81_FR_67154 81 FR 66965 - Agency Forms Undergoing Paperwork Reduction Act Review

81 FR 66965 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 189 (September 29, 2016)

Page Range66965-66966
FR Document2016-23506

Federal Register, Volume 81 Issue 189 (Thursday, September 29, 2016)
[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Pages 66965-66966]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23506]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0852]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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 [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Prevalence Survey of Healthcare-Associated Infections (HAIs) and 
Antimicrobial Use in U.S. Acute Care Hospitals--Revision--National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    Preventing healthcare-associated infections (HAIs) and reducing the 
emergence and spread of antimicrobial resistance are priorities for the 
CDC and the U.S. Department of Health and Human Services (DHHS). 
Improving antimicrobial drug prescribing in the United States is a 
critical component of strategies to reduce antimicrobial resistance, 
and is a key component of the President's National Strategy for 
Combating Antibiotic Resistant Bacteria (CARB), which calls for 
``inappropriate inpatient antibiotic use for monitored conditions/
agents'' to be ``reduced 20% from 2014 levels'' (page 9, https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf). To achieve these goals and improve patient 
safety in the United States, it is necessary to know the current burden 
of infections and antimicrobial drug use in different healthcare 
settings, including the types of infections and drugs used in short-
term acute care hospitals, the pathogens causing infections, and the 
quality of antimicrobial drug prescribing.
    Today more than 5,000 short-term acute care hospitals participate 
in national HAI surveillance through the CDC's National Healthcare 
Safety Network (NHSN, OMB Control No. 0920-0666, expiration 12/31/18). 
These hospitals' surveillance efforts are focused on those HAIs that 
are required to be reported as part of state legislative mandates or 
Centers for Medicare & Medicaid Services (CMS) Inpatient Quality 
Reporting (IQR) Program. Hospitals do not report data on all types of 
HAIs occurring hospital-wide. Data from a previous prevalence survey 
showed that approximately 28% of all HAIs are included in the CMS IQR 
Program. Periodic assessments of the magnitude and types of HAIs 
occurring in all patient populations in hospitals are needed to inform 
decisions by local and national policy makers and by hospital infection 
prevention professionals regarding appropriate targets and strategies 
for HAI prevention.
    The CDC's hospital prevalence survey efforts began in 2008-2009. A 
pilot survey was conducted over a 1-day period at each of nine acute 
care hospitals in one U.S. city. This pilot phase was followed in 2010 
by a phase 2, limited roll-out HAI and antimicrobial use prevalence 
survey, conducted in 22 hospitals across 10 Emerging Infections Program 
sites (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, 
New Mexico, New York, Oregon, and Tennessee). A full-scale, phase 3 
survey was conducted in 2011, involving 183 hospitals in the 10 
Emerging Infections Program (EIP) sites. Data from this survey 
conducted in 2011 showed that there were an estimated 722,000 HAIs in 
U.S acute care hospitals in 2011, and about half of the 11,282 patients 
included in the survey in 2011 were receiving antimicrobial drugs. The 
survey was repeated in 2015-2016 to update the national HAI and 
antimicrobial drug use burden; data from this survey will also provide 
baseline information on the quality of antimicrobial drug prescribing 
for selected, common clinical conditions in hospitals. Data collection 
is ongoing at this time.
    A revision of the prevalence survey's existing OMB approval is 
sought to reduce the data collection burden and to extend the approval 
to allow another short-term acute care hospital survey to be conducted 
in 2019. Data from the 2019 survey will be used to evaluate progress in 
eliminating HAIs and improving antimicrobial drug use.
    The 2019 survey will be performed in a sample of up to 300 acute 
care hospitals, drawn from the acute care hospital populations in each 
of the 10 EIP sites (and including participation from many hospitals 
that participated in prior phases of the survey). Infection prevention 
personnel in participating hospitals and EIP site personnel will 
collect demographic and clinical data from the medical records of a 
sample of eligible patients in their hospitals on a single day in 2019, 
to identify CDC-defined HAIs and collect information on antimicrobial 
drug use. The survey data will be used to estimate the prevalence of 
HAIs and antimicrobial drug use and describe the distribution of 
infection types and pathogens. The data will also be used to determine 
the quality of antimicrobial drug prescribing. These data will inform 
strategies to reduce and eliminate healthcare-associated infections--a 
DHHS Healthy People 2020 objective (http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=17). This survey project 
also supports the CDC Winnable Battle goal of improving national 
surveillance for healthcare-associated infections (http://www.cdc.gov/

[[Page 66966]]

winnablebattles/Goals.html) and the CARB National Strategy (https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf) 
and Action Plan (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf).
    There are no costs to the respondents other than their time. The 
total estimated annual burden hours is 1,860. This represents a 
reduction in the total estimated annual burden hours from the previous 
approval due to a reduction in the number of respondents.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Infection preventionist...............  Healthcare Facility                  100               1           45/60
                                         Assessment (HFA).
Infection preventionist...............  Patient Information Form             100              63           17/60
                                         (PIF).
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
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. 2016-23506 Filed 9-28-16; 8:45 am]
BILLING CODE 4163-18-P



                                                                           Federal Register / Vol. 81, No. 189 / Thursday, September 29, 2016 / Notices                                          66965

                                                    Board of Governors of the Federal Reserve             Proposed Project                                      hospitals in one U.S. city. This pilot
                                                  System, September 26, 2016.                                                                                   phase was followed in 2010 by a phase
                                                                                                            Prevalence Survey of Healthcare-
                                                  Michele Taylor Fennell,
                                                                                                          Associated Infections (HAIs) and                      2, limited roll-out HAI and
                                                  Assistant Secretary of the Board.                       Antimicrobial Use in U.S. Acute Care                  antimicrobial use prevalence survey,
                                                  [FR Doc. 2016–23549 Filed 9–28–16; 8:45 am]             Hospitals—Revision—National Center                    conducted in 22 hospitals across 10
                                                  BILLING CODE 6210–01–P                                  for Emerging and Zoonotic Infectious                  Emerging Infections Program sites
                                                                                                          Diseases (NCEZID), Centers for Disease                (California, Colorado, Connecticut,
                                                                                                          Control and Prevention (CDC).                         Georgia, Maryland, Minnesota, New
                                                                                                                                                                Mexico, New York, Oregon, and
                                                  DEPARTMENT OF HEALTH AND                                Background and Brief Description                      Tennessee). A full-scale, phase 3 survey
                                                  HUMAN SERVICES
                                                                                                             Preventing healthcare-associated                   was conducted in 2011, involving 183
                                                  Centers for Disease Control and                         infections (HAIs) and reducing the                    hospitals in the 10 Emerging Infections
                                                  Prevention                                              emergence and spread of antimicrobial                 Program (EIP) sites. Data from this
                                                                                                          resistance are priorities for the CDC and             survey conducted in 2011 showed that
                                                  [30Day–16–0852]
                                                                                                          the U.S. Department of Health and                     there were an estimated 722,000 HAIs in
                                                                                                          Human Services (DHHS). Improving                      U.S acute care hospitals in 2011, and
                                                  Agency Forms Undergoing Paperwork                                                                             about half of the 11,282 patients
                                                  Reduction Act Review                                    antimicrobial drug prescribing in the
                                                                                                          United States is a critical component of              included in the survey in 2011 were
                                                     The Centers for Disease Control and                  strategies to reduce antimicrobial                    receiving antimicrobial drugs. The
                                                  Prevention (CDC) has submitted the                      resistance, and is a key component of                 survey was repeated in 2015–2016 to
                                                  following information collection request                the President’s National Strategy for                 update the national HAI and
                                                  to the Office of Management and Budget                                                                        antimicrobial drug use burden; data
                                                                                                          Combating Antibiotic Resistant Bacteria
                                                  (OMB) for review and approval in                                                                              from this survey will also provide
                                                                                                          (CARB), which calls for ‘‘inappropriate
                                                  accordance with the Paperwork                                                                                 baseline information on the quality of
                                                                                                          inpatient antibiotic use for monitored
                                                                                                                                                                antimicrobial drug prescribing for
                                                  Reduction Act of 1995. The notice for                   conditions/agents’’ to be ‘‘reduced 20%
                                                                                                                                                                selected, common clinical conditions in
                                                  the proposed information collection is                  from 2014 levels’’ (page 9, https://
                                                                                                                                                                hospitals. Data collection is ongoing at
                                                  published to obtain comments from the                   www.whitehouse.gov/sites/default/files/
                                                                                                                                                                this time.
                                                  public and affected agencies.                           docs/carb_national_strategy.pdf). To                     A revision of the prevalence survey’s
                                                     Written comments and suggestions                     achieve these goals and improve patient               existing OMB approval is sought to
                                                  from the public and affected agencies                   safety in the United States, it is                    reduce the data collection burden and to
                                                  concerning the proposed collection of                   necessary to know the current burden of               extend the approval to allow another
                                                  information are encouraged. Your                        infections and antimicrobial drug use in              short-term acute care hospital survey to
                                                  comments should address any of the                      different healthcare settings, including              be conducted in 2019. Data from the
                                                  following: (a) Evaluate whether the                     the types of infections and drugs used                2019 survey will be used to evaluate
                                                  proposed collection of information is                   in short-term acute care hospitals, the               progress in eliminating HAIs and
                                                  necessary for the proper performance of                 pathogens causing infections, and the                 improving antimicrobial drug use.
                                                  the functions of the agency, including                  quality of antimicrobial drug                            The 2019 survey will be performed in
                                                  whether the information will have                       prescribing.                                          a sample of up to 300 acute care
                                                  practical utility; (b) Evaluate the                        Today more than 5,000 short-term                   hospitals, drawn from the acute care
                                                  accuracy of the agencies estimate of the                acute care hospitals participate in                   hospital populations in each of the 10
                                                  burden of the proposed collection of                    national HAI surveillance through the                 EIP sites (and including participation
                                                  information, including the validity of                  CDC’s National Healthcare Safety                      from many hospitals that participated in
                                                  the methodology and assumptions used;                   Network (NHSN, OMB Control No.                        prior phases of the survey). Infection
                                                  (c) Enhance the quality, utility, and                   0920–0666, expiration 12/31/18). These                prevention personnel in participating
                                                  clarity of the information to be                        hospitals’ surveillance efforts are                   hospitals and EIP site personnel will
                                                  collected; (d) Minimize the burden of                   focused on those HAIs that are required               collect demographic and clinical data
                                                  the collection of information on those                  to be reported as part of state legislative           from the medical records of a sample of
                                                  who are to respond, including through                   mandates or Centers for Medicare &                    eligible patients in their hospitals on a
                                                  the use of appropriate automated,                       Medicaid Services (CMS) Inpatient                     single day in 2019, to identify CDC-
                                                  electronic, mechanical, or other                        Quality Reporting (IQR) Program.                      defined HAIs and collect information on
                                                  technological collection techniques or                  Hospitals do not report data on all types             antimicrobial drug use. The survey data
                                                  other forms of information technology,                  of HAIs occurring hospital-wide. Data                 will be used to estimate the prevalence
                                                  e.g., permitting electronic submission of               from a previous prevalence survey                     of HAIs and antimicrobial drug use and
                                                  responses; and (e) Assess information                   showed that approximately 28% of all                  describe the distribution of infection
                                                  collection costs.                                       HAIs are included in the CMS IQR                      types and pathogens. The data will also
                                                     To request additional information on                 Program. Periodic assessments of the                  be used to determine the quality of
                                                  the proposed project or to obtain a copy                magnitude and types of HAIs occurring                 antimicrobial drug prescribing. These
                                                  of the information collection plan and                  in all patient populations in hospitals               data will inform strategies to reduce and
                                                  instruments, call (404) 639–7570 or                     are needed to inform decisions by local               eliminate healthcare-associated
                                                  send an email to omb@cdc.gov. Written                   and national policy makers and by                     infections—a DHHS Healthy People
                                                  comments and/or suggestions regarding                   hospital infection prevention                         2020 objective (http://
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                                                  the items contained in this notice                      professionals regarding appropriate                   www.healthypeople.gov/2020/
                                                  should be directed to the Attention:                    targets and strategies for HAI                        topicsobjectives2020/
                                                  CDC Desk Officer, Office of Management                  prevention.                                           overview.aspx?topicid=17). This survey
                                                  and Budget, Washington, DC 20503 or                        The CDC’s hospital prevalence survey               project also supports the CDC Winnable
                                                  by fax to (202) 395–5806. Written                       efforts began in 2008–2009. A pilot                   Battle goal of improving national
                                                  comments should be received within 30                   survey was conducted over a 1-day                     surveillance for healthcare-associated
                                                  days of this notice.                                    period at each of nine acute care                     infections (http://www.cdc.gov/


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                                                  66966                         Federal Register / Vol. 81, No. 189 / Thursday, September 29, 2016 / Notices

                                                  winnablebattles/Goals.html) and the                              www.whitehouse.gov/sites/default/files/                 estimated annual burden hours is 1,860.
                                                  CARB National Strategy (https://                                 docs/national_action_plan_for_                          This represents a reduction in the total
                                                  www.whitehouse.gov/sites/default/files/                          combating_antibotic-resistant_                          estimated annual burden hours from the
                                                  docs/carb_national_strategy.pdf) and                             bacteria.pdf).                                          previous approval due to a reduction in
                                                  Action Plan (https://                                              There are no costs to the respondents                 the number of respondents.
                                                                                                                   other than their time. The total
                                                                                                                  ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                Average
                                                                                                                                                                                             Number of
                                                                                                                                                                           Number of                          burden per
                                                                  Type of respondents                                                Form name                                             responses per
                                                                                                                                                                          respondents                          response
                                                                                                                                                                                             respondent         (in hrs.)

                                                  Infection preventionist .....................................   Healthcare Facility Assessment (HFA) ..........                  100                  1                45/60
                                                  Infection preventionist .....................................   Patient Information Form (PIF) ......................            100                 63                17/60



                                                  Leroy A. Richardson,                                             of automated collection techniques or                   to publish a 30-day notice in the
                                                  Chief, Information Collection Review Office,                     other forms of information technology to                Federal Register concerning each
                                                  Office of Scientific Integrity, Office of the                    minimize the information collection                     proposed collection of information,
                                                  Associate Director for Science, Office of the                    burden.                                                 including each proposed extension or
                                                  Director, Centers for Disease Control and                                                                                reinstatement of an existing collection
                                                  Prevention.                                                      DATES: Comments on the collection(s) of
                                                                                                                   information must be received by the                     of information, before submitting the
                                                  [FR Doc. 2016–23506 Filed 9–28–16; 8:45 am]
                                                                                                                   OMB desk officer by October 31, 2016.                   collection to OMB for approval. To
                                                  BILLING CODE 4163–18–P                                                                                                   comply with this requirement, CMS is
                                                                                                                   ADDRESSES: When commenting on the
                                                                                                                   proposed information collections,                       publishing this notice that summarizes
                                                                                                                   please reference the document identifier                the following proposed collection(s) of
                                                  DEPARTMENT OF HEALTH AND
                                                                                                                   or OMB control number. To be assured                    information for public comment:
                                                  HUMAN SERVICES
                                                                                                                   consideration, comments and                               1. Type of Information Collection
                                                  Centers for Medicare & Medicaid                                  recommendations must be received by                     Request: Extension of a currently
                                                  Services                                                         the OMB desk officer via one of the                     approved collection; Title of
                                                                                                                   following transmissions: OMB, Office of                 Information Collection: Request for
                                                  [Document Identifier: CMS–R–297 (CMS–                            Information and Regulatory Affairs,                     Employment Information; Use: Section
                                                  L564)]                                                           Attention: CMS Desk Officer, Fax                        1837(i) of the Social Security Act
                                                                                                                   Number: (202) 395–5806 OR, Email:                       provides for a special enrollment period
                                                  Agency Information Collection
                                                                                                                   OIRA_submission@omb.eop.gov.                            for individuals who delay enrolling in
                                                  Activities: Submission for OMB                                     To obtain copies of a supporting
                                                  Review; Comment Request                                                                                                  Medicare Part B because they are
                                                                                                                   statement and any related forms for the                 covered by a group health plan based on
                                                  AGENCY: Centers for Medicare &                                   proposed collection(s) summarized in                    their own or a spouse’s current
                                                  Medicaid Services, Department of                                 this notice, you may make your request                  employment status. Disabled
                                                  Health and Human Services.                                       using one of following:                                 individuals with Medicare may also
                                                                                                                     1. Access CMS’ Web site address at                    delay enrollment because they have
                                                  ACTION: Notice.
                                                                                                                   http://www.cms.hhs.gov/                                 large group health plan coverage based
                                                  SUMMARY:    The Centers for Medicare &                           PaperworkReductionActof1995.                            on their own or a family member’s
                                                  Medicaid Services (CMS) is announcing                              2. Email your request, including your
                                                                                                                                                                           current employment status. When these
                                                  an opportunity for the public to                                 address, phone number, OMB number,
                                                                                                                                                                           individuals apply for Medicare Part B,
                                                  comment on CMS’ intention to collect                             and CMS document identifier, to
                                                                                                                                                                           they must provide proof that the group
                                                  information from the public. Under the                           Paperwork@cms.hhs.gov.
                                                                                                                     3. Call the Reports Clearance Office at               health plan coverage is (or was) based
                                                  Paperwork Reduction Act of 1995                                                                                          on current employment status. Form
                                                  (PRA), federal agencies are required to                          (410) 786–1326.
                                                                                                                                                                           Number: CMS–R–297 (CMS–L564)
                                                  publish notice in the Federal Register                           FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                           (OMB control number: 0938–0787);
                                                  concerning each proposed collection of                           Reports Clearance Office at (410) 786–
                                                                                                                                                                           Frequency: Once; Affected Public:
                                                  information, including each proposed                             1326.
                                                                                                                                                                           Private sector (Business or other for-
                                                  extension or reinstatement of an existing                        SUPPLEMENTARY INFORMATION: Under the                    profits and Not-for-profit institutions);
                                                  collection of information, and to allow                          Paperwork Reduction Act of 1995 (PRA)                   Number of Respondents: 15,000; Total
                                                  a second opportunity for public                                  (44 U.S.C. 3501–3520), federal agencies                 Annual Responses: 15,000; Total
                                                  comment on the notice. Interested                                must obtain approval from the Office of                 Annual Hours: 5,000. (For policy
                                                  persons are invited to send comments                             Management and Budget (OMB) for each                    questions regarding this collection
                                                  regarding the burden estimate or any                             collection of information they conduct                  contact Lindsay Scully at 410–786–
                                                  other aspect of this collection of                               or sponsor. The term ‘‘collection of                    6843.)
                                                  information, including any of the                                information’’ is defined in 44 U.S.C.
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                                                                                                                                                                              Dated: September 26, 2016.
                                                  following subjects: The necessity and                            3502(3) and 5 CFR 1320.3(c) and
                                                  utility of the proposed information                              includes agency requests or                             William N. Parham, III,
                                                  collection for the proper performance of                         requirements that members of the public                 Director, Paperwork Reduction Staff, Office
                                                  the agency’s functions; the accuracy of                          submit reports, keep records, or provide                of Strategic Operations and Regulatory
                                                  the estimated burden; ways to enhance                            information to a third party. Section                   Affairs.
                                                  the quality, utility, and clarity of the                         3506(c)(2)(A) of the PRA (44 U.S.C.                     [FR Doc. 2016–23537 Filed 9–28–16; 8:45 am]
                                                  information to be collected; and the use                         3506(c)(2)(A)) requires federal agencies                BILLING CODE 4120–01–P




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Document Created: 2016-09-29 04:15:04
Document Modified: 2016-09-29 04:15:04
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
FR Citation81 FR 66965 

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