2017-14792. 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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the CDC information collection project titled “CDC Diabetes Prevention Recognition Program (DPRP).” This revision of DPRP Standards and Operating Procedures (i.e., DPRP Standards)will allow continued collection of nationwide, de-identified data against the implementation of the National Diabetes Prevention Programs (National DPPs) using a set of evidence-based standards. CDC uses this data to effectively manage the DPRP.

DATES:

Written comments must be received on or before September 12, 2017.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2017-0053 by any of the following methods:

• Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
• Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

Please note: All public comment should be submitted 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 Leroy A. Richardson, 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

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; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Proposed Project

CDC Diabetes Prevention Recognition Program (DPRP) (OMB Control Number 0920-0909, exp. 12/31/2017)—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 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 will be eligible as MDPP suppliers.

CDC requests an additional three-year 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 2011-2017, and feedback from applicant organizations and internal and external partners, CDC plans to revise the DPRP Standards and the associated information collection.

Key changes relate to incorporation of variables needed to ensure the seamless implementation of the CMS MDPP benefit. The majority of the additional data elements included in the current Standards revision are the result of new CMS requirements for MDPP suppliers. In particular, CMS is requiring de-identified participant-level data submission every 6 months. While data submissions every 6 months are included to align with the CMS MDPP supplier requirements, this change will also benefit organizations that are not MDPP suppliers, as it will allow them to receive more feedback in an effort to make necessary mid-course corrections and successfully achieve either preliminary or full recognition status. Semiannual evaluation of organization performance was part of the initial 2011 OMB approval for CDC's DPRP information collection.

One data element has been revised and eleven additional data elements have been added in either the one-time application form or within the evaluation data elements:

Application Form

(1) Class Type (revised)

(2) Organization Type (new)

(3) Lifestyle Coach Training Entity (new)

(4) CDC Grantee (yes/no) (new)

Evaluation Data Elements

(6) Participant's Education (new)

(7) Delivery Mode (new)

(8) Session ID (new)

(9) Session Type (new)

(10) Lifestyle Coach Medicare National Provider Identification Number as Supplied by CMS (new)

(11) Enrollment Source (new)

(12) Payer Type (new)

Additional changes to the DPRP Standards or DPRP information collection may be requested during the period of the Revision request, as CDC continues discussions with recognized programs and potential applicants and reviews results from ongoing studies.

During the period of this Revision, CDC estimates receipt of approximately 500 DPRP application forms per year. The estimated burden per one-time, up-front application response is 1 hours (annualized to 500 hours one-time across all new organizations). In addition, CDC estimates receipt of semi-annual evaluation data submissions from the same 500 additional organizations per year; estimated at 2 hours per response. The total estimated average annualized evaluation burden to respondents is 7,676 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 Web site. 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 forthcoming MDPP benefit. Participation in the DPRP is voluntary, data are de-identified, no Personally Identifiable Information is collected by CDC, and there are no costs to respondents other than their time. CDC seeks to request a three-year approval.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Avg. burden per response (in hours)	Total burden (in hours)
Public sector organizations that deliver type 2 diabetes prevention programs	DPRP Application Form	150	1	1	150
	DPRP Evaluation Data	350	2	2	1,400
Private sector organizations that deliver type 2 diabetes prevention programs	DPRP Application Form	350	1	1	350
	DPRP Evaluation Data	1,444	2	2	5,776
Total					7,676

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.