A19 FOCUS Solicitation Amendment 19AUG24.docx
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- Communities FOCUS Notification
- Solicitation number
- 75D301-24-R-87613
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This document appears to be a Solicitation for an evaluation of the Centers for Disease Control and Prevention's (CDC) Fostering Overall Community Understanding and Support (FOCUS) Learning Collaborative and related vaccine confidence and demand activities.
The purpose of this acquisition is to evaluate the experiences of jurisdictions, local health departments, and community partners in implementing activities to address barriers to increasing vaccine uptake in at-risk communities, as well as the experiences and learnings from participation in the FOCUS Learning Collaborative. The contractor will review documentation from the Learning Collaborative, conduct focus groups and key informant interviews, and provide evaluation support to jurisdiction partners upon request. Key objectives include assessing the feasibility, barriers, and facilitators of interventions, and identifying technical assistance and capacity building needs for program evaluation. The period of performance is September 30, 2024 to September 29, 2025.
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| Questions Answers 75D301-24-R-87613 DSD ARISE.xlsx | XLSX spreadsheet | |
| A19 FOCUS Solicitation_PWS 25JUL24.docx | DOCX document |
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Solicitation 75D301-24-R-87613
TABLE OF CONTENTS
| Section |
| Document/Clause/Provision |
| Page No. |
| A |
| Solicitation/Contract Form |
| N/A |
| B |
| Supplies or Services and Prices/Costs |
| 2 |
| C |
| Performance Work Statement |
| 3 |
| I |
| Contract Clauses |
| 15 |
| J |
| List of Attachments |
| 32 |
| K |
| Representations, Certifications, & Other Statements of Offerors or Respondents |
| 36 |
| L |
| Instructions, Conditions, and notices to Offerors or Respondents |
| 37 |
| M |
| Evaluation Factors for Award |
| 40 |
SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS
| ITEM |
| SUPPLIES / SERVICES |
| QTY / UNIT |
| UNIT PRICE |
| EXTENDED PRICE |
| 0001 |
| VCD FOCUS Learning Collaborative |
As described in the Performance Work Statement below.
PoP: 30 Sep 2024 – 29 Sep 2025 Severable Firm-Fixed-Price 1 Job
SECTION C – PERFORMANCE WORK STATEMENT
Performance Work Statement Title: Evaluation of Communities of FOCUS Learning Collaborative and Immunization Partner Vaccine Confidence and Demand-related Activities
Period of performance of this contract is: September 30, 2024, to September 29, 2025
SECTION 1 – BACKGROUND
Vaccine hesitancy has increased nationally over the past decade, resulting in decreasing coverage, particularly in some communities, where resistance to vaccination is high. The ensuing low coverage in these communities put them at risk of outbreaks, threatening not only the public health in those communities, but public health at large. Vaccine preventable diseases, such as measles, are at risk of losing their elimination status, attained via high coverage with 2-dose measles, mumps, and rubella (MMR) vaccine. Similarly, the emergence of the first case of polio in the US in 2021 highlighted the threat to public health associated with low vaccine coverage. CDC and the World Health Organization consider the emergence of measles cases as a signal for low coverage with vaccines more generally; persistent outbreaks of measles in communities across the US call for significant efforts to address vaccine hesitancy concerns and raise uptake of vaccines in close-knit communities with low coverage).
Given the elevated risk of outbreaks in close-knit communities with low vaccination coverage, CDC has launched Fostering Overall Community Understanding and Support (FOCUS). It aims to increase vaccination coverage in communities that are at increased risk for vaccine preventable diseases (VPD) as a part of the Let’s RISE initiative[footnoteRef:2]. Communities of FOCUS include those that have had consistently lower routine childhood vaccination rates for one or more vaccines, had recent VPD outbreaks, and where continued public health efforts have not increased vaccination coverage. FOCUS activities will include 3 Phases: 1) Build-Understand community and jurisdictional needs; launch workgroups; 2) Implement- learning collaborative and coordinate with national, state, and local agencies; and 3) Grow- Identify additional communities and areas within jurisdictions for FOCUS expansion. [2: Routine Immunizations on Schedule for Everyone (RISE) | CDC]
The FOCUS Learning Collaborative (LC) will provide opportunities for engaging with peers working with similar communities, access to subject matter experts and space for sharing resources. Proposed LC implementation is planned for June –December 2024. Compilation of strategies will continue for an additional 3 months.
SUBSECTION A – Definitions
· The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency under the Department of Health and Human Services.
· Closeknit communities refer to bound together by intimate social or cultural ties.
· Communities of FOCUS; priority communities of the FOCUS initiative
· Vaccine hesitancy refers to the delay in acceptance or refusal of vaccines despite availability of vaccination services.
· Vaccine demand generation refers to activities that aim to increase vaccine acceptance and uptake. These activities may include, but are not limited to, engagement of community leaders as vaccine ambassadors, motivational interviewing by healthcare providers, and others as appropriate to the population and setting.
· Vaccine confidence refers to the trust that patients, their families, and their providers have in recommended vaccines, providers who administer vaccines, and processes and policies that lead to vaccine development, licensure or authorization, manufacturing, and recommendations for use.
SECTION 2 – PURPOSE/OBJECTIVE
The purpose of the acquisition is to evaluate: 1) experiences implementing or participating in activities to address-barriers to increasing vaccine uptake in communities of focus by jurisdiction, local health department, and the community partner levels, particularly in jurisdictions with low vaccine coverage and at elevated risk of outbreaks of vaccine preventable diseases (i.e., measles) and 2) experiences and learnings derived from participation in the FOCUS Learning Collaborative led by CDC. These evaluations will provide qualitative data. The work will include assessments of feasibility of interventions, barriers to implementation, and facilitators for successful adoption at the community level. Finally, this work aims to identify technical assistance and capacity building needs in program evaluation and the evaluation of interventions at the jurisdiction or other levels.
SECTION 3 – SCOPE OF WORK
The contractor shall review and synthesize notes and other documents collected and produced during FOCUS Learning Collaborative sessions convened by CDC and attended by relevant immunization partners from the jurisdiction-level; the contractor shall produce a report summarizing these documents and describing the landscape of vaccine demand generating activities underway. This review and report will be used by the contractor to identify key themes to be explored in focus group sessions and key informant interviews with state immunization program staff and other immunization partners (e.g., local health department staff, community-based organizations).
The first series of focus groups will concentrate on participant feedback about the FOCUS Learning Collaborative. Participants will be asked about their participation, if they found it easy to engage with other participants, their feelings about the value of the information shared and whether they plan to adopt or operationalize any of the interventions discussed by their peers.
The second series of focus groups and key informant interviews will probe into the details of vaccine confidence and demand interventions within each participating jurisdiction, gathering detailed information about the type, design and implementation of the activities, and barriers or facilitators to implementation. Participants will be asked for their thoughts about the effectiveness of interventions, best ways to reach the communities of FOCUS, future adoption of approaches, other planned interventions, and needs for evaluation or other support, among other topics.
The contractor shall offer evaluation support to jurisdiction partners, where requested and appropriate. Such support may include the development of evaluation plans, methodology, and design of indicators for both process and impact evaluations of vaccine confidence and demand-related activities, as feasible. The contractor will be responsible for providing only assistance and guidance for evaluation plans but not responsible for completing the evaluations.
SECTION 4 – TASKS TO BE PERFORMED
Task 1: Conduct review of documented interventions and other activities implemented and summarize types of interventions, experiences shared during FOCUS Learning Collaborative listening sessions.
1. The review of notes, slides, and other documents will be done in close coordination with CDC staff responsible for managing the FOCUS initiative and vaccine confidence and demand activities.
a. CDC will provide notes and documents related to the FOCUS Learning Collaborative and the FOCUS initiative.
b. Contractor will draft brief report synthesizing notes and other documents from the FOCUS Learning Collaborative.
2. Develop and conduct key informant interviews with jurisdiction participants from the FOCUS Learning Collaborative to collect feedback about their participation in the Learning Collaborative. Questions may include, but are not limited to, experiences with peer-to-peer exchange, and plans for future adoption of activities discussed in the Collaborative.
3. Provide key informant interview and focus group transcripts and notes to CDC.
4. Develop and submit a summary report of the document review and key informant interviews, describing key learnings from the FOCUS Learning Collaborative, future needs identified through the LC, and recommendations to CDC/technical monitor.
Task 2: Develop and conduct key informant interviews and/or focus groups with representatives from jurisdictions engaged in work to increase vaccine uptake in communities of focus, along with local health department and community-based organization immunization partners, as appropriate and feasible to better understand activities implemented or planned within these communities.
1. Develop key informant interview guide and/or focus group questionnaire.
a. Review of FOCUS Learning Collaborative submissions by the jurisdiction and literature review of vaccine hesitancies and interventions implemented in communities of focus will inform the interview guides.
b. Questions will include, at minimum, detailed description of intervention or other demand generation activities; experiences with implementing interventions, including barriers and facilitators to implementation, critical relationships for success, strategies used for partner engagement, and evaluation of outcomes. Interviews will focus also on the costs/benefits of vaccine demand generation activities. Participants will also be asked for suggestions and ideas about program improvement and evaluation technical assistance needs. Questionnaire should be tailored to each group.
c. Submit a draft of key informant interview guide and/or focus group questionnaire to CDC/technical monitor.
2. Conduct key informant interviews and/or focus groups.
a. Record/document interviews and/or focus group discussions.
b. Submit interviews and/or focus group discussion transcription notes to CDC/technical monitor.
Task 3: Analyze interview and/or focus group discussions and summarize results/findings of Task 2.
1. Present results/findings to CDC/technical monitor meeting objectives of the contract.
2. Submit a report summarizing evaluation of jurisdiction and other partner activities analysis, key informant interview/focus group results/findings to CDC/technical monitor.
Task 4: Provide technical assistance to jurisdictions and partners to evaluate, and build capacity to evaluate, local efforts to address vaccine hesitancy, build demand, and increase coverage.
1. The contractor will be responsive to evaluation and technical assistance needs requested by partners by helping design plans both for the prospective evaluation of new activities, focusing on both process and impact evaluation, and for retrospective evaluation of activities undertaken to date. Retrospective evaluations will be process-oriented, and focus on feasibility of implementation, successful implementation of tasks as planned, barriers encountered during implementation, among other measures; these retrospective evaluations will not measure impact of the intervention. The contractor will be responsible for providing assistance and guidance for evaluation plans but not responsible for completing the evaluations.
2. Develop reports of all evaluation assistance provided to partners, recommendations for future assistance and other activities. The report will be delivered to CDC at the completion of activities.
Task 5: Conduct at minimum one meeting per month with CDC/technical monitor to provide updates on the project progress
1. Provide written updates on progress meeting notes to CDC/technical monitor.
SECTION 5 – GOVERNMENT FURNISHED PROPERTY
Not applicable
SECTION 6 – PLACE OF PERFORMANCE
Contract may be performed entirely off site (contractor’s facility or other) or at a government facility with specified allowances for telework (onsite with telework). Place of performance at a government facility shall be within Atlanta, U.S.
SECTION 7 – TRAVEL
Travel is not anticipated.
SECTION 8 – DELIVERABLES/REPORTING SCHEDULE
| Task |
| Deliverable |
| Quantity/Format |
| Due Date |
| Deliver To |
| Brief report synthesizing documents and other materials from the FOCUS Learning Collaborative (Task 1.1.b) |
| Report |
| One |
| NLT 30 days following competition of FOCUS Learning Collaborative meetings |
CDC/Technical monitor
| A draft of key informant interview guide/focus group questionnaire for FOCUS Learning Collaborative participants (Task 1.2) |
| Word document |
| One |
| NLT 8 weeks post award |
| CDC/Technical monitor |
| Key informant interview/focus group transcription notes (Task 1.3) |
| Word document |
| One |
| NLT 2 weeks after each informant interview/focus group meeting |
| CDC/Technical monitor |
| Summary report of FOCUS Learning Collaborative findings & recommendations, including the summary of documents and focus group findings. (Task 1.4) |
| Report |
| One |
| NLT 330 days from award |
| CDC/Technical monitor |
| A draft of key informant interview guide/focus group questionnaire for representatives from jurisdictions engaged in work to increase vaccine uptake in communities of focus (Task 2.1) |
| Word document |
| One |
| NLT 12 weeks post award |
| CDC/Technical monitor |
| Key informant interview/focus group transcription notes (Task 2.2) |
| Word document |
| One |
| NLT 14 business days after key informant interview/focus group meetings |
| CDC/Technical monitor |
| Present findings of focus groups/key informant interviews in PowerPoint to CDC (Task 3.1) |
| PowerPoint presentation |
| One |
| NLT 30 days following competition of FOCUS Learning Collaborative meetings |
| CDC/Technical monitor |
| Report summarizing evaluation of jurisdiction and other partner activities analysis, key informant interview/focus group results/findings (Task 3.2) |
| Report |
| One |
| NLT 24 weeks post award |
| Report(s) of evaluation assistance provided to partners, recommendations for future assistance and other activities. (Task 4.2) |
| Report(s) |
| TBD, dependent on partner requests – ongoing |
| NLT 30 days after assistance activities are completed |
| CDC/Technical monitor |
| Regular project update/progress meeting notes (Task 5.1) |
| Meeting notes |
| One document per meeting |
| Within 5 business days after each meeting |
| CDC/Technical monitor |
SECTION 9 – REFERENCE MATERIALS
N/A
SECTION 10– MINIMUM VENDOR QUALIFICATIONS
Health services research organization experience with immunization services delivery.
SECTION 11 – ADDITIONAL REQUIREMENTS
Information Security and Privacy
A. 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: |
Confidentiality: [ ] Low [X ] Moderate [ ] High Integrity: [ ] Low [X ] Moderate [ ] High Availability: [ ] Low [X ] Moderate [ ] High Overall Risk Level: [ ] Low [X] Moderate [ ] High 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:
[ ] No PII [X] 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: [ ] Low [X] 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 as outlined in CDC polices 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 prior to performing any work on behalf of HHS. |
| 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 keys. 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 7 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 OpDiv 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.
| A. | 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 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. All contractor employees that will be conducting work with animals must complete the associated required training. |
| 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. |
| B. | 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 CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources. |
| 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. |
| C. | Incident Response |
The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Team (CSIRT) 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 another 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 within 30 days. |
| 3) | Report all suspected and confirmed information security and privacy incidents and breaches to the CDC Computer Security Incident Response Team (CSIRT) at 866-655-2245 and 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. | cooperates and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach; |
| b. | does not include any sensitive information in the subject or body of any reporting e-mail; and |
| c. | encrypts 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 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. |
| D. | 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: Public Trust Level 5.
E. 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.
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 7 days 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.
| F. | Contract Initiation and Expiration |
| 1) | General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS 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 shall follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012). |
| 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 1 day of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request. |
| G. | 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.
Capital Planning and Investment Control/Project Management, Data, and Records Retention H. 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.
I. Data All data, software and supporting materials acquired or produced under this contract shall become the property of the United States Government and subject to FAR 52.227-14 -- Rights in Data – General (May 2014), which is hereby incorporated by reference. The Contractor shall not place a copyright or assert a right that in any way limits or infringes on the Government’s use of any of the materials for which the Contractor develops, provides and/or receives payment under this contract award. The contractor shall use Government’s provided tools for storing/ backing up all code, and technical documentation related to tasks under this contract.
1. Data Collection and Monitoring The contractor shall provide ongoing support for collecting quantitative and qualitative data and conducting related data management processes. The contractor shall continuously improve the development, organization, and maintenance of processes for data collection, monitoring, and related data management activities.
2. Data Quality The contractor shall ensure that data/datasets provide the highest data quality possible and are suitable for their intended uses in decision making, planning, and operations. The dimensions of data quality include, but are not limited to, accuracy, completeness, consistency, currency, precision, privacy, timeliness, and validity.
| 3. | To ensure data quality, the contractor shall provide routine and ongoing data quality ̶ monitoring, control, assurance, improvement, and oversight ̶ for (1) national- and local-level data submitted to CDC, (2) data and datasets generated from CDC studies, and (3) any other CDC-managed data. The contractor shall also ensure data quality for all deliverables such as accurate and complete data management documentation, tracking information, and data tables, summaries, reports, presentations, etc. |
| 4. | As required by the Federal Source Code Policy set out in OMB Memo M-16-21, all computer software first produced in the performance of this contract shall be open-source software and shall be available for Government-wide use and for use by the public with data use rights under FAR 52.227-14 Rights in Data - General, unless otherwise specified in writing by the contract officer. The Contractor (and/or any subcontractor) shall maintain, at all times, a working, current and fully documented copy of all project or activity custom-developed source code in a repository from the CDC Recognized List of Source Code Repositories. |
| J. | Capital Planning and Investment Control/Project Management |
The Federal Government mandates the prudent management of IT investments. Capital Planning and Investment Control (CPIC) is a continuous and integrated process for managing the risk and returns if information technology (IT) investments. The CPIC process fully integrates with the CDC’s overall budget, finance, acquisition, strategic planning, enterprise architecture, security, and other relevant processes. CPIC also aligns with DHHS Enterprise Performance Life Cycle (EPLC) framework and is used for all IT related decisions.
The contractor will follow the EPLC framework, which will provide a standard structure for planning, managing, and overseeing IT projects over their entire life cycle. The framework consists of ten life cycle phases. Within each phase, activities, responsibilities, reviews, and deliverables are defined/ Templates for the deliverables are available to the contractor after award. Exit criteria are established for each phase and Stage Gate reviews are conducted through CDC’s IT Governance process to ensure that the project’s management quality, soundness, and technical feasibility remain adequate, and the project is ready to move forward to the next phase. All IT projects in support of this task must adhere to the EPLC requirements and pass each Stage Gate as appropriate. More information about EPLC can be found at https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/policy-for-information-technology-enterprise-performance.html.
Human Subjects Protections in Research Required for all service contracts. CDC Scientific Requirements specify that CIOs must indicate when the protection of human subjects may apply so potential offerors can consider and address these requirements in their proposal.
CIOs must submit a STARS Determination with a PR if the contractor will:
- Collect, obtain, use, analyze, transfer or store data, information, or biological material; or
- Interact with individuals external to CDC such as members of the general public, private institutions, state, local or foreign governments, or
- Engage CDC employees or CDC non-employees (other contractors, fellows, students) in activities that are not otherwise part of their official duties.
Paperwork Reduction Act (PRA) Required for all service contracts. CDC Scientific Requirements specify that CIOs must indicate when PRA requirements may apply so potential offerors can consider and address these requirements in their proposal.
CIOs must submit a STARS Determination with a PR if the contractor will:
- Collect, obtain, use, analyze, transfer or store data or information.
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:
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.
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
SECTION I – CLAUSES
The following clauses are incorporated:
INCORPORATED BY REFERENCE
52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
http://www.acquisition.gov/far/ http://www.hhs.gov/hhsar/
(End of Clause) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)
(a) (1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.
(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.
(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.
(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.
52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.
(End of Clause)
FAR 52.222-54 Employment Eligibility Verification (May 2022)
(a) Definitions. As used in this clause- Commercially available off-the-shelf (COTS) item—
| (1) | Means any item of supply that is— |
| (i) | A commercial product (as defined in paragraph (1) of the definition of “commercial product” at Federal Acquisition Regulation (FAR) 2.101); |
| (ii) | Sold in substantial quantities in the commercial marketplace; and |
| (iii) | Offered to the Government, without modification, in the same form in which it is sold in the commercial marketplace; and |
| (2) | Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Per 46 CFR 525.1 (c)(2), "bulk cargo" means cargo that is loaded and carried in bulk onboard ship without mark or count, in a loose unpackaged form, having homogenous characteristics. Bulk cargo loaded into intermodal equipment, except LASH or Seabee barges, is subject to mark and count and, therefore, ceases to be bulk cargo. |
Employee assigned to the contract means an employee who was hired after November 6, 1986 (after November 27, 2009, in the Commonwealth of the Northern Mariana Islands), who is directly performing work, in the United States, under a contract that is required to include the…
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