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

Forms and Documents

Document Name	Status
Form 5 Interviewer Administrative Forms (Attachment 9) Form and Instruction	New
Form 2 Pathologist Administrative Form (Attachment 8) Form and Instruction	New
Form 1 Patient Screener, Core & Occupational Exposure Questionnaires_AsiaLymph (Attachments 3, 4 & 5) Form and Instruction	New
Supporting_State_B_v11_3-2-12.docx Supporting Statement B	2012-03-09
FRN Emergency_2-17-2012.pdf Supplementary Document	2012-03-09
Attach 10 - AsiaLymph Study Organization.doc Supplementary Document	2012-03-09
Attach 7 - Contact and Consent_Forms_2-26-12.pdf Supplementary Document	2012-03-09
Attach 6E2 - Dalin Tsu-Chi Hospital_IRB_English.doc Supplementary Document	2012-03-09
Attach 6E1 - Dalin Tsu-Chi Hospital_IRB_original.pdf Supplementary Document	2012-03-09
Attach 6D2 - Tianjin Medial Univeristy_IRB_English.docx Supplementary Document	2012-03-09
Attach 6D1 - Tianjin Medical University_IRB_original.pdf Supplementary Document	2012-03-09
Attach 6C2 Sichuan University_IRB_English.docx Supplementary Document	2012-03-09
Attach 6C1 Sichuan University_IRB_original.pdf Supplementary Document	2012-03-09
Attach 6B - Hong Kong Univeristy IRB.pdf Supplementary Document	2012-03-09
Attach 6A - NCI and NIH IRB.pdf Supplementary Document	2012-03-09
Attach 2 - Consultants.docx Supplementary Document	2012-03-09
Memo_Request_Limited_Ethnic_Category_3-2-2012.doc Supplementary Document	2012-03-09
Executive_summary_AsiaLymph_3-2-2012.doc Supplementary Document	2012-03-09
Attach 1 - protocol_and_bibliography.pdf Supplementary Document	2012-03-09
Supporting_State_A_v18_3-2-12.docx Supporting Statement A	2012-03-09

IC Document Collections

IC ID	Document Title	Status
201514	Interviewer Administrative Forms (Attachment 9) Form and Instruction	New
201513	Pathologist Administrative Form (Attachment 8) Form and Instruction	New
201512	Patient Screener, Core & Occupational Exposure Questionnaires_AsiaLymph (Attachments 3, 4 & 5) Form and Instruction	New

ICR Details

OMB Control No: 0925-0654	ICR Reference No: 201203-0925-003
Status: Historical Active	Previous ICR Reference No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/12/2012
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/12/2012
	Date Received in OIRA: 03/10/2012
Terms of Clearance: This emergency ICR is approved for 6 months with the understanding that, in order for continued approval, the standard notice and comment periods will be followed before the end of the 6-months. Chinese language versions of the instruments must also be provided.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	6 Months From Approved
Responses	8,606	0	0
Time Burden (Hours)	5,302	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: AsiaLymph will confirm and extend previous findings and yield novel insights into the causes of lymphoma in both Asia and in the United States. The major postulated risk factors for evaluation in this study are chemical exposures (i.e., organochlorines, trichloroethylene, and benzene) and genetic susceptibility. Other factors potentially related to lymphoma, such as viral infections, ultraviolet radiation exposure, medical conditions, and other lifestyle factors will also be studied.

Emergency Justfication: This is a request for an emergency clearance of the "AsiaLymph Study" on the grounds that this is essential to the mission of National Cancer Institute (NCI) and that NCI cannot reasonably comply with the normal clearance procedures and this would likely prevent or substantially disrupt the collection of information (5CFR 1320.13). In addition, prevention of the study would cause public harm through the loss of 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. The planned start date for AsiaLymph is March 12, 2012.

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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:
	77 FR 9665	02/17/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Patient Screener, Core & Occupational Exposure Questionnaires_AsiaLymph (Attachments 3, 4 & 5)	1, 2, 3	Screener and Core Questionnaire AsiaLymph ,   Occupational Exposure Qx (examples) ,   Occupational Exposure Qx (complete set)
Pathologist Administrative Form (Attachment 8)	2	Pathologist Administrative Form
Interviewer Administrative Forms (Attachment 9)	5	Interviewer Administrative Forms

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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	8,606	0	0	8,606	0	0
Annual Time Burden (Hours)	5,302	0	0	5,302	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $909,200

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: 03/10/2012

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