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 1 Phase III CATI v. 2 Instrument for Agricultural Health Study Form and Instruction	Modified
Form 12 BEEA Home Visit CAPI for Agricultural Health Study Form and Instruction	New
Form 10 BEEA Schedule Home Visit Script for Agricultural Health Study Form and Instruction	New
Form 9 BEEA Home Visit CAPI for Agricultural Health Study Form and Instruction	New
Form 7 BEEA CATI Eligibility Screener for Agricultural Health Study Form and Instruction	New
Form 5 Phase III Buccal Cell Reminder, Missing or Damaged Scripts for Agricultural Health Study Form and Instruction	New
Form 2 Phase III Telephone Interview and Buccal Cell Scripts for Agricultural Health Study Form and Instruction	Modified
Passback_Attachment_Biomarker Study Protocol 2010-02-25.doc Supplementary Document	2010-05-21
Supporting State B_4-2010_v 3_highlight.docx Supporting Statement B	2010-04-28
Attach 26_BEEA IRB Approvals.pdf Supplementary Document	2010-05-20
Attach 22_BEEA consent forms.pdf Supplementary Document	2010-04-29
Attach 14_Phase III Buccal Consent Forms.pdf Supplementary Document	2010-04-29
Attach 12 - Phase III IRB Approvals.pdf Supplementary Document	2010-04-28
Attach 11_STARS_AHS Confidentiality Agreement.pdf Supplementary Document	2010-04-28
Attach 9_Contractor Confidentialiy Agreement.dot Supplementary Document	2010-04-28
Attach 8_ NIH Privacy Act Memo.pdf Supplementary Document	2010-05-20
Attach 7_Certificate of Confidentiality_NCI-02-028A.pdf Supplementary Document	2010-04-28
Attach 6_NAP Members_consultants (2).docx Supplementary Document	2010-04-28
Attach 5_International Ag Consort Consultants.doc Supplementary Document	2010-04-28
Attach 1_Bibliography.doc Supplementary Document	2010-04-28
Pre-Submission Cover Memo_Ag Health.docx Supplementary Document	2010-04-28
Attach 27_Letter for CBC lymphocyte assay results_NCI_generic.doc Supplementary Document	2010-04-29
Attach 25A&B_BEEA Advance Letters for First Post-Diazinon Application Visit.pdf Supplementary Document	2010-04-29
Attach 24_BEEA pre-visit reminder letters and script.pdf Supplementary Document	2010-04-29
Attach 23_BEEA consent mailing letters and pre-visit prep.pdf Supplementary Document	2010-04-29
Attach 21_BEEA introductory letters and information sheets.pdf Supplementary Document	2010-04-29
Attach 17B_Buccal Remail Consent Form Cover Letter Iowa.rtf Supplementary Document	2010-04-29
Attach 18B_Buccal Remail Kit Cover Letter Iowa.doc Supplementary Document	2010-04-29
Attach 13_Phase III buccal contact scripts and letters.pdf Supplementary Document	2010-04-29
Attach 15_Phase III buccal kit cover letters and instructions.pdf Supplementary Document	2010-04-29
Attach 10_Phase III Introductory letters.pdf Supplementary Document	2010-04-29
Supporting State A_4-2010_v.3_highlight.docx Supporting Statement A	2010-04-29

IC Document Collections

IC ID	Document Title	Status
7302	Phase III CATI v. 2 Instrument for Agricultural Health Study Form and Instruction	Modified
192872	BEEA Home Visit CAPI for Agricultural Health Study Form and Instruction	New
192871	BEEA Schedule Home Visit Script for Agricultural Health Study Form and Instruction	New
192870	BEEA Home Visit CAPI for Agricultural Health Study Form and Instruction	New
192869	BEEA CATI Eligibility Screener for Agricultural Health Study Form and Instruction	New
192868	Phase III Buccal Cell Reminder, Missing or Damaged Scripts for Agricultural Health Study Form and Instruction	New
185933	Phase III Telephone Interview and Buccal Cell Scripts for Agricultural Health Study Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0406	ICR Reference No: 201005-0925-004
Status: Historical Active	Previous ICR Reference No: 200807-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
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 with change	Conclusion Date: 05/21/2010
	Date Received in OIRA: 05/12/2010
Terms of Clearance: Approved consistent with revised documents uploaded on 5/20/2010. In the event of subsequent phases, NCI/NIH will sumbit a change package that describes the design and protocol for the next phase of the study before beginning the data collection for that phase.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved	10/31/2011
Responses	1,780	0	6,861
Time Burden (Hours)	550	0	4,140
Cost Burden (Dollars)	0	0	0

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Abstract: The Agricultural Health Study (AHS) is a cohort study of 89,568 licensed pesticide applicators and their spouses in Iowa and North Carolina to be followed for 20 years or more. The focus of the phase III follow-up period (2005-2013) is to update exposure information and health histories by means of a computer assisted telephone interview, and to follow the cohort to determine disease incidence and mortality. This request is to complete the follow-up for phase III including interviews and buccal cell collection, and to incorporate a new biomarker component of the AHS, the Study of Biomarkers of Exposures and Effects in Agriculture (BEEA). In BEEA, we will conduct computer-assisted telephone (CATI) and in-person (CAPI) interviews, and will collect blood and urine samples from a subset of AHS participants. The stimulus for the AHS comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. The new biomarker component of the AHS will allow us to evaluate risk of monoclonal gammopathy of undetermined significance (MGUS), a pre-clinical marker for multiple myeloma, and to assess the biological plausibility and mechanism-of-action of associations between pesticides and cancers observed in earlier AHS studies.

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Authorizing Statute(s): US Code: 42 USC 285a 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:
	75 FR 9902	03/04/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 9902	03/04/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
BEEA Home Visit CAPI for Agricultural Health Study	9	Attach 19 BEEA CAPI
BEEA Schedule Home Visit Script for Agricultural Health Study	10	Attach 25C and 25D Scripts for Scheduling Post-Application Visit
Phase III CATI v. 2 Instrument for Agricultural Health Study	1	Phase III CATI
Phase III Telephone Interview and Buccal Cell Scripts for Agricultural Health Study	2, 3	Phase III Interview Script and Consent ,   Phase III Buccal Script and Consent
Phase III Buccal Cell Reminder, Missing or Damaged Scripts for Agricultural Health Study	5, 6, 4	Attach 17A Buccal Missing Script ,   Attach 18A Buccal Script for Missing or Damaged Samples ,   Attach 16 Buccal Reminder Script
BEEA CATI Eligibility Screener for Agricultural Health Study	7, 8	Attach 20A BEEA CATI for RANDOM Select Group ,   Attach 20B BEEA CATI Screen for RANDOM Group
BEEA Home Visit CAPI for Agricultural Health Study	12	Attach 19 BEEA CAPI

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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	1,780	6,861	0	-5,081	0	0
Annual Time Burden (Hours)	550	4,140	0	-3,590	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 a decrease in burden from the previous submission approved in October, 2008. The substantial decrease in burden for this revision is accounted for by fewer Phase III participants being interviewed. The phase III collection was scheduled from November 2005 through November 2011 and has been impacted by restricted scheduling due to the planting season and budgetary issues, resulting in the need for additional time to complete the questionnaire administration. This request will allow the Agricultural Health Study to complete phase III of its research and to add an important additional component, the study of Biomarkers of Exposures and Effects in Agriculture (BEEA) which will help NCI investigators to identify occupational exposures in the agricultural environment that increase the risk of monoclonal gammopathy of undetermined significance (MGUS).

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Annual Cost to Federal Government: $537,041

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 05/12/2010

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