Follow-up of Kidney Cancer Patients from the Central European Multicenter Case-Control Study (CEERCC) (NCI)

Forms and Documents

Document Name	Status
Form 2 Abstraction Form for Physicians (CEERCC) Form	New
Form 1 Lifestyle Questionnaire for Patients or Next-of-Kin (CEERCC) Form	New
Attach 4_REVISED_Privacy act Memo.doc Supplementary Document	2009-05-07
CEERCC.Survival SSB_10.10.08.docx Supporting Statement B	2009-01-02
Attach 8_Power for Sample Size.docx Supplementary Document	2009-01-02
Attach 5_ConsentForms.docx Supplementary Document	2009-01-02
Attach 4_Privacy act Memo.doc Supplementary Document	2009-01-02
Attach 1_CEERCC manuscripts.docx Supplementary Document	2009-01-02
Attach 3_IRB Approval.pdf Supplementary Document	2009-01-02
Attach 2_IRB Protocol.03.16.08.docx Supplementary Document	2009-01-02
SSA_REVISED_3-27-09.doc Supporting Statement A	2009-05-07

IC Document Collections

IC ID	Document Title	Status
187789	Abstraction Form for Physicians (CEERCC) Form	New
187788	Lifestyle Questionnaire for Patients or Next-of-Kin (CEERCC) Form	New

ICR Details

OMB Control No: 0925-0599	ICR Reference No: 200901-0925-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Follow-up of Kidney Cancer Patients from the Central European Multicenter Case-Control Study (CEERCC) (NCI)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/20/2009
	Date Received in OIRA: 01/13/2009
Terms of Clearance: Approved consistent with revisions uploaded on 5/7/2009.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2011	24 Months From Approved
Responses	450	0	0
Time Burden (Hours)	296	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of the "Follow-up of Kidney Cancer Patients from the Central European Multicenter Case-Control Study" is to obtain information on the 5-year survival status of kidney cancer patients that were enrolled in a Central European Case-control Study of Kidney Cancer that was conducted between 2001-2004. This study is needed to collect additional information since initial diagnosis so that we can identify additional factors that may pertain to or modify disease outcome. The information will be used to identify and disseminate information that can distinguish determinants of kidney cancer survival, to aid in the prevention and treatment of cancer recurrence and progression. The respondents will include 1100 patients (or next-of-kin, if the patients are deceased) that were deemed histologically confirmed kidney cancer cases and that had participated in an earlier case-control study. Additionally, 20 physicians will be employed to abstract hospital records, pathology reports and treatment information.

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Authorizing Statute(s): US Code: 42 USC 413(285a-2) 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:
	73 FR 65387	11/03/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 1697	01/13/2009
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Lifestyle Questionnaire for Patients or Next-of-Kin (CEERCC)	1	Lifestyle Questionnaire
Abstraction Form for Physicians (CEERCC)	2	Abstraction

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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	450	0	0	450	0	0
Annual Time Burden (Hours)	296	0	0	296	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 collection of information.

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Annual Cost to Federal Government: $164,880

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)? 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: 01/13/2009

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