CDC Cervical Cancer Study (CX3)

Forms and Documents

Document Name	Status
Focus Groups with Health Care Providers Form	Modified
Follow-up Provider Survey Form	Modified
Follow-up Patient Survey Form	Modified
0920-0814_Part B_04 27 2012.docx Supporting Statement B	2012-05-16
F2 Analysis tables revised.pdf Supplementary Document	2012-05-16
G3 Certificate of Confidentiality.pdf Supplementary Document	2012-05-16
G2 Battelle IRB Approval.pdf Supplementary Document	2012-05-16
G1 CDC IRB approval.docx Supplementary Document	2012-05-16
F1 Variables collected revised.docx Supplementary Document	2012-05-16
E Medical Records Review.doc Supplementary Document	2012-05-16
B2 Summary of Public Comments and CDC Response.pdf Supplementary Document	2012-05-16
Attachment B1 Federal Register Notice.pdf Supplementary Document	2012-05-16
A Authorizing Legislation.doc Supplementary Document	2012-05-16
Att E2d_Script for reminder phone call_0209.doc Supplementary Document	2009-02-23
Att E2a_Initial postcard_0209.doc Supplementary Document	2009-02-23
Att E2c_Reminder postcard_0209.doc Supplementary Document	2009-02-23
Att E2b_Cover letter patient follow-up survey_0209.doc Supplementary Document	2009-02-23
Att E1c_HPV patient consent form not including patient survey_0209.doc Supplementary Document	2009-02-23
Att Elb_HPV patient consent form including patient survey_0209.doc Supplementary Document	2009-02-23
Att D2a_ Cover letter -- follow-up provider surveys_0209.doc Supplementary Document	2009-02-23
C2a Consent Form for Provider Focus Group Interviews.docx Supplementary Document	2012-05-17
C1a Cover Letter for Follow-up Provider Survey.docx Supplementary Document	2012-05-17
D1e SCRIPT FOR REMINDER TELEPHONE CALL.doc Supplementary Document	2012-05-17
D1d Reminder postcard.doc Supplementary Document	2012-05-17
D1b Initial Postcard.doc Supplementary Document	2012-05-17
D1c Cover Letter for Patient Follow-up Survey.docx Supplementary Document	2012-05-17
D1a Patient Consent Survey.pdf Supplementary Document	2012-05-17
0920-0814_Part A_04 27 2012.docx Supporting Statement A	2012-05-16

IC Document Collections

IC ID	Document Title	Status
188627	Cx3 Study - Follow-up Patient Survey Other-WORD	Removed
188626	Cx3 Study - Patient Enrollment Form Other-WORD	Removed
188625	Cx3 Study - Patient Recruitment Other-WORD	Removed
188624	Cx3 Study - Baseline Patient Survey Other-WORD	Removed
188623	Cx3 Study - Follow-up Provider Survey Other-WORD	Removed
188622	Focus Groups with Health Care Providers Form	Modified
188621	Follow-up Provider Survey Form	Modified
188620	Follow-up Patient Survey Form	Modified

ICR Details

OMB Control No: 0920-0814	ICR Reference No: 201205-0920-008
Status: Historical Active	Previous ICR Reference No: 200903-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: CDC Cervical Cancer Study (CX3)
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: 07/02/2012
	Date Received in OIRA: 05/22/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	12 Months From Approved	06/30/2012
Responses	295	0	7,632
Time Burden (Hours)	135	0	1,006
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to examine whether or not there is an increase in the cervical cancer screening interval to 3 years for women in the target age range with a normal Pap test and a negative HPV DNA test.

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Authorizing Statute(s): US Code: 42 USC 241 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:
	77 FR 9960	02/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 28881	05/16/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Follow-up Patient Survey	none	Follow-up Patient Survey
Follow-up Provider Survey	none	Follow-up Provider Survey
Focus Groups with Health Care Providers	none	Provider Focus Group Moderator Guide
Cx3 Study - Follow-up Provider Survey
Cx3 Study - Baseline Patient Survey
Cx3 Study - Patient Recruitment
Cx3 Study - Patient Enrollment Form
Cx3 Study - Follow-up Patient Survey

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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	295	7,632	0	-7,337	0	0
Annual Time Burden (Hours)	135	1,006	0	-871	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: Miscellaneous Actions

Short Statement: This is a revision with reduction in burden hours. Due to a decrease in the number of instruments to be fielded in this phase of data collection (the period of this Revision ICR), there will be an overall reduction in burden hours. The following instruments will be discontinued: the Initial Clinic Survey, the Follow-Up Clinic Survey, the Baseline Provider Survey, the Patient Screening Script, the Patient Enrollment Form, and the Baseline Patient Survey. Information collection for these study components was completed.

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Annual Cost to Federal Government: $817,586

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: 05/22/2012

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