Human Exposure to Cynobacterial (Blue-green Algal) Toxins in Drinking Water: Risk of Exposure to Microcystins from Public Water Systems

Forms and Documents

Document Name	Status
SS Part B Blue-green algae 8-29-07.doc Supporting Statement B	2007-09-07
Att 9 Public Comment and Response.doc Supplementary Document	2007-09-07
Att 8 CDC IRB Approval 8-14-07.doc Supplementary Document	2007-09-07
Att 7 Recruitmentng Flyer.doc Supplementary Document	2007-09-07
Att 2 60day FRN.pdf Supplementary Document	2007-09-07
Att 1 PHSA Section 301.doc Supplementary Document	2007-09-07
SS Part A blue-green algae 8-29-07.doc Supporting Statement A	2007-09-07

IC Document Collections

IC ID	Document Title	Status
6975	Human Exposure to Cynobacterial (Blue-green Algal) Toxins in Drinking Water: Risk of Exposure to Microcystins from Public Water Systems Other-Screener	Modified
182390	10-Day Post-exposure Questionnaire Other-10-Day Post Exposure Questionnaire	New
182389	Post-exposure Questionnaire Other-Post-exposure Questionnaire	New
182388	Consent and Pre-exposure Questionnaire Other-Consent and Pre-exposure Questionnaire	New

ICR Details

OMB Control No: 0920-0527	ICR Reference No: 200710-0920-007
Status: Historical Active	Previous ICR Reference No: 200506-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Human Exposure to Cynobacterial (Blue-green Algal) Toxins in Drinking Water: Risk of Exposure to Microcystins from Public Water 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 without change	Conclusion Date: 02/08/2008
	Date Received in OIRA: 10/17/2007
Terms of Clearance: Approved consistent with the continuation of the prior terms of clearance specifically: OMB approves the requested survey for purposes of exploratory research, consistent with the limitations of the proposed experimental design. These limitations include lack of blood sampling from controls for purposes of comparison, reliance on a self-selected sample, lack of a systematic approach to site selection and insufficient information for determining study power. As such, OMB does not approve the collection for purposes of developing public health standards for microcystin levels, for assessing health risks associated with microcystin exposures, or for providing gerneralizable or representative data with respect to the effects of microcystins on humans. Rather, this project may provide the basis for developing more refined designs for future research.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved
Responses	425	0	0
Time Burden (Hours)	69	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this data collection is to assess human exposure to microcystins in recreational waters. The study will focus on verifying exposure, collecting symptom data, and assessing microcystins in serum. The results from this study will be useful to health agencies in states where seasonal or year-round blue-green algae blooms occur. The methods for data collection include environmental sampling, questionnaires, and blood sampling.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Servic 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:
	72 FR 6570	02/12/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 52132	09/12/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Human Exposure to Cynobacterial (Blue-green Algal) Toxins in Drinking Water: Risk of Exposure to Microcystins from Public Water Systems
Consent and Pre-exposure Questionnaire
Post-exposure Questionnaire
10-Day Post-exposure 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	425	0	0	425	0	0
Annual Time Burden (Hours)	69	0	0	69	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 request is for a reinstatement of a previously approved data collection.

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Annual Cost to Federal Government: $49,642

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: 10/17/2007

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