Draft Guideline-Centers for Disease Control and Prevention Draft Guideline for the Prevention of Surgical Site Infections, 4724-4725 [2014-01674]
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Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Notices
required by the CSTHEA to submit
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report to Congress, as deemed
appropriate, about the health effects of
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consistent with accepted reporting
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ESTIMATED ANNUALIZED BURDEN HOURS
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respondent
Average
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(in hours)
Smokeless Tobacco Manufacturers, Packagers, and Importers.
SLT Nicotine and Ingredient and Report .......
13
1
1,713
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. 2014–01649 Filed 1–28–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2014–0003]
Draft Guideline—Centers for Disease
Control and Prevention Draft Guideline
for the Prevention of Surgical Site
Infections
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (DHHS).
ACTION: Notice of availability and
request for public comment.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS) requests public
comment on the Draft Guideline for the
Prevention of Surgical Site Infections
(SSIs) (draft Guideline). The Draft
Guideline addresses new and updated
strategies for the prevention of SSI in
healthcare settings. This draft Guideline
can be found at https://
www.regulations.gov Docket No. CDC–
2014–0003. CDC is also publishing the
supporting appendices that include
primary evidence, study evaluation, and
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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18:28 Jan 28, 2014
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data evaluation tables that were used in
developing the draft Guideline
recommendations at https://
www.regulations.gov.
The draft Guideline is designed for
use by infection prevention staff,
healthcare epidemiologists,
administrators, nurses, and personnel
responsible for developing,
implementing, and evaluating infection
prevention and control programs for
healthcare settings across the
continuum of care. The
recommendations contained in the draft
Guideline are based on a targeted
systematic review of the best available
evidence for specific topics related to
the prevention of surgical site infections
(SSI).
DATES: Comments must be received on
or before February 28, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2014–
0003, by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Division of Healthcare Quality
Promotion, National Center for
Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control
and Prevention, Attn: Guideline for the
Prevention of Surgical Site Infections,
Docket No. CDC–2014–0003, 1600
Clifton Road NE., Mailstop A07,
Atlanta, Georgia 30333.
Instructions: All submissions received
must include the agency name and
docket number or RIN. All relevant
public comments received will be
posted publicly to www.regulations.gov
without change, including any personal
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or proprietary information provided. To
download an electronic version of the
draft Guideline and appendices, access
https://www.regulations.gov.
Written materials identified by Docket
No. CDC–2014–0003 will be available
during the comment period for public
inspection Monday through Friday,
except for legal holidays, 9 a.m. until
4:30 p.m. Eastern Standard Time, at
CDC Library, 1600 Clifton Road NE.,
Atlanta, Georgia 30333. Please call
ahead to (404) 639–1717 and request a
Library representative schedule your
visit. All public comments will be
reviewed and considered prior to
finalizing the draft Guideline.
FOR FURTHER INFORMATION CONTACT: Erin
Stone, Division of Healthcare Quality
Promotion, National Center for
Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control
and Prevention, 1600 Clifton Road NE.,
Mailstop A–31, Atlanta, Georgia 30333;
Telephone: (404) 639–4000.
SUPPLEMENTARY INFORMATION: Since
2010 CDC has collaborated with
national partners, academicians, public
and private health professionals, and
other partners to create this draft
Guideline. Additionally, CDC sought
input in each phase of development
from subject matter experts in surgery,
infectious diseases, and orthopedics
through a Guideline Expert Panel
formed to develop the new draft
Guideline. CDC also received input from
the Healthcare Infection Control
Practices Advisory Committee (HICPAC)
throughout the development of the draft
Guideline. HICPAC includes
representatives from public health,
E:\FR\FM\29JAN1.SGM
29JAN1
Federal Register / Vol. 79, No. 19 / Wednesday, January 29, 2014 / Notices
infectious diseases, regulatory and other
federal agencies, professional societies,
and other stakeholders. This new draft
Guideline will not be a federal rule or
regulation.
Dated: January 22, 2014.
Stacey Hoffman,
Acting Director, Division of Executive
Secretariat Centers for Disease Control and
Prevention.
[FR Doc. 2014–01674 Filed 1–28–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Influenza Diagnostic Testing and
Reporting
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: General notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) located
within the Department of Health and
Human Services (HHS) is seeking to
assess new technologies that improve
rapid influenza diagnostic testing and
supplement national laboratory-based
surveillance for human influenza
infections. In particular, the Influenza
Division within the National Center for
Immunization and Respiratory Diseases
(NCIRD) at HHS/CDC proposes to
evaluate new or improved point of care
diagnostic tests for influenza virus
detection that incorporate the capability
to transmit influenza diagnostic test
results electronically, such as through
wireless communication technology, for
more timely diagnosis of human
influenza and/or other respiratory
pathogen infections in outpatient/
ambulatory and emergency room
healthcare practices.
DATES: HHS/CDC will accept inquiries/
proposals until December 31, 2015.
ADDRESSES: You may submit your
inquiry/proposal by email:
FluDiagnosticTests@cdc.gov.
All information submitted to HHS/
CDC will be kept confidential as
allowed by relevant federal law,
including the Freedom of Information
Act (5 U.S.C. 552) and the Trade Secrets
Act (18 U.S.C. 1905). Responses are
preferred in electronic format. CDC does
not intend to publish the results of these
evaluations.
FOR FURTHER INFORMATION CONTACT:
Influenza Division, Centers for Disease
Control and Prevention. Email:
FluDiagnosticTests@cdc.gov.
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SUMMARY:
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HHS/CDC
uses epidemiologic, laboratory, clinical,
and biostatistical sciences to prevent
and control vaccine preventable
infectious diseases. HHS/CDC also
conducts applied research in a variety of
settings, and translates the findings of
this research into public health practice.
HHS/CDC/NCIRD Influenza Division
has lead technical responsibility for
research, development, and evaluation
of diagnostic tools for influenza and
application of these to national
surveillance and epidemiologic studies
of influenza. Improving influenza
diagnostic testing is part of HHS/CDC/
NCIRD Influenza Division’s strategic
plan and includes support of the
development of expanded respiratory
pathogen tests on existing test
platforms; development of advanced
sequence detection methods for
identifying novel influenza strains with
pandemic potential; rapid identification
of antiviral resistant influenza strains;
rapid identification of influenza
immunological response to determine
the presence or absence of circulating
antibodies specific for influenza viruses;
and the development and
characterization of stable diagnostic
reagents or reference material and
controls, for application with existing
diagnostic test systems on established
platforms.
HHS/CDC/NCIRD Influenza Division
seeks to collaborate on evaluations of
any new or improved diagnostic tests
for the detection of human influenza
viruses. The tests may range from high
complexity molecular assays providing
genetic sequence information to point of
care type tests that facilitate more timely
diagnosis of human influenza infections
and/or other respiratory pathogen
infections in ambulatory and emergency
room healthcare practices. Assays
should present sensitivity and
specificity higher than currently
available products.
For commercial products with
approval for use by the US Food and
Drug Administration (FDA), HHS/CDC/
NCIRD Influenza Division is seeking to
evaluate the potential supplementation
of current national laboratory-based
influenza surveillance data with
influenza test result data that can be
transmitted directly to a public health
entity (state, local, or CDC) from the test
platform electronically, such as through
wireless technology. Direct test
platform-based reporting capability has
been newly established. Current
surveillance incorporates data from
healthcare provider offices and
laboratories through manual or
automated reporting functions;
however, most of the current testing
SUPPLEMENTARY INFORMATION:
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platforms do not have the capacity to
directly transmit reports. Such reports
represent a new data source and thus
require evaluation and determination of
appropriate data use agreements.
HHS/CDC/NCIRD Influenza Division
is also interested in collaborating with
organizations working on validation of
novel and improved respiratory
specimen collection materials and
methods that can enable reliable and
consistent self-collection or collection
by non-expert personnel. Data obtained
from the evaluation can be compared
through analytical assessments and be
used by HHS/CDC in making
recommendations and decisions for
diagnosis of influenza in the health
setting. Products may be evaluated at
HHS/CDC and/or at collaborating
laboratories and if appropriate, may be
used in epidemiologic validation
studies.
Interested organizations that have
candidate products are invited to
approach the HHS/CDC/NCIRD
Influenza Division to assess whether the
available product(s) are at a sufficient
stage of development and how HHS/
CDC can collaborate on evaluations and
comparative analysis.
Information To Submit
At a minimum, submitted information
should include the following for each
candidate product: (a) Product package
insert or detailed instructions for use;
(b) Detailed information to determine if
the product is calibrated to a recognized
standard; (c) Preliminary data
demonstrating suitability for validation
studies and clinical trial data on
sensitivity and specificity; (d) Whether
the product is FDA approved; and (e)
Statement of how HHS/CDC/NCIRD
Influenza Division could collaborate on
product evaluation or further
development.
Dated: January 22, 2014.
Stacey Hoffman,
Acting Director, Division of Executive
Secretariat Centers for Disease Control and
Prevention.
[FR Doc. 2014–01670 Filed 1–28–14; 8:45 am]
BILLING CODE 4163–18–P
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29JAN1
]]>Agencies
[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Pages 4724-4725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2014-0003]
Draft Guideline--Centers for Disease Control and Prevention Draft
Guideline for the Prevention of Surgical Site Infections
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (DHHS).
ACTION: Notice of availability and request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS) requests
public comment on the Draft Guideline for the Prevention of Surgical
Site Infections (SSIs) (draft Guideline). The Draft Guideline addresses
new and updated strategies for the prevention of SSI in healthcare
settings. This draft Guideline can be found at https://www.regulations.gov Docket No. CDC-2014-0003. CDC is also publishing
the supporting appendices that include primary evidence, study
evaluation, and data evaluation tables that were used in developing the
draft Guideline recommendations at https://www.regulations.gov.
The draft Guideline is designed for use by infection prevention
staff, healthcare epidemiologists, administrators, nurses, and
personnel responsible for developing, implementing, and evaluating
infection prevention and control programs for healthcare settings
across the continuum of care. The recommendations contained in the
draft Guideline are based on a targeted systematic review of the best
available evidence for specific topics related to the prevention of
surgical site infections (SSI).
DATES: Comments must be received on or before February 28, 2014.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2014-
0003, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Division of Healthcare Quality Promotion, National
Center for Emerging and Zoonotic Infectious Diseases, Centers for
Disease Control and Prevention, Attn: Guideline for the Prevention of
Surgical Site Infections, Docket No. CDC-2014-0003, 1600 Clifton Road
NE., Mailstop A07, Atlanta, Georgia 30333.
Instructions: All submissions received must include the agency name
and docket number or RIN. All relevant public comments received will be
posted publicly to www.regulations.gov without change, including any
personal or proprietary information provided. To download an electronic
version of the draft Guideline and appendices, access https://www.regulations.gov.
Written materials identified by Docket No. CDC-2014-0003 will be
available during the comment period for public inspection Monday
through Friday, except for legal holidays, 9 a.m. until 4:30 p.m.
Eastern Standard Time, at CDC Library, 1600 Clifton Road NE., Atlanta,
Georgia 30333. Please call ahead to (404) 639-1717 and request a
Library representative schedule your visit. All public comments will be
reviewed and considered prior to finalizing the draft Guideline.
FOR FURTHER INFORMATION CONTACT: Erin Stone, Division of Healthcare
Quality Promotion, National Center for Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., Mailstop A-31, Atlanta, Georgia 30333; Telephone: (404) 639-4000.
SUPPLEMENTARY INFORMATION: Since 2010 CDC has collaborated with
national partners, academicians, public and private health
professionals, and other partners to create this draft Guideline.
Additionally, CDC sought input in each phase of development from
subject matter experts in surgery, infectious diseases, and orthopedics
through a Guideline Expert Panel formed to develop the new draft
Guideline. CDC also received input from the Healthcare Infection
Control Practices Advisory Committee (HICPAC) throughout the
development of the draft Guideline. HICPAC includes representatives
from public health,
[[Page 4725]]
infectious diseases, regulatory and other federal agencies,
professional societies, and other stakeholders. This new draft
Guideline will not be a federal rule or regulation.
Dated: January 22, 2014.
Stacey Hoffman,
Acting Director, Division of Executive Secretariat Centers for Disease
Control and Prevention.
[FR Doc. 2014-01674 Filed 1-28-14; 8:45 am]
BILLING CODE 4163-18-P
