View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0923-0041
ICR Reference No:
202408-0923-001
Status:
Active
Previous ICR Reference No:
202301-0923-001
Agency/Subagency:
HHS/TSDR
Agency Tracking No:
0923-0041-24HW
Title:
[ATSDR] National Amyotrophic Lateral Sclerosis (ALS) Registry
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:
08/12/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/05/2024
Terms of Clearance:
Prior TOC continue to apply: 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 of prevalence rates. Furthermore, any research based on registry data should highlight what is known about its lack of representativeness due to its self-selected nature. ATSDR endeavors to improve both the completeness and representativeness of the data over time.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2026
05/31/2026
05/31/2026
Responses
11,649
0
11,549
Time Burden (Hours)
1,763
0
1,758
Cost Burden (Dollars)
0
0
0
Abstract:
As mandated by Congress, the goal is to continue collecting data for the National Amyotrophic Lateral Sclerosis (ALS) Registry to better describe the incidence and prevalence of ALS and to identify risk factors for the disease. ATSDR endeavors to improve the completeness, representativeness, and accuracy of the Registry data over time. This change request involves minor changes to a consent form and addition of incentives.
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:
87 FR 59421
09/30/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 2918
01/17/2023
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
15
IC Title
Form No.
Form Name
ALS Biorepository Collection Form- Saliva
none
ALS Biorepository Saliva Collection
ALS Biorepository Specimen Processing
none
Biorepository Specimen Processing
ALS Case Registration
none
Case registration
ALS DIsease Progression Survey
none
Disease Progression Survey
ALS Registry Research Application
n/a
National Amyotrophic Lateral Sclerosis (ALS) Registry Research Application Form (rev. May 2021)
ALS Validation Questions
none
Case validation questions
Annual Update for Projects Receiving Specimens or Data
none
Annual update for projects receiving specimens and/data
Essential Questionnaire
n/a
Essential Questionnaire
Follow-up Questions - ALS-associated and Clinical Factors
n/a
ALS-associated and Clinical Factors
Follow-up Questions - Demography
n/a
Demography
Follow-up Questions - Environmental Factors
n/a
Environmental Factors
Follow-up Questions - Lifestyle Information
n/a
Lifestyle Information
Incentives Pilot Project Sign Up form – Only for Texas Registrants
n/a
Incentive Project Sign Up Form
National Office Outreach Reporting
none
National Office Outreach Reporting
Outreach Reporting Form for Chapters and Districts
none
Chapter/District Outreach Reporting
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
11,649
11,549
0
100
0
0
Annual Time Burden (Hours)
1,763
1,758
0
5
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:
Addition of a minor sign up form.
Annual Cost to Federal Government:
$3,640,822
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
No
Agency Contact:
Kevin Joyce 404 639-1944 kdj7@cdc.gov
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:
08/05/2024
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