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

Forms and Documents

Document Name	Status
CDC Water and Health Study (paper 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
0920-0960 Epi Study of Health Effects associated with LPE_SSB_OMB_16FEB2016.docx Supporting Statement B	2016-02-17
0920-0960 Epi Study of Health Effects LPE in Drinking Water_SSA_OMB_16FEB2016.docx Supporting Statement A	2016-02-17
C.Pilot Evaluation Log Frame.pdf Supplementary Document	2014-09-26
OMB Appendix A Authorizing Legislation 42 CFR 241.pdf Supplementary Document	2013-03-22

IC Document Collections

IC ID	Document Title	Status
204806	Utility Customer Information - Line Listings Other-WORD	Modified
204805	Low Pressure Event Form - Ultrafilter and Grab Samples Other-WORD	Modified
204803	Low Pressure Event Form - Grab Samples Other-WORD	Modified
204802	CDC Water and Health Study (paper questionnaire) Form	Modified
204801	CDC Water and Health Study (Web-Based Questionnaire) Other-Screen shots	Modified

ICR Details

OMB Control No: 0920-0960	ICR Reference No: 201510-0920-007
Status: Historical Active	Previous ICR Reference No: 201409-0920-014
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/22/2016
	Date Received in OIRA: 11/19/2015
Terms of Clearance: 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 five 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 in the pilot, 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	08/31/2018	30 Months From Approved	03/31/2016
Responses	2,095	0	2,095
Time Burden (Hours)	571	0	571
Cost Burden (Dollars)	0	0	0

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Abstract: Approximately 200 million cases of acute gastrointestinal illness (AGI) occur in the U.S. each year. The Centers for Disease Control and Prevention requests approval for data collection to assess whether individuals exposed to low pressure events in water distribution system are at increased risk for acute gastrointestinal or respiratory illnesses.. The ICR requests a 30 month extension. No changes are being made to the information collection instruments or respondents. Increase time is required to complete the 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:
	80 FR 52287	08/28/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 67760	11/03/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
CDC Water and Health Study (Web-Based Questionnaire)
CDC Water and Health Study (paper questionnaire)	none	Paper-based Questionaire
Low Pressure Event Form - Grab Samples
Low Pressure Event Form - Ultrafilter and Grab Samples
Utility Customer Information - Line Listings

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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	2,095	2,095	0	0	0	0
Annual Time Burden (Hours)	571	571	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $319,796

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: 11/19/2015

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