Information Collection Request

Epidemiologic Study of Health Effects Associated with Low Pressure Events in Drinking Water Distribution Systems

ICR 201811-0920-007 · OMB 0920-0960 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-0960 Line Listing Environmental Engineer Form New Available
Form 0920-0960 Line Listings Billing Clerk Form Modified Available
Form 0920-0960 Low Pressure Event Form - Grab Samples Form Modified Available
Form 0920-0960 Low Pressure Event Form - Ultrafilter and Grab Samples Form Modified Available
Form 0920-0960 CDC Water and Health Study (paper questionnaire) Form Modified Available
Form 0920-0960 CDC Water and Health Study (Web-Based Questionnaire) Form Modified Available
S.Customer Contact.docx Supplementary Document Uploaded 2016-02-17 Available
H.Cover Letter E-mail.msg Supplementary Document Uploaded 2016-02-17 Repair queued
E7. Utility Water Sample Fact Sheet.docx Supplementary Document Uploaded 2016-02-17 Available
E6. Utility Customer Fact Sheet.docx Supplementary Document Uploaded 2016-02-17 Available
E5. Utility Promotional Postcard.pdf Supplementary Document Uploaded 2016-02-17 Available
E4. Utility Social Media Posts.docx Supplementary Document Uploaded 2016-02-17 Available
E3. Utility Newsletter Paragraph.docx Supplementary Document Uploaded 2016-02-17 Available
E2. Utility Radio PSA.docx Supplementary Document Uploaded 2016-02-17 Available
E1. Utility Press Release.docx Supplementary Document Uploaded 2016-02-17 Available
D.Pilot Summary and Evaluation Report.pdf Supplementary Document Uploaded 2016-02-17 Available
P.Final Appeal Letter.docx Supplementary Document Uploaded 2016-02-17 Available
O.Phone script.docx Supplementary Document Uploaded 2016-02-17 Available
K.Survey2 Cover Letter Paper.docx Supplementary Document Uploaded 2015-11-06 Available
J.Thank youReminder Letter.docx Supplementary Document Uploaded 2015-11-06 Available
I.Consent Brochure.pdf Supplementary Document Uploaded 2016-02-17 Available
G.Cover Letter Paper.docx Supplementary Document Uploaded 2016-02-17 Available
F.Advance Letter.docx Supplementary Document Uploaded 2016-02-17 Available
CDC Water and Health Study needs your help .msg Supplementary Document Uploaded 2015-11-06 Available
Q.IRB Approval Continuation.docx Supplementary Document Uploaded 2016-02-17 Available
Attach B 60 day published.pdf Supplementary Document Uploaded 2015-11-06 Available
Supporting Statement B.docx Supporting Statement B Uploaded 2018-11-29 Repair queued
SupSta A.3-26-19 (003).docx Supporting Statement A Uploaded 2019-03-26 Available
C. Pilot Evaluation Log Frame.pdf Supplementary Document Uploaded 2018-11-29 Available
OMB Appendix A Authorizing Legislation 42 CFR 241.pdf Supplementary Document Uploaded 2013-03-22 Available
ICR Details
0920-0960 201811-0920-007
Active 201510-0920-007
HHS/CDC 0920-0960
Epidemiologic Study of Health Effects Associated with Low Pressure Events in Drinking Water Distribution Systems
Reinstatement with change of a previously approved collection   No
Regular
Approved with change 03/26/2019
Retrieve Notice of Action (NOA) 01/16/2019
Previous terms continue: Approved consistent with the understanding that this prospective cohort study is designed to provide insights into whether individuals exposed to low-pressure events in selected water distribution systems are at an increased risk for acute gastrointestinal or respiratory illnesses. The seven utilities studied are not intended to be representative of population exposures or illness rates across the United States more broadly. Furthermore, given low response rates, CDC commits to highlighting the implications of any nonresponse bias identified for the generalizability of the study results.
  Inventory as of this Action Requested Previously Approved
03/31/2022 36 Months From Approved
475 0 0
199 0 0
0 0 0

This is a request from CDC for a reinstatement with changes of an existing data collection. The purpose of this data collection is to continue to conduct an epidemiologic study in the U.S. (similar to a study conducted in Norway (Nygard, Wahl et al. 2007)) to assess whether individuals exposed to low pressure events in the water distribution system are at an increased risk for acute gastrointestinal or respiratory illnesses. Pursuant to the terms of clearance, a non-substantive change request was required after completion of a pilot study and was approved on 11/12/2014. Pilot study data collection, analysis, and evaluation took longer than expected, and there were delays in implementing data infrastructure and IT updates needed to scale-up the procedures for a multi-site study. To address this, we are asking for a 36 month reinstatement for data collection.

US Code: 42 USC 301 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  83 FR 44053 08/29/2018
83 FR 64576 12/17/2018
No

  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 475 0 0 -1,620 0 2,095
Annual Time Burden (Hours) 199 0 0 -372 0 571
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Changing Forms
The burden for survey participants and water utility participants has decreased from the burden shown in the current inventory. Previously we indicated that we needed 12-18 months for new data collection. To address potential scheduling challenges discovered during the pilot, the study team will plan for scheduling conflicts and conduct a staggered scale-up to multiple utility sites, which will require a reinstatement of 36 months of data collection. The Line Listing Environmental Engineer was not an add on the burden was separated according to the occupation of the work being performance per respondent.

$515,651
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
Uncollected
Thelma Sims 4046394771

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/16/2019