Biomonitoring of Great Lakes Populations Program

Forms and Documents

Document Name	Status
Form 0923-0044 Michigan Biomonitoring of Great Lakes Populations Form and Instruction	New
Form 0923-0044 Mi Informed Consent for Repeat Appointments Form and Instruction	New
Form 0923-0044 Michigan Department of Community Health Telephone Questions for Scheduling (repeated appointments) Form and Instruction	New
MI Contact Information Sheet Form	Unchanged
NY - Network Questions - Burmese Form	Unchanged
NY Interview - Burmese Form	Unchanged
NY Consent - Burmese Form	Unchanged
NY Screener - Burmese Form	Unchanged
NY Questionnaire Form	Unchanged
NY Consent Form	Unchanged
NY Responder Script Form	Unchanged
NY Nonresponder Script Form	Unchanged
NY Online Screener Form	Unchanged
NY Mail-in Screener Form	Unchanged
MN Participation Record Form	Unchanged
MN Clinic Visit Form Form	Unchanged
MN Participant Questionnaire Form	Unchanged
MN Contact Information Form	Unchanged
MN Consent Form	Unchanged
MN Refusal Questions Form	Unchanged
MN Recruitment Script Form	Unchanged
MI Biomonitoring Questionnaire Form	Modified
MI Informed Consent Form	Unchanged
MI Scheduling Questionnaire Form	Unchanged
MI Screener Form	Unchanged
0923-0044 Change Request Justification 20140724.docx Justification for No Material/Nonsubstantive Change	2014-07-30
GreatLakes_SSB_20130911_clean[1].doc Supporting Statement B	2013-09-20
0923-0044 Change Request Justification 20130912(1).docx Justification for No Material/Nonsubstantive Change	2013-09-20
Att6a_NY_FctSht_LA_20120619.docx Supplementary Document	2012-09-27
Att4a1._MI_Dtrt_AOC_Brochure_20120712.pdf Supplementary Document	2012-09-27
GreatLakes_modified SSA_20140724.docx Supporting Statement A	2014-07-30

IC Document Collections

IC ID	Document Title	Status
212542	Michigan Biomonitoring of Great Lakes Populations Form and Instruction	New
212541	Mi Informed Consent for Repeat Appointments Form and Instruction	New
212540	Michigan Department of Community Health Telephone Questions for Scheduling (repeated appointments) Form and Instruction	New
204369	MI Contact Information Sheet Form	Unchanged
201475	NY - Network Questions - Burmese Form	Unchanged
201474	NY Interview - Burmese Form	Unchanged
201473	NY Consent - Burmese Form	Unchanged
201472	NY Screener - Burmese Form	Unchanged
201471	NY Questionnaire Form	Unchanged
201470	NY Consent Form	Unchanged
201469	NY Responder Script Form	Unchanged
201468	NY Nonresponder Script Form	Unchanged
201467	NY Online Screener Form	Unchanged
201466	NY Mail-in Screener Form	Unchanged
201465	MN Participation Record Form	Unchanged
201464	MN Clinic Visit Form Form	Unchanged
201463	MN Participant Questionnaire Form	Unchanged
201462	MN Contact Information Form	Unchanged
201461	MN Consent Form	Unchanged
201460	MN Refusal Questions Form	Unchanged
201459	MN Recruitment Script Form	Unchanged
201458	MI Biomonitoring Questionnaire Form	Modified
201457	MI Informed Consent Form	Unchanged
201456	MI Scheduling Questionnaire Form	Unchanged
201455	MI Screener Form	Unchanged

ICR Details

OMB Control No: 0923-0044	ICR Reference No: 201407-0923-001
Status: Historical Active	Previous ICR Reference No: 201309-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 20576
Title: Biomonitoring of Great Lakes Populations Program
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: 08/28/2014
	Date Received in OIRA: 08/19/2014
Terms of Clearance: Prior terms of clearance apply.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2015	10/31/2015	10/31/2015
Responses	7,981	0	7,906
Time Burden (Hours)	1,025	0	1,000
Cost Burden (Dollars)	0	0	0

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Abstract: We are requesting approval to re-contact, re-screen, and re-collect blood and urine specimens and questionnaire responses for 25 previously enrolled study participants (shoreline anglers) attributed to the Detroit River area. During the analysis of serum samples, the National Center for Environmental Health Division of Laboratory Sciences informed our program that external contamination of 25 samples collected from these participants occurred due to equipment failure. The reason for repeating the questionnaire and urine sample is to chronologically align information collected on exposure parameters per responses to the questionnaire and the body burden measurements of all analytes.

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Authorizing Statute(s): PL: Pub.L. 111 - 88 1 Name of Law: Dept of Interior, Environment, and Related Agencies Act of 2010
   US Code: 42 USC 9604 Name of Law: CERCLA
   US Code: 42 USC 9626 Name of Law: Superfund Act of 1986
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 25

IC Title	Form No.	Form Name
MI Screener	none	MI screener
MI Scheduling Questionnaire	none	MI Scheduling Questionnaire
MI Informed Consent	none	MI Consent
MI Contact Information Sheet	none	MI Contact Info Sheet
MI Biomonitoring Questionnaire	none	MI Biomonitoring Questionnaire
MN Recruitment Script	none	MN Recruitment Script
MN Refusal Questions	none	MN Refusal Questions
MN Consent	none	MN Consent
MN Contact Information	none	MN Contact Information
MN Participant Questionnaire	none	MN Participant Questionnaire
MN Clinic Visit Form	none	MN Clinic Visit
MN Participation Record	none	MN Participation Record
NY Mail-in Screener	none	NY Mail-in Screener
NY Online Screener	none	NY Online Screener
NY Nonresponder Script	none	NY Nonresponder Script
NY Responder Script	none	NY Responder Script
NY Consent	none	NY Consent
NY Questionnaire	none	NY Questionnaire
NY Screener - Burmese	none, none	NY Screener - Burmese ,   Screener - Burmese translation
NY Consent - Burmese	none, none	NY Consent - Burmese ,   NY Consent - Burmese translation
NY Interview - Burmese	none, none	NY Interview - Burmese ,   Interview - Burmese translation
NY - Network Questions - Burmese	none, none	NY Network Questions - Burmese ,   Network Questions - Burmese translation
Mi Informed Consent for Repeat Appointments	0923-0044	Att2_MI_Consent 20140724
Michigan Biomonitoring of Great Lakes Populations	0923-0044	Att3_MI_BiomQs_20120619
Michigan Department of Community Health Telephone Questions for Scheduling (repeated appointments)	0923-0044	Att1_MI_PhoneQs 20140724

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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	7,981	7,906	0	75	0	0
Annual Time Burden (Hours)	1,025	1,000	0	25	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We are requesting approval to re-contact, re-screen, and re-collect blood and urine specimens, and questionnaire responses for 25 previously enrolled study participants (shoreline anglers) attributed to the Detroit River area. During the analysis of serum samples, the National Center for Environmental Health Division of Laboratory Sciences informed our program that external contamination of 25 samples collected from these participants occurred due to equipment failure. The reason for repeating the questionnaire and urine sample is to chronologically align information collected on exposure parameters per responses to the questionnaire and the body burden measurements of all analytes. We are requesting an increase of 26 burden hours for Year 2 only.

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Annual Cost to Federal Government: $3,800,000

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? Yes

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: 08/19/2014

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