[ATSDR] National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

Document	Type	Status	Availability
Incentive Project Sign Up Form	Form and Instruction	Removed	Available
ALS-associated and Clinical Factors	Form and Instruction	Modified	Available
Environmental Factors	Form and Instruction	Modified	Available
Lifestyle Information	Form and Instruction	Modified	Available
Demography	Form and Instruction	Modified	Available
ALS Biorepository Saliva Collection	Form	Modified	Available
National Office Outreach Reporting	Form	Modified	Available
Chapter/District Outreach Reporting	Form	Modified	Available
Annual update for projects receiving specimens and/data	Form	Modified	Available
National Amyotrophic Lateral Sclerosis (ALS) Registry Research Application Form (rev. May 2021)	Form and Instruction	Modified	Available
Biorepository Specimen Processing	Form	Modified	Available
Disease Progression Survey	Form	Modified	Available
Essential Questionnaire	Form and Instruction	Modified	Available
Case registration	Form	Modified	Available
Case validation questions	Form	Modified	Available
Attach5 Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2026-05-11	Available
Attach6B National Office Outreach Repo.xlsx	Supplementary Document	Uploaded 2026-05-11	Available
Attach8 Survey Burden Calculation.docx	Supplementary Document	Uploaded 2026-05-11	Available
Attach7 Biorepository Pilot Summary Report.pdf	Supplementary Document	Uploaded 2026-05-11	Available
Attach9 Prevalence Rate State 4yr avg.xlsx	Supplementary Document	Uploaded 2026-05-11	Available
Attach1Public Health Law 110-373.docx	Supplementary Document	Uploaded 2026-05-08	Available
Attach2a Public Comments Received.docx	Public Comments	Uploaded 2026-05-08	Available
Attach3Summary of Changes.docx	Supplementary Document	Uploaded 2026-05-08	Available
Attach4 IRB 2026 Approval Memo 5768.pdf	Supplementary Document	Uploaded 2026-05-08	Available
APPENDIX_D1_-_Consent_Forms[1].docx	Supplementary Document	Uploaded 2026-05-08	Available
0 - 60-day FRN Publication Request Form - Registry 2025.docx	Supplementary Document	Uploaded 2026-05-08	Available
0923-0041 Change Request Justification 05172024_V1.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-08-02	Available
Appendix U - Incentives Pilot Proposal - New.docx	Supplementary Document	Uploaded 2024-08-02	Available
Appendix D - Consent Forms - Clean.docx	Supplementary Document	Uploaded 2024-08-02	Available
0- SSB National ALS Registry 2026.docx	Supporting Statement B	Uploaded 2026-05-07	Available
0- SSA National ALS Registry 2026.docx	Supporting Statement A	Uploaded 2026-05-07	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
269810	Incentives Pilot Project Sign Up form – Only for Texas Registrants	Form and Instruction	Removed	Incentive Project Sign Up Form
257949	Follow-up Questions - ALS-associated and Clinical Factors	Form and Instruction	Modified	ALS-associated and Clinical Factors
257948	Follow-up Questions - Environmental Factors	Form and Instruction	Modified	Environmental Factors
257947	Follow-up Questions - Lifestyle Information	Form and Instruction	Modified	Lifestyle Information
257946	Follow-up Questions - Demography	Form and Instruction	Modified	Demography
224351	ALS Biorepository Collection Form- Saliva	Form	Modified	ALS Biorepository Saliva Collection
222089	National Office Outreach Reporting	Form	Modified	National Office Outreach Reporting
222088	Outreach Reporting Form for Chapters and Districts	Form	Modified	Chapter/District Outreach Reporting
222087	Annual Update for Projects Receiving Specimens or Data	Form	Modified	Annual update for projects receiving specimens and/data
222085	ALS Registry Research Application	Form and Instruction	Modified	National Amyotrophic Lateral Sclerosis (ALS) Registry Research Application Form (rev. May 2021)
222083	ALS Biorepository Specimen Processing	Form	Modified	Biorepository Specimen Processing
192032	ALS DIsease Progression Survey	Form	Modified	Disease Progression Survey
192031	Essential Questionnaire	Form and Instruction	Modified	Essential Questionnaire
192030	ALS Case Registration	Form	Modified	Case registration
192029	ALS Validation Questions	Form	Modified	Case validation questions

ICR Details

OMB Control No: 0923-0041	ICR Reference No: 202605-0923-001
Status: Received in OIRA	Previous ICR Reference No: 202408-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-26-0185
Title: [ATSDR] National Amyotrophic Lateral Sclerosis (ALS) Registry
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/12/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2026
Responses	11,549	11,649
Time Burden (Hours)	1,757	1,763
Cost Burden (Dollars)	0	0

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Abstract: As mandated by Congress, the goal is to continue collecting data for the National Amyotrophic Lateral Sclerosis (ALS) Registry to better describe the incidence and prevalence of ALS and to identify risk factors for the disease. ATSDR endeavors to improve the completeness, representativeness, and accuracy of the Registry data over time. This change request involves minor changes to a consent form and addition of incentives. In this revision, as required by the E.O., all use of the term "gender" has been replaced with "sex."

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Authorizing Statute(s): PL: Pub.L. 110 - 373 2 Name of Law: Amendment to the Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 59829	12/22/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 24238	05/05/2026
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
ALS Biorepository Collection Form- Saliva	none	ALS Biorepository Saliva Collection
ALS Biorepository Specimen Processing	none	Biorepository Specimen Processing
ALS Case Registration	none	Case registration
ALS DIsease Progression Survey	none	Disease Progression Survey
ALS Registry Research Application	n/a	National Amyotrophic Lateral Sclerosis (ALS) Registry Research Application Form (rev. May 2021)
ALS Validation Questions	none	Case validation questions
Annual Update for Projects Receiving Specimens or Data	none	Annual update for projects receiving specimens and/data
Essential Questionnaire	n/a	Essential Questionnaire
Follow-up Questions - ALS-associated and Clinical Factors	n/a	ALS-associated and Clinical Factors
Follow-up Questions - Demography	n/a	Demography
Follow-up Questions - Environmental Factors	n/a	Environmental Factors
Follow-up Questions - Lifestyle Information	n/a	Lifestyle Information
Incentives Pilot Project Sign Up form – Only for Texas Registrants	n/a	Incentive Project Sign Up Form
National Office Outreach Reporting	none	National Office Outreach Reporting
Outreach Reporting Form for Chapters and Districts	none	Chapter/District Outreach Reporting

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	11,549	11,649	0	-100	0	0
Annual Time Burden (Hours)	1,757	1,763	0	-6	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This revision request for PRA clearance aims to enhance the National ALS Registry's value for researchers. Key updates include: expanding the consent form to allow interagency data exchange with Unite Genomics, updating terminology from "gender" to "sex" as required by the EO, and revising biorepository consent and research application forms to clarify genomic data sharing, cell line use, and sample details. This collection is seeking 1751 annual burden hours for three years of approval.

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Annual Cost to Federal Government: $3,640,822

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/12/2026

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