National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Biorepository Saliva Collection Form	Form	New	Available
National Office Outreach Reporting	Form	New	Available
Outreach Reporting for Chapters and Districts	Form	New	Available
Annual Update for Projects Receiving Specimens or Data	Form	New	Available
Registry Research Application	Form	New	Available
Biorepository Specimen Processing Form	Form	New	Available
Disease Progression Survey - survey modules	Form	Modified	Available
Voluntary ALS Survey Modules	Form	Modified	Available
ALS Case Registration	Form	Modified	Available
ALS Case Validation Questions	Form	Modified	Available
Attach_8E-National ALS Biorepository (Saliva) Consent Form 20161024.docx	Supplementary Document	Uploaded 2016-11-08	Available
Attachment_14- Bioorepository Pilot Study Report 20161024.pdf	Supplementary Document	Uploaded 2016-11-08	Available
Attach_11A-ALS Registry Research Application Form clean 20161103.docx	Supplementary Document	Uploaded 2016-11-08	Available
Attach_10-Privacy Impact Assessment V2.pdf	Supplementary Document	Uploaded 2016-06-22	Available
Attach_9B-IRB Approval to add biorepository.docx	Supplementary Document	Uploaded 2016-06-22	Available
Attach_9A-Current IRB Approval memo.docx	Supplementary Document	Uploaded 2016-06-22	Available
Attach_8D-National ALS Biorepository Consent Form Addendum (PM Skin) final.docx	Supplementary Document	Uploaded 2016-06-22	Available
Attach_8C-National ALS Biorepository (Postmortem) Consent Form final.docx	Supplementary Document	Uploaded 2016-06-22	Available
Attach_8B-National ALS Biorepository (Biospecimen) Consent Form clean 20161024.docx	Supplementary Document	Uploaded 2016-11-08	Available
Attach_8A-National ALS Registry Consent Form final.docx	Supplementary Document	Uploaded 2016-06-22	Available
Attach_7-Privacy Statement.doc	Supplementary Document	Uploaded 2016-06-22	Available
Attach_3-Summary of Changes to ICR.docx	Supplementary Document	Uploaded 2016-06-22	Available
Attach_2-60-day-FRN.pdf	Supplementary Document	Uploaded 2016-06-22	Available
Attach_1-Public Health Law 110-373.doc	Supplementary Document	Uploaded 2016-06-22	Available
SSB National ALS Registry clean 20161103.docx	Supporting Statement B	Uploaded 2016-11-08	Available
SSA National ALS Registry clean 20161103.docx	Supporting Statement A	Uploaded 2016-11-08	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0923-0041	ICR Reference No: 201606-0923-001
Status: Historical Active	Previous ICR Reference No: 201305-0923-004
Agency/Subagency: HHS/TSDR	Agency Tracking No:
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: 11/08/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/01/2016
Terms of Clearance: 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	11/30/2019	36 Months From Approved	11/30/2016
Responses	8,549	0	16,895
Time Burden (Hours)	1,882	0	1,375
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 includes the addition of a biospecimine repository and a mechanism for researchers to access data.

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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:
	81 FR 21876	04/13/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 43202	07/01/2016
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	Biorepository Saliva Collection Form
ALS Biorepository Specimen Processing	none	Biorepository Specimen Processing Form
ALS Case Registration	none	ALS Case Registration
ALS DIsease Progression Survey	none	Disease Progression Survey - survey modules
ALS Registry Research Application	none, none	Registry Research Application
ALS Validation Questions	none	ALS Case Validation Questions
Annual Update for Projects Receiving Specimens or Data	none	Annual Update for Projects Receiving Specimens or Data
National Office Outreach Reporting	none	National Office Outreach Reporting
Outreach Reporting Form for Chapters and Districts	none	Outreach Reporting for Chapters and Districts
Voluntary Survey Modules	none	Voluntary ALS Survey Modules

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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	8,549	16,895	0	-8,346	0	0
Annual Time Burden (Hours)	1,882	1,375	0	507	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: Revisions include an increase in burden due to the addition of the Global Unique Identifiers, a biorepository, an application for researchers to request specimens and/or data, and the reporting of partners' outreach activities to better measure impact. Burden is off one hour due to rounding.

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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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 07/01/2016

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