Health Effects of Microbial Pathogens in Recreational Waters; National Epidemiological and Environmental Assessment of Recreational (NEEAR) Water Study (Renewal)

Forms and Documents

Document Name	Status
2081ss04b.doc Supporting Statement B	2008-09-15
2081ss04.doc Supporting Statement A	2008-09-16

IC Document Collections

IC ID	Document Title	Status
25045	Health Effects of Microbial Pathogens in Recreational Waters; National Epidemiological and Environmental Assessment of Recrea- tional (NEEAR) Water Study (Renewal) Other-Survey	Modified

ICR Details

OMB Control No: 2080-0068	ICR Reference No: 200812-2080-001
Status: Historical Active	Previous ICR Reference No: 200702-2080-001
Agency/Subagency: EPA/ORD	Agency Tracking No: 2081.04
Title: Health Effects of Microbial Pathogens in Recreational Waters; National Epidemiological and Environmental Assessment of Recreational (NEEAR) Water Study (Renewal)
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 without change	Conclusion Date: 04/23/2009
	Date Received in OIRA: 12/15/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2012	36 Months From Approved	04/30/2009
Responses	42,000	0	14,000
Time Burden (Hours)	15,750	0	5,250
Cost Burden (Dollars)	0	0	0

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Abstract: This study will be conducted and the information collected by the Epidemiology and Biomarkers Branch, Human Studies Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency.(EPA) Participation of adults and children in this collection of information is strictly voluntary. This information is being collected as part of a research program consistent with the Section 3(a)(v)(1) of the Beaches Environmental Assessment and Coastal Health Act of 2000 and the strategic plan for EPA's Office of Research and development and the Office of Water. The purpose of this study is to examine the health effects associated with swimming exposure at beach sites designated as recreational areas. The Beaches Act and ORD's strategic plan has identified research on effects of microbial pathogens in recreational waters as a high-priority research area with particular emphasis on developing new water quality indicator guidelines for recreational waters. The EPA has broad legislative authority to establish water quality criteria and to conduct research to support these criteria. This data collection is for a series of epidemiological studies to evaluate exposure to and effects of microbial pathogens in marine and fresh recreational waters as part of the EPA's research program on exposure and health effects of microbial pathogens in recreational waters. Health effects data collection was previously conducted in a pilot study, four freshwater coastal sites, and three marine sites under OMB number 2080-0068. The results will be used to help inform the development of new national water quality and monitoring guidelines. The questionnaire health data will be compared with routinely collected water quality measurements. The analysis will focus on determining whether any water quality parameters are associated with increased prevalence of swimming-related health effects.

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Authorizing Statute(s): None

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:
	73 FR 27818	05/14/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 54797	09/23/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Health Effects of Microbial Pathogens in Recreational Waters; National Epidemiological and Environmental Assessment of Recrea- tional (NEEAR) Water Study (Renewal)

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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	42,000	14,000	0	28,000	0	0
Annual Time Burden (Hours)	15,750	5,250	0	10,500	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: Because of increased pressure to expeditiously complete the study, the study team may complete more than two beaches per year, thus increasing the number of participants enrolled in the study annually. In the last renewal information collection request (ICR), the tables in Sections 6(a) and 6(c) reflect the estimated respondent burden and agency burden and cost for 2-3 beaches (1-2 beaches per year). This renewal burden estimate reflects 2-3 beaches per year for the next three years. This change substantially increased the number of respondents expected annually. The increase in total respondents for the 3-year period is 42,000 (or approximately 14,000 annually.)

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Annual Cost to Federal Government: $7,847,330

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/23/2008

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