Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers

Forms and Documents

Document Name	Status
Fax to Determine if Mailing was Received Form and Instruction	New
Fax to Determine Provider Status Form and Instruction	New
Att 33 - Human Subjects Exemption Determination.docx Supplementary Document	2015-09-25
AppndxS Key Informnt Intervw Thank You Letter.docx Supplementary Document	2015-09-25
AppndxQ Key Informnt Intervw Partcpnt Confrmtn Letter.docx Supplementary Document	2015-09-25
AppndxP Key Informnt Intervw Invtn Phone Call Chcklst.doc Supplementary Document	2015-09-25
AppndxO Key Informnt Intervw Informed Consent.docx Supplementary Document	2015-09-25
AppndxN Key Informnt Intervw Partcpnt Invtn Letter.docx Supplementary Document	2015-09-25
AppndxM Train-the-trainr Thank You Letter.docx Supplementary Document	2015-09-25
AppndxL1 Train-the-trainr Presntn.pdf Supplementary Document	2015-09-25
AppndxK Train-the-trainr Partcpnt Confrmtn Letter.docx Supplementary Document	2015-09-25
AppndxI Train-the-trainr Partcpnt Invtn Letter.docx Supplementary Document	2015-09-25
AppndxH Fax Cover Faild Followp Phone Call2.docx Supplementary Document	2015-09-25
AppndxE Fax Cover Rsnd Promtnl Matrls.docx Supplementary Document	2015-09-25
AppndxC9 Registry Poster.docx Supplementary Document	2015-09-25
AppndxC8 PALS Quick Start Guide.docx Supplementary Document	2015-09-25
AppndxC7 Patient Guide Pamphlt.docx Supplementary Document	2015-09-25
AppndxC6 Get the Facts Infographic.docx Supplementary Document	2015-09-25
AppndxC5 Contin Med Edu Flyer.docx Supplementary Document	2015-09-25
AppndxC4 Provdr Guide Pamphlt.docx Supplementary Document	2015-09-25
AppndxC2 Tailrd Cover Letter Grp3.docx Supplementary Document	2015-09-25
AppndxC1 Tailrd Cover Letter Grp1&2.docx Supplementary Document	2015-09-25
Att 9 - Protocol Appendix C3_ATSDR Endorsement Letter.docx Supplementary Document	2015-09-25
Att 3 - Public Comment Received to the 60 Day FRN.docx.doc Supplementary Document	2015-09-25
Att 1 - ALS Registry Act.docx.doc Supplementary Document	2015-09-25
Att 2 - 60-Day FRN_Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers.pdf Supplementary Document	2015-09-25
SSB Promotion of the National ALS Registry to Non-referral Centers_Clean.doc Supporting Statement B	2015-07-07
SSA Promotion of the National ALS Registry to Non-referral Centers_Clean (00000002).doc Supporting Statement A	2015-07-07

IC Document Collections

IC ID	Document Title	Status
217354	Key Informant Interview Instruction	New
217353	Train-the-Trainer Presentation Other-Presentation	New
217352	Key Informant Interview Invitation Phone Call Instruction	New
217351	Train-the-Trainer Invitation Phone Call Instruction	New
217350	Fax to Determine if Mailing was Received Form and Instruction	New
217349	Follow-Up Phone Call (Three Months Post-Mailing) Instruction	New
217347	Follow-Up Phone Call (One Week Post-Mailing) Instruction	New
217346	Fax to Determine Provider Status Form and Instruction	New
217345	Initial Project Phone Call Instruction	New

ICR Details

OMB Control No: 0923-0053	ICR Reference No: 201507-0923-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No: 15TG
Title: Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers
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 without change	Conclusion Date: 09/30/2015
	Date Received in OIRA: 07/15/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	24 Months From Approved
Responses	4,531	0	0
Time Burden (Hours)	344	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive and fatal neuromuscular disease. ATSDR has implemented a National ALS Registry to, among many objectives, learn more about the etiology of the disease. This project serves to pilot-test educational and promotional outreach activities among select non-referral center neurology practices to inform neurologists and their staff about the Registry, to encourage them to inform their ALS patients about the Registry, and to increase persons with ALS self-enrollment in the Registry's web portal. These activities will support ATSDR in fulfilling its congressional mandate.

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Authorizing Statute(s): PL: Pub.L. 110 - 373 399R Name of Law: ALS Registry 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:
	80 FR 15614	03/24/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 40065	07/13/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Fax to Determine Provider Status	NA	Fax Cover Sheet to Determine Provider Status - Promotion of the National ALS Registry to Non-referral Centers
Follow-Up Phone Call (Three Months Post-Mailing)
Follow-Up Phone Call (One Week Post-Mailing)
Fax to Determine if Mailing was Received	NA	Fax Cover Sheet to Determine if Mailing was Received - Promotion of the National ALS Registry
Train-the-Trainer Invitation Phone Call
Key Informant Interview Invitation Phone Call
Train-the-Trainer Presentation
Key Informant Interview
Initial Project Phone Call

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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	4,531	0	0	4,531	0	0
Annual Time Burden (Hours)	344	0	0	344	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: Submission of 0923-15TG is a New ICR

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Annual Cost to Federal Government: $458,251

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]? 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: 07/15/2015

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