Notice2026-08666
Agency Forms Undergoing Paperwork Reduction Act Review
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
May 5, 2026
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Full Text
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<title>Federal Register, Volume 91 Issue 86 (Tuesday, May 5, 2026)</title>
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[Federal Register Volume 91, Number 86 (Tuesday, May 5, 2026)]
[Notices]
[Pages 24238-24239]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08666]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-26-0041]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Agency
for Toxic Substances and Disease Registry (ATSDR) has submitted the
information collection request titled the ``National Amyotrophic
Lateral Sclerosis (ALS) Registry'' to the Office of Management and
Budget (OMB) for review and approval. ATSDR previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on December 22, 2025, to obtain comments from
the public and affected agencies. ATSDR received 14 comments during the
comment period. This notice serves to allow an additional 30 days for
public and affected agency comments.
ATSDR will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
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 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 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
[[Page 24239]]
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). ATSDR aims to achieve more complete
ALS case ascertainment by adding new data sources, 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. 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 and saliva collection. The changes include
the addition of the language describing genomic data sharing and
associated risk, clarification on the limited use of established cell
line for commercial gain, and absence of cell line establishment for
commercial gain. Furthermore, update has been made for the ALS research
application forms in Part B to include a biospecimen sample and aliquot
sizes that were was 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
respondents respondent (in hours)
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Persons with ALS...................... ALS Case Validation 1,670 1 2/60
Questions.
ALS Case Registration 1,500 1 10/60
Form.
Essential Questionnaire. 750 1 6/60
Disease Progression 750 3 5/60
Survey.
Follow-up Questions-- 750 1 2/60
Demography.
Follow-up Questions-- 750 1 32/60
Lifestyle Information.
Follow-up Questions-- 750 1 23/60
Environmental Factors.
Follow-up Questions--ALS- 750 1 7/60
associated and Clinical
Factors.
ALS Biorepository 325 1 30/60
Specimen Processing
Form and In-Home
Collection.
ALS Biorepository Saliva 350 1 10/60
Collection.
Researchers........................... ALS Registry Research 36 1 30/60
Application Form.
Annual Update........... 24 1 15/60
ALS Service Organizations............. Chapter/District 135 12 5/60
Outreach Reporting Form.
National Office Outreach 2 12 20/60
Reporting Form.
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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. 2026-08666 Filed 5-4-26; 8:45 am]
BILLING CODE 4163-18-P
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