Colorectal Cancer Screening Demonstration Program

Forms and Documents

Document Name	Status
Attachment 6. Cost Reimbursement Data Reporting Form and Instructions Form and Instruction	New
Attachment 5. Annual Aggregate Data on Medically Ineligible Clients Form Form and Instruction	New
Attachment 4. Medical Complications Reporting Form and Instructions Form and Instruction	New
Attachment 2a. Colorectal Cancer Clinical Data Elements for FOBT Programs Form	New
Attachment 2a. Colorectal Cancer Clinical Data Elements for Colonoscopy Programs Form	New
CS Response.doc Supplementary Document	2007-07-24
30-Day FRN for 0920-05CJ - Pub 2-13-2007.pdf Supplementary Document	0000-00-00
0920-05CJ ATTACHMENT 1 Authorizing Leg.doc Supplementary Document	0000-00-00
0920-05CJ ATTACHMENT 11 Statistical Consultants.doc Supplementary Document	0000-00-00
0920-05CJ Attachment 10 Data Coll Flowchart.pdf Supplementary Document	0000-00-00
0920-05CJ ATTACHMENT 9 Demonstration Program Sites.doc Supplementary Document	0000-00-00
0920-05CJ ATTACHMENT 8 Data Consultants.doc Supplementary Document	0000-00-00
0920-05CJ ATTACHMENT 7 60-day FRN.pdf Supplementary Document	0000-00-00
0920-05CJ ATTACHMENT 3 Sample Feedback.doc Supplementary Document	0000-00-00
0920-05CJ Supporting Statement 02.14.07.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
179138	Attachment 6. Cost Reimbursement Data Reporting Form and Instructions Form and Instruction	New
179137	Attachment 5. Annual Aggregate Data on Medically Ineligible Clients Form Form and Instruction	New
179136	Attachment 4. Medical Complications Reporting Form and Instructions Form and Instruction	New
179135	Attachment 2a. Colorectal Cancer Clinical Data Elements for FOBT Programs Form	New
179134	Attachment 2a. Colorectal Cancer Clinical Data Elements for Colonoscopy Programs Form	New

ICR Details

OMB Control No: 0920-0745	ICR Reference No: 200703-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Colorectal Cancer Screening Demonstration Program
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: 07/25/2007
	Date Received in OIRA: 03/21/2007
Terms of Clearance: Approved consistent with CDC memo submitted to OMB

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2010	36 Months From Approved
Responses	3,520	0	0
Time Burden (Hours)	1,270	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC requests approval to collect individual patient-level screening, diagnostic and treatment data in association with five new colorectal cancer (CRC) screening demonstration programs designed for low-income persons 50 years and older, who are inadequately insured for colorectal cancer screening services. These data will be used to evaluate proram implementation screening outcomes and costs, and will inform future organized CRC screening efforts. Respondents or program awardees are state or county health departments or university hospitals systems.

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Authorizing Statute(s): US Code: 42 USC 301 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:
	71 FR 36344	06/26/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 6733	02/13/2007
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
Attachment 2a. Colorectal Cancer Clinical Data Elements for FOBT Programs	None	Colorectal Cancer Clinical Data Elements
Attachment 2a. Colorectal Cancer Clinical Data Elements for Colonoscopy Programs	None	Colorectal Cancer Clinical Data Elements
Attachment 4. Medical Complications Reporting Form and Instructions	None	Medical Complications Reporting Form
Attachment 5. Annual Aggregate Data on Medically Ineligible Clients Form	None	Annual Aggregate Data on Medically Ineligible Clients Form
Attachment 6. Cost Reimbursement Data Reporting Form and Instructions	None	Cost Data Form and Instructions

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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	3,520	0	0	3,520	0	0
Annual Time Burden (Hours)	1,270	0	0	1,270	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 data collection.

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Annual Cost to Federal Government: $504,516

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]? 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)? Uncollected

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: 03/21/2007

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