A1b Statement of Work SAM.docx

Statement of Work / Performance Work Statement Title: National Program of Cancer Registries Public Use Dataset Hosting Management – IMS

Period of performance of this contract is: 02/12/2026- 2/11/2030 Base Period: 02/12/2026- 2/11/2027 Option Period One: 02/12/2027- 2/11/2028 Option Period Two: 02/12/2028- 2/11/2029 Option Period Three: 02/12/2029- 2/11/2030

SECTION 1 – BACKGROUND

Congress established the National Program of Cancer Registries (NPCR) in 1992 by enacting the Cancer Registries Amendment Act (Public Law 102-515; 42 USC 280e-280e-4). This legislation authorizes the CDC to provide funds to states and territories to improve existing cancer registries; to plan and implement registries where none existed; to develop model legislation and regulations for states to enhance the viability of registry operations; to set standards for data completeness, timeliness, and quality; to provide training for registry personnel; and to help establish a computerized reporting and data-processing system.

The Division of Cancer Prevention and Control (DCPC), Cancer Surveillance Branch (CSB) in the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) is responsible for administering and monitoring the NPCR. CDC currently supports 46 states, the District of Columbia, Puerto Rico, Virgin Islands, and the Pacific Island Jurisdictions for population-based cancer registries. Beginning in 2001, NPCR-funded state and territorial recipients began reporting their incidence data to CDC’s National Program of Cancer Registries – Cancer Surveillance System (NPCR-CSS). The NPCR-CSS is designed to collect, process, evaluate, enhance, analyze, and disseminate cancer incidence data submitted to CDC by the NPCR state and territorial awardees.

The United States Cancer Statistics (USCS) are the official federal statistics on cancer incidence and mortality. The statistics are produced by DCPC, in cooperation with three cancer data sources: CDC’s NPCR, National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program, CDC’s National Center for Health Statistics (NCHS) National Vital Statistics System. USCS data are disseminated in various data products, including an online data visualizations tool and a researcher public use database. Overall, the data contained in USCS are used to monitor cancer trends over time, determine cancer patterns in various populations, and guide planning and evaluation of cancer control programs.

NPCR’s mission includes using cancer surveillance data for epidemiologic research 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 comply with Congressional mandates, to fulfill agency responsibilities for public health surveillance, meet the needs of state public health departments, and national cancer prevention and control objectives.

To carry out NPCR’s mission and to meet mandates for increasing data access, NPCR and USCS data must be stored and publicly accessible to search, retrieve, and analyze and unrestricted access to public use databases made available for surveillance and epidemiologic research. All data collected and maintained by NPCR-CSS must be managed, presented, published, and released with strict attention to confidentiality and security, consistent with the general principles and guidelines established by CDC for confidential case data and specific restrictions imposed on NPCR-CSS data and in accordance with data sharing agreements between CDC and each NPCR recipient. Special care must be given to cancer incidence data that are not directly identifiable because geographic and small cell data may be indirectly identifying when combined with detailed information in case reports, laboratory reports, medical records, or linkage with other data files.

Agencies, organizations, and individuals outside CDC require access to data that is only available in NPCR and USCS data products. A combination of confidentiality protection measures will be employed for all NPCR and USCS public use datasets which will not contain information that is identifiable or potentially identifiable according to currently accepted procedures for reducing disclosure risk. Researchers analyzing these data will sign a data use agreement or acknowledge terms of use which includes a clause that requires them to determine whether there is a need for complementary cell suppression and to apply suppression as needed.

Datasets generated using the NPCR-CSS analytic data include the U.S. Cancer Statistics public use and delay-adjusted databases and the NPCR survival and prevalence database. In addition to the datasets being used for epidemiological and surveillance research purposes, these data are used to produce data products accessible to the public, including the USCS Data Visualizations and CDC WONDER tools. Data sources, case definitions, basic registry eligibility criteria (e.g. required data completeness and quality, population denominator sources, methods for calculating incidence rates, and the rationale for specific cell suppression thresholds) are as described in the USCS Data Visualizations tool’s technical notes, U.S. Cancer Statistics public use database technical documentation, and the USCS WONDER documentation.

SEER*Stat software, developed by the National Cancer Institute under contract with Information Management Services, Inc. (IMS), is utilized to produce analytic and public use datasets, and to make these datasets available to researchers. SEER*Stat statistical software provides an accessible and intuitive mechanism for the analysis of cancer-related datasets. It is a powerful software tool to view individual cancer records, evaluate data quality, and to produce statistics for studying the impact of cancer on a population. It offers robust security features, enabling fine-grained access control while maintaining strict confidentiality of sensitive data. SEER*Stat software is the method by which official federal statistics on cancer are generated and is the primary statistical software used by the cancer research community, including each state cancer registry. Even though the software is publicly available, the mechanism for hosting network-based datasets to carry out NPCR’s mission (e.g., loading, hosting, and deleting datasets, running batch queries, responding to public use data requests) is maintained by IMS only. CDC has had previous contracts with IMS for data hosting, processing batch queries, managing data user access and reporting.

SECTION 2 – PURPOSE/OBJECTIVE

Network-based data hosting management services – including loading, hosting, and deleting datasets, batch processing queries, responding to access requests, and managing public user access and reporting – will be obtained in order to comply with Congressional mandates, fulfill agency responsibilities for public health surveillance, and meet the needs of state public health departments and national cancer prevention and control objectives.

SECTION 3 – SCOPE OF WORK

CDC NPCR utilizes the software product SEER*Stat to produce national cancer statistics (e.g., cancer incidence and mortality age-adjusted rates; survival, prevalence, trend, and projection estimates), evaluate and monitor data quality, analyze data, and produce data products for internal and external users. SEER*Stat software is an industry standard statistical analytic tool in the cancer surveillance and research community. It is the primary statistical software used in each state cancer registry as well as by researchers in other agencies, organizations, and educational institutions. With seamless integration and a user-friendly interface, it empowers organizations to derive insights efficiently without compromising on data protection. To make the datasets available to the public under current the data release policy between CDC and NPCR recipients, the datasets must be hosted on the SEER*Stat network-based system. This requires the contractor to conduct data lifecycle management, provide technical assistance to CDC staff creating datasets, and provide access to end-users, track usage, and respond to inquiries related to datasets. The contractor is also able to run batch queries, which enable efficient and accurate production of output needed for data evaluation and data reporting. The contractor will provide all labor, materials, and equipment required to complete the tasks outlined below.

SECTION 4 – TASKS TO BE PERFORMED

The contractor shall perform the following tasks for network-based dataset hosting management services within the SEER*Stat statistical software for multiple NPCR-CSS public use datasets. The contractor will host NPCR and USCS datasets CDC annually produces, may host up to 350 additional analysis datasets, provide secure access controls to the data, provide unlimited authorized users access to the data and analytical tools, and provide administrative and technical support to CDC and authorized users including training, tracking database access, and response to data user inquiries. Automated analytical tools will use standard statistical methods to study the impact of cancer on a population.

Task 1: SEER*Stat dataset processing tasks Provide access and statistical reporting tools to authorized users to support data sharing and analysis of CDC-sponsored datasets and similar public use datasets through a web-based or client-server application.

1. Download new and updated datasets from a CDC server. Unzip the dataset and add to the SEER*Stat server. Perform basic testing of the data (e.g. rates by year and registry). Identify problems and alert CDC staff. Contractor staff will correct, if possible, by modifying the configuration file, otherwise CDC staff or CDC contractors will recreate the file.

2. Provide and update user access for specific datasets, as needed.

a. Establish and maintain a task request and tracking mechanism

b. Establish and maintain mechanisms for public database user access

i. Establish mechanism to receive public database user access requests

ii. Process data requests within 2 business days of receipt

c. Manage user accounts

i. Add and remove user access to analytic databases per CDC request

ii. Add user access to CDC public use databases upon receipt of a Data Use Agreement (DUA) or request form and remove access when accounts expire or are disabled due to inaction in completing annual DUA

d. Provide minimal technical support for CDC database-specific questions. Inquiry forward to CDC for data-item related issues.

3. Maintain electronic information on all NPCR and USCS datasets, including dataset name, user access to each dataset, and number of analyses each user has performed for each dataset in the past month, calendar quarters, and ever, and the date the dataset was last accessed by the user.

4. Provide technical support related to dataset creation and fixes as needed and instructor-led training in SEER*Prep, SEER*Stat, JoinPoint, or other IMS developed tools or software, as determined by CDC.

Task 2: Public use dataset tasks Perform approximately 5 analyses of incidence data annually per CDC specifications and review. Annual analyses will include, but are not limited to, creation of data summary tables for the NCI-hosted State Cancer Profiles website (http://statecancerprofiles.cancer.gov) and other analyses that are approved by the State Cancer Profiles Steering Committee; data for the CDC’s Environmental Public Health Tracking National Portal; and data for CDC’s Chronic Disease Indicators.

1. State Cancer Profiles Request

a. Using a SEER*Stat dataset provided by CDC, produce summary tables as specified by CDC for the State Cancer Profile website.

2. Environmental Public Health Tracking (EPHTN) Request

a. NPCR and SEER incidence statistics shall be produced as specified by CDC, requiring multiple SEER*Stat sessions and SAS processing. Counts are produced and stratified by cancer site, county, age, race, ethnicity, and sex. Cell count suppression of the data is applied by the EPHTN staff.

3. Chronic Disease Indicators Request

a. NPCR incidence, SEER incidence, and NCHS US mortality statistics shall be produced as specified by CDC, requiring multiple SEER*Stat sessions and SAS processing. Five-year average age adjusted rates and counts are produced in .CSV format for states, selected counties, and a few grouped counties for all races and all ages for the following cancer sites, but not limited to these sites: all, breast, cervix, colorectal, lung, melanoma, oral cavity, and prostate. Cell count suppression is applied to the output.

4. Public-Use Survival Dataset

a. Evaluate the NPCR Analytic Survival Dataset for quality development and reliability and to provide recommendations for development of a Public-Use Analytic Survival Dataset. NPCR raw data files may be provided to produce analytic survival datasets.

Task 3: Mortality reports Annually, Contractor shall create and process individual text sessions from mortality files for each year by county, sex, race/origin (12 groups), age, and primary site to provide a single output report within two (2) weeks after receiving the request. The batch queries enable efficient and accurate production of reports needed to determine completeness of case ascertainment, a data quality standard criterion.

1. Using mortality and SEER*Stat session files provided by CDC NPCR, contractor converts SEER*Stat session queries to text sessions.

2. Contractor creates script for each mortality year applicable to each submission file, beginning with the 2002 mortality year through the most current analytic year, and each race and ethnicity combination.

3. Contractor creates and processes a batch script, using the contractor’s servers (e.g., Linux), for all text sessions and exports results to text files.

4. Contractor merges all output files into a single report and provides the report to CDC.

Task 4: Report on progress and cost of all contract activities.

1. Submit quarterly Progress Reports throughout the contract period to the Government describing in detail the data management and technical assistance provided to the awardees and to CDC for activities related to this contract.

2. Submit a cost report that corresponds with each invoice cycle.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

CDC will provide the contractor with analytic datasets.

SECTION 6 – PLACE OF PERFORMANCE

Work will be performed at the contractor’s facility.

SECTION 7 – TRAVEL

All travel must be in accordance with the Federal Travel Regulations (FTR). Contractor shall obtain COR preapproval of estimated travel expenses prior to occurrence. Charges will be submitted for actual costs as incurred. The contractor shall ensure that the requested travel costs shall not exceed the amount authorized in this task order.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy Procurements Requiring Information Security and/or Physical Access Security Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

· Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

· Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

· Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X] No PII [ ] Yes PII Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [X] Low [ ] Moderate [ ] High

4) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

5) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

6) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

8) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

10) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and CDC-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR and ISSO within 30 days of contract award.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keyshttp://csrc.nist.gov/publications/. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

11) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the CDC non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

12) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the CDC SOP or designee with completing a PIA for the system or information within 30 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

b. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/CDC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete CDC specific Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and any CDC-specific rules, as applicable.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

Incident Response The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/CDC CSIRT teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII” .

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send CDC approved notifications to affected individuals following CDC’s designated process.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the CDC’s Computer Security Incident Response Team (CSIRT) [CSIRT@CDC.gov], COR, CO, CDC SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information HHS and CDC’s incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

Position Sensitivity Designations All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels may apply to this solicitation/contract: Not Applicable and Level 1: Non-sensitive, depending on roles and responsibilities.

Homeland Security Presidential Directive (HSPD)-12 The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2. For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12) Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within the CDC Specified timeline of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 7 days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, and HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. The EPLC framework provides a standard structure for planning, managing, and governing IT projects from concept to disposition. The framework consists of ten phases to review the project’s management quality, soundness, and technical feasibility remain adequate, and the project is ready to move forward to the next phase. Within each phase, the activities, responsibilities, reviews, and deliverables are defined. All new information systems development or major enhancement tasks supported by the contractor should utilize CDC’s North Star Architecture as a “blueprint” to guide any decisions on technologies and processes and projects must be reviewed and approved by NCCDPHP’s local governance, the CDC Information Technology and Data Governance (ITDG) Board and the CDC Architectural Review Team (ART). All IT projects must follow the CDC EPLC framework and methodology, pass each review as appropriate, and meet all conditions outlined during the stage gate, ITDG, ART reviews, and attend all required meetings. The contractor shall use NCCDPHP approved stage gate templates, adhere to tailored processes, and utilize the NCCDPHP Project Process Agreement (PPA). The contractor shall produce all required EPLC documentation per project phases. The work must be in accordance with the HHS Contract Closeout Guide (2012). HHS EPLC requirements may be located here: Policy for Information Technology (IT) Enterprise Performance | HHS.gov.

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 7 days before an employee stops working under this contract.

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Contractor Employee Separation Checklist when an employee terminates work under this contract within 7 days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

Records Management and Retention The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/CDC policies.

Data Analysis: CDC’s Enterprise Data and Visualization (EDAV) Platform and CDC’s One Data Platform (1CDP) should be used for all data, analytics and visualization projects. For NEW data collection, management, analysis, and visualization projects, the project team must meet with local governance for review of the business need then with the OCIO team to determine if the business need can be met by the enterprise capabilities for data management, analysis, and/or visualization. For new or ongoing data activities, CDC (or CDC contractors) must avoid building new or duplicative analytic or visualization tools or purchasing licenses (e.g., Tableau resources). The project team must: 1. Identify the existing analytic or visualization solution or tool in use or planned to use. 2. Avoid purchasing or building new or duplicative analytic or visualization tools or licenses, unless an exception is granted by CDC; 3. Consult with the EDAV and/or 1CDP team to identify opportunities for integration or use of enterprise services; and 4. If appropriate, prepare a migration plan and timeline to shift away from siloed solutions to enterprise services (e.g., plan for migrating to the EDAV/1CDP platform, including technical and workforce development components); 5. When appropriate, all datasets should have metadata available in a CDC metadata catalog.

Artificial Intelligence (AI): Any uses of artificial intelligence tools or technology should follow CDC’s Guidance for Generative Artificial Intelligence which establishes principles and practices for the responsible use, development, and procurement of generative artificial intelligence technology by CDC staff, to support the agency’s public health mission to equitably protect the nation’s health, safety, and security. CDC data cannot be stored into a non-CDC tool with AI capabilities. Contractor’s may not utilize non-CDC AI technology to transcribe calls with CDC staff.

Requirements for Government Information Processed on Government or Contractor Owner Systems A. Security Requirements for Government Information Processed on Government or Contractor Owner Systems

1) Federal Policies. The Contractor (and/or any subcontractor) shall comply with applicable federal laws that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P); Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, Security and Privacy Controls for Federal Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Departmental policies.

2) Security Assessment and Authorization (SA&A). A valid authority to operate (ATO) certifies that the Contractor’s information system meets the contract’s requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s). The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, CDC’s SA&A Standard Operating Procedures, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

CDC’s acceptance of the ATO does not alleviate the Contractor’s responsibility to ensure the system security and privacy controls are implemented and operating effectively.

a. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package to the C/I/O Information Systems Security Officer. The following SA&A deliverables are required to complete the SA&A package.

· System Security Plan (SSP) – The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and CDC policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

· Security Assessment Plan/Report (SAP/SAR) – The security assessment shall be conducted by a CDC assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and CDC policies. The assessor will document the assessment results in the SAR. Thereafter, the Contractor, in coordination with CDC shall assist in the assessment of the security controls and update the SAR at least annually.

· Independent Assessment - When applicable, the Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all “high” deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

· POA&M – The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and CDC policies. All high-risk and medium weaknesses must be mitigated within CDC defined timeframes from the date the weaknesses are formally identified and documented. CDC will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, CDC may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly or as requested by CDC.

· Contingency Plan and Contingency Plan Test – The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and CDC policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

· E-Authentication Questionnaire – The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines. Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

b. Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, and HHS IS2P. The following are the minimum requirements for ISCM:

· Annual Assessment/Pen Test - Assess the system security and privacy controls (or ensure an assessment of the controls is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (this may involve penetration testing conducted by the agency or independent third-party.) In addition, review all relevant SA&A documentation (SSP, POA&M, Contingency Plan, etc.) and provide updates by specified due date provided by CDC.

· Asset Management - Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all…