Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture (NCI)

Forms and Documents

Document Name	Status
Form 7 Attachment 25: Paper/pen, CAWI or CATI Instruments for Private Applicators for AHS Form and Instruction	Modified
Form 14 Attachment 26: Paper/pen, CAWI, and CATI for Proxy for AHS Form and Instruction	New
Form 5 Attachment 19: BEEA Home Visit CAPI, Blood, & Urine x 3 Form and Instruction	Modified
Form 1 Attachment 10: BEEA Schedule Home Visit Scripts for AHS Form and Instruction	Modified
Form 3 Attachment 19: BEEA Home Visit CAPI, Blood, & Urine x 1 for AHS Form and Instruction	Modified
Form 2 Attachment 20 or 21: BEEA CATI Screener for AHS Form and Instruction	Modified
Form 1 Attachment 9: Reminder, Missing or Damaged Scripts for AHS Form and Instruction	Modified
Form 12 Attachment 25: Paper/pen, CAWI or CATI for Spouses for AHS Form and Instruction	Modified
Supporting State B_1107012.docx Supporting Statement B	2013-02-08
Attachment 28_AHS_PrivacyImpactAssessments.pdf Supplementary Document	2013-02-05
Attachment 27_PhaseIV_HFUP_FAQs_CAWI_CATI.docx Supplementary Document	2013-02-05
Attachment 24_Phase_IV_HFUP_Letters.pdf Supplementary Document	2013-02-05
Attachment 23_Phase_IV_HFUP_IRB_Appr_Signature_Pages.pdf Supplementary Document	2013-02-05
Attachment 22_BEEA_Objectives.doc Supplementary Document	2013-02-05
Attachment 18_BEEA_Consent_Forms.pdf Supplementary Document	2013-02-05
Attachment 17_BEEA_Letters.pdf Supplementary Document	2013-02-05
Attachment 16_Phase_IV_Buccal_Cell_Collection_Information.pdf Supplementary Document	2013-02-05
Attachment 15_Phase_IV_Buccal_Consents.docx Supplementary Document	2013-02-05
Attachment 14_Phase_IV_Buccal_Cell_Pre-Contact_Letters.pdf Supplementary Document	2013-02-05
Attachment 13_BEEA_IRB_Approval_Signature_Pages.pdf Supplementary Document	2013-02-05
Attachment 12_Phase_IV_Buccal_Cell_IRB_Approval_Signature_Pages.pdf Supplementary Document	2013-02-05
Attachment 11_BEEA_FAQs.pdf Supplementary Document	2013-02-05
Attachment 08_STARS_AHS_Confidentiality_Agreement.pdf Supplementary Document	2013-02-05
Attachment 07_Contractor_Confidentialiy_Agreement.dot Supplementary Document	2013-02-05
Attachment 06_ NIH_Privacy_Act_Memo.pdf Supplementary Document	2013-02-05
Attachment 05_Certificate_Of_Confidentiality_NCI-02-028A.pdf Supplementary Document	2013-02-05
Attachment 04_NAP_Members_Consultants.doc Supplementary Document	2013-02-05
Attachment 03_AGRICOH_Steering_Committee_Mbr_2011.pdf Supplementary Document	2013-02-05
Attachment 02_Bibliography.docx Supplementary Document	2013-02-05
Attachment 01_List_Of_Attachments_2012.docx Supplementary Document	2013-02-05
Cover Memo_Ag Health_12132012_FINAL.docx Supplementary Document	2013-02-05
Attachment 09-1_Phase_IV_Initial_Script_Consent_Buccal_Cell.docx Supplementary Document	2013-02-06
Supporting State A_1102012.docx Supporting Statement A	2013-02-08

IC Document Collections

IC ID	Document Title	Status
7302	Attachment 25: Paper/pen, CAWI or CATI Instruments for Private Applicators for AHS Form and Instruction	Modified
205828	Attachment 26: Paper/pen, CAWI, and CATI for Proxy for AHS Form and Instruction	New
192872	Attachment 19: BEEA Home Visit CAPI, Blood, & Urine x 3 Form and Instruction	Modified
192871	Attachment 10: BEEA Schedule Home Visit Scripts for AHS Form and Instruction	Modified
192870	Attachment 19: BEEA Home Visit CAPI, Blood, & Urine x 1 for AHS Form and Instruction	Modified
192869	Attachment 20 or 21: BEEA CATI Screener for AHS Form and Instruction	Modified
192868	Attachment 9: Reminder, Missing or Damaged Scripts for AHS Form and Instruction	Modified
185933	Attachment 25: Paper/pen, CAWI or CATI for Spouses for AHS Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0406	ICR Reference No: 201302-0925-004
Status: Historical Active	Previous ICR Reference No: 201005-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No: 18763
Title: Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture (NCI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/19/2013
	Date Received in OIRA: 02/15/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2016	36 Months From Approved	05/31/2013
Responses	25,551	0	1,780
Time Burden (Hours)	10,465	0	550
Cost Burden (Dollars)	0	0	0

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Abstract: The Agricultural Health Study (AHS) program staff is requesting approval of this revision to begin information collection in February, 2013. AHS is a cohort study of 89,568 licensed pesticide applicators (both private and commercial applicators) and the spouses of the private applicators in Iowa and North Carolina that is to be followed for 20 years or more. The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers, including lymphatic and hematopoietic system, connective tissue, skin, brain, prostate, stomach and lips. This suggests a common set of exposures which may explain the high rates in farmers and rising rates in the general population. NCI is primarily interested in cancer outcomes and NIEHS is interested in other disease outcomes. For this phase of the data collection, NIEHS will be taking the lead role in collecting information for this phase of the study. This revision is to initiate and complete the phase IV follow-up interview (2013-2015) as well as to continue and complete the ongoing Study of Biomarkers of Exposures Effects in Agriculture (BEEA) and buccal cell collections. The primary objective of the AHS study remains to be determination of the health effects resulting from occupational and environmental exposures in agriculture. Similar questionnaires are being used as in previous AHS interviews to obtain information on non-cancer outcomes. New for phase IV, questionnaire data will be collected by using one of three methods of the cohort member's choosing: self-administered computer assisted web survey; self-administered paper-and-pen; or an interviewer administered computer assisted telephone interview. Additionally, because loss to follow up of diseased individuals is a critical issue, we have added proxy interviews for those deceased or too ill to complete themselves will be completed by using one of the three methods.

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Authorizing Statute(s): US Code: 42 USC 285l Name of Law: Public Health Service Act
  

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 72871	12/06/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 8151	02/05/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Attachment 25: Paper/pen, CAWI or CATI Instruments for Private Applicators for AHS	7, 6, 9, 8	CATI ,   Paper/pen, CAWI or CATI ,   Paper and Pencil ,   CAWI-CATI
Attachment 25: Paper/pen, CAWI or CATI for Spouses for AHS	12, 10, 11, 13	CAWI-CATI ,   CAWI ,   CATI ,   Paper/Pen
Attachment 9: Reminder, Missing or Damaged Scripts for AHS	1, 3, 2, 4	Reminder Call Script for Iowa Buccal Cell Respondents ,   Missing Buccal Cell Consent Forms Call Script ,   Reminder Call Script for North Carolina Buccal Cell Respondents ,   Damaged or Missing Buccal Cell Sample Call Script
Attachment 20 or 21: BEEA CATI Screener for AHS	2, 3	CATI Eligibility Script_Randomly Selected Respondents ,   CATI Eligibility Script_Recently Exposed Respondents
Attachment 19: BEEA Home Visit CAPI, Blood, & Urine x 1 for AHS	3	BEEA Home Visit CAPI, Blood, & Urine x 1
Attachment 10: BEEA Schedule Home Visit Scripts for AHS	1, 2, 3	BEEA Previsit Reminder Script ,   BEEA Iowa Schedule PostApp Visit Script ,   BEEA North Carolina Schedule PostApp Visit Script
Attachment 19: BEEA Home Visit CAPI, Blood, & Urine x 3	5	BEEA Home Visit CAPI, Blood, & Urine x 3
Attachment 26: Paper/pen, CAWI, and CATI for Proxy for AHS	15, 16, 17, 14	CAWI Proxy ,   CATI Proxy ,   CAWI-CATI Proxy ,   Paper-Pen Proxy

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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	25,551	1,780	0	23,771	0	0
Annual Time Burden (Hours)	10,465	550	0	9,915	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: This revision is a program change due to agency discretion and represents an increase in burden from the previous submission approved in 2010. The increase in burden for this revision is accounted for by the initiation of the phase IV follow up scheduled from February 2013 through December 2015. As well, this is a continuation to complete the information collection related to the Study of Biomarkers of Exposures Effects in Agriculture (BEEA) and buccal cells. Similar questionnaires are being used to ones that have been employed in previous AHS interviews to obtain information on non-cancer outcomes. New for phase IV, questionnaire data will be collected by using one of three methods of the cohort member's choosing: self-administered computer assisted web survey; self-administered paper-and-pen; or an interviewer administered computer assisted telephone interview. Additionally, because loss to follow up of diseased individuals is a critical issue, we have added proxy interviews for those deceased or too ill to complete themselves will be completed by using one of the three methods. The Agricultural Health Study has been conducted through contractors since its inception. An additional change is that the National Institutes of Environmental Health (NIEHS) will be taking the lead role in collecting updated health information for this phase of the study. For this reason, the OMB clearance number is being transferred from that National Cancer Institute to NIEHS.

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Annual Cost to Federal Government: $1,246,372

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: 02/15/2013

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