2025-23599Notice

Weigh In on ALS Tracking: ATSDR Seeks Public Input Now

Published Date: 12/22/2025

Notice

Summary

The Agency for Toxic Substances and Disease Registry wants your thoughts on their plan to keep collecting info about people with ALS, a serious disease. This helps them understand how many people have ALS and what might cause it. If you want to share your opinion, you have until February 20, 2026, to comment—no money changes, just a chance to help shape the data collection.

Analyzed Economic Effects

4 provisions identified: 0 benefits, 1 costs, 3 mixed.

Biorepository Consent Now Covers Genomics

ATSDR updated biorepository premortem consent language to describe genomic data sharing risks and clarified whether established cell lines may be used for commercial gain; specimen collections include in-home (blood, urine, hair, nails, saliva) and postmortem (brain, spinal cord, cerebrospinal fluid, bone, muscle, skin). Researchers may request access to specimens and data through ATSDR's application process.

Research Application Forms Updated; New Part E

ATSDR revised ALS research application forms to list additional biospecimen sample and aliquot sizes, add a postmortem sample and price that were not previously listed, and add a new Part E for researchers who amend a formerly approved application (e.g., affiliation change or extra sample request).

New Unite Genomics Data-Share Option

If you have ALS and join the National ALS Registry, the consent form is revised to allow an interagency data exchange with a third-party platform called Unite Genomics so you may choose to share personal health information through an integration between the Registry portal and Unite Genomics. ATSDR says this update will not change respondent burden hours and participation remains voluntary.

Estimated Respondent Time Burden: 1,757 Hours

CDC/ATSDR requests OMB approval for an estimated 1,757 annual burden hours for the National ALS Registry (OMB Control No. 0923-0041, Exp. Date 05/31/2026). ATSDR states there are no costs to respondents other than their time and that participation is voluntary.

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Key Dates

Published Date
Comments Due
12/22/2025
2/20/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Agency for Toxic Substances and Disease Registry
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