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	Modified
ALS Case Reporting Form Form	Modified
CDC Protocol #5923_CLEAN copy_ State-Metro ALS Surveillance Protocol.doc Supplementary Document	2011-11-14
CDC Protocol#5923_ Amendment approval.doc Supplementary Document	2011-11-14
ICR#0923-0043_Justification for unsubstantive change_11.2.2011.doc Justification for No Material/Nonsubstantive Change	2011-11-14

IC Document Collections

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

ICR Details

OMB Control No: 0923-0043	ICR Reference No: 201111-0923-002
Status: Historical Active	Previous ICR Reference No: 201102-0923-001
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/06/2012
	Date Received in OIRA: 11/15/2011
Terms of Clearance: Previous TOC apply.

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

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Abstract: This nonsubstantive change request is to notify OMB of the three additional sites that were selected for this project, as per terms of clearance.

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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

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	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	3,186	0	0	0	0
Annual Time Burden (Hours)	703	703	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: $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: 11/15/2011

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