Att 9._ HSR Determination

Print Date: 9/25/23

Title:

Chronic Q Fever in the United States Advanced Clinical Surveillance Amendment 1

Project Id:

0900f3eb82219553

Accession #:

NCEZID-EPI-12/6/18-c6a94

Project Contact:

David McCormick

Organization:
Status:

Pending Clearance : Amendment

Intended Use:

Project Determination

Estimated Start Date:

12/31/2018

Estimated Completion Date:

12/31/2029

CDC/ATSDR HRPO/IRB Protocol #:
seeking to add a module to existing surveillance under OMB 0920-0009

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

9/25/23

Youngblood_Laura L. (zfk9) CIO HSC

9/25/23

Vice_Rudith (nhr9) OMB / PRA

45 CFR 46.102(l)(2)

ICRO:
Returned with No Decision

9/30/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Urgent

Date Needed:

09/26/2023

Priority Justification:

Determination from HRSO needed by 9/26 to ensure compliance with OMB/PRA deadlines.

Determination Start Date:

09/18/23

Description:

Currently, chronic Q fever cases are reported via the National Notifiable Disease Surveillance System, and supplementary clinical,
laboratory, and demographic data are collected using a case report form (CRF). Acute and chronic Q fever cases are still reported
using the same CRF, with risk factor, exposure history, and clinical questions applied to both forms of the disease. This limits the
amount and quality of data collected about chronic Q fever in particular, since its presentation is very different from acute Q fever.
Only endocarditis and hepatitis are listed as options for clinical disease on the current CRF; data on osteomyelitis, osteoarthritis, or
vascular infections are not systematically collected. It is unknown how frequently, or in what patients, these other chronic Q fever
presentations occur in the United States. We are creating an enhanced surveillance module for chronic Q fever to answer these
unknowns. Additionally, data regarding case progression for patients with Q fever are limited. We plan to collect data from the
treating physician regarding clinical course, treatment, and complications over a two-year period for each patient in order to improve
the efficacy and accuracy of clinical consultations provided by CDC.

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 the project is to gather additional and more specific clinical data not otherwise collected during the course of routine
surveillance for chronic Q fever. This information will allow for better characterization of the clinical presentation and risk factors of
chronic Q fever in the United States.
Systematically collect detailed information on the disease manifestations, clinical management, and epidemiology of chronic Q

Objective:

fever.

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?:

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Coxiella burnetii ; Q Fever ; 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

Method Categories:

Surveillance Support

Methods:

The purpose of this project is to obtain additional clinical and epidemiological information on cases of chronic Q fever for which RZB
staff is consulted by the provider. After assisting the clinician with his/her clinical management questions, an RZB staff member will
complete a REDCap survey by asking questions of the requesting clinician (Attachment 3). The Chronic Q Fever Case Investigation
Form collects different data than the standard surveillance case report form and will not duplicate data collection efforts already in
place. The name and contact information for the requesting clinician, but not the patient, will be collected in order to facilitate followup. At intervals of 6, 12, 18, and 24 months after the initial consult, an RZB staff member will recontact the requesting clinician and
administer the follow-up questionnaire (Attachment 4). Chronic Q fever cases are defined as those patients who meet the clinical
and laboratory criteria defined by the Council for State and Territorial Epidemiologists (CSTE) for a chronic Q fever case (Appendix
4). Typically, Phase I IgG exceeds Phase II IgG in chronic disease; however those with appropriate clinical disease manifestations
(endocarditis, vascular infection, osteomyelitis/osteoarthritis, chronic hepatitis) that have a reciprocal IgG antibody titer of Phase I
>800 will be included, regardless of Phase II levels.

Collection of Info, Data or Biospecimen:

# RZB staff members will enter data into a CDC REDCap database. # Data collection topics will include basic demographics,
previous Q fever history, patient risk factors, clinical findings, laboratory and other diagnostic data, treatment information, and case
outcome. # Personally identifiable information on the patient will not be collected or included in the electronic data used for analysis.
# This is a growing dataset with open enrollment; whenever RZB staff identify an appropriate case, we will invite the clinician to
participate in the enhanced surveillance component.

Expected Use of Findings/Results and their impact:

# The results from this project will be summarized regularly. The results will be included in a manuscript and submitted for
publication in the peer-reviewed literature when of public health interest. # The results of this analysis are intended for physicians
and medical researchers studying chronic Q fever. The results will help characterize an under-recognized disease and help educate
physicians on identifying, diagnosing, and treating these cases.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding yet to be added .....

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?
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

CITI Good Clinical Practice
Exp. Date

David
McCormick

04/17/2026

07/05/2026

07/05/2026

07/05/2026

Nicolette
Bestul

08/07/2026

Paige
Armstrong

02/28/2025

09/29/2024

09/29/2024

Data
DMP
Proposed Data Collection Start Date:

2/1/19

Proposed Data Collection End Date:

12/31/28

Proposed Public Access Level:

Restricted

Restricted Details:

Staff Role

Email

Phone

Organization

Principal
Investigator

yup1@cdc.
gov

970-2254272

EPIDEMIOLOGY

Co-Investigator

pue8@cdc.
gov

404-7183827

EPIDEMIOLOGY

Co-Investigator

yzu9@cdc.
gov

404-6398450

EPIDEMIOLOGY

Data Sharing Agreement

Data Use Type:
Data Use Type URL:
Data Use Contact:
Public Access Justification:
How Access Will Be Provided for Data:
Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Dataset yet to be added...

Supporting Info
No Supporting Info

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date