National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

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

ICR Details

OMB Control No: 0923-0041	ICR Reference No: 201908-0923-003
Status: Active	Previous ICR Reference No: 201809-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0041
Title: 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
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/31/2020
	Date Received in OIRA: 09/12/2019
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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	01/31/2020
Responses	8,549	0	8,549
Time Burden (Hours)	1,945	0	1,882
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 revision adds an organized sports participation survey, and 2 additional questions to the registration form.

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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 Case Registration	none, none	Case registration
Voluntary Survey Modules	none, none	Voluntary Survey Modules ,   Sports participation module
ALS DIsease Progression Survey	none	Disease Progression Survey
ALS Biorepository Specimen Processing	none	Biorepository Specimen Processing
ALS Validation Questions	none	Case validation questions
Annual Update for Projects Receiving Specimens or Data	none	Annual update for projects receiving specimens and/data
ALS Registry Research Application	none	Registry Research Application
Outreach Reporting Form for Chapters and Districts	none	Chapter/District Outreach Reporting
National Office Outreach Reporting	none	National Office Outreach Reporting
ALS Biorepository Collection Form- Saliva	none	ALS Biorepository Saliva Collection

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ICR Summary 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	8,549	8,549	0	0	0	0
Annual Time Burden (Hours)	1,945	1,882	0	63	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: This revision request includes a adds an organized sports participation survey, and 2 additional questions to the registration form. There is an annual burden increase of 63 hours.

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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? Uncollected

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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: 09/12/2019

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