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

Forms and Documents

Document Name	Status
Form 0920-0960 Line Listing Environmental Engineer Form	New
Form 0920-0960 Line Listings Billing Clerk Form	Modified
Form 0920-0960 Low Pressure Event Form - Grab Samples Form	Modified
Form 0920-0960 Low Pressure Event Form - Ultrafilter and Grab Samples Form	Modified
Form 0920-0960 CDC Water and Health Study (paper questionnaire) Form	Modified
Form 0920-0960 CDC Water and Health Study (Web-Based Questionnaire) Form	Modified
S.Customer Contact.docx Supplementary Document	2016-02-17
H.Cover Letter E-mail.msg Supplementary Document	2016-02-17
E7. Utility Water Sample Fact Sheet.docx Supplementary Document	2016-02-17
E6. Utility Customer Fact Sheet.docx Supplementary Document	2016-02-17
E5. Utility Promotional Postcard.pdf Supplementary Document	2016-02-17
E4. Utility Social Media Posts.docx Supplementary Document	2016-02-17
E3. Utility Newsletter Paragraph.docx Supplementary Document	2016-02-17
E2. Utility Radio PSA.docx Supplementary Document	2016-02-17
E1. Utility Press Release.docx Supplementary Document	2016-02-17
D.Pilot Summary and Evaluation Report.pdf Supplementary Document	2016-02-17
P.Final Appeal Letter.docx Supplementary Document	2016-02-17
O.Phone script.docx Supplementary Document	2016-02-17
K.Survey2 Cover Letter Paper.docx Supplementary Document	2015-11-06
J.Thank youReminder Letter.docx Supplementary Document	2015-11-06
I.Consent Brochure.pdf Supplementary Document	2016-02-17
G.Cover Letter Paper.docx Supplementary Document	2016-02-17
F.Advance Letter.docx Supplementary Document	2016-02-17
CDC Water and Health Study needs your help .msg Supplementary Document	2015-11-06
Q.IRB Approval Continuation.docx Supplementary Document	2016-02-17
Attach B 60 day published.pdf Supplementary Document	2015-11-06
Supporting Statement B.docx Supporting Statement B	2018-11-29
SupSta A.3-26-19 (003).docx Supporting Statement A	2019-03-26
C. Pilot Evaluation Log Frame.pdf Supplementary Document	2018-11-29
OMB Appendix A Authorizing Legislation 42 CFR 241.pdf Supplementary Document	2013-03-22

IC Document Collections

IC ID	Document Title	Status
234243	Line Listing Environmental Engineer Form	New
204806	Line Listings Billing Clerk Form	Modified
204805	Low Pressure Event Form - Grab Samples Form	Modified
204803	Low Pressure Event Form - Ultrafilter and Grab Samples Form	Modified
204802	CDC Water and Health Study (paper questionnaire) Form	Modified
204801	CDC Water and Health Study (Web-Based Questionnaire) Form	Modified

ICR Details

OMB Control No: 0920-0960	ICR Reference No: 201811-0920-007
Status: Active	Previous ICR Reference No: 201510-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0960
Title: Epidemiologic Study of Health Effects Associated with Low Pressure Events in Drinking Water Distribution Systems
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/26/2019
	Date Received in OIRA: 01/16/2019
Terms of Clearance: 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
Expiration Date	03/31/2022	36 Months From Approved
Responses	475	0	0
Time Burden (Hours)	199	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: 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
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 44053	08/29/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 64576	12/17/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
CDC Water and Health Study (Web-Based Questionnaire)	0920-0960	CDC Water and Health Study (web-based)
CDC Water and Health Study (paper questionnaire)	0920-0960	CDC Water and Health Study (paper-based)
Low Pressure Event Form - Ultrafilter and Grab Samples	0920-0960	LOW PRESSURE EVENT FORM
Low Pressure Event Form - Grab Samples	0920-0960	LOW PRESSURE EVENT FORM
Line Listings Billing Clerk	0920-0960	Customer Contact
Line Listing Environmental Engineer	0920-0960	Customer Contact Questionnaire

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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	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

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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: 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.

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Annual Cost to Federal Government: $515,651

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? 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: 01/16/2019

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