[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26874-26876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12136]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-0980]


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 March 6, 
2019 to obtain comments from the public and affected agencies. CDC did 
not receive comments 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.

[[Page 26875]]

    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]. 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, Expiration Date: 08/31/2019)--Revision--National 
Center for Environmental Health (NCEH), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    CDC is requesting OMB approval 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), 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. EHS-Net 
developed a standardized protocol for identifying, reporting, and 
analyzing data relevant to foodborne illness outbreak environmental 
assessments.
    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. Currently, 31 state and local health departments are 
registered to report data on outbreaks to NEARS. Based on our 
experience over the past five years, we expect up to 10 additional 
local and state public health departments to register to report 
outbreak data to NEARS over the next three years. It is not possible to 
determine exactly how many outbreaks will occur in the future, nor 
where they will occur. Based on past trends, it is likely that up to 
300 foodborne illness outbreaks may be reported annually to NEARS from 
up to 41 entities for the duration of the next PRA clearance. Only 
programs in the jurisdictions in which these outbreaks occur would 
report to NEARS. Thus, not every program of the approximate 3,000 
programs will respond every year. Assuming each outbreak occurs in a 
different jurisdiction, there will be one respondent per outbreak.
    The activities associated with NEARS that require a burden estimate 
consist of training, observing, data recording, and data reporting 
events. The first activity is the training for the food safety program 
personnel participating in NEARS. These staff will be encouraged to 
attend a Skype Meeting (i.e., webinar) training session conducted by 
CDC staff. 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. 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 programs and about five staff being trained 
at each participating program, the total estimated burden associated 
with this training is 100 hours.
    Food safety program personnel participating in NEARS will also be 
encouraged to complete CDC's Environmental Assessment Training Series 
(EATS). This eCourse provides training to staff on how to use a systems 
approach in foodborne illness outbreak environmental assessments. We 
estimate the burden of this training to be a maximum of 10 hours. 
Respondents will only have to take this training one time. Assuming a 
maximum participation of up to 10 programs and approximately five staff 
being trained at each program, the estimated burden associated with 
this training is 500 hours.
    Data reporting activities for NEARS will be done once for 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 of 300 outbreaks, the estimated annual burden is 150 hours for 
recording observations.
    The manager interview will be conducted at each establishment 
associated with an outbreak and data is initially recorded using pen 
and paper. The respondents for this activity are the retail food 
managers of the outbreak establishments. 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. Each interview and data reporting will 
take about 20 minutes. Assuming a maximum of 300 outbreaks, the 
estimated annual burden is 400 hours. Web-based data entry for both 
data recording and the manager interview will be combined. Data entry 
into the NEARS system is expected to take approximately 40 minutes for 
the combined activities, for a total of 200 burden hours. The total 
estimated annual burden for this information collection is 1,350 hours.

[[Page 26876]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Food safety program personnel......  NEARS Food Safety Program                50               1               2
                                      Training.                               50               1              10
                                     NEARS e-Learning
                                      (screenshots).
                                     NEARS Data Recording (paper             300               1           30/60
                                      form).
                                     NEARS Data reporting and                300               1           40/60
                                      manager's interview (web
                                      entry).
Retail food personnel..............  NEARS Manager Interview....           1,200               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. 2019-12136 Filed 6-7-19; 8:45 am]
 BILLING CODE 4163-18-P