A19. RFTOP - Task 1 - Issued.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ IS X IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

1 34

1. REQUEST NO.

75D301-26-Q-99270

2. DATE ISSUED

3. REQUISITION/PURCHASE REQUEST NO.

000HCRGD-2026-99270

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY Centers for Disease Control and Prevention Chamblee Campus Building 108, MS S108-4 4770 Buford Hwy Atlanta GA 303413717

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

Henrietta Fumbah (770) 488-8239

8. TO: 9. DESTINATION

a. NAME b. COMPANY a. NAME OF CONSIGNEE

c. STREET ADDRESS b. STREET ADDRESS

c. CITY

d. CITY e. STATE f. ZIP CODE d. STATE e. ZIP CODE

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

See RFP for IDIQ

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

This task order will be evaluated and considered for award in concurence with the Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease

Pathogens IDIQ.

12. DISCOUNT FOR PROMPT PAYMENT a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

d. CITY e. STATE f. ZIP CODE c. TITLE (Type or print) NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 18 (REV. 6-95)

Previous edition not usable Prescribed by GSA FAR (48 CFR) 53.215-1(a)

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule)

75D301-26-Q-79270

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Scalable Wastewater Surveillance for

Routine and Emerging Infectious Disease Pathogens Task Order 1 ddPCR Testing for IAV up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

9/15/2026 – 9/14/2027

20800 /Each

$0.00 $0.00

0002 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Task Order 1 ddPCR Testing for IAV H1 up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

20800 Each

0003 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Task Order 1 ddPCR Testing for IAV H3 up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

20800 Each

0004 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Task Order 1 ddPCR Testing for IAV H5 up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

20800 Each $0.00 $0.00

0005 Scalable Wastewater Surveillance for

Pathogens Task Order 1 ddPCR Testing for IBV up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

9/15/2026 – 9/14/2027

20800 Each $0.00 $0.00

0006 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Task Order 1 ddPCR Testing for RSV up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

9/15/2026 – 9/14/2027

20800 Each $0.00 $0.00

0007 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Task Order 1 ddPCR Testing for Wild Type Measles up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

9/15/2026 – 9/14/2027

20800 Each $0.00 $0.00

0008 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Task Order 1 ddPCR Testing for SARS-CoV-2 up to 20800 samples

Firm Fixed Price Severable Services

Period of Performance:

20800 Each $0.00 $0.00

0009 Scalable Wastewater Surveillance for

Pathogens Task Order 1

Wild-Type Measles Sequencing Sequencing up to 6240 samples

Firm Fixed Price Severable Services

Period of Performance:

9/15/2026 – 9/14/2027

6240 Each $0.00 $0.00

0010 Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens Task Order 1

Program Implementation - Wastewater Testing Program Implementation

Firm Fixed Price Severable Services

Period of Performance:

1 Job $0.00 $0.00

SECTION C – PERFORMANCE WORK STATEMENT

Project Title: Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens

Task Order One

Kickoff Meeting shall occur within 10 business days of task order award.

Weekly technical project meetings shall be held with CDC technical team.

Monthly status reports: 12 per contract year in Microsoft word format, within 10 days of the prior month, emailed to the COR and technical team.

Final report: Due two weeks before end of the period of performance.

Task 1: Establish wastewater testing services with selected sites to support twice weekly sample collection and shipment to the testing laboratory.

1.1. Testing services shall be provided for up to a total of 200 public wastewater treatment facilities across the US, its territories, and tribal lands.

1.1.1. Contractor shall continue existing testing services for all sites carried over from the previous contract within one month of contract award up to 200 sites.

1.2. Contractor shall have the capability to test liquid influent (untreated) wastewater. Contractor shall provide self-contained sampling kits and shipping materials to participating public wastewater treatment facilities for refrigerated transport of liquid wastewater influent, which shall include either 24-hour composite samples (if capacity is 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.

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

1.4. 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.

Public wastewater treatment utilities shall include wastewater flow rate at time of sample collection.

1.5. 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 to the participating public wastewater treatment utilities.

1.6. 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.

1.7. The contractor shall monitor the participating public wastewater treatment utilities 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.

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

1.9. The contractor shall have the capacity to submit quantitative digital or droplet digital PCR data and sequencing data to CDC via an Application Programming Interface (API) connection within 4 weeks of contract initiation. CDC shall provide key points of contact to enable API submission.

Task 2: Quantitative Testing

2.1. The contractor shall conduct laboratory analysis to quantify infectious diseases in wastewater. IAV, H1, H3, and H5 subtypes of IAV, IBV, RSV, wild-type Measles, and SARS-CoV-2 (i.e., report results as copies/volume) on all samples received (up to 200 sites submitting two samples per week) shall be the initial infectious disease pathogens tested for.

2.2. The analysis shall be conducted via digital or 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 for the National Wastewater Surveillance System. Data submission standards, as defined in the NWSS data dictionary, shall be shared with the contractor by CDC. (Appendix)

2.3. 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 with the understanding these methods may be shared publicly.

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.

2.4. Results shall be submitted to CDC within 36 hours 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. The contractor shall notify CDC no less than 14 calendar days before QC/QA or sequencing protocol changes are implemented.

Task 3: Sequencing

3.1. The contractor shall conduct targeted sequencing on the first ten positive samples for each testing site. Once the ten positive samples at a site have been tested, the contractor shall test every fifth positive sample at the site up to a total of 30% of positive samples per site for the one-year period of performance.

The contractor shall conduct targeted sequencing on samples for genetic characterization of Measles virus including subclade identification, and other relevant genomic assessments as directed by CDC.

Sequencing shall include selected genomic regions. Sequencing methods shall be suitable for wastewater samples, accounting for genome fragmentation, high viral diversity, and low RNA abundance.

3.2. Sequencing shall be conducted using high-quality read instrumentation, such as Illumina, unless other machines are required in the future. Contractor shall provide metadata on the sample information and how the sequence data was generated. The PHA4GE (Pathogen-agnostic Harmonized-genomics-for-public-health surveillance) wastewater metadata template shall be submitted for the sequenced samples.

3.3 Raw sequence data and sample metadata shall be submitted to the National Center for Biotechnology Information (NCBI) and the CDC within ten days from receipt of sample unless otherwise directed by CDC. All raw human reads shall be removed prior to submission.

3.4. Sequence Data and Quality Assessment

The contractor(s) 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 to be approved by CDC, prior to submission of any raw sequences to NCBI.

3.4.1. CDC recognizes that multiple technologies may be used to accurately sequence infectious diseases and shall review protocols that use other quality and coverage standards.

3.4.2. 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.

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

3.4.3. 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. At least 90% of sequenced dPCR positive samples with a concentration above a threshold to be determined by the contractor’s validation spike-in studies in the first two months of the start of the Task 1 work, shall have 100% of the defined genomic regions covered at a minimum depth of 50×. Raw sequencing data submitted to CDC shall meet a minimum average base quality standard of Q30, or an equivalent platform-appropriate quality threshold, as documented in the contractor’s sequencing protocol and approved by CDC prior to implementation.

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

3.4.5. 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.

Task 4: 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. Primer additions: The contractor shall be able to incorporate additional primer pairs into amplification assays within a timeframe determined at the task level at the request of the CDC to enable rapid response to emerging mutations or additional targets.

4.1.2. 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

4.2.1. 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 and other laboratories 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.

Task 5: 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, display on contractor websites, 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. The Contractor shall cooperate with CDC if CDC determines it shall respond directly.

5.7.4. Safeguards: The Contractor shall implement administrative, physical, and technical safeguards to reasonably and appropriately protect samples and data and prevent unauthorized use or disclosure.

Safeguards may include encrypted storage, access control, staff training, and audit logging.

5.7.5. Unauthorized Use or Mis-Disclosure: If the Contractor becomes aware of any misuse or disclosure not permitted under this contract, the Contractor shall verbally notify CDC within twenty-four (24) hours and follow with a written report within three (3) business days detailing the event and any corrective actions. The Contractor shall provide any additional information as reasonably requested by CDC.

GOVERNMENT FURNISHED MATERIALS

CDC will provide a list of priority wastewater treatment facilities for enrollment. CDC will provide the NWSS data dictionary and data submission criteria. CDC will also provide written documentation that this work is part of the National Wastewater Surveillance System to support enrollment efforts.

DELIVERABLES/REPORTING SCHEDULE

Items

Related Task

Description

Quantity or No.

of Copies

Delivery Date

Deliver To

Kick off meeting

All funded contract tasks

Conference call 1 Within 10 days of contract award

COR and CO

Monthly status reports

All funded contract tasks

Word document 12 per task year

Within 10 days of the prior month

TM, COR

Weekly project meetings tasks

Weekly meeting with CDC contract management team

52 Weekly

TM, COR

Data submission template tasks

Example data file with format that will be used to submit all quantitative data

1 First 14 calendar days

Task Technical Team and TM

Data collection instrument tasks

Form used to collect sample and facility metadata from wastewater facilities days

Laboratory Protocol tasks

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

First 14 calendar days of award

Sequencing Protocols

All funded contract tasks

Complete and up-to-date written documentation of all sequencing process controls, quality assurance measures including positive and negative controls.

Sequencing metadata

All funded contract tasks

The PHA4GE (Pathogen-agnostic Harmonized-genomics-for-public-health surveillance) wastewater metadata template shall be submitted for the sequenced samples.

Per sequenced sample

First 14 calendar

Sequencing manifest tasks

Report including sequencing status for all samples, sample pooling, NCBI submission date and accession number

1 per week Upon start of sequencing.

Task Technical Team and TM

Testing performance report tasks

Report including QA/QC statistics, turnaround time, percent of samples requiring retest

Every two weeks

Upon start of testing.

Task Technical Team

Final report tasks

Report documenting satisfactory completion of all deliverables

1 At the end of each contract year.

TM, COR

SPECIAL CONSIDERATIONS

Information Security and Privacy

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification

(hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO.

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

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

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

i. Protect the:

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

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

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

ii. Categorize all information owned and/or collected/managed on behalf of CDC and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories.

Based on information provided by the ISSO, CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [X] Low [ ] Moderate [ ] High Integrity: [X] Low [ ] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High Overall Impact Level: [X] Low [ ] Moderate [ ] High

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

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

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

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

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

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

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

PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's PII.

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

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

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

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

i. Marked appropriately;

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

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

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

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

g. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by CDC or collected by the contractor on behalf of CDC must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any CDC records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

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

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

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

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

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

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

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

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

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

i. Comply with the HHS Standard for Encryption of Computing Devices and

Information to prevent unauthorized access to government information.

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

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

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current

FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

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

CSPO.

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

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable CDC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract.

Thereafter, the employees must complete CDC Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with CDC training policies.

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

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with CDC policy.

A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior

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

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing agency data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of

Compromise (IOCs) provided by CDC Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII)1, an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes

1 Memorandum is available at: https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf http://csrc.nist.gov/publications/ a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information (PII).2"

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

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

ii. All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with the current FIPS 140 validation certificate from the NIST CMVP.

iii. All contractors and subcontractors shall participate in regular training on how to identify and report a breach

iv. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send [CDC Component] approved notifications to affected individuals [insert CDC Component Specific timeline, process, and format].

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) [CDC Component inserted contact information should be cited here], COR, CO, CDC CPO (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC Component and CDC policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

Not include any sensitive information in the subject or body of any reporting e-mail; and

Encrypt sensitive information in attachments to email, media, etc.

vi. Comply with OMB M-17-12, Preparing for and Responding to a Breach of

Personally Identifiable Information, and CDC Component and CSPO privacy breach response policies when handling PII breaches.

2 Standard is available at: https://cdc.sharepoint.com/teams/OCIO-CSPO- PUBDOCS/Standards/CSPO%20Responding%20to%20Breaches%20of%20Personally%20Identifiable%20Informati on.pdf

vii. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation [CDC Component insert timeline if required].

viii. All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

ix. Cloud service providers shall use guidance provided in the FedRAMP Incident Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

x. Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the contractor or its subcontractor failed to provide adequate safeguards for PII.

5. Position Sensitivity Designations All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

The requiring activity representative, in conjunction with Personnel Security, shall use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

6. Homeland Security Presidential Directive (HSPD)-12 The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; CDC HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO 30 days prior to the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon the 30 days change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, CDC Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the CDC EPLC framework and methodology and in accordance with the CDC Office of Financial Resources (OFR) Contract Closeout Guide and HHS Closeout Guide:

Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within 15 days before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR.

Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with CDC policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the CDC Out-Processing Checklist (http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract within 15 days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 --…