A multi-center international hospital-based case-control study of lymphoma in Asia (AsiaLymph) (NCI)

Forms and Documents

Document Name	Status
Form 9 Tracking Forms Form and Instruction	New
Form 8 Pathology sample request and tracking form Form and Instruction	New
Form 3 Core Questionnaire & Occupational Job Module Consented Patient Controls Form and Instruction	New
Form 1 Core Questionnaire & Occupational Job Module Form and Instruction	New
Form 1 Consent Form Form and Instruction	New
Form 1 Screener and Core Questionnaire Form and Instruction	New
Form 9 Interviewer Administrative Forms (Attachment 9) Form and Instruction	Removed
Form 8 Pathologist Administrative Form (Attachment 8) Form and Instruction	Removed
Form 3A Patient Screener, Core & Occupational Exposure Questionnaires_AsiaLymph (Attachments 3, 4 & 5) Form and Instruction	Removed
Attach-2-consultants.pdf Supplementary Document	2015-10-29
Attach-1-AsiaLymph-Revised-Protocol-and-Bibliography.doc Supplementary Document	2015-10-29
Attach-18-Memo_Request_Limited_Ethnic_Category_3-2-2012.pdf Supplementary Document	2015-10-29
Attach-17-Interviewer-labor-rates.docx Supplementary Document	2015-10-29
Attach-16-Pathology-labor-rates.docx Supplementary Document	2015-10-29
Attach-15-Translation-of-average-wage-doc-for-Chengdu&Tianjin-highlight.doc Supplementary Document	2015-10-29
Attach-14-Hong-Kong-average_salary-2015-Q1-highlight-page31.pdf Supplementary Document	2015-10-29
Attach-13-Hourly-salary-calculations-for-each-of-the-three-study-centers-in-AsiaLymph.doc Supplementary Document	2015-10-29
Attach-12-AsiaLymph-Study-Organization.pdf Supplementary Document	2015-10-29
Attach-7-Script_for_initial_contact_with_potential_study_subjects-revised.doc Supplementary Document	2015-10-29
Attach-6E2-Tianjin-Tumor-Hospital-Medical-University-IRB-Approval-English.docx Supplementary Document	2015-10-29
Attach-6E1-Tianjin-Tumor-Hospital-Medical-University-IRB-Approval-Original.pdf Supplementary Document	2015-10-29
Attach-6D2-West-China-Hospital-Sichuan-University-IRB-Approval-English.docx Supplementary Document	2015-10-29
Attach-6D1-West-China-Hospital-Sichuan-University-IRB-Approval-Original.pdf Supplementary Document	2015-10-29
Attach-6C-University-of-Hong-Kong-IRB-Approval.pdf Supplementary Document	2015-10-29
Attach-6B-NIH-Approval.pdf Supplementary Document	2015-10-29
Attach-6A-NCI-IRB-approval.pdf Supplementary Document	2015-10-29
SSB_Revised 02-24-2016 (1).docx Supporting Statement B	2016-02-29
SSA 10.29.2015.docx Supporting Statement A	2015-10-29
30 day FRN.pdf Supplementary Document	2015-10-29

IC Document Collections

IC ID	Document Title	Status
218787	Tracking Forms Form and Instruction	New
218786	Pathology sample request and tracking form Form and Instruction	New
218785	Core Questionnaire & Occupational Job Module Consented Patient Controls Form and Instruction	New
218784	Core Questionnaire & Occupational Job Module Form and Instruction	New
218783	Consent Form Form and Instruction	New
218782	Screener and Core Questionnaire Form and Instruction	New
201514	Interviewer Administrative Forms (Attachment 9) Form and Instruction	Removed
201513	Pathologist Administrative Form (Attachment 8) Form and Instruction	Removed
201512	Patient Screener, Core & Occupational Exposure Questionnaires_AsiaLymph (Attachments 3, 4 & 5) Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0654	ICR Reference No: 201510-0925-005
Status: Historical Active	Previous ICR Reference No: 201209-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: A multi-center international hospital-based case-control study of lymphoma in Asia (AsiaLymph) (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: 03/04/2016
	Date Received in OIRA: 10/30/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	03/31/2016
Responses	7,423	0	8,606
Time Burden (Hours)	3,262	0	5,302
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for an extension of the "AsiaLymph Study" which includes non-substantive changes to the questionnaire but no changes to burden requested, scope or methodology of the study. The project focuses on collecting critically needed information to understand and reduce the cancer burden from lymphoid malignancies in the Asian population, the incidence of which has risen in recent decades. Specifically, environmental exposures to industrial emissions, genetic susceptibility, viral exposures, early life exposures, ultraviolet (UV) radiation exposures, and other risk factors for lymphoma overall and specifically for populations in Asia will continue to be examined.

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Authorizing Statute(s): US Code: 42 USC 411(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:
	80 FR 52325	08/28/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 66548	10/29/2015
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Pathologist Administrative Form (Attachment 8)	8	Administrative form for the Pathologist
Interviewer Administrative Forms (Attachment 9)	9	Administrative forms for the Interviewer
Patient Screener, Core & Occupational Exposure Questionnaires_AsiaLymph (Attachments 3, 4 & 5)	3A, 3B, 3C, 3D, 3E, 3F, 3G, 3H, 4, 5	Screener and Core Questionnaire-Hong Kong (English) ,   Screener and Core Questionnaire-Hong Kong (Chinese) ,   Screener and Core Questionnaire-Chengdu (English) ,   Screener and Core Questionnaire-Chengdu (Chinese) ,   Screener and Core Questionnaire-Taiwan (English) ,   Screener and Core Questionnaire-Taiwan (Chinese) ,   Screener and Core Questionnaire-Tianjin (English) ,   Screener and Core Questionnaire-Tianjin (Chinese) ,   Occupational Job Exposure Modules - examples ,   Occupational Job Exposure Modules - complete set ,   Screener and Core Questionnaire-Hong Kong (English) ,   Screener and Core Questionnaire-Hong Kong (Chinese) ,   Screener and Core Questionnaire-Chengdu (English) ,   Screener and Core Questionnaire-Chengdu (Chinese) ,   Screener and Core Questionnaire-Taiwan (English) ,   Screener and Core Questionnaire-Taiwan (Chinese) ,   Screener and Core Questionnaire-Tianjin (English) ,   Screener and Core Questionnaire-Tianjin (Chinese) ,   Occupational Job Exposure Modules - examples ,   Occupational Job Exposure Modules - complete set
Consent Form	1, 2	Attachment 8 Revised Informed Consent Cases ,   Attachment 9 Revised Informed Consent Controls
Core Questionnaire & Occupational Job Module	2, 3, 6, 7, 4, 1, 5	Attachment 5 Occupational Job Modules ,   Attachment 3A Updated Screener and Core Questionnaire Hong-Kong English ,   Attachment 3B Updated Screener and Core Questionnaire Hong-Kong Chinese ,   Attachment 3C Updated Screener and Core Questionnaire Chengdu-English ,   Attachment 3D Updated Screener and Core Questionnaire Chengdu-Chinese ,   Attachment 3E Updated Screener and Core Questionnaire Tianjin-English ,   Attachment 3F Updated Screener and Core Questionnaire Tianjin-Chinese
Tracking Forms	9	Attachment 11 Admin Forms Interviewers
Core Questionnaire & Occupational Job Module Consented Patient Controls	4, 1, 3, 5, 6, 7, 2	Attachment 3B Updated Screener and Core Questionnaire Hong-Kong Chinese ,   Attachment 3C Updated Screener and Core Questionnaire Chengdu-English ,   Attachment 3D Updated Screener and Core Questionnaire Chengdu-Chinese ,   Attachment 3E Updated Screener and Core Questionnaire Tianjin-English ,   Attachment 3F Updated Screener and Core Questionnaire Tianjin-Chinese ,   Attachment 5 Occupational Job Modules ,   Attachment 3A Updated Screener and Core Questionnaire Hong-Kong English
Screener and Core Questionnaire	1, 4, 3, 5, 6, 2	Attachment 3A Updated Screener and Core Questionnaire Hong-Kong English ,   Attachment 3B Updated Screener and Core Questionnaire Hong-Kong Chinese ,   Attachment 3C Updated Screener and Core Questionnaire Chengdu-English ,   Attachment 3D Updated Screener and Core Questionnaire Chengdu-Chinese ,   Attachment 3E Updated Screener and Core Questionnaire Tianjin-English ,   Attachment 3F Updated Screener and Core Questionnaire Tianjin-Chinese
Pathology sample request and tracking form	8	Attachment 10 Admin Form pathologist

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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	7,423	8,606	0	-1,183	0	0
Annual Time Burden (Hours)	3,262	5,302	0	-2,040	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: $736,119

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: 10/30/2015

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