Resource for the Collection and Evaluation of Human Tissues and Cells from Donors with an Epidemiology Profile (NCI)

Forms and Documents

Document Name	Status
Form 5 Refusal Questionnaire Form and Instruction	Modified
Form 4 Liver Supplement Form and Instruction	Modified
Form 3 Prostate Supplemental Questionnaire Form and Instruction	Modified
Form 2 Main Questionnaire No. 1 Form and Instruction	Modified
Form 1 Telephone Screener Form	Modified
SSB-REVISED_Resource of Tissues and Cells NCI_11-12-2010.doc Supporting Statement B	2010-11-20
Attach 25 - Report-Prostate Pilot to NCI-IRB-03-06.doc Supplementary Document	2010-11-20
Attach 24 - Control Recruitment in 11 Months.doc Supplementary Document	2010-11-20
Attach 23 - Current-Selected- MVA Cohort.doc Supplementary Document	2010-11-20
Attach 20 - Staff Pledge Of Confidentiality.doc Supplementary Document	2010-11-20
Attach 19 - REVISED_HIPAA- Pop Controls 11-11-2010.doc Supplementary Document	2010-11-20
Attach 18 - REVISED_Consent Forms UMD and JHU_11-10-2010.doc Supplementary Document	2010-11-20
Attach 17 - Data Security and Confidentiality Plan.doc Supplementary Document	2010-11-20
Attach 15 - REVISED - Letter of Introduction-PopContr_11-10-2010.doc Supplementary Document	2010-11-20
Attach 14 - NCI-ScienticAdvisorySiteVisitors092008.doc Supplementary Document	2010-11-20
Attach 13 - LHC-Expert Scientific Advisors.doc Supplementary Document	2010-11-20
Attach 12 - Privacy Act SORN-Memo.pdf Supplementary Document	2010-11-20
Attach 11 - Paper to Electronic-Tablet-Questionaires.doc Supplementary Document	2010-11-20
Attach 10 - Paperless Questionnaires.doc Supplementary Document	2010-11-20
Attach 9 - Contract-SupportedPublications..doc Supplementary Document	2010-11-20
Attach 5 - Geographic Distribution.doc Supplementary Document	2010-11-20
Attach 4 - Clinical Exemption Approval.doc Supplementary Document	2010-11-20
Attach 3 - IRB Consents.doc Supplementary Document	2010-11-20
Attach 2 - Figure 2. Molecular Epi Services and Products.doc Supplementary Document	2010-11-20
Attach 1- Figure 1. Resource Services and Products.doc Supplementary Document	2010-11-20
Cover Memo_REVISED_Resource of Tissues_11-16-2010.doc Supplementary Document	2010-11-20
Memo Response OMB Passbacks_Resource of Tissues_11-16-2010.doc Supplementary Document	2010-11-20
Attach 22 - REVISED_Telephone Interview Script_11-10-2010.doc Supplementary Document	2010-11-20
SSA-REVISED_Resource of Tissues and Cells_11-12-2010.doc Supporting Statement A	2010-11-20

IC Document Collections

IC ID	Document Title	Status
194466	Refusal Questionnaire Form and Instruction	Modified
194465	Liver Supplement Form and Instruction	Modified
194464	Prostate Supplemental Questionnaire Form and Instruction	Modified
194463	Main Questionnaire No. 1 Form and Instruction	Modified
194462	Telephone Screener Form	Modified

ICR Details

OMB Control No: 0925-0623	ICR Reference No: 201012-0925-005
Status: Historical Active	Previous ICR Reference No: 201008-0925-005
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Resource for the Collection and Evaluation of Human Tissues and Cells from Donors with an Epidemiology Profile (NCI)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/30/2010
	Date Received in OIRA: 12/17/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	36 Months From Approved
Responses	2,500	0	0
Time Burden (Hours)	692	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Laboratory of Human Carcinogenesis (LHC) conducts case-control studies that require recruitment and collection of personal information from cancer patients and normal, population controls via an NCI Resource Contract. The patient portion has been granted Clinical Exemption by NIH (10/28/09: #2009-09-002). The collection of information from population controls requires OMB Clearance. Personal information is first collected on controls using the State of Maryland Motor Vehicle Administration records to find individuals matching (by age, sex, race and jurisdiction) recruited cancer patients. Contacted by phone numbers found via internet engine searches, controls who enroll in the studies provide personal information to be compared to cancer patients in order to identify social, occupational, and environmental factors contributing to the development of human cancer of the lung, prostate, liver and pancreas.

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Authorizing Statute(s): US Code: 42 USC 410 (285) Name of Law: Public Health Service Act
   US Code: 42 USC 411 (285a) Name of Law: Public Health Service Act
   US Code: 42 USC 412 (285a-1) 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 34146	06/16/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 52351	08/25/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Main Questionnaire No. 1	2	Main Questionnaire No. 1
Liver Supplement	4	Liver Supplement
Telephone Screener	1	Telephone Screener
Prostate Supplemental Questionnaire	3	Prostate Supplemental Questionnaire
Refusal Questionnaire	5	Refusal Questionnaire

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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	2,500	0	0	0	0	2,500
Annual Time Burden (Hours)	692	0	0	0	0	692
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: $118,510

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: 12/17/2010

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