A19_Solicitation - Revised 7.31.2024.pdf

1 RFP 75D301-24-R-72969

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-72969

Solicitation Type

Request for Proposal

FAR 12 Commercial Items & FAR 15 Contracting by Negotiation

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

7/9/2024

Questions Due Date

7/15/2024

Proposal Date

8/9/2024 11:00 AM EST

Solicitation Table of Contents

Section Page Number

Section A Description of Requirement 2

Section B Supplies or Services and Prices/Costs 3

Section C Performance Work Statement 7

Section D Contract Terms and Conditions 38

Section E Instructions, Conditions, and Notices to Offerors 56

Section F Evaluation Factors for Award 85 mailto:xur0@cdc.gov mailto:uwo8@cdc.gov

2 RFP 75D301-24-R-72969

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

FIRM-FIXED-PRICE contract type for the requirement.

b. The solicitation number is 75D301-24-R-72969. 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 dated 05/22/2024 .

d. This procurement has been designated 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 for commercial collection, testing, and genetic sequencing of biological samples (e.g. nasal and saliva) from international travelers’ arriving in the United States, and aircraft wastewater testing and sequencing to detect

SARS-CoV-2 variants in aircraft wastewater samples .

g. The contract anticipated period of performance is 8/26/2024 – 8/25/2027, inclusive of base period and all option periods.

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 and solicitation terms and conditions are included in Sections D and E.

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 and on page 1 of this document.

3 RFP 75D301-24-R-72969

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Traveler-based Genomic Surveillance Program

Multiplex Traveler Nasal Swab Testing

Tasks 1, 4, 5

Severable Services

Firm Fixed Price

Period of Performance: 8/26/2024 – 12/25/2024

4 Months $ $

0002 Traveler-based Genomic Surveillance Program

Multiplex Wastewater Testing

Tasks 2, 4, 5

Period of Performance: 8/26/2024 – 2/25/2025

6 Months $ $

0003 Option for Increased Quantity

Multiplex Traveler Nasal Swab Testing

Task 6

This optional surge CLIN may be exercised multiple times during the period of performance not to exceed the total maximums of this CLIN.

Period of Performance: 8/26/2024 – 8/25/2025

Maximum of

190,000 samples

$ per sample $

0004 Option for Increased Quantity

Multiplex Wastewater Testing

Task 7

1,000 additional

0005 Optional Task 3

Pilots of New Technologies or Modalities

Task 3

4 Projects $250,000 per project

$1,000,000

TOTAL POTENTIAL CONTRACT VALUE of LINE ITEMS 0001 - 0005 $_______________

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1001 Traveler-based Genomic Surveillance Program

Tasks 1, 4, 5

Period of Performance: 12/26/2024 – 8/25/2025

8 Months $ $

1002 Traveler-based Genomic Surveillance Program

Tasks 2, 4, 5

Period of Performance: 2/26/2025 – 2/25/2026

12 Months $ $

TOTAL POTENTIAL CONTRACT VALUE of LINE ITEMS 1001 and 1002 $_______________

2001 Traveler-based Genomic Surveillance Program

Period of Performance: 8/26/2025 – 8/25/2026

2002 Traveler-based Genomic Surveillance Program

Period of Performance: 2/26/2026 – 8/25/2026

6 Months $ $

2003 Optional for Increased Quantity

190,000

2004 Optional for Increased Quantity

1,000 additional

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2005 Optional Task 3

TOTAL POTENTIAL CONTRACT VALUE of LINE ITEMS 2001 - 2005 $_______________

3001 Traveler-based Genomic Surveillance Program

Period of Performance: 8/26/2026 – 8/25/2027

3002 Traveler-based Genomic Surveillance Program

3003 Optional for Increased Quantity

190,000

3004 Option for Increased Quantity the total maximums of this CLIN.

Maximum of

1,000 additional

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3005 Optional Task 3

TOTAL POTENTIALCONTRACT VALUE of LINE ITEMS 3001 - 3005 $_______________

TOTAL POTENTIAL CONTRACT VALUE of LINE ITEMS 0001 – 3005 $_______________

B.1 Optional Task (Task 3) – Separately Priced Line Items

The Government may require the delivery of additional support effort under the numbered line items: 0005, 2005, and 3005 identified in the Schedule as Optional Task 3 up to the extended price stated in the Schedule. 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 surge support. The Contracting Officer may choose to issue a bilateral modification.

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SECTION C – PERFORMANCE WORK STATEMENT

Title: Traveler-based Genomic Surveillance Program

SECTION 1 – BACKGROUND

Travelers are an important population to consider when tracking new and emerging infectious diseases because they move from place to place quickly and can get and spread infectious diseases. Public health surveillance for importation of emerging infectious diseases has traditionally focused on travelers presenting to health clinics after symptom onset.1 COVID-19 presented unique challenges for this surveillance approach because it is estimated that ~ 30% of people with SARS-CoV-2 infection are asymptomatic. It is likely that by the time new or concerning variants of SARS-CoV-2 are detected through routine clinical surveillance there is already community transmission.

During the COVID-19 pandemic, genomic sequencing to detect variants increased significantly in communities in the United States (U.S.). International travel played an important role in the spread of novel variants of concern

(VOCs) to the U.S. Using traveler-based surveillance at airports provides a platform for the detection of new variants, important pathogens and other public health threats before they spread through US communities.

Information from this platform provides an important aspect of pandemic readiness, helping to guide public health response.

CDC's Traveler-based Genomic Surveillance (TGS) Program was established in 2021 during the COVID-19 pandemic. This Program has been highly effective in enhancing early detection and filling gaps in global disease surveillance. TGS has detected numerous Omicron variants including: BA.2, BA.3, BQ.1, BQ1.1, XBB, CH.1.1 up to 6 weeks before they were reported globally.2 TGS also identified the first detection in Asia of BA.2.86, a new variant with > 30 mutations.3 Data from TGS has been shown to correlate with community SARS-CoV-2 incidence rates from many countries and can be used to predict trends. This Program has been nimble and scalable. During the 2022 removal of the zero COVID policy in China and subsequent surge of cases, TGS expanded collection operations to gather many more samples from travelers arriving from China and surrounding hubs to provide near real time SARS-CoV-2 genomic sequencing information from the region. TGS data has also provided important real-world evidence supporting the effectiveness of mitigation strategies such as predeparture testing which can be used for decision making in future outbreaks and pandemics.4

Traveler-based genomic surveillance can be achieved through many modalities and is not limited to direct contact with the traveler and clinical specimens. Approaches that have been used include testing and sequencing wastewater from airplanes and wastewater and air samples from airports to detect and characterize strains of multiple pathogens. Early detection of pathogens beyond SARS-CoV-2 is part of public health readiness, buying critical time for implementation of mitigation strategies and helping to decrease health and economic impacts.

Pilots studies are underway to demonstrate feasibility of using the TGS platform for multipathogen detection.

1Hamer DH, Rizwan A, Freedman DO, Kozarsky P, Libman M. GeoSentinel: past, present and future. Journal of Travel Medicine.

2020;27(8):taaa219.

2 Wegrzyn R, Appiah G, Morfino R, Milford S, Walker A, Ernst E, Darrow W, Li S, Robison K, MacCannell D, Dai D, Brintha P

Girinathan, Allison L Hicks, Bryan Cosca, Gabrielle Woronoff, Alex M Plocik, Birgitte B Simen, Leah Moriarty, Sarah Anne J

Guagliardo, Martin S Cetron, Cindy R Friedman, Early Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Variants

Using Traveler-based Genomic Surveillance at 4 US Airports, September 2021–January 2022, Clinical Infectious Diseases, Volume 76, Issue 3, 1 February 2023, Pages e540–e543, https://doi.org/10.1093/cid/ciac461 3 Bart SM, Rothstein AP, Philipson CW, et al. Notes from the Field: Early Identification of the SARS-CoV-2 Omicron BA.2.86

Variant by the Traveler-Based Genomic Surveillance Program — Dulles International Airport, August 2023. MMWR Morb Mortal

Wkly Rep 2023;72:1168–1169. DOI: http://dx.doi.org/10.15585/mmwr.mm7243a3.

4 Bart SM, Smith TC, Guagliardo SA, et al. Effect of Predeparture Testing on Postarrival SARS-CoV-2–Positive Test Results

Among International Travelers — CDC Traveler-Based Genomic Surveillance Program, Four U.S. Airports, March–September

2022. MMWR Morb Mortal Wkly Rep 2023;72:206–209. DOI: http://dx.doi.org/10.15585/mmwr.mm7208a2.

https://wwwnc.cdc.gov/travel/page/travel-genomic-surveillance

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SECTION 2 – PURPOSE/OBJECTIVE

The Traveler-based Genomic Surveillance program (TGS) plays an important role in U.S. national biosecurity through its two major goals: (1) early detection of new SARS-CoV-2 variants and other pathogens and (2) filling in gaps in global biosurveillance.

The purpose of TGS is to utilize samples from travelers (clinical and environmental) to test, sequence and monitor trends of SARS-CoV-2 and other important pathogens and public health threats ( e.g. antimicrobial resistance) . TGS is voluntary and enrolls travelers from a wide array of countries. Prioritization of arriving flights is based on factors such as travel volume, geographic region, available sequencing data, disease prevalence and seasonality, etc. TGS is flexible and nimble and maintains the ability to surge capacity depending on public health needs. The de-identified raw data and samples collected belong to CDC. Samples from travelers undergo reverse transcription PCR (RT-PCR) testing and genetic sequencing on all positive samples. The turn-around-time from sample collection to reporting of sequencing results is within 10 days. The program leverages a variety of sampling modalities, including individual testing, pooled testing, wastewater testing, and air sampling. TGS uses a variety of molecular testing techniques and sequencing approaches.

SECTION 3 – SCOPE OF WORK

The contractor shall collect biological and environmental samples at designated airports. The contractor shall establish nasal sample collection sites in six (6) major international airports located in the U.S., and environmental (e.g., wastewater and air) sampling at seven (7) U.S. airports. Traveler enrollment is voluntary and anonymous. The contractor shall develop digital data collection instruments, ensuring that no personal identifying information is collected. The contractor shall be responsible for sample collection and ensure that samples are shipped, processed, stored, and tested appropriately.

The contractor shall provide all raw data outputs including sequencing and demographic clinical and travel data to CDC. The contractor shall develop and provide a weekly report that includes a summary of the findings, and upload data to the National Center for Biotechnology Information (NCBI) database.

The contractor shall surge as needed to collect additional samples from countries of interest.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Traveler Nasal Swab Testing

1.1 Sample collection

a. The contractor shall establish a sample collection sites (kiosk, booth, etc. with CDC-approved signage) at six (6) major international airports located in the U.S.

b. The contractor shall set up a collection site in the arrivals area to obtain dry nasal swab samples from travelers from international flights. Collection sites may be in the public area of the airport, the Customs and Border Protection (CBP) secure area or Federal Inspection Services (FIS) area depending on airport layout and approvals.

c. The contractor shall enroll a minimum of 4,000 travelers per week (210,000 per year) across all sites.

The contractor shall focus collection efforts from arriving passengers from the designated flights identified by CDC subject matter experts (SMEs). The contractor may provide incentives to participants to boost enrollment with CDC SME approval.

d. Enrollment shall consist of obtaining from the traveler (1) informed consent, (2) completed questionnaire, and (3) two self-collected lower nasal swabs.

One swab will be placed in a pool (group) with approximately 10 other traveler samples. The second swab will be placed in an individual tube. The contractor shall use sterile nasal swabs and viral transport media for all samples.

e. The contractor shall pool samples at the point of collection in the airport. Samples will be pooled by flight origin as directed by the CDC.

f. All samples shall be collected using appropriate equipment and stored and shipped in viral transport media or as directed by CDC SMEs.

g. The contractor shall utilize an existing survey mechanism (i.e. Commercial Off the Shelf (COTS) or https://www.ncbi.nlm.nih.gov/

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proprietary software) for travelers to provide consent to participate in the voluntary and anonymous

Program and complete a brief questionnaire. This is not a software development contract, therefore, the contractor shall not develop software to complete this task. The questionnaire shall be available in multiple languages. It will link to the sample collected but shall not contain any personally identifiable information.

h. All public-facing language, signage, and materials used in this Program must be approved by CDC

SMEs.

i. All testing shall be performed at no charge to travelers.

j. The contractor shall not report test results to participants.

1.2 PCR Testing

a. The contractor shall ship pooled samples to an off-site laboratory for multipathogen RT-PCR testing.

b. The multipathogen RT-PCR testing panel shall include up to 10 targets including SARS-CoV-2, Flu

A/B, RSV, other pathogens as determined by CDC SMEs.

c. When pools yield a positive PCR result the corresponding individual samples will undergo RT-PCR testing, as directed by CDC SMEs.

d. The contractor shall conduct RT-PCR tests on the individual swabs that were collected from each traveler in the positive pool.

e. In consultation with CDC SMEs, the contractor shall ensure that the appropriate method of whole genome sequencing and latest versions of primers are used.

f. The contractor shall report results of the PCR test to CDC within 24-48 hours of sample collection in a format as directed by CDC SMEs.

g. The contractor shall share validation data for each test used, and shall provide data on continuous monitoring reports of positive and negative controls.

1.3 Genomic Sequencing

a. The contractor shall ensure all positive samples undergo whole genome sequencing using the appropriate sequencing method in consultation with CDC SMEs.

b. The contractor shall conduct sequencing that is appropriate for the pathogen of interest and shall submit the raw sequence data and sample metadata to National Center for Biotechnology Information (NCBI) database. Next generation sequencing that accounts for genome fragmentation, short reads, long reads, potentially high viral diversity, and the relatively low abundance of viral RNA, such as tiled amplicon approaches are acceptable.

c. As a precautionary measure, the contractor shall retain all extracts, samples, and sequencing libraries for a period of thirty (30) days, in the event repeat sequencing is required or a specific virus sample is required for further characterization and culture.

d. As directed by CDC SMEs, the contractor shall transfer samples to CDC laboratories for characterization and culture. All storage and transportation of the samples shall be performed following

CDC's guidance to guarantee stability throughout the process.

e. The contractor shall retain in-house bioinformaticians who shall review and interpret sequencing data and phylogenetic information in consultation with CDC SMEs.

f. The contractor shall report sequencing results to CDC within 10 days of sample collection. The contractor shall dispose of and inactivate samples in accordance with CDC guidelines for laboratory safety.

Task 2: Multiplex Wastewater Testing Sampling and testing of wastewater

The contractor shall perform aircraft wastewater surveillance, including sample collection and testing of wastewater samples from aircraft lavatory and airport triturator drain samples.

a. The contractor shall secure any necessary contractual agreements with airports and aircraft operators to obtain wastewater sample collection in airport and aircraft facilities.

b. The contractor shall use a closed system device for collection of airplane wastewater and an autosampling device for collection of triturator wastewater.

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c. The contractor shall collect and process 24 wastewater samples per week across all airports yielding

1250 samples per year.

d. In consultation with CDC SMEs, the contractor shall conduct multiplex d-PCR testing of all wastewater samples for no more than 10 targets including pathogens such as SARS-CoV-2, RSV, Flu A and B and

Mpox and other important pathogens. The contractor shall conduct genetic sequencing of all positive samples for the pathogen of interest using appropriate methodologies.

e. The contractor shall perform bioinformatic analysis of pathogens in wastewater including SARS-CoV-

2 variant and lineage detection.

f. The contractor shall submit wastewater testing data to relevant national databases.

g. The contractor shall report sequencing results to CDC within 10 days of collection. The contractor shall dispose of and inactivate samples in accordance with CDC guidelines for laboratory safety.

Task 3: Novel modalities for sampling and testing

a. At least once per quarter, the contractor shall report to CDC any new modalities, technologies, and approaches that could be used to enhance or improve this genomic surveillance system. The contractor shall implement these new modalities wherever possible as directed by CDC SMEs.

b. In consultation with CDC SMEs, the contractor shall perform pilot studies of new technology.

c. Pilots of novel modalities, collaborations with outside researchers, or changes to testing processes or protocols shall be reviewed and approved by CDC SMEs in advance.

Task 4: Reporting and Data Analysis

a. The contractor shall provide all raw data outputs including sequencing and demographic clinical and travel data to CDC. The contractor shall develop and provide a weekly report that includes a summary of the findings, and upload data to the National Center for Biotechnology Information (NCBI) database.

b. The contractor shall maintain an internal dashboard and pipeline of data that flows to CDC. As directed by CDC SMEs, the contractor shall provide data to a public-facing dashboard.

c. The contractor shall monitor data in real time and provide weekly and ad-hoc reports as requested, to include:

1) Results of RT-PCR tests for pools and individuals (positive, negative, or inconclusive).

2) Sequencing data: consensus genome, VCF, BAM files for each sample (sequences with ≥90% coverage and ≥10% read depth).

3) SARS-CoV-2 lineage reports.

4) Interpretation of findings by trained bioinformatician, in consultation with CDC SMEs.

d. The contractor shall upload results, sequences, and appropriate meta-data to public databases at the direction of CDC SMEs.

Task 5: Quality

a. Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this SOW. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which it assures that the work complies with the requirement of the contract. The Quality Control Plan shall be submitted to the Government within 30 days after contract award. If changes are made to the Quality Control Plan, the revised document shall be submitted within 5 working days. After acceptance of the quality control plan, the contractor shall receive the Contracting Officer’s acceptance in writing of any proposed change to the Quality Control

Plan.

b. Quality Assurance: The Government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the

Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

c. Key Personnel: The contractor shall identify any key personnel for this requirement. The contractor https://www.ncbi.nlm.nih.gov/

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shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate who shall act for the contractor when the manager is absent, shall be designated in writing to the Contracting Officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between the core hours of 8:00 a.m. to 4:30p.m. Eastern

Standard Time, Monday thru Friday except Federal holidays or when the Government facility is closed for administrative reasons.

d. Identification of Contractor Employees: All contract personnel attending meetings, answering

Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

e. Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government-owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting

Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights. Any sub-contracts established by the Contractor shall include provisions acknowledging the Government’s data rights.

Optional Tasks

Optional Task 6: Option for Increased Quantity Traveler Nasal Swab Testing The contractor may be asked to perform an increase in enrollment and testing during the period of performance; optional surge testing CLINs may be exercised multiple times during the period of performance up to the maximum numbers indicated below. Optional Task 6 includes a repeat of Tasks 1 as specified above with the addition of a maximum of 190,000 travelers.

Optional Task 7: Option for Increased Quantity Wastewater Testing The contractor may be asked to perform an increase in testing during the period of performance; optional surge testing CLINs may be exercised multiple times during the period of performance up to the maximum numbers indicated below. Optional Task 7 includes a repeat of Task 2 as specified above, with the addition of a maximum of 1,000 flights per year.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

No Government Furnished Property (GFP) is anticipated.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Nasal and wastewater work on this contract shall be performed at the following international airports, as well as the contractor’s off-site laboratory or other remote facilities:

1. New York John F. Kennedy International Airport (JFK)

2. Newark Liberty International Airport (EWR)

3. San Francisco International Airport (SFO)

4. Washington Dulles International Airport (IAD)

5. Seattle-Tacoma International Airport (SEA)

6. Miami International Airport (MIA)

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Wastewater sampling, options for increased quantity, and pilots of new technologies or modalities may require performance at various additional locations to be specified at time of award based on agreement between the CDC and contractor, including:

1. Hartsfield Jackson Atlanta International Airport (ATL)

2. Los Angeles International Airport (LAX)

3. Boston Logan International Airport (BOS)

4. Chicago O’Hare International Airport (ORD)

5. Dallas Fort Worth International Airport (DFW)

6. Other US-based international airports as identified by CDC SMEs

Note minimum vendor qualification for access and airport badging as outlined in Section 10.

SUBSECTION B – CONTRACT SUPPORT HOURS

The contractor shall determine support hours necessary to provide adequate flight coverage and obtain required samples from flights originating in countries as specified by CDC SMEs. Contract support hours may need to be adjusted throughout the period of performance as flight schedules change with travel seasonality/demand.

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SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Performance

Objective

Performance

Objective

Description Performance Standard Reporting Schedule

Task 1.1 Establish a sample collection site

(kiosk, booth etc.) at US

International airports in multiple U.S.

states

Establish airport sampling sites at (six) 6 major

U.S. international airports within 1 month of award

The contractor will enroll a minimum of 4,000 travelers per week (210,000 per year) across all airports. Enrollment will consist of obtaining (1) voluntary consent, (2) completed questionnaire, and

(3) self-collected double swabs from all travelers.

Weekly

Tasks 1.2 – 1.3 Pooled and reflex individual sample collection and processing

PCR results are expected within 24-48 hours of sample collection.

Sequencing results are expected within 10 days of sample collection.

Weekly

Emerging or unusual results should be flagged and reported in real time

Task 2 Wastewater sampling

Collect and process wastewater samples from aircraft lavatories for 24 flights per week yielding

1,250 samples per year across all airports.

PCR results are expected within 24-48 hours of sample collection.

Sequencing results are expected within 10 days of sample collection.

Weekly

Task 3 Novel methods Monitor and report on new modalities, technologies, and approaches that could be used to enhance or improve this genomic surveillance system

Quarterly

Task 4 Submission of data summaries

Provide data summaries and reports weekly 95% of the time

Weekly

Optional

Additional sampling

Enroll a maximum of 190,000 additional travelers across all airports.

PCR results are expected within 24-48 hours of sample collection.

Sequencing results are expected within 10 days of sample collection.

Optional

Wastewater sampling

Collect and process additional wastewater samples from aircraft lavatories for up to 1,000 flights per year.

PCR results are expected within 24-48 hours of sample collection.

Sequencing results are expected within 10 days of sample collection.

Required Reports/Documentation and Content

(1) Weekly Data and Technical Report

The contractor shall prepare and submit weekly technical progress reports in narrative form which shall contain a summary of program results during the reporting period, and bioinformatic analysis. Examples of acceptable reports/format will be shared at time of award.

(2) Weekly Operational Status Report

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The contractor shall prepare and submit a weekly operational status report, which includes at minimum progress toward the each of performance metrics outlined in the performance matrix below. This report shall be in sufficient detail to disclose all work started and results achieved during the reporting period, an indication of any current problems which may impede performance, the proposed corrective action, and the work forecast for the next period. This document shall report progress and planning to correspond with the work schedule contained in the program plan.

(3) Ah hoc reporting

The contractor shall prepare and submit ad hoc reports on specific program-related questions, variants or pathogens of interest, or bioinformatic analysis at the direction of CDC SMEs.

(4) Annual summary report

The contractor shall prepare and submit an annual summary report, documenting overall trends, key results, and performance summary.

Reporting Period All monthly reporting periods shall end on the last day of a calendar month.

(1) For contracts awarded (i.e., effective date) on or before the fifteenth (15th) of a calendar month, the initial reporting period shall end on the last day of the calendar month during which the contract became effective.

(2) For contracts awarded (i.e., effective date) on or after the sixteenth (16th) of a calendar month, the initial reporting period shall end on the last day of the month immediately following the month during which the contract became effective.

Delivery of Reports One copy of each report, in draft and/or final form as required by the contract, shall be delivered via email to the

CDC Contracting Officer’s Representative (COR) and CDC technical monitors as indicated by the COR. All contract correspondence, including final approval of reports, shall be done by the COR only.

SUBSECTION A – PERFORMANCE MATRIX

Desired

Outcomes Required Services

SLA Performance

Standard

(completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level

(AQL)

Monitoring

Method

(Quality

Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

Participant enrollment

Number of participants (including breakout by location, and country of interest) Quantities as specified in Task 1

No deviation without

COR

approval.

Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Number of individual tests (Pos/Neg) N/A – tracked for reference only

N/A Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Number of pools N/A – tracked for reference only

N/A Weekly

KPI/QASP

report

Weekly

KPI/QASP

Favorable or

Unfavorable

Evaluation

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Outcomes Required Services

SLA Performance

Standard

(completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level

(AQL)

Monitoring

Method

(Quality

Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives report

Early detection of new SARS-CoV-2 variants and other pathogens

Early identification of variants and pathogens

Rapid identification of variants, and new mutations.

95% Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Average PCR TAT (days) - Collection to

PCR Result Within 24-48 hours 98% Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Average Sequencing TAT (days) -

Collection to Sequence Within 10 days 98% Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Unusable Pools <1% per week 98% Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Unusable Individual Samples (Indiv

Unusable/Total # Participants) <1% per week 98% Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Geographic sensitivity and ability to fill in gaps in global biosurveillance

Number of Countries >130 90% Weekly

Performance

Evaluation

Percent of participants from countries of interest

70% of total participants from countries of interest

90% Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Aircraft and airport wastewater surveillance

Wastewater Samples collected

Quantities as specified in Task 2

No deviation without

COR

approval.

Weekly

KPI/QASP

report

Favorable or

Unfavorable

Performance

Evaluation

Wastewater flights targeted

Per CDC SMEs 90% Weekly report

Favorable or

Unfavorable

Performance

Evaluation

Wastewater Sequencing TAT (Collection to

Seq Delivery)

Within 10 days 90% Weekly

KPI/QASP

Favorable or

16 RFP 75D301-24-R-72969

Outcomes Required Services

SLA Performance

Standard

(completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level

(AQL)

Monitoring

Method

(Quality

Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives report Evaluation

Data Quality % of records passing QA Checks

95% 95% Weekly

Performance

Evaluation

Metadata completion rate (overall) >95% 98% Weekly

Performance

Evaluation

Novel Modalities Quarterly reports on novel modalities and opportunities to streamline program or testing operations

1 report per quarter No deviation without

COR

approval.

Quarterly Favorable or

Unfavorable

Performance

Evaluation

Badging Report of any security violation, or incident which would impact vendor’s ability to retain badging authority at airports

Zero incidents per period of performance

No deviation without

COR

approval.

Incident reporting, and remediation plan within 48 hours

CDR,

Favorable or

Unfavorable

Performance

Evaluation, Contract

Termination

Data Management Execute/ perform all required tasks according to Task 4.

All required milestones and deliverables as specified in Task 4.

98% accuracy

(completene ss)

Bi-weekly and

Monthly customer review of deliverables

Favorable or

Unfavorable

Performance

Evaluation

SECTION 8 – REFERENCE MATERIALS

No reference materials will be provided for this contract.

SECTION 9 – MINIMUM VENDOR QUALIFICATIONS

The contractor shall have an established capacity to obtain staff access to the Security Identification Display

Area (SIDA, defined at 49 CFR 1542.205), Air Operations Area (AOA, defined at 49 CFR 1540.5) and Customs security areas (defined at 19 CFR 122.181) within the participating airports included in this contract, to include access to secure Customs and Border Protection areas such as the Federal Inspection Services (FIS) area and the

CDC Port Health Station area.

Access requirements can vary depending on the airport. The contractor is responsible for researching and meeting these access requirements with the local badging and CBP offices at each airport. Most airports require contractors to establish Authorized Signatories before issuing airport identification badges. At some locations, contractors may have to obtain airport security bonds and CBP customs seals (as described in 19 C.F.R. 122.181-

189), complete vetting and clearing processes, complete airport-specific training, or fulfill other requirements https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=53d651cb40dea4d23e3c12c66e153c01&ty=HTML&h=L&mc=true&r=SECTION&n=se49.9.1542_1205 https://www.ecfr.gov/current/title-49/subtitle-B/chapter-XII/subchapter-C/part-1540/subpart-A/section-1540.5 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=53d651cb40dea4d23e3c12c66e153c01&ty=HTML&h=L&mc=true&r=SECTION&n=se19.1.122_1181

17 RFP 75D301-24-R-72969

before staff can obtain the necessary credentials to access SIDA and Customs security areas within the airport.

The contractor is responsible for training and escorting staff who have not yet been issued SIDA badges by the airport.

Contractor staff shall comply with any additional airport policies, procedures, or requirements for access to airport grounds or the SIDA. The contractor’s badging authority at the port of entry may be revoked if infractions of airport rules occur.

Note for staffing plan purposes: airport security processing for non-US citizens can take more than 60 days.

Contractor staff shall comply with any airport, building or port safety policies, procedures, or requirements for access to airport grounds or the SIDA, building or port facility.

SECTION 10 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

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.

Note to the Requiring Activity Representative: Complete the following section using the information obtained from the Information Security and Privacy Certification Checklist.

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

18 RFP 75D301-24-R-72969

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: [ ] Low [ x ] Moderate [ ] High

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

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

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

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

Note to the Requiring Activity Representative: This information may be included after award in the event it is not yet available at the time of acquisition. Section d must be included in all contracts regardless of whether personally identifiable information (PII) is involved.

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 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

19 RFP 75D301-24-R-72969

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

20 RFP 75D301-24-R-72969

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…