National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

Document Name	Status
Form No number ALS Twice Yearly Survey Form	New
Form No number ALS One-time Survey Form	New
Form No number ALS Registration Form	New
Form No number ALS Validation Questions Form	New
ALS registry protocol clean.doc Supplementary Document	2010-07-08
Attachment 10 - scoring ALSFRS.docx Supplementary Document	2010-07-08
ALS_Registry_SS_Part_B_revised70710.doc Supporting Statement B	2010-07-08
Attachment 8-Consent form.doc Supplementary Document	2010-01-20
Attachment 9-IRB approval.doc Supplementary Document	2010-01-20
Attachment 7-Privacy statement.doc Supplementary Document	2010-01-20
Attachment 3d - MDA OMB response.pdf Supplementary Document	2010-01-20
Attachment 3c - MDA Registry Comment.doc Supplementary Document	2010-01-20
Attachment 3b- ALSA OMB response.pdf Supplementary Document	2010-01-20
Attachment 3a - ALSA Registry comment.pdf Supplementary Document	2010-01-20
Attachment 2- 60-day FRN.doc Supplementary Document	2010-01-20
Attachment 1- public law.doc Supplementary Document	2010-01-20
ALS_Registry_SS_Part_A_revised70710.doc Supporting Statement A	2010-07-08

IC Document Collections

IC ID	Document Title	Status
192032	ALS Twice Yearly Survey Form	New
192031	ALS One-time Survey Form	New
192030	ALS Registration Form	New
192029	ALS Validation Questions Form	New

ICR Details

OMB Control No: 0923-0041	ICR Reference No: 201002-0923-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No:
Title: National Amyotrophic Lateral Sclerosis (ALS) Registry
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/19/2010
	Date Received in OIRA: 02/18/2010
Terms of Clearance: OMB approval for the registry is granted contingent upon ATSDR/CDC agreement not to disseminate statistics describing those in the ALS registry until after the complete baseline (i.e., all cases from all four administrative data sources -Medicare, Medicaid, VHA, and VBA ) have been added to the registry. Clearance is also contingent on ATSDR/CDC’s commitment to always clearly articulate the lack of representativeness in the risk factor information that is collected via the self-administered questionnaire, thus the limitations that places on conclusions that might be drawn about associations.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	36 Months From Approved
Responses	29,339	0	0
Time Burden (Hours)	2,300	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Agency for Toxic Substances and Disease Registry (ATSDR) requests clearance for creation of the National Amyotrophic Lateral Sclerosis (ALS) Registry. ALS is a complex neurodegenerative disease of unknown etiology, but is believed to be the result of a combination of genetic and environmental factors.

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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:
	74 FR 25552	05/29/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 4568	01/28/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
ALS Validation Questions	No number	ALS Validation Questions
ALS Registration	No number	ALS Registration
ALS One-time Survey	No number	ALS Survey Modules
ALS Twice Yearly Survey	No number	ALS Survey Modules

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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	29,339	0	0	29,339	0	0
Annual Time Burden (Hours)	2,300	0	0	2,300	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 is a request for a new data collection.

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Annual Cost to Federal Government: $800,000

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? No

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]? Uncollected

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: 02/18/2010

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