Data Collection for Public Cancer Epidemiology Descriptive Cohort Database (NCI)

Forms and Documents

Document Name	Status
Form 5 Attachment C2 Annual Update Biospecimen and Cancer Count Information Spreadsheet Form and Instruction	New
Form 4 Attachment C1 Initial Biospecimen and Cancer Count Information Spreadsheet Form and Instruction	New
Form 3 CEDCD Annual Data Collection Form Form and Instruction	New
Form 2 CEDCD Initial Data Collection Form Form and Instruction	New
Form 1 Cancer Epidemiology Descriptive Cohort Database (CEDCD) Approval Form Form	New
Attachment H_Privacy Act Memo.doc Supplementary Document	2014-09-19
Attachment G NCI IRB Exempt.pdf Supplementary Document	2014-09-19
Attachment F_List of Consultants.docx Supplementary Document	2014-09-19
Attachment E_Non-PAR-Funded CEDCD Principal Investigators.docx Supplementary Document	2014-09-19
Attachment D_PAR-Funded CEDCD Principal Investigators.docx Supplementary Document	2014-09-19
SSA CEDCD 9 5 2014 Final.docx Supporting Statement A	2014-09-19

IC Document Collections

IC ID	Document Title	Status
213182	Attachment C2 Annual Update Biospecimen and Cancer Count Information Spreadsheet Form and Instruction	New
213181	Attachment C1 Initial Biospecimen and Cancer Count Information Spreadsheet Form and Instruction	New
213180	CEDCD Annual Data Collection Form Form and Instruction	New
213178	CEDCD Initial Data Collection Form Form and Instruction	New
213173	Cancer Epidemiology Descriptive Cohort Database (CEDCD) Approval Form Form	New

ICR Details

OMB Control No: 0925-0706	ICR Reference No: 201409-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Data Collection for Public Cancer Epidemiology Descriptive Cohort Database (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 without change	Conclusion Date: 11/05/2014
	Date Received in OIRA: 09/23/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2017	36 Months From Approved
Responses	700	0	0
Time Burden (Hours)	550	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for approval of a new information collection. The NCI Epidemiology and Genomics Research Program (EGRP) supports large-scale collaborations across numerous cancer epidemiology cohorts. This public website will allow investigators to know what data and specimens exist among other cohorts. Respondents will be cohort Principal Investigators. The data collection forms will be sent to participating cohort PIs annually to update any information that has changed so that the CEDCD website will remain current. No cohort participant-level data is being collected from any of the cohorts.

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Authorizing Statute(s): US Code: 42 USC 285 section 410 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:
	79 FR 34766	06/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 177	09/12/2014
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
CEDCD Initial Data Collection Form	2	Initial Data Collection Form
CEDCD Annual Data Collection Form	3	Attachment B2 CEDCD Annual Update Data Collection Form
Attachment C1 Initial Biospecimen and Cancer Count Information Spreadsheet	4	Initial Biospecimen and Cancer Count Information Form
Attachment C2 Annual Update Biospecimen and Cancer Count Information Spreadsheet	5	CEDCD Annual Update Biospecimen and Cancer Count Information Spreadsheet
Cancer Epidemiology Descriptive Cohort Database (CEDCD) Approval Form	1	Approval 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	700	0	0	700	0	0
Annual Time Burden (Hours)	550	0	0	550	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: new submission

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Annual Cost to Federal Government: $75,500

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 09/23/2014

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