National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

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

IC Document Collections

IC ID	Document Title	Status
224351	ALS Biorepository Collection Form- Saliva Form	Unchanged
222089	National Office Outreach Reporting Form	Unchanged
222088	Outreach Reporting Form for Chapters and Districts Form	Unchanged
222087	Annual Update for Projects Receiving Specimens or Data Form	Unchanged
222085	ALS Registry Research Application Form and Instruction	Unchanged
222083	ALS Biorepository Specimen Processing Form	Unchanged
192032	ALS DIsease Progression Survey Form	Unchanged
192031	Voluntary Survey Modules Form	Unchanged
192030	ALS Case Registration Form	Unchanged
192029	ALS Validation Questions Form	Unchanged

ICR Details

OMB Control No: 0923-0041	ICR Reference No: 202108-0923-001
Status: Received in OIRA	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	Date Submitted to OIRA: 08/16/2021

	Requested	Previously Approved
Expiration Date	01/31/2023	01/31/2023
Responses	8,549	8,549
Time Burden (Hours)	1,945	1,945
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. 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

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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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	8,549	8,549	0	0	0	0
Annual Time Burden (Hours)	1,945	1,945	0	0	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: 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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