Anniston Community Health Survey: Follow up and Dioxin Analyses (ACHS-II)

Forms and Documents

Document Name	Status
Att9_ACHS_non-participants_091313.docx Supplementary Document	2013-10-30
Att8_CommunicationsPlan_Forms_091313.docx Supplementary Document	2013-10-30
ACHS_II_ListAtt_091313.docx Supplementary Document	2013-10-30
SuppStmt_B_ACHS_II_091313.docx Supporting Statement B	2013-10-30
Att7_SampleSize PowerCalc.docx Supplementary Document	2013-04-29
Att6.4_PCBsDioxChemRept.docx Supplementary Document	2013-04-29
Att6.3_ClinTestRept.docx Supplementary Document	2013-04-29
Att6.2_AdvReptScript.docx Supplementary Document	2013-04-29
Att6.1_BdyBldPressMsRept.docx Supplementary Document	2013-04-29
Att5_IRB Appr.pdf Supplementary Document	2013-04-29
Att4.2_ReportableClinicalTests.docx Supplementary Document	2013-04-29
Att4.3_ReportablePCBsChemicals.docx Supplementary Document	2013-04-29
Att4.1_ProjectYearLabAnalytes.docx Supplementary Document	2013-04-29
Att2_FRN_60d_ACHS II.pdf Supplementary Document	2013-04-29
Att1_AuthLegsl_ACHS II.docx Supplementary Document	2013-04-29
Att3.6_ReminderTelScript.docx Supplementary Document	2013-04-29
Att3.2_StudyFactSht.docx Supplementary Document	2013-04-29
Att3.8_ConsentForm.docx Supplementary Document	2013-04-29
Att3.2a_ListofChemicals.docx Supplementary Document	2013-04-29
SuppStmt_A_ACHS_II_20131029.docx Supporting Statement A	2013-10-30

IC Document Collections

IC ID	Document Title	Status
206836	Questionnaire Materials Other-WORD	New
206835	Blood Draw Form Other-WORD	New
206834	Medication Form Other-WORD	New
206833	Update Contact information Form Other-WORD	New
206832	Survey for Refusals Other-WORD	New
206831	Recruitement Telephone Script Other-WORD	New

ICR Details

OMB Control No: 0923-0049	ICR Reference No: 201305-0923-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No: 19379
Title: Anniston Community Health Survey: Follow up and Dioxin Analyses (ACHS-II)
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 with change	Conclusion Date: 11/01/2013
	Date Received in OIRA: 05/08/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	24 Months From Approved
Responses	1,493	0	0
Time Burden (Hours)	226	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Agency for Toxic Substances and Disease Registry (ATSDR) funded the 2005-2007 Anniston Community Health Survey (ACHS) and found serum PCB levels among Anniston participants three-to-seven-fold higher than among the general U.S. population. PCBs were also positively associated with hypertension, elevated blood pressure, and diabetes in select cohort subgroups. Researchers from ATSDR and National Institutes of Health (NIH) plan to conduct a follow-up to the original ACHS, called the ACHS-II. For this follow-up study, a sample of 500 participants will be enrolled from the original ACHS cohort. The major goal of the ACHS-II is to obtain repeated measures of PCBs and health outcomes, five to seven years after baseline, identical to the original ACHS and to complement those with the measurements of dioxin-like coplanar PCB congeners, dibenzo-p-dioxins and furans, polybrominated diphenyl ethers and heavy metals not measured before in this population.

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Authorizing Statute(s): US Code: 42 USC 103 Name of Law: Comprehensive Environmental Response, Compensation, and Liability
  

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:
	77 FR 58394	09/20/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 23767	04/22/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Recruitement Telephone Script
Survey for Refusals
Update Contact information Form
Medication Form
Blood Draw Form
Questionnaire Materials

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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	1,493	0	0	1,493	0	0
Annual Time Burden (Hours)	226	0	0	226	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 NEW collection request for a new OMB Control Number.

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Annual Cost to Federal Government: $782,000

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: 05/08/2013

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