81 FR 3421 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 13 (January 21, 2016)

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.

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3421-3423]
From the Federal Register Online  [www.thefederalregister.org]
[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

[[Page 3422]]

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.

[[Page 3423]]



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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
                                                 ---------------------------------------------------------------
    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]
BILLING CODE 4163-18-P