[ATSDR] National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Incentive Project Sign Up Form	Form and Instruction	New	Available
Incentives Pilot Project Sign Up form – Only for Texas Registrants	Form and Instruction	New	Repair queued
ALS-associated and Clinical Factors	Form and Instruction	Unchanged	Available
Follow-up Questions - ALS-associated and Clinical Factors	Form and Instruction	Unchanged	Repair queued
Environmental Factors	Form and Instruction	Unchanged	Available
Follow-up Questions - Environmental Factors	Form and Instruction	Unchanged	Repair queued
Lifestyle Information	Form and Instruction	Unchanged	Available
Follow-up Questions - Lifestyle Information	Form and Instruction	Unchanged	Repair queued
Demography	Form and Instruction	Unchanged	Available
Follow-up Questions - Demography	Form and Instruction	Unchanged	Repair queued
ALS Biorepository Saliva Collection	Form	Unchanged	Available
ALS Biorepository Collection Form- Saliva	Form	Unchanged	Repair queued
National Office Outreach Reporting	Form	Unchanged	Available
National Office Outreach Reporting	Form	Unchanged	Repair queued
Chapter/District Outreach Reporting	Form	Unchanged	Available
Outreach Reporting Form for Chapters and Districts	Form	Unchanged	Repair queued
Annual update for projects receiving specimens and/data	Form	Unchanged	Available
Annual Update for Projects Receiving Specimens or Data	Form	Unchanged	Repair queued
National Amyotrophic Lateral Sclerosis (ALS) Registry Research Application Form (rev. May 2021)	Form and Instruction	Unchanged	Available
ALS Registry Research Application	Form and Instruction	Unchanged	Repair queued
Biorepository Specimen Processing	Form	Unchanged	Available
ALS Biorepository Specimen Processing	Form	Unchanged	Repair queued
Disease Progression Survey	Form	Unchanged	Available
ALS DIsease Progression Survey	Form	Unchanged	Missing upstream
Essential Questionnaire	Form and Instruction	Unchanged	Available
Essential Questionnaire	Form and Instruction	Unchanged	Missing upstream
Case registration	Form	Unchanged	Available
ALS Case Registration	Form	Unchanged	Repair queued
Case validation questions	Form	Unchanged	Available
ALS Validation Questions	Form	Unchanged	Repair queued
0923-0041 Change Request Justification 05172024_V1.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-08-02	Available
0923-0041 Change Request Justification 05172024_V1.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-08-02	Repair queued
Appendix U - Incentives Pilot Proposal - New.docx	Supplementary Document	Uploaded 2024-08-02	Available
Appendix U - Incentives Pilot Proposal - New.docx	Supplementary Document	Uploaded 2024-08-02	Repair queued
P_AppS.B-6b COVID-19 Biorepostiory InfoSht_042821.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppS.B-6b COVID-19 Biorepostiory InfoSht_042821.docx	Supplementary Document	Uploaded 2023-01-17	Missing upstream
P_AppS.B-6a COVID-19 Restart Plan 04282021.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppS.B-6a COVID-19 Restart Plan 04282021.docx	Supplementary Document	Uploaded 2023-01-17	Repair queued
P_AppF Privacy Statement.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppF Privacy Statement.docx	Supplementary Document	Uploaded 2023-01-17	Repair queued
P_AppE7 NCHS Comments Surveys.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppE7 NCHS Comments Surveys.docx	Supplementary Document	Uploaded 2023-01-17	Repair queued
P_AppE - Survey Introduction_final.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppE - Survey Introduction_final.docx	Supplementary Document	Uploaded 2023-01-17	Missing upstream
P_AppD4 Biorepository Saliva Consent.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppD4 Biorepository Saliva Consent.docx	Supplementary Document	Uploaded 2023-01-17	Repair queued
P_AppD3 Biorepository Postmortem Consent.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppD3 Biorepository Postmortem Consent.docx	Supplementary Document	Uploaded 2023-01-17	Repair queued
P_AppD2 Biorepository Consent.docx	Supplementary Document	Uploaded 2023-01-17	Available
P_AppD2 Biorepository Consent.docx	Supplementary Document	Uploaded 2023-01-17	Missing upstream
Appendix D - Consent Forms - Clean.docx	Supplementary Document	Uploaded 2024-08-02	Available
Appendix D - Consent Forms - Clean.docx	Supplementary Document	Uploaded 2024-08-02	Repair queued
0 - List of Attach and Append.docx	Supplementary Document	Uploaded 2023-01-17	Available
0 - List of Attach and Append.docx	Supplementary Document	Uploaded 2023-01-17	Missing upstream
Att9 Prevalence Rate State 4yr avg.xlsx	Supplementary Document	Uploaded 2023-01-12	Available
Att9 Prevalence Rate State 4yr avg.xlsx	Supplementary Document	Uploaded 2023-01-12	Available
Att8 Survey Burden Calculation.docx	Supplementary Document	Uploaded 2023-01-12	Available
Att8 Survey Burden Calculation.docx	Supplementary Document	Uploaded 2023-01-12	Repair queued
Att7 Biorepository Pilot Study Report.pdf	Supplementary Document	Uploaded 2023-01-12	Available
Att7 Biorepository Pilot Study Report.pdf	Supplementary Document	Uploaded 2023-01-12	Repair queued
Att5 Privacy Impact Assessment 2020.pdf	Supplementary Document	Uploaded 2023-01-12	Available
Att5 Privacy Impact Assessment 2020.pdf	Supplementary Document	Uploaded 2023-01-12	Missing upstream
Att4 IRB Approval Memo.docx	Supplementary Document	Uploaded 2023-01-12	Available
Att4 IRB Approval Memo.docx	Supplementary Document	Uploaded 2023-01-12	Missing upstream
Att3 Summary of Changes.docx	Supplementary Document	Uploaded 2023-01-12	Available
Att3 Summary of Changes.docx	Supplementary Document	Uploaded 2023-01-12	Repair queued
Att2 60-day FRN.pdf	Supplementary Document	Uploaded 2023-01-12	Available
Att2 60-day FRN.pdf	Supplementary Document	Uploaded 2023-01-12	Available
Att1 Public Law 110-373.docx	Supplementary Document	Uploaded 2023-01-12	Available
Att1 Public Law 110-373.docx	Supplementary Document	Uploaded 2023-01-12	Repair queued
0- SSB National ALS Registry.docx	Supporting Statement B	Uploaded 2023-01-12	Available
0- SSB National ALS Registry.docx	Supporting Statement B	Uploaded 2023-01-12	Repair queued
0-SSA National ALS Registry - Clean.docx	Supporting Statement A	Uploaded 2024-08-02	Available
0-SSA National ALS Registry - Clean.docx	Supporting Statement A	Uploaded 2024-08-02	Missing upstream

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0923-0041	ICR Reference No: 202408-0923-001
Status: Active	Previous ICR Reference No: 202301-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0041-24HW
Title: [ATSDR] National Amyotrophic Lateral Sclerosis (ALS) Registry
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/12/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/05/2024
Terms of Clearance: Prior TOC continue to apply: This collection is approved consistent with the understanding that ATSDR will not be disseminating any prevalence or incidence estimates based solely on the registration component of the Registry. Rather, registration results will be combined with administrative record results prior to dissemination of prevalence rates. Furthermore, any research based on registry data should highlight what is known about its lack of representativeness due to its self-selected nature. ATSDR endeavors to improve both the completeness and representativeness of the data over time.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2026	05/31/2026	05/31/2026
Responses	11,649	0	11,549
Time Burden (Hours)	1,763	0	1,758
Cost Burden (Dollars)	0	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.

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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:
	87 FR 59421	09/30/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 2918	01/17/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 15

table that charts list of burden

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

table that charts list of burden

	Total Approved	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	11,649	11,549	0	100	0	0
Annual Time Burden (Hours)	1,763	1,758	0	5	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: Addition of a minor sign up form.

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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: 08/05/2024

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