[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50098-50099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-18-1090; Docket No. CDC-2018-0089]


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 proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
revision of information collection project titled Formative and 
Summative Evaluation of Scaling the National Diabetes Prevention 
Program (National DPP) in Underserved Areas. This revision is to allow 
CDC to continue collecting the information needed to assess the 
effectiveness of its program, ``Scaling the National DPP in Underserved 
Areas'', and to collect more targeted information on CDC grantees' 
success in reaching both general and priority populations in 
underserved areas.

DATES: CDC must receive written comments on or before December 3, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0089 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. 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 M. 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

    Formative and Summative Evaluation of Scaling the National Diabetes 
Prevention Program in Underserved Areas (OMB No. 0920-1090, exp. 12/31/
2018)--Revision--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 (National 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 are 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

[[Page 50099]]

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 1800 CDC-recognized organizations in 50 
states, the District of Columbia, Puerto Rico, and the Virgin Islands 
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 ten 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 goals for 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 
changes to the evaluation forms are proposed to ensure that reporting 
and evaluation requirements are consistent with the aims of the new 
cooperative agreement and reflect the lessons learned from the original 
funded national organizations and their affiliate delivery sites. 
Evaluation data elements have been added or modified accordingly. Also, 
the method of data collection has converted from using an Excel 
spreadsheet to a web-based data system to allow for real-time feedback 
and technical assistance.
    The reporting burden of this collection of information is estimated 
to vary between two and four hours with an average of three hours per 
grantee response (decreased from 12 hours), and between four and six 
hours with an average of five hours per affiliate delivery site 
response (increased from an average of 45 minutes per response). These 
estimated burden hours include the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information by 
the grantee and affiliate delivery site to submit information directly 
to 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 368 annualized burden hours. There are no costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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National DPP Affiliate          Evaluation Form              100               1               5             500
 Delivery Sites.                 for Sites.
National DPP Grantees.........  Evaluation Form               10               1               3              30
                                 for Grantees.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             530
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Jeffrey M. Zirger,
Acting 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.
[FR Doc. 2018-21571 Filed 10-3-18; 8:45 am]
BILLING CODE 4163-18-P