CDC Determination: IRB Approval is Not Required

Print Date: 1/4/21

Title:

National Program of Cancer Registries-Cancer Surveillance System (NPCR-CSS)

Project Id:

0900f3eb81c2e837

Accession #:

NCCDPHP-SRT-11/10/20-2e837

Project Contact:

Wilson_Reda J. (dfo8)

Organization:

NCCDPHP/DCPC/CSB/SRT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

10/20/2020

Estimated Completion Date:

10/20/2050

CDC/ATSDR HRPO/IRB Protocol #:

2594

OMB Control #:

0920-0469

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

12/29/20

Redmond Leonard_Joan (jrl3) CIO HSC

12/29/20

Still-LeMelle_Terri (cse6) OMB / PRA

45 CFR 46.102(l)(2)

ICRO:
Returned with No Decision

12/30/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Determination Start Date:

11/10/20

Description:

The National Program of Cancer Registries (NPCR) is legislatively mandated under 42 USC 280e-280e-4 to improve cancer
registries; to plan and implement registries where none exist; to set standards for data completeness, timeliness, and quality; to
provide data collection and analytic training; and to help establish a computerized reporting and data-processing system. This
project is the means through which the Federal government's official cancer statistics are produced and published in the United
States Cancer Statistics (USCS), https://www.cdc.gov/cancer/uscs/index.htm, an annual web-based report on cancer incidence,
mortality, and survival. Overall, the data contained in USCS is used to monitor cancer trends over time, determine cancer patterns
in various populations, and guide planning and evaluation of cancer control programs. This report can be used for public health
action, program planning and evaluation, and study question formulation. The NPCR-CSS system is a public health surveillance
project for cancer incidence (>1.7 million cases diagnosed each year), mortality (~600,000 deaths each year), and survival and is
not intended to be a research project. The NPCR-CSS has a current IRB approval under Protocol #2594. This is a new
determination request to reclassify the project as public health surveillance to align with the current Assurance of Confidentiality
criteria; the AoC for NPCR-CSS is active (expiration date: 05/30/2025). The existing NPCR-CSS is a system to receive data files
from NPCR awardees for data evaluation, evaluation of compliance with NPCR Program Standards, and creation of analytic data
sets including the U.S. Cancer Statistics database, public use data sets, and restricted access data sets. NPCR-CSS has existing
approval from the Office of Management and Budget for an information collection request (OMB #0920-0469). NPCR's mission
includes using high quality cancer surveillance data for public health surveillance and to monitor trends in cancer risk factors,
incidence, mortality, and survival for cancer prevention and control. NPCR-CSS#s objective is to provide integrated and
comprehensive cancer information systems to facilitate these activities in order to meet national cancer prevention and control
objectives, fulfill agency responsibilities for public health surveillance, comply with Congressional mandates, and better meet the
needs of state public health departments. This project is considered public health surveillance practice for the dissemination of
important facts about the burden of cancer in the U.S. and as the foundation for providing education and information about cancer
incidence, mortality and survival.

IMS/CIO/Epi-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

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

NPCR-CSS is an ongoing project with a previously approved DMP and determination reviews and operates under IRB Protocol
#2594. This entry is for the reclassification of the project as public health surveillance to align with the Assurance of Confidentiality
reclassification based on recent changes to the Common Rule. NPCR-CSS's goal is to make datasets available that address public
health surveillance activities (e.g., publishing routine surveillance reports, tracking national health objectives for special populations,
over time, and by geographic boundaries), evaluate cancer initiatives and guide program planning (e.g., identifying patterns of
cancer diagnosis and treatment, identifying regions with higher proportions of late-stage cancer), and secondary analyses of the
NPCR-CSS datasets that assist the cancer surveillance community to address specific cancer-related research questions that
support the purpose of this public health surveillance program (e.g., monitoring the frequency and distribution of disease, evaluating
cancer prevention and control activities, program planning and evaluation). NPCR#s mission is to monitor trends in cancer risk
factors, incidence, mortality, and survival for cancer prevention and control and includes providing cancer surveillance data for
epidemiologic research. The purpose of the NPCR-CSS is to provide a system to receive data files from NPCR-funded programs for
data evaluation, to determine compliance with NPCR Program Standards, and to create an aggregated data file from which analytic
data sets are created including the US Cancer Statistics database, public use datasets, and restricted access data sets. The data
contained in the NPCR-CSS system does not have direct identifiable information, individuals cannot be directly identified, and there
is no interaction with human subjects or specimen collection. However, the data does contain potentially identifiable information
(county, ZIP code, age, date of birth, etc.). The potentially identifiable information is recoded to further protect confidentiality; e.g.,
individual age recoded to 10-year age groups.

Objective:

This project does not require nonfederal people or institutions to respond or disclose information to a third party or the public. The
project does require NPCR-funded programs, 50 programs are currently funded, to create and submit a de-identified data file of
cancer incidence in their respective geographic coverage area. NPCR-CSS has existing approval from the Office of Management
and Budget for an information collection request (OMB #0920-0469). This de-identified file is submitted to CDC's contractor
according to specifications developed by NPCR using a nationally recognized standard record layout. The data collected by the
NPCR-funded programs is initially reported by healthcare facilities (e.g., hospitals) and providers (e.g., physicians and laboratories)
based on information recorded in the medical record. CDC may provide technical assistance to the NPCR-funded programs as it
relates to preparing a de-identified data file, assuring high data quality, uploading the file to a secure document server hosted by
CDC#s contractor. This project does not involve research conducted by NIH.

Activities or Tasks:

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:

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, CDC employees or agents will obtain or use anonymous or unlinked 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:

Analytic Services (can be data/specimen TA for non-research,research,investigations); QA/QI; Secondary Data Analysis;
Surveillance Support; Technical Assistance

Methods:

NPCR-funded central cancer registries submit de-identified data to CDC on an annual basis where the data are edited,
standardized, and aggregated into the NPCR-CSS. This Public Health Surveillance protocol covers the analysis and dissemination
of these data for 1) surveillance activities, 2) program planning and evaluation, 3) secondary data analysis, and 4) creation of public
use datasets. The design of the specific analysis and dissemination activities depend on the specific activity.
NPCR-funded central cancer registries continuously receive cancer incidence data, including information on diagnosis, treatment,
and outcomes, on individuals residing, diagnosed, or treated within their geographic boundaries. Cases available in the NPCR-CSS
dataset are defined as all invasive and in situ cancers (with the exception of basal and squamous carcinoma of the skin and

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results:

carcinoma in situ of the cervix) and benign and borderline tumors of the brain and central nervous system. Central cancer registries
must report to CDC data items specified in 42 USC 280e-280e-4 and those needed for NPCR surveillance and program planning
and evaluation. More data items are collected at the central cancer registry level than are reported to CDC. Mandated data
elements that are available for analysis and dissemination include: 1) demographic data (e.g. age groups, race, sex, residence at
diagnosis); 2) cancer data (e.g., primary site, morphology, date of diagnosis, diagnostic confirmation, stage at diagnosis); and 3)
treatment data. Patient follow-up status (e.g., vital status, cause of death) is also reported though it is not mandated by 42 USC
280e-280e-4. All variables are defined by the Uniform Data Standards Committee of the North American Association of Central
Cancer Registries (NAACCR), a standard setting organization for cancer registries. Changes to data items or conversion issues are
handled by this committee and disseminated to the NAACCR membership. NPCR#s commitment to standards for data quality
includes requiring central cancer registries to conform to standard definitions so that data are comparable across geographic
boundaries. Data quality evaluations assure the validity and reliability of the reported information.
When standards of completeness and quality have been met for the NPCR-CSS final submission, CDC aggregates state data and
makes them available in non-confidential, pre-calculated rates on the Internet in a format that facilitates obtaining data by sex, race,
age, geographic area, and other common factors of interest. Any data published from NPCR-CSS in surveillance reports, either in
printed copy or on the Internet, are scrutinized to assure that the confidentiality of the individual is protected. Current users of the
NPCR-CSS data must sign a data release agreement as outlined in a data release policy that is updated annually. Restrictedaccess data sets are available with appropriate processes in place to protect confidentiality and security. The NPCR-CSS helps
CDC continue to meet its public health responsibilities by providing routine surveillance reports on the national cancer burden by
demographic characteristics, tumor characteristics, survival time, and other items of interest to the public health agencies
responsible for the design, implementation, and evaluation of cancer prevention and control activities. CDC#s prevention efforts are
enhanced by the ability to target areas with high rates of cancer with appropriate screening such as mammography, Pap tests, and
colorectal cancer screening. The Agency for Healthcare Research and Quality (AHRQ) includes measures for effectiveness of care
in cancer. Since 2002, CDC and the NCI, have published the United States Cancer Statistics (USCS) containing a set of official
federal cancer incidence statistics for the entire US population. Cancer information collected under NPCR-CSS is very important to
evaluate the success and remaining challenges in meeting CDC program goals and objectives, as well as to identify areas that can
benefit from education and training, technical assistance, and other resources.

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?

Yes

Is an assurance of confidentiality in place or
planned?

Yes

Is a certificate of confidentiality in place or planned? No
Is there a formal written agreement prohibiting the
release of identifiers?

Funding

No

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Contract

National Program of Cancer Registries Cancer Surveillance System (NPCR-CSS)

200-2010-37215-0022

2017

4

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

N/A

Population - Minors

N/A

Population - Prisoners

N/A

Population - Pregnant Women

N/A

Population - Emancipated Minors

N/A

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 & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

Jessica
King

09/20/2022

Manxia
Wu

09/19/2022

Mary
O'neil

09/23/2022

Simple
Singh

09/19/2022

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

09/05/2021

CoInvestigator

gzk3@cdc.
gov

770-4884279

DATA ANALYSIS
SUPPORT TEAM

11/20/2021

CoInvestigator

ilb8@cdc.
gov

770-4883189

CANCER SURVEILLANCE
BRANCH

CoInvestigator

dbi8@cdc.
gov

770-4888247

SURVEILLANCE
RESEARCH TEAM

CoInvestigator

hjv3@cdc.
gov

770-488-2

SURVEILLANCE
RESEARCH TEAM

12/04/2021

11/09/2021

Data
DMP
Proposed Data Collection Start Date:

9/20/17

Proposed Data Collection End Date:

9/19/50

Proposed Public Access Level:

Public, Non-Public, Restricted

Non-Public Details:
Reason For Not Releasing Data:

Other - Dataset includes indirection identifiable information that, in combination with other information, reduces data confidentiality

Restricted Details:
Data Use Type:

Research Data Center

Data Use Type URL:

https://www.cdc.gov/rdc/B1DataType/Dt131.htm

Data Use Contact:

Reda Wilson

Public Access Justification:

NPCR#s mission is to monitor trends in cancer risk factors, incidence, mortality, and survival for cancer prevention and control and
includes providing cancer surveillance data for epidemiologic research. Providing a public access dataset facilitates analyses
outside the CDC.

How Access Will Be Provided for Data:

NPCR defines public web-based query systems as datasets that are comprised of aggregated data (i.e., not individual case-specific
data or microdata) that have been modified according to accepted procedures to block breaches of confidentiality and prevent
disclosure of the patient#s identity or confidential information and have a database behind a CDC firewall that is either case-specific
microdata or pre-analyzed data tables. These public web-based systems can be accessed at https://www.cdc.gov/cancer/uscs and
https://wonder.cdc.gov/cancer.html. There are no restrictions on access to public web-based query systems. A public release
disclosure statement cautions users against inappropriate use of the data or inappropriate disclosure of information. In addition to
the web-based systems, the NPCR/SEER USCS Incidence Public-Use Research Dataset (PUD) is available. The PUD is defined
as the version of the full NPCR/SEER USCS microdata (i.e., individual case-specific data) that have been modified as needed to
minimize the potential for disclosure of confidential information. It consists of a subset of data items published in USCS. This
dataset does not contain personal identifiers such as a patient#s name, street address, or Social Security number as this
information is not transmitted by central cancer registries to CDC as part of their annual data submission. Certain data items, such
as date of birth, and reporting-source (death certificate only and autopsy) cases have also been removed from this research dataset
to minimize the potential identification of individuals with the occurrence of rare cancer in a person of certain age or racial or ethnic
group or living in a specific county. The dataset is available publicly through SEER*Stat software after signing an NPCR and SEER
# U.S. Cancer Statistics Research Data Use Agreement. A Public Release Disclosure Statement cautions users against
inappropriate use of the data or inappropriate disclosure of information. Cell suppression of <16 cases is automatic and the
SEER*Stat case listing function is disabled as additional data protection measures.

Plans for Archival and Long Term Preservation:

Data for the public web-based query systems are archived at https://www.cdc.gov/cancer/uscs/dataviz/archive.htm. Older versions
of the Public-Use Research Dataset continue to be maintained within the SEER*Stat software.

Spatiality
Country

State/Province

County/Region

United States

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