Priority: Submit response to OMB’s proposed changes to regulations governing federal awards 

The Office of Management and Budget (OMB) issued a proposed rule to revise the Uniform Guidance governing federal grants and financial assistance (91 FR 32198; OMB-2026-0034). The proposal represents a significant framework overhaul to the Uniform Guidance (2 CFR Part 200), which serves as a primary regulatory framework for federal awards distributed to research universities, non-profits, and other recipients. This proposal, which is the largest revision to the Uniform Guidance since its initial release in 2013, represents the effort to codify the Trump Administration’s grantmaking priorities and ongoing activities. 

These changes establish new oversight and accountability standards and also substantially expand agency discretion over award design, selection, and termination. Essentially, these changes weaken longstanding award processes by creating more opportunities for political interference in federal funding decisions. For example, these changes support the termination of grants for discretionary and/or ideological reasons (i.e., aligned with administration priorities, such as prohibiting grants supporting science deemed as “DEI” or those with foreign collaborations) and restrict legal challenges to those decisions. Through these revisions, the administration can exert more political control over funding processes that have traditionally been guided by objective, merit-based evaluation.

The Uniform Guidance touches all corners of the federal government, covering 42 co-issuing agencies across the executive branch. It also affects every county that receives federal funding, whether directly or as a pass-through entity.

Action opportunity: All interested parties are strongly encouraged to submit comments on the docket by the July 13 deadline. Check back here for updates on possible sign-on opportunities from the broader health and science communities. 

Priority: Provide comment to CMS on sweeping new Medicaid community engagement requirements

The Centers for Medicare & Medicaid Services (CMS) has issued an interim final rule (91 FR 33348; CMS-2454-IFC) implementing new statutory requirements for certain adults in Medicaid to meet an 80 hours per month work requirement as a condition of eligibility (referred to as “Medicaid community engagement”).  Among other substantial changes, the rule requires medically-frail individuals not only to confirm that they have a qualifiable condition but, for certain medically-frail individuals, also demonstrate the condition prevents them from working. Individuals living with mild cognitive impairment or in the early stages of Alzheimer’s disease or a related disorder, along with their family care partners, are particularly vulnerable to increased administrative burden created by this new rule, and are at greater risk of coverage disruptions and added stress as they navigate these more complex Medicaid eligibility and reporting requirements. According to initial estimates, these sweeping new requirements are expected to reduce federal Medicaid spending by $326 billion and cost 5.3 million people their Medicaid coverage. 

States must generally implement this requirement no later than January 1, 2027. Individuals who qualify for a medical exemption from work requirements will be allowed to self-attest to their health conditions initially, but are expected to get medical care and documentation verifying their conditions beginning in 2028. 

This rule is being issued as an Interim Final Rule with Comment (IFC) to remain consistent with the legislative directive and implementation timeline established by Public Law 119-21, while allowing CMS to continue to collect and consider public feedback.

Action opportunity: LEAD Coalition members and allies are strongly encouraged to provide comments on the docket by the July 31 deadline. To learn more about the recent changes associated with PL 119-21 and how advocates can respond effectively, review the new Shifting Ground report from the LEAD Coalition and UsAgainstAlzheimer’s. 

Respond to FDA’s request for information and comments on PFDD meetings

The U.S. Food and Drug Administration (FDA) has issued a request for information and comments (FDA-2026-N-3947) to collect examples about how previous patient-focused drug development (PFDD) meetings have impacted stakeholders’ drug development efforts.

In response to requests to better understand the outcomes of PFDD meetings, FDA is seeking to collect information about their impacts outside of specific regulatory decisions. The FDA recognizes that there are many significant outcomes, such as community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas, that can occur in forums to which FDA is not typically a party. Similarly, changes made by medical product developers in response to patient input may not be communicated to FDA outside of a formal regulatory submission.

Action opportunity: All interested parties – including patient organizations, medical product developers, healthcare providers, and academic researchers – are encouraged to submit comments on the docket by the June 30 deadline.

Submit feedback to NIH on return of results to research participants

The Office of Science Policy (OSP) at the National Institutes of Health (NIH) is undertaking a comprehensive policy development process to establish requirements tied to the responsible return of summary-level study results to research participants for all NIH-funded clinical research. Public input is vital to ensuring NIH develops a policy that is flexible, forward-thinking, and serves the best interest of the research participants and the researcher community. NIH is interested in understanding what information should be included in the summary-level results, best practices for participant engagement to ensure that results are returned in meaningful ways, and the timing of sharing summary level results. 

Action opportunity: Interested parties – including study participants, researchers, clinicians, and the broader public— are encouraged to provide feedback to NIH OSP via the available form to help shape the future return of results policy.

Respond to NIH RFI on drug development to prevent or treat specific aging-related conditions

The National Institute on Aging (NIA) has released a request for information (RFI; NOT-AG-26-001) on the development of disease-modifying drugs to prevent or treat specific aging-related conditions. There is evidence that some biologic mechanisms contribute both to physiologic aging changes and to specific aging-related conditions, but few drugs expressly target these mechanisms to modify such conditions.

The RFI seeks input from academic and industry stakeholders who have identified relevant therapeutic targets or are actively developing such drugs. Responses to the RFI will aid NIA in assessing the extent to which potential mechanistic targets for interventions have been identified and validated and will inform planning for possible drug development research initiatives.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to submit comments to NIA_DrugDevelopment@NIH.gov by the July 1 deadline.

Submit comments and register to participate in the NDSS Externally-Led PFDD Meeting

The National Down Syndrome Society (NDSS) is hosting an Externally-Led Patient Focused Drug Development (EL-PFDD) meeting with the U.S. Food and Drug Administration (FDA) on June 2, at 10 a.m. ET, about Down syndrome-associated Alzheimer’s disease (DS-AD). 

The goal of the virtual meeting is to show the FDA and other decision makers how DS-AD impacts the lives of adults with Down syndrome and their families. Topics include the symptoms of DS-AD, individual experiences with available treatments, and hopes for future therapies. The insights shared during the PFDD meeting will help inform future FDA regulatory policies to better reflect the unique challenges that Alzheimer’s disease has on the Down syndrome community.

Action opportunity: All interested parties are encouraged to register for the virtual meeting and submit comments using the online form. Comments will be accepted through July 1; all input will be aggregated and added to the Voice of the Patient Report.

Provide comment on FDA’s proposed rule to remove “gender” terminology in Title 21

The U.S. Food and Drug Administration (FDA) has issued a proposed rule (FDA-2026-N-2886) to modify certain terminology in Title 21 of the Code of Federal Regulations to comply with President Trump’s Executive Order 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” 

The proposed rule, if finalized, would remove the term “gender” wherever it appears and either delete it or replace it with the term “sex”,as applicable, along with other editorial changes.

Though FDA expressed that the policy “does not impact industry practice” and they “do not anticipate any measurable change in industry,” some legal experts see potential for broader damaging impacts on representativeness of clinical trial cohorts, especially individuals from groups that have been underrepresented in research, and therefore risk to the generalizability of research results.

Action opportunity: Interested parties are encouraged to submit comments on the docket by the July 6 deadline.

Deadline Extended: Provide feedback on FDA’s request for information on drug repurposing 

 The U.S. Food and Drug Administration (FDA) has announced it is soliciting input on drug repurposing efforts to help address unmet medical needs across a range of diseases and conditions (FDA-2026-N-4492). 

Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up-to-date.

Additionally, the Reagan-Udall Foundation for the FDA will hold a hybrid public workshop on drug repurposing on August 5. The meeting will include an overview of comments submitted to the public docket as well as discussion of potential approaches for prioritizing and selecting promising candidates for drug repurposing.

Drug repurposing plays an important role in Alzheimer’s disease (AD) drug development. Repurposed agents account for 35% of AD drugs in development, and nearly half of Phase 2 drugs (Cummings et al., 2026).

Action opportunity: Interested parties are encouraged to submit comments on the docket by the July 11 deadline (initial deadline was June 11 prior to a 30-day extension).

Apply for trio of ACL funding opportunities 

The U.S. Administration for Community Living (ACL) has opened three new funding opportunities relevant to the Alzheimer’s disease and related disorders (AD/ADRD) community.

Advancing State Implementation of the National Strategy to Support Family Caregivers 

ACL has released a notice of funding opportunity (NOFO) to support state implementation of the principles, recommendations, and actions as stated in the National Strategy to Support Family Caregivers (HHS-2026-ACL-AOA-CGNS-0032). Grantees will be expected to address at least three of the Strategy’s goals to more effectively recognize, assist, support, and engage family caregivers. In addition, awardees are required to collaborate with their state’s developmental disabilities agency, as well as at one additional state agency over the course of the project. Eligible applicants include state units on aging.

Alzheimer’s Disease Programs Initiative – Dementia Capable States and Communities

ACL has released a NOFO to strengthen the ability of states and communities to serve people living with Alzheimer’s disease and related dementias and their caregivers in their homes and communities (HHS-2026-ACL-AOA-ADPI-0002). The two options for applicants include expanding access to dementia-capable home and community-based services in states (Option A) and communities (Option B). The dementia-capable systems resulting from program activities under either option are expected to provide quality, person-centered services and supports that help individuals living with dementia and their caregiver remain independent and safe in their communities. Eligible applicants include state/tribal/county/city/township governments, non-profits, Native American tribal organizations, and public/private/state institutions of higher education.

Lifespan Respite Care Program: State Grants

ACL has released a NOFO to enhance state systems and capacities to deliver respite care and related services to family caregivers of children and adults across all age groups, disabilities, and chronic conditions (HHS-2026-ACL-AOA-LRLI-0053). There are two applications options contained in this NOFO. Option A is for states that have never had a Lifespan Respite Care grant or for states seeking to restart or rebuild core respite infrastructure and statewide program activities. Option B is for states that have previously received Lifespan Respite Care funding and are seeking to expand, enhance, and sustain existing respite program activities. Programs should identify and address gaps in respite availability, improve access for unserved and underserved populations, reduce duplication across systems, and ensure services remain responsive to the individualized needs of family caregivers across the lifespan. Eligible applicants include state units on aging or state agencies that administer Medicaid programs.

Action opportunity: Eligible organizations are encouraged to submit proposals by the July 22 deadline for each of these ACL funding opportunities.

Respond to FDA’s call for input on new Expedited IND pilot program to accelerate time from drug identification to first-in-human studies 

The U.S. Food and Drug Administration (FDA) is soliciting input on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program (91 FR 37996; FDA-2026-N-4699), to shorten the time it takes from drug identification to first-in-human studies. while protecting clinical trial participants. FDA is requesting information on the potential pilot program, which would establish a network of qualified research institutions that would partner with sponsors to develop and review protocols for first-in-human clinical trials intended for an IND submission to FDA. Information provided through this public docket will help the FDA refine the approach and consider other opportunities to accelerate time to first-in-human clinical trials.

Action opportunity: Interested parties may submit comments on the docket by the July 22 deadline.

Submit comments to FDA’s call for input on safer starting doses for first-in-human clinical trials 

The U.S. Food and Drug Administration (FDA) is soliciting input on new draft guidance intended to help sponsors determine safer starting doses for first-in-human clinical trials of certain drugs and biologics (91 FR 38004; FDA-2026-D-6539). Historically, first-in-human starting doses have been based largely on animal toxicology studies, which may not adequately estimate human risk. Through this guidance, FDA is signaling stronger support for model-informed drug development, specifically the use of Quantitative Systems Pharmacology (QSP), to establish starting doses in first-in-human trials. The guidance is particularly relevant for advanced biologics and immune-modulating therapies where safety concerns can arise at very low doses.

Action opportunity: Interested parties may submit comments on the docket by the July 24 deadline.

Provide comment on NIH’s proposal to limit the number of simultaneous grants per PI 

The National Institutes of Health (NIH) has released a request for information (RFI; NOT-OD-26-086) on a proposal to limit the number of simultaneous NIH Research Project Grants (RPGs) that any individual investigator can hold as a principal investigator (PI) or multi-PI. NIH argues that concentrating large numbers of grants among a relatively small group of investigators may reduce overall scientific productivity and innovation. The agency also states that a cap could broaden the distribution of funding across institutions and geographic regions, support more investigators, strengthen the biomedical workforce, and improve project oversight and mentoring. Note: This aim appears in conflict with current efforts to expand multi-year funding practices, in which NIH commits research dollars up front for entire project periods, limiting near-term flexibility and drastically reducing the ability to redistribute funds more broadly across investigators and institutions.

The RFI asks stakeholders to weigh in on potential caps of two, three, or four simultaneous RPGs. NIH estimates that a cap of four grants could free approximately $1.28 billion for roughly 1,900 additional awards, while a cap of two grants could free about $3.53 billion for more than 5,200 additional awards. Under the primary implementation approach, investigators above the cap would gradually reduce their grant portfolios through renewals, grant relinquishments, or PI transfers before receiving new awards. NIH is also considering an alternative, more rapid implementation approach that would require institutions to bring investigators into compliance within one year.

NIH has requested feedback specifically on the advantages/disadvantages of the proposed policy, the optimal cap level, proposed implementation strategies, and any unintended consequences or policy loopholes.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to submit comments via the NIH form by the August 3 deadline.

Respond to NIH’s RFI on measuring and rewarding scientific impact 

The National Institutes of Health (NIH) is seeking input on how scientific impact should be measured and rewarded. Through its Request for Information (RFI; NOT-OD-26-087), NIH elevates the new agency-wide Replication and Reproducibility Initiative and – in alignment with this initiative – requests input on specific metrics to measure and incentivize collaborative, rigorous, and impactful research.

This RFI notes that biomedical research traditionally has rewarded productivity, often measured in publication and citation counts. NIH aims to shift toward a new framework that places greater emphasis on reproducibility, data and software sharing, mentorship, collaboration, translation of discoveries into practice, foundational scientific exploration, and public impact. Based on input, NIH aims to develop and adopt new metrics that are expected to influence grant review, promotion and tenure processes, and scientific careers more broadly.

By redefining research success, this effort has the power to reshape how and what research questions are pursued, and ultimately what types of research are conducted. Researchers, trainees, institutions, professional societies, and other research stakeholders should consider both the potential benefits and unintended consequences of these changes, including new biases that could emerge, in responses to the RFI.

Action opportunity: All interested parties are encouraged to respond to the RFI via the online submission form by the August 19 deadline.

Provide feedback on FDA’s revised draft guidance on substantial evidence of effectiveness for drugs and biologics 

The U.S. Food and Drug Administration (FDA) published revised guidance on the demonstration of substantial evidence of effectiveness for drugs and biologics (91 FR 37994; FDA-2019-D-4964). The updated guidance, revised based on public comment and advances in drug development, indicates that two positive Phase 2 trials are not a rigid requirement. Instead, the guidance signals that one, strong pivotal trial — coupled with other confirmatory evidence— may be sufficient to satisfy the evidence of effectiveness standard. 

For sponsors, this revision offers greater flexibility to leverage a broader range of evidence to support approval, which may be  advantageous for certain disease types with small patient populations, e.g., rare diseases, genetically-defined conditions. When final, this guidance will replace the 1998 guidance titled “Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.

Action opportunity: Interested parties may submit comments on the docket by the September 22 deadline.

Urge Members of Congress to co-sponsor dementia-specific legislation

Alzheimer’s Screening and Prevention (ASAP) Act

Congressmen Vern Buchanan (R-FL) and Paul Tonko (D-NY), and Senators Susan Collins (R-ME) and Catherine Cortez Masto (D-NV), have introduced the Alzheimer’s Screening and Prevention (ASAP) Act (H.R. 6130/S.3267). This bipartisan legislation aims to ensure timely access to innovative screening tests that can detect Alzheimer’s disease and related forms of dementia in their earliest stages.

Under current law, Medicare can cover only preventive services that Congress has specifically authorized or that are recommended by the U.S. Preventive Services Task Force (USPSTF). This process can delay coverage for years after screening tests receive Food and Drug Administration (FDA) approval. The ASAP Act modernizes that process by authorizing the Secretary of Health and Human Services to provide Medicare coverage for FDA-approved or cleared blood-based biomarker tests for the early detection of Alzheimer’s and other dementias. For more information about the ASAP Act, read the Alzheimer’s Impact Movement press release, ASAP Act Fact Sheet, and the joint LEAD Coalition/Alzheimer’s Association/AIM letters to Congress encouraging all Representatives and Senators to become co-sponsors.

Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act

Senators Shelley Moore Capito (R-WV) and Mark Warner (D-VA) have reintroduced the Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act, bipartisan legislation to encourage early assessment and diagnosis of Alzheimer’s. Companion legislation was also introduced in the U.S. House of Representatives by Representatives Linda T. Sánchez (D-CA), Darren LaHood (R-IL), Doris Matsui (D-CA), and Gus Bilirakis (R-FL). The CHANGE Act (S. 1799 / H.R. 3501) would better utilize the existing Welcome to Medicare initial exam and Medicare annual wellness visits to screen, detect, and diagnose Alzheimer’s and related dementias in their earliest stages. An early documented diagnosis communicated to the patient and caregiver enables timely access to care planning services along with available medical and non-medical treatments, and optimizes peoples’ ability to build a care team, participate in support services, and enroll in clinical trials. For additional information, see the bill text and the and the LEAD Coalition letters to Congress encouraging all Representatives and Senators to become co-sponsors.

Accelerating Access to Dementia & Alzheimer’s Provider Training (AADAPT) Act

Representatives Troy Balderson (R-OH), Nanette Barragán (D-CA), Darin LaHood (R-IL) and Paul Tonko (D-NY) and Senators Shelley Moore Capito (R-WV), Amy Klobuchar (D-MN), Jerry Moran (R-KS), Cory Booker (D-NJ), Dan Sullivan (R-AK), Andy Kim (D-NJ), James Lankford (R-OK), and Maria Cantwell (D-WA) have reintroduced the bipartisan Accelerating Access to Dementia & Alzheimer’s Provider Training (AADAPT) Act (H.R. 3747/S.4036). The AADAPT Act would provide grants to providers participating in structured Alzheimer’s and dementia virtual education programs to build on their knowledge of detection, diagnosis, care, and treatment of Alzheimer’s and other forms of dementia. The legislation would address knowledge gaps and workforce capacity issues being faced by primary care providers across the nation, connecting their practices with dementia care experts using free, remote continuing education. These programs have added importance in reaching rural and medically underserved areas where primary care providers are especially strained. Read the full legislative text.

Bridging Relief in Delayed Government Enrollment (BRIDGE) for Young Onset Alzheimer’s Disease Act

The Bridging Relief in Delayed Government Enrollment (BRIDGE) for Young Onset Alzheimer’s Disease Act of 2025 (H.R. 6799) would provide more timely coverage of treatment and care for individuals living with young-onset Alzheimer’s by removing the 29-month waiting period for individuals under the age of 65 to qualify for Medicare after obtaining Social Security Disability Insurance. For more information, please see the one-pager.

Global Alzheimer’s Initiative Now (GAIN) Act

Representatives Ami Bera (D-CA), Brian Fitzpatrick (R-PA) and Young Kim (R-CA) have reintroduced the bipartisan Global Alzheimer’s Initiative Now (GAIN) Act (H.R.3674). The GAIN Act would authorize the United States to participate formally in the Davos Alzheimer’s Collaborative (DAC), a global public–private–patient partnership advancing Alzheimer’s and dementia research, diagnosis, treatment, and care. Alzheimer’s and dementia affect nearly 60 million people globally and cost the world economy more than $1.3 trillion annually—an amount that doubles every decade. DAC aims to raise and deploy $700 million over six years and currently supports 19 health systems in 12 countries, including the United States. Read the full legislative text.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of these important pieces of legislation. 

Support the Geriatrics Workforce Improvement Act

U.S. Senators Susan Collins (R-ME) and Tim Kaine (D-VA) have introduced the Geriatrics Workforce Improvement Act (S.2699) to reauthorize funding for the Geriatrics Workforce Enhancement Program (GWEP) and the Geriatrics Academic Career Awards (GACA). Both programs were last authorized in 2020 as part of the CARES Act and are set to expire at the end of September, 2025. The Geriatrics Workforce Improvement Act would reauthorize the GWEP and GACA programs at a combined $48.2 million per year over the next five years.

The GWEP is the only federally funded program that exists to educate and train health professionals in geriatrics. There are currently 42 GWEP recipients. GACA support early-career training of junior faculty to develop emerging leaders in geriatric education and clinical care. There are currently 25 GACA recipients funded under four-year awards through June of 2027.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of the Geriatrics Workforce Improvement Act.

Support the Older Americans Act (OAA) Reauthorization Act

The Older Americans Act (OAA) Reauthorization Act (S.2120) has been reintroduced in the Senate by Senators Bill Cassidy (R-LA), Bernie Sanders (I-VT), Rick Scott (R-FL), Kirsten Gillibrand (D-NY), Susan Collins (R-ME), Tim Kaine (D-VA), Markwayne Mullin (R-OK), Edward Markey (D-MA), Lisa Murkowski (R-AK), and Ben Ray Luján (D-NM).. The legislation would renew funding and strengthens services for American seniors. Senator Collins is an original cosponsor of the bill, and she was a member of the bipartisan working group that authored this legislation. Since 1965, the OAA has supported and improved the lives of seniors—particularly those who are low-income—through programs that promote nutrition, improve transportation options, support caregivers, offer employment and community service opportunities, and prevent abuse and neglect. This critical law was last reauthorized in 2020.

Specifically, this legislation would reauthorize OAA programs through Fiscal Year 2030 and make improvements to promote innovation and flexibility, strengthen program integrity, and better support family caregivers and direct care workers. The bill also takes steps to better serve Tribal seniors and those with disabilities in their communities. The OAA authorizes an array of services through a network of 56 State Units on Aging and more than 600 Area Agencies on Aging serving older Americans throughout the nation. In the last year alone, OAA programs served more than 12 million caregivers and older adults, including providing more than 2.4 million seniors with at-home or congregate meals.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of the Older Americans Act (OAA) Reauthorization Act.