From the Alliance for Regenerative Medicine on October 1, 2025:
DSF is sharing the information below, originally posted by the Alliance for Regenerative Medicine, to highlight potential impacts on the Dravet syndrome community.
As of midnight on October 1st, the U.S. federal government has entered shutdown mode. That means that thousands of federal workers have been furloughed and only activities deemed “essential” or funded by permanent, mandatory, or advanced appropriations will continue. Similarly, functions financed by user fees or trust funds generally proceed so long as essential staff are retained, with some limitations.
The Department of Health and Human Services (HHS) contingency plans for a government shutdown can be found here: https://www.hhs.gov/
The FDA’s plan can be found here: https://www.hhs.gov/about/
According to its FY 2026 contingency staffing plan, the FDA will retain 86 percent of its staff.
Activities funded through user fees, including approval of new medical products, the review of requests to conduct clinical research, the issuance of guidance, and other necessary activities to help patients access new therapies and generic and biosimilar treatment options.
The agency cannot accept or process new user fees during a shutdown, but it can spend user fees already collected. So, FDA cannot accept a new submission that has an associated user fee during a government shutdown (e.g., new drug application, abbreviated new drug application, biologic license application, medical device premarket application, premarket notification (510(k)), De Novo). Such submissions will be placed in a queue for formal processing and acceptance once normal operations resume. FDA can continue working on an application or submission that has already been received by the agency, along with the associated user fee, during a shutdown. In this case, user fee funded activities that can continue include application review meetings and pre-approval inspections. Because the FDA cannot accept new user fees, however, the funding for review activities is limited to the carryover balance of user fees that have been received and processed by the agency but not otherwise obligated. This sum remains available for use during a shutdown, until it has been spent.
Some work can also continue on submissions that do not require a user fee (e.g., investigational new drug (IND) applications and applications that qualify for fee exemptions). This activity is also dependent upon the availability of carryover funds.
The Centers for Medicare and Medicaid Services (CMS) plan can be found here: https://www.hhs.gov/about/
According to its FY26 contingency staffing plan, CMS will retain 53% of its staff. Programs and activities that will continue include:
Medicare payments to providers and Medicare Advantage Organizations, plus related Medicare program activities including implementation of the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program, which has its own appropriations under the IRA;
Medicaid and CHIP payments to states, as these programs are funded via mandatory funding streams. CMS will have sufficient funding for Medicaid to fund the first quarter of FY 2026, based on the advance appropriation provided in the FY 2025 continuing resolution enacted in March 2025;
Operations for the federal health insurance Marketplace (HealthCare.gov), such as eligibility determinations, which can be funded using carryover from its user fee collections; and
Other non-discretionary activities, including:
Health Care Fraud and Abuse Control Program, which coordinates federal, state, and local law enforcement actions with respect to health care fraud and abuse; and
Center for Medicare & Medicaid Innovation (CMMI) activities, since CMMI’s funding comes from a permanent appropriation for activities initiated under section 1115A of the Social Security Act.
Although CMS does not spell out which activities may be affected during the shutdown, it is likely that longer-term rulemaking and policymaking functions would be stalled as a result of limited staff to review and provide operational support. CMS payment rule development and other policy decisions, notably, would depend on the funding source and duration of a lapse in appropriation.
The National Institutes of Health (NIH) plan can be found here: https://www.hhs.gov/about/
According to its FY26 contingency staffing plan, NIH will retain about 25% of its staff.
Activities that continue will be largely centered on the ongoing operations at its biomedical research hospital, the NIH Clinical Center, to maintain the safety and continued care of its patients.
Activities that will not continue include:
All NIH grant peer review meetings, advisory council meetings, issuance of new awards, and program/grants management activities.
The admission of new patients at the NIH Clinical Center (unless deemed medically necessary by the NIH Clinical Center Director).
Basic research conducted by NIH scientists.
Translational research conducted by NIH scientists that develops clinical applications of scientific knowledge.
Training of graduate students and postdoctoral fellows at NIH facilities.
Scientific meetings at NIH facilities.
Travel of NIH scientists to scientific meetings.
The Office of Management and Budget issued a memorandum to agency and department heads on the status of the shutdown. On September 24th, OMB Director Vought reportedly issued another memo directing agency heads to consider Reduction in Force (RIF) notices for all employees in programs, projects, or activities whose discretionary funding lapsed, another source of funding is unavailable, and the project is inconsistent with President Trump’s priorities. On a call with House Republicans, Vought indicated that federal layoffs could begin in the next day or two but did not indicate which departments or programs would be affected.