05-19827. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-371-5983 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Assessing Diabetes Detection Initiative for Policy Decisions—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Type 2 diabetes is a chronic disease that affects more than 18 million Americans, approximately 5 million of whom do not know that they have the disease. As the disease progresses, it often causes severe complications, including heart disease, blindness, lower extremity arterial disease, and kidney failure. Native Americans, African Americans, Latino Americans, and some Asian Americans and Pacific Islanders are disproportionately affected by diabetes. Identifying persons who have undiagnosed diabetes and treating them could prevent or delay diabetes complications.

In November 2003 the Diabetes Detection Initiative (DDI) was launched in 10 pilot sites around the U.S. to identify a portion of the estimated 5 million people with undiagnosed Type 2 diabetes, targeting specific areas in each of 10 locales in which residents are likely to be at higher risk for Type 2 diabetes. Implementation of the DDI involved distributing a paper-and-pencil risk test. Individuals whose score indicated that they were at an increased risk for diabetes were advised to see their regular doctor (or to schedule an appointment at one of several clinics that had agreed to participate in the DDI) to receive a finger-stick or other tests to confirm whether or not they have diabetes. Whether or not the DDI should be expanded to other communities depends on the health benefits and costs of the program. The CDC is planning to conduct a study to provide this critical information.

The planned study will assess the resources used, the cost per case detected, and the perceived benefit of the DDI to participants. Data for the economic assessment will be obtained by conducting surveys of local DDI implementation teams, leadership at participating health clinics, and patients at participating health clinics. The results of the study will also provide information needed for conducting a more complete cost-effectiveness analysis of screening for undiagnosed diabetes.

The point-of-contact (Implementation team member) in each of the 10 regions will be sent a mail survey to collect information regarding the staff time and other resources used to implement the DDI program (including the staff time and resources used by community-based organizations that participated in the DDI implementation). These planning and implementation activities include participating in meetings and conference calls, recruiting clinics and community-based organizations to participate in the DDI, distributing risk tests, organizing health fairs and other community events, and designing media campaigns to promote the DDI.

The health clinic leadership survey will be mailed to one person at each of the 43 clinics that participated in the DDI implementation. The survey will collect information regarding the costs associated with the clinic's participation in the DDI. These will include the medical costs of providing care to patients who visited the clinic as a result of the DDI, staff time associated with DDI planning and implementation, and any staff time that was devoted to performing finger stick tests at locations other than the health clinic (e.g., health fairs, shopping malls, work sites, housing complexes). Of the 43 clinics to be surveyed, we expect that 30 (70%) will complete the survey.

A computer-assisted in-person interview will be administered to 600 clinic patients—60 in each of the 10 regions in which the pilot DDI was implemented. The survey will collect background information, out-of-pocket medical and non-medical direct health care costs (e.g., co-payments, transportation costs, value of patients' time associated with the clinic visit), and preferred features of a diabetes screening program. There are no costs to respondents other than their time.

Estimate of Annualized Burden Hours

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
Implementation team members	10	1	2	20
Clinic staff	30	1	1	30
Patients at DDI clinics	600	1	20/60	200
Total	640			250

Dated: September 27, 2005.

Betsey Dunaway,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.