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	Modified
Form 15F Buccal Cell Collection for Agricultural Health Study Form and Instruction	New
Supporting State B_AHS_4-21-08.doc Supporting Statement B	2008-06-19
Attach 13D_Buccal Contact Letter with kit Iowa NHL.mar08.doc Supplementary Document	2008-06-19
Attach 13C_Buccal Pre-contact Letter Iowa NHL.mar08.doc Supplementary Document	2008-06-19
Attach 13B_Buccal Cell Contact Letter with Kit Iowa Prostate.doc Supplementary Document	2008-06-19
Attach 13A_Buccal Cell Pre-Contact Letter Iowa Prostate.doc Supplementary Document	2008-06-19
Attach 10C_Intro-Consent Letter Spouse.rtf Supplementary Document	2008-06-19
Attach 10B_Intro Letter North Carolina.doc Supplementary Document	2008-06-19
Attach 10A_ Intro Letter-Consent Iowa.rtf Supplementary Document	2008-06-19
Attach 4C_ Buccal Script Iowa NHL.mar08.doc Supplementary Document	2008-06-19
Attach 4B_Buccal Script Iowa Prostate.doc Supplementary Document	2008-06-19
Cover Memo_Ag Health.doc Supplementary Document	2008-06-19
Attach 18B_Buccal Remail Kit Cover Letter Iowa.doc Supplementary Document	2008-06-19
Attach 18A_Buccal Recontact Script for Damaged or Missing Buccal Sample Iowa.doc Supplementary Document	2008-06-19
Attach 17B_Buccal Remail Consent Form Cover Letter Iowa.rtf Supplementary Document	2008-06-19
Attach 17A_Buccal Cell Missing Consent Form Script Iowa.doc Supplementary Document	2008-06-19
Attach 16B_Buccal Cell Remind Script North Carolina.doc Supplementary Document	2008-06-19
Attach 15G_Buccal FAQs North Carolina.doc Supplementary Document	2008-06-19
Attach 4A_Buccal Script North Carolina.doc Supplementary Document	2008-06-19
Attach 16A_Buccal Cell Remind Script Iowa.doc Supplementary Document	2008-06-19
Attach 15E_Buccal Cell Kit Cover Letter North Carolina.doc Supplementary Document	2008-06-19
Attach 15D_Answers_to_questions Iowa NHL.mar08.DOC Supplementary Document	2008-06-19
Attach 15C_Answers_to_questions Iowa Prostate.DOC Supplementary Document	2008-06-19
Attach 3B_Interview Script and Consent North Carolina.doc Supplementary Document	2008-06-19
Attach 15A_Buccal Kit Cover Letter Iowa.doc Supplementary Document	2008-06-19
Attach 14A_Buccal Consent Form Iowa.docx Supplementary Document	2008-06-19
Attach 12D_IRB NC Knott.pdf Supplementary Document	2008-06-19
Attach 14B_Buccal Cell Consent Form North Carolina.doc Supplementary Document	2008-06-19
Attach 12C_IRB_Iowa 2007 Main.pdf Supplementary Document	2008-06-19
Attach 12B_Westat 2007 IRB_7874-Annual.doc Supplementary Document	2008-06-19
Attach 12A_IRB NCI.doc Supplementary Document	2008-06-19
Attach 11_Collaborator_Confidentiality.doc Supplementary Document	2008-06-19
Attach 9_Contractor Confidentialiy Agreement.dot Supplementary Document	2008-06-19
Attach 8_Privacy Act Memo.doc Supplementary Document	2008-06-19
Attach 7_Confidentiality Certificate.pdf Supplementary Document	2008-06-19
Attach 6_NAP Members_consultants.doc Supplementary Document	2008-06-19
Attach 5_International Ag Consort Consultants.doc Supplementary Document	2008-06-19
Attach 1_Bibliography.doc Supplementary Document	2008-06-19
Attach 3A_Interview Script and Consent Iowa.rtf Supplementary Document	2008-06-19
Attach 15B_Buccal Directions Iowa.doc Supplementary Document	2008-06-19
Supporting State A_ver4_7-30-08.doc Supporting Statement A	2008-07-30

IC Document Collections

IC ID	Document Title	Status
7302	Phase III CATI v. 2 Instrument for Agricultural Health Study Form	Modified
185933	Buccal Cell Collection for Agricultural Health Study Form and Instruction	New

ICR Details

OMB Control No: 0925-0406	ICR Reference No: 200807-0925-003
Status: Historical Active	Previous ICR Reference No: 200506-0925-001
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/24/2008
	Date Received in OIRA: 07/30/2008
Terms of Clearance: Clearance is provided to continue the data collection for Phase III of this project, consistent with the prior terms of clearance. NCI/NIH will sumbit a change package that describes the design and protocol for Phase IV of the study before beginning the data collection for that phase.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2011	36 Months From Approved	10/31/2008
Responses	6,861	0	24,733
Time Burden (Hours)	4,140	0	44,270
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 (2005-2008) 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 for 20,583 enrolled subjects who were not contacted previously due to a slow release of funding to the field centers resulting in an unexpected slow rate of data collection. The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. A small sub-set of the cohort (N=993) will be asked to participate in the buccal cell collection to assess the effect of inherited polymorphisms and the interaction of environment and genomic predisposition.

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Authorizing Statute(s): US Code: 42 USC 285a-2 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:
	73 FR 23473	04/30/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 38227	07/03/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Phase III CATI v. 2 Instrument for Agricultural Health Study	1	Phase III CATI v. 2 for AHS
Buccal Cell Collection for Agricultural Health Study	15F, 2	Swab ,   CATI v. 2

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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	6,861	24,733	0	0	-17,872	0
Annual Time Burden (Hours)	4,140	44,270	0	0	-40,130	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $449,333

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)? Uncollected

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: 07/30/2008

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