[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Pages 32177-32178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-19BCG; Docket No. CDC-2019-0053]


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 
information collection project titled Core Elements of Antimicrobial 
Stewardship in Nursing Homes. The goal of the information collection is 
to assess the impact of an intervention on the knowledge, attitudes, 
practices, and perceived provider-level barriers to appropriate 
antibiotic prescribing in a sample of health care providers in nursing 
homes. The data will be used to monitor the effect of an intervention 
aimed at improving the antibiotic stewardship behaviors of prescribers 
in long-term care settings.

DATES: CDC must receive written comments on or before September 3, 
2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0053 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

    Core Elements of Antimicrobial Stewardship in Nursing Homes--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The purpose of this survey is to follow-up on formative research 
(OMB Control Number 0920-1154), which assessed the knowledge, 
attitudes, practices and perceived provider-level barriers to 
appropriate antibiotic prescribing in a sample of health care providers 
in nursing homes. This survey was developed building upon foundational 
work previously completed. The questions were originally pre-tested 
among a select group (n=9) of prescribers recruited from the 
participating corporations to both obtain responses, as well as 
performing cognitive assessment to ensure clarity and robustness of 
content.
    The preliminary findings suggested that the questions presented 
were clear and correctly understood and that the topics covered were 
meaningful. The inclusion of length of time in practice was 
specifically relevant as preliminary findings from the interviews, 
albeit limited, suggest that a prescriber's approach and attitudes 
surrounding antibiotic prescribing may be impacted by professional 
tenure. Specifically, respondents described that the longer a 
prescriber had been in practice, the more reluctant they were to modify 
their prescribing behaviors.
    General findings consistently centered on the variability in nurse/
provider communication. Themes of poor communication encompassed 
multiple elements. Key themes included: Poor structure of information 
sharing, the role of gatekeepers to the prescriber, insufficient or 
otherwise irrelevant detail, and an absence of therapy recommendation 
from the nurses. Additionally, respondents described the physical 
environment/geographic context that contributed to possible instances 
of over-prescribing: Limited availability of timely or rapid test 
laboratory results, sites with affiliated labs that are closed on the 
weekends (thus requiring a staff member to drive a sample multiple 
hours to the nearest hospital), limited antibiotic options in the 
facility's Emergency Kit (from which staff frequently draw when 
starting a prescription).
    The current phase incorporates the findings from previous 
exploratory work and aims to address the quality of communication 
between the nurses and prescribers while also respecting the rational 
for initial antibiotic initiation. As the decision to initiate an 
antibiotic prescription is largely influenced by factors beyond the 
scope of this project, the current study targeted the role of the 
antibiotic follow-up to engage the prescriber post-prescription to 
reassess

[[Page 32178]]

the appropriateness of the initial prescription. Additional topics were 
identified as important to the respondents as they expressed support to 
include questions that cover individual perceptions of responsibility/
autonomy, the importance of the role of family and other social 
pressures when deciding to make antibiotic decisions, and the process 
of following up with the resident post-prescription. The group of 
respondents were comprised of a semi-convenience sample, with efforts 
to target key administrative and practicing roles within the healthcare 
setting to obtain a diverse and inclusive perspective.
    Information will be used to provide descriptive analysis reports of 
the prescribing climate within long-term care settings. We will use 
these data as comparison to the initial survey deployment to 
characterize any change demonstrated within the current antimicrobial 
stewardship environment with an effort to identify key elements based 
on staff interactions, perceived challenges, and any identifiable gaps 
in knowledge. The specific elements within the survey will be used to 
identify common needs shared across prescribers as areas for further 
training or intervention development (e.g., identified barriers to 
education or training resources will result in a more robust education 
component to be included in future work). While this second survey is 
not intended to establish a direct causal relationship, it does aim to 
capture differences in a pre/post analysis style review without which, 
the initial survey would simply provide a snapshot of current levels of 
knowledge, attitudes, practices and perceived provider-level barriers 
to appropriate antibiotic prescribing.

                                        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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Doctors.......................  Core Elements of              75               1           30/60              38
                                 Antimicrobial
                                 Stewardship in
                                 Nursing Homes.
Nurse Practitioners...........  Core Elements of              25               1           30/60              12
                                 Antimicrobial
                                 Stewardship in
                                 Nursing Homes.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              50
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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. 2019-14300 Filed 7-3-19; 8:45 am]
 BILLING CODE 4163-18-P