CDC Cervical Cancer Study (CX3)

Forms and Documents

Document Name	Status
SS_B_0209.doc Supporting Statement B	2009-02-23
FW 5439 Site-Restriction - IRB Approval of New Protocol (Expedited) .htm Supplementary Document	2009-03-02
Att I_Battelle IRB letter.pdf Supplementary Document	2009-02-23
H2_Analysis tables.doc Supplementary Document	2009-02-23
H1_Variables collected.doc Supplementary Document	2009-02-23
Att G_Laboratory protocol_0209.doc Supplementary Document	2009-02-23
Att F_Chart Review Plan_0209.doc Supplementary Document	2009-02-23
Att E4_Patient bookmark_0209.doc Supplementary Document	2009-02-23
Att E3_Patient brochure_0209.doc Supplementary Document	2009-02-23
Att D3_Outline for planned provider intervention.doc Supplementary Document	2009-02-23
Att B1_60-day FRN 03.07.08.pdf Supplementary Document	2009-02-23
Att A_Applicable Law PHSA.docm Supplementary Document	2009-02-23
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
Att D1a_Cover letter -- baseline provider survey_0209.doc Supplementary Document	2009-02-23
Att C2a_Cover letter -- follow-up clinic survey.doc Supplementary Document	2009-02-23
Att C1a_ Cover letter -- initial clinic survey.doc Supplementary Document	2009-02-23
SS_A_0209.doc Supporting Statement A	2009-03-05

IC Document Collections

IC ID	Document Title	Status
188627	Cx3 Study - Follow-up Patient Survey Other-WORD	New
188626	Cx3 Study - Patient Enrollment Form Other-WORD	New
188625	Cx3 Study - Patient Recruitment Other-WORD	New
188624	Cx3 Study - Baseline Patient Survey Other-WORD	New
188623	Cx3 Study - Follow-up Provider Survey Other-WORD	New
188622	Cx3 Study - Baseline Provider Survey Other-WORD	New
188621	Cx3 Study - Follow-up Survey Other-WORD	New
188620	Cx3 Study - Initial Clinic Survey Other-WORD	New

ICR Details

OMB Control No: 0920-0814	ICR Reference No: 200903-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: CDC Cervical Cancer Study (CX3)
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: 06/24/2009
	Date Received in OIRA: 03/31/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2012	36 Months From Approved
Responses	7,632	0	0
Time Burden (Hours)	1,006	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: CDC will conduct a pilot study to determine whether Pap test screening intervals increase with the additional of HPV testing along with Pap screening. The pilot study will be conducted at clinics in Illinois and will be used to inform policies for the Natinal Breast and Cervical Cancer Early Detection Program (NCCEDP)

---

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 12449	03/07/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 9615	03/05/2009
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Cx3 Study - Baseline Provider Survey
Cx3 Study - Follow-up Provider Survey
Cx3 Study - Follow-up Survey
Cx3 Study - Baseline Patient Survey
Cx3 Study - Patient Recruitment
Cx3 Study - Patient Enrollment Form
Cx3 Study - Follow-up Patient Survey
Cx3 Study - Initial Clinic Survey

---

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	7,632	0	0	7,632	0	0
Annual Time Burden (Hours)	1,006	0	0	1,006	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 information collection request to address the current debate about the optimal screening interval for cervical cancer using a combination of the Pap test and HPV testing.

---

Annual Cost to Federal Government: $514,648

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? Yes

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

---

Common Form ICR:  No

---

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: 03/31/2009

---