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

Forms and Documents

Document Name	Status
Line Listings (Pilot) Form	New
LPE Form and Samples (Pilot) Form	New
Line Listings (Multi-site) Form	New
LPE Form and Samples ( Multi-Site) Form	New
Paper-Based Questionnaire (Pilot and Mult-site) Form	New
Web-Based Questionnaire (Pilot and Multi-site) Form	New
OMB Appendix N IRB Approval Continuation Memo.pdf Supplementary Document	2013-03-22
OMB Appendix M Utility customer information.docx Supplementary Document	2013-03-22
OMB Appendix K Final appeal letter.docx Supplementary Document	2013-03-22
OMB Appendix J Replacement survey mailing cover letter.docx Supplementary Document	2013-03-22
OMB Appendix I Thank You Reminder notecard text.pdf Supplementary Document	2013-03-22
OMB Appendix F Consent brochure.pdf Supplementary Document	2013-03-22
OMB Appendix E Cover letter initial survey mailing.docx Supplementary Document	2013-03-22
OMB Appendix D Advance letter.docx Supplementary Document	2013-03-22
OMB Appendix C Pilot evaluation logical framework.pdf Supplementary Document	2013-03-21
Supporting Statement Part B Revised 3-15-2013 water distribution.docx Supporting Statement B	2013-03-22
OMB Appendix M Utility customer information.docx Supplementary Document	2013-03-22
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
Supporting Statement Part A Revised 3-15-2013 water distribution.docx Supporting Statement A	2013-03-22

IC Document Collections

IC ID	Document Title	Status
204806	Line Listings (Pilot) Form	New
204805	LPE Form and Samples (Pilot) Form	New
204804	Line Listings (Multi-site) Form	New
204803	LPE Form and Samples ( Multi-Site) Form	New
204802	Paper-Based Questionnaire (Pilot and Mult-site) Form	New
204801	Web-Based Questionnaire (Pilot and Multi-site) Form	New

ICR Details

OMB Control No: 0920-0960	ICR Reference No: 201211-0920-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Epidemiologic Study of Health Effects Associated with Low Pressure Events in Drinking Water Distribution Systems
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/25/2013
	Date Received in OIRA: 11/09/2012
Terms of Clearance: Approval is provided for implementation of the pilot study. Approval will only be provided for the full study when CDC submits a nonsubstantive change request to OMB. That change request will detail the results of the pilot study and the protocol changes are necessary as a result of the pilot. CDC should make changes to the protocol between the pilot and the full study to increase response rates if pilot study response is below 60% or there is significant nonresponse bias.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved
Responses	2,291	0	0
Time Burden (Hours)	585	0	0
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.

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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: 6

IC Title	Form No.	Form Name
Web-Based Questionnaire (Pilot and Multi-site)	none	Web-based Questionaire
Paper-Based Questionnaire (Pilot and Mult-site)	none	Paper-based Questionaire
LPE Form and Samples ( Multi-Site)	none	LPE Form
Line Listings (Multi-site)	none	Line Listings
LPE Form and Samples (Pilot)	none	LPE Form
Line Listings (Pilot)	none	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	2,291	0	0	2,291	0	0
Annual Time Burden (Hours)	585	0	0	585	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: This is a new data collection request.

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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: 11/09/2012

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