[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36920-36921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13570]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-16KA]
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
Monitoring and Coordinating Personal Protective Equipment (PPE) in
Healthcare to Enhance Domestic Preparedness for Ebola Response--New--
National Center for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The National Institute for Occupational Safety and Health (NIOSH)
has the authority under the Occupational Safety and Health Act [29 CFR
671] to ``develop recommendations for health and safety standards'', to
``develop information on safe levels of exposure to toxic materials and
harmful physical agents and substances'', and to ``conduct research on
new safety and health problems''. There is growing national concern for
better understanding of the particular personal protective equipment
(PPE) needs of healthcare workers to ensure the health and safety of
this workforce during times of pandemic disease or bioterrorist threat.
The use and effectiveness of the proper PPE are paramount to the
management and mitigation of the effects of a disaster. NIOSH is
requesting a three approval from OMB to develop an ongoing Personal
Protective Technology (PPT) sentinel surveillance system in the
[[Page 36921]]
hospital setting that will document data used to evaluate and monitor
use and effectiveness for PPE usage in healthcare workers including
Ebola protection.
NIOSH conducted a pilot study and partnered with four hospitals
where respirator-related data were collected from a variety of
stakeholders (less than 10 respondents) including Infection Control,
Occupational Health, Emergency Preparedness, Environmental Health &
Safety, and Purchasing. Surveillance metrics were established and
shared with pilot participants on a regular basis throughout the pilot.
Partners identified key performance indicators that this data might
provide, such as the average number of respirators used per isolation
order in the hospital, and identification of stakeholders and protocols
impacting effective respirator use. Recommendations were made for
monitoring schedules and survey improvement. The data collected during
the pilot study provided experience and knowledge of respirator
selection, availability, fit testing, usage patterns, outcomes, and
confounders of respirator use and effectiveness at the four
participating hospitals.
NIOSH now seeks approval to execute an approach for a minimum
viable product (MVP) multi-hospital (15-20), real-time monitoring
phase. The 15-20 facilities shall reflect the tiered approach
recommended by CDC involving Frontline Healthcare Facilities, Ebola
Assessment Hospitals and Ebola Treatment Centers. The effort shall be
built upon the experience and knowledge obtained from the pilot
projects, and shall be structured as the next step in the establishment
of a national system to monitor usage and training for PPE used to
protect against the Ebola virus based on current CDC recommendations.
With this effort, the contractor shall develop and deploy the system to
include a contingent of the domestic acute healthcare facilities in
this three tier approach. The system content shall include status
information for all PPE categories identified for protection against
the hazards of Ebola exposure. The system will use a general interface
engine designed to accept, validate, and process data from multiple,
disparate sources.
The system will be developed to identify PPE replenishment needs to
facilitate local, state, and eventually regional resource sharing and
local purchasing as needed. It will also be compatible with PPE
previously used at these facilities to allow seamless continuity of
patient care and worker protection. This capacity will offer a much-
improved process for monitoring and maintaining appropriate PPE
supplies through the constant, real-time monitoring of user demand,
thus avoiding the misdirection of tens of millions of dollars' worth of
respirators and other PPE to facilities that may not use distributed
supplies due to a mismatch between products typically used and the
supplies provided.
Respondents targeted for this study include hospital managers (also
referred to in some cases as executives, coordinators or supervisors).
These individuals are responsible for the day-to-day administration
and/or implementation of the MVP. It is estimated that a sample of up
to 20 hospitals will agree to participate among a variety of Ebola and
Frontline treatment facilities. Participation will require no more than
255 minutes of workers' time per quarter. The hospitals will complete a
baseline form and will also send quarterly and annual response as
explained in the table below.
The Emergency and Crisis surveys are administered to hospitals via
text message. The emergency survey is designed for an event spanning
multiple weeks (e.g., pandemic). There are 3 preset questions that are
related to Ebola and PPT supply concerns. The crisis survey is designed
for an unanticipated scenario in which we may need to push ad hoc
questions on a daily basis to hospitals. They will only be administered
in a non-routine situation. During the 3 year approval period, we will
test/train hospitals on each survey. However, they will not be part of
the regular data collection.
Estimated Annualized Burden Hours
The baseline form is completed once by each hospital as they come
onboard. It is the same as the annual survey but will take longer to
complete, because all fields in the collection tool will need to be
entered. The annual form is completed by the hospitals in each year
following their start and will take about a third of the time to
complete than the baseline form. Example: Year one, 5 hospitals on
start (baseline); year two, 6 new (baseline) and 5 from previous year
(annual); year three, 9 new (baseline) and 11 from previous years
(annual). Thus, taking the sum of the previous year hospitals (annual)
leads to a total of 16. The quarterly form is completed by all
participating hospitals four times a year. The emergency and crisis
forms are completed by all participating hospitals as needed, but at
least once for training, and uses the annualized number in the baseline
form.
The total estimated annual burden hours are 230. There are no costs
to respondents other than their time.
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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Hospital.............................. Baseline................ 7 1 8
Hospital.............................. Annual.................. 5 1 3
Hospital.............................. Quarterly............... 12 4 3
Hospital.............................. Emergency............... 7 4 15/60
Hospital.............................. Crisis.................. 7 7 10/60
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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. 2016-13570 Filed 6-7-16; 8:45 am]
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