83_FR_39912 83 FR 39757 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 39757 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 155 (August 10, 2018)

Page Range39757-39758
FR Document2018-17174

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 ``Dental Survey: Improving outpatient antibiotic use through implementation and evaluation of Core Elements of Outpatient Antibiotic Stewardship.'' This information collection request will generate data to assess knowledge, attitudes, practices and perceived barriers to appropriate antibiotic prescribing in a representative sample of dental providers. Results will be used to inform interventions for this specific provider population and support our efforts to improve antimicrobial stewardship within outpatient clinics.

Federal Register, Volume 83 Issue 155 (Friday, August 10, 2018)
[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39757-39758]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17174]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18APX; Docket No. CDC-2018-0066]


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 ``Dental Survey: Improving 
outpatient antibiotic use through implementation and evaluation of Core 
Elements of Outpatient Antibiotic Stewardship.'' This information 
collection request will generate data to assess knowledge, attitudes, 
practices and perceived barriers to appropriate antibiotic prescribing 
in a representative sample of dental providers. Results will be used to 
inform interventions for this specific provider population and support 
our efforts to improve antimicrobial stewardship within outpatient 
clinics.

DATES: CDC must receive written comments on or before October 9, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0066 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

[[Page 39758]]

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

    Dental Survey: Improving outpatient antibiotic use through 
implementation and evaluation of Core Elements of Outpatient Antibiotic 
Stewardship--New Information Collection Request--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Antibiotic resistance is a growing problem that has been shown to 
be a result of wide-spread antibiotic use and misuse. While efforts to 
improve antibiotic use to date have been primarily implemented in the 
inpatient setting, the majority of antibiotics are prescribed in the 
outpatient setting. Up to 50% of all antibiotics prescribed for acute 
respiratory tract infections (ARI) are proposed to be inappropriate. 
Interventions that have been demonstrated to decrease inappropriate use 
include audit-and-feedback, academic detailing, clinical decision 
support systems (CDSS), provider-focused public commitments to reduce 
inappropriate antibiotic use, and delayed antibiotic prescriptions. 
However, current data is limited due to short study timeframes and lack 
of sustainability.
    In a pilot project, phone interviews were conducted with six dental 
providers and three pediatricians, specifically those who could speak 
to the knowledge, attitudes and behaviors of their peers. PRA was 
deemed not applicable by the NCEZID PRA representative for this pilot. 
We identified six dental providers that were recruited for a phone 
interview with our team's healthcare psychologist. Semi-structured 
interviews were used to assess: (1) Knowledge about antibiotic 
prescribing (what constitutes appropriate and inappropriate 
prescribing); (2) the providers current antibiotic prescribing 
practices; (3) beliefs about the consequences of inappropriate and 
appropriate prescribing (e.g., consequences for the provider, for 
individual patients, and for the healthcare system); (4) attitudes 
about antibiotic prescribing (expected negative and positive reactions 
to appropriate prescribing); (5) subjective norms (beliefs related to 
what is ``normal'' antibiotic prescribing for the provider and for 
peers); (6) control beliefs related to appropriate prescribing (factors 
that make appropriate prescribing easy or difficult, e.g., barriers); 
and (7) future planned behaviors along with perceived solutions to 
promote appropriate antibiotic prescribing.
    During the analysis of the six dental interviews it was determined 
by the team that these interviews contained very unique information in 
terms of knowledge, attitudes and behaviors compared to other non-
dental providers. Therefore, it was also determined that information 
saturation was not reached during this first data collection phase. We 
want to continue our data collect efforts within this specific 
population. This information will be crucial in future design of 
scalable and sustainable outpatient antibiotic stewardship 
interventions that incorporate all Core Elements of Outpatient 
Antibiotic Stewardship and to be able to implement it across a network 
of dental outpatient facilities.
    The total estimated annual Burden Hours are 50. There will be no 
anticipated costs to respondents other than their time.

                                                            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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Providers...............................  Dental Survey CDC Outpatient SHEPheRD..             100               1              .5              50
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............              50
--------------------------------------------------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-17174 Filed 8-9-18; 8:45 am]
 BILLING CODE 4163-18-P



                                                                                     Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices                                                                                               39757

                                                                                                                     ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                  Number of                 Avg. burden
                                                                                                                                                                       Number of                   responses                                          Total burden
                                                         Type of respondents                                               Form name                                                                                        per response
                                                                                                                                                                      respondents                     per                                               (in hrs.)
                                                                                                                                                                                                                              (in hrs.)
                                                                                                                                                                                                  respondent

                                               Traditional Office-based Physicians                      2018 Physician Induction Interview                                             122                           1                    30/60                 61
                                                 or Staff.                                                (NAMCS–1).
                                               Traditional Office-based Physicians                      2019+ Physician Induction Interview                                         1,097                            1                   30/60                 549
                                                 or Staff.                                                (NAMCS–1).
                                               Traditional Office-based Physicians                      2018 Pulling, re-filing medical                                                 99                          30                     1/60                 50
                                                 or Staff.                                                record forms (FR abstracts).
                                               Traditional Office-based Physicians                      2019+ Pulling, re-filing medical                                              893                           30                     1/60                447
                                                 or Staff.                                                record forms (FR abstracts).
                                               MU Office-based Physician Staff ......                   2019+ MU Physician Induction                                               2,000                              1                   45/60              1,500
                                                                                                          Interview (NAMCS–PFI).
                                               MU Office-based Physician Staff ......                   2019+ Pulling, re-filing medical                                            2,000                            1                   60/60               2,000
                                                                                                          record forms (MU Onboarding).
                                               Community Health Center Executive/                       2018 Induction Interview—service                                                12                           1                    30/60                  6
                                                 Medical Directors.                                       delivery site (NAMCS–201).
                                               Community Health Center Executive/                       2019+ Induction Interview—service                                              104                           1                    30/60                 52
                                                 Medical Directors.                                       delivery site (NAMCS–201).
                                               Community Health Center Providers                        2018 Induction Interview—Providers                                               27                          1                   30/60                  14
                                                                                                          (NAMCS–1).
                                               Community Health Center Providers                        2019+ Induction Interview—Pro-                                                 234                            1                   30/60                117
                                                                                                          viders (NAMCS–1).
                                               Community Health Center Provider                         2018 Pulling, re-filing medical                                                 27                          30                     1/60                 14
                                                 Staff.                                                   record forms (FR abstracts).
                                               Community Health Center Provider                         2019+ Pulling, re-filing medical                                              234                           30                     1/60                117
                                                 Staff.                                                   record forms (FR abstracts).
                                               Traditional Physician Office-based                       2018 Pulling, re-filing medical                                                   3                         10                      1/60                 1
                                                 and Community Health Center                              record forms (FR abstracts) for
                                                 Staff.                                                   the Reabstraction Study.
                                               Traditional Physician Office-based                       2019+ Reinterview Study ................                                      100                             1                   15/60                 25
                                                 and Community Health Center
                                                 Staff.

                                                    Total ...........................................   ..........................................................   ........................   ........................   ........................          4,953



                                               Jeffrey M. Zirger,                                                     general public and other Federal                                                 • Mail: Jeffrey M. Zirger, Information
                                               Acting Chief, Information Collection Review                            agencies the opportunity to comment on                                        Collection Review Office, Centers for
                                               Office, Office of Scientific Integrity, Office                         a proposed and/or continuing                                                  Disease Control and Prevention, 1600
                                               of the Associate Director for Science, Office                          information collection, as required by                                        Clifton Road NE, MS–D74, Atlanta,
                                               of the Director, Centers for Disease Control                           the Paperwork Reduction Act of 1995.                                          Georgia 30329.
                                               and Prevention.                                                        This notice invites comment on a                                                 Instructions: All submissions received
                                               [FR Doc. 2018–17175 Filed 8–9–18; 8:45 am]                             proposed information collection project                                       must include the agency name and
                                               BILLING CODE 4163–18–P                                                 titled ‘‘Dental Survey: Improving                                             Docket Number. CDC will post, without
                                                                                                                      outpatient antibiotic use through                                             change, all relevant comments to
                                                                                                                      implementation and evaluation of Core                                         Regulations.gov.
                                               DEPARTMENT OF HEALTH AND                                               Elements of Outpatient Antibiotic                                                Please note: Submit all comments
                                               HUMAN SERVICES                                                         Stewardship.’’ This information                                               through the Federal eRulemaking portal
                                                                                                                      collection request will generate data to                                      (regulations.gov) or by U.S. mail to the
                                               Centers for Disease Control and                                                                                                                      address listed above.
                                               Prevention                                                             assess knowledge, attitudes, practices
                                                                                                                      and perceived barriers to appropriate                                         FOR FURTHER INFORMATION CONTACT: To
                                               [60Day–18–18APX; Docket No. CDC–2018–                                  antibiotic prescribing in a representative                                    request more information on the
                                               0066]                                                                  sample of dental providers. Results will                                      proposed project or to obtain a copy of
                                                                                                                      be used to inform interventions for this                                      the information collection plan and
                                               Proposed Data Collection Submitted                                     specific provider population and                                              instruments, contact Jeffrey M. Zirger,
                                               for Public Comment and                                                 support our efforts to improve                                                Information Collection Review Office,
                                               Recommendations                                                        antimicrobial stewardship within                                              Centers for Disease Control and
                                               AGENCY: Centers for Disease Control and                                outpatient clinics.                                                           Prevention, 1600 Clifton Road NE, MS–
                                               Prevention (CDC), Department of Health                                                                                                               D74, Atlanta, Georgia 30329; phone:
                                                                                                                           CDC must receive written
                                                                                                                      DATES:
                                                                                                                                                                                                    404–639–7570; Email: omb@cdc.gov.
                                               and Human Services (HHS).                                              comments on or before October 9, 2018.
daltland on DSKBBV9HB2PROD with NOTICES




                                               ACTION: Notice with comment period.                                                                                                                  SUPPLEMENTARY INFORMATION: Under the
                                                                                                                      ADDRESSES:  You may submit comments,                                          Paperwork Reduction Act of 1995 (PRA)
                                               SUMMARY:   The Centers for Disease                                     identified by Docket No. CDC–2018–                                            (44 U.S.C. 3501–3520), Federal agencies
                                               Control and Prevention (CDC), as part of                               0066 by any of the following methods:                                         must obtain approval from the Office of
                                               its continuing effort to reduce public                                   • Federal eRulemaking Portal:                                               Management and Budget (OMB) for each
                                               burden and maximize the utility of                                     Regulations.gov. Follow the instructions                                      collection of information they conduct
                                               government information, invites the                                    for submitting comments.                                                      or sponsor. In addition, the PRA also


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                                               39758                                 Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices

                                               requires Federal agencies to provide a                                 New Information Collection Request—                                           prescribing); (2) the providers current
                                               60-day notice in the Federal Register                                  National Center for Emerging and                                              antibiotic prescribing practices; (3)
                                               concerning each proposed collection of                                 Zoonotic Infectious Diseases (NCEZID),                                        beliefs about the consequences of
                                               information, including each new                                        Centers for Disease Control and                                               inappropriate and appropriate
                                               proposed collection, each proposed                                     Prevention (CDC).                                                             prescribing (e.g., consequences for the
                                               extension of existing collection of                                                                                                                  provider, for individual patients, and for
                                               information, and each reinstatement of                                 Background and Brief Description
                                                                                                                                                                                                    the healthcare system); (4) attitudes
                                               previously approved information                                           Antibiotic resistance is a growing                                         about antibiotic prescribing (expected
                                               collection before submitting the                                       problem that has been shown to be a                                           negative and positive reactions to
                                               collection to the OMB for approval. To                                 result of wide-spread antibiotic use and                                      appropriate prescribing); (5) subjective
                                               comply with this requirement, we are                                   misuse. While efforts to improve                                              norms (beliefs related to what is
                                               publishing this notice of a proposed                                   antibiotic use to date have been                                              ‘‘normal’’ antibiotic prescribing for the
                                               data collection as described below.                                    primarily implemented in the inpatient                                        provider and for peers); (6) control
                                                 The OMB is particularly interested in                                setting, the majority of antibiotics are                                      beliefs related to appropriate prescribing
                                               comments that will help:                                               prescribed in the outpatient setting. Up                                      (factors that make appropriate
                                                 1. Evaluate whether the proposed                                     to 50% of all antibiotics prescribed for                                      prescribing easy or difficult, e.g.,
                                               collection of information is necessary                                 acute respiratory tract infections (ARI)                                      barriers); and (7) future planned
                                               for the proper performance of the                                      are proposed to be inappropriate.                                             behaviors along with perceived
                                               functions of the agency, including                                     Interventions that have been                                                  solutions to promote appropriate
                                               whether the information will have                                      demonstrated to decrease inappropriate                                        antibiotic prescribing.
                                               practical utility;                                                     use include audit-and-feedback,
                                                 2. Evaluate the accuracy of the                                                                                                                       During the analysis of the six dental
                                                                                                                      academic detailing, clinical decision
                                               agency’s estimate of the burden of the                                 support systems (CDSS), provider-                                             interviews it was determined by the
                                               proposed collection of information,                                    focused public commitments to reduce                                          team that these interviews contained
                                               including the validity of the                                          inappropriate antibiotic use, and                                             very unique information in terms of
                                               methodology and assumptions used;                                      delayed antibiotic prescriptions.                                             knowledge, attitudes and behaviors
                                                 3. Enhance the quality, utility, and                                                                                                               compared to other non-dental providers.
                                                                                                                      However, current data is limited due to
                                               clarity of the information to be                                                                                                                     Therefore, it was also determined that
                                                                                                                      short study timeframes and lack of
                                               collected; and                                                                                                                                       information saturation was not reached
                                                 4. Minimize the burden of the                                        sustainability.
                                                                                                                                                                                                    during this first data collection phase.
                                               collection of information on those who                                    In a pilot project, phone interviews
                                                                                                                      were conducted with six dental                                                We want to continue our data collect
                                               are to respond, including through the                                                                                                                efforts within this specific population.
                                               use of appropriate automated,                                          providers and three pediatricians,
                                                                                                                      specifically those who could speak to                                         This information will be crucial in
                                               electronic, mechanical, or other                                                                                                                     future design of scalable and sustainable
                                               technological collection techniques or                                 the knowledge, attitudes and behaviors
                                                                                                                      of their peers. PRA was deemed not                                            outpatient antibiotic stewardship
                                               other forms of information technology,                                                                                                               interventions that incorporate all Core
                                               e.g., permitting electronic submissions                                applicable by the NCEZID PRA
                                                                                                                      representative for this pilot. We                                             Elements of Outpatient Antibiotic
                                               of responses.                                                                                                                                        Stewardship and to be able to
                                                 5. Assess information collection costs.                              identified six dental providers that were
                                                                                                                      recruited for a phone interview with our                                      implement it across a network of dental
                                               Proposed Project                                                       team’s healthcare psychologist. Semi-                                         outpatient facilities.
                                                 Dental Survey: Improving outpatient                                  structured interviews were used to                                               The total estimated annual Burden
                                               antibiotic use through implementation                                  assess: (1) Knowledge about antibiotic                                        Hours are 50. There will be no
                                               and evaluation of Core Elements of                                     prescribing (what constitutes                                                 anticipated costs to respondents other
                                               Outpatient Antibiotic Stewardship—                                     appropriate and inappropriate                                                 than their time.

                                                                                                                     ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                Average
                                                                                                                                                                                                  Number of                                              Total
                                                                 Type of                                                                                               Number of                                              burden per
                                                                                                                           Form name                                                            responses per                                           burden
                                                               respondents                                                                                            respondents                                              response
                                                                                                                                                                                                  respondent                                          (in hours)
                                                                                                                                                                                                                               (in hours)

                                               Dental Providers ................................        Dental Survey                CDC         Outpatient                            100                           1                          .5                 50
                                                                                                          SHEPheRD.

                                                    Total ...........................................   ..........................................................   ........................   ........................   ........................                50



                                               Jeffrey M. Zirger,
                                               Acting Chief, Information Collection Review
                                               Office, Office of Scientific Integrity, Office
                                               of the Associate Director for Science, Office
                                               of the Director, Centers for Disease Control
daltland on DSKBBV9HB2PROD with NOTICES




                                               and Prevention.
                                               [FR Doc. 2018–17174 Filed 8–9–18; 8:45 am]
                                               BILLING CODE 4163–18–P




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Document Created: 2018-08-10 01:57:41
Document Modified: 2018-08-10 01:57:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesCDC must receive written comments on or before October 9, 2018.
ContactTo 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]
FR Citation83 FR 39757 

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