A19 Combined Synopsis-Solicitation 75D30124R73073.pdf

REQUEST FOR PROPOSAL (RFP)

Issued By Centers for Disease Control and Prevention Chamblee Campus Building 102, MS 102-4 4770 Buford Highway Atlanta, GA 30341-3717

Solicitation Number 75D301-24-R-73073

Solicitation Type Request for Proposal FAR Part 12 - Commercial Items & FAR Part 13 - Simplified Acquisition Procedures

CDC Point of Contact Information Contract Specialist: Taylor Wellman, xur0@cdc.gov, 404-498-6020 Contracting Officer: H. Dale Bish, uwo8@cdc.gov, 404-498-1313

Solicitation Issue Date 7/23/2024

Questions Due Date 7/30/2024

Proposal Date

8/13/2024 3:00 PM (ET)

Solicitation Table of Contents

Section Document/Clause/Provision Page No.

A Description of the Requirement 2 B Contract Line Items 4 C Contract Documents, Exhibits or Attachments 11 D Contract Terms and Conditions 29 E Solicitation Provisions 58

SECTION A - DESCRIPTION OF THE REQUIREMENT

(1) Description

a. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format FAR Subpart 12.6, as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Centers for Disease Control and Prevention intends to award a Time & Materials contract type for the requirement.

b. The solicitation number is 75D301-24-R-73073. The solicitation is issued as a Request for Proposals (RFP).

c. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-05 effective 05/22/2024.

d. This procurement has been designated a small business set-aside competed under NAICS 541380 – Testing Laboratories and Services with small business size standard $19M.

e. See Section B of this solicitation for contract line item number structure.

f. See Section C for the Performance Work Statement. This procurement is to provide digital PCR-based assay development, optimization, and validation services leading to a portfolio of sensitive and robust assays to support wastewater testing with the CDC and STLT public health partners.

g. The contract anticipated period of performance is September 2, 2024 – September 1, 2029, consisting of one (1) 12-month base period and four (4) 12-month options.

h. The provision at FAR 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition.

i. The provision at FAR 52.212-2, Evaluation-Commercial Items, is applicable and indicates the evaluation procedures to be used.

j. The provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, is to be included as part of the System for Award Management registration. If for any reason it is not a part of the System for Award Management registration, then include a copy with the proposal.

k. The FAR clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition.

l. A The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. The additional FAR clauses cited in the clause are applicable to the acquisition.

m. Additional contract terms and conditions are included in this solicitation in Section D, Terms and Conditions, and Section E, Solicitation Provisions, Instructions to Offerors, & Evaluation Criteria.

n. The Defense Priorities and Allocations System (DPAS) is not applicable.

o. The date, time and place offers are due is indicated in the System for Award Management posting.

p. The name, telephone number, and email address of the individual to contact for information regarding the solicitation is indicated in the System for Award Management posting.

SECTION B – CONTRACT LINE ITEMS

Base Period / Year 1:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Assay Support Services

Perform Tasks 1 - 5 during the base period, in accordance with PWS herein.

POP: 9/2/2024 - 9/1/2025

Time & Materials

Severable Services

1 Job

0002 Other Direct Costs

Other Direct Costs (ODCs) during the base period.

POP: 9/2/2024 - 9/1/2025

Time & Materials

Severable Services

1 Job

0003 Additional PCR Platform

Optional Task 6: Additional digital PCR platform optimization and validation

POP: 9/2/2024 - 9/1/2025

Time & Materials

Severable Services

1 Job

0004 Sequencing Primer Design and Development

Optional Task 7: Sequencing primer design and development

POP: 9/2/2024 - 9/1/2025

Time & Materials

0005 Wastewater Matrix Validation

Optional Task 8: Wastewater matrix validation

POP: 9/2/2024 - 9/1/2025

Total Value of Base Period/Year 1 = $_____________________

Option 1 / Year 2:

1001 Assay Support Services

Perform Tasks 1 - 5 during the first option period, in accordance with PWS herein.

POP: 9/2/2025 - 9/1/2026

1002 Other Direct Costs

Other Direct Costs (ODCs) during the first option period.

POP: 9/2/2025 - 9/1/2026

Time & Materials

Severable Services

1 Job

1003 Additional PCR Platform

Optional Task 6: Additional digital PCR platform optimization and validation

POP: 9/2/2025 - 9/1/2026

Time & Materials

1004 Sequencing Primer Design and Development

Optional Task 7: Sequencing primer design and development

POP: 9/2/2025 - 9/1/2026

Time & Materials

Severable Services

1 Job

1005 Wastewater Matrix Validation

Optional Task 8:Wastewater matrix validation

POP: 9/2/2025 - 9/1/2026

Total Value of Option Year 1/Year 2 = $_____________________

Option 2 / Year 3:

2001 Assay Support Services

Perform Tasks 1 - 5 during the second herein.

POP: 9/2/2026 - 9/1/2027

2002 Other Direct Costs

Other Direct Costs (ODCs) during the second option period.

POP: 9/2/2026 - 9/1/2027

Time & Materials

2003 Additional PCR Platform

Optional Task 6: Additional digital PCR platform optimization and validation

POP: 9/2/2026 - 9/1/2027

Time & Materials

Severable Services

1 Job

2004 Sequencing Primer Design and Development

Optional Task 7: Sequencing primer design and development

POP: 9/2/2026 - 9/1/2027

Time & Materials

Severable Services

1 Job

2005 Wastewater Matrix Validation

Optional Task 8:Wastewater matrix validation

POP: 9/2/2026 - 9/1/2027

Total Value of Option Year 2/Year 3 = $_____________________

Option 3 / Year 4:

3001 Assay Support Services

Perform Tasks 1 - 5 during the third herein.

POP: 9/2/2027 - 9/1/2028

3002 Other Direct Costs

Other Direct Costs (ODCs) during the third option period.

POP: 9/2/2027 - 9/1/2028

Time & Materials

Severable Services

1 Job

3003 Additional PCR Platform

Optional Task 6: Additional digital PCR platform optimization and validation

POP: 9/2/2027 - 9/1/2028

Time & Materials

Severable Services

1 Job

3004 Sequencing Primer Design and Development

Optional Task 7: Sequencing primer design and development

POP: 9/2/2027 - 9/1/2028

Time & Materials

Severable Services

1 Job

3005 Wastewater Matrix Validation

Optional Task 8:Wastewater matrix validation

POP: 9/2/2027 - 9/1/2028

Total Value of Option Year 3/Year 4 = $_____________________

Option 4 / Year 5:

4001 Assay Support Services

Perform Tasks 1 - 5 during the fourth herein.

POP: 9/2/2028 - 9/1/2029

4002 Other Direct Costs

Other Direct Costs (ODCs) during the fourth option period.

POP: 9/2/2028 - 9/1/2029

Time & Materials

Severable Services

1 Job

4003 Additional PCR Platform

Optional Task 6: Additional digital PCR platform optimization and validation

POP: 9/2/2028 - 9/1/2029

Time & Materials

Severable Services

1 Job

4004 Sequencing Primer Design and Development

Optional Task 7: Sequencing primer design and development

POP: 9/2/2028 - 9/1/2029

Time & Materials

4005 Wastewater Matrix Validation

Optional Task 8:Wastewater matrix validation

POP: 9/2/2028 - 9/1/2029

Total Value of Option Year 4/Year 5 = $_____________________

Total Contract Value (Base + Options) = $__________________

B.1 Optional Tasks (Tasks 6, 7, & 8) – Separately Priced Line Items

The Government may require the delivery of additional support effort under the numbered line items: 0003, 0004, 0005, 1003, 1004, 1005, 2003, 2004, 2005, 3003, 3004, 3005, 4003, 4004, & 4005. The Contracting Officer may exercise the option by written notice to the Contractor within the period of performance of the CLIN associated with the optional task line item as shown in the Schedule above. The exact period of performance for the optional task will be established at the time it is exercised. If exercised, the period of performance end date will coincide with the base or option period end date for which it is associated.

The Contractor will be notified in writing, by letter or email, at least 7 days before the optional task line item is exercised. After that written notification, a funded, unilateral modification will be issued to actually exercise the optional task support. The Contracting Officer may choose to issue a bilateral modification.

SECTION C - CONTRACT DOCUMENTS, EXHIBITS OR

ATTACHMENTS

Performance Work Statement

Title: National Wastewater Surveillance System Multi-Pathogen Assay Development, Optimization, Validation, and Support

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 (STLT) 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 December 2023, NWSS includes 114 laboratories across 42 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 and other pathogens in wastewater.

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 and the NWSS Wastewater Data Dashboard.

To build upon the success of the CDC NWSS SARS-CoV-2 surveillance in the United States, we will expand wastewater testing and reporting beyond existing SARS-CoV-2 to new SARS-CoV-2 variants and additional clinically important targets that are shed by humans or other sources into the waste stream. Human pathogen molecular targets will be surveilled in wastewater across multiple categories, including new SARS-CoV-2 variants, bacteria, viruses, parasites, fungi, disease vectors, 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 development, optimization, validation, and implementation of digital PCR-based assays for wastewater testing. These multi-pathogen assays 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 wastewater testing because it offers flexibility to add, modify, and subtract assays as needed to meet public health goals, it has the capacity for increased target sensitivity, is more tolerant of sample contaminants that could inhibit assay reactions, is more precise than other molecular testing methods, and it does not require an additional standard curve for quantitation. In addition, these multi-pathogen assays 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 testing.

SECTION 2 – PURPOSE

The purpose of this contract is to build and validate a portfolio of sensitive and robust molecular testing assays for use by CDC, CDC public health partners, and environmental health laboratories to interrogate wastewater for multiple pathogens, antimicrobial resistance (AR), and vector targets in a standardized digital PCR format.

SECTION 3 – SCOPE OF WORK

The Contractor shall provide digital PCR-based assay development, optimization, and validation services leading to a portfolio of sensitive and robust assays to support wastewater testing with the CDC and STLT public health partners.

The tasks shall include:

Development, optimization, and validation of up to 30 multiplexed digital PCR-based multi-pathogen, antimicrobial resistance (AR), infectious disease source tracking, and vector assays for wastewater testing, as defined by the NWSS Team.

In silico evaluation of potential, adopted, and developed assays across multiple quality metrics Production or acquisition of quantified reference material for all assay targets Optimization of developed multiplex assays for operation and compatibility with multiple digital PCR platforms Validation of all assays using quantified reference material in accordance with CDC guidelines Production and provision of complete multi-pathogen, multi-platform digital PCR assays for validation testing at CDC and up to 5 public health partner laboratories Provision of technical assistance to the CDC NWSS Team and public health partners for validation, implementation, troubleshooting, and interpreting results using the developed multiplex, multi-pathogen assays

Re-development and re-optimization for existing targets with suboptimal performance Implementation of interchangeable multiplexing for seasonal targets or rapid testing responses

To adjust to changing public health priorities and to prepare for future disease responses and pandemics, the contract shall include optional tasks. These optional tasks shall include:

Multi-platform assay optimization for future digital PCR platforms, such as the Applied Biosystems QuantStudio Absolute Q digital PCR instrument

Design and development of sequencing primers Multiplex assay validation using wastewater matrices

The Contractor will not be performing inherently governmental functions.

SECTION 4 – TASKS TO BE PERFORMED

To address the purpose and objectives of this contract for the development, construction, optimization, and validation of multiplexed, multi-pathogen, multi-platform digital PCR-based molecular assays, the contractor shall:

Requirements:

I. Kickoff Meeting

II. The contractor shall develop, optimize and validate up to 30 multiplexed, multi-pathogen, digital PCR-based assays, as defined by the NWSS Team. The Contractor shall develop digital PCR assays for public health relevant molecular targets from viral, bacterial, parasitic, fungal, antimicrobial resistance, disease vector and process control categories.

III. The contractor shall construct multi-pathogen assays based on existing PCR assays and targets provided by the CDC NWSS Team, or they shall develop new assays for targets that do not have existing PCR assays.

a. Priorities during assay optimization and development shall include assay performance and sensitivity, compatibility, and creation of simple, cost-efficient workflows that do not compromise test quality or value.

IV. The contractor shall work with the CDC NWSS Team to identify the most relevant PCR assays for development, optimization, validation, and incorporation.

V. Primer and probe sequences from existing PCR assays and targets shall be conserved during optimization, but further assay development, such as swapping out probes or fluorescent chemistries, adding, removing, or replacing one or more primer or probe nucleotides, shall be undertaken when needed on a case-by-case basis in consultation with the CDC NWSS Team.

VI. Assays shall be multiplexed with 4 or more target reactions per assay well. Where this level of multiplexing is unable to be achieved, the contractor shall work with the CDC NWSS Team to determine alternative constructions or assay combinations. Assays from the same categories shall be multiplexed together to maintain utility and modularity, when possible.

VII. The number of assay targets shall not vary significantly, but pathogen target categories may change as new information is incorporated.

VIII. The Contractor shall conduct in silico evaluation of potential, adopted, and developed assays (individually and in multiplexed format) across various quality metrics that are provided by the NWSS Team to determine the suitability of a proposed assay for incorporation or development. Metrics shall include, at a minimum, inclusivity, exclusivity, and multiplexing compatibility.

IX. To maximize compatibility with existing instrumentation at partner laboratories and to simplify data analysis and reporting to the CDC NWSS Team, multiplexed assay combinations shall be optimized and validated on multiple digital PCR platforms, including the Bio-Rad QX series droplet digital PCR platform, Qiagen Qiacuity series digital PCR platform, and Roche Digital LightCycler platform. Any additional digital PCR instruments that are added as an Optional Task for additional platform optimization and validation activities shall also be added to Base Task platform optimization and validation services in subsequent years.

a. Validation shall occur using non-infectious, quantified reference material to be defined in technical consultation with the NWSS Team, and in accordance with CDC guidelines to be provided by the NWSS Team.

b. Assay validation metrics shall include, at a minimum, limit of detection (LOD) and precision (reproducibility) for each assay and PCR platform.

c. After assay development, optimization and validation, the Contractor shall provide quality control and performance reports, validation procedures and resulting metrics to the NWSS Team verifying assay specifications and performance. The contractor may be required to conduct further assay optimization, re-development, or validation at their facility, as determined by the NWSS Team, to address assay limitations, deficiencies, or incompatibilities.

X. After review and acceptance of the Contractor’s validation results indicating acceptable assay performance by the CDC NWSS Project Lead or designee, the Contractor shall manufacture or acquire and distribute finalized assays to the NWSS Team and up to 5 NWSS public health partners, along with quantified reference material, for all assay validation procedures. Reference material shall be provided individually frozen or other suitable cold storage for each assay target. Digital PCR assays shall be provided in a format and concentration agreed upon by the Contractor and the CDC NWSS Project Lead or designee, such as a frozen format with 20X or 22X primers and probe solutions for each multiplexed assay combination. The contractor shall supply necessary instruction for use documentation, including validation results, procedures, metrics, laboratory procedures for setting up, running, and interpreting assays, a list of assay components and specifications, additional components and reagents needed for testing, and technical notes as needed to properly conduct assay validation testing on the appropriate digital PCR platforms. The Contractor shall also provide technical support to the NWSS Team and up to 5 NWSS public health partners for validating, implementing, troubleshooting, and interpreting results using the developed multiplex, multi-pathogen assays.

XI. Assay components (such as master mixes) chosen for development and production shall be compatible with and recommended for the respective digital PCR platforms, and their use shall not void manufacturer warranties or support contracts. All assay constituents (such as primer and probe sequences, concentrations, assay reagents), assay setup and run conditions (such as volumes and combinations, instrument settings, run times and temperatures), result interpretation guidance or instructions, and quantified reference materials shall be produced or acquired and made available for distribution to the CDC NWSS Team and NWSS public health partners without restrictions on their use, distribution, or modification. Assays, quantified reference material, or information regarding the multi-pathogen assays shall not be shared with 3rd parties, apart from collaborating NWSS public health partners, unless agreed upon by the CDC NWSS Team.

XII. Re-development and re-optimization of existing developed multi-pathogen digital PCR assays or targets with suboptimal performance; optimization and validation of developed multiplex assays on future digital PCR platforms, such as the Applied Biosystems QuantStudio Absolute Q Digital PCR platform (Note that any additional digital PCR instruments that are introduced in the platform optimization and validation activities as part of Optional Task 6 will also be added to Base Task 2 during subsequent exercised option years without a requirement for exercising Optional Task 3 again for that same instrument); development and validation of interchangeable multiplexing for assays targeting seasonal pathogens or for targets that could foreseeably require rapid response testing; development of targeted primers for tiled amplicon sequencing and targeted sequencing; and multiplex assay validation and testing using quantified reference material and wastewater matrices, in alignment with CDC validation guidelines for external test method distribution.

The Contractor shall perform the following tasks:

Task 1. Design up to 30 multiplexed digital PCR-based multi-pathogen assays for wastewater testing of public health relevant targets in viral, bacterial, parasitic, fungal, antimicrobial resistance, infectious disease source tracking, disease vector and assay and process control categories, as defined by the NWSS Team.

1.1 Working with the CDC NWSS Team, obtain and/or identify information for assay primers, probes, and initial run conditions for all multi-pathogen assays to be multiplexed.

1.2 Design assays for new targets that do not have existing, validated assays or re-design new assays for existing targets that have been determined to have suboptimal performance.

1.3 Design multiplex combinations with 4 or more target reactions per assay well. Where this level of multiplexing is unable to be achieved, work with the CDC NWSS Team to determine alternative constructions or assay combinations. Assays from the same categories shall be multiplexed together to maintain utility and modularity, when possible.

1.4 Conduct in silico evaluation of potential, adopted, and developed assays (individually and in multiplexed format) across various quality metrics provided by the NWSS Team, including, but not limited to, inclusivity, exclusivity, and multiplexing compatibility.

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

1.4.b Provide assay designs and in silico testing results to the Government for evaluation.

Task 2. Develop, construct, and optimize multiplexed assays for multiple digital PCR platforms.

2.1 Obtain assay primers, probes and reagents.

2.2 Using non-infectious quantified reference material, defined in technical consultation with the NWSS Team, determine optimal assay run temperatures and conditions on the Bio-Rad QX series droplet digital PCR platform, Qiagen Qiacuity series digital PCR platform, and Roche Digital LightCycler platform.

2.3 Evaluate multiplexing assay interference.

2.4 Further optimize and develop multiplexed assays, including titrations for primer and probe concentrations.

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

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

2.7 Note that any additional digital PCR instruments that are introduced in the platform optimization and validation activities as part of Optional Task 6 will also be added to Task 2 during subsequent exercised option years without a requirement for exercising Optional Task again for that same instrument.

Task 3. Multiplex assay validation

3.1 Perform validation for developed and optimized assays on all PCR platforms using quantified reference material based on CDC validation testing guidelines to be provided by the Government.

3.2 Provide validation experimental design, workplan, and validation results and metrics to the Government.

Validation metrics will include, at a minimum, experimental measurements of limit of detection and precision, for each multiplexed assay.

3.3 As needed based on validation results, iterate assay designs, multiplexing, combinations, or concentrations to achieve validation minimum performance parameters on multiple digital PCR platforms.

3.4 Provide quality control and performance reports, validation procedures and resulting metrics to the NWSS

Team verifying assay specifications and performance.

Task 4. Assay re-development, re-optimization, re-validation, and production

4.1 The Contractor shall re-develop, re-optimize, and re-validate multiplexed assays that exhibit suboptimal performance, have become obsolete, or have been updated or changed based on public health need. The Contractor shall produce (or procure) and distribute assays according to base period task guidelines and deliverables in a timeframe agreed upon by the NWSS Project Lead or designee and the Contractor.

Task 5. Assay Interchangeable multiplexing for increased flexibility

5.1 The Contractor shall evaluate, design, develop, optimize, validate and produce interchangeable multiplexing schemes for seasonal or regional testing targets, or for rapid response testing scenarios. The Contractor shall produce (or procure) and distribute assays according to base period task guidelines and deliverables in a timeframe agreed upon by the NWSS Team and the Contractor.

Optional Task 6: Additional digital PCR platform optimization and validation

6.1 The Contractor shall optimize and validate existing multipathogen assays for future digital PCR platforms, such as the Applied Biosystems QuantStudio Absolute Q digital PCR system. The Contractor shall produce (or procure) and distribute assays according to base period task guidelines and deliverables in a timeframe agreed upon by the NWSS Team and the Contractor.

Please note that any additional digital PCR instruments introduced in the platform optimization and validation activities as part of Optional Task 6 shall also be added to Task 2 during subsequent exercised option years without a requirement for exercising Optional Task 6 again for that same instrument. For example, if assays are optimized and validated on the Applied Biosystems QuantStudio Absolute Q platform in Option Year 1 as part of Optional

Task 6, then that instrument shall be added to the list of platforms on which assays shall be optimized and validated for Task 2 in subsequent option years.

Optional Task 7: Sequencing primer design and development

7.1 The Contractor shall design and develop sequencing primers and adapters for tiled amplicon and targeted sequencing approaches in wastewater following base period task reporting guidelines and, in a timeframe, agreed upon by the NWSS Project Lead or designee and the Contractor. Contractor shall also produce (or procure) primers and other required oligonucleotides and distribute to CDC.

Optional Task 8: Multiplex assay validation using wastewater matrices

8.1 The Contractor shall perform validation for developed and optimized assays with quantified reference material and wastewater matrices, based on CDC validation testing guidelines to be provided by the Government.

8.2 The Contractor shall provide validation experimental design and workplan, and validation results and metrics to the Government. Validation metrics shall include, at a minimum, experimental measurements of limit of detection, and precision, for each multiplexed assay and instrument following base period task reporting guidelines and, in a timeframe, agreed upon by the NWSS Project Lead or designee and the Contractor.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

The Government will provide to the contractor a list of all existing PCR assays and targets to include and consider for assay development. The list will include primer, probe, and target sequences, existing assay run conditions and references, if available. The Government will also provide acceptable validation guidelines and requirements to be used for assay validation procedures.

SECTION 6 – PERIOD OF PERFORMANCE

The base period of performance for this contract will be 12 months from the time of the award, with 4 option periods of 12 months each. See Section B.

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 of the base period and all subsequent option years.

Task/ Deliverable

Description

Delivery Date (from time of award)

Deliver To

Kickoff Meeting Conference Call Within 10 days of contract award

COR, CO, CDC

NWSS Team

Base Task Assays design progress report

Report and presentation of design candidates for proposed multiplex assays

1 month CDC NWSS Team

Base Task: Assays in silico testing final report

Final report and presentation of in silico testing of proposed multiplex assay candidates

1.5-2 months CDC NWSS Team

Base Task Assays optimization progress report

Report and presentation on assay optimization at approximately the mid-way point of testing

3-4 months CDC NWSS Team

Base Task: Final multiplex assays optimization and QC progress report

Final report and presentation on final optimization, specifications, and performance for all assays

5-6 months CDC NWSS Team

Base Task (per CDC NWSS approval):

Mastermix comparison

Report and presentation on cost comparisons and performance for assays.

5-6 months CDC NWSS Team

Base Task: Assays validation design progress report

Report and presentation of validation design and protocol for proposed multiplex assays, including planned reference materials, and metrics to be captured

6-7 months CDC NWSS Team

Base Task: Assays validation progress report

Report and presentation on assay validation at approximately the mid-way point of testing

7-8 months CDC NWSS Team

Base Task: Final multiplex assays validation report and delivery timeline

Final report and presentation on assays validation. Provide timeline for delivery of validated assays, protocols, and quantified reference material to NWSS Team and NWSS public health partners

8-9 months CDC NWSS Team

Base Task: Delivery of assays, protocols and reference material

Deliver validated assays, protocols, and reference material to NWSS Team and NWSS public health partners

9-10 months CDC NWSS Team and NWSS public health partners

Base Task: Technical support and assistance

Provide technical support and assistance to NWSS Team and NWSS public health partners for validation testing, implementation and interpretation

10-12 months CDC NWSS Team and NWSS public health partners

Base Task: Final report and presentation

Final report and presentation on delivered assays, support provided to the NWSS Team and public health partners, challenges and opportunities

12 months CDC NWSS Team

Base Task: Assay re-development, re-optimization, re-validation, and production

Re-develop, re-optimize, re-validate and produce assays following base period task guidelines and deliverables

1-12 months, as agreed upon by NWSS Team and Contractor

CDC NWSS Team

Base Task : Assay interchangeable multiplexing

Evaluate, design, develop, and optimize, validate and produce interchangeable multiplexing schemes as needed following base period task guidelines and deliverables

1-12 months, as agreed upon by NWSS Team and Contractor

CDC NWSS Team

*Optional Task 6:

Additional digital PCR platform optimization and validation

Optimize, validate, and produce existing multipathogen assays on future digital PCR platforms, following base period task guidelines and deliverables in a timeframe agreed upon by the NWSS Team and the Contractor.

1-12 months, as agreed upon by NWSS Team and Contractor

CDC NWSS Team

*Optional Task 7:

Sequencing primer design and development

Design, develop, report, and produce (or procure) sequencing primers and adapters for tiled amplicon and targeted sequencing in a timeframe agreed upon by the NWSS Team and the Contractor

1-12 months, as agreed upon by NWSS Team and Contractor

CDC NWSS Team

*Optional Task 8: Assay validation using wastewater matrices

Validate multiplexed assays using wastewater matrices and provide final report in a timeframe agreed upon by the NWSS Team and the Contractor.

1-12 months, as agreed upon by NWSS Team and Contractor

CDC NWSS Team

*Deliverable is only applicable if optional CLIN has been exercised.

SECTION 8 – REFERENCE MATERIALS

SECTION 9 – POINT OF CONTACT INFORMATION

Provided at time of award.

SECTION 10 – PAYMENT TERMS

Contractor shall submit monthly invoices against the Time & Material CLINs.

SECTION 11 – 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 12 – RESERVED

SECTION 13 – INFORMATION SECURITY

Standard-1: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO.

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

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

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

i. Protect the:

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

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

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

ii. Categorize all information owned and/or collected/managed on behalf of CDC and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories. Based on information provided by the ISSO, CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [ x ] Low [ ] Moderate [ ] High

Integrity: [ x ] Low [ ] Moderate [ ] High

Availability: [ x ] Low [ ] Moderate [ ] High

Overall Impact Level: [ x ] Low [ ] Moderate [ ] High

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

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

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or CDC security and/or privacy officials.

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

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

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following:

Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

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

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract.

The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with CDC policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

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

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

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

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

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

f. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST

CMVP.

g. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by CDC or collected by the contractor on behalf of CDC must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract.

The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any CDC records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

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

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

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

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

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

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

j. Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to always assume HTTPS to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult HHS/CDC Policy for Internet and Email Security for additional information.

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

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

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

ii. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

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

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

v. Use the Key Management system on the CDC personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

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

2. Training Requirements

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

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

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

3. Rules of Behavior

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

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing agency data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Information Security Awareness Training.