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

Forms and Documents

Document Name	Status
Form 7 Attachment 25: Paper/pen, CAWI or CATI Instruments for Private Applicators for AHS Form and Instruction	Removed
Form 12 BEEA Pre-Home Visit Script Form and Instruction	New
Form 26 Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen Form and Instruction	New
Form 23 Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen Form and Instruction	New
Form 23 Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen Form and Instruction	New
Form 22 BEEA 'Life in a Day" Smartphone Application Form and Instruction	New
Form 21 BEEA "Life in a Day" Smartphone App Consent and Setup Form and Instruction	New
Form 20 Control Home Visit CAPI, Blood,Buccal cell, Urine & Dust Form and Instruction	New
Form 12 BEEA Pre-Home Visit Script Form and Instruction	New
Form 11 BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
Form 19 IA/NC Pre-Visit Show Card Form and Instruction	New
Form 18 IA/NC Control Home Visit Consent Form and Instruction	New
Form 17 Control CATI Eligibility Script Form and Instruction	New
Form 16 Pre-Farm Visit Script Form and Instruction	New
Form 15 IA/NC Consent for AMG Farm Visit Form and Instruction	New
Form 13 BEEA AMG Home Visit CAPI, Blood, Urine, Buccal cell & Dust Form and Instruction	New
Form 12 BEEA Pre-Home Visit Script Form and Instruction	New
Form 11 BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
Form 10 BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card Form and Instruction	New
Form 14 BEEA REG IA/NC Post-Exposure Scheduling Script Form and Instruction	New
Form 13 BEEA REG Home Visit CAPI, Blood, Buccal cell, Urine & Dust Form and Instruction	New
Form 11 BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
Form 10 BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card Form and Instruction	New
Form 13 BEEA RSG Home Visit CAPI, Blood, Buccal cell, Urine & Dust Form and Instruction	New
Form 12 BEEA Pre-Homme Visit Script Form and Instruction	New
Form 11 BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
Form 10 BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card Form and Instruction	New
Form 8 BEEA IA/NC Consent for RSG Home Visit or REG Home Visit or AMG Home Visit Form and Instruction	New
Form 4 BEEA CATI Screening Script for RSG Eligibility, REG Eligibility or AMG Eligibility Form and Instruction	New
Form 3 Phase IV Buccal Kit Follow up Scripts Form and Instruction	New
Form 2 Phase IV Buccal IA/NC Written Consent for Buccal Kit Form and Instruction	New
Form 1 Phase IV Buccal IA/NC Scripts for Verbal Consent for Buccal Kit Form and Instruction	New
Form 1 Attachments: 17.5 -17.6; 18; 22.2 consent forms, show cards, and dust questionnaire Form and Instruction	Removed
Form 15 Attachment 26: Paper/pen, CAWI, and CATI for Proxy for AHS Form and Instruction	Removed
Form 5 Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 3 Form and Instruction	Removed
Form 2 Attachment 10: BEEA Schedule Home Visit Scripts for AHS Form and Instruction	Removed
Form 3 Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 1 for AHS Form and Instruction	Removed
Form 3 Attachment 20 or 21: BEEA CATI Screener for AHS Form and Instruction	Removed
Form 1 Attachment 9: Reminder, Missing or Damaged Scripts for AHS Form and Instruction	Removed
Form 12 Attachment 25: Paper/pen, CAWI or CATI for Spouses for AHS Form and Instruction	Removed
30 day NIEHS AHS2016-09296.pdf Supplementary Document	2016-04-25
0925–0406 30-Day Notice PUblished.pdf Supplementary Document	2016-04-15
AHS OMB Supporting Statement_A_04-2016.doc Supporting Statement A	2016-04-11
Attachment 28_AHS_PrivacyImpactAssessments.pdf Supplementary Document	2016-04-06
Attachment 27_PhaseIV_HFUP_FAQs_CAWI_CATI.pdf Supplementary Document	2016-04-06
Attachment 24_Phase_IV_HFUP_Letters.pdf Supplementary Document	2016-04-06
Attachment 23 Phase IV_HFUP_IRB Appr Signature Pages.pdf Supplementary Document	2016-04-06
Attachment 22-1_BEEA_Objectives and Revisions.pdf Supplementary Document	2016-04-06
Attachment 17-1 thru 17-19_BEEA_Supplementary_Letters_Directions_Results.pdf Supplementary Document	2016-04-06
Attachment 16_Phase_IV_Buccal_Cell_Collection_Information.pdf Supplementary Document	2016-04-06
Attachment 14_Phase_IV_Buccal_Cell_Pre-Contact_Letters.pdf Supplementary Document	2016-04-06
Attachment 13_BEEA IRB Approvals.pdf Supplementary Document	2016-04-06
Attachment 12_AHS Phase IV IRB.pdf Supplementary Document	2016-04-06
Attachment 11_BEEA Brochures.pdf Supplementary Document	2016-04-06
Attachment 08_STARS_AHS_Confidentiality_Agreement.pdf Supplementary Document	2016-04-06
Attachment 07_Contractor_Confidentialiy_Agreement.pdf Supplementary Document	2016-04-06
Attachment 06_ NIH_Privacy_Act_SORN_Memo.pdf Supplementary Document	2016-04-06
Attachment 05_Certificate_Of_Confidentiality_NCI-02-028A.pdf Supplementary Document	2016-04-06
Attachment 04_NAP Members2015.pdf Supplementary Document	2016-04-06
Attachment 03_AGRICOH_Steering_Committee_Mbr_2011.pdf Supplementary Document	2016-04-06
Attachment 02_Bibliography.pdf Supplementary Document	2016-04-06
Attachment 01_List Of Attachments_2016.pdf Supplementary Document	2016-04-06
AHS OMB Supporting Statement_B_03-2016.doc Supporting Statement B	2016-04-06

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	Removed
220930	BEEA Pre-Home Visit Script Form and Instruction	New
220929	Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen Form and Instruction	New
220928	Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen Form and Instruction	New
220927	Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen Form and Instruction	New
220925	BEEA 'Life in a Day" Smartphone Application Form and Instruction	New
220924	BEEA "Life in a Day" Smartphone App Consent and Setup Form and Instruction	New
220923	Control Home Visit CAPI, Blood,Buccal cell, Urine & Dust Form and Instruction	New
220922	BEEA Pre-Home Visit Script Form and Instruction	New
220921	BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
220920	IA/NC Pre-Visit Show Card Form and Instruction	New
220919	IA/NC Control Home Visit Consent Form and Instruction	New
220918	Control CATI Eligibility Script Form and Instruction	New
220916	Pre-Farm Visit Script Form and Instruction	New
220915	IA/NC Consent for AMG Farm Visit Form and Instruction	New
220914	BEEA AMG Home Visit CAPI, Blood, Urine, Buccal cell & Dust Form and Instruction	New
220913	BEEA Pre-Home Visit Script Form and Instruction	New
220912	BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
220911	BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card Form and Instruction	New
220909	BEEA REG IA/NC Post-Exposure Scheduling Script Form and Instruction	New
220908	BEEA REG Home Visit CAPI, Blood, Buccal cell, Urine & Dust Form and Instruction	New
220906	BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
220904	BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card Form and Instruction	New
220903	BEEA RSG Home Visit CAPI, Blood, Buccal cell, Urine & Dust Form and Instruction	New
220901	BEEA Pre-Homme Visit Script Form and Instruction	New
220898	BEEA Paper/Pen Duct Questionnaire Form and Instruction	New
220896	BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card Form and Instruction	New
220895	BEEA IA/NC Consent for RSG Home Visit or REG Home Visit or AMG Home Visit Form and Instruction	New
220894	BEEA CATI Screening Script for RSG Eligibility, REG Eligibility or AMG Eligibility Form and Instruction	New
220893	Phase IV Buccal Kit Follow up Scripts Form and Instruction	New
220891	Phase IV Buccal IA/NC Written Consent for Buccal Kit Form and Instruction	New
220890	Phase IV Buccal IA/NC Scripts for Verbal Consent for Buccal Kit Form and Instruction	New
208235	Attachments: 17.5 -17.6; 18; 22.2 consent forms, show cards, and dust questionnaire Form and Instruction	Removed
205828	Attachment 26: Paper/pen, CAWI, and CATI for Proxy for AHS Form and Instruction	Removed
192872	Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 3 Form and Instruction	Removed
192871	Attachment 10: BEEA Schedule Home Visit Scripts for AHS Form and Instruction	Removed
192870	Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 1 for AHS Form and Instruction	Removed
192869	Attachment 20 or 21: BEEA CATI Screener for AHS Form and Instruction	Removed
192868	Attachment 9: Reminder, Missing or Damaged Scripts for AHS Form and Instruction	Removed
185933	Attachment 25: Paper/pen, CAWI or CATI for Spouses for AHS Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0406	ICR Reference No: 201604-0925-001
Status: Historical Active	Previous ICR Reference No: 201308-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 20219
Title: Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture
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: 06/09/2016
	Date Received in OIRA: 04/26/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	09/30/2016
Responses	29,641	0	25,711
Time Burden (Hours)	11,438	0	10,678
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 the Study of Biomarkers of Exposures and Effects in Agriculture (BEEA) to extend the ongoing field period, and add a control respondent group, and a smartphone application (app) component. Respondents in the new BEEA control group will be selected from lists of registered voters in Iowa and North Carolina and screened to ensure they have not worked in farming. They will receive one BEEA home visit that will be modeled on the protocol received by the other participants, but with a modified computer assisted in-person interview (CAPI) that asks for other occupational exposures instead of farming exposures. Respondents for the pilot smartphone app will be selected from all BEEA participants except controls. They will be asked to download and use a smartphone app to document their daily farm routine on 30 days over a 6-month period. The smartphone app component uses procedures similar to those employed by other NCI studies.

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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:
	80 FR 74115	11/27/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 23737	04/22/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 31

IC Title	Form No.	Form Name
BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card	10	Attachment 17-7 and 17-8 BEEA IA/NC Pre-Visit Prep Showcards
BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card	10	Attachment 17-7 and 17-8 BEEA IA/NC Pre-Visit Prep Showcards
BEEA RSG/REG/AMG IA/NC Pre-Visit Show Card	10	Attachment 17-7 and 17-8 BEEA IA/NC Pre-Visit Prep Showcards
IA/NC Consent for AMG Farm Visit	15	Attachment 18-7 and 18-8 BEEA IA/NC Informed Consent Air Monitoring Farm Visit
Pre-Farm Visit Script	16	Attachment 10-4 BEEA Pre-Visit Reminder Call Script Air Monitoring
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
Attachments: 17.5 -17.6; 18; 22.2 consent forms, show cards, and dust questionnaire	1, 2, 3	BEEA Show Cards ,   BEEA Consent Form - Dust ,   BEEA Dust Specimen Questionnaire
Attachment 25: Paper/pen, CAWI or CATI Instruments for Private Applicators for AHS	7, 9, 6, 8	CATI ,   Paper and Pencil ,   Paper/pen, CAWI or CATI ,   CAWI-CATI
Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen	28, 26, 27	Attachment 26-1 AHS Phase IV Health Follow-up CAWI Proxy Survey ,   Attachment 26-2 AHS Phase IV Health Follow-up CATI Proxy Survey Script ,   Attachment 26-3 AHS Phase IV Health Follow-up Paper & Pen Proxy Survey
Attachment 25: Paper/pen, CAWI or CATI for Spouses for AHS	12, 10, 11, 13	CAWI-CATI ,   CAWI ,   CATI ,   Paper/Pen
Attachment 20 or 21: BEEA CATI Screener for AHS	3, 1	CATI Eligibility Script_Recently Exposed Respondents ,   Attachment 20: BEEA CATI Script
BEEA RSG Home Visit CAPI, Blood, Buccal cell, Urine & Dust	13	Attachment 19-1 BEEA CAPI Questionnaire
Control CATI Eligibility Script	17	Attachment 20-4 BEEA CATI Script Control Group
BEEA Paper/Pen Duct Questionnaire	11	Attachment 21 Dust Questionnaire
BEEA "Life in a Day" Smartphone App Consent and Setup	21	Attachment 22-3 and 22-4 BEEA IA NC Smartphone App Consent
BEEA REG IA/NC Post-Exposure Scheduling Script	14	Attachment 10-2 and 10-3 IA-NC BEEA REG Post Exposure Scheduling Script
BEEA AMG Home Visit CAPI, Blood, Urine, Buccal cell & Dust	13	Attachment 19-1 BEEA CAPI Questionnaire
BEEA Pre-Homme Visit Script	12	Attachment 10-1 BEEA Previsit Reminder Call Script
BEEA Pre-Home Visit Script	12	Attachment 10-1 BEEA Previsit Reminder Call Script
BEEA Pre-Home Visit Script	12	Attachment 10-1 BEEA Previsit Reminder Call Script
Control Home Visit CAPI, Blood,Buccal cell, Urine & Dust	20	Attachment 19-2 BEEA CAPI Questionnaire Controls
BEEA Pre-Home Visit Script	12	Attachment 10-1 BEEA Previsit Reminder Call Script
IA/NC Control Home Visit Consent	18	Attachment 18-9 thru 18-11 BEEA IA NC Informed Consent Control Group RSG and REG
Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen	23, 24, 25	Attachment 25-1 AHS Phase IV Health Follow-up CAWI Participant Survey ,   Attachment 25-2 AHS Phase IV Health Follow-up CATI Proxy Survey Script ,   Attachment 25-3 AHS Phase IV Health Follow-up Paper & Pen Participant Survey
Attachment 10: BEEA Schedule Home Visit Scripts for AHS	1, 2, 3	BEEA Iowa Schedule PostApp Visit Script ,   BEEA North Carolina Schedule PostApp Visit Script ,   BEEA Previsit Reminder Script
Attachment 26: Paper/pen, CAWI, and CATI for Proxy for AHS	15, 17, 14, 16	CATI Proxy ,   Paper-Pen Proxy ,   CAWI Proxy ,   CAWI-CATI Proxy
Phase IV Buccal Kit Follow up Scripts	3	Attachment 9.2 thru 9.5 Phase IV Buccal kit Follow up Scripts
BEEA CATI Screening Script for RSG Eligibility, REG Eligibility or AMG Eligibility	4, 5, 6	Attachment 20-1 BEEA CATI Script Random Select Group ,   Attachment 20-2 BEEA CATI Script Recent Exposed Group ,   Attachment 20-3 BEEA CATI Script Recently Exposed +Air Monitoring Group
BEEA IA/NC Consent for RSG Home Visit or REG Home Visit or AMG Home Visit	7, 8, 9	Attachment 18-3 and 18-4 BEEA IA/NC Informed Consent Recent Exposure Group ,   Attachment 18-5 and 18-6 BEEA IA/NC Informed Consent Air Monitoring Home Visit ,   Attachment 18-1 and 18-2 BEEA IA/NC Informed Consent Random Select Group
BEEA Paper/Pen Duct Questionnaire	11	Attachment 21 Dust Questionnaire
BEEA Paper/Pen Duct Questionnaire	11	Attachment 21 Dust Questionnaire
IA/NC Pre-Visit Show Card	19	Attachment 17-16 and 17-17 BEEA IA NC Pre-Visit Prep Showcards Controls
BEEA 'Life in a Day" Smartphone Application	22	Attachment 22-2 BEEA Smartphone App Screenshots and User Workflow
Phase IV Follow-up CAWI Survey, CATI Script or Paper/Pen	23, 24, 25	Attachment 25-1 AHS Phase IV Health Follow-up CAWI Participant Survey ,   Attachment 25-2 AHS Phase IV Health Follow-up CATI Proxy Survey Script ,   Attachment 25-3 AHS Phase IV Health Follow-up Paper & Pen Participant Survey
BEEA Paper/Pen Duct Questionnaire	11	Attachment 21 Dust Questionnaire
BEEA REG Home Visit CAPI, Blood, Buccal cell, Urine & Dust	13	Attachment 19-1 BEEA CAPI Questionnaire
Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 1 for AHS	3	BEEA Home Visit CAPI, Blood, & Urine x 1
Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 3	5	BEEA Home Visit CAPI, Blood, & Urine x 3
Phase IV Buccal IA/NC Scripts for Verbal Consent for Buccal Kit	1	Attachment 9.1 Phase IV Buccal IA_NC Verbal Consent Script
Phase IV Buccal IA/NC Written Consent for Buccal Kit	2	Attachment 15.1 and 15.2 Phase IV Buccal IA_NC Consent Form

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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	29,641	25,711	0	3,930	0	0
Annual Time Burden (Hours)	11,438	10,678	0	760	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: Revision

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Annual Cost to Federal Government: $1,652,142

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: 04/26/2016

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