Biomonitoring of Great Lakes Populations Program III

Forms and Documents

Document Name	Status
Form 0923-0056 Updated Questions on Fish Consumption - Licensed Anglers Form and Instruction	New
Follow-Up Survey - Burmese Immigrants and Descendants Form and Instruction	Unchanged
Network Size Questions - Burmese Immigrants and Descendants Form and Instruction	Unchanged
Form 0923-0056 Clinic Visit and Body Measurements - Burmese Immigrants and Descendants Form and Instruction	Unchanged
Form 0923-0056 Study Questionnaire - Burmese Immigrants and Descendants Form and Instruction	Modified
Contact Information Form - Burmese Immigrants and Descendants Form and Instruction	Unchanged
Form 0923-0056 Eligibility Screening Survey - Burmese Immigrants and Descendants Form and Instruction	Modified
Follow-Up Survey - Licensed Anglers Form and Instruction	Unchanged
Clinic Visit Checklist and Body Measurements - Licensed Anglers Form and Instruction	Unchanged
Form 0923-0056 Study Questionnaire - Licensed Anglers - Screenshot Form and Instruction	Modified
Form 0923-0056 Study Questionnaire - Licensed Anglers - Paper Form and Instruction	Modified
Form 0923-0056 Eligibility Screening Survey - Licensed Anglers - Screenshots Form and Instruction	Modified
Form 0923-0056 Eligibility Screening Survey - Licensed Anglers - Paper Form and Instruction	Modified
8c.RDS_Coupon_Burm_20180111_clean.pdf Supplementary Document	2018-01-16
5a.Recruitment Mailings 20180111_clean.pdf Supplementary Document	2018-01-16
4b.Map Waterbody of Interest_20180111__clean.docx Supplementary Document	2018-01-16
4a.ProgramOverview 20180109 clean.docx Supplementary Document	2018-01-16
6b.Consent_Burm_20180111_clean.docx Supplementary Document	2018-01-16
6a.Consent_LicAng_20180111_clean.docx Supplementary Document	2018-01-16
5e.PhoneScripts_LicAng 20170111_clean.docx Supplementary Document	2018-01-16
0923-0056 Change Request Justification and crosswalk table 20180110.docx Justification for No Material/Nonsubstantive Change	2018-01-16
0923-0056 Change Request Justification and crosswalk table attm5b.docx Justification for No Material/Nonsubstantive Change	2017-10-31
0923-0056 Change Request Justification and crosswalk table.docx Justification for No Material/Nonsubstantive Change	2017-07-21
5f.Appointment reminder letters revised.docx Supplementary Document	2017-07-21
5a.RecruitmentManterial invite letter revised.docx Supplementary Document	2017-07-21
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
5a.RecruitmentMaterials.pdf 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
SSB GL3 20180110 clean.docx Supporting Statement B	2018-01-16
SSA GL3 20180109 clean.docx Supporting Statement A	2018-01-16

IC Document Collections

IC ID	Document Title	Status
229748	Updated Questions on Fish Consumption - Licensed Anglers Form and Instruction	New
226333	Follow-Up Survey - Burmese Immigrants and Descendants Form and Instruction	Unchanged
226332	Network Size Questions - Burmese Immigrants and Descendants Form and Instruction	Unchanged
226331	Clinic Visit and Body Measurements - Burmese Immigrants and Descendants Form and Instruction	Unchanged
226330	Study Questionnaire - Burmese Immigrants and Descendants Form and Instruction	Modified
226329	Contact Information Form - Burmese Immigrants and Descendants Form and Instruction	Unchanged
226328	Eligibility Screening Survey - Burmese Immigrants and Descendants Form and Instruction	Modified
226327	Follow-Up Survey - Licensed Anglers Form and Instruction	Unchanged
226326	Clinic Visit Checklist and Body Measurements - Licensed Anglers Form and Instruction	Unchanged
226325	Study Questionnaire - Licensed Anglers - Screenshot Form and Instruction	Modified
226324	Study Questionnaire - Licensed Anglers - Paper Form and Instruction	Modified
226323	Eligibility Screening Survey - Licensed Anglers - Screenshots Form and Instruction	Modified
226321	Eligibility Screening Survey - Licensed Anglers - Paper Form and Instruction	Modified

ICR Details

OMB Control No: 0923-0056	ICR Reference No: 201801-0923-002
Status: Historical Active	Previous ICR Reference No: 201710-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0056-18KX
Title: Biomonitoring of Great Lakes Populations Program III
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: 01/25/2018
	Date Received in OIRA: 01/17/2018
Terms of Clearance: Previous terms continue: 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	07/31/2020	07/31/2020
Responses	749	0	731
Time Burden (Hours)	229	0	227
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of the Biomonitoring of Great Lakes Populations Program III (0923-0056) is to evaluate body burden levels of legacy contaminants and chemicals of emerging concern in susceptible Great Lakes populations in Milwaukee and the surrounding southeastern area of Wisconsin. Findings from the biomonitoring study will be used to inform participants and other community stakeholders about ways to maximize benefits and minimize risks while consuming locally caught fish in the Great Lakes basin and guide public health action to protect Great Lakes populations from potential exposure to harmful chemicals. The purpose of this Non-Substantive Change Request is to expand the recruitment boundary of the waterbodies due to recruitment challenges experienced by the Wisconsin DHS, These changes result in small changes to a number of Information Collection Instruments and a slight increase in Burden Hours, however the overall scope and direction of the package has not changed.

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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: 13

IC Title	Form No.	Form Name
Clinic Visit Checklist and Body Measurements - Licensed Anglers	NA	Clinic Visit Checklist and Body Measurements - Licensed Anglers
Updated Questions on Fish Consumption - Licensed Anglers	0923-0056	Updated Fish Consumption Survey - FISH EATEN IN THE LAST 12 MONTHS
Eligibility Screening Survey - Licensed Anglers - Paper	0923-0056	Eligibility Screening Survey for Licensed Anglers (Paper) 16JAN2018
Eligibility Screening Survey - Licensed Anglers - Screenshots	0923-0056	Eligibility Screening Survey for Licensed Anglers (Screenshot) - 16JAN2018
Study Questionnaire - Licensed Anglers - Paper	0923-0056	Study Questionnaire for Licensed Anglers (Paper) - 16JAN2018
Study Questionnaire - Licensed Anglers - Screenshot	0923-0056	Study Questionnaire for Licensed Anglers (Screenshot) - 16JAN2018
Follow-Up Survey - Licensed Anglers	NA	Follow-Up Survey for Licensed Anglers
Eligibility Screening Survey - Burmese Immigrants and Descendants	0923-0056	Eligibility Screening Survey for Burmese Immigrants and their Descendants - 16JAN2018
Contact Information Form - Burmese Immigrants and Descendants	NA	Contact Information Form for Burmese Immigrants and their Descendants
Study Questionnaire - Burmese Immigrants and Descendants	0923-0056	Study Questionnaire - Burmese Immigrants and their Descendants - 16JAN2018
Clinic Visit and Body Measurements - Burmese Immigrants and Descendants	0923-0056	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	749	731	0	18	0	0
Annual Time Burden (Hours)	229	227	0	2	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: Non-Substantive Change to OMB-approved Biomonitoring of Great Lakes Populations Program III (0923-0056) includes changes to expand the recruitment boundary of the study and addition of updated questions to survey.

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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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 01/17/2018

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