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

Forms and Documents

Document Name	Status
Line Listings (Multi-site) Form	Removed
Att L_CDC Water and Health Study (paper questionnaire) Form	Modified
Justification for Change 9-26-14.docx Justification for No Material/Nonsubstantive Change	2014-09-26
P.Final Appeal Letter.docx Supplementary Document	2014-09-26
O.Replacement Survey Cover Letter.docx Supplementary Document	2014-09-26
N.Thank youReminder Letter.docx Supplementary Document	2014-09-26
K.Consent Brochure.pdf Supplementary Document	2014-09-26
J.Cover Letter Paper.docx Supplementary Document	2014-09-26
I.Advance Letter (revised).docx Supplementary Document	2014-09-26
J.Cover Letter Paper.docx Supplementary Document	2014-09-26
E.IRB Approval Continuation.docx Supplementary Document	2014-09-26
C.Pilot Evaluation Log Frame.pdf Supplementary Document	2014-09-26
D.Phone script (revised).docx Supplementary Document	2014-09-26
Mini SupSta Part B 9-26-14.docx Supporting Statement B	2014-09-26
OMB Appendix B Federal Register 60 day notice 2012-7020.pdf Supplementary Document	2013-03-22
OMB Appendix A Authorizing Legislation 42 CFR 241.pdf Supplementary Document	2013-03-22
Mini SupSta Part A 092614.docx Supporting Statement A	2014-09-26

IC Document Collections

IC ID	Document Title	Status
204806	Att H._Utility Customer Information Other-WORD	Modified
204805	Att G._Low Pressure Event Form Other-WORD	Modified
204804	Line Listings (Multi-site) Form	Removed
204803	Att G_Low Pressure Event Form Other-WORD	Modified
204802	Att L_CDC Water and Health Study (paper questionnaire) Form	Modified
204801	Att M_CDC Water and Health Study (Web-Based Questionnaire) Other-Screen shots	Modified

ICR Details

OMB Control No: 0920-0960	ICR Reference No: 201409-0920-014
Status: Historical Active	Previous ICR Reference No: 201211-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No: 14AXX
Title: Epidemiologic Study of Health Effects Associated with Low Pressure Events in Drinking Water Distribution Systems
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: 11/12/2014
	Date Received in OIRA: 10/03/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	03/31/2016	03/31/2016
Responses	2,095	0	2,291
Time Burden (Hours)	571	0	585
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 to the terms of clearance, a non-substantive change request is required after completion of the pilot study.

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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:
	77 FR 17066	03/23/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 65894	10/31/2012
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Line Listings (Multi-site)	none	Line Listings
Att M_CDC Water and Health Study (Web-Based Questionnaire)
Att L_CDC Water and Health Study (paper questionnaire)	none	Paper-based Questionaire
Att G_Low Pressure Event Form
Att G._Low Pressure Event Form
Att H._Utility Customer Information

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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	2,291	0	-196	0	0
Annual Time Burden (Hours)	571	585	0	-14	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There increased estimated burden of 34 hours to complete the full study (571 hours compared to 537 hours in the original information request). Since completion of the pilot, which it was determined that we originally underestimated the amount of time required to collect and ship the ultrafiltration water samples.

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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: 10/03/2014

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