CDC Determination: IRB Approval is Not Required

Print Date: 4/14/22

Title:

National Notifiable Diseases Surveillance System

Project Id:

0900f3eb81eee7aa

Accession #:

-CSELS-4/14/22-ee7aa

Project Contact:

Kim Gadsden-knowles

Organization:

CSELS

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

04/18/2022

Estimated Completion Date:

05/31/2025

CDC/ATSDR HRPO/IRB Protocol #:
0920-0728

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

4/14/22

Ayers_Tracy (eyk6) CIO HSC

4/14/22

Ayers_Tracy (eyk6) OMB/PRA

45 CFR 46.102(l)(2)

ICRO:
PRA Applies

OMB Approval date: 3/16/21
OMB Expiration date: 3/31/24

4/14/22

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Urgent

Date Needed:

04/18/2022

Priority Justification:

The determination is needed by 4/18/2022 so that it can be attached to the NNDSS PRA Revision that will be submitted to ICRO
and OMB.

Determination Start Date:

04/14/22

Description:

The Public Health Services Act (42 U.S.C. 241) authorizes CDC to disseminate nationally notifiable condition information. The
National Notifiable Diseases Surveillance System (NNDSS) is based on data collected at the state, territorial and local levels
because of legislation and regulations in those jurisdictions that require health care providers, medical laboratories, and other
entities to submit health-related data on reportable conditions to public health departments. These reportable conditions, which
include infectious and non-infectious diseases, vary by jurisdiction depending upon each jurisdiction#s health priorities and needs.
Each year, the Council of State and Territorial Epidemiologists (CSTE), supported by CDC, determines which reportable conditions
should be designated nationally notifiable or under standardized surveillance. The NNDSS currently facilitates the submission and
aggregation of case notification data voluntarily submitted to CDC from 60 jurisdictions: 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). This information is shared across jurisdictional boundaries and both surveillance and
prevention and control activities are coordinated at regional and national levels.

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
To provide the official source of statistics in the United States for nationally notifiable conditions. Data will be used to monitor the

Goals/Purpose

occurrence and spread of nationally notifiable conditions.

Objective:

To collect case notifications (electronically, by email, and by fax) for nationally notifiable conditions from public health departments
in every U.S. state, New York City, Washington DC, 5 U.S. territories, and 3 freely associated states for public health surveillance.
PRA applies. This data collection is covered by OMB# 0920-0728, National Notifiable Diseases Surveillance System. The NNDSS
data collection and use is non-research; it is for public health surveillance / public health practice. The purpose of NNDSS is to
prevent or control disease and improve health, or to improve a public health program or service. NNDSS is focused on controlling
health problems in the population from which the information is gathered.

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:

Not Selected

Measuring Disparities:

Yes

Studying Social Determinants of Health (SDOH):

Yes

SDOH Economic Stability:

Yes

SDOH Education:

Not Selected

SDOH Health Care Access:

Not Selected

SDOH Neighborhood and Environment:

Not Selected

SDOH Social and Community Context:

Not Selected

SDOH Indices:

Not Selected

Other SDOH Topics:

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:

Other - Case notifications are submitted from 60 jurisdictions. See details in description.

Tags/Keywords:

Public Health Surveillance ; Disease Notification ; Nationally Notifiable Conditions

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 or use identifiable (including
coded) private data or biological specimens ; CDC employees will participate as co-authors in presentation(s) or publication(s) ;
CDC employees will provide substantial technical assistance or oversight

Method Categories:

Surveillance Support; Technical Assistance

Methods:

No statistical sampling methods are used. Public health departments review, process and analyze reportable conditions data and
voluntarily submit case notification data on nationally notifiable conditions to CDC. The Council of State and Territorial
Epidemiologists (CSTE), local, state, and territorial health departments and CDC work jointly to decide which conditions are
nationally notifiable and added to NNDSS.

Collection of Info, Data or Biospecimen:

Over 90% of case notifications are sent to CDC by automated electronic Health Level 7 (HL7) or National Electronic
Telecommunications System for Surveillance (NETSS) messaging. Some case notification messages are sent to CDC by
nonautomated mechanisms including fax, email, secure file upload, and data entry to a secure website. These different
mechanisms used to send case notifications to CDC vary by the jurisdiction and disease or condition. All 50 states, all cities (New
York City and Washington, D.C.) and one territory (Puerto Rico) submit STD case notifications (STD case notifications account for
approximately 87% of all case notifications received by CDC) by automated electronic messaging. Most territories and all freely
associated states send STD case notifications by non-automated methods including fax (only quarterly aggregate data are sent by
fax), email, secure file upload, and data entry to a secure website.

Expected Use of Findings/Results and their impact:

Data are used by CDC subject matter experts to monitor the occurrence of the conditions, identify populations or geographic areas
at high risk, plan prevention and control programs and policies, allocate resources appropriately, and evaluate the effectiveness of
programs and policies. The data are also used by CDC to trace cases and their contacts, 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 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
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

Council of State and Territorial Epidemiologists

Staff
Staff
Member

Kim
Gadsdenknowles

SIQT
Exp.
Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

02/10
/2024

CITI Good Clinical
Practice Exp. Date

Staff Role

Project
Coordinator

Email

Phone

Organization

4044980355

CENTER FOR SURVEILLANCE EPIDEMIOLOGY
AND LABORATORY SERVICES

Data
DMP
Proposed Data Collection Start Date:

4/18/22

Proposed Data Collection End Date:

5/31/25

Proposed Public Access Level:

Public

Public Access Justification:

For certain nationally notifiable conditions, CDC releases national data to the public through CDC#s web-based query system
known as CDC WONDER (http://wonder.cdc.gov/). NNDSS data are also published on Data.CDC.gov (https://data.cdc.gov/) and
DATA.GOV (http://www.data.gov/).

How Access Will Be Provided for Data:

Privacy is protected in a number of ways. CDC WONDER, Data.CDC.gov, and DATA.GOV only provide summary statistics of
aggregate data to their users. Data for CDC WONDER are produced by CDC programs, which have already stripped the data of all
PII before providing these public-use data sets to CDC WONDER. Furthermore, CDC WONDER dynamically imposes privacy and
suppression constraints on all query results sets produced by the CDC WONDER web application, in compliance with each data
set#s specific data use policy. CDC WONDER and Data.CDC.gov are also subject to and have met CDC#s Security Assessment
and Authorization (SA&A) process, in which the CDC WONDER constraints are examined and validated by the CDC#s Office of the
Chief Information Security Officer (OCISO). Only public use, non-PII data in the form of summary statistics are uploaded to Data.
CDC.gov per OCISO policy. In addition, NNDSS data published on Data.CDC.gov are also published on DATA.GOV.

Plans for Archival and Long Term Preservation:

NNDSS data are kept by the CDC as a 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

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