[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24150-24151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-19ARD; Docket No. CDC-2019-0037]


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 information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled ``An Evaluation of CDC's STEADI Older Adult Fall Prevention 
Initiative in a Primary Care Setting.'' This new data collection effort 
is an essential component to determine the impact of CDC's Stopping 
Elderly Accidents, Deaths, and Injuries (STEADI) initiative on falls, 
emergency department visits, and hospitalizations due to falls.

DATES: CDC must receive written comments on or before July 23, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0037 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 Jeffery 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

    Evaluation of CDC's STEADI Older Adult Fall Prevention Initiative 
in a Primary Care Setting--New--National Center for Injury Prevention 
and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

[[Page 24151]]

Background and Brief Description

    Falls are the leading cause of both fatal and non-fatal injuries 
among older adults, defined as age 65 and older. From 2007 to 2016, 
fall death age-adjusted rates increased by 31% with almost 30,000 older 
adults dying as the result of a fall in 2016. The economic consequences 
of falls are significant and growing as the population ages, with 
medical costs of older adult falls estimated at $50 billion. CDC 
created the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) 
initiative to guide health care providers' fall prevention activities 
in the primary care setting.
    This new data collection effort is an essential component to 
determine the impact of CDC's Stopping Elderly Accidents, Deaths, and 
Injuries (STEADI) initiative on falls, emergency department visits, and 
hospitalizations due to falls. It will help CDC determine the impact of 
less resource intense versions of STEADI, and evaluate the process of 
implementing STEADI fall prevention initiative in a primary care 
setting to provide context for the impact evaluations. The study 
population will be limited to adults 65 and older who have an 
outpatient visit during the study period and screen as high risk for 
falls at the selected primary care clinics implementing the STEADI fall 
prevention initiative. The study population for the process evaluation 
will include the clinical implementation staff at the selected clinics 
where the intervention will take place (physicians, physician 
assistants/nurse practitioners, study research nurses, and practice or 
operations manager).
    Two data collection methods will be used; the CDC's Stay 
Independent Fall Risk Screener will be administered to older adult 
patients at selected primary care clinics to determine which older 
adults are at high risk for a fall. Those who screen at high risk will 
be assigned, based on clinic attended and week of attendance, to one of 
three study arms. Patient surveys will be used to determine whether or 
not these patients experience a fall during the study period, are 
treated for a fall, and/or use any fall prevention strategies 
throughout the study period. Four surveys will be administered to each 
patient during a 12-month period: One baseline survey and three follow-
up surveys. Older adults will also be asked to keep track of their 
falls in a monthly falls diary, so they can accurately recall and 
report the information during the 12-month period for the patient 
surveys. The process evaluation interviews will be used to understand 
the attitudes of clinical staff towards the implementation process, 
barriers and facilitators to implementation, and the implementation 
fidelity to core components of the STEADI initiative. Descriptive 
statistics and cross tabulations will be used to describe quantitative 
data from the patient survey and process evaluation data. Risk ratios 
of the effect of the intervention on post-intervention falls will be 
calculated comparing intervention and control groups while controlling 
for demographic, health, attitude, and behavior variables.
    The data collected from this study will be used to: Demonstrate the 
impact of STEADI and different components of STEADI on falls and fall 
injuries in a primary care setting and improve the implementation of 
STEADI in a primary care setting. There are no costs to the respondents 
other than their time. The total estimated annualized burden hours is 
3,836.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent        (hours)         (hours)
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Patient.......................  Stay Independent           5,093               1           10/60             849
                                 Fall Risk
                                 Screener.
                                Patient Consent          * 1,333               1           12/60             267
                                 Form.
                                Patient Baseline           1,000               1           15/60             250
                                 Survey.
                                Patient Follow-              896               3           15/60             672
                                 up Survey.
                                Patient Falls                896              12           10/60           1,792
                                 Diary.
Nurse.........................  Nurse Interview                1               1               1               1
                                 Guide/Consent.
Physician/Physician Assistants/ Provider                       3               1               1               3
 Nurse Practitioners.            Interview Guide/
                                 Consent.
Clinic operations Manager.....  Operations                     2               1               1               2
                                 Manager Guide/
                                 Consent.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,836
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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. 2019-10838 Filed 5-23-19; 8:45 am]
BILLING CODE 4163-19-P