A11a DRAFT SOW_HHS-CDC-OPHDST(LC)-SS-24-001.docx

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Leverage Contractor for User Research with General Public Federal contract opportunity
Solicitation number
HHS-CDC-OPHDST(LC)-SS-24-001
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

About this file

This document is a Draft Statement of Work (SOW) for a federal contract opportunity titled "Leverage Contractor for User Research with General Public" from the Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) Office of Public Health Data, Surveillance, and Technology (OPHDST).

The purpose of this contract is to obtain user research services to support the CDC's SAPHIRE (Sharing Actionable Public Health Information in a Responsive Environment) system, which provides data visualizations and insights to the public. The contractor will recruit and manage diverse participant pools, including general public and accessibility-focused studies, to conduct 6 total user research studies over a 6-month period from August 2024 to January 2025. The contractor must have over 15 years of experience, a proprietary panel of 50,000+ participants, and geographic diversity within the US. The insights gained will enable the CDC and APL-JHU design teams to develop personas, user journeys, UX designs, and other deliverables to inform the SAPHIRE system. This effort supports recent legislation and Executive Orders around user-centered design and engagement of underrepresented communities.

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DRAFT Statement of Work Title: Leverage Contractor for user research with general public

Period of Performance: August 1, 2024 to January 31, 2025 Section 1 - Background

As part of CDC’s focus on Human Centered Design, OPHDST’s Inform and Disseminate Division needs to collect information from the public on an ongoing basis to inform the improvement and development of dashboards and other tools for data dissemination. CDC will offer these dashboards and other tools as a service to the public, the end user as a part of SAPHIRE. Standing for Sharing Actionable Public Health Information in a Responsive Environment, SAPHIRE is a system for quickly creating and distributing CDC data visualizations, insights, and related content to public users to empower them to make informed public health decisions. SAPHIRE connects to the Public Health Data Strategy Milestone 3.1 by enabling external users, such as STLTs and the public, to have expanded access to data and visualizations for four CDC data assets, including emergency department, mortality and case data, to support public health decision-making. Some of the top priority questions that we need to explore are around the audiences for SAPHIRE and their needs. By conducting user research, the team building SAPHIRE capabilities will be able to answer these questions and deliver what is needed to achieve the milestone. SAPHIRE user research will impact how we enhance our ability to showcase data sources stewarded by OPHDST (e.g., Emergency Departments, Case Surveillance, Laboratory, and Healthcare), NCHS (e.g., mortality), and programs via existing data platforms (data.cdc.gov and CDC Wonder) and Data Channels on cdc.gov (Emergency Department data, Respiratory Virus Response, and potentially Firearms and heat-related illnesses). This information will be transmitted to the public via cdc.gov websites and pages as well as other platforms such as news publishers, social media, and STLT publications. To ensure that this information is useful, actionable, and accessible to the public, the Design team within the Inform & Disseminate Division will need to conduct foundational user research and work with a Contractor to ensure speedy, effective participant recruitment. Working with a Contractor will ensure the audiences that inform our projects and deliverables (persona development, user needs, product roadmaps, division strategy and direction) are diverse and represent key demographics that we need to understand to uncover needs, values, and behavior. This will ensure the content we create and disseminate is relevant. As recruiting participants is both time-consuming and challenging, leveraging a Contractor to conduct this work will ensure that research is completed both on-time and with the specified audience—instead of relying on proxies and hypothesis around what we think users might need. It also ensures that the Design team focuses on creating research plans, designing prototypes as needed, moderating sessions, analysis and synthesis of research data, and actioning results.

Working with a Contractor will provide measurable impacts in the following areas:

· Increase recruitment and participation of representative and diverse members of the public

· Reduce FTE time spent on operational task around recruitment and participant management

· Decreasing recruitment time will speed along Design projects and enable quicker collection of insights that inform our product strategies and business outcomes

· Speedier research equates to being able to conduct more research with more audiences Increasing the frequency and type of research will positively impact the user experience as we will have the insights we need to inform the products and services we are building.

Additionally, robust user research will bring our work closer to aligning to recent legislation and executive orders including—

· 21st Century Integrated Digital Experiences Act: “Requirements for New Websites and Digital Services…is designed around user needs with data-driven analysis influencing management and development decisions, using qualitative and quantitative data to determine user goals, needs, and behaviors, and continually test the website, web-based form, web-based application, or digital service to ensure that user needs are addressed.”

· Executive Order 14058 of December 13, 2021: “Strengthening the democratic process requires providing direct lines of feedback and mechanisms for engaging the American people in the design and improvement of Federal Government programs, processes, and services.”

· Executive Order 13985 of January 20, 2021: “agencies shall consult with members of communities that have been historically underrepresented in the Federal Government and underserved by, or subject to discrimination in, Federal policies and programs.”

Subsection A – Definitions N/A

Section 2 – Purpose/Objective

A Contractor will open access to the public and increase the speed to recruit diverse participants needed to conduct foundational research in support of SAPHIRE. SAPHIRE is a system for quickly creating and distributing CDC data visualizations, insights, and related content to public users to empower them to make informed public health decisions. The insights we gain from our foundational research will enable the CDC and APL-JHU Design teams to build and influence deliverables such as personas, user journeys, UX wireframes and concepts, requirements and feature documentations. This documentation will be shared with division leadership, CDC and APL-JHU technical/engineering teams, CDC Communications teams, and CDC Scientists to build SAPHIRE Data Channels that encompass visualizations, interpretations, and context and guidance for the public audience.

Section 3 - Scope of Work

The purpose of this acquisition is for the CDC to obtain 4 General public focused studies and 2 Accessibility focused studies for user research for FY24. Each study will have a duration of no longer than one month for a total of 6 month contract period. The Contractor, as an independent organization and not an agent of the Government shall furnish all labor, equipment, materials, supplies, and other costs, if required, to provide technical knowledge and experience for the following tasks.

· Ensure that study criteria are met

· Schedule sessions

· Manage participants

· Enable feedback to be tracked

Vendor Qualifications

· The Contractor must have over 15 years of experience.

· The Contractor must have a propriety panel of over 50,000 qualified participants.

· The Contractor must have participants from a range of geographies within the United States.

Technical Requirements The Contractor must have over 15 years of experience. The Contractor must have a propriety panel of over 50,000 qualified participants and must have participants from a range of geographies within the United States.

The Contractor will work with the Design team to build and execute recruiting screeners to ensure correct audiences criteria is reached, including the following (which may overlap):

1. General Public focused studies (4)- the research study is to understand how public audiences discover, consume, and take action on public health information., The below are the following requirements:

· Specified total number of participants per study as provided by the Inform & Disseminate Design team Ex. One study will include 10 participants.

· Specified mix of gender representation per study as provided by the Inform & Disseminate Design team. Ex. A single, 10-participant study will include at least 5 participants who identify as Female.

· Specified mix of race/ethnic representation per study as provided by the Inform & Disseminate Design team. Ex. A single, 10-participant study will include at least 2 people who identify as Black or African American, 2 people who identify as Latino or Latinx, 2 people who identify as Asian or Asian American etc.

· Specified mix of LGBTQ+ representation per study as provided by the Inform & Disseminate Design team. Ex. A single, 10-participant study will include at least 2 participants who identify as LGBTQ+.

· Specified mix of age representation. Ex. A single, 10-participant study will be entirely focused on those who are age 65 or older.

· Specified mix of participants who identify as immunocompromised. Ex. A single, 10-participant study will be entirely focused on those who identify as immunocompromised.

· Specified mix of participants who identify as parents. Ex. A single, 10-participant study will be entirely focused on those who are parents to children under the age of 18 who live at home.

· Specified mix of data literacy. Ex. A single, 10-participant study will include will be entirely focused on those who indicate low interest in data dashboards per screener questionnaire.

· Specified mix of participants who are caretakers for older adults. Ex. A single, 10-participant study will include will be entirely focused on those who indicate they care for an older relative etc. per screener questionnaire.

· Specified mix of participants in pre-determined geographic areas. Ex. A single, 10-participant study will include will be entirely focused on those who live in the southwestern United States.

2. Accessibility focused studies (2) - the research study is to understand how people with disabilities and/or use assistive technology discover, consume, and take action on public health information., The below are the following requirements:

· Specified mix of gender representation per study as provided by the Inform & Disseminate Design team. Ex. A single, 10-participant study will include at least 5 participants who identify as Female.

· Specified mix of race/ethnic representation per study as provided by the Inform & Disseminate Design team. Ex. A single, 10-participant study will include at least 2 people who identify as Black or African American, 2 people who identify as Latino or Latinx, 2 people who identify as Asian or Asian American etc.

· Specified mix of LGBTQ+ representation per study as provided by the Inform & Disseminate Design team. Ex. A single, 10-participant study will include at least 2 participants who identify as LGBTQ+.

· Specified mix of persons with disabilities per study as provided by the Inform & Disseminate Design team. Ex. A single, 10-participant study will include at least 5 participants who are blind or have a visual impairment.

· Specified mix of age representation. Ex. A single, 10-participant study will be entirely focused on those who are age 65 or older.

· Specified mix of participants who identify as immunocompromised. Ex. A single, 10-participant study will be entirely focused on those who identify as immunocompromised.

· Specified mix of participants who identify as parents. Ex. A single, 10-participant study will be entirely focused on those who are parents to children under the age of 18 who live at home.

· Specified mix of data literacy. Ex. A single, 10-participant study will include will be entirely focused on those who indicate low interest in data dashboards per screener questionnaire.

· Specified mix of participants who are caretakers for older adults. Ex. A single, 10-participant study will include will be entirely focused on those who indicate they care for an older relative etc. per screener questionnaire.

· Specified mix of participants in pre-determined geographic areas. Ex. A single, 10-participant study will include will be entirely focused on those who live in the southwestern United States.

In addition to the timely recruiting of the right mix of participants based on specified criteria as provided by the Design team, the Contractor will collect NDAs as needed, interface with both the participant and the designated moderator to schedule the session(s), remind/check-in with participants of upcoming session(s), reschedule as needed per participant or moderator, and provide gratuity to participants. The Contractor will interface with Design team to track participants for no-shows and feedback while maintaining protections and adhering to best practices and PII regulations.

Section 4 – Task To Be Performed Task 1: General Public focused studies -

1a. Contractor will recruit 10 participants who meet study criteria The research project lead will provide the Contractor with a list of specific participant criteria per study.

· Provide list of participants who meet demographic requirements

· Ensure participants consent to participating

· Ensure participants have any software and hardware needed for interview (ex. Video conferencing software, mobile phone)

· Collect NDAs from participants if needed 1b. Contractor will schedule research interview sessions The Contractor will work with the research moderator(s) to schedule participants based on moderator availability and study timeframe. Confirm availability of moderator

· Confirm availability of participant

· Schedule the interview

· Provide moderator and project lead with schedule for all participants

· Reschedule interview dates when needed 1c. Contractor will manage participants.

The Contractor will lead all operational management of participants.

· Confirm consent and other documentation signed ahead of interview

· Confirm contact information of participants and provide moderator-participant communication ahead of designated interview time if needed.

· Ensure and confirm participant has correct information for interview, including time, video conference link or location if interview conducted in-person

· Provide spreadsheet for moderator(s) to provide feedback to Contractor on participants

· Respond and act on any concerns brought to Contractor about the participants Task 2: Accessibility focused studies -

2a. Contractor will recruit 10 participants who meet study criteria The research project lead will provide the Contractor with a list of specific participant criteria per study.

· Provide list of participants who meet demographic requirements

· Ensure participants consent to participating

· Ensure participants have any software and hardware needed for interview (ex. Video conferencing software, mobile phone)

· Collect NDAs from participants if needed 2b Contractor will schedule research interview sessions The Contractor will work with the research moderator(s) to schedule participants based on moderator availability and study timeframe. Confirm availability of moderator

· Confirm availability of participant

· Schedule the interview

· Provide moderator and project lead with schedule for all participants

· Reschedule interview dates when needed 2c. Contractor will manage participants.

The Contractor will lead all operational management of participants.

· Confirm consent and other documentation signed ahead of interview

· Confirm contact information of participants and provide moderator-participant communication ahead of designated interview time if needed.

· Ensure and confirm participant has correct information for interview, including time, video conference link or location if interview conducted in-person

· Provide spreadsheet for moderator(s) to provide feedback to Contractor on participants

· Respond and act on any concerns brought to Contractor about the participants

Section 5 – Government Furnished Property No Government material will be furnished.

Section 6 – Place of Performance Contractor Facility

Section 7 – Travel N/A

Section 8 – Deliverables/Reporting Schedule

Task
Deliverable
Quantity/Format
Due Date
Deliver To
Task 1a: General Public focused studies
· List of participants who have agreed to participant in the study

· Manage participant consent

· Collect NDAs as needed

Spreadsheet with study criteria, participant demographic information, confirmed access to software/hardware, and whether they have signed documentation
[TBD]
Design Lead
Task 1b: Contractor will schedule research interview sessions
Session schedule
Spreadsheet with schedule and corresponding participants

Calendar invites

Email confirmation

[TBD]
Study Moderator
Task 1c: Contractor will manage participants
· Manage participants

· Feedback on participant

Spreadsheet with notes field for each participant
[TBD]
Study Moderator
Task 2a: General Public focused studies
· List of participants who have agreed to participant in the study

· Manage participant consent

· Collect NDAs as needed

Spreadsheet with study criteria, participant demographic information, confirmed access to software/hardware, and whether they have signed documentation
[TBD]
Design Lead
Task 2b: Contractor will schedule research interview sessions
· Session schedule
Spreadsheet with schedule and corresponding participants

Calendar invites

Email confirmation

[TBD]
Study Moderator
Task 2c: Contractor will manage participants
· Manage participants

· Feedback on participant

Spreadsheet with notes field for each participant
[TBD]
Study Moderator

Section 9 – Reference Materials N/A Section 10 – Minimum Vendor Qualifications N/A Section 11 – Additional Requirements Rights to Data. All contracts that require data to be produced, furnished, acquired, or used in meeting contract performance requirements, must contain terms that delineate the respective rights and obligations of the Government and the Contractor regarding the use, reproduction, and disclosure of that data. Data rights clauses do not specify the type, quantity or quality of data that is to be delivered, but only the respective rights of the Government and the Contractor regarding the use, disclosure, or reproduction of the data. Accordingly, the contract must specify the data to be delivered.

The Contractor (and/or any subcontractor) must protect information that is deemed sensitive from unauthorized disclosure to persons, organizations or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably available information, is deemed sensitive or proprietary by CDC must be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

Paperwork Reduction Act (PRA)

[ENTER TEXT HERE]

Section 508 Compliance Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats is available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Printing

[ENTER TEXT HERE]

[ENTER TITLE OF OTHER CLEARANCE REQUIRED]

[ENTER TEXT HERE]

OTHER CONSIDERATIONS AND ADDITIONAL INFORMATION FOR OFFICE OF ACQUISITION SERVICES

SECTION 1 – PROPOSED CONTRACT TYPE

Firm Fixed Price

SECTION 3 – EVALUATION FACTORS

Work Requirement / Performance Standard
Acceptable Quality Level
Surveillance Method
Incentive for Meeting Performance Standard
Perform of all tasks listed in the deliverables schedule
Work completed at acceptable quality, and with a professional demeanor.

- Not more than 2 documented complaints of performance within a one month period per contractor

- Document CDC customer complaints as they occur

- The Design Lead will perform a monthly assessment of quality, instrument performance, and business relations.

- Contractor’s performance is documented as past performance using CPARS which is considered for future awards.

Monthly Debrief per study
Delivery due at the end of each month
-100% review of monthly deliverables report
- Contractor’s performance is documented as past performance using CPARS which is considered for future awards.

The Paperwork Reduction Act of 1995 (PRA) Without an existing OMB approval:

OMB Paperwork Reduction Act of 1995 (PRA) Offerors are advised that any activities involving information collections (i.e., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements, etc.) from 10 or more non-Federal entities, including State and local governmental agencies, are subject to the conditions of the PRA. Under the PRA, a Federal agency sponsoring a standardized data collection or directly obtaining standardized or substantially similar information from ten or more persons or entities (other than Federal employees within the scope of their employment) in any 12-month period must obtain advance written approval from the Office of Management and Budget (OMB).” Regardless of form or format (oral, written, or electronically transmitted), responses of opinion or fact requested or required by or for CDC, except those specifically exempted or excluded, are subject to the provisions of the PRA and its implementing regulation, 5 CFR 1320 (Controlling Paperwork Burdens on the Public).” The program agrees to submit a separate PRA determination for each information collection activity upon awarding of funds. All such information collections must undergo OMB project determinations by CDC and may require OMB PRA clearance prior to the start of the proposed activity.

(End of provision) Security and Privacy Language

1. Baseline Security Requirements:

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

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

ii. 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 CDC 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.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

· 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.

ii. Categorize all information owned and/or collected/managed on behalf of CDC/OPHDST and information systems that store, process, and/or transmit CDC information 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. Based on information provided by the System Security and Privacy Officer (previously referred to as ISSO), CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality:
[ ]
N/A
[ ]
Low
[X]
Moderate
[ ]
High
Integrity:
[ ]
N/A
[ ]
Low
[X]
Moderate
[ ]
High
Availability
[ ]
N/A
[X]
Low
[ ]
Moderate
[ ]
High
Overall Impact Level:
[ ]
N/A
[ ]
Low
[X]
Moderate
[ ]
High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of CDC/OPHDST regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC/OPHDST 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 all applicable security and privacy policies by contacting the CO/COR or CDC/OPHDST security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable CDC Component privacy policies and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (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.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's PII.

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

· If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within 90 days after completion of the PTA and in accordance with CDC policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

· The Contractor must support the agency 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.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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 disposingof the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for 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,

iv. Returned to HHS/CDC control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Confidentiality and Nondisclosure of Information. Any information provided to the Contractor (and/or any subcontractor) by CDC or collected by the Contractor on behalf of CDC must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any CDC records may be made available or disclosed must 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 must be protected in accordance with HHS/CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

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

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

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

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

i. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115- 232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The Contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

j. 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 must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to always assume HTTPS to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult HHS/CDC Policy for Internet and Email Security for additional information. According to the CDC Web policy, all CDC web content must reside on a CDC.gov domain and must be hosted on CDC or CDC-authorized information systems.

k. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents CDC specify which documents/forms will be provided to contractor] to comply with contract deliverables as appropriate.

l. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

ii. 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 encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet CDC and OPHDST 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).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. Use the Key Management system on the CDC 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 keys http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

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

2. Training Requirements:

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

b. 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/CDC policy and the CDC Role-Based Training (RBT) of Personnel with Significant Security Responsibilities.

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

3. Rules of Behavior:

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing agency 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.

4. Incident Response:

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII) (Memorandum https://www.whitehouse.gov/wp- content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf), an incident is "an occurrence that (1) actually or imminently 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" and a privacy breach is "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." For additional information on the CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information (PII).

b. Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC must include in the following requirements:

i. The Contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage of a suspected or confirmed breach.

ii. All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with the current FIPS 140 validation certificate from the NIST CMVP.

iii. All contractors and subcontractors shall participate in regular training on how to identify and report a breach

iv. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send OPHDST approved notifications to affected individuals within 24 hours.

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) at csirt@cdc.gov or telephone at 866-655-2245, COR, CO, CDC CPO (or his or her designee), and other stakeholders, including breaches 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 Component and CDC 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, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

· Not include any sensitive information in the subject or body of any reporting e-mail; and

· Encrypt sensitive information in attachments to email, media, etc.

vi. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and CDC Component and CSPO privacy breach response policies when handling PII breaches.

vii. 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.

viii. All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

ix. Cloud service providers shall use guidance provided in the FedRAMP Incident Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

x. Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the Contractor or its subcontractor failed to provide adequate safeguards for PII.

5. 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 apply to this solicitation/contract.

· N/A Note to the Requiring Activity Representative: The Requiring Activity Representative, in conjunction with Personnel Security, must use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

6. Homeland Security Presidential Directive (HSPD)-12:

The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS/CDC HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster:

The Contractor (and/or any subcontractor) must 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 must be submitted to the COR and/or CO by the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon 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 must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration:

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, CDC Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the Contractor must follow the CDC EPLC framework and methodology and in accordance with the CDC Office of Financial Resources (OFR) Contract Closeout Guide and HHS Closeout Guide: Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC System Development Life Cycle requirements, 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.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must 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.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and System Security and Privacy Officer (previously referred to as ISSO) before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The Contractor (and/or any subcontractors) must 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 must 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.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the OPHDST Contractor Employee Separation Checklist when an employee terminates work under this contract within 2 hours of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention:

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 156 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and CDC Policy for Records Management and OPHDST policies and must not dispose of any records unless authorized by CDC/ OPHDST.

b. If a Contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with CDC/ OPHDST policies.

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