HS Research Determination

Print Date: 9/5/24

Title:

Antimicrobial Resistance Laboratory Network

Project Id:

0900f3eb82091b38

Accession #:

NCEZID-OAR-1/18/23-91b38

Project Contact:

Masiray Swaray

Organization:

NCEZID/DHQP/OAR

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

01/01/2016

Estimated Completion Date:

01/01/2033

CDC/ATSDR HRPO/IRB Protocol #:
0920-1310

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

9/5/24

Peterson_James M. (iyr1) CIO HSC

9/5/24

Vice_Rudith (nhr9) OMB / PRA

45 CFR 46.102(l)(2)

ICRO:
PRA Applies

OMB Approval date: 5/23/23
OMB Expiration date: 5/31/26

9/5/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

01/24/23

Description:

CDC#s AR Lab Network supports nationwide lab capacity to rapidly detect antimicrobial resistance and inform local responses to
prevent spread and protect people.

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

The AR Lab Network builds capacity to rapidly detect AR in healthcare and the community, inform local responses to prevent
spread, and protect people from AR threats. The AR Lab Network includes public health labs in all 50 states and Puerto Rico,
including seven regional labs and the National Tuberculosis Molecular Surveillance Center (National TB Center). State and local
laboratories will build or sustain capacity to detect and support response to concerning resistance. The Network tracks changes in
resistance and helps identify and respond to outbreaks faster. This project determination is intended to serve as an umbrella
determination for any sub-project involving only the use of pathogen isolate data. Special projects or other activities with new data
collections may need review to ensure they are covered by this determination or if a separate determination is recommended.
Implementation of AR Lab Network activities will result in: #Increased state, local, and regional public health laboratory capacity to
detect and confirm AR using CDC-recommended methods #Rapid identification and containment of AR threats including novel
resistance #Timely and effective response to HAI/AR outbreaks #Improved coordination and information sharing with epidemiology,

Objective:

laboratory, and prevention partners to support outbreak response and prevention efforts #Improved test results and data reporting
to partners including public health epidemiologists, laboratorians, healthcare partners, and CDC to inform surveillance efforts and
outbreak response #Enhanced molecular surveillance of AR threats #Enhanced capacity for detection of outbreaks and
transmission of Mtb

Does your project measure health disparities among Not Selected
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?:

Not Selected

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

Not Selected

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 ; Programmatic Work

Target Populations to be Included/Represented:

Other - State and local health departments

Tags/Keywords:

Laboratories ; Drug Resistance, Bacterial ; Drug Resistance, Multiple, Fungal ; Neisseria gonorrhoeae ; Candida ;
Enterobacteriaceae ; Pseudomonas aeruginosa ; Streptococcus pneumoniae ; Mycobacterium tuberculosis ; Clostridium difficile

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

Method Categories:

Culture; Pathogen-specific Research; Proficiency Testing; Secondary Data Analysis; Secondary Specimen Analysis; Surveillance
Support

Methods:

State and regional labs will perform various testing to improve detection and laboratory diagnostics for rapid detection and faster
response to outbreaks and emerging antibiotic resistance related to healthcare-associated infections (i.e, bacterial and fungal
pathogens).

Collection of Info, Data or Biospecimen:

Participating laboratories will report all testing results to CDC using a secure online web-portal, REDCap, or Health Level 7 (HL7)
transmission. All testing results that indicate immediate threats to patient safety and require rapid public health action will be
communicated to CDC and local public health authorities within one day of identification. Participating labs will also submit an
annual report describing current testing methods and an annual performance measurement report. Specimen and isolate level
testing data from AR Lab Network participants will be shared with CDC via secure FISMA compliant mechanisms such as HL7 or
RedCap. Data will be coded using the ARLN ID, with sending laboratory holding the keys to linked PII. In some cases, DOB is sent
where age is not available for HL7 transmission. Keys to linking PII are held at the PHL may be shared with public health officials to
facilitate public health action (such as an outbreak investigation) but will not be sent to CDC. All specimen level data will be stored in
secure access restricted databases at CDC to ensure confidentiality of this data. Prior to sharing aggregated data via reports or
publications, procedures will be in place to ensure the granularity of the data is sufficient to protect privacy of individuals and their
protected health information. Additional precautions will be taken if reporting rare events that may be linked to individuals. Data
collected for public health purposes via the AR Lab Network may be de-identified or aggregated for use in secondary analysis by
the recipient program. All secondary analysis should ensure privacy of specimen level data is maintained.
The results from laboratory testing will be used to (1) identify and contain new and emerging antibiotic resistant threats, including

Expected Use of Findings/Results and their impact:

Could Individuals potentially be identified based on
Information Collected?

carbapenemase-producing organisms that can spread carbapenem-resistance through mobile genetic elements, (2) describe the
geographical distribution of antibiotic resistant threats, (3) detect novel resistance phenotypes and genotypes among healthcareassociated organisms, (4) describe and reduce the spread of resistance mechanisms, and (5) provide data for regional, state, and
local infection prevention programs to set priorities and mount targeted containment and prevention responses.
No

Funding

Funding Type

Funding Title

Funding
#

Original Budget
Yr

# Years
Award

CDC Cooperative
Agreement

Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious
Diseases (ELC)

CK191904

2019

5

HSC Review

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Budget
Amount

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
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp. Date

CITI Biomedical
Exp. Date

Cau Pham

09/23
/2025

01/07/2022

Dawn
Sievert
Stephanie
Gumbis

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Program
Official

whi4@cdc.
gov

404-7185642

STD LABORATORY REFERENCE &
RESEARCH BRANCH

04/21
/2026

Program
Lead

alz1@cdc.
gov

404-7183270

DIVISION OF HEALTHCARE QUALITY
PROMOTION

08/14
/2026

Program
Lead

gpf1@cdc.
gov

404-6394778

OFFICE OF ANTIMICROBIAL
RESISTANCE

04/22/2022

Data
DMP
Proposed Data Collection Start Date:

1/1/16

Proposed Data Collection End Date:

1/1/33

Proposed Public Access Level:

Public

Public Access Justification:

The isolate data generated by testing of pathogens at state health department, regional public health, and CDC labs will have public
health importance for the control of antimicrobial resistance such that at least aggregate data should be released. Whole genome
sequence data and accompanying metadata will be released on NCBI. Future release of other individual-level isolate data may also
be considered after de-identification for secondary research use. All such data releases shall be designed to maintain personal
privacy and prevent association of protected health information with any individuals. No personal identifying information will be
included.

How Access Will Be Provided for Data:

Aggregated data will be shared via scientific publications, annual reports and other published materials and through CDC
maintained dashboards (such as the AR & Patient Safety Portal) to provide this information to the public and the public health
community. Whole genome sequencing data from AR Lab Network testing data will be made available to publicly available
databases such as NCBI and GISAID. Metadata associated with these results should also ensure privacy with no ability to link to
individual patients per the CDC program recommendations.

Plans for Archival and Long Term Preservation:

Spatiality

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

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Supporting Info
Current

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

09/05/2024

NOA 0920-1310 (2023)

Notice of Action

NOA 0920-1310_2023.pdf

Peterson_James
M. (iyr1)
CIO HSC

09/05/2024

N/A

HS Research Determination Memo

090524MS-NR-signed.pdf

Swaray_Masiray
(sui9)
Project Contact

09/04/2024

Final version of project
determination

Other

AR Laboratory Network_Umbrella Package
Protocol_09042024_final.docx

Peterson_James
M. (iyr1)
CIO HSC

09/03/2024

HSC added comments and edits
using tracked changes.

Protocol

AR Laboratory Network_Umbrella Package
Protocol_08292024_clean with HSC comments.docx

Swaray_Masiray
(sui9)
Project Contact

08/30/2024

Project Determination for AR Lab
Network

Other

AR Laboratory Network_Umbrella Package
Protocol_08292024_clean_for IRB initial review.docx

Peterson_James
M. (iyr1)
CIO HSC

04/14/2023

HSC comments added.

Protocol

Antimicrobial Resistance Laboratory Network umbrella
determination HSC comments.docx

Peterson_James
M. (iyr1)
CIO HSC

02/06/2023

TEMPLATE: PLEASE FOLLOW
OUTLINE GUIDANCE FOR
COMPLETING

Other

NCEZID Project Determination Request 2021.docx

Swaray_Masiray
(sui9)
Project Contact

01/24/2023

It is under G2. AR Lab Network in
the NOFO.

Notice of Funding Opportunity

ELC_CK19-1904_2022_Continuation_Guidance_BP4 (1).
pdf