Human Subjects Determination

Print Date: 1/31/25

Title:

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

Project Id:

0900f3eb81c80e50

Accession #:

NCCDPHP-SRT-1/21/21-7f4b4

Project Contact:

Reda J Wilson

Organization:

NCCDPHP/DCPC/CSB/SERT

Status:
Intended Use:

Funding Determination

Estimated Start Date:

10/20/2021

Estimated Completion Date:

10/19/2050

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:
No

1/22/21

Redmond Leonard_Joan (jrl3) CIO HSC

PRA:
PRA Applies

1/25/21

Still-LeMelle_Terri (cse6) OMB / PRA

Description & Funding

Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

01/21/21

Description:

Cancer is the second leading cause of death in the United States. 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. To monitor cancer burden, data are collected by 46 states, the District of
Columbia, Puerto Rico, the U.S. Pacific Island Jurisdictions, and the U.S. Virgin Islands that receive funding from NPCR. Two
requirements that awardees fulfill include: (1) reporting data to CDC for the United States Cancer Statistics (USCS) data products
and (2) reporting on the integration of surveillance, registry operations and health information systems, the utilization of established
data standards, and the electronic exchange of health data through the Program Evaluation Instrument (NPCR-PEI). The NPCRCSS Request for Proposal (RFP) Statement of Work (SOW) is for the data management, maintenance and technical assistance for
these two requirements. The RFP SOW has 2 tasks; (1) support the NPCR-CSS and CSS STAR Registry, including providing a
system to annually receive data from NPCR awardees and (2) support the NPCR-PEI, including deploying the evaluation
instrument, creating analytic datasets, and maintaining a web-based data query system. The RFP SOW provides (1) a system for
managing the NPCR-CSS web-based document server, to include a data monitoring system, data evaluation reports, data quality
indicator reports, master aggregated files, analytic databases, and request tracking system; and (2) a web-based system to deploy
the NPCR-PEI to include an analytic database, report query system, and request tracking system. This contract is for the data
management, maintenance and technical assistance for these requirements. 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 previously received IRB approval under Protocol #2594 that was recently
closed in response to the project#s reclassification as public health surveillance in alignment with the current Assurance of
Confidentiality criteria; the NPCR-CSS AoC is active (expiration date: 05/30/2025). NPCR-CSS has existing approval from the
Office of Management and Budget (OMB) for an information collection request (OMB #0920-0469). NPCR-PEI has existing
approval from OMB for an information collection request (OMB #0920-0706).

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

NPCR-CSS and NPCR-PEI are ongoing projects with previous determination reviews. This entry is for IRB/PRA determination for
the RFP SOW. The purpose of this project is to provide an integrated and comprehensive contract for responsive, efficient, and cost
effective information management services, which incorporates all appropriate technical and security requirements and
consideration. The purpose of task 1 is to operate the existing NPCR-CSS and CSS STAR to receive, process, evaluate, aggregate,
enhance, analyze and disseminate cancer incidence data submitted to CDC by NPCR awardees. The NPCR-CSS system
evaluates compliance with NPCR Program Standards and creates master aggregated data files and analytic databases including
the USCS, survival, prevalence, public use, and restricted access datasets. Task 2 is to operate the existing web-based NPCR-PEI
system to receive and process self-reported data from NPCR awardees, create analytic datasets, and display a web-based query
system.

Objective:

The NPCR-CSS/NPCR-PEI RFP SOW objective is to obtain information management services for the ongoing NPCR-CSS and
NPCR-PEI projects. Both projects require NPCR-funded programs, 50 programs are currently funded, to: (1) create and submit a deidentified data file of cancer incidence in their respective geographic coverage area through the NPCR-CSS under OMB #09200469 and (2) respond to a series of questions, through an internet-based questionnaire, addressing the integration of surveillance,
registry operations and health information systems, the utilization of established data standards, and the electronic exchange of
health data under OMB #0920-0706.

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

Funding

Funding Type

Funding Title

CDC Contract

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

HSC Review

Funding #

Original Budget Yr

# Years Award

2021

5

Budget Amount

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

Jessica
King

07/13
/2026

Manxia
Wu

07/28
/2026

Mary
O'neil

09/23
/2025

Simple
Singh

07/05
/2026

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

09/05/2021

CoInvestigator

gzk3@cdc.
gov

7704884279

DATA ANALYSIS
SUPPORT TEAM

11/20/2021

CoInvestigator

ilb8@cdc.
gov

7704883189

CANCER
SURVEILLANCE
BRANCH

CoInvestigator

dbi8@cdc.
gov

7704888247

SURVEILLANCE
RESEARCH TEAM

CoInvestigator

hjv3@cdc.
gov

770488-2

SURVEILLANCE
RESEARCH TEAM

12/14/2027

Supporting Info

11/09/2021

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Current

CDC Staff
Member and
Role
Wilson_Reda J.
(dfo8)

Date Added

01/22/2021

Project Contact

Description

NPCR-CSS/NPCR-PEI Concept

Supporting Info Type

Other

Clearance Summary

Supporting Info

NPCR-CSS Concept Clearance 2020 ClearanceSummary.
pdf

Wilson_Reda J.
(dfo8)
Project Contact

01/22/2021

NPCR-CSS DMP Clearance
Summary

Other

NPCR-CSS DMP Clearance Summary.pdf

Wilson_Reda J.
(dfo8)
Project Contact

01/21/2021

NPCR-CSS RFP SOW

Statement of Work

CSS.PEI-Statement-of-Work.12-17-2020 with IT security.
508.docx