Research Determination

Print Date: 6/27/24

Title:

Minimal Data Necessary for Case Data During an Emergency Response

Project Id:

0900f3eb823d1eac

Accession #:

OPHDST-SO-6/24/24-cfcec

Project Contact:

Kim Gadsden-knowles

Organization:

OPHDST/SARR/SO

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

09/30/2024

Estimated Completion Date:

09/30/2027

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

6/25/24

Broussard_Cheryl S. (gnp2) Human Subjects Coordinator

6/25/24

Broussard_Cheryl S. (gnp2) OMB/PRA Coordinator

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Higher Priority

Date Needed:

07/05/2024

Priority Justification:

The determination is needed by 6/28/2024 so that it can be attached to the new Generic Clearance for the Collection of MDN that
will be submitted to ICRO and then to OMB for approval.

CDC Priority Area for this Project:

Readiness and Response

Determination Start Date:

06/25/24

Description:

The Minimal Data Necessary (MDN) for Case Data During an Emergency Response project is specifically designed to collect the
MDN and response-specific data as needed, for confirmed, probable, and suspected cases of any disease or condition that is the
subject of an emergency response at CDC. During an emergency response, CDC uses case data from State, tribal, local, and
territorial (STLT) health departments to inform actions that need to be taken at all levels of public health and by the public. STLT
health departments and CDC need to exchange data on confirmed, probable, and suspected cases rapidly. Timely notification of
cases from STLT to CDC is critical to provide situational awareness at the federal level to support decision making, particularly for
public health threats that escalate quickly and cross jurisdictions. Case data from 60 STLT health departments will be collected for
the duration of each emergency response. The 60 STLT jurisdictions include: public health departments in every U.S. state, New
York City, Washington DC, 5 U.S. territories (American Samoa, the Commonwealth of Northern Mariana Islands, Guam, Puerto
Rico, and the U.S. Virgin Islands), and 3 freely associated states (Federated States of Micronesia, the Republic of the Marshall
Islands, and the Republic of Palau).

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

To allow, state, tribal, local, and territorial (STLT) health departments and CDC to exchange data on confirmed, probable, and
suspected cases rapidly during a public health emergency response.

Objective:

To collect the minimum data necessary for confirmed, probable, and suspected cases of any disease or condition that is the subject
of an emergency response.

Does your project measure health disparities among Yes
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:

Other - Case data are submitted from 60 STLT jurisdictions. See description

Tags/Keywords:

Public Health Surveillance ; Disease Notification ; readiness and response

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; Technical Assistance

Methods:

No statistical sampling methods are used. Public health departments review, process, analyze and voluntarily submit case data to
CDC.

Collection of Info, Data or Biospecimen:

Case data will be sent to CDC by STLT health departments through Data Collation and Integration for Public Health Event
Response (DCIPHER). DCIPHER is a secure, scalable tool used to collate, prepare, analyze, and visualize. DCIPHER can connect
to virtually any system or data source, enabling data integration agnostic of source or format, and providing near real-time insights
into public health problems. While DCIPHER will be the main data collection tool used to collect case data during emergency
responses, jurisdictions may use other automated or non-automated mechanisms to send case data to CDC under very limited
circumstances. The mechanisms include but are not limited to fax, email, secure file upload, and data entry to a secure website.

Expected Use of Findings/Results and their impact:

Data will be used for ongoing situational awareness and to monitor the occurrence and spread of the disease or condition. Other
uses may include identifying populations or geographic areas at high risk; planning prevention and control programs and policies;
and allocating resources appropriately. The data may also be used by CDC to obtain travel histories and other information to
describe and manage outbreaks and conduct public health follow-up to minimize the spread of disease.

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 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?

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? No
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

Sarah
Rodriguez

02/21/2027

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

Data
DMP
Proposed Data Collection Start Date:

9/30/24

Proposed Data Collection End Date:

9/29/27

Proposed Public Access Level:

Public

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

Project
Coordinator

xqn3@cdc.
gov

703-4594830

DETECT AND MONITOR
DIVISION

Public Access Justification:

Aggregate case data from each emergency response may be available to the public on https://cdc.data.gov and https://data.gov.

How Access Will Be Provided for Data:

Case data will be stored in DCIPHER. DCIPHER is a cloud-based platform used across CDC, by other federal partners, and by
STLTbpublic health jurisdictions to collect, collate, share, and link multiple sources of public health, outbreak, and event response
data. It is designed to facilitate data interpretation and to inform public health decisions. DCIPHER operates in a FedRAMPapproved cloud environment and receives continuous deployment, upgrades, and patching. Personally identifiable information (PII)
is collected, and information can be retrieved by PII. However, information is not retrieved by PII. Jurisdictions remove most PII
before data are submitted to CDC, but some data elements (e.g., date of birth, date of diagnosis, county of residence) could
potentially be combined with other information to identify individuals. Privacy is protected in several ways. https://cdc.data.gov, and
https://data.gov only provide summary statistics of aggregate data to their users. https://cdc.data.gov is also subject to and have
met CDC#s Security Assessment and Authorization (SA&A) process through CDC#s Office of the Chief Information Officer (OCIO).
Only public use, non-PII data in the form of summary statistics are uploaded to https://cdc.data.gov per OCIO#s policy.

Plans for Archival and Long Term Preservation:

Case data are kept by the CDC as an historical public health record, per CDC's "Scientific and Research Project Records Control
Schedule", section 1a ("Authorized Disposition: PERMANENT"). Records Schedule N1-442-09-1.

Spatiality

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

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