbsp;Enjoy what remains of summer.&nbsp;There’s always hope for something. Just not always… not always what we want.&nbsp;- James S.A. Corey, The Mercy of Gods&nbsp;&nbsp;

Hobbling Towards the End of the Year

NCATS Director of the Division of Clinical Innovation

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Michael G. Kurilla M.D., Ph.D.

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We’re back, it’s FY26 now, aaaaaand we’re already behind. The USG is once again open for business after 43 days (now the longest shutdown ever). Most staff are still digging out from the avalanche of emails that accumulated over that time. At the same time, hundreds of study sections (&gt;400) have been cancelled and will need to be rescheduled even including ones that were scheduled for after the shutdown due to issues with recruitment, assignments, and travel arrangements. This will impact the UM1 reviews. While we were just getting caught up from all the earlier delays in FY25, it appears that we’ll be playing catchup for much of FY26. Councils right now are still taking place as planned but expect some adjustments. In addition, NCATS (as well as other NIH ICs) may also run into quorum concerns for Council further into 2026. The resolution of the shutdown has left NIH with another continuing resolution (CR) that now runs through January 30th (this means NCATS January Council: 1/29, will take place). There were three full year appropriations bills included (military construction/VA, Agriculture which includes the FDA, and the legislative branch) in the CR. We may see more full year appropriation bills before 1/30, but the one with NIH (Labor, Health and Human Services, Education, and Related Agencies, aka ‘Labor H’) is likely to be one of the more contentious bills, so we (NIH) may be looking at another CR or even another full year CR for the rest of FY26. Official travel will require lengthier justifications and additional eyeballs for review, so longer lead times, especially for conferences and workshops, will be necessary. CTSA Program visits are unscathed so far from this policy.&nbsp; &nbsp;For those of us (&lt;10) who were here throughout the shutdown (designated as ‘excepted’), while the building was quiet, there were a few activities to keep us occupied, necessitating ‘recalling’ certain staff for specific tasks. The biggest issue during this time was N3C. Many of you have been aware that N3C was forced to shut down prior to the USG shutdown. NCATS’ contract with Palantir was up for renewal in late September and HHS declined to approve that renewal. This decision in no way reflects HHS opinion on the scientific merits of N3C; rather, this contract (along with other similar HHS contracts) was caught up in a larger ongoing activity across HHS that is focused on enhancing data sharing across HHS by standardizing how the whole department (as opposed to individual departmental agencies) approaches IT infrastructure and resources. A considerable amount of effort was expended to ensure that all N3C data remained secure and that nothing was lost as a result of this temporary suspension of activities. Joni and I were granted pontifical dispensation to address (virtually) the CTSA Steering Committee during the annual meeting as all N3C-related activities were deemed ‘excepted work.’ Unfortunately, at this point we don’t have a date when N3C will be restored but stay tuned as we anticipate coming back bigger and better than ever. We were able to temporarily open (through the end of next week) the enclave for researchers to download their work. We will be rolling out more details on the transition over the next few months. Together, we’ll all survive FY26! Project planning isn’t about avoiding changes, it’s about controlling them. No project plan ever survives contact with the enemy. - Dennis E Taylor, We Are Legion (We Are Bob) &nbsp;

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Familiar Territory