2020-12810. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on CDC Diabetes Prevention Recognition Program (DPRP). This collection allows CDC to administer the Diabetes Prevention Recognition Program (DPRP) and collects information needed by the Centers for Medicare & Medicaid Services (CMS) to support the Medicare Expanded Model (Medicare Diabetes Prevention Program [MDPP]).

DATES:

CDC must receive written comments on or before August 14, 2020.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2020-0070 by any of the following methods:

• Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
• Mail: Jeffrey Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. 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;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. 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 submissions of responses.

5. Assess information collection costs.

Proposed Project

CDC Diabetes Prevention Recognition Program (DPRP)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC's Division of Diabetes Translation (DDT) established and administers the National DPP's Diabetes Prevention Recognition Program (DPRP), which recognizes organizations that deliver diabetes prevention programs according to evidence-based requirements set forth in the “Centers for Disease Control and Prevention Diabetes Prevention Recognition Program Standards and Operating Procedures” (DPRP Standards). Additionally, the Centers for Medicare and Medicaid Services (CMS) Medicare Diabetes Prevention Program (MDPP) expansion of CDC's National DPP was announced in early 2016, when the Secretary of Health and Human Services determined that the Diabetes Prevention Program met the statutory criteria for inclusion in Medicare's expanded list of healthcare services for beneficiaries (https://innovation.cms.gov/​initiatives/​medicare-diabetes-prevention-program/​). This is the first time a preventive service model from the CMS Innovation (CMMI) Center has been expanded. After extensive testing of the DPP model in 17 sites across the U.S. in 2014-2016, CMS proposed the MDPP in Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh § 424.59), authorizing CDC-recognized organizations to prepare for enrollment as MDPP suppliers beginning in January 2018 in order to bill CMS for these services. Only organizations in good standing with the CDC DPRP are eligible as MDPP suppliers. CDC continues to work with CMS to support the MDPP.

CDC requests an additional three years of OMB approval to continue collecting the information needed to administer the DPRP and information needed by CMS to support the MDPP benefit. Based on experience with the DPRP from 2011-2020, including data analysis, and feedback from applicant organizations and internal and external partners, CDC plans to revise the DPRP Standards and the associated information collection.

Key changes are a direct result of DPRP data analyses and discussion with National DPP stakeholders, including those serving vulnerable populations. Key changes allow for the optional collection of Hemoglobin A1C levels, and for weight/physical activity minutes to be combined (a new method), to determine Full recognition; the required collection of Application Delivery Mode questions; revised organizational type information; program enrollment motivation/enrollment source information; adding Gender; and the removal of Session ID.

Three data elements have been minimally revised and no other data elements have been added to the one-time application form; and, three elements have been revised, one has been deleted, and four have been added to the evaluation data elements, as per below:

Application Form:

(1) Delivery Mode—follow-up questions (revised)

(2) Class Type (revised)

(3) Organization Type (revised)

Evaluation Data Elements:

(4) Enrollment Motivation (new)

(5) Enrollment Source (new)

(6) Session ID (deleted)

(7) HBA1C Value (new)

(8) Participant's Gender (new)

During the period of this Revision, CDC estimates receipt of approximately 300 DPRP application forms per year. The estimated burden per one-time, up-front application response is one hour (annualized to 300 hours one-time across all new organizations). In addition, CDC estimates receipt of semi-annual evaluation data submissions from the same 300 additional organizations per year; estimated at two hours per response. The total estimated average annualized evaluation burden to respondents is 6,676 hours. This includes an estimate of the time needed to extract and compile the required data records and fields from an existing electronic database, review the data, create or enter a data file in the required format (i.e., CSV file), and submit the data file via the National DPP website for upload into the DPRP Data Portal. The estimated burden per response is modest since the information requested for DPRP recognition is routinely collected by most organizations that deliver lifestyle change programs for their own internal evaluation and possible insurance reimbursement purposes, including Medicare under the MDPP benefit. Participation in the DPRP is voluntary, data are de-identified, no Personally Identifiable Information (PII) is collected by CDC, and there are no costs to respondents other than their time. CDC is requesting a three-year approval.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Public sector organizations that deliver type 2 diabetes prevention programs	DPRP Application Form DPRP Evaluation Data	90 290	1 2	1 2	90 1,160
Private sector organizations that deliver type 2 diabetes prevention programs	DPRP Application Form DPRP Evaluation Data	210 1,304	1 2	1 2	210 5,216
Total					6,676

Jeffrey M. Zirger,

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