Information Collection Request

CDC Cervical Cancer Study (CX3)

ICR 200903-0920-010 · OMB 0920-0814 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
SS_B_0209.doc Supporting Statement B Uploaded 2009-02-23 Available
FW 5439 Site-Restriction - IRB Approval of New Protocol (Expedited) .htm Supplementary Document Uploaded 2009-03-02 Available
Att I_Battelle IRB letter.pdf Supplementary Document Uploaded 2009-02-23 Repair queued
H2_Analysis tables.doc Supplementary Document Uploaded 2009-02-23 Available
H1_Variables collected.doc Supplementary Document Uploaded 2009-02-23 Available
Att G_Laboratory protocol_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att F_Chart Review Plan_0209.doc Supplementary Document Uploaded 2009-02-23 Repair queued
Att E4_Patient bookmark_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att E3_Patient brochure_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att D3_Outline for planned provider intervention.doc Supplementary Document Uploaded 2009-02-23 Available
Att B1_60-day FRN 03.07.08.pdf Supplementary Document Uploaded 2009-02-23 Available
Att A_Applicable Law PHSA.docm Supplementary Document Uploaded 2009-02-23 Available
Att E2d_Script for reminder phone call_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att E2a_Initial postcard_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att E2c_Reminder postcard_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att E2b_Cover letter patient follow-up survey_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att E1c_HPV patient consent form not including patient survey_0209.doc Supplementary Document Uploaded 2009-02-23 Repair queued
Att Elb_HPV patient consent form including patient survey_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att D2a_ Cover letter -- follow-up provider surveys_0209.doc Supplementary Document Uploaded 2009-02-23 Available
Att D1a_Cover letter -- baseline provider survey_0209.doc Supplementary Document Uploaded 2009-02-23 Repair queued
Att C2a_Cover letter -- follow-up clinic survey.doc Supplementary Document Uploaded 2009-02-23 Available
Att C1a_ Cover letter -- initial clinic survey.doc Supplementary Document Uploaded 2009-02-23 Available
SS_A_0209.doc Supporting Statement A Uploaded 2009-03-05 Available
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-0814 200903-0920-010
Historical Active
HHS/CDC
CDC Cervical Cancer Study (CX3)
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 06/24/2009
Retrieve Notice of Action (NOA) 03/31/2009
  Inventory as of this Action Requested Previously Approved
06/30/2012 36 Months From Approved
7,632 0 0
1,006 0 0
0 0 0

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)

US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  73 FR 12449 03/07/2008
74 FR 9615 03/05/2009
Yes

  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
Yes
Miscellaneous Actions
No
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.

$514,648
Yes Part B of Supporting Statement
Yes
Uncollected
Uncollected
No
Uncollected
Thelma Sims 4046394771

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/31/2009