[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]
 BILLING CODE 4163-18-P