Creation of State and Metropolitan Area Based Surveillance Projects for Amyotrophic Lateral Sclerosis (ALS)

Forms and Documents

Document Name	Status
ALS Medical Record Verification Form Form	New
ALS Case Reporting Form Form	New
5923_ Amendment.docx Supplementary Document	2011-03-31
State-Metro ALS Surveillance Protocol-V3-CLEAN.doc Supplementary Document	2011-03-31
Attachment 9 - letters to providers with HIPAA.docx Supplementary Document	2011-03-31
Attachment 8 - outreach materials.docx Supplementary Document	2011-03-31
Attachment 1- public law.doc Supplementary Document	2011-03-31
state_based_surv_SS_Part_B_33111-final.doc Supporting Statement B	2011-03-31
Attachment 7 5923 Amendment Approval8-6-10 (2).pdf Supplementary Document	2011-01-31
Attachment 6 5923 New Approval.pdf Supplementary Document	2011-01-31
Attachment 5 -State-based surveillance protocol.doc Supplementary Document	2011-01-31
Attachment 2 60-day FRN.pdf Supplementary Document	2011-01-31
Attachment 1- public law.doc Supplementary Document	2011-01-31
State_based_surv_SS_Part A_33111-final.doc Supporting Statement A	2011-03-31

IC Document Collections

IC ID	Document Title	Status
196100	Line Listing Instruction	New
196099	Training for Reporting Instruction	New
196098	ALS Medical Record Verification Form Form	New
196097	ALS Case Reporting Form Form	New

ICR Details

OMB Control No: 0923-0043	ICR Reference No: 201102-0923-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No:
Title: Creation of State and Metropolitan Area Based Surveillance Projects for Amyotrophic Lateral Sclerosis (ALS)
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: 04/01/2011
	Date Received in OIRA: 02/02/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved
Responses	3,186	0	0
Time Burden (Hours)	703	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: On October 10, 2008, President Bush signed S. 1382: ALS Registry Act which amended the Public Health Service Act to provide for the establishment of an Amyotrophic Lateral Sclerosis (ALS) Registry. The activities described are part of the effort to create the National ALS Registry. The purpose of the registry is to: (1) better describe the incidence and prevalence of ALS in the United States; (2) examine appropriate factors, such as environmental and occupational, that might be associated with the disease; (3) better outline key demographic factors (such as age, race or ethnicity, gender, and family history) associated with the disease; and (4) better examine the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS. The registry will collect personal health information that may provide a basis for further scientific studies of potential risks for developing ALS. This project purposes to collect information specific data related to ALS. The objective of this project is to develop state-based and metropolitan area-based surveillance projects for ALS. The primary goal of the state-based and metropolitan area-based surveillance project is to use these data to evaluate the completeness of the National ALS Registry. The secondary goal of the surveillance project is to obtain reliable and timely information on the incidence and prevalence of ALS and to better describe the demographic characteristics (e.g., age, race, sex, and geographic location) of those with ALS. Neurologists or their staff will complete an ALS Case Reporting Form on each of their ALS patients. This will be transmitted to the state or metropolitan health department. An ALS Medical Record Verification Form will be collected on a subset of cases reported. Surveillance items to be collected include information to make sure that there are no duplicates.

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Authorizing Statute(s): PL: Pub.L. 110 - 280 S1382 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:
	75 FR 28621	05/21/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 69086	11/10/2010
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
ALS Case Reporting Form	none, none	Case Reporting Form
ALS Medical Record Verification Form	none	Medical Record Verification Form
Training for Reporting
Line Listing

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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	3,186	0	0	3,186	0	0
Annual Time Burden (Hours)	703	0	0	703	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 new ICR.

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Annual Cost to Federal Government: $2,765,000

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? 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: 02/02/2011

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