Nominate an expert for NASEM’s consensus study on interventions to prevent, slow, or delay cognitive impairment and dementia

The National Academies of Sciences, Engineering, and Medicine (NASEM) has launched a new consensus study to examine the current evidence on interventions that may prevent, slow, or delay cognitive impairment and dementia. Building on NASEM’s 2017 report, Preventing Cognitive Decline and Dementia: A Way Forward, this study will revisit the substantial body of research with updates from the last decade.

As part of the study, NASEM will commission an Evidence-based Practice Center (EPC) to update and expand (to include causes of dementia other than Alzheimer’s disease) a prior systematic review that served as the primary basis for the 2017 report. The EPC’s independent systematic review will consider evidence published since then, incorporate evidence on non-pharmacological and pharmacological interventions, and determine whether the strength of evidence has advanced. A NASEM ad hoc committee will inform the systematic evidence review and, based on its findings, make recommendations for future research and public health actions.

NASEM staff are seeking nominations for individuals with expertise in the following areas to serve on the ad hoc committee: 

• clinical research on cognitive impairment and dementia
• pharmacological interventions for preventing cognitive impairment and dementia
• nonpharmacological interventions for preventing cognitive impairment and dementia
• cognitive aging and health
• epidemiology
• geriatrics
• behavioral and social sciences
• systematic review methodology
• public health and health communication

Nominations may also inform potential speakers and participants for public meetings and peer reviewers for associated publications resulting from the study activity. 

Action opportunity: Individuals may nominate themselves and/or peers to serve as volunteer experts via this form by the October 12 deadline.

Provide feedback on proposed changes to NIH peer review outcome reporting

The National Institutes of Health (NIH) is requesting input on proposed changes to how outcomes from NIH peer review are reported (NOT-OD-26-088). Under the proposal, NIH would replace the reporting of final overall impact scores and percentiles with three categories: “most competitive,” “competitive,” and “not discussed.” Applications in these categories would reflect the top 25%, 26-50%, and the bottom 50% (inclusive of “not discussed” applications) of final overall impact scores, respectively. The proposed approach is intended to reduce the emphasis on numerical scores while providing NIH Institutes, Centers, and Offices with greater flexibility to consider peer review outcomes alongside other factors when making funding decisions. Concerningly, by replacing standardized numerical scores with broad categorical labels, peer review outcomes would become much less transparent, reducing predictability for applicants and creating new opportunities for political influence on funding decisions. Diminished transparency makes normal congressional oversight more difficult and less rigorous, and risks weakening the general public’s confidence in the scientific integrity of NIH decision-making. 

Action opportunity: Interested parties are encouraged to provide comments on the proposed peer review reporting changes by the October 13 deadline.

Submit comments to CMS on the RAPID coverage pathway

The Centers for Medicare and Medicaid (CMS) has issued a proposed procedural notice (CMS-3487-NC) outlining the process the agency will use to expedite approval of new devices covered by Medicare. Announced in April, the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway applies to U.S. Food and Drug Administration (FDA) Breakthrough-designated devices that address unmet medical needs for Medicare beneficiaries. To be eligible for the RAPID coverage pathway, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS. The agencies will use existing programs and coverage frameworks to analyze and approve devices that demonstrate positive clinical health outcomes in a timelier and more predictable way during the premarket phase. By aligning CMS and FDA evidence expectations in advance, the RAPID coverage pathway is designed to reduce significantly the review time between FDA market authorization and Medicare national coverage determinations (NCDs). For additional information, see the RAPID pathway infographic, the CMS factsheet and the FDA fact sheet.

Action opportunity: Interested parties are encouraged to provide comments on the docket by the October 13 deadline.

Provide input to PCORI on questions guiding a systematic review of AD biomarkers

The Patient-Centered Outcomes Research Institute (PCORI) is soliciting public input on draft key questions that will guide a systematic review examining biomarkers used to diagnose and stage Alzheimer’s disease (AD) across different populations. PCORI is seeking feedback on whether the proposed questions adequately address issues that matter to individuals living with AD, care partners, providers, and the broader health care community, as well as whether the review’s planned population, interventions, comparators, outcomes, timing, and settings (PICOTS) appropriately capture the available evidence and important research gaps.

Public input could help shape the scope of the systematic review and ensure that the evidence considered reflects the needs and experiences of diverse populations affected by the disease. PCORI is also inviting respondents to identify additional research needs, relevant studies or publications, and other information that may be important to understanding the existing literature on biomarkers for diagnosis and staging.

Action opportunity: Interested parties are encouraged to submit comments via this form by October 14 at 5pm ET.

Submit nominations for the RAISE Act Family Caregiving Advisory Council 

The Administration for Community living (ACL) is seeking nominations — initially authorized by the Recognize, Assist, Include, Support, and Engage Family (RAISE) Caregivers Act of 2017 (Public Law 115-119) — for the RAISE Family Caregiving Advisory Council. The RAISE Council will support implementation of the update to the National Strategy to Support Family Caregivers, which is expected to be released later this year. Implementation efforts will include new developments, challenges, opportunities, and solutions to better recognize and support family caregivers, along with recommendations to build upon the accomplishments of the National Family Caregiving Strategy in future reports. 

Up to 15 non-federal voting members from the following groups will be appointed for three-year terms: family caregivers; older adults who need long-term services and supports; individuals with disabilities; healthcare and social service providers; providers of long-term services and supports; employers; paraprofessional workers; state and local officials; accreditation bodies; veterans; and as appropriate, other experts and advocates engaged in family caregiving. Those selected to serve on the Advisory Council will reflect the wide range of experiences of family caregivers and care recipients.

Any person or organization may nominate one or more qualified individuals for membership. Current Advisory Council members whose terms are expiring may also submit a nomination for consideration. Terms are limited to two consecutive terms. Nomination packages must include a nomination letter not to exceed one (1) page that provides all of the following information:

• The reason(s) for nominating the individual;
• The constituency being represented (from the list above; may be more than one);
• The nominee’s particular, relevant experience and/or professional expertise or lived experience;
• Contact information for the nominee [name, title (if applicable), address, phone, and email address]; and
• The nominee’s resume (not to exceed two (2) pages) if the nomination is based on their professional capacity or qualifications. A resume is optional otherwise.

Action opportunity: Interested parties are encouraged to submit nominations electronically to RAISE.mail@acl.hhs.gov by the October 14 deadline. 

Provide input on FDA’s proposed PDUFA VIII recommendations for FY 2028–2032

The U.S. Food and Drug Administration (FDA) released the proposed PDUFA VIII commitment letter, outlining recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2028–2032. PDUFA is a federal program that allows the FDA to collect user fees from pharmaceutical and biotechnology companies in exchange for resources that support the review of human drug applications. The program is periodically reauthorized by Congress and establishes performance goals and commitments intended to make the drug review process more predictable and efficient. This commitment letter represents the FDA’s proposed recommendations for the next five-year iteration of the program and will inform the broader reauthorization process.

The FDA is hosting a hybrid meeting on September 16 to discuss the recommendations with the public and also accepting written comments on the commitment letter.

Action opportunity: Interested parties can register for the hybrid public meeting and request to provide a verbal statement during the public comment session. Requests to provide public comment must be submitted by September 2. Written comments can be submitted on the docket through the October 16 deadline.

Provide feedback to inform FDA’s regulatory approach for generative AI-enabled medical devices

The U.S. Food and Drug Administration (FDA) has issued a discussion paper on how generative AI (GenAI)-enabled medical devices could be regulated and is seeking feedback on relevant topics (FDA-2026-N-7874). The effort, led by the FDA Digital Health Center of Excellence, aims to consider how existing approaches may need to evolve to address the unique capabilities and risks of GenAI-enabled devices while continuing to support innovation and patient safety. The discussion paper offers potential frameworks and raises questions about regulatory considerations specific to GenAI, including risk assessment, premarket evaluation, and postmarket monitoring.

Action opportunity: All interested parties are encouraged to provide comments on the docket by the October 19 deadline.

Submit comments on the 2028 National Health Interview Survey Redesign

The Centers for Disease Control and Prevention (CDC) National Center for Health Statistics (NCHS) is seeking public input on a planned redesign of the National Health Interview Survey (NHIS), expected to be implemented in 2028. The NHIS is one of the nation’s primary sources of information on the health of the U.S. population, providing critical data on chronic conditions, healthcare access and utilization, functioning and disability, health insurance, preventive services, and other important health topics. NCHS has released proposed adult and child questionnaires and information about planned changes to the survey’s design and content. According to NCHS, these decisions will affect the NHIS data available for the next decade.

Input on the proposed redesign from organizations that represent and serve older adults, people with disabilities, caregivers, and their communities can help ensure the NHIS continues to provide relevant, accurate, and useful information for the populations served. Comments may address the proposed survey content, structure, or other aspects of the redesign. Multiple comments addressing separate topics are welcome, and comments may be submitted anonymously.

Action opportunity: All interested parties are encouraged to submit comments (Docket No. CDC-2026-1387) by the October 20 deadline.

Respond to NIH’s RFI on sharing clinical research results with participants

The National Institutes of Health (NIH) is seeking input on a proposed policy that would require NIH-supported clinical research to share plain language, summary-level study results with research participants. Through its Request for Information (RFI; NOT-OD-26-113), NIH proposes making the responsible return of research findings a required part of NIH-supported clinical research, with the goal of strengthening transparency and meaningful partnerships between researchers and study participants.

The proposed policy would apply broadly to NIH-supported clinical research—including, but not limited to, clinical trials—and require researchers to share a concise overview of study objectives, methods, key findings, limitations, and potential implications with participants. For clinical trials, results would need to be shared within one year of the primary completion date or by the applicable ClinicalTrials.gov reporting deadline, whichever is later. 

By making the return of research results a standard expectation, this effort could reshape how investigators engage with participants throughout the research process. Sharing results will demonstrate respect for participants’ contributions and likely strengthen trust, potentially enhancing recruitment, retention, and engagement efforts. However, the proposed policy could create new resource and implementation challenges for researchers, particularly around developing clear, accessible, and culturally-appropriate materials, and determining when and how results should be shared.

Through the RFI, NIH is seeking input on how to implement these requirements in ways that are feasible and minimally-burdensome for researchers and institutions. NIH also is seeking input on what information participants value, effective approaches for communicating results in plain language, and circumstances in which sharing may not be appropriate.

Action opportunity: All interested parties are encouraged to respond to the RFI by completing NIH’s online submission form before the October 26 deadline.

Respond to PCORI RFI on high-priority evidence needs

The Patient-Centered Outcomes Research Institute (PCORI) is seeking input on high-priority evidence needs that could be addressed through patient-centered comparative clinical effectiveness research (CER) to help people make informed health and healthcare decisions. Through this Request for Information (RFI), PCORI is seeking input on research questions that:  

• Compare healthcare treatment options, care delivery approaches or system-level strategies. 
• Explore whether treatments work differently across different groups and communities. 
• Address current healthcare challenges that affect patient health outcomes. 
• Reflect care delivered across a variety of settings, including clinical, community, home and virtual care.

Respondents are asked to consider describing the evidence gap or healthcare issue, who needs this evidence, and the types of healthcare options that could be compared. PCORI will use input from the RFI to better understand important evidence needs and help inform the future evolution of its funding opportunities. 

Action opportunity: All interested parties are encouraged to respond to the RFI by the November 2 deadline. There is not a required format for responses, but responses may be brief or detailed and should not exceed 500 words. Respondents may submit more than one idea.

Apply to NIA funding opportunities for clinician-scientists starting careers in aging and AD/ADRD research

The National Institute on Aging (NIA), part of the National Institutes of Health (NIH), has released two funding opportunities to support early-career clinician-scientists pursuing research opportunities in the aging field. These include: 

• GEMSSTAR Program: Grants for Early Medical/Surgical Specialists’ Transition to Aging Research (R03 Clinical Trial Optional)
  • Supports clinician-scientists trained in medical or surgical specialties who are seeking to launch careers in aging- or geriatric-focused research. 
  • Provides two years of support for transdisciplinary aging research, with annual budgets of up to $125,000 in direct costs. 
    • NIA intends to commit $3,000,000 in FY 2027–2029 to fund 15 awards focused on general aging topics, and an additional $800,000 each FY to fund 4 awards focused on Alzheimer’s disease and related disorders (AD/ADRD).
• Beeson Program: The Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Clinical Trial Not Allowed)
  • Supports clinician-scientists with research experience interested in further advancing an independent research career in aging. 
  • Provides up to the overall direct cost limit of $225,000 per year toward the research development costs of the award recipient.
    • NIA intends to commit $1,944,000 in FY 2027–2029 to fund approximately 8 general aging awards each year and an additional $972,000 each FY to fund approximately 4 AD/ADRD awards.

Action opportunity: Qualified clinician-scientists are encouraged to explore these opportunities and begin preparing applications. New applications for both programs are due November 10 by 5:00 p.m. local time of the applicant organization and must be submitted via grants.gov.

Nominate qualified experts and consumer representatives to FDA advisory committees

The U.S. Food and Drug Administration (FDA) is seeking nominations from scientists, clinicians, researchers, technical professionals, patient advocates, and consumer representatives to broaden the expertise and perspectives informing its advisory committees. These committees bring together scientific experts along with patient advocates and consumer representatives to evaluate the evidence on drugs, vaccines, biologics, medical devices, and other FDA-regulated products — providing independent recommendations that help the FDA make well-informed decisions on behalf of the U.S. public.

Self-nominations for committee membership are welcome, and members may serve terms of up to four years. Organizations and individuals with relevant scientific expertise or community and consumer experience are encouraged to apply.

Action opportunity: Interested parties are encouraged to submit nominations for FDA advisory committees via the centralized application portal by the respective deadlines. Consumer representative nominations must be submitted by November 15 while nominations for scientific, technical, professional, and other voting members must be submitted by November 30.

Encourage support for AD/ADRD-relevant legislation

There are several pieces of legislation relevant to the Alzheimer’s disease and Alzheimer’s disease-related disorders (AD/ADRD) community. The bills being tracked by the LEAD Coalition are listed on our Our Activities page and real-time action updates are available via the legislative tracking spreadsheet. We especially want to call attention to the ASAP Act (H.R.6130/ S.3267) and CHANGE Act (H.R.3501 / S.1799), for which the Coalition has submitted letters of support (ASAP; CHANGE).

Action opportunity:  We encourage all LEAD Coalition members and allies to track and support these pieces of legislation. If relevant legislation is missing from our list, we encourage individuals to share bills with the LEAD Coalition’s Federal Policy Director, Courtney Wallin (cwallin@leadcoalition.org), for review and consideration.