[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8101-8103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-0980; Docket No. CDC-2019-0011]


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 effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled 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.

DATES: CDC must receive written comments on or before May 6, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0011 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

National Environmental Assessment Reporting System (NEARS) (OMB Control 
No. 0920-0980, Exp. 8/31/2019)--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) (0920-0980) 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

[[Page 8102]]

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.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Food safety program personnel.  NEARS Food                    50               1               2             100
                                 Safety Program
                                 Training.
                                NEARS e-Learning              50               1              10             500
                                 (screenshots).
                                NEARS Data                   300               1           30/60             150
                                 Recording
                                 (paper form).
                                NEARS Data                   300               1           40/60             200
                                 reporting and
                                 manager's
                                 interview (web
                                 entry).
Retail food personnel.........  NEARS Manager               1200               1           20/60             400
                                 Interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,350
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[[Page 8103]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-04012 Filed 3-5-19; 8:45 am]
 BILLING CODE 4163-18-P