Research Determination (Forms 5-9)

Print Date: 9/19/24

Title:

The National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS) and Select Isolate Response Initiative
(SIRI)

Project Id:

0900f3eb8244160e

Accession #:

NCEZID-NARMS-8/23/24-21dd3

Project Contact:

Laura A Ford

Organization:

NCEZID/DFWED/EDEB/NARMS

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

08/23/2024

Estimated Completion Date:

08/25/2036

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

9/3/24

Peterson_James M. (iyr1) CIO HSC

9/16/24

Vice_Rudith (nhr9) OMB / PRA

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Standard

Date Needed:

09/26/2024

Priority Justification:
CDC Priority Area for this Project:

Readiness and Response

Determination Start Date:

09/16/24

Description:

Each year, approximately 4.9 million bacterial enteric illnesses occur in the United States, resulting in an estimated 35,800
hospitalizations and 1,093 deaths. Most bacterial enteric infections are self-limited and do not require antibiotics, but antibiotics are
indicated for patients with severe disease or risk factors for severe disease. The growing proportion of antimicrobial-resistant
bacterial enteric infections limits treatment options and creates opportunities for resistance to spread to other pathogens. Extendedspectrum beta-lactamase-producing Escherichia coli and antimicrobial-resistant Campylobacter, nontyphoidal Salmonella,
Salmonella serotype Typhi, and Shigella have been classified as serious public health threats, which require prompt and sustained
action. The National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS) is a collaboration among CDC, the
US Food and Drug Administration, the US Department of Agriculture, and state and local health departments, that monitors
resistance in enteric bacteria. Antimicrobial resistance data can inform the development of public health interventions and policies
designed to protect people from the threat of resistant enteric infections. Data can be collected through routine surveillance to
measure antimicrobial resistance in bacteria isolated from people or through surveillance of antimicrobial resistance during
outbreaks. Surveillance of resistance during outbreaks can help investigators identify the source of an outbreak or provide clues
about the source of the outbreak. Investigations of outbreaks of resistant Salmonella traced to food-producing animals can show
how animal and human health are linked. Additionally, to help focus efforts for preventing antimicrobial-resistant bacterial enteric
illness, there is a need to monitor and assess risk factors and outcomes associated with resistance. State and local health
departments routinely conduct patient interviews to investigate cases and outbreaks of illness caused by enteric pathogens. The
interviews typically include demographics, clinical information such as symptoms, duration, severity, and treatment, and risk factor
and exposure information, such as recent travel, food consumption, and animal contact. For patients with bacterial enteric infections
that have concerning antimicrobial resistance, the CDC NARMS team would like to request information from initial patient
interviews. If additional information would further enhance the existing surveillance data provided by health departments, the CDC
NARMS team may want to request medical and pharmacy records, as well as request or perform supplemental interviews,
additional phenotypic and genotypic testing on isolates, shopper records, food, environmental, or animal sampling, or field
investigations if needed. This enhanced surveillance will both monitor for and assess emerging antimicrobial resistance of concern
and inform public health response and mitigation efforts.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

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

NARMS routine and outbreak surveillance: The goal of NARMS routine and outbreak surveillance is to track and report antimicrobial
resistance data on enteric bacteria collected from humans through routine frequency-based surveillance and from outbreaks
associated with contaminated foods, contact with animals, and human to human transmission. SIRI: The goal of the select isolate
response initiative (SIRI) is to enhance public health surveillance and reporting of antibiotic-resistance threats. Characterizing
exposures, risk factors, and sources of illness for resistant enteric infections can inform efforts to prevent additional infections and
the spread of disease. Additionally, describing risk factors and the clinical outcomes of resistant enteric infections may improve
clinical education and awareness of emerging health threats.

Objective:

NARMS routine and outbreak surveillance: Objectives include, 1. Detect emerging trends of resistance. 2. Link enteric illnesses
(resistant and susceptible) to specific sources and risk factors. 3. Monitor for emerging genetic mechanisms that confer resistance
and assess their spread among enteric bacteria. 4. Collaborate on investigation of enteric disease, including multistate foodborne
outbreaks. 5. Educate consumers about foodborne antimicrobial threats and food safety practices that protect against these threats.
6. Guide public health priorities. 7. Provide information and recommendations that promote the judicious use of antimicrobial agents.
SIRI: The objective is to obtain information about persons with bacterial enteric infections that have concerning resistance, their
infections, and their environments and food sources to identify potential exposures and clinical consequences of infection. This
includes obtaining information from: 1. Initial interview data (e.g., demographics, recent travel, food consumption, and animal
contact) 2. Supplementary interview data (e.g., more focused questions about travel, food consumption, and/or animal contact) 3.
Medical and pharmacy records 4. Additional testing on isolates (e.g., long-read sequencing, antimicrobial susceptibility testing) 5.
Shopper records, food, environmental, or animal testing and field investigations (e.g., request swabs of reptile environments or
request collection of leftover foods of interest) 6. Additional testing for patients or contacts (e.g., stool culture, CIDT, or other
diagnostic test for screening of symptomatic or asymptomatic contacts, patients with ongoing symptoms, post-symptomatic patients
suspected of carriage)

Does your project measure health disparities among No
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

No

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

Yes

Activities or Tasks:

New Collection of Information, Data, or Biospecimens ; Secondary Data or Specimen Analysis ; Purchase, Use, or Transfer of
Information, Data, Biospecimens or Materials

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Drug Resistance, Bacterial ; Public Health Surveillance ; Salmonella ; Campylobacter ; Shigella ; Shiga-Toxigenic Escherichia coli ;
Vibrio

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 or agents will obtain data by intervening or interacting
with participants ; CDC employees or agents will obtain or use identifiable (including coded) private data or biological specimens ;
CDC employees will participate as co-authors in presentation(s) or publication(s)

Method Categories:

Exposure Investigation; Genetic Sequencing; Record Review; Secondary Data Analysis; Secondary Specimen Analysis;
Surveillance Support

Methods:

NARMS routine and outbreak surveillance: State and large urban public health departments submit Salmonella, Campylobacter,
Shigella, E. coli, and Vibrio isolates to CDC for antimicrobial susceptibility testing according to a preestablished sampling strategy
(routine surveillance) or in response to request by investigators (outbreak surveillance). Isolates that have undergone whole
genome sequencing (WGS), either by state health departments or CDC and submitted to PulseNet, are also screened for predicted
resistance based on the presence of genes and mutations known to confer antimicrobial resistance. Health departments submit
limited metadata along with each isolate (e.g., age, sex, and state of residence). SIRI: CDC investigators identify isolates with
concerning resistance patterns based on AST results or WGS data uploaded to PulseNet. Investigators follow up with
epidemiologists at state or local health department to obtain additional patient and isolate information, as described below.
Depending on the resistance pattern and available information, additional epidemiological records (including primary interview
records, medical records, or pharmacy records) and additional laboratory testing (of the original isolate, or environmental or food
testing) could be requested.

Collection of Info, Data or Biospecimen:

NARMS routine and outbreak surveillance: 54 participating state and local public health departments send a sample of enteric
bacterial isolates for routine surveillance and a sample of outbreak isolates (when requested) for outbreak surveillance to CDC.
Basic metadata (e.g., age, gender, and state of residence) are submitted with the isolates. State and local health departments
submit data, or the CDC team enters data, to the NARMS data system by one of two methods: by directly entering the data via a
web-based entry form and submitting that data to CDC, or by field mapping an electronic file to NARMS form fields and uploading
data en masse to CDC. The CDC NARMS laboratory staff perform broth microdilution antimicrobial susceptibility testing on these
isolates using the the Sensititre# semiautomated platform, and the CDC team enters the numerical results into the NARMS system
using a SWIN export file (.csv) captured from the laboratory testing device. The SWIN export file and contents must meet NARMS
system validation requirements. Additionally, public health laboratories, with state and local health departments, submit sequence
data for enteric bacteria isolates to PulseNet. PulseNet has received a non-research determination for their work. Data from
PulseNet to NARMS go through the Data Broker, an internal web service that allows the NARMS application to access additional
data shared by PulseNet. The NARMS data system receives information nightly on antimicrobial resistance genes, mutations, and
plasmids gleaned from whole genome sequence data and limited demographic information submitted to PulseNet. NARMS CDC
team members with approval rights review and determine acceptability of laboratory data, predicted resistance data, and
demographic data fields through approval interfaces built into the NARMS data system. As only basic metadata is available in the
NARMS data system, isolate resistance data may be linked with additional patient epidemiological data collected by other CDC
public health surveillance systems to further assess and respond to antimicrobial resistant infections and outbreaks. NARMS data
may be linked with data from the National Surveillance Team (OMB Control Number 0920-0728, expiration 3/31/2027), FoodNet
(Exempt Research Protocol 6182, reviewed June 23, 2023), the National Outbreak Reporting System (NORS) (OMB Control
Number 9020-1304, expiration 8/31/2025), or with data collected as part of a cluster or outbreak investigation and stored in SEDRIC
(OMB Control number 0920-0997, expiration 9/30/2026). SIRI: For isolates with concerning resistance, CDC investigators will
contact epidemiologists at state or local health departments to request information from the state or local health department#s case
investigation, including copies of state/local case report forms which typically capture demographic information, illness information
(symptoms, hospitalization, treatment, outcomes), and other exposure or risk factor information (travel, food history, animal and

water exposures, other risk factor information). We have reached the character limit - please see the attachment for more
information on data and biospecimen collection.

Expected Use of Findings/Results and their impact:

Approved NARMS routine and outbreak surveillance data will be released back to the submitting state or local public health
department. Routine and outbreak surveillance data with limited demographic data may also be made available online (e.g.,
NARMS Now: Human Data, BEAM Dashboard, FDA#s Integrated data platform, Sanford Guide), in agency reports, or outbreak
web postings. Additionally, information about resistant infections, including risk factors or exposures and outcomes, may be
summarized and disseminated to support public health activities and other infection control and prevention efforts; inform various
stakeholders; inform the establishment and revision of criteria used to interpret antimicrobial susceptibility tests; and educate clinical
management. The information may be used in public health reports and presentations; peer-reviewed publication; web posts or
other health messaging to health care providers, clinical and public health laboratories, and the public; and communications with
other stakeholders.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers (including
coded data)?:

Yes

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

CDC Cooperative Agreement

ELC Cooperative Agreement

HSC Review

Funding #

Original Budget Yr

# Years Award

Budget Amount

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

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 HIPAA 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

Will you be working with an outside Organization or Institution? Yes

Institution

FWA #

FWA Exp Date

All US State Health Departments

Institution

Funding

Funding Restriction Amount

ELC Cooperative Agreement

Funding Restriction Percentage

Funding Restriction Reason

Funding Restriction has been Lifted

All US State Health Departments

Institution

Institution Role(s)

Institution
Project Title

All US State Health
Departments

Obtaining Consent; Obtaining, Storing or Transferring Identifiable Private Information or
Identifiable Biospecimens

Institution

Regulatory Coverage

All US State Health Departments

IRB Review is Not Required

Institution

Registered IRB

IRB Registration Exp. Date

Institution Project
Tracking #

IRB Review Status

IRB Approval Status

All US State Health Departments

Institution
All US State Health Departments

IRB Approval Date

IRB Approval Exp. Date

Relying Institution IRB

Prime
Institution

Staff

Staff
Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

Beth Karp

08/19
/2026

12/01/2024

Caroline
Snyder

07/27
/2026

Felicita
Medalla

06/12
/2025

HAIMANOT
KEBBEDE

08/09
/2026

Hayat Caidi

07/11
/2026

07/27/2021

Jared
Reynolds

09/01
/2026

12/26/2021

Jason
Folster

06/26
/2026

Jean
Whichard

12/14
/2025

Laura
Cooley

11/09
/2026

Laura Ford

05/12
/2026

Louise
Francois
Watkins

08/28
/2026

Meseret

08/09

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

jyo2@cdc.
gov

4046395097

NARMS Team

CoInvestigator

qmm3@cdc.
gov

4047181673

NARMS Team

CoInvestigator

fhm1@cdc.
gov

4046393426

NARMS Team

CoInvestigator

rcu1@cdc.
gov

4047188448

National Surveillance Team

CoInvestigator

foi0@cdc.
gov

4046390766

NATIONAL ANTIMICROBIAL
RESISTANCE
SURVEILLANCE TEAM

CoInvestigator

uvz6@cdc.
gov

4046393519

NARMS Team

02/28/2027

CoInvestigator

gux8@cdc.
gov

404639-8

NATIONAL ANTIMICROBIAL
RESISTANCE
SURVEILLANCE TEAM

12/14/2025

CoInvestigator

zyr3@cdc.
gov

4046392000

ENTERIC DISEASES
LABORATORY BRANCH

12/13/2021

CoInvestigator

whz3@cdc.
gov

4046392096

NARMS Team

06/26/2026

CoInvestigator

qdz4@cdc.
gov

4047181141

NARMS Team

CoInvestigator

hvu9@cdc.
gov

4046394755

NARMS Team

Co-

vkl2@cdc.

07/27/2025

01/02/2022

06/23/2026

12/26/2021

02/17/2025

12/26/2021

02/20/2025

CITI Good Laboratory
Practice Exp. Date

404-

Birhane

/2026

09/02/2027

Investigator

gov

Naeemah
Logan

09/12
/2026

12/31/2021

CoInvestigator

nqz8@cdc.
gov

6392775
4047186837

NARMS Team

NARMS Team

Data
DMP
Proposed Data Collection Start Date:

8/23/24

Proposed Data Collection End Date:

8/25/36

Proposed Public Access Level:

Restricted

Restricted Details:
Data Use Type:

Other - Data Use Agreement and Non-Disclosure Agreement

Data Use Type URL:

https://wwwn.cdc.gov/NARMS/Landing_Pages/LandingPageCDCAdmin.aspx; https://dcipher.cdc.gov/

Data Use Contact:

narms@cdc.gov; sedric@cdc.gov

Public Access Justification:

Only listed staff and those with access to the NARMS Data System or SEDRIC will have access to the data. However, an aggregate
summary of the data or de-identified data may be provided publicly (e.g., NARMS Now). If other individuals inside or outside of CDC
request this information, they will be referred to narms@cdc.gov or sedric@cdc.gov or to state/local health departments to request
access.

How Access Will Be Provided for Data:

Data collected will be stored in the NARMS data system, on a secure shared drive, or in SEDRIC. Records will be coded to protect
patient privacy and confidentiality. State health departments will retain access to all information from their respective states
including keys to coded data (keys will not be shared to CDC). No data will be accessed or used by anyone who is not working on
this project or does not have access to the NARMS system or SEDRIC. If other individuals inside or outside of CDC request this
information, they will be referred to narms@cdc.gov, sedric@cdc.gov, or state/local health departments for access.

Plans for Archival and Long Term Preservation:

NARMS routine and outbreak surveillance: Isolate metadata and resistance data are stored in the NARMS data system, which is a
web application with two distinct servers hosting the web application and relational database management system. These servers
are physically and logically separated from each other. Users of the system consist of both external state users and internal CDC
NARMS users. External users access the system by passing through the CDC firewall while internal users access the system from
within the firewall. CDC is going through a data modernization initiative, and as part of that initiative, the NARMS application is
currently being refactored for relocation from on-premises servers to the cloud by November 1, 2024. Any isolates submitted to
CDC will be stored indefinitely in the Enteric Diseases Laboratory Branch#s (EDLB) freezer collections along with all other isolates
per EDLB and CDC policy. Audit trail for isolate location and final disposition are captured in the NARMS system. SIRI:
Questionnaire data will be transmitted to CDC through via fax, encrypted email, or a secure data sharing platform. Supplementary

questionnaires will be stored on the CDC shared drive. Data will be entered into a secure database (e.g., Excel, Epi Info, RedCap,
SEDRIC) stored on the CDC shared drive or share point and analyzed by CDC. Biospecimen data will be linked with questionnaire
data by matching isolate information in the NARMS data system with questionnaire data by isolate identifier. Data will be stored at
state or local health departments according to state protocols. Coded information will be stored at CDC in folders on a secure share
drive or in SEDRIC.

Spatiality
Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Peterson_James
M. (iyr1)
CIO HSC

09/03/2024

N/A

HS Research Determination Memo

090324LF-NR-signed.pdf

Ford_Laura
(qdz4)
Project Contact

08/30/2024

Revised protocol.

Protocol

NARMS Project Determination Request_Aug30clean.
docx

Peterson_James
M. (iyr1)
CIO HSC

08/29/2024

HSC added comments and edits
using tracked changes.

Protocol

NARMS Project Determination Request_Aug19 HSC
edits and comments.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

Metadata collected with isolate
submission.

Other-Metadata collected

A. NARMS Metadata&logsheet Screen grab.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

SIRI Module 1

Data Collection Form

Form 5 - NARMS SIRI Module 1.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

SIRI Module 2

Data Collection Form

Form 6 - NARMS SIRI Module 2.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

NARMS Umbrella Project
Determination Request

Protocol

NARMS Project Determination Request_Aug19.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

SIRI Module 3

Data Collection Form

Form 7 - NARMS SIRI Module 3.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

SIRI Module 4

Data Collection Form

Form 8 - NARMS SIRI Module 4.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

SIRI Module 5

Data Collection Form

Form 9 - NARMS SIRI Module 5.docx

Current

Ford_Laura
(qdz4)
Project Contact

08/23/2024

Verbal consent for additional
samples.

Consent Form

G. Verbal Consent - samples.docx