0920-1046 SS Part B_Final

National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Monitoring Activities

OMB No. 0920-1046 Exp.11/30/2021

Supporting Statement B

Program Official/Contact

Dara Schlueter, MPH

Health Scientist

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

P: 404-498-1782

F: 770-488-4760

Sax9@cdc.gov

11/1/2021

TABLE OF CONTENTS

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS 3

B1. Respondent Universe and Sampling Methods 3

B2. Procedures for the Collection of Information 3

B3. Methods to Maximize Response Rates and Deal with No Response 4

B4. Tests of Procedures or Methods to be Undertaken 5

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 5

REFERENCES 6

ATTACHMENTS

Attachment 1: Authorizing Legislation

Attachment 2: Breast and Cervical Cancer Mortality Prevention Act of 1990

Attachment 3: NBCCEDP Logic Model

Attachment 4: NBCCEDP Evaluation Question Matrix

Attachment 5: Annual NBCCEDP Survey

Attachment 5a: Annual NBCCEDP Survey (screenshots)

Attachment 5b: NBCCEDP Survey Introductory Email

Attachment 5c: NBCCEDP Survey Reminder Email

Attachment 6: NBCCEDP Clinic-Level Data Collection Instruments

Attachment 6a: NBCCEDP Clinic-Level Data Collection Instruments (screenshots)

Attachment 6b: NBCCEDP Clinic-Level Data Collection Introductory Email

Attachment 6c: NBCCEDP Clinic-Level Data Collection Reminder Email

Attachment 7: NBCCEDP Quarterly Program Update

Attachment 7a: NBCCEDP Quarterly Program Update (screenshots)

Attachment 7b: NBCCEDP Quarterly Program Update Pre-Administration Email

Attachment 7c: NBCCEDP Quarterly Program Update Administration Email

Attachment 7d: NBCCEDP Quarterly Program Update Reminder Email

Attachment 8: NBCCEDP Service Delivery Projection Worksheet

Attachment 8a: NBCCEDP Service Delivery Projection Worksheet (screenshots)

Attachment 9: MDE Data Definitions

Attachment 10: Institutional Review Board Approval

Attachment 11: 60-Day Federal Register Announcement

Attachment 11a: 60-Day FRN Public Comment and CDC Response

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

B1. Respondent Universe and Sampling Methods

The respondent universe is comprised of the 70 recipients of the Centers for Disease Control and Prevention (CDC) National Breast and Cervical Cancer Early Detection Program (NBCCEDP) funded under Program Announcement CDC-RFA-DP22-2202 (hereafter DP22-2202). Recipients include states and the District of Columbia; U.S. territories; and tribes and tribal organizations. The information collection efforts described concern the entire universe of potential respondents (see Table B.1). As collecting information from the entire population of respondents is feasible, a sampling strategy will not be employed.

This revision of OMB No. 0920-1046 is being proposed in order to monitor and evaluate program implementation and outcomes. In particular, processes related to implementation of evidence-based interventions (EBIs) in partner health systems will be monitored and a primary outcome of interest – breast and cervical cancer screening rates within partner health system clinics - will be evaluated. DP22-2202 requires that CDC monitor and evaluate NBCCEDP processes and outcomes.

Table B.1. Potential Respondent Universe

State or Tribe Health Departments/University Recipients	Potential Respondent	N
NBCCEDP Recipients	Program Directors/Program Coordinators	70
Total Universe of Potential Respondents		70

B2. Procedures for the Collection of Information

Information will be collected in five forms. First, an online survey will be distributed to all individuals within the respondent universe (Attachment 5a). Eligible respondents include the NBCCEDP program director, program coordinator, or other designated official of the program performing day-to-day managerial activities (N=70). We anticipate only one response per recipient. An introductory email notification (Attachment 5b) will be sent to all NBCCEDP program directors informing them of the planned information collection, announcing the dates the survey will remain open, and providing relevant web-links to the survey instrument. Recipients will be encouraged to have the person most familiar with the day-to-day operations of the program complete the survey. CDC will not collect personal information on the respondent - only the name of the recipient in which the responder is employed will be collected. Respondents will have a period of 42 days (30 business days) to complete the survey. We estimate the time burden to be no more than 56 minutes per recipient for the NBCCEDP Recipient Survey. A reminder email that notes the deadline for responding will be sent to program directors in non-responder states/tribes/universities 10 days before information collection ends (Attachment 5c). Results of the information collection, in the form of recipient-specific and summary reports, will be disseminated once analysis is complete.

The second information collection involves NBCCEDP clinic-level data elements (Attachment 6a). NBCCEDP program directors/program managers/data managers will submit aggregate clinic-level data for each of their health system partner clinics (average of six per recipient) annually via a web-based instrument during an established time period following the end of each program year. An introductory email notification will be sent to all NBCCEDP program directors informing them of the information collection and due date (Attachment 6b). A reminder email that notes the deadline will be sent to program directors 10 days before data collection period ends (Attachment 6c). All information will be collected and reported in aggregate for each clinic. No patient-level information will be collected. We estimate the time burden to be no more than 45 minutes per clinic and estimate an average of 6 responses per recipient annually for breast cancer activities and 6 responses per recipient annually for cervical cancer activities. Results will be used to gauge progress in reaching the primary outcome of interest – increased breast and cervical cancer screening.

The third information collection, the Quarterly Program Update (QPU) involves program-level data (Attachment 7a). The QPU is an online survey that will be distributed to all individuals within the respondent universe; namely, the program director/program manager for each recipient program (N=70). We anticipate four responses per recipient per program year (one response following the end of each quarter - October, January, April, and July). One week prior to administration, an introductory email informing them of the forthcoming information collection, including the scheduled date of delivery for the survey and due date for completion (Attachment 7b). Recipients will be encouraged to have the person most familiar with the day-to-day operations of the program complete the survey. At the start of administration, respondents will receive an additional email (Attachment 7c) providing instructions for completing the program update survey and a web link to access the information collection. Respondents will have a period of ten business days to complete the survey. A reminder email (Attachment 7d) that notes the deadline for responding will be sent to all non-responders ten business days after information collection begins. Results of the information collection, including recipient-specific and aggregate reports, will be shared with internal CDC staff only to inform tailored TA and guidance efforts.

The fourth information collection, the Service Delivery Projection Worksheet, is an online instrument that collects program-level estimates for the number of women expected to receive clinical services for breast and/or cervical cancer during that program year (Attachment 8a). The respondent universe includes the program director/program manager for the recipient program (N=70). Recipients are required to submit service delivery projects with their applications and continuing applications each year. Results will be used to inform CDC’s tailored TA and training.

The fifth information collection, the Minimum Data Elements (MDEs), includes aggregate screening and diagnostic follow-up data for the breast and cervical services they provide (Attachment 9). Recipients submit a MDE data file and an accompanying submission narrative semi-annually to the CDC through its data management contractor on April 15 and October 15. As a longstanding program, the majority of recipients are familiar with the cyclical process involved in MDE data collection and reporting. All MDE submission files must be submitted electronically using the secure nbccedp.org web site. Recipients must run their data through the MDE Edits Application supplied by the data contractor prior to submission. The MDE Edits Application performs basic validation routines and reports on invalid values, missing items, and cross-item edits. The MDE Edits Application can only be run on an MDE data file. The MDE file must first be sorted by the unique Patient ID. Recipients are reminded that data should be edited on a routine basis (weekly, monthly, etc.), not solely at the time of submission. An explanation of problem areas should be highlighted in the Submission Narrative. A current version of the MDE Edits Application is available for recipients to download from the nbccedp.org web site.

B3. Methods to Maximize Response Rates and Deal with No Response

Advance notifications (Attachments 5b, 6b, 7b) and a reminder emails (Attachments 5c, 6c, 7d) are used to maximize response rates for the information collections. The notifications will be sent to the respondents via emails generated by the web-based survey software. These communications will be signed by the CDC Branch Chief of the Program Services Branch.

The purpose of this information collection is to identify and monitor implementation activities and changes in the primary outcome of interest – breast and cervical screening rates in grantees’ partner health systems. The information collection will also identify training and technical assistance needs of state, tribal and university grantees. These monitoring activities will help to identify successful activities that need to be maintained, replicated, or expanded, as well as provide insight into areas that need improvement. Higher response rates will yield more reliable information; however, no scientific inferences will be made.

B4. Tests of Procedures or Methods to be Undertaken

The Annual NBCCEDP Survey, the Clinic-Level Data Collection Instruments, the QPU, and the NBCCEDP Service Delivery Projection Worksheet pilot tested by public health professionals to assess the clarity of questions and response categories, variable definitions, and the estimated time required to complete the information collection (i.e., burden) by item, as well as testing the usability of the web instruments. Feedback obtained via pilot testing was incorporated into final development of each instrument. The burden estimate for the revised annual survey was updated to reflect an increased number of survey questions. The burden estimates for the clinic-level data collection and the MDEs remained the same.

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

The information collection was designed by a project team from CDC’s Division of Cancer Prevention and Control. Colleagues from University of Washington and University of Colorado provided additional consultation. Staff from Information Management Services (IMS) will collect and analyze data. Statistical consultation will be provided by CDC statisticians and Bill Helsel.