National Amyotrophic Lateral Sclerosis (ALS) Registry

Forms and Documents

Document	Type	Status	Availability
ALS Twice Yearly Survey	Form	Modified	Repair queued
ALS One-time Survey	Form	Modified	Repair queued
ALS Registration	Form	Modified	Repair queued
ALS Validation Questions	Form	Modified	Repair queued
ICR#0923-0041_CLEAN_ALS_Registry_SupStmt_Part_B_8.30.2013_Version.doc	Supporting Statement B	Uploaded 2013-09-11	Repair queued
Attach_11-Privacy Impact Assessment.docx	Supplementary Document	Uploaded 2013-05-01	Available
Attach_10-Scoring ALSFRS.docx	Supplementary Document	Uploaded 2013-05-01	Repair queued
Attach_9-Current IRB approval letter.doc	Supplementary Document	Uploaded 2013-05-01	Repair queued
Attach_7-Privacy statement.doc	Supplementary Document	Uploaded 2013-05-01	Repair queued
Attach_3- Public Comment to 60-Day FRN.doc	Supplementary Document	Uploaded 2013-05-01	Repair queued
Attach_2-60 Day FRN_Published 2.12.2013.pdf	Supplementary Document	Uploaded 2013-05-01	Repair queued
Attach_1-Public Health Law 110-373.doc	Supplementary Document	Uploaded 2013-05-01	Repair queued
Attachment 8 - Screen Shot Consent Form-revised.docx	Supplementary Document	Uploaded 2013-05-02	Repair queued
ICR#0923-0041_CLEAN_ALS_Registry_SupStmt_Part_A_8.30.2013_Version.doc	Supporting Statement A	Uploaded 2013-09-11	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
192032	ALS Twice Yearly Survey	Form	Modified
192031	ALS One-time Survey	Form	Modified
192030	ALS Registration	Form	Modified
192029	ALS Validation Questions	Form	Modified

ICR Details

OMB Control No: 0923-0041	ICR Reference No: 201305-0923-004
Status: Historical Active	Previous ICR Reference No: 201002-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 19438
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: 09/12/2013
	Date Received in OIRA: 05/13/2013
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. Any dissemination of such estimates must clearly highlight the significant limitations associated with a) the potential for double counting; b) administrative records coverage; and c) non-response bias in the registry. ATSDR endeavors to improve both the completeness and representativeness of the data over time.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved	09/30/2013
Responses	16,895	0	29,339
Time Burden (Hours)	1,375	0	2,300
Cost Burden (Dollars)	0	0	0

---

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

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 9922	02/12/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 26780	05/08/2013
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
ALS Validation Questions	none	ALS Registry Validation Questions
ALS Registration	none	ALS Registry Registration
ALS One-time Survey	none, none	6a - Previously approved surveys ,   6b - New Surveys
ALS Twice Yearly Survey	none, none	6a - Previously approved surveys ,   6b - New surveys

---

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	16,895	29,339	0	-12,444	0	0
Annual Time Burden (Hours)	1,375	2,300	0	-925	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a revision request. Change in respondent burden is based on program change. The original application has been revised to include 10 additional risk factor surveys based on the scientific literature. The topics covered by the 10 additional surveys include residential history, life-time occupational exposure, home pesticide use, hobbies, hormonal and reproductive history (women only), caffeine use, trauma, health insurance, open-ended supplemental questions, and clinical signs and symptoms. The activities described are part of the ongoing effort to maintain the National ALS Registry.

---

Annual Cost to Federal Government: $1,100,000

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

---

Common Form ICR:  No

---

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: 05/13/2013

---