A19. Request for Proposal IDIQ - updated.pdf

11. DELIVERY FOR FOB

DESTINATION UNLESS

BLOCK IS MARKED

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER

PAGE 1 OF

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

75D301-26-R-73493

6. SOLICITATION

ISSUE DATE

8/13/2026

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME Henrietta Fumbah Wei

b. TELEPHONE NUMBER (No collect calls)

(770) 488-8239

8. OFFER DUE DATE/

LOCAL TIME

9/2/2026 5PM

9. ISSUED BY CODE 15948 10. THIS ACQUISITION IS 12. DISCOUNT TERMS

OFR - Office of Acquisition Services Chamblee Campus Building 108 4770 Buford Highway Atlanta, GA 30341-

X UNRESTRICTED

SET ASIDE: % FOR

SMALL BUSINESS

SMALL DISADV. BUSINESS

8(A)

SIC: 514380

SIZE STANDARD: $19M

X SEE SCHEDULE

13a. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB X RFP

15. DELIVER TO CODE 11205 16. ADMINISTERED BY CODE 15948

CDC (NCEZID)

1600 CLIFTON ROAD

BLDG 23, 4TH FLOOR

ATLANTA, GA 30329-4018

OFR - Office of Acquisition Services Chamblee Campus Building 108 4770 Buford Highway Atlanta, GA 30341- CODE 18a. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100 Atlanta, GA 30333-0080

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

“Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens” IDIQ

Questions Due: 5:00 PM (ET), August 19, 2026 RFP Due: 5:00 PM (ET) September 2, 2026

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) $0.00

X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA X ARE ARE NOT ATTACHED.

X 27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA X ARE ARE NOT ATTACHED.

28.

X

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 1 COPIES

TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT TO

THE TERMS AND CONDITIONS SPECIFIED HEREIN.

AWARD OF CONTRACT: REFERENCE OFFER

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (Signature of Contracting Officer)

30b. NAME AND TITLE OF SIGNER (Type or print)

30c. DATE SIGNED

31b. NAME OF CONTRACTING OFFICER (Type or print) Howard D Bish

31c. DATE SIGNED

32a. QUANTITY IN COLUMN 21 HAS BEEN 33. SHIP NUMBER 34. VOUCHER NUMBER

RECEIVED INSPECTED

PARTIAL FINAL

36. PAYMENT 37. CHECK NUMBER

32b. SIGNATURE OF AUTHORIZED GOV’T REPRESENTATIVE 32c. DATE COMPLETE PARTIAL FINAL

41a. I CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT 41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC’D 42d. TOTAL CONTAINERS

40. PAID BY

AUTHORIZED FOR LOCAL REPRODUCTION SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT STANDARD FORM 1449 (10-95)

ACCEPTED, AND CONFORMS TO THE

CONTRACT, EXCEPT AS NOTED

35. AMOUNT VERIFIED

CORRECT FOR

17a. CONTRACTOR/

OFFEROR

FACILITY

CODE

IS CHECKED

Page i

TABLE OF CONTENTS

Section Page Number

Supplies or Services and Prices/Costs (Section B) 1

Performance Work Statement (Section C) 8

Contract Terms and Conditions (Section D) 23

Solicitation Provisions (Section E) 54

Instructions to Offerors (Section F) 60

Evaluation Factors and Basis of Award (Section G) 68

Attachments (Section H) 73

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

MAXIMUM VALUE

0001 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens IDIQ

Minimum Value: $10,000.00

Ordering Period:

09/15/2026 – 09/14/2031

Maximum Value

Not Separately Priced

$145,000,000.00

B.1 Purpose

The Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Indefinite Delivery/Indefinite Quantity (IDIQ) Contract is established to support the Centers for Disease Control and Prevention (CDC) in conducting ongoing wastewater surveillance for infectious disease pathogens, rapidly responding to emerging infectious disease threats and outbreaks, and strengthening preparedness for future public health emergencies. The contract will provide CDC with a scalable, flexible, and responsive mechanism for procuring wastewater surveillance services across multiple pathogens, geographic areas, surveillance objectives, and levels of operational need.

The Contractor, acting as an independent contractor and not as an agent, employee, or representative of the Government, shall furnish all labor, materials, equipment, facilities, supplies, technical expertise, management, supervision, administrative support, and other resources necessary to perform the requirements identified in the Performance Work Statement (PWS) and individual task orders.

Although this IDIQ contract is established primarily to support the National Center for Zoonotic and Emerging Infectious Diseases (NCEZID), the contract vehicle may be utilized by other CDC organizational components, subject to approval by NCEZID and compliance with applicable ordering procedures and contract terms.

B.2 Ordering of Services

Services under this contract shall be acquired through the issuance of individual task orders in accordance with the terms and conditions of the IDIQ contract and applicable Federal Acquisition Regulation (FAR) requirements. Funding shall be obligated at the individual task order level. CDC anticipates issuing multiple task orders following award of the IDIQ contract, each addressing a defined requirement and establishing a specific period of performance, scope, deliverables, performance requirements, and funding.

In accordance with FAR 16.506 and applicable ordering procedures, each task order shall be within the scope of the basic contract, issued during the authorized ordering period, and within the maximum contract value. Task orders shall address the Government's requirements as specified in the applicable Request for Task Order Proposal (RFTOP) and resulting task order.

The Contractor shall not commence performance, incur costs, or otherwise undertake work under this contract until authorized by a task order or other written authorization issued by the Contracting Officer.

Only a duly authorized CDC Contracting Officer may issue a task order, authorize performance, or otherwise obligate the Government under this contract. The Contractor shall not rely upon direction or representations from any Government employee other than the Contracting Officer to establish, modify, or expand the Government's contractual obligations.

The Government shall have no obligation to reimburse the Contractor for costs incurred or work performed prior to issuance of an applicable task order or other written authorization by the Contracting Officer.

B.3 Type of Contract

This contract is a single award Indefinite Delivery/Indefinite Quantity (IDIQ) contract with Firm-Fixed- Price (FFP) task orders.

B.4 Minimum Guarantee

The Government guarantees that task order(s) with an aggregate value of at least $10,000.00 will be issued under this IDIQ contract during the contract ordering period.

If the total amount obligated under task orders issued during the ordering period is less than the guaranteed minimum, the Government shall satisfy its minimum contractual obligation by payment of the difference between the amount actually obligated and $10,000.00, subject to the terms and conditions of the contract and applicable fiscal law.

Once task order(s) totaling $10,000.00 or more have been issued and obligated during the ordering period, the Government's minimum guarantee shall be deemed satisfied. The minimum guarantee does not constitute a commitment by the Government to issue task orders beyond the guaranteed minimum.

B.5 Maximum Contract Value

The aggregate maximum value of all task orders issued under the resultant IDIQ contract shall not exceed $145,000,000.00 over the life of the contract, unless otherwise modified in accordance with applicable law and contract terms.

The maximum contract value represents the Government's maximum ordering authority and does not constitute a commitment by the Government to order services in an amount equal to the maximum value.

If the Government's actual requirements do not result in task orders collectively reaching the maximum contract value, such circumstance shall not constitute a basis for an equitable price adjustment, claim for anticipated profits, or other compensation beyond amounts properly due under issued task orders.

B.6 Service Contract Labor Standards

The labor categories anticipated under this contract, including scientists, research associates, project managers, and other professional personnel, are generally expected to consist of bona fide professional employees who may be exempt from the requirements of the Service Contract Labor Standards, as applicable.

Applicability of the Service Contract Labor Standards shall be determined in accordance with the requirements applicable to the individual task order and the labor categories and services proposed thereunder. Where applicable, the Contractor shall comply with all requirements of the Service Contract Labor Standards, including applicable Department of Labor wage determinations, minimum wages, health and welfare requirements, and fringe benefit requirements.

Each task order shall be reviewed independently, as appropriate, to determine the applicability of the Service Contract Labor Standards and any associated wage determination or labor standards requirements.

B.7 Non-Personal Services Contract Statement

This is a non-personal services contract. The Government will establish requirements, evaluate Contractor performance, and exercise appropriate contractual and technical oversight; however, the Contractor shall retain responsibility and control over the manner and means by which its employees and subcontractors perform the work, subject to the requirements of the contract and applicable task orders.

The Contractor shall be solely responsible for the supervision, management, direction, compensation, and control of its employees and subcontractors. Nothing in this contract shall be construed to create an employer-employee relationship between the Government and Contractor personnel.

The Contractor shall be responsible for its acts and omissions and those of its employees, agents, and subcontractors to the extent provided by applicable law and the terms of the contract. The Contractor shall indemnify and hold the Government harmless to the extent required by applicable law and the contract with respect to liabilities arising from the Contractor's performance, including acts or omissions of the Contractor or its personnel.

B.8 Performance-Based Preference

Pursuant to FAR 37.101 and applicable acquisition policy, the Contracting Officer shall utilize performance-based acquisition methods to the maximum extent practicable.

Task orders should, to the maximum extent practicable, define measurable and objective performance requirements, performance standards, deliverables, service levels, quality requirements, acceptance criteria, and appropriate performance metrics. Requirements shall be structured to focus on measurable outcomes and results rather than prescribing the specific methods by which the Contractor must accomplish the work, except where such methods are necessary to satisfy Government requirements, statutory or regulatory requirements, scientific integrity, quality assurance, biosafety, security, or other mission-critical considerations.

B.9 Contract Structure

The basic IDIQ contract establishes the general scope of services, ordering procedures, contract terms and conditions, ordering period, minimum guarantee, and maximum contract value applicable to task orders issued under the contract.

The ordering period of the basic IDIQ contract shall be sixty (60) months. During the ordering period, CDC anticipates issuing multiple task orders addressing requirements identified in the PWS and other requirements that fall within the scope of the basic contract.

Each task order shall establish its own discrete period of performance, independent of the period of performance of the basic IDIQ contract. Task orders shall identify the applicable scope, schedule, funding, deliverables, performance requirements, and other task-order-specific terms.

No task order shall extend more than sixty (60) months beyond the expiration date of the basic IDIQ contract, unless otherwise authorized by applicable law, regulation, and the terms of the basic contract.

B.10 Task Orders

Task orders shall specify and authorize the work to be performed by the Contractor in response to a defined Government requirement. Each task order shall, as applicable, identify:

1. The scope and objectives of the requirement;

2. The applicable Performance Work Statement or task order Statement of Work;

3. The period of performance and key milestones;

4. Technical requirements and performance standards;

5. Required deliverables, products, reports, data, and/or services;

6. Acceptance criteria for deliverables and services;

7. Applicable quality assurance and quality control requirements;

8. Applicable security, privacy, confidentiality, data-use, and information-handling requirements;

9. Government-Furnished Property, Information, or Facilities, as applicable;

10. Government and Contractor points of contact;

11. Applicable references and standards;

12. Reporting requirements; and

13. The total firm-fixed price and any other applicable pricing or funding information.

Each task order shall constitute a separate authorization to perform the specified work and shall be subject to the terms and conditions of the basic IDIQ contract.

A Contracting Officer's Representative (COR) may be designated in writing for each task order. The task order COR shall be responsible for technical oversight and monitoring of Contractor performance within the authority delegated by the Contracting Officer. The COR shall not have authority to alter the terms, scope, price, period of performance, or other contractual obligations of the task order. Only the Contracting Officer may authorize such changes.

B.11 Award of Task Orders

Following award of the basic IDIQ contract, services shall be ordered through the issuance of individual task orders in accordance with the ordering procedures established in the contract and applicable FAR requirements.

a. Task Orders

1. A written task order issued by an authorized CDC Contracting Officer, in accordance with the terms and conditions of the basic contract, shall be the contractual instrument authorizing the acquisition of services under this IDIQ contract.

2. Task orders may be placed directly with the Contractor by a CDC Contracting Officer following issuance of a Request for Task Order Proposal (RFTOP), as applicable, and completion of the Government's task order evaluation and selection procedures.

3. Upon issuance of a task order, the Contractor shall be responsible for performing the requirements specified in the task order in accordance with the terms and conditions of the basic IDIQ contract, the task order, and applicable laws and regulations.

4. In accordance with applicable FAR requirements, task orders issued under the resultant IDIQ contract shall be subject to the applicable publication and synopsis requirements and exceptions.

b. Ordering Procedures

(1) Request for Task Order Proposal (RFTOP)

When the Government identifies a requirement for services within the scope of this contract, the Contracting Officer may issue a written Request for Task Order Proposal (RFTOP) to the Contractor. The RFTOP will contain information sufficient to permit the Contractor to prepare a responsive proposal and will include information comparable to that contained in a competitive solicitation, as appropriate to the requirement.

The RFTOP may include, but is not limited to:

• A Performance Work Statement or Statement of Work describing the Government's requirement;

• Required technical approach and methodology;

• Performance objectives and standards;

• Deliverables and reporting requirements;

• Period of performance and milestones;

• Proposal preparation instructions;

• Evaluation factors and relative importance;

• Pricing instructions and required cost or price information;

• Staffing requirements and labor categories;

• Data, security, privacy, confidentiality, or other compliance requirements; and

• Any additional task-order-specific terms and conditions.

The Contractor shall respond to each RFTOP in accordance with the instructions, format, and deadline specified by the Contracting Officer. RFTOPs may be transmitted electronically. The Contractor shall maintain the electronic mail and electronic submission capabilities necessary to receive RFTOPs and submit timely responses.

(2) Task Order Proposal Evaluation and Selection Procedures

The Contractor shall submit its proposal to the designated CDC Contracting Office by the date and time specified in the RFTOP. Unless otherwise specified or agreed to by the parties, the Government anticipates providing a minimum of fourteen (14) calendar days for proposal submission. The Government may establish a shorter response period when the urgency or complexity of the requirement warrants expedited acquisition, including the emergency procedures described below.

Unless otherwise specified in the RFTOP, the Contractor's response shall include a Technical Proposal and Price Proposal.

The Technical Proposal shall address the Contractor's proposed technical approach, staffing plan, management approach, quality assurance approach, schedule, relevant capabilities, and any other information specified in the RFTOP.

The proposal shall include a labor-hour and staffing matrix identifying, for each proposed labor category or position, the number of proposed labor hours associated with each major task component or subtask.

The matrix shall clearly demonstrate the relationship among proposed personnel, labor categories, level of effort, and the specific work to be performed.

The Contractor shall also provide a detailed pricing or budget breakdown identifying the proposed price associated with each major subtask, labor category, material, subcontract, other direct cost, and/or other cost element required by the RFTOP.

The Government will evaluate proposals in accordance with the evaluation factors and procedures identified in the applicable RFTOP. Evaluation may include technical merit, understanding of the requirement, technical approach, staffing and management capability, past performance or relevant experience, price, and other factors identified in the RFTOP.

(3) Contractor Responsibility for Performance

Upon issuance of a task order by an authorized CDC Contracting Officer, the Contractor shall be responsible for performing the task order in accordance with all applicable requirements of the basic IDIQ contract and task order.

The Contractor shall promptly notify the Contracting Officer of any actual or anticipated condition that may materially affect the Contractor's ability to meet task order requirements, schedules, deliverables, performance standards, or other contractual obligations.

(4) Issuance and Authorization to Commence Work

Task orders shall be issued by an authorized CDC Contracting Officer and shall contain written specifications describing the nature, scope, and requirements of the work to be performed.

The Contractor shall be authorized to commence performance only upon receipt of a properly issued task order or other written authorization from the Contracting Officer. The Contractor shall not commence work based solely on discussions, technical direction, or requests from Government personnel who lack Contracting Officer authority to obligate the Government.

(5) Urgent and Emergency Task Order Requests

To support CDC's public health mission and the potential need for rapid response to emerging infectious disease threats, outbreaks, or other urgent public health requirements, the Government may issue expedited RFTOPs requiring a proposal response within five (5) calendar days or less, when circumstances warrant.

The Contractor shall maintain sufficient organizational readiness, staffing flexibility, technical capability, and proposal response capacity to support expedited and emergency requirements. The applicable RFTOP will identify the required response period, submission requirements, evaluation procedures, and any other expedited acquisition provisions.

An expedited RFTOP response requirement does not, by itself, authorize the Contractor to commence performance. Performance shall begin only upon issuance of a task order or other written authorization by the Contracting Officer.

B.12 Evaluation of Contractor Performance

Contractor performance shall be evaluated at the task order level in accordance with applicable Government procedures, contract requirements, and the Contractor Performance Assessment Reporting System (CPARS).

Task order performance evaluations may consider, as applicable, the quality and timeliness of deliverables, achievement of performance objectives, technical quality, responsiveness, management effectiveness, adherence to schedules, quality assurance and quality control, regulatory and contractual compliance, and overall performance against the requirements of the task order.

Task order-level performance information may be considered by the Government in accordance with applicable acquisition regulations and policies when evaluating the Contractor's performance on future procurements and task order competitions.

The Contractor shall cooperate fully with the Government's performance assessment process and shall provide timely responses to requests for information, clarification, or supporting documentation associated with performance evaluations.

B.13 Ordering List by Ordering Period

A chart will be included in the resulting IDIQ contract to specify pricing per ordering period.

Supplies/Services Year 1 Year 2 Year 3 Year 4 Year 5 ddPCR (per test) Genomic Sequencing (per test)

Metagenomic Sequencing (per test)

Program Implementation

SECTION C – PERFORMANCE WORK STATEMENT

Project Title:

Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC)’s mission is to protect America from health, safety, and security threats. The government accomplishes this mission through the generation, collection, analysis and application of critical public health information for action and provision of timely technical assistance to state, local, tribal, and territorial (STLT) jurisdictions. Wastewater surveillance, the detection and 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 inform public health interventions. Wastewater surveillance provides actionable data that enables public health departments to respond to infectious disease threats. CDC’s wastewater surveillance program (NWSS) resides in the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID).

The National Wastewater Surveillance System (NWSS) is a CDC coordinated surveillance system that is implemented through STLT health departments. Implementation of this surveillance approach requires considerable effort, resources, and coordination at the state and local level. However, not all health departments have an environmental microbiology laboratory capable of testing wastewater. This contract serves to support rapid implementation of wastewater surveillance for CDC as well as supplement STLT capacity for routine and emerging pathogen wastewater surveillance. Historically, CDC’s wastewater testing contract supported up to 400 separate locations across state, local and territorial public health jurisdictions.

Supporting CDC’s need to rapidly respond to emerging threats and to supplement STLT capacity through commercial wastewater testing services is a critical and urgent need to support the nation's ongoing response to infectious disease. Wastewater data can provide an early warning of emerging infectious diseases and additional clinically important targets that are shed by humans or other sources into the waste stream such as influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), and wild-type Measles virus. Human pathogen molecular targets are surveilled in wastewater across multiple categories, including bacteria, viruses, fungi, as well as determinants of antibiotic resistance. Wastewater data also provides a robust measure of community infection trends at the height of surges when clinical testing can have insufficient capacity. This testing contract will provide essential support and capacity building by continuing to capture infectious disease surveillance data for all communities served by sewer systems including those in US territories, tribal nations, and states.

SECTION 2 – PURPOSE

As part of CDC’s ongoing wastewater surveillance program, the CDC’s Rapid Response Research and Surveillance Branch (R3SB) works with health departments, partners, and other federal agencies to detect and mitigate the effects and spread of emerging infectious diseases and other pathogens and leverages these efforts to build capacity to protect against future infectious disease outbreaks, public health emergencies, and threats. The purpose of this contract is to provide flexible, timely wastewater surveillance that complements and supports existing wastewater surveillance networks managed by STLT health departments. The contract shall support ongoing wastewater infectious disease monitoring, rapidly respond to emerging outbreaks, and prepare for future public health responses by facilitating wastewater surveillance of multiple pathogens. Through sample collection and shipment from public wastewater treatment facilities, to conducting quantitative measurement of pathogen levels using digital PCR and sequencing, contract services will enable flexible, rapid, and supportive wastewater surveillance data to CDC and STLT health departments.

Program’s implementation will establish a scalable and flexible wastewater surveillance network that supplements state, local, tribal, and territorial (STLT) capacity and supports CDC’s ability to monitor routine and emerging infectious disease threats. The contractor will establish service relationships with CDC-selected wastewater treatment facilities across the United States, territories, and tribal lands, provide participating facilities with sampling and shipping supplies and training, and support collection and shipment of wastewater samples at least twice weekly. Sites will be onboarded following CDC approval and in coordination with STLT health departments, with priority given to facilities that participated in previous CDC testing contracts. Samples will be tracked from receipt through laboratory testing and data reporting and analyzed using quantitative dPCR/ddPCR methods, with sequencing performed on selected samples to support pathogen characterization, variant identification, and detection of emerging threats.

Implementation will also include secure, routine transmission of complete and validated data to CDC in accordance with the NWSS data dictionary, ongoing monitoring of facility participation and sampling compliance, and regular communication regarding program performance, risks, and issues. This coordinated approach will provide timely, high-quality wastewater surveillance data while maintaining the operational flexibility needed to expand testing and sequencing as new public health threats emerge.

SECTION 3 – SCOPE

The contractor shall, as an independent organization and not as part of the Government, furnish all necessary services, qualified personnel, and materials to perform the following contract requirements.

The requirements for this wastewater testing services contract shall be:

1. The contractor shall establish service relationships with up to 500 selected public wastewater treatment facilities across the US, its territories, and tribal lands. Facilities shall be selected for testing by CDC in coordination with STLT health departments. The contractor shall have the ability and capacity to identify new potential sites for inclusion, to be approved by CDC in coordination with STLT health departments.

The contractor shall provide sampling and shipping supplies at no cost to the participating public wastewater treatment utilities, and the contractor shall be responsible for managing shipping logistics to support public wastewater treatment utility partners. Wastewater samples shall be collected and shipped at a minimum of twice per week. The contractor shall establish a mechanism to collect the utility metadata required for NWSS data submission, including point of contact for the utility, point of contact for the local health department, flow rates at the time of sample collection, sewershed polygons and other required data elements listed in the NWSS data dictionary of which updated versions shall be shared with the vendor by the Government.

2. The contractor shall complete quantitative digital (dPCR) or digital droplet (ddPCR) PCR-based testing for up to 25 infectious disease pathogen targets and shall submit data to CDC within 36 hours maximum of sample receipt by the contractor. Test methods, including sample collection, storage, sample processing (concentration and extraction), assay selection and validation data, and sample results and analysis, shall meet the data submission standards for NWSS. Data submission standards, as defined in the NWSS data dictionary, shall be shared with the contractor by CDC. The contractor shall share protocols for all test method components with CDC with the understanding these methods may be shared publicly. In some cases, sample processing and assay test methods selection shall require dry and wet lab validation by the contractor prior to implementation to evaluate and confirm methods are fit for use and purpose, including the production of validation data. Validation requirements shall be defined by CDC;

validation design, results and analyses shall be furnished by the contractor to CDC in a format that can be shared publicly, and validation results and analyses, including raw data, shall be shared with, reviewed, and approved by CDC prior to contractor method implementation. At the request of CDC, the contractor shall evaluate, optimize, validate, and update any current or new test methods to modify and improve performance. Testing shall only be done by a single laboratory located within the continental United States of America.

3. The contractor shall complete sequencing of a subset of samples that have the minimum concentrations necessary to generate high quality sequence data, or lower concentration samples if requested by CDC.

Contractor shall have demonstrated capacity for rapid turnaround time from sample collection to submission to CDC. Raw sequence data shall be submitted to CDC within a timeframe designated at the task order level.

4. The contractor shall have the ability to perform metagenomic sequencing with the capacity to sequence one billion reads (or equivalent, dependent upon platform) from each sample, from 100 samples per week.

Research and development costs shall not be covered by this contract.

SECTION 4 – REQUIREMENTS

The following are tasks that may be included in subsequent task orders.

Meeting Schedules Kickoff Meeting shall occur within 10 days of task order award. Weekly project meetings shall be held as indicated at the task order level.

Reporting requirements shall be determined at the task order level.

Requirement One: Establish wastewater testing services with selected sites to support twice weekly sample collection and shipment to the testing laboratory.

Testing services shall be provided for wastewater facilities across the US, its territories, and tribal lands.

Facilities participating in previous CDC testing contracts shall be given priority for enrollment with testing initiation within four weeks of contract award.

After a courtesy review of marketing materials by CDC, the contractor shall market the program to health departments and utilities and provide contact information to CDC for initial contract discussion.

Health departments shall confirm with CDC mutual interest in participation by both the health department and the local utility. The health departments and utilities shall not be onboarded by the contractor until the CDC provides approval to initiate the onboarding process.

Should requests for sites to be included in wastewater testing exceed the capacity of the contract, the contractor shall, in accordance with the CDC, review site criteria furnished by CDC upon award for prioritization in enrollment, as needed. Additional criteria shall be determined in partnership with CDC and STLT health departments.

The contractor shall have the capacity to work with communities across all 50 states and territories including federally recognized Indian tribes according to IHS. 1.1. Contractor shall provide self-contained sampling kits and shipping materials to participating wastewater facilities for refrigerated transport of liquid wastewater influent, which shall include either 24-hour composite samples (if capacity available at wastewater facility) or grab samples. Sample volumes shall be sufficient to allow for all required testing, repeat testing if necessary, and for at least 15 ml raw wastewater remainders which shall be shipped to CDC for archiving by CDC.

1.2 Contractor shall provide training to wastewater facility staff on proper collection, packaging, and shipping of wastewater samples to the contractor.

1.3. Contractor shall provide sampling and shipping kits to each facility in a manner that supports at a minimum twice weekly sample collection and shipping. Instructions for collecting and packaging samples for shipment per Department of Transportation shipping regulations shall be provided by the contractor. Sampling supplies shall support the reporting of wastewater flow rate at time of sample collection by the utility collecting the sample.

1.4. Contractor shall be responsible for maintaining adequate supplies of testing kits and shipping materials to support the continuous flow of testing throughout the contract period. This shall include sample collection supplies and shipping materials at no cost for the participating utilities.

1.5. Sample remainders and derivatives, both untreated wastewater and total nucleic acid extracts, shall be properly cold chain stored and shipped on dry ice to the CDC Biorepository on a schedule designated at the task level and based on contractor storage capacity. All sample remainders and derivatives shall be owned by CDC.

1.6. The contractor shall monitor the facilities for adherence to the testing schedule as the absence of data collection can impair the monitoring of requested pathogen concentrations in sewage. Sampling gaps shall be reported to CDC weekly.

1.7. In addition to sample collection services, contractor shall maintain a data management system that facilitates tracking of facility participation and compliance with the sampling schedule. The data system shall track samples from receipt through testing and data reporting.

1.8. The contractor shall have the capacity to submit quantitative digital/droplet digital PCR data and sequencing data to CDC via an interface designated at the task level within a timeframe designated at the task level.

Requirement Two: Quantitative Testing

The contractor shall conduct laboratory analysis to quantify infectious diseases in wastewater.

The infectious diseases will be identified at the task level.

2.1 The analysis shall be conducted via digital/droplet digital polymerase chain reaction (dPCR or ddPCR). The testing protocol shall include measurement of recovery efficiency, matrix inhibition evaluation, and human fecal normalization that meet the data submission requirements identified at the task level. Data submission standards, as defined at the task order level (data dictionary), shall be shared with the contractor by CDC.

2.2 Complete laboratory protocols, including for sample collection, transport, accessioning, storage, processing and concentration, nucleic acid extraction, dPCR or ddPCR, sequencing, and assay validation data creation and analysis shall be provided to CDC prior to method implementation to ensure proper analysis and interpretation of the results. Assay validation methods, results and analyses, including raw data, shall be shared with and approved by CDC prior to contractor method implementation for a pathogen target. Validation requirements shall be defined by CDC and include, but are not limited to, limit of blank and limit of detection for each pathogen target, positive/negative controls, and extraction blanks.

Validation designs, results and analyses shall be furnished by the contractor to CDC for each test target in a format that can be shared publicly within two weeks of test method implementation. The contractor shall notify CDC no less than 14 calendar days before any quantitative protocol changes are implemented, if those changes are not explicitly requested by CDC.

2.3 Results shall be submitted to CDC within a time frame designated at the task order level of sample receipt by the contractor. Each sample result shall include at least the minimum required data fields and meet data submission requirements for NWSS to be considered complete. Data submission standards, as defined in the NWSS data dictionary, including QA/QC controls, shall be shared with the contractor by CDC.

Requirement Three: Sequencing

3.1 The contractor shall conduct targeted amplicon sequencing on a subset of samples for genetic characterization of infectious disease pathogens including variant identification, antiviral resistance detection, and other relevant genomic assessments as directed by CDC. For each pathogen, sequencing shall include both focused analysis of selected genomic regions of pathogens of concern and/or whole-genome sequencing, depending on surveillance objectives and data needs as identified at the task order level. Deep, focused amplification sequencing shall provide information for a core set of informative regions, detecting variation at high sensitivity. Whole-genome (or otherwise broad, tiled amplicon) amplification sequencing shall be applied to generate comprehensive genomic coverage for pathogens identified at the task order level to support lineage assignment, variant discovery, and evolutionary analysis. Sequencing methods shall be suitable for wastewater samples, accounting for genome fragmentation, high viral diversity, and low RNA abundance. Sequencing shall be conducted using high-quality read instrumentation, such as Illumina, unless other machines are required in the future to remain aligned with the evolving science. Contractor shall provide metadata on the sample information and how the sequence data was generated. Metadata for sequenced samples shall be submitted in accordance with the PHA4GE (Pathogen-agnostic Harmonized-genomics-for-public-health surveillance) wastewater metadata format.

3.2 The contractor shall have the capability to perform untargeted shotgun metagenomic sequencing for an amount of reads per sample identified at the task order level and sequenced on a time frame identified at the task order level. The contractor shall have the capability to perform hybrid capture or other enrichment and/or depletion methods identified at the task order level to support detection and characterization of both known and emerging pathogens, enabling early recognition of unexpected or novel targets. This approach shall complement targeted sequencing and be used as directed by CDC at the task level for broad genomic surveillance. The contractor shall be required to provide a description of their capabilities to meet this requirement, including equipment.

3.3 Raw sequence data and sample metadata shall be submitted to the National Center for Biotechnology Information (NCBI) and the CDC within a schedule that will be determined at the task order level. All raw human reads shall be removed prior to submission.

3.4 Sequence Data and Quality Assessment

3.4.1 The contractor shall provide CDC with raw reads and shall filter human reads out of any datasets using the sra-human-scrubber (https://github.com/ncbi/sra-human-scrubber) human read removal tool (HRRT), or a tool with equivalent or better performance, prior to submission of any raw sequences to NCBI.

3.4.2 CDC recognizes that multiple technologies may be used to accurately sequence infectious diseases and shall review protocols that use other quality and coverage standards at the task order level.

3.4.3 The contractor shall provide CDC with complete and up-to-date written documentation of any laboratory protocols for sample extraction, nucleic acid quantification, targeted amplification, library construction and sequencing with the understanding these methods may be shared publicly.

3.4.4 The offeror shall provide CDC with complete and up-to-date written documentation of all sequencing process controls, quality assurance measures including positive and negative controls with the understanding these methods may be shared publicly.

3.5 The contractor shall notify CDC no less than 14 calendar days before QC/QA or sequencing protocol changes are implemented.

3.6 All sample remainders and sample derivatives shall be owned by CDC. Sample remainders shall not be retained or used by the contractor, unless written permission is granted by CDC. Sample remainders and derivatives, including at least 15 ml of raw wastewater and any remaining extracted nucleic acids, shall be shipped to the CDC Biorepository for archiving. Samples shall be properly frozen, stored, and shipped frozen to maintain cold chain and sample integrity (i.e., dry ice).

Samples shall be shipped at least monthly.

https://github.com/ncbi/sra-human-scrubber

Requirement Four: Flexibility and Adaptive Capacity

To ensure that sequencing operations under this mechanism remain responsive to evolving public health needs, the contractor shall maintain technical and operational flexibility as described below. These provisions apply to all related activities.

4.1 Assay Adaptability

4.1.1 Panel modifications: The contractor shall maintain the ability to update the hybrid capture panel within one month of CDC request to include new or emerging targets not fully covered by existing designs.

4.1.2. Untargeted sequencing option: The contract shall include an option to employ untargeted (agnostic) sequencing approaches, activated only at CDC request at the task level. If used, human reads must be immediately removed and never stored or analyzed, either through bioinformatics filtering and/or laboratory-based depletion methods.

4.1.3. Primer additions: The contractor shall be able to rapidly incorporate additional primer pairs into molecular assays as appropriate within a timeframe determined at the task level at the request of CDC to enable rapid response to emerging mutations or additional targets.

4.1.4. Pathogen expansion: The contractor shall maintain capability to include additional pathogens for detection and concentration (via PCR) and genomic detection and characterization (via sequencing) as new threats are identified.

4.2 Sequencing Depth Scaling

Sequencing depth shall be adjustable to reflect the size, population, and epidemiologic importance of the contributing sewershed. Larger catchments with higher population density shall receive proportionally deeper sequencing coverage to enable detection of minority variants.

4.3 Shipping and Receiving

4.3.1. Receiving samples: The contractor shall maintain capacity to process and analyze samples submitted from jurisdictions outside the primary project area when directed by CDC.

4.3.2. Transferring samples: The contractor shall have mechanisms to rapidly transfer samples to other CDC-designated laboratories for specialized sequencing or characterization, while maintaining full chain-of-custody documentation.

4.3.2.1. Outgoing samples shall be shipped within three (3) days of CDC request.

4.3.2.2. Shipments shall follow appropriate cold chain management protocols, with documentation including chain-of-custody forms, tracking numbers, and receipt confirmations.

Requirement Five: Data and Program Management

5.1 The contractor shall establish data reporting format and test data transfer protocols between Contractor and the CDC as outlined at the task order level. Data transfer for both quantitative and sequencing data shall be via a secure method designated at the task order level and compliant with authentication and encryption standards designated at the task order level. The data format shall comply with the NWSS data dictionary. The Contractor shall validate data transfers through test datasets prior to routine reporting, including error handling and logging of failed transmissions. Any additional fields necessary to comply with reporting shall be appended to the end of the designated dataset.

5.2 Contractor shall provide regular data streams to the CDC at a schedule designated at the task order level, on scheduled days agreed upon with CDC. Data stream shall be determined once data sets are determined. Each data submission shall be validated for accuracy and completeness prior to transmission. The Contractor shall promptly notify the CDC of any failed or delayed transmissions and provide corrective actions.

5.3 The Contractor shall ensure full compliance with all contract requirements. A designated Program Manager, with sufficient corporate authority, shall serve as the primary point of contact and oversee execution of all tasks. The Program Manager shall ensure that all necessary management, technical, contract, engineering, implementation, and maintenance resources are available, qualified, and sufficient to perform all contract requirements. The Program Manager shall also provide regular performance reports to CDC and ensure staff are trained and certified as needed for wastewater surveillance and data management activities.

5.4 The Contractor shall continuously monitor the performance of this contract, including all subcontracts, to provide the Government with timely assessments of program progress, risks, and issues. The Contractor shall develop and execute a Communication Plan, approved by the CDC, detailing methods, approach, and cadence for reporting status, issues, and risks to CDC and relevant external stakeholders. Documentation of adherence to the Communication Plan, including records of communications and actions taken, shall be included in the monthly update deliverable.

5.5 The Contractor shall ensure facilities adhere to the testing schedule, as missed collections can impair monitoring of pathogen concentrations in sewage. Because participation is voluntary, facilities may opt out or lack to comply with the testing schedule. The Contractor shall contact any facility that misses a collection date. If a facility misses an entire week of sample collection, the Contractor shall notify the CDC Project Manager in writing, including details of interactions with the facility and resolution status. If the Contractor cannot reach the facility after three attempts, CDC shall be notified. Facilities that consistently miss sampling events, defined as two or more missed collections within four weeks, shall also be reported to CDC. CDC may choose to replace non-responsive facilities. The Contractor shall document all communications and attempts.

5.6 The Contractor shall ensure all submitted data are accurate, complete, and comply with the designated data dictionary, including proper file types, formats, column headings, and data standards.

The CDC Technical Monitor shall notify the Contractor of any data quality issues. The Contractor shall isolate and resolve these issues within a defined timeframe and document validation of the corrections. If an issue recurs, the Contractor shall submit a corrective action plan to CDC detailing steps to prevent reoccurrence, subject to CDC review and approval.

5.7 Data Use: The Contractor shall acknowledge that samples subject to this contract are sensitive, and violations of this section shall be deemed a material breach of the Contract.

5.7.1. Ownership and Sensitivity: All samples and data generated under this contract are the sole property of CDC and are considered sensitive. Any violation of this section shall constitute a material breach of the contract.

5.7.2. Permitted Use: The Contractor shall not use data for purposes other than those explicitly described in this contract without prior written approval from CDC. Prohibited uses include, but are not limited to, research publications, data sharing with other public or private entities, inclusion in marketing materials, or any derivative analysis for external purposes. The Contractor shall provide data reports to participating facilities only with CDC approval.

5.7.3. Legal Process Notification: The Contractor shall notify CDC, both verbally and in writing, of any instance in which samples or data are subject to a subpoena, court order, administrative order, or other legal process (including FOIA requests). Notification shall occur as soon as feasible, and no later than five (5) business days prior to the applicable response deadline.