Download:
pdf |
pdfPrint Date: 7/18/22
Title:
National Environmental Assessment Reporting System (NEARS) OMB Package
Project Id:
0900f3eb81ecc76a
Accession #:
NCEH-FT-1/25/22-72adc
Project Contact:
Erin D Moritz
Organization:
NCEH/ATSDR/DEHSP/WFEHSB/FT
Status:
Pending Regulatory Clearance
Intended Use:
Project Determination
Estimated Start Date:
09/01/2022
Estimated Completion Date:
08/31/2025
CDC/ATSDR HRPO/IRB Protocol #:
N/A
OMB Control #:
0920-0980
Determinations
Determination
Justification
Completed
Entered By & Role
3/25/22
Abel_Jason A. (jza5) CIO HSC
Not Research / Other
HSC:
Does NOT Require HRPO
Review
45 CFR 46.102(l)
Quality Assurance / Improvement
PRA:
3/25/22
PRA Applies
Abel_Jason A. (jza5) CIO OMB / PRA
Description & Funding
Description
Priority:
Standard
Date Needed:
04/08/2022
Determination Start Date:
03/25/22
Description:
This package requests a three-year Paperwork Reduction Act (PRA) clearance for the National Environmental Assessment
Reporting System (NEARS), OMB Control No. 0920-0980, Expiration Date: 08/31/2022. This includes revision of a previously
approved information collection request (ICR).
IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:
No
IMS Activation Name:
Not selected
Primary Priority of the Project:
Not selected
Secondary Priority(s) of the Project:
Not selected
Task Force Associated with the Response:
Not selected
CIO Emergency Response Name:
Not selected
Epi-Aid Name:
Not selected
Lab-Aid Name:
Not selected
Assessment of Chemical Exposure Name:
Not selected
Goals/Purpose
The goal of NEARS is to continue to improve public health practice by providing a standardized, detailed reporting system for food
safety programs, to collect foodborne outbreak environmental assessment data, and to establish a sound epidemiological basis for
disease prevention activities.
Objective:
The foodborne outbreak environmental assessment data reported to NEARS will be used to characterize data on food vehicles and
monitor trends; identify contributing factors and their environmental antecedents; generate hypotheses, guide planning, and
implementation; evaluate food safety programs; and ultimately assist to prevent future outbreaks.
Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:
Yes
Measuring Disparities:
Not Selected
Studying Social Determinants of Health (SDOH):
Not Selected
Assessing Impact:
Not Selected
Methods to Improve Health Equity Research and
Practice:
Not Selected
Other:
Not Selected
Activities or Tasks:
New Collection of Information, Data, or Biospecimens
Target Populations to be Included/Represented:
Businesses
Tags/Keywords:
Foodborne Diseases ; Outbreak investigation ; Public Health Surveillance
CDC's Role:
Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided ; CDC employees will participate as co-authors in presentation(s) or
publication(s) ; CDC employees will provide substantial technical assistance or oversight ; CDC is providing funding
Method Categories:
Individual Interviews (Qualitative); Observation; Outbreak Investigation; Technical Assistance
Methods:
During foodborne illness outbreak investigations, environmental health specialists collect detailed environmental data by conducting
environmental assessments. These data identify how and why the food became contaminated with pathogens, and how and why
these pathogens were not eliminated before ingestion. When reported to CDC via NEARS, this information provides an opportunity
to systematically monitor and evaluate environmental factors, which can then be used to develop effective foodborne illness
outbreak response and preventative controls.
Collection of Info, Data or Biospecimen:
Data from foodborne outbreak environmental assessments are collected by environmental health professionals responding to
foodborne outbreaks at retail food establishments. Data are collected through direct observations at the establishment, and through
manager interviews or pen-and-paper at the establishment. Participating food safety programs then enter their data into a secured
web-based system designed to make data entry easy for respondents.
Expected Use of Findings/Results and their impact:
The information collected through NEARS is primarily used by the CDC to identify and understand environmental factors
(contributing factors and environmental antecedents) associated with foodborne illness outbreaks. Data collected through NEARS
will also be used to describe outbreaks and outbreak responses, describe environmental factors associated with outbreaks, and
describe the associations between environmental antecedents and specific contributing factors.
Could Individuals potentially be identified based on
Information Collected?
No
Funding
Funding Type
Funding Title
Funding #
Original Budget Yr
# Years Award
Budget Amount
CDC Cooperative Agreement
Environmental Health Specialists Network
RFA-EH-20-001
2020
5
1540700.00
HSC Review
HSC Attributes
Quality Assurance / Improvement
Yes
Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office
No
Estimated number of study participants
Population - Children
Protocol Page #:
Population - Minors
Protocol Page #:
Population - Prisoners
Protocol Page #:
Population - Pregnant Women
Protocol Page #:
Population - Emancipated Minors
Protocol Page #:
Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research
Requested consent process waviers
Informed consent for adults
No Selection
Children capable of providing assent
No Selection
Parental permission
No Selection
Alteration of authorization under HIPPA Privacy
Rule
No Selection
Requested Waivers of Documentation of Informed Consent
Informed consent for adults
No Selection
Children capable of providing assent
No Selection
Parental permission
No Selection
Consent process shown in an understandable language
Reading level has been estimated
No Selection
Comprehension tool is provided
No Selection
Short form is provided
No Selection
Translation planned or performed
No Selection
Certified translation / translator
No Selection
Translation and back-translation to/from target
language(s)
No Selection
Other method
No Selection
Clinical Trial
Involves human participants
No Selection
Assigned to an intervention
No Selection
Evaluate the effect of the intervention
No Selection
Evaluation of a health related biomedical or
behavioral outcome
No Selection
Registerable clinical trial
No Selection
Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus
No Selection
Human genetic testing is planned now or in the
future
No Selection
Involves long-term storage of identfiable biological
specimens
No Selection
Involves a drug, biologic, or device
No Selection
Conducted under an Investigational New Drug
exemption or Investigational Device Exemption
No Selection
Institutions & Staff
Institutions
Institutions yet to be added .....
Staff
Staff
Member
SIQT
Exp. Date
CITI Biomedical
Exp. Date
CITI Social &
Behavioral Exp. Date
Adam
Kramer
04/05
/2025
12/31/2022
Beth
Wittry
12/29
/2023
Erin
Mortiz
Laura
Brown
Phone
Organization
CoInvestigator
4044981228
FOOD
12/19/2021
CoInvestigator
7704887333
FOOD
12/27
/2024
12/31/2021
CoInvestigator
4044982756
FOOD
01/25
/2025
12/20/2021
Principal
Investigator
770488-2
WATER FOOD AND ENVIRONMENTAL
HEALTH SERVICES BRANCH
Data
DMP
Proposed Data Collection Start Date:
9/1/22
Proposed Data Collection End Date:
8/31/25
CITI Good Clinical
Practice Exp. Date
Staff Role
Email
nrj8@cdc.
gov
Proposed Public Access Level:
Public
Public Access Justification:
Data will be released publicly with each publication.
How Access Will Be Provided for Data:
Datasets will be release on the CDC Stacks Public Health Publications website. The sites of the food safety program will be deidentified and free text reviewed to ensure it contains no identifying information available for the restaurant or program. All data are
stored behind the CDC firewall.
Plans for Archival and Long Term Preservation:
Spatiality
Spatiality (Geographic Locations) yet to be added .....
Dataset
Dataset
Title
Dataset
Description
Data Publisher
/Owner
Public Access
Level
Public Access
Justification
External
Access URL
Download
URL
Type of Data
Released
Collection
Start Date
Dataset yet to be added...
Supporting Info
Current
CDC Staff
Member and
Role
Moritz_Erin
(nrj8)
PRA Reviewer
Davis_Stephanie
I. (sgd8)
PRA Reviewer
Date Added
Description
Supporting Info Type
Supporting Info
07/15/2022
Zip file containing the revised 30
day FRN and ICR and supporting
documents.
Paperwork Reduction Act Form
NEARS OMB Submitted 7-15-22.zip
Paperwork Reduction Act Form
NEARS 30D FRN ICR rev OS.zip
07/12/2022
Zipfile of NEARS 30D FRN and
Revision ICR. Please address
comments and revisions. Add
attachments marked
PLACEHOLDER. I have edited the
burden table to include NEARS
Collection End
Date
registration to match the NCEZID
DFWED OES PIA system
description.
Current
Moritz_Erin
(nrj8)
PRA Reviewer
07/07/2022
Zip file containing the 30 day FRN
and ICR for the NEARS
surveillance system.
Paperwork Reduction Act Form
NEARS OMB Submitted 7722.zip
Davis_Stephanie
I. (sgd8)
PRA Reviewer
06/24/2022
Zipfile of 30D FRN and ICR
reviewed with comments from OS
Paperwork Reduction Act Form
Files rev OS.zip
Moritz_Erin
(nrj8)
PRA Reviewer
06/22/2022
Compressed file includes
supporting statements A and B,
relevant attachments, the 30-day
FRN, and burden worksheets.
Paperwork Reduction Act Form
NEARS OMB Submitted 06222022.zip
Davis_Stephanie
I. (sgd8)
PRA Reviewer
05/09/2022
30D FRN publication request and
revision ICR files with OS
comments to address.
Paperwork Reduction Act Form
Files rev OS.zip
04/27/2022
The updated compressed file
contains: Supporting Statement A,
Supporting Statement B,
attachments and appendix
documents, the 30 day FRN, and
the 30 day FRN Publication
Request Form.
Paperwork Reduction Act Form
Submit to STARS 04272022.zip
03/17/2022
Compressed file contains:
Supporting Statement A,
Supporting Statement B, 10
attachments (including the 60 day
FRN [Attachment 3]), and the 60
day FRN Publication Request
Form.
Paperwork Reduction Act Form
NEARS OMB Package.zip
Moritz_Erin
(nrj8)
Project Contact
Moritz_Erin
(nrj8)
Project Contact
File Type | application/pdf |
File Modified | 0000-00-00 |
File Created | 2022-07-18 |