[Federal Register Volume 84, Number 205 (Wednesday, October 23, 2019)]
[Notices]
[Pages 56813-56816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living


Agency Information Collection Activities; Submission for OMB 
Review; Public Comment Request; Chronic Disease Self-Management 
Education Program; OMB# 0985-0036

AGENCY: Administration for Community Living (ACL), HHS.

ACTION: Notice.

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SUMMARY: The Administration for Community Living is announcing that the 
proposed collection of information listed above has been submitted to 
the Office of Management and Budget (OMB) for review and clearance as 
required under the Paperwork Reduction Act of 1995. This 30-Day notice 
collects comments on the information collection requirements related to 
ACL's Chronic Disease Self-Management Education grant program (Proposed 
Extension with Changes of a Currently Approved Collection [ICR Rev]).

DATES: Submit written comments on the collection of information by 
November 22, 2019.

ADDRESSES: Submit written comments on the collection of information by:
    (a) Email to: [email protected], Attn: OMB Desk Officer 
for ACL;
    (b) Fax to 202.395.5806, Attn: OMB Desk Officer for ACL; or
    (c) By mail to the Office of Information and Regulatory Affairs, 
OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235, 
Washington, DC 20503, Attn: OMB Desk Officer for ACL.

FOR FURTHER INFORMATION CONTACT: Kristie Kulinski 
([email protected]) or (202) 795-7379.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has 
submitted the following proposed collection of information to OMB for 
review and clearance. The ``Empowering Older Adults and Adults with 
Disabilities through Chronic Disease Self-Management Education (CDSME) 
Programs'' cooperative agreement program has been financed through the 
Prevention and Public Health Fund (PPHF). The statutory authority for 
cooperative agreements under the most recent program announcement (FY 
2019) is contained in the Department of Defense and Labor, Health and 
Human Services, and Education Appropriations Act, 2019 and Continuing 
Appropriations Act, 2019, Public Law 115-245; Public Health Service 
Act, 42 U.S.C. 300u-2 (Community Programs) and 300u-3 (Information 
Programs); and the Patient Protection and Affordable Care Act, 42 
U.S.C. 300u-11 (Prevention and Public Health Fund). The Empowering 
Older Adults and Adults with Disabilities through CDSME Programs 
initiative supports a national resource center and awards competitive 
grants to deliver and sustain evidence-based CDSME interventions.
    OMB approval of the existing set of data collection tools expires 
on October 31, 2019 (OMB Control Number 0985-0036). This data 
collection continues to be necessary for monitoring program operations 
and outcomes. ACL proposes to use the following tools: (1) Semi-annual 
program reports to monitor grantee progress; and (2) a set of tools 
used to collect information at each program completed by the program 
facilitators (Program Information Cover Sheet and Attendance Log) and a 
Participant Information Survey completed by each participant to 
document their demographic and health characteristics. ACL is not 
requesting renewal of Host/Implementation Organization Information 
Form. ACL intends to continue using an online data entry system for the 
program and participant survey data. In addition to non-substantive 
formatting edits, minor changes are being proposed to two of the four 
currently approved tools, as indicated below. All changes proposed are 
based on feedback from a focus group that included a sub-set of current 
grantees, as well as consultation with subject matter experts.

Comments in Response to the 60-Day Federal Register Notice

    A notice was published in the Federal Register on July 9, 2019 
(Vol. 84, Number 131; pp. 32746-32747). Thirteen emails were received 
with comments. Based on the comments, some minor modifications were 
made to the proposed survey instruments.
    In addition to the public comments, feedback on the current forms 
was sought from the following:

[[Page 56814]]

     ACL Performance and Evaluation subject matter experts
     National Chronic Disease Self-Management Education 
Resource Center
     One grantee focus group (fewer than nine participants)
    Based on this collective feedback, the following modifications to 
the currently approved forms are being proposed:

                                         Participant Information Survey
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              Topic/issue                           Comment                           ACL response
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Participant ID........................  More than one respondent        Compared to previous versions, the
                                         indicated that the unique       Participant ID is now to be completed
                                         identifier is cumbersome and    by onsite staff and/or program leaders.
                                         presents an opportunity for     The National CDSME Resource Center will
                                         mistakes due to its length.     be providing training and technical
                                         Also a comment that the         assistance on the best strategies for
                                         change may make it difficult    documenting the Participant ID. The
                                         to evaluate at the individual   change is primarily driven by increased
                                         level across years.             attention to the application of the
                                                                         highest standards for safeguarding data
                                                                         collected by our grantees. After
                                                                         extensive review of evidence-based
                                                                         program data collection processes, ACL
                                                                         and the Resource Center are working to
                                                                         elevate standards to ensure the privacy
                                                                         and security of all data collected from
                                                                         participants. As such, the use of the
                                                                         existing Participant ID, which includes
                                                                         components of the participants' names
                                                                         and year of birth, could potentially
                                                                         provide clues into the person's
                                                                         identity, especially if coupled with
                                                                         other demographic data.
Provider Referral.....................  Specific to Question #1 (Did    ACL will incorporate this suggested
                                         your health care provider       revision.
                                         suggest that you take this
                                         program?), replace the word
                                         ``take'' with ``attend.''
Sex/Gender............................  More than one respondent        As a federal agency, ACL references the
                                         suggested the incorporation     American Community Survey (implemented
                                         of a non-binary response        by the Census Bureau) as a benchmark
                                         option, in addition to male/    for demographic questions. To remain
                                         female.                         consistent with the U.S. Census/
                                                                         American Community Survey, ACL will
                                                                         continue to use male/female response
                                                                         options.
                                        Suggestion to delineate either  This wording has been used for the past
                                         sex or gender (question         6 years without issue and preserves
                                         currently reads, ``Are you .    data collection continuity.
                                         . . male/female?'')
LGBTQ Identification..................  Suggestion to incorporate a     As noted previously, ACL works to align
                                         question to allow individuals   our data collection with what is
                                         to self-identify their sexual   collected by the U.S. Census around
                                         orientation.                    demographic information. Census does
                                                                         not currently collect information on
                                                                         sexual orientation.
Chronic Conditions List...............  Suggestion to add HIV to        Collection of HIV/AIDS data requires
                                         chronic conditions list.        additional special care in the
                                                                         collection and sharing of this data
                                                                         because persons with HIV/AIDS can face
                                                                         discrimination. In some states, added
                                                                         protections require providers to
                                                                         request additional permission from the
                                                                         patient to share information related to
                                                                         HIV/AIDS status.
                                                                        HIV/AIDS has not been asked in prior
                                                                         iterations of this survey. Centers for
                                                                         Medicare & Medicaid Services (CMS) data
                                                                         from 2017 shows that across all
                                                                         beneficiaries (age 65+), HIV/AIDS
                                                                         accounted for .1% of cases nationally.
                                                                         The goal is not to capture an
                                                                         exhaustive list of chronic conditions;
                                                                         rather, the most common based the
                                                                         public data and the experience of
                                                                         current/prior grantees. This question
                                                                         also allows participants to select
                                                                         `Other' (without an open-ended
                                                                         response).
Social Isolation                        Multiple comments received, as
                                         detailed below:
                                        Truncate Question #16 (How      The item stems from validated tools in
                                         often do you feel lonely or     the National Institutes of Health's
                                         isolated from those around      PROMIS item bank (v2.0)--Social
                                         you?) to remove ``from those    Isolation. The original version is
                                         around you'' at end.            written in the first person. Loneliness
                                                                         was added to improve literacy (reduce
                                                                         grade level)
                                        Question #16 (and               It is also an adaptation from the UCLA
                                         corresponding post-test         Loneliness Scale (v3, #14). ``How often
                                         Question #3) adds to the        do you feel isolated from others?''
                                         survey length and may           (Never to Always), which has been
                                         perceived by some as            extensively used for decades (Russell,
                                         intrusive. Additionally,        1996). It continues to be validated
                                         wording may be off-putting      with older adults (Ausin et al, 2019;
                                         for participants who are        Domenech-Abella, et al, 2017).
                                         expecting a positive,
                                         strengths-based experience.
                                        Specific to post-test Question  The item has also been used successfully
                                         #3, comment that item is not    by CMS in social screening efforts
                                         likely to show change from      (Accountable Health Communities Health-
                                         pre- to post-, especially       Related Social Needs Screening), as
                                         given the negative direction.   well as Kaiser Permanente.
                                         Suggestion to ask at post-
                                         test only and frame as
                                         ``After taking this class,
                                         how much more connected to
                                         others do you feel?'' or
                                         something similar.

[[Page 56815]]

 
                                        Comment that a single social    ACL appreciates the suggestion to
                                         isolation question may not      collect more data but has decided in
                                         provide useful information.     the interest of balancing data
                                         Suggestion to include sub-      collection and burden to not include
                                         questions specific to           additional elements on the survey.
                                         companionship, worry about
                                         being alone, shared interests
                                         and ideas, and participation
                                         in social clubs or religious
                                         groups.
Chronic Conditions Language...........  Suggestion to replace           ACL appreciates that ``ongoing'' may be
                                         ``chronic'' health              considered synonymous with ``chronic'';
                                         condition(s) with ``ongoing''   however, we will continue to use the
                                         health condition(s).            term chronic, as this is the vernacular
                                                                         generally used within the U.S.
                                                                         Department of Health and Human Services
                                                                         (e.g., Centers for Disease Control and
                                                                         Prevention, Centers for Medicare &
                                                                         Medicaid Services, etc.).
For Whom Attending Program............  Comment that Question #12 (For  ACL agrees with this comment; we will
                                         whom are you attending this     remove the question from the survey.
                                         program?) lengthens the
                                         questionnaire without
                                         substantial benefit (purpose
                                         is unclear).
Disability Status.....................  Proposed revision to Question   The six-item set of questions used in
                                         #15 includes three sub-parts    the American Community Survey (ACS) are
                                         to independently assess         the minimum standard for disability
                                         various facets of disability    survey questions. Questions and answers
                                         status; the current version     in this set cannot be changed. The six
                                         combines all three parts into   questions define disability from a
                                         a single item. Suggestion to    functional perspective and are
                                         keep question as is (single     collectively a meaningful measure of
                                         item).                          disability for data collection and
                                                                         reporting.
                                        A comment was received that     Edits initially proposed by ACL utilize
                                         suggested using the Behavior    five of the six BRFSS questions
                                         Risk Factor Surveillance        specific to disability status (hearing,
                                         System (BRFSS) questions to     vision, mobility, self-care, and
                                         assess disability.              independent living). ACL will add the
                                                                         question related to cognition (Because
                                                                         of a physical, mental, or emotional
                                                                         condition, do you have difficulty
                                                                         concentrating, remembering, or making
                                                                         decisions?).
Confidence Managing Chronic Conditions  Suggestion to revise wording    ACL appreciates this comment and
                                         in Question #17 (How            proposes revising the language to read,
                                         confident are you that you      ``How sure are you that you can manage
                                         can manage your chronic         your condition so you can do the things
                                         conditions?) to reference       you need and want to do?'' to be
                                         both physical and emotional     inclusive of both physical and
                                         concerns.                       emotional health concerns.
                                        Positive comment received
                                         regarding inclusion of
                                         question at post-test
                                         (Question #2) to assist with
                                         evaluating change over time.
Health Status.........................  Specific to post-test Question  ACL is interested in utilizing this
                                         #1 (In general, would you say   question to assess changes in self-
                                         that your health is), comment   rated health at pre/post intervention.
                                         that this question seems        If changes are not detected, we will
                                         unnecessary unless the          consider removal of this item during
                                         underlying assumption is that   the next data collection renewal.
                                         CDSME changes self-perceived
                                         health.
                                        Positive comment received
                                         regarding inclusion of self-
                                         rated health at post-test
                                         (Question #1) to assist with
                                         evaluating change over time.
Satisfaction Question.................  Request to add satisfaction     A satisfaction question has not been
                                         question back into the post-    part of the required data collection
                                         survey.                         elements, though some grantees choose
                                                                         to collect this information
                                                                         voluntarily.
Additional Questions..................  Suggestion to incorporate       ACL appreciates the suggestion to
                                         questions specific to: Formal   collect more data but has decided in
                                         referral by physician,          the interest of balancing data
                                         weight, exercise,               collection and burden to not include
                                         medications, and health care    additional elements on the survey.
                                         utilization.
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                                         Program Information Cover Sheet
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              Topic/issue                           Comment                           ACL response
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Funding Source........................  Specific to Question #7,        ACL suggests that local program
                                         program facilitators may not    coordinators complete this question
                                         know the funding source         prior to submitting form for data
                                         (determined by other program    entry.
                                         staff).
                                        Another comment was received    ACL will incorporate this revision.
                                         suggesting that ACL clarify
                                         that the intent of question
                                         is to capture direct sources
                                         of funding support (vs.
                                         indirect/global support).
                                        Another comment was received    ACL will work with the National CDSME
                                         that it would be helpful to     Resource Center to develop a brief
                                         have a description of funding   overview of the various funding sources
                                         sources.                        listed. Grantee can distribute this
                                                                         information to their partners.

[[Page 56816]]

 
National Resource Center and National   Suggestion to use a term other  ACL awarded a five-year cooperative
 Database Language.                      than ``chronic disease'', as    agreement in 2016 that specifically
                                         there are many programs in      designates a National Chronic Disease
                                         the menu of health promotion    Self-Management Education (CDSME)
                                         programs.                       Resource Center. This resource center
                                                                         houses the National CDSME Database. ACL
                                                                         may consider modifying the name of the
                                                                         National CDSME Resource Center if/when
                                                                         it is re-competed in 2021; however,
                                                                         such a change is not appropriate at
                                                                         this time.
Consent to Receive Information from     A comment was received that     Requesting this consent through a
 National CDSME Resources Center.        the addition of this question   standard data collection form is the
                                         seems unnecessary to have as    most direct manner ACL can use to
                                         a standard question, since it   ensure that program facilitators can
                                         should only be asked once of    opt in to receiving technical
                                         each leader. A suggestion was   assistance communications from our
                                         made to ask this question at    National CDSME Resource Center. ACL is
                                         leader trainings instead.       unable to require grantees to share
                                                                         information collected via facilitator
                                                                         trainings.
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                                                 Attendance Log
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              Topic/issue                           Comment                           ACL response
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Format................................  Suggestion to modify format     Participant signatures are not required
                                         from portrait to landscape to   by ACL with respect to this data
                                         accommodate participant         collection effort (and ACL does not
                                         signature.                      retain the names of CDSME
                                                                         participants). If other partners/
                                                                         funders require participant signature,
                                                                         grantee should modify the format
                                                                         accordingly.
Program Name..........................  Suggestion to add program name  The very top of the form has an editable
                                         to form.                        field (Your Program Name) that can be
                                                                         customized by the grantee.
Participant Phone/Email Address.......  Suggestion to collect           ACL does not collect any personally
                                         participant phone number and    identifiable information from
                                         email address for               participants. Grantees can
                                         facilitators to use for         independently request this information
                                         reminder follow-up.             from participants as needed for
                                                                         programmatic reminders.
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    The proposed data collection forms may be found on the ACL website 
at https://www.acl.gov/about-acl/public-input.
    Estimated Program Burden: ACL estimates the burden of this 
collection of information as follows:

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                                           Number of          Responses per          Hours per    Annual  burden
  Respondent/data collection activity     respondents          respondent            response          hours
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Program facilitators (Program                    1,350  Once per program........             .33           445.5
 Information Cover Sheet, Attendance
 Log).
Program participants (Participant               13,500  1.......................             .20           2,700
 Information Survey).
Data entry staff (Program Information               65  Once per program times               .17           229.5
 Cover Sheet, Attendance Log,                            1,350 programs.
 Participant Information Survey).
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    Total.............................  ..............  ........................  ..............           3,375
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    Dated: October 16, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019-23121 Filed 10-22-19; 8:45 am]
BILLING CODE 4154-01-P