Agency for Toxic Substances and Disease Registry Seeks Public Input on Revisions to National ALS Registry Data Collection
On May 5, 2026, the Agency for Toxic Substances and Disease Registry (ATSDR) initiated a 30-day public comment period regarding proposed revisions to the information collection request for the National Amyotrophic Lateral Sclerosis (ALS) Registry. This crucial step, mandated by the Paperwork Reduction Act of 1995, invites feedback from the public and affected agencies on planned updates designed to strengthen the registry's capacity for scientific research and enhance its overall utility in understanding and combating ALS. This development signifies an ongoing commitment to refining data collection methods for a critical public health initiative.
Background of the National ALS Registry
The National ALS Registry was established by Public Law 110-373, known as the ALS Registry Act, in 2008. This legislation amended the Public Health Service Act, tasking ATSDR with two primary objectives. First, to develop a system for collecting comprehensive data on amyotrophic lateral sclerosis and other motor neuron disorders that may mimic or progress to ALS. Second, to create a national registry for storing this data to build a population-based understanding of ALS cases.
Since its inception, the registry has pursued key operational goals. Its primary aim is to gather reliable information on the incidence and prevalence of ALS, alongside detailed demographic characteristics such as age, race, sex, and geographic location of individuals affected. A secondary, yet equally vital, goal involves collecting additional data on potential risk factors for ALS. This includes a broad spectrum of information such as family history of ALS, smoking history, military service, residential history, lifetime occupational exposures, home pesticide use, hobbies, sports participation, hormonal and reproductive history for women, caffeine use, trauma, health insurance status, open-ended supplemental questions, and clinical signs and symptoms.
Individuals with ALS began joining the registry in 2010. Participation is voluntary and involves a validation process followed by online enrollment. Participants can complete up to 17 voluntary survey modules, each taking approximately five minutes. New registrants also undertake a longitudinal disease progression survey, adapted from the ALS Functional Rating Scale-Revised (ALSFRS-R), at regular intervals during their initial three years. In 2016, a biorepository component was added, allowing interested registrants to provide specimens like blood, urine, hair, nails, saliva, and postmortem samples including brain, spinal cord, and cerebral spinal fluid. Researchers can request access to these specimens and data through an ATSDR application process, subject to approval for scientific merit and human subjects protection. ATSDR also collaborates with ALS service organizations for outreach, expanding case identification beyond self-enrollment to include national administrative databases such as Medicare, Veterans Health Administration, and Veterans Benefits Administration. Future plans include incorporating state ALS registries and non-profit ALS organizations to achieve more complete case ascertainment.
Key Revisions and Their Implications
The current notice outlines several minor yet impactful revisions to the registry's information collection plan, all of which have been approved by the organization's Institutional Review Board (IRB) and do not affect burden hours for participants. These changes are primarily designed to enhance the registry's utility for the research community.
One significant update involves the Consent Form, now including the addition of an interagency data exchange between Unite Genomics and the National ALS Registry. This revision allows participants to share personal health information with ATSDR via an integration between the Registry portal and Unite Genomics, a third-party online platform. This integration aims to streamline data sharing for research purposes, potentially accelerating discoveries by providing researchers with more comprehensive datasets. However, it also underscores the importance of clear communication regarding data privacy and security protocols to participants.
Another change, mandated by an Executive Order in February 2025, is the replacement of the term "gender" with "sex" throughout all registry documents. ATSDR clarified that this is a minor terminology update, as the current protocol consistently collects data solely on a registrant's biological sex, defined as male or female. This adjustment reflects a broader federal directive aimed at standardizing terminology in government data collection.
Further revisions pertain to the ALS Biorepository pre-mortem patient consent forms for biospecimen and saliva collection. These updates clarify language regarding genomic data sharing and associated risks, provide clarification on the limited use of established cell lines for commercial gain, and explicitly state the absence of cell line establishment for commercial gain. These modifications are critical for transparency and participant protection, ensuring individuals are fully informed about how their biological samples and genetic data may be used. The ALS research application forms have also been refined. Part B now includes previously unlisted biospecimen sample and aliquot sizes. Part C adds a postmortem sample and its associated price. Furthermore, a new form, Part E, has been introduced specifically for researchers making changes to previously approved applications, such as affiliation status updates or requests for additional samples for an existing study. These adjustments aim to make the research application process more precise and efficient.
Opportunity for Public Comment
The Office of Management and Budget (OMB) is specifically interested in public comments addressing several key areas. These include evaluating the necessity and practical utility of the proposed information collection, assessing the accuracy of ATSDR's estimated burden, and suggesting ways to enhance the quality, utility, and clarity of the information collected. OMB also seeks input on methods to minimize the burden on respondents, potentially through the use of automated or electronic collection techniques, and to assess information collection costs. This comment period provides a vital mechanism for stakeholders, including patients, researchers, and advocacy groups, to contribute to the ongoing improvement of this critical public health resource.
Significance for ALS Research and Patients
These revisions collectively aim to strengthen the National ALS Registry's foundational role in advancing ALS research. By facilitating more robust data exchange and clarifying consent processes for genomic and biospecimen data, the registry positions itself to offer researchers richer, more integrated datasets. This could lead to a deeper understanding of ALS etiology, progression, and potential therapeutic targets. The voluntary nature of participation for persons with ALS remains a cornerstone of the registry, emphasizing patient autonomy in contributing to scientific discovery. The estimated annual burden for the information collection is 1,757 hours, with no costs to respondents other than their time, underscoring the commitment to minimize imposition on participants. ALS service organizations, under contract with ATSDR, continue to report their outreach information, highlighting the collaborative effort required to maintain and expand the registry's reach.
