2019-05155. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Formative and Summative Evaluation of Scaling the National Diabetes Prevention Program (National DPP) in Underserved Areas to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on October 4, 2018 to obtain comments from the public and affected agencies. CDC received and responded to five sets of unique public comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Formative and Summative Evaluation of Scaling the National Diabetes Prevention Program (National DPP) in Underserved Areas (OMB No. 0920-1090, exp. 12/31/2018)—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The CDC-led National Diabetes Prevention Program (DPP) is a partnership of public and private organizations working collectively to build the infrastructure for nationwide delivery of an evidence-based lifestyle change program to prevent or delay type 2 diabetes among adults with prediabetes. The National DPP lifestyle change program is founded on the science of the Diabetes Prevention Program research study and several translation studies that followed, which showed that making modest behavior changes helped people with prediabetes lose 5% to 7% of their body weight and reduce their risk of developing type 2 diabetes by 58% (71% for people over 60 years old). From 2012 to 2017, CDC funded six national organizations through a cooperative agreement to establish and expand multistate networks of over 200 program delivery organizations that were able to meet national standards and achieve the outcomes proven to prevent or delay onset of type 2 diabetes. CDC has conducted a formative and summative evaluation of this program and used the evaluation findings and lessons learned to provide data-driven technical assistance to the grantees and other organizations delivering the National DPP lifestyle change program. The data and lessons learned from DP12-1212 were also used to inform decision-making and policy, including the development of the Centers for Medicare & Medicaid Services (CMS) Medicare Diabetes Prevention Program (MDPP). As of April 1, 2018, the MDPP Expanded Model provides coverage for the National DPP lifestyle change program for eligible Medicare beneficiaries.

Despite the fact that over 1,700 CDC-recognized organizations in 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, and other U.S.-affiliated island jurisdictions/territories offer the National DPP lifestyle change program, there are still many geographic areas with few, or no, in-person delivery programs. In addition, some populations, including Medicare beneficiaries, men, African-Americans, Asian-Americans, Hispanics, American Indians, Alaska Natives, Pacific Islanders, and people with visual impairment or physical disabilities, are under-enrolled relative to their estimated numbers and disease burden. To address these gaps, CDC funded a new, five-year cooperative agreement with ten new national organizations in September 2017, “Scaling the National DPP in Underserved Areas” (DP17-1705). CDC funded 10 national organizations with affiliate program delivery sites in at least three states, each to start new CDC-recognized organizations in underserved areas and to enroll both general and priority populations in new or existing CDC-recognized organizations. The DP17-1705 grantees will work on activities designed to accomplish three main goals:

(1) Build the infrastructure in underserved areas necessary to deliver the National DPP lifestyle change program to the general population and to priority populations, including Medicare beneficiaries, men, African-Americans, Asian-Americans, Hispanics, American Indians, Alaska Natives, Pacific Islanders, and non-institutionalized people with visual or physical disabilities;

(2) Tailor and adapt the program to address the unique needs and challenges of the enrolled participants; and

(3) Provide participants with specialized support needed to successfully complete the program and achieve 5-7% weight loss. Through this new cooperative agreement, it is anticipated that enrollment, retention, and achievement of 5-7% weight loss in the targeted populations will increase.

At this time, CDC requests an additional three years of OMB approval to continue collecting information needed to evaluate the effectiveness of CDC's funding for the new grantees. The data collection will allow CDC to continue to provide data-driven, tailored programmatic technical assistance to ensure continuous quality improvement for each year of the cooperative agreement. A number of additional changes to the evaluation forms are proposed based on the public comments received from the previously published notice on October 4, 2018 to reduce burden on respondents. Evaluation data elements have been modified accordingly to ensure that reporting and evaluation requirements are consistent with the aims of the new cooperative agreement and reflect lessons learned from the original funded national organizations and their affiliate delivery sites. Also, the method of data collection has changed from an Excel spreadsheet to a web-based data system to allow for real-time feedback and technical assistance. The estimated reporting burden has increased and is expected to vary between three and five hours with an average of four hours per grantee response (increased from average of three hours in the previous notice), and between five and seven hours with an average of six hours per affiliate delivery site response (increased from an average of five hours in the previous notice). These estimated burden hours include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and entering data in the web-based data system. The number of respondents will increase with the increased number of grantees. These changes result in a net increase of 478 annualized burden hours. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
National DPP Affiliate Delivery Sites	Evaluation Form for Sites	100	1	6
National DPP Grantees	Evaluation Form for Grantees	10	1	4

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.