National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
ALS Biorepository Saliva Collection	Form	Unchanged	Repair queued
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	Repair queued
Sports participation module	Form	Unchanged	Available
Voluntary Survey Modules	Form	Unchanged	Available
Voluntary Survey Modules	Form	Unchanged	Repair queued
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
NCHS survey feedback_2020.docx	Supplementary Document	Uploaded 2021-08-16	Repair queued
APPENDIX E - Surveys_mh_v3_Clean_updated2.docx	Supplementary Document	Uploaded 2021-08-16	Repair queued
ALS Registry Protocol V23e_clean.docx	Supplementary Document	Uploaded 2021-08-16	Repair queued
EssentialQuestionnaire_EnvironmentalFactors.png	Supplementary Document	Uploaded 2021-08-16	Repair queued
EssentialQuestionnaire_LifeStyleFactors .png	Supplementary Document	Uploaded 2021-08-16	Repair queued
EssentialQuestionnaire_Demography.png	Supplementary Document	Uploaded 2021-08-16	Repair queued
EssentialQuestionnaire_Clinical Factors.png	Supplementary Document	Uploaded 2021-08-16	Repair queued
0923-0041_Change_Request_Justification_Survey_State_Data_and_New_Sources_062020[1].docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-08-11	Repair queued
0923-0041 Change Request Justification 07192021_v4 clean.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-07-22	Repair queued
Appendix S - ALSBiorepository_Protocol-Amendment 6- v2 track changes (1).docx	Supplementary Document	Uploaded 2021-05-18	Available
Appendix S - ALSBiorepository_Protocol-COVID-19 Restart Plan v1 clean.docx	Supplementary Document	Uploaded 2021-05-18	Repair queued
Appendix B6b COVID-19 Biorepostiory Infomation Sheet_042821.docx	Supplementary Document	Uploaded 2021-05-18	Repair queued
Appendix B6a COVID-19 Restart Plan 04282021.docx	Supplementary Document	Uploaded 2021-05-18	Repair queued
Researcher Application Webpage_Changes highlighted.jpg	Supplementary Document	Uploaded 2021-05-18	Repair queued
Attach_11A-ALS Registry Research Application Form revised 12022020.docx	Supplementary Document	Uploaded 2021-05-18	Repair queued
Attach14Birpstry Pilot Stdy Rprt.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach12BSaliva Collection Inst 20161024.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach10 Privary Impact Assessment ALS.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach9Current IRB Approval Memo.doc	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach8DNational ALS Biorepository (Saliva) Cnsnt Frm.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach8CNational ALS Biorepository (Postmortem) Cnsnt Frm.docx	Supplementary Document	Uploaded 2019-08-26	Available
Attach8BNational ALS Biorepository Cnsnt Frm.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach8ANational ALS Registry Cnsnt Form.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach7Privacy Statement.doc	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach3 Summary of Changes to 0923-0041 ICR 20191203 clean.docx	Supplementary Document	Uploaded 2019-12-22	Repair queued
Attach2ALS Registry 60 day FRN.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
Attach1Public Health Law 110-373.doc	Supplementary Document	Uploaded 2019-08-26	Repair queued
SSB National ALS Registry.docx	Supporting Statement B	Uploaded 2019-08-26	Repair queued
SSA National ALS Registry_20191211 clean.docx	Supporting Statement A	Uploaded 2019-12-22	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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	Voluntary Survey Modules	Form	Unchanged	Sports participation module
192031	Voluntary Survey Modules	Form	Unchanged	Voluntary Survey Modules
192031	Voluntary Survey Modules	Form	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: 202108-0923-001
Status: Historical Inactive	Previous ICR Reference No: 202105-0923-002
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0041-21GZ
Title: 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: Withdrawn and continue	Conclusion Date: 03/07/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/16/2021
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	01/31/2023	01/31/2023	05/31/2023
Responses	8,549	0	8,549
Time Burden (Hours)	1,945	0	1,945
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. Based on feedback from patients, caregivers, researchers as well as the National Center for Health Statistics, Collaborating Center for Questionnaire Design and Evaluation Research (see attachment NCHS Survey feedback), we are requesting to modify the surveys to make them more user-friendly and easier to navigate for patients. We feel the enhancements will increase completion rates for all surveys.

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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:
	84 FR 24143	05/24/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 47954	09/11/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

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
National Office Outreach Reporting	none	National Office Outreach Reporting
Outreach Reporting Form for Chapters and Districts	none	Chapter/District Outreach Reporting
Voluntary Survey Modules	none, none	Voluntary Survey Modules ,   Sports participation module

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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: No

Burden Reduction Due to:

Short Statement:

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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? Yes

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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: 08/16/2021

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