60 day FRN

Attachment B 60 day FRN.pdf

Evaluating the implementation and impact of an opioid medication management program, in a hospital discharge setting, to reduce falls in older adults

60 day FRN

OMB: 0920-1285

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2520

Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices

Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019–01324 Filed 2–6–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–19–19GH; Docket No. CDC–2018–
0116]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 information collection project
titled ‘‘Evaluating the implementation
and impact of a fall prevention program,
including opioid medication
management, in a hospital discharge
setting.’’ This study will evaluate the
implementation and impact of a fall
prevention program in a hospital
discharge setting. Components of the
program will target opioid medication
management in the acute and post-acute
settings, and referral to clinically
effective programs to reduce the risk of
falls and opioid misuse.
DATES: CDC must receive written
comments on or before April 8, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0116 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.
SUMMARY:

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17:23 Feb 06, 2019

Jkt 247001

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 Leroy A.
Richardson, 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
Evaluating the implementation and
impact of a fall prevention program,
including opioid medication
management, in a hospital discharge
setting—New—National Center for

PO 00000

Frm 00034

Fmt 4703

Sfmt 4703

Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Falls are the leading cause of injury,
and injuries leading to death in older
adults. Medications which affect the
central nervous system can cause side
effects that increase the chances of
falling, such as dizziness, sedation,
confusion, blurred vision, and
orthostatic hypotension. Opioids are
strongly associated with increased fall
risk in older adults. When opioids are
taken with other medications, like
benzodiazepines, there can be a
synergistic effect on cognition and
physical function, potentially leading to
a more pronounced injury or
unintentional overdose.
A key intervention in the Centers for
Disease Control and Prevention (CDC)’s
fall prevention program STEADI
(Stopping Elderly Accidents, Deaths,
and Injuries) initiative is medication
management to reduce the fall risk.
Medication review and management,
especially upon care transitions, can
reduce inappropriate opioid use, the
risk of injury, and improve patient
health. This data collection will
evaluate the implementation and impact
of a fall prevention program, including
opioid medication management, in a
hospital discharge setting. Components
of the program will target opioid
medication management in the acute
and post-acute settings and referral to
clinically effective programs to reduce
the risk of falls and opioid misuse. This
data collected will be used to: (1)
Examine post-discharge use of opioids
or alternative therapies for pain
management among older adult
patients, (2) examine post-discharge
compliance and follow up by older
adults with primary care doctors and/or
specialist referrals for pain management
and fall prevention efforts, (3) identify
rate of readmission for a fall by level of
patient compliance and follow-up postdischarge, (4) evaluate the uptake of the
program by clinical staff, and (5)
identify opportunities for program and
process improvement.
The study population will be limited
to older adults (65 years and older)
considered high risk due to opioid use
identified during discharge at a specific
Medical Center inpatient. The study
population for the clinical staff
evaluation questionnaire will be limited
to the same Medical Center clinical staff
(i.e., nurses, pharmacists, physicians)
involved in older-adult patient pain
management and post-discharge
planning that work in hospital units
where this program has been

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07FEN1

2521

Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
implemented. The study population for
the primary care provider postdischarge questionnaire will be Primary
Care Providers (PCP) associated with the
same Medical Center who care for older
adult study patients discharged each
month. Four questionnaires will be
administered. (1) The Pre-discharge
patient questionnaire will be used to
survey older adults in the hospital
(before discharge). (2) The Post-

discharge patient questionnaire will be
used to survey the older adults that
completed the pre-discharge survey
three additional times (at 14, 30 and 60
days) after being discharged from the
Medical Center. (3) The Clinical staff
evaluation questionnaire will be used to
survey clinical staff at the Medical
Center. (4) The Primary Care Provider
(PCP) post-discharge questionnaire will
be used to survey primary care

providers involved in the care of
patients discharged. The open-ended
questions will be analyzed to identify
themes, and results will be presented by
theme. Frequencies, cross-tabs, and
regression analysis will be used for
categorical questions.
The total estimated annualized
burden hours is 622. There are no costs
to respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours
(in hours)

Type of respondent

Form name

Older adult Patients ...........................

Survey correspondence to patients
and consent form for patients.
Pre-discharge Patient ......................
Post-discharge Patient .....................
Survey correspondence to clinical
staff.
Clinical staff evaluation Questionnaire.
Survey correspondence to primary
care providers.
PCP post discharge survey .............

2,299

1

2/60

77

800
800
100

1
3
1

10/60
10/60
1/60

133
400
2

50

1

5/60

4

100

1

1/60

2

50

1

5/60

4

..........................................................

........................

........................

........................

622

Clinical staff .......................................
(Pharmacists, nurses, physicians) ....
Primary care providers (PCP) ...........

Total ...........................................

Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019–01331 Filed 2–6–19; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–19–19IJ; Docket No. CDC–2018–
0118]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS)
ACTION: Notice with comment period.
AGENCY:

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

SUMMARY:

VerDate Sep<11>2014

17:23 Feb 06, 2019

Jkt 247001

proposed information collection project
titled Improving Performance
Measurement and Monitoring by CDC
programs. The purpose of this project is
to evaluate the progress of CDC partners
that receive awards distributed via
cooperative agreements from the Office
of Grants Services (OGS)
DATES: CDC must receive written
comments on or before April 8, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0118 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,

PO 00000

Frm 00035

Fmt 4703

Sfmt 4703

Centers for Disease Control and
Prevention, 1600 Clifton Road, NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].
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,

SUPPLEMENTARY INFORMATION:

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07FEN1


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