[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49846-49847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17357]
[[Page 49846]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-0980]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``National Environmental Assessment Reporting
System (NEARS)'' to the Office of Management and Budget (OMB) for
review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
April 08, 2022, to obtain comments from the public and affected
agencies. CDC received one comment related to the previous notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
National Environmental Assessment Reporting System (NEARS) (OMB
Control No. 0920-0980, Exp. 08/31/2022)--Revision--National Center for
Environmental Health (NCEH), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC is requesting a three-year Paperwork Reduction Act (PRA)
clearance for the National Environmental Assessment Reporting System
(NEARS) to collect data from foodborne illness outbreak environmental
assessments routinely conducted by local, state, territorial, or tribal
food safety programs during outbreak investigations. Prior to the
development of NEARS, environmental assessment data were not collected
at the national level. The data reported through this surveillance
system provides timely information on the causes of outbreaks,
including environmental factors associated with outbreaks, and are
essential to environmental public health regulators' efforts to respond
more effectively to outbreaks and prevent future, similar outbreaks.
This surveillance system was specifically designed to link to CDC's
National Outbreak Reporting System (NORS) (OMB Control No. 0920-1304,
Exp. 09/30/2023), a disease (e.g., enteric diseases transmitted by
food) outbreak surveillance system. NEARS was developed by the
Environmental Health Specialists Network (EHS-Net), a collaborative
network of CDC, the U.S. Food and Drug Administration (FDA), the U.S.
Department of Agriculture (USDA), and nine state food safety programs
(California, Connecticut, Georgia, Iowa, New York, Minnesota, Oregon,
Rhode Island, and Tennessee). The network consists of environmental
health specialists (EHSs), epidemiologists, and laboratorians.
While conducting environmental assessments during outbreak
investigations is routine for food safety program officials, reporting
information from the environmental assessments to CDC is not routine.
Local, state, federal, territorial, and tribal food safety programs are
the primary respondents for this data collection. One official from
each participating program will report environmental assessment data on
outbreaks. These programs are typically located in public health or
agriculture agencies. In the U.S., there are approximately 3,000 such
agencies.
Not every program of the approximate 3,000 programs will register
for NEARS and respond every year. Currently, 34 programs have entered
outbreak data into NEARS. We expect up to 10 additional programs will
register to participate in NEARS over the next three years, to reach a
maximum of 44 reporting programs.
It is not possible to determine exactly how many outbreaks will
occur in the future, nor where they will occur. Over the past six
years, we received 1,261 reports to NEARS, with the highest number of
307 reports in 2018, and a yearly average of 210 reports. Based on
these reporting trends, we estimate that each participating program
will report up to seven foodborne illness outbreaks per year;
therefore, up to 308 outbreaks may be reported annually to NEARS for
the duration of the next PRA clearance.
The activities associated with NEARS that require a burden estimate
consist of registration, training, observing, data recording, and data
reporting events. Food safety programs interested in participating in
NEARS must first register to use the system. The anticipation of 10 new
programs over the next three years is rounded to three new programs per
year. Therefore, the total estimated annual burden associated with
registration is one hour (10 minutes per hour x three registrations =
0.5 hours rounded to one hour).
The next activity is the training for the food safety program
personnel participating in NEARS. These staff will be encouraged to
attend a Microsoft Teams/Zoom Meeting (i.e., webinar) training session
conducted by CDC staff. This training is voluntary and will cover
identifying environmental factors, logging in and entering data into
the web-based NEARS data entry system, and troubleshooting problems.
Training burden is based on the maximum expected participation from the
reporting entities which could be up to 10 additional local and state
health departments (most current participants have already taken the
training). We estimate the burden of this training to be a maximum of
two hours. Respondents will only be required to take this training one
time. Assuming a maximum participation of up to 10 new programs and
about five staff being trained at each participating program, the total
estimated burden associated
[[Page 49847]]
with this training is 100 hours (two hours x 10 entities x five staff
per entity).
Although not a requirement, food safety program personnel
participating in NEARS will also be encouraged to complete CDC's
Environmental Assessment Training Series (EATS). This e-Learning course
provides training to staff on how to use a systems approach in
foodborne illness outbreak environmental assessments. Participants
acquire in-depth skills and knowledge to investigate foodborne illness
outbreaks as a member of a larger outbreak response team, identify an
outbreak's environmental causes, and recommend appropriate control
measures. The course is presented in the context of a simulated virtual
environment where participants can interact and practice the skills
being learned. We estimate the burden of this training to be a maximum
of 10 hours. Respondents will only take this training one time.
Assuming a maximum participation of up to 10 new programs and
approximately five staff being trained at each program, the estimated
burden associated with this training is 500 hours (10 hours x 10
entities x five staff per entity).
Data reporting activities for NEARS will be done once at each
establishment involved in the outbreak. Information collection
activities for NEARS consist of the following: NEARS data reporting and
NEARS manager interview.
For each outbreak, the respondent (one official from each
participating program) will spend around 30 minutes recording
environmental assessment data on pen and paper. Assuming a maximum
number of 308 outbreaks, the estimated annual burden is 150 hours (30
minutes per outbreak x 300 outbreaks) for recording observations.
The manager interview will be conducted on pen and paper at each
establishment associated with an outbreak. The respondents for this
activity are the retail food managers of the outbreak establishments.
Manager interviews are a routine part of outbreak investigations;
however, food safety program personnel participating in NEARS conduct a
structured interview and will thus conduct their interviews slightly
differently than they would if they were not participating in NEARS.
For this reason, we have presented the burden for this interview
separately. Most outbreaks are associated with only one establishment;
however, some are associated with multiple establishments. We estimate
that a maximum of four manager interviews will be conducted per
outbreak (n = 4 x 308 = 1,232). Each interview and data reporting will
take about 20 minutes. The estimated annual burden is 411 hours (20
minutes x 1,232 manager interviews).
Entering data into the NEARS Data Reporting Form (web entry) is
combined for both the environmental assessment and the manager
interviews and is expected to take approximately 40 minutes, for a
total of 205 burden hours (40 minutes x 308 outbreaks).
As part of this Revision information collection request (ICR), the
requested changes to the NEARS Data Recording Form (paper form) include
an update to the definitions for contributing factors based on national
workgroup recommendations. In addition, one question was added to
obtain a measure of the community's social vulnerability in the census
tract where the food establishment is located. The social vulnerability
index (SVI) will be added to the NEARS Data Reporting Form (web entry)
as a change request in the next fiscal year. These form modifications
are not anticipated to change the time burden per response.
Due to the anticipated increase in reporting sites from 34 to 44
registered food safety programs with each reporting up to seven
outbreaks each year, the total estimated annual burden for this
information collection is 1,371 hours. This reflects an increase in
time burden of 21 hours over the previously approved 1,350 hours. The
total number of respondents is 1,951 per year. This reflects an
increase of 51 respondents over the previously approved 1,900
respondents. There are no costs to the respondents other than their
time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Food safety program personnel......... NEARS Food Safety 3 1 10/60
Program Registration.
NEARS Food Safety 50 1 2
Program Training.
NEARS e-Learning 50 1 10
(screenshots).
NEARS Data Recording 44 7 30/60
(paper form).
NEARS Data Reporting and 44 7 40/60
Manager's Interview
(web entry).
Retail food personnel................. NEARS Manager Interview. 1,232 1 20/60
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-17357 Filed 8-11-22; 8:45 am]
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