A19 - 2022 07 30 - 75D301-22-Q-75423 - Section B and SOW.docx

Section B – Supplies or Services and Prices/Costs

Base Period All work performed under this CLIN shall be in accordance with the Statement of Work (SOW).

This is a fixed-price CLIN. Services are determined to be severable services.

Period of Performance: 12 months from date of award

Option Period 1 All work performed under this CLIN shall be in accordance with the Statement of Work (SOW).

This is a fixed-price CLIN. Services are determined to be severable services.

Period of Performance: 12 months from end of Base Period

Statement of Work (SOW) Title: National Wastewater Surveillance System Multi-Pathogen Assay Panel Optimization and Development

SECTION 1 – BACKGROUND

Wastewater surveillance, the measurement of pathogen levels in wastewater, is used to evaluate community-level infection trends, augment traditional surveillance that leverages clinical tests and services (e.g., case reporting), and monitor public health interventions. CDC launched the National Wastewater Surveillance System (NWSS) in September 2020 to coordinate wastewater surveillance programs implemented by state, tribal, local, and territorial health departments to support the COVID-19 pandemic response. In the United States, wastewater surveillance was not previously implemented at the national level. As of August 2021, NWSS includes 37 states, four cities, and two territories. CDC developed NWSS to coordinate and build the nation’s capacity to track the presence of SARS-CoV-2, the virus that causes COVID-19, in wastewater samples collected across the country. NWSS complements traditional surveillance and enables health departments to intervene earlier with focused support in communities experiencing increasing concentrations of SARS-CoV-2 in wastewater.

In nearly 80% of U.S. households, fecal waste is transported from homes to wastewater treatment plants within hours. Wastewater represents a pooled community stool sample that can provide information on infection trends in the community served by the sewer network (sewershed), which can range in size from fewer than 2,000 to >3 million persons. People infected with SARS-CoV-2 can shed the virus in their feces, even if they don’t have symptoms. The virus can then be detected in wastewater, enabling wastewater surveillance to capture presence of SARS-CoV-2 shed by people with and without symptoms. This allows wastewater surveillance to serve as an early warning that COVID-19 is spreading in a community. By measuring SARS-CoV-2 levels in untreated wastewater over time, public health officials can determine if infections are increasing or decreasing in a sewershed. Data from wastewater testing support public health mitigation strategies by providing additional crucial information about the prevalence of COVID-19 in a community. Data from wastewater testing are meant to complement existing COVID-19 surveillance systems by providing an efficient community sample, data for communities where timely COVID-19 clinical testing is underused or unavailable, and data for different communities within a county. Unlike other types of COVID-19 surveillance, wastewater surveillance does not depend on people having access to healthcare, people seeking healthcare when sick, or availability of COVID-19 testing.

Wastewater surveillance is a valuable tool to guide health departments’ COVID-19 response efforts. State health departments have used wastewater data to allocate testing resources, evaluate possible irregularities in traditional surveillance, refine health messaging, and forecast clinical resource needs at the community level. CDC developed NWSS to coordinate and build capacity for wastewater surveillance and transform independent local implementation efforts into a robust, sustainable national surveillance system. Early warning systems, such as wastewater surveillance, can help track the spread of SARS-CoV-2 variants across communities (2). Robust, sustainable implementation of wastewater surveillance requires public health capacity for wastewater testing, analysis, and interpretation. Partnerships between wastewater utilities and public health departments are needed to leverage wastewater surveillance data for the COVID-19 response for rapid assessment of emerging threats and preparedness for future pandemics.

Initial SARS-CoV-2 wastewater surveillance efforts in the United States were led by academic researchers, commercial laboratories, and wastewater utilities, with limited public health engagement. Laboratories used diverse testing methods with different performance characteristics, which complicated data analysis and interpretation for public health action. Thus, CDC implemented the NWSS framework which allows health departments to coordinate sample collection and laboratory testing, upload data to a CDC platform (NWSS Data Collation and Integration for Public Health Event Response (DCIPHER) portal) for analysis, and use findings to guide public health actions. To facilitate robust analysis, data comparability, and appropriate interpretation, the NWSS data platform receives SARS-CoV-2 RNA measurements and quality control data, performs automated data quality checks, adjusts SARS-CoV-2 concentrations for wastewater composition and method performance, and performs regression analyses from serial measurements to classify SARS-CoV-2 wastewater trends. A dashboard available to public health departments provides data visualization, and the results are available to the public through CDC’s COVID Data Tracker.

To build upon the success of the CDC NWSS SARS-CoV-2 surveillance in the United States, we will expand wastewater testing and reporting in the coming years beyond SARS-CoV-2 to additional clinically important targets that are shed in human feces. Approximately 30 human pathogen molecular targets will be surveilled in wastewater across multiple categories, including bacteria, viruses, parasites, and fungi, as well as determinants of antibiotic resistance. In order to standardize this testing across public health and partner environmental laboratories, and to ensure reliable, actionable results, NWSS will support the optimization and development of a digital PCR-based panel of assays. This multi-pathogen assay panel will be, in part, based on existing, proven molecular assays and targets currently in use at the CDC and elsewhere. Digital PCR was chosen for this assay panel because it offers flexibility to add, modify, and subtract assays at will, it has the capacity for increased target sensitivity, it is more tolerant of sample contaminants that could inhibit the assay reaction, it is more precise than other molecular testing methods, and it does not require additional reactions or inclusion of standard curves for quantitation. In addition, the multi-pathogen assay panel will be compatible with digital PCR instruments currently in use at many public health and partner laboratories in the US, thus NWSS will leverage existing infrastructure and expertise to standardize and advance wastewater-based surveillance.

References:

Douglas MG, Amadei CA, Campbell JR, et al. 2021. Strengthening Public Health Surveillance Through Wastewater Testing: An Essential Investment for the COVID-19 Pandemic and Future Health Threatsexternal icon. Washington, DC: World Bank.

Kirby AE, Walters MS, Jennings WC, et al. Using Wastewater Surveillance Data to Support the COVID-19 Response — United States, 2020–2021. MMWR Morb Mortal Wkly Rep 2021;70:1242–1244. DOI: http://dx.doi.org/10.15585/mmwr.mm7036a2external icon.

Kirby AE, Welsh RM, Marsh ZA, et al. Notes from the Field: Early Evidence of the SARS-CoV-2 B.1.1.529 (Omicron) Variant in Community Wastewater — United States, November–December 2021. MMWR Morb Mortal Wkly Rep 2022;71:103–105. DOI: http://dx.doi.org/10.15585/mmwr.mm7103a5external icon.

McClary-Gutierrez JS, Mattioli MC, Marcenac P, Silverman AI, Boehm AB, Bibby K, et al. SARS-CoV-2 Wastewater Surveillance for Public Health Action. Emerg Infect Dis. 2021;27(9):1-8.

SECTION 2 – PURPOSE

This project involves the CDC National Wastewater Surveillance System (NWSS) and the Contractor.

The overall objective of this project is to construct and optimize a multi-pathogen, digital PCR-compatible assay panel from existing PCR assays in use at the CDC and elsewhere, for use by CDC, CDC public health partners, and environmental laboratories to interrogate wastewater for multiple pathogen and antimicrobial resistance (AR) targets in a standardized format.

At the Contractor’s facilities the Contractor is expected to (1) create a multi-pathogen assay optimization and development plan for approximately 30 existing PCR assays or molecular targets, (2) construct and optimize duplexed reactions for the multi-pathogen digital PCR assay panel for compatibility with the Bio-Rad QX series droplet digital PCR platform and the Qiagen Qiacuity series digital PCR platform, (3) in consultation with the Government, undertake assay development and refinement when necessary to address item #2 or to address design or development challenges or questions, and (5) provide complete multi-pathogen digital PCR assay panels to the CDC for matrix validation and pilot testing at partner laboratories.

Assay optimization, development, validation, and final small-scale production will occur over 12 months.

SECTION 3 – SCOPE OF WORK

The Contractor shall construct a multiplexed, multi-pathogen, digital PCR-based assay panel consisting of approximately 30 existing PCR assays or molecular targets. The Contractor shall work with the Government to identify the most relevant qPCR assays for optimization and incorporation, and to the extent possible, assays from the same categories will be multiplexed together to maintain panel modularity. The number of assay targets in the panel will not vary significantly, but pathogen target categories may change as new information is incorporated.

Assay Target Category

Pathogens or Targets Total Number of Targets Included in Category

To maximize compatibility with existing instrumentation at partner laboratories and to simplify data analysis and reporting to the Government, the panel will be developed for operation on the Bio-Rad QX series droplet digital PCR platform and the Qiagen Qiacuity series digital PCR platform, and will be limited to fluorescent dyes and corresponding instrument channels that are common to both instruments. At the present time, this includes FAM and VIC/HEX. Priorities during assay optimization and development should include assay panel performance and sensitivity, compatibility, and creation of simple, cost-efficient workflows that do not compromise test quality or value. Assay components (such as master mixes) chosen for development and production should be compatible with and recommended for the respective digital PCR instruments, and their use should not void manufacturer warranties or support contracts. Primer and probe sequences from existing PCR assays and targets should be conserved during optimization, but further assay development, such as adding, removing, or replacing one or more primer or probe nucleotides, can be undertaken when needed on a case-by-case basis in consultation with the Government. Final assay panel components (primer and probe sequences, concentrations, assay reagents) and run conditions (instrument settings, run times and temperatures) will be made available to the Government for public distribution without restrictions on their use or modification.

Assays or information regarding the multi-pathogen assay panel shall not be shared with 3rd parties, apart from those included in the pilot testing phase, unless agreed upon by the Government.

SECTION 4 – TASKS TO BE PERFORMED

To address the objective of the study to construct and optimize a multi-pathogen, digital PCR-compatible assay panel, the Contractor shall complete a series of tasks. The process, in general narrative format, is as follows.

The Contractor shall construct the multi-pathogen assay panel based on existing PCR assays and targets provided by the Government, which will then be optimized and validated on the Bio-Rad and Qiagen instrument platforms with non-infectious positive control material (such as positive control plasmids, RNA, or gBlocks). Quality control and performance reports verifying assay panel specifications will be supplied to the Government at this time. The Contractor shall provide the initial, validated assay panel to the Government 5 months after contract awarding to allow for CDC validation testing using an appropriate wastewater matrix. Based on CDC matrix validation results that indicate assay performance, sensitivity, compatibility, quality and/or value, the Contractor may be required to conduct further assay optimization or development at their facility, as determined by the Government, to address assay limitations, deficiencies, or incompatibilities. The complete, validated panel will then be shared with the Government 9 months after contract awarding for final QC and verification testing. After QC and verification (9.5 months after contract awarding), the panel will be produced at small-scale by the Contractor and shared with either the Government or external pilot testing laboratories for evaluation. The Contractor shall also supply other necessary documentation, including laboratory procedures for setting up, running, and interpreting the assay panel, a list of assay components and specifications, additional components and reagents needed for testing, and technical notes as needed to properly conduct assay panel testing on the Bio-Rad and Qiagen instrument platforms. The Contractor shall also provide technical support to pilot testing laboratories, as needed, during the pilot testing phase.

The Contractor shall perform the following tasks.

Task 1. Design Assay Panel and Conduct In Silico Testing on both digital PCR platforms.

1. Working with the Government, obtain and/or identify information for assay primers, probes, and initial run conditions for all assays that will be optimized to run on the two digital PCR platforms.

2. Design and obtain non-infectious plasmid, RNA, or gBlock control material for each assay target or assay control.

3. Design assay combinations and assess duplexing compatibility in silico.

4. As needed based on in silico results, iterate assay designs, multiplexing, and combinations to achieve optimal assay performance on both digital PCR platforms.

5. Provide assay panel design and in silico testing results to the Government for evaluation.

Task 2. Construct and Optimize Assay Panel for both digital PCR platforms.

1. Obtain assay primers, probes and reagents.

2. Using non-infectious control material, determine optimal assay run temperatures and conditions on the Bio-Rad QX series ddPCR platform and the Qiagen Qiacuity series dPCR platform.

3. Check for duplexing interference.

4. Further optimize and develop duplexed assays, including titrations for primer and probe concentrations.

5. Determine the limit of detection (LOD) for each assay in the panel.

6. As needed based on experimental results, iterate assay designs, multiplexing, combinations, and concentrations to achieve optimal assay performance on both digital PCR platforms.

7. Based on project progress and approval from the Government, compare commercially-available master mixes with- or without- reverse transcriptase for targets containing DNA genomes.

8. Provide assay experimental performance results and QC information verifying assay panel specifications to the Government.

Task 3. CDC Assay Panel Validation and Further Optimization.

1. Provide optimized assays to the Government for matrix validation testing

2. Provide necessary documentation, including laboratory procedures for setting up, running, and interpreting the assay panel to the Government.

3. Conduct further optimization and development, as required and requested, based on CDC validation testing results and feedback to achieve optimal assay performance on both digital platforms.

Task 4. Produce Assay Panels for Pilot Testing and Support Assay Panel Evaluation.

1. Produce, at small-scale, optimized and validated assay panels.

2. Provide digital PCR assays in frozen, panel format (20X or 22X primers and probe solutions for each multiplexed pair) to the Government for quality control testing and verification.

3. Provide assay master mix ordering information.

4. Provide assay kits and technical support to pilot laboratories.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

The Government will provide to the Contractor a list of all existing PCR assays and targets to include in the assay panel. The list will include primer, probe, and target sequences, existing assay run conditions and references, if available.

SECTION 6 – PERIOD OF PERFORMANCE

The anticipated Period of Performance is 2 years from the time of purchase order contract award. This includes a 12-month Base Period and a 12-month Option Period.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

In addition to the Contractor reporting, presentation, and delivery schedule detailed below, informal monthly update meetings with a presentation will be held in months without a planned report or presentation. This includes informal update meeting presentations during months 7, 8, 10 and 11.

SECTION 8 – POINT OF CONTACT INFORMATION

Government and Contractor Points of Contact will be identified at the time of award.

SECTION 9 – PAYMENT TERMS

In accordance with FAR 52.232–32 Performance Based Payments (April 2012), upon successful completion of an event, the Contractor may request performance-based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the COR that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone. Milestone payments are subject to the terms of FAR 52.232–32 incorporated in the Clauses Section of this contract.

In accordance with FAR 52.232–28 Invitation to Propose Performance-based Payments (March 2000), Contractor is invited to propose a milestone payment schedule to be invoiced and paid on a fixed-price basis.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

The Contractor shall have skill and demonstrated experience in the design, construction, and optimization of digital PCR assays.

SECTION 11 – EVALUATION FACTORS

1. Technical Evaluation:

The Contractor shall have the capability to optimize and validate a digital PCR-based assay panel of ~30 targets and controls for both the Qiagen Qiacuity series digital PCR platform and the BioRad QX series ddPCR platform.

Contractor is to provide a brief description and/or discussion of their technical approach for providing the digital PCR assay optimization and validation services required for this Purchase Order. Also provide information reflecting experience of assigned staff, including a resume or curriculum vitae (CV) of each primary scientist and a short biography.

This criterion will be evaluated according to the soundness, practicality, and feasibility of the Contractor’s technical approach for providing the services required for the anticipated purchase order contract.

2. Price Evaluation:

A price analysis of the quote will be conducted to determine the reasonableness of the Contractor’s price.

SECTION 12 – SPECIAL CONSIDERATIONS

Electronic and Information Technology Accessibility

(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-aboard.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 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.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, Offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(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 are 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.

Information Security & Privacy The below information complies with CDC Security and Privacy compliance requirements for E-Government Act of 2002 (FISMA 2002) and Federal Information Security Modernization Act of 2014 (FISMA 2014) Security Compliance Standard-1: Procurements Requiring Information Security and/or Physical Access Security

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

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

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

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

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

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

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

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

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

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

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

[ x ] No PII [ ] Yes PII

4) 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 [ ] Moderate [ ] High

5) 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 32 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.

6) 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.

7) 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).

8) 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). .

9) 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.

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

11) 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.

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 CDC Cybersecurity Program Office (CSPO).

12) 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, as applicable. 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.

13) 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 in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

a. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of PII are collected that could introduce 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 Security Awareness Training (SAT), 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 (RBT) within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least annually in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

All HHS employees and Contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

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.

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

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally Identifiable Information” (03 January 2017) states:

Definition of an Incident:

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.

Definition of a Breach:

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.

It further adds:

A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment. A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII for an other than authorized purpose.

The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII”.

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

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

2) 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 so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

3) All Contractors and Subcontractors shall participate in regular training on how to identify and report a breach.

4) All Contractors and Subcontractors shall report a suspected or confirmed breach in any medium as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC and incident management policy, and United States Computer Emergency Readiness Team (US-CERT) notification guidelines. To this end, the Contractor (and/or any Subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC) or CDC Computer Incident Response Team (CSIRT) within 24 hours via email at csirt@cdc.gov or telephone at 866-655-2245, whether the response is positive or negative.

5) 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.

6) All Contractors and Subcontractors shall allow for an inspection, investigation, forensic analysis, and any other action necessary to ensure compliance with HHS/CDC Policy and the HHS/CDC Breach Response Plan and to assist with responding to a breach.

7) 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.

8) Identify roles and responsibilities, in accordance with HHS/CDC Breach Response Policy and the HHS/CDC Breach Response Plan. To this end, the Contractor shall NOT notify affected individuals unless and until so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, all notifications must be pre-approved by the appropriate CDC officials, consistent with HHS/CDC Breach Response Plan, and the Contractor shall then send CDC- approved notifications to affected individuals; and,

9) 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.

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 requiring activity representative, in conjunction with Personnel Security, shall 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.

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.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12)

Roster. The Contractor (and/or any Subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility of all staff working under this acquisition where the Contractor shall 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 by the effective date of this contract. Any revisions to the roster as a result of staffing changes shall 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 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).

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html CDC EPC Requirements: https://www2a.CDC.gov/CDCup/library/other/eplc.htm

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 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.