Notice2025-23599
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 22, 2025
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Abstract
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Amyotrophic Lateral Sclerosis (ALS) Registry. The National ALS Registry collects information from persons with ALS to better describe the prevalence and potential risk factors for ALS.
Full Text
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<title>Federal Register, Volume 90 Issue 243 (Monday, December 22, 2025)</title>
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[Federal Register Volume 90, Number 243 (Monday, December 22, 2025)]
[Notices]
[Pages 59829-59831]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23599]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[60Day-26-0041; Docket No. ATSDR-2025-0001]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Department of Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR),
as part of its continuing effort to reduce public burden and maximize
the utility of government information, invites the general public and
other federal agencies the opportunity to comment on a continuing
information collection, as required by the Paperwork Reduction Act of
1995. This notice invites comment on a proposed information collection
project titled National Amyotrophic Lateral Sclerosis (ALS) Registry.
The National ALS Registry collects information from persons with ALS to
better describe the prevalence and potential risk factors for ALS.
DATES: ATSDR must receive written comments on or before February 20,
2026.
ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2025-0001 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. ATSDR will post, without change, all relevant
comments to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#93fcfef1d3f0f7f0bdf4fce5"><span class="__cf_email__" data-cfemail="87e8eae5c7e4e3e4a9e0e8f1">[email protected]</span></a>.
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
[[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
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Persons with ALS........ ALS Case Validation 1,670 1 2/60 56
Questions.
ALS Case Registration 1,500 1 10/60 250
Form.
Essential 750 1 6/60 75
Questionnaire.
Disease Progression 750 3 5/60 188
Survey.
Follow-up Questions-- 750 1 2/60 25
Demography.
Follow-up Questions-- 750 1 32/60 400
Lifestyle Information.
Follow-up Questions-- 750 1 23/60 288
Environmental Factors.
Follow-up Questions-- 750 1 7/60 88
ALS-associated and
Clinical Factors.
ALS Biorepository 325 1 30/60 162
Specimen Processing
Form and In-Home
Collection.
[[Page 59831]]
ALS Biorepository 350 1 10/60 58
Saliva Collection.
Researchers............. ALS Registry Research 36 1 30/60 18
Application Form.
Annual Update......... 24 1 15/60 6
ALS Service Chapter/District 135 12 5/60 135
Organizations. Outreach Reporting
Form.
National Office 2 12 20/60 8
Outreach Reporting
Form.
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Total............... ...................... .............. .............. .............. 1,757
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-23599 Filed 12-19-25; 8:45 am]
BILLING CODE 4163-18-P
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