SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Proposed Project

National Amyotrophic Lateral Sclerosis (ALS) Registry (OMB Control No. 0923-0041, Exp. Date 05/31/2026)—Revision—Agency for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

The Agency for Toxic Substances and Disease Registry (ATSDR) is requesting a three-year Paperwork Reduction Act (PRA) clearance for a Revision Information Collection Request (ICR) titled the “The National Amyotrophic Lateral Sclerosis (ALS) Registry” (OMB Control No. 0923-0041, Exp. Date 05/31/2026).

In 2008, Public Law 110-373 (the ALS Registry Act) amended the Public Health Service Act for the Agency for ( printed page 59830) Toxic Substances and Disease Registry (ATSDR) to: (1) develop a system to collect data on amyotrophic lateral sclerosis (ALS) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, or progress to ALS; and (2) establish a national registry for the collection and storage of such data to develop a population-based registry of cases. Under these two mandates, ATSDR established the National Amyotrophic Lateral Sclerosis (ALS) Registry.

The primary operational goal of the Registry is to obtain reliable information on the incidence and prevalence of ALS, and to better describe the demographic characteristics (age, race, sex, and geographic location) of persons with ALS. The secondary operational goal of the surveillance system/registry is to collect additional information on potential risk factors for ALS, including, but not limited to, family history of ALS, smoking history, military service, residential history, lifetime occupational exposure, home pesticide use, hobbies, participation in sports, hormonal and reproductive history (women only), caffeine use, trauma, health insurance, open-ended supplemental questions, and clinical signs and symptoms.

With those goals in mind, persons with ALS first joined the Registry in 2010. Those interested in taking part answered a series of validation questions. If determined to be eligible, they created an online account to enroll in the Registry. Next, they were asked to complete up to 17 one-time voluntary survey modules, each taking up to five minutes. New registrants were also asked to complete a longitudinal disease progression survey (modified from the ALS Functional Rating Scale—Revised [ALSFRS-R]) at regular intervals over their first three years in the Registry.

A biorepository component was added in 2016. At the time of enrollment, interested registrants can request additional information about the biorepository and provide additional contact information. ATSDR selects a geographically representative sample from among the interested registrants to collect specimens. There are two types of specimen collections, in-home and postmortem. The in-home collection includes blood, urine, hair, nails, and saliva. The postmortem collection includes the brain, spinal cord, cerebral spinal fluid (CSF), bone, muscle, and skin.

Researchers can now request access to registrants' specimens, data, or both through an ATSDR research application process. Once approved for scientific merit, validity, and human subjects protections, ATSDR makes the requested data and/or specimens available to the requester. ATSDR also collaborates with ALS service organizations to conduct outreach activities through their local chapters and districts as well as on a national level. The service organizations provide ATSDR with monthly reports on their outreach efforts in support of the Registry.

In addition to identifying cases through Registry enrollment, ATSDR currently identifies additional cases from three large national administrative databases (Medicare, Veterans Health Administration, and Veterans Benefits Administration). As a third revision, ATSDR aims to achieve more complete ALS case ascertainment by adding new data sources (totaling less than nine), including state ALS registries and non-profit ALS organizations.

Since the last continuation, there have been only minor updates to documents. All changes have been approved by the organization's IRB. These changes have no impact on the burden hours. This is a Revision request for PRA clearance for the 60-day ICR package. The revisions requested are designed to strengthen the usefulness of the National ALS Registry for researchers. The revisions include:

1. Updating the Consent Form to include the addition of an interagency data exchange between Unite Genomics and the National ALS Registry. Participants will have the opportunity to share personal information relating to their health history with ATSDR through an integration between the Registry portal and a third-party online platform called Unite Genomics. This update will not impact burden hours.

2. As required by the E.O. in February 2025, all use of the term “gender” has been replaced with “sex.” All changes made are minor changes to terminology as the current protocol only collects data on the registrant's sex (male/female). Changes have been made throughout the documents.

3. The OMB package being submitted reflects changes recently approved by IRB to the ALS Biorepository premortem patient consent forms for the biospecimen (D2) and saliva (D4) collection. The changes include the addition of the language describing genomic data sharing and associated risk for both Appendix D2 and D4, clarification on the limited use of established cell line for commercial gain for Appendix D2, and absence of cell line establishment for commercial gain for Appendix D4. Furthermore, updates have been made for the ALS research application forms (M1) in Part B to include a biospecimen sample and aliquot sizes that were not previously listed, in Part C to add a postmortem sample and price that was not previously listed, and to include a new form “Part E” which is only applicable to the researchers making changes to their formerly approved application such as their affiliation status or additional sample request for the same study.

CDC requests OMB approval for an estimated 1,757 annual burden hours. There are no costs to the respondents other than their time. Participation in this information collection is completely voluntary for persons with ALS and for researchers. ALS service organizations report their outreach information under contract with ATSDR.

Estimated Annualized Burden Hours

90 FR 59829