81 FR 36920 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 110 (June 8, 2016)

Page Range		36920-36921
FR Document		2016-13570
Federal Register, Volume 81 Issue 110 (Wednesday, June 8, 2016)
[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36920-36921]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13570]


-----------------------------------------------------------------------

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.

----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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
36920 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices

businesses offering pest control services need to target recruitment to about twice instrument will be provided with each
to residents in areas where I. scapularis as many people as we intend to enroll. individual project submission for OMB
ticks transmit diseases to humans. Surveys may be conducted daily, review. The maximum estimated,
Specifically, these target populations weekly, monthly, or bi-monthly per annualized burden hours are 98,833
include those residing or working in the participant for a defined period of time hours. There is no cost to respondents
14 highest incidence states for Lyme (whether by phone or web survey), other than their time.
disease (CT, DE, ME, MD, MA, MN, NH, depending on the survey or study. The
surveys will range in duration from Insights gained from KAP surveys will
NJ, NY, PA, RI, VT, VA, WI). We aid in prioritizing which prevention
anticipate conducting one to two approximately 5–30 minutes. Each
participant may be surveyed 1–64 times methods should be evaluated in future
surveys per year, for a maximum of six randomized, controlled trials and
in one year; this variance is due to
surveys conducted over a three year ultimately help target promotion of
differences in the type of information
period. Depending on the survey, we collected for a given survey. proven prevention methods that could
aim to enroll 500–10,000 participants Specific burden estimates for each yield substantial reductions in TBD
per study. It is expected that we will study and each information collection incidence.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden per
Type of respondent Form name responses per burden
respondents * response
respondent * hours
(in hours) *

General public, individuals or house- Screening instrument ....................... 20,000 1 15/60 5,000
holds.
Consent form .................................... 10,000 1 20/60 3,333
Introductory Surveys ........................ 10,000 1 30/60 5,000
Monthly surveys ............................... 10,000 12 15/60 30,000
Final surveys .................................... 10,000 1 30/60 5,000
Daily surveys .................................... 10,000 60 5/60 50,000
Pest Control Operators ..................... PCO Survey ..................................... 1,000 1 30/60 500

Total ........................................... ........................................................... ........................ ........................ ........................ 98,833

Leroy A. Richardson, proposed collection of information is Proposed Project
Chief, Information Collection Review Office, necessary for the proper performance of Monitoring and Coordinating Personal
Office of Scientific Integrity, Office of the the functions of the agency, including
Associate Director for Science, Office of the
Protective Equipment (PPE) in
whether the information will have Healthcare to Enhance Domestic
Director, Centers for Disease Control and
practical utility; (b) Evaluate the Preparedness for Ebola Response—
Prevention.
accuracy of the agencies estimate of the New—National Center for Occupational
[FR Doc. 2016–13573 Filed 6–7–16; 8:45 am]
burden of the proposed collection of Safety and Health (NIOSH), Centers for
BILLING CODE 4163–18–P
information, including the validity of Disease Control and Prevention (CDC).
the methodology and assumptions used;
(c) Enhance the quality, utility, and Background and Brief Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES clarity of the information to be The National Institute for
collected; (d) Minimize the burden of Occupational Safety and Health
Centers for Disease Control and the collection of information on those (NIOSH) has the authority under the
Prevention who are to respond, including through Occupational Safety and Health Act [29
the use of appropriate automated, CFR 671] to ‘‘develop recommendations
[30Day–16–16KA] for health and safety standards’’, to
electronic, mechanical, or other
Agency Forms Undergoing Paperwork technological collection techniques or ‘‘develop information on safe levels of
Reduction Act Review other forms of information technology, exposure to toxic materials and harmful
e.g., permitting electronic submission of physical agents and substances’’, and to
The Centers for Disease Control and responses; and (e) Assess information ‘‘conduct research on new safety and
Prevention (CDC) has submitted the collection costs. health problems’’. There is growing
following information collection request national concern for better
to the Office of Management and Budget To request additional information on understanding of the particular personal
(OMB) for review and approval in the proposed project or to obtain a copy protective equipment (PPE) needs of
accordance with the Paperwork of the information collection plan and healthcare workers to ensure the health
Reduction Act of 1995. The notice for instruments, call (404) 639–7570 or and safety of this workforce during
the proposed information collection is send an email to omb@cdc.gov. Written times of pandemic disease or
published to obtain comments from the comments and/or suggestions regarding bioterrorist threat. The use and
mstockstill on DSK3G9T082PROD with NOTICES

public and affected agencies. the items contained in this notice effectiveness of the proper PPE are
Written comments and suggestions should be directed to the Attention: paramount to the management and
from the public and affected agencies CDC Desk Officer, Office of Management mitigation of the effects of a disaster.
concerning the proposed collection of and Budget, Washington, DC 20503 or NIOSH is requesting a three approval
information are encouraged. Your by fax to (202) 395–5806. Written from OMB to develop an ongoing
comments should address any of the comments should be received within 30 Personal Protective Technology (PPT)
following: (a) Evaluate whether the days of this notice. sentinel surveillance system in the

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Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices 36921

hospital setting that will document data the Ebola virus based on current CDC also send quarterly and annual response
used to evaluate and monitor use and recommendations. With this effort, the as explained in the table below.
effectiveness for PPE usage in healthcare contractor shall develop and deploy the The Emergency and Crisis surveys are
workers including Ebola protection. system to include a contingent of the administered to hospitals via text
NIOSH conducted a pilot study and domestic acute healthcare facilities in message. The emergency survey is
partnered with four hospitals where this three tier approach. The system designed for an event spanning multiple
respirator-related data were collected content shall include status information weeks (e.g., pandemic). There are 3
from a variety of stakeholders (less than for all PPE categories identified for preset questions that are related to Ebola
10 respondents) including Infection protection against the hazards of Ebola and PPT supply concerns. The crisis
Control, Occupational Health, exposure. The system will use a general survey is designed for an unanticipated
Emergency Preparedness, interface engine designed to accept, scenario in which we may need to push
Environmental Health & Safety, and validate, and process data from ad hoc questions on a daily basis to
Purchasing. Surveillance metrics were multiple, disparate sources. hospitals. They will only be
established and shared with pilot The system will be developed to administered in a non-routine situation.
participants on a regular basis identify PPE replenishment needs to During the 3 year approval period, we
throughout the pilot. Partners identified facilitate local, state, and eventually will test/train hospitals on each survey.
key performance indicators that this regional resource sharing and local However, they will not be part of the
data might provide, such as the average purchasing as needed. It will also be regular data collection.
number of respirators used per isolation compatible with PPE previously used at
Estimated Annualized Burden Hours
order in the hospital, and identification these facilities to allow seamless
of stakeholders and protocols impacting continuity of patient care and worker The baseline form is completed once
effective respirator use. protection. This capacity will offer a by each hospital as they come onboard.
Recommendations were made for much-improved process for monitoring It is the same as the annual survey but
monitoring schedules and survey and maintaining appropriate PPE will take longer to complete, because all
improvement. The data collected during supplies through the constant, real-time fields in the collection tool will need to
the pilot study provided experience and monitoring of user demand, thus be entered. The annual form is
knowledge of respirator selection, avoiding the misdirection of tens of completed by the hospitals in each year
availability, fit testing, usage patterns, millions of dollars’ worth of respirators following their start and will take about
outcomes, and confounders of respirator and other PPE to facilities that may not a third of the time to complete than the
use and effectiveness at the four use distributed supplies due to a baseline form. Example: Year one, 5
participating hospitals. mismatch between products typically hospitals on start (baseline); year two, 6
NIOSH now seeks approval to execute used and the supplies provided. new (baseline) and 5 from previous year
an approach for a minimum viable Respondents targeted for this study (annual); year three, 9 new (baseline)
product (MVP) multi-hospital (15–20), include hospital managers (also referred and 11 from previous years (annual).
real-time monitoring phase. The 15–20 to in some cases as executives, Thus, taking the sum of the previous
facilities shall reflect the tiered coordinators or supervisors). These year hospitals (annual) leads to a total
approach recommended by CDC individuals are responsible for the day- of 16. The quarterly form is completed
involving Frontline Healthcare to-day administration and/or by all participating hospitals four times
Facilities, Ebola Assessment Hospitals implementation of the MVP. It is a year. The emergency and crisis forms
and Ebola Treatment Centers. The effort estimated that a sample of up to 20 are completed by all participating
shall be built upon the experience and hospitals will agree to participate among hospitals as needed, but at least once for
knowledge obtained from the pilot a variety of Ebola and Frontline training, and uses the annualized
projects, and shall be structured as the treatment facilities. Participation will number in the baseline form.
next step in the establishment of a require no more than 255 minutes of The total estimated annual burden
national system to monitor usage and workers’ time per quarter. The hospitals hours are 230. There are no costs to
training for PPE used to protect against will complete a baseline form and will respondents other than their time.

Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)

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

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
mstockstill on DSK3G9T082PROD with NOTICES

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

VerDate Sep<11>2014 17:30 Jun 07, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 E:\FR\FM\08JNN1.SGM 08JNN1
Document Created: 2016-06-08 03:10:36
Document Modified: 2016-06-08 03:10:36
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 36920
81 FR 36920 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 110 (June 8, 2016)

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