[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.
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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]
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