Biomonitoring of Great Lakes Populations Program

Forms and Documents

Document Name	Status
MI Contact Information Sheet Form	New
NY - Network Questions - Burmese Form	Modified
NY Interview - Burmese Form	Modified
NY Consent - Burmese Form	Modified
NY Screener - Burmese Form	Modified
NY Questionnaire Form	Modified
NY Consent Form	Modified
NY Responder Script Form	Modified
NY Nonresponder Script Form	Modified
NY Online Screener Form	Modified
NY Mail-in Screener Form	Modified
MN Participation Record Form	Modified
MN Clinic Visit Form Form	Modified
MN Participant Questionnaire Form	Modified
MN Contact Information Form	Modified
MN Consent Form	Modified
MN Refusal Questions Form	Modified
MN Recruitment Script Form	Modified
MI Biomonitoring Questionnaire Form	Modified
MI Informed Consent Form	Modified
MI Scheduling Questionnaire Form	Modified
MI Screener Form	Modified
Att7c_CLIA_Certs_20120531.docx Supplementary Document	2012-10-04
3-GreatLakes_SSB_20120712.doc Supporting Statement B	2012-09-27
Att10c2_metals_results_letter (Burmese Translation).pdf Supplementary Document	2012-10-01
Att10c1_chem_results_letter (Burmese Translation).pdf Supplementary Document	2012-10-01
Att7d_Lab_Contact_Info.docx Supplementary Document	2012-10-01
Att7b_Prgm_QAQC_Proc_20120927_clean.docx Supplementary Document	2012-10-01
Att7a_ChemAnalytes 20120927_clean.docx Supplementary Document	2012-10-01
2-GreatLakes_SSA_ListAtt_20120927_clean.docx Supplementary Document	2012-10-01
Att10c_NY_Results_Commun 20120619.docx Supplementary Document	2012-09-27
Att10b_MN_Results_Commun_20120619.doc Supplementary Document	2012-09-27
Att10a_MI_Results_Commun_20120712.doc Supplementary Document	2012-09-27
Att10_Results_Commun_20120723.docx Supplementary Document	2012-09-27
Att9_Non-research_20120131.docx Supplementary Document	2012-09-27
Att8_Outside_Consults_20120131.docx Supplementary Document	2012-09-27
Att6_NY_ICFlow 20120619.docx Supplementary Document	2012-09-27
Att4_MI_ICFlow 20120619.docx Supplementary Document	2012-09-27
Att5_MN_ICFlow 20120619.docx Supplementary Document	2012-09-27
Att3b_Prgrm_Smmry_Flw_Chrt_20120619.docx Supplementary Document	2012-09-27
Att3a_State_Cprtv_Agrmnt_Prtnrs_20120619.docx Supplementary Document	2012-09-27
Att2_60dyFRN_20111104.pdf Supplementary Document	2012-09-27
Att1_AuthLegsl_20120131.docx Supplementary Document	2012-09-27
2-GreatLakes_SSA_Refs_20120619.docx Supplementary Document	2012-09-27
Att6a_NY_FctSht_LA_20120619.docx Supplementary Document	2012-09-27
Att4a1._MI_Dtrt_AOC_Brochure_20120712.pdf Supplementary Document	2012-09-27
2-GreatLakes_SSA_20120927_clean.docx Supporting Statement A	2012-10-01

IC Document Collections

IC ID	Document Title	Status
204369	MI Contact Information Sheet Form	New
201475	NY - Network Questions - Burmese Form	Modified
201474	NY Interview - Burmese Form	Modified
201473	NY Consent - Burmese Form	Modified
201472	NY Screener - Burmese Form	Modified
201471	NY Questionnaire Form	Modified
201470	NY Consent Form	Modified
201469	NY Responder Script Form	Modified
201468	NY Nonresponder Script Form	Modified
201467	NY Online Screener Form	Modified
201466	NY Mail-in Screener Form	Modified
201465	MN Participation Record Form	Modified
201464	MN Clinic Visit Form Form	Modified
201463	MN Participant Questionnaire Form	Modified
201462	MN Contact Information Form	Modified
201461	MN Consent Form	Modified
201460	MN Refusal Questions Form	Modified
201459	MN Recruitment Script Form	Modified
201458	MI Biomonitoring Questionnaire Form	Modified
201457	MI Informed Consent Form	Modified
201456	MI Scheduling Questionnaire Form	Modified
201455	MI Screener Form	Modified

ICR Details

OMB Control No: 0923-0044	ICR Reference No: 201210-0923-001
Status: Historical Active	Previous ICR Reference No: 201203-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No:
Title: Biomonitoring of Great Lakes Populations Program
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: 10/11/2012
	Date Received in OIRA: 10/03/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2015	36 Months From Approved
Responses	7,664	0	0
Time Burden (Hours)	938	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In 2009, the federal Great Lakes Restoration Initiative (GLRI) was established under the stewardship of the U.S. Environmental Protection Agency (US EPA) to protect, restore, and maintain the Great Lakes ecosystem in partnership with 15 other federal agencies. The task force of federal agencies developed the GLRI Action Plan which covers fiscal years 2010 to 2014. In the first 2 years the U.S. EPA has received over three quarters of a billion dollars through the Obama administration's stimulus funding to make substantial progress towards restoring the Great Lakes to ecological health. Under an interagency agreement with the US EPA, the Agency for Toxic Substances and Disease Registry (ATSDR) established the Great Lakes Biomonitoring Program under its 1980 Comprehensive Environmental Response Compensation and Liability Act (CERCLA) authority. The ATSDR Great Lakes Biomonitoring Program aims to provide a human exposure assessment to Great Lakes contaminants among targeted subpopulations concurrent with the onset of restoration activities. The Agency for Toxic Substances and Disease Registry (ATSDR) announced a funding opportunity called the "Biomonitoring of Great Lakes Populations Program" (CDC-RFA-TS10-1001). From the applicants for this cooperative agreement, ATSDR awarded funds to the Michigan Department of Community Health (MDCH), the Minnesota Department of Health (MDH), and the New York State Department of Health (NYS DOH) to conduct non-research studies of human exposures and to advance jurisdiction-specific public health actions. This public health effort focuses on vulnerable or susceptible subpopulations with the potential for increased risk of exposure to persistent contaminants common to the Great Lakes watersheds and ecosystems.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 6842	11/04/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 12594	03/01/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 22

IC Title	Form No.	Form Name
MI Screener	none	MI screener
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 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

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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	7,664	0	0	7,664	0	0
Annual Time Burden (Hours)	938	0	0	938	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 is a resubmission of a new ICR.

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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: 10/03/2012

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