[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3421-3423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01040]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-16KA; Docket No. CDC-2016-0011]
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.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a newly proposed
information collection project entitled ``Monitoring and Coordinating
Personal Protective Equipment (PPE) in Healthcare to Enhance Domestic
Preparedness for Ebola Response''. The development of an ongoing
Personal Protective Technology (PPT) sentinel surveillance system in
the hospital setting will document data used to evaluate and monitor
use and effectiveness for PPE usage in healthcare workers including
Ebola protection.
DATES: Written comments must be received on or before March 21, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0011 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson, 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. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted 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 the 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 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 OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of
information
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is necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; (d) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques or other forms of
information technology; and (e) estimates of capital or start-up costs
and costs of operation, maintenance, and purchase of services to
provide information. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, disclose
or provide information to or for a Federal agency. This includes the
time needed to review instructions; to develop, acquire, install and
utilize technology and systems for the purpose of collecting,
validating and verifying information, processing and maintaining
information, and disclosing and providing information; to train
personnel and to be able to respond to a collection of information, to
search data sources, to complete and review the collection of
information; and to transmit or otherwise disclose the information.
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 PPT sentinel
surveillance system in the 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 following is an explanation of the number of respondents for
the annualized burden table. The baseline form is completed once by
each hospital as they come onboard (20/3 = 7 rounded up). The annual
form is completed by the hospitals in each year following their
onboarding. Example: Year one, 5 hospitals onboarded; year two 6 new +
5 from previous year; year three 9 new + 11 from previous years. Thus,
taking the sum of the previous year hospitals leads to 16 total (16/3 =
5 rounded down). The quarterly form is completed by all onboarded
hospitals four times a year. The emergency and crisis forms are
completed on all onboarded hospitals as needed but at least once for
training and use the annualized number in the baseline form.
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Average Total burden
Number of Number of burden per per
Type of respondent Form name respondents responses per response (in respondent
respondent hours) (hours)
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Hospital...................... Baseline........ 7 1 8 56
Hospital...................... Annual.......... 5 1 3 15
Hospital...................... Quarterly....... 12 4 3 144
Hospital...................... Emergency....... 7 4 15/60 7
Hospital...................... Crisis.......... 7 7 10/60 8
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Total..................... ................ .............. .............. .............. 230
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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. 2016-01040 Filed 1-20-16; 8:45 am]
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