Biomonitoring of Great Lakes Populations Program III

Forms and Documents

Document Name	Status
Follow-Up Survey - Burmese Immigrants and Descendants Form and Instruction	New
Network Size Questions - Burmese Immigrants and Descendants Form and Instruction	New
Clinic Visit and Body Measurements - Burmese Immigrants and Descendants Form and Instruction	New
Study Questionnaire - Burmese Immigrants and Descendants Form and Instruction	New
Contact Information Form - Burmese Immigrants and Descendants Form and Instruction	New
Eligibility Screening Survey - Burmese Immigrants and Descendants Form and Instruction	New
Follow-Up Survey - Licensed Anglers Form and Instruction	New
Clinic Visit Checklist and Body Measurements - Licensed Anglers Form and Instruction	New
Study Questionnaire - Licensed Anglers - Screenshot Form and Instruction	New
Study Questionnaire - Licensed Anglers - Paper Form and Instruction	New
Eligibility Screening Survey - Licensed Anglers - Screenshots Form and Instruction	New
Eligibility Screening Survey - Licensed Anglers - Paper Form and Instruction	New
12b. WI_ResearchDetermination.pdf Supplementary Document	2017-04-10
12a.ATSDR_ResearchDetermination_GL3.pdf Supplementary Document	2017-04-10
11.LabSOPcomb_metal_PCB_PFC_PAH.pdf Supplementary Document	2017-04-10
10b.ResultsPacket.docx Supplementary Document	2017-04-10
10a.EarlyResults.doc Supplementary Document	2017-04-10
8d.GiftcardLetter_Burm.docx Supplementary Document	2017-04-10
8c.RDS_Coupon_Burm.pdf Supplementary Document	2017-04-10
6b.Consent_Burm.docx Supplementary Document	2017-04-10
6a.Consent_LicAng.docx Supplementary Document	2017-04-10
5a.RecruitmentMaterials.pdf Supplementary Document	2017-04-10
4b.Map.docx Supplementary Document	2017-04-10
4a.ProgramOverview.docx Supplementary Document	2017-04-10
3.PublicCommentResponse.docx Supplementary Document	2017-04-10
2.60dayFederalRegisterNotice.pdf Supplementary Document	2017-04-10
1.AuthLegislation ATSDR.docx Supplementary Document	2017-04-10
BGLPP3-SSB.docx Supporting Statement B	2017-04-10
BGLPP3-SSA 10APR2017.docx Supporting Statement A	2017-04-10

IC Document Collections

IC ID	Document Title	Status
226333	Follow-Up Survey - Burmese Immigrants and Descendants Form and Instruction	New
226332	Network Size Questions - Burmese Immigrants and Descendants Form and Instruction	New
226331	Clinic Visit and Body Measurements - Burmese Immigrants and Descendants Form and Instruction	New
226330	Study Questionnaire - Burmese Immigrants and Descendants Form and Instruction	New
226329	Contact Information Form - Burmese Immigrants and Descendants Form and Instruction	New
226328	Eligibility Screening Survey - Burmese Immigrants and Descendants Form and Instruction	New
226327	Follow-Up Survey - Licensed Anglers Form and Instruction	New
226326	Clinic Visit Checklist and Body Measurements - Licensed Anglers Form and Instruction	New
226325	Study Questionnaire - Licensed Anglers - Screenshot Form and Instruction	New
226324	Study Questionnaire - Licensed Anglers - Paper Form and Instruction	New
226323	Eligibility Screening Survey - Licensed Anglers - Screenshots Form and Instruction	New
226321	Eligibility Screening Survey - Licensed Anglers - Paper Form and Instruction	New

ICR Details

OMB Control No: 0923-0056	ICR Reference No: 201703-0923-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No: 17IY
Title: Biomonitoring of Great Lakes Populations Program III
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: 07/19/2017
	Date Received in OIRA: 04/12/2017
Terms of Clearance: Approved consistent with the understanding that the core program objective is to provide a current ‘snap shot’ of human exposure levels among susceptible subpopulations living around the Milwaukee AOC. This surveillance project will not investigate health outcomes or biological effects from such exposures. The biomonitoring results will not be generalized beyond the selected AOC and the defined subpopulations under study. The design does not support the ability to draw conclusions about the statistical significance of differences between either the populations being studies or with data from nationally representative populations (e.g., NHANES), as the underlying assumptions in all of these samples are very different.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved
Responses	731	0	0
Time Burden (Hours)	227	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this program is to evaluate body burden levels of legacy and emerging contaminants in susceptible Great Lakes populations in the Milwaukee Estuary Area of Concern (AOC) in Wisconsin. The aims of this information collection are: 1) to assess contaminants levels in blood and urine of residents who consume fish from the AOC and 2) to use project findings to inform public health officials and offer guidance on public health actions to reduce exposure to Great Lakes contaminants. The two subpopulations included in this study are: licensed anglers in the Milwaukee area that eat fish from the AOC and Burmese immigrants and their descendants that eat fish from the AOC.

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Authorizing Statute(s): US Code: 42 USC 9604 Name of Law: CERCLA / SARA
  

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:
	82 FR 124	01/03/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 16832	04/06/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Eligibility Screening Survey - Licensed Anglers - Paper	NA	Eligibility Screening Survey for Licensed Anglers - Paper
Eligibility Screening Survey - Licensed Anglers - Screenshots	NA	Eligibility Screening Survey for Licensed Anglers - Screenshot
Study Questionnaire - Licensed Anglers - Paper	NA	Study Questionnaire for Licensed Anglers - Paper
Study Questionnaire - Licensed Anglers - Screenshot	NA	Study Questionnaire for Licensed Anglers - Screenshot
Clinic Visit Checklist and Body Measurements - Licensed Anglers	NA	Clinic Visit Checklist and Body Measurements - Licensed Anglers
Follow-Up Survey - Licensed Anglers	NA	Follow-Up Survey for Licensed Anglers
Eligibility Screening Survey - Burmese Immigrants and Descendants	NA	Eligibility Screening Survey for Burmese Immigrants and their Descendants
Contact Information Form - Burmese Immigrants and Descendants	NA	Contact Information Form for Burmese Immigrants and their Descendants
Study Questionnaire - Burmese Immigrants and Descendants	NA	Study Questionnaire - Burmese Immigrants and their Descendants
Clinic Visit and Body Measurements - Burmese Immigrants and Descendants	NA	Clinic Visit Checklist and Body Measurements - Burmese Immigrants and their Descendants
Network Size Questions - Burmese Immigrants and Descendants	NA	Network Size Questions for Respondent-driven Sampling - Burmese Immigrants and their Descendants
Follow-Up Survey - Burmese Immigrants and Descendants	NA	Follow-Up Survey - Burmese Immigrants and their Descendants

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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	731	0	0	731	0	0
Annual Time Burden (Hours)	227	0	0	227	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: Submission of 0923-17IY - Biomonitoring of Great Lakes Populations Program III is a New ICR.

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Annual Cost to Federal Government: $633,000

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: 04/12/2017

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