[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
----------------------------------------------------------------------------------------------------------------


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]
BILLING CODE 4163-18-P