Proposed Data Collection Submitted for Public Comment and Recommendations, 32177-32178 [2019-14300]

Download as PDF Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices Jeffrey M. Zirger Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–14303 Filed 7–3–19; 8:45 am] BILLING CODE 4163–18–P 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 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 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. jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:54 Jul 03, 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 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: omb@cdc.gov. 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). PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 32177 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 E:\FR\FM\05JYN1.SGM 05JYN1 32178 Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices 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 semiconvenience 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 Form name Doctors .............................................. Core Elements of Antimicrobial Stewardship in Nursing Homes. Core Elements of Antimicrobial Stewardship in Nursing Homes. Nurse Practitioners ........................... Total ........................................... ........................................................... 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–19–19ACB] Agency Forms Undergoing Paperwork Reduction Act Review jbell on DSK3GLQ082PROD with NOTICES Number of respondents Type of respondents In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled ‘‘The Drug Overdose Surveillance and Epidemiology (DOSE)’’ to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on April 2, 2019 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. VerDate Sep<11>2014 17:54 Jul 03, 2019 Jkt 247001 Frm 00060 Fmt 4703 Average burden per response (in hours) Total burden (in hours) 75 1 30/60 38 25 1 30/60 12 ........................ ........................ ........................ 50 The Office of Management and Budget is particularly interested in comments that: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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 submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, PO 00000 Number of responses per respondent Sfmt 4703 Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Drug Overdose Surveillance and Epidemiology (DOSE)—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description The rapid increase in opioid overdose deaths since 2013, numerous severe fentanyl and fentanyl analog outbreaks occurring since 2015 across the United States, and the declaration of the opioid overdose epidemic as a national public health emergency on October 26, 2017 have highlighted the urgent need to rapidly establish and enhance timely surveillance of suspected drug, opioid, heroin, and stimulant overdoses. These data are critical to inform timely local, state, and regional response, especially to acute and/or widespread multi-state outbreaks. This new data collection effort is an essential component toward reducing the opioid crisis, one of HHS Department’s top priorities. DOSE data is critical to our ability to rapidly identify outbreaks and provide situational awareness of changes in emergency department (ED) visits involving suspected drug, opioid, heroin and stimulant overdoses at the local, state, and regional level. This will E:\FR\FM\05JYN1.SGM 05JYN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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


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