Colorectal Cancer Screening Program

Forms and Documents

Document Name	Status
Form 2 Cost Assessment Tool Form and Instruction	Modified
Attachment 5. Annual Aggregate Data on Medically Ineligible Clients Form Form and Instruction	Removed
Attachment 4. Medical Complications Reporting Form and Instructions Form and Instruction	Removed
Attachment 2a. Colorectal Cancer Clinical Data Elements for FOBT Programs Form	Removed
Form 1 Clinical Data Elements (CCDE) Form and Instruction	Modified
ATTACHMENT 6 Data Consultants.doc Supplementary Document	2010-04-08
Attachment 2b. Public Comment and CDC Response.docx Supplementary Document	2010-04-08
ATTACHMENT 2a. 60-DAY FRN.pdf Supplementary Document	2010-04-08
Attachment 5b Cost Assessment Tool Users Manual.doc Supplementary Document	2010-04-08
0920-05CJ ATTACHMENT 2b CRCSDP Data Users Manual (v101).pdf Supplementary Document	2007-02-14
ATTACHMENT 3c CCDE Comparison Table.pdf Supplementary Document	2010-04-08
ATTACHMENT 4abc Sample Feedback.doc Supplementary Document	2010-04-08
Attachment 3b CCDE Data Users Manual.docx Supplementary Document	2010-04-08
0920-0745_Supporting Statement_Part A 03.29.10.doc Supporting Statement A	2010-04-08

IC Document Collections

IC ID	Document Title	Status
179138	Cost Assessment Tool Form and Instruction	Modified
179137	Attachment 5. Annual Aggregate Data on Medically Ineligible Clients Form Form and Instruction	Removed
179136	Attachment 4. Medical Complications Reporting Form and Instructions Form and Instruction	Removed
179135	Attachment 2a. Colorectal Cancer Clinical Data Elements for FOBT Programs Form	Removed
179134	Clinical Data Elements (CCDE) Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0745	ICR Reference No: 201004-0920-014
Status: Historical Active	Previous ICR Reference No: 200703-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Colorectal Cancer Screening Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/03/2010
	Date Received in OIRA: 04/28/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2013	36 Months From Approved	07/31/2010
Responses	9,776	0	3,520
Time Burden (Hours)	3,010	0	1,270
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is expanding the Colorectal Cancer Screening Program, which provides screening services to individuals age 50 and older who have inadequate access to CRC screening services. Program grantees will report clinical data elements and cost information to CDC for purposes of program evaluation and improvement. The word "Demonstration" is being taken out of the previously approved title.

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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:
	75 FR 5086	02/01/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 17921	04/08/2010
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
Clinical Data Elements (CCDE)	1	Colorectal Cancer Control Program (CRCCP) Colorectal Cancer Clinical Data Elements (CCDE) Data Definition Table
Cost Assessment Tool	2	Colorectal Cancer Control Program Cost Assessment Tool--User's Guide
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 2a. Colorectal Cancer Clinical Data Elements for FOBT Programs	None	Colorectal Cancer Clinical Data Elements

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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	9,776	3,520	0	6,256	0	0
Annual Time Burden (Hours)	3,010	1,270	0	1,740	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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: The term "Demonstration" will be deleted from the title of the information collection; the clinical data component will be simplified; and an activity-based economic data collection will replace the cost reimbursement data collection. The information collected from funded sites will be used to monitor and evaluate the CRC screening program. The overall estimated burden will increase due to the increase in the number of funded CRC screening sites.

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Annual Cost to Federal Government: $829,385

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]? 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: 04/28/2010

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