Justification for Change

Justification for Change

OMB No. 0920-0571, exp. 1/31/2010

Minimum Data Elements (MDEs) for the

National Breast and Cervical Cancer Early Detection Program (NBCCEDP)

The Centers for Disease Control and Prevention (CDC) requests OMB approval of a change request for the information collection currently entitled “Minimum Data Elements (MDEs) / System for Technical Assistance Reporting (STAR) for the National Breast and Cervical Cancer Early Detection Program (NBCCEDP).” Congress established the NBCCEDP in 1991 and authorized the CDC to provide funding to states for the development and maintenance of early detection programs designed to ensure that under-served, low income, and under-insured women receive access to breast and cervical cancer screening services. The NBCCEDP currently funds 68 grantees including all 50 states, 5 U.S. Territories, 12 American Indian/Alaska Native Organizations and the District of Columbia. The current approval is based on a previous program requirement that NBCCEDP-funded grantees must report clinical data on breast and cervical cancer screening services to the CDC in a minimum data elements (MDE) format semiannually; and must also report program infrastructure data to the CDC via STAR annually.

This Change request describes the following proposed modifications:

1. Discontinue collection of infrastructure information through STAR.

Infrastructure information has been underutilized by the CDC and did not effectively serve the program monitoring and evaluation purposes for which it was intended. Many of the data elements were reported to the CDC as free text information and were difficult to standardize for analyses. As a result, CDC has relaxed the STAR program infrastructure reporting requirements and as of FY 2007, the STAR reporting requirements are not included for the current 5-year award cycle. This modification will significantly reduce burden to respondents.

2. Modify the title of the information collection to reflect discontinuation of STAR.

Self-explanatory; see current title and proposed new title above.

3. Modify the content of the MDE data collection.

NBCCEDP awardees will continue to report clinical screening and follow-up information to CDC in the Minimum Date Elements (MDE) format. This information remains critical for grantee oversight and program administration. The MDE data set was last revised in October 2002 and changes are proposed at this time to reflect changes in policy and clinical practice. The new data elements will allow CDC to monitor clinical follow-up according to currently utilized clinical procedures, to capture costs associated with these procedures and analyze outcomes, and to standardize the MDE data set with the Breast Imaging Reporting and Data System (BI-RADS), a method of classification used by radiologists to interpret and report the results of imaging procedures used in breast cancer screening and diagnosis. Data elements will also be added to support linkage with State Central Cancer Registries. Finally, under-utilized data elements will be deleted and some data elements will be repositioned to improve logical flow. The proposed changes will not affect the previously estimated burden for MDEs.