[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Notices]
[Pages 36214-36215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0909; Docket No. CDC-2020-0070]


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.

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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: 404-639-7570; Email: 
[email protected].

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 Sec.  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

[[Page 36215]]

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
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Public sector organizations     DPRP Application              90               1               1              90
 that deliver type 2 diabetes    Form.                       290               2               2           1,160
 prevention programs.           DPRP Evaluation
                                 Data.
Private sector organizations    DPRP Application             210               1               1             210
 that deliver type 2 diabetes    Form.                     1,304               2               2           5,216
 prevention programs.           DPRP Evaluation
                                 Data.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           6,676
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-12810 Filed 6-12-20; 8:45 am]
BILLING CODE 4163-18-P