A19 75D301-26-Q-79208.doc

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ

PAGE OF PAGES

1. REQUEST NO.

75D301-26-Q-79208

2. DATE ISSUED

08/17/2026

3. REQUISITION/PURCHASE REQUEST NO.

000HCRJB-2026-97469

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

OFR - Office of Acquisition Services

4770 Buford Highway

Atlanta GA 303413717

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

Iris Gonzalez

c. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

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 Request for Quotations (RFQ) is issued to obtain pricing for all labor, material and supplies required for the Market forecast analyses for West Nile virus in accordance with the Statement of Work herein.

This will be a Time and Materials contract.

Please email questions and quotes to:

CS: Iris Gonzalez at QSX8@CDC.GOV Deadline for questions: August 20, 2026, 10:00AM EST Deadline for quotes: August 26, 2026, 10:00AM EST

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NOTE: Additional provisions and representations

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

c. COUNTY

AREA CODE

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 18 (REV. 6-95)

Previous edition not usable

Prescribed by GSA

FAR (48 CFR) 53.215-1(a)

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

Base Period: 09/30/2026 - 09/29/2027

Market forecast analyses for West Nile virus ADB requires a subject matter expert (SME) in epidemiology, health economics and biopharmaceutical market analysis to conduct market forecast analysis for a West Nile Virus (WNV) vaccine and a WNV monoclonal antibody as outlines in the Statement of Work.

POP: 09/30/2026 - 09/29/2027

This is a Time and Materials Line Item.

This is a Severable Services Line

All travel must be in accordance with the

Federal Travel Regulations (FTR).

Contractor shall obtain COR preapproval of estimated travel expenses prior to occurrence. Charges will be submitted for actual costs as incurred. The contractor shall ensure that the requested travel costs shall not exceed the amount authorized in this task order.

POP: 09/30/2026 - 09/29/2027

Travel funds for contractors

Direct Reimburseable Line Item

Total:

B.1

Statement of Work

Title: Market forecast analyses for West Nile virus (WNV) vaccine and anti-WNV monoclonal antibody for prophylaxis

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) aims to prevent disease, disability, and death caused by a wide range of infectious diseases. NCEZID focuses on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people). NCEZID’s work is guided in part by a holistic "One Health" strategy, which recognizes the vital interconnectedness of microbes and the environment. Through a comprehensive approach involving many scientific disciplines, we can attain better health for humans and animals and improve our environment.

To carry out our mission, NCEZID uses many different tactics: providing leadership in public health, conducting exemplary science, strengthening preparedness efforts, establishing public health policy, sharing vital health information with the public, and building partnerships. Each of the center's seven divisions works with partners to protect and improve the public's health in the United States and worldwide.

This project supports the Division of Vector-Borne Diseases (DVBD). To achieve their mission to reduce illness and death due to vector-borne diseases (VBDs), DVBD carries out activities that align with the five goals of the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (Vector-Borne Diseases National Strategy):

Goal 1: Better understand when, where, and how people are exposed to and become sick or die from VBDs

Goal 2: Develop, evaluate, and improve tools, methods, and guidance to detect vector-borne pathogens and diagnose VBDs

Goal 3: Develop, evaluate, and improve tools, methods, and guidance to prevent and control VBDs

Goal 4: Develop and assess drugs and treatment strategies for VBDs

Goal 5: Disseminate and implement public health tools, programs, and collaborations to prevent, detect, diagnose, and respond to VBD threats

SECTION 2 – PURPOSE

The Contractor shall, as an independent organization and not as an agent of the Government, conduct two market forecast analyses, including for: 1) human West Nile virus (WNV) vaccine; and 2) anti-WNV monoclonal antibody (mAb) given as seasonal pre-exposure prophylaxis to prevent severe WNV disease.

SECTION 3 – SCOPE OF WORK

The contractor shall perform two market forecast analyses, one for a human WNV vaccine and one for an anti-WNV mAb given as pre-exposure prophylaxis seasonally to prevent severe WNV disease.

Each market forecast analysis will include use of demand and return on investment methodological approaches, a landscape assessment for currently available products (e.g., human WNV vaccine, anti-WNV mAb) in development, information from proxy vaccines and mAbs, Market Information for Access to Vaccines database, and interviews with key vaccine and mAb decision-makers.

Upon the conclusion of each analysis the contractor shall disseminate the findings to CDC and the scientific community through peer-reviewed publications.

SECTION 4 – TASKS TO BE PERFORMED

The contractor shall conduct a comprehensive set of activities to inform the completion of two separate market forecast analyses: one for a human WNV vaccine and one for an anti-WNV mAb intended for seasonal pre-exposure prophylaxis to prevent severe WNV disease. Tasks will include synthesis of epidemiologic data to characterize disease burden, geographic distribution, seasonality, and populations at higher risk for severe WNV disease. The contractor shall use available target product profiles or use otherwise available data to estimate characteristics of the vaccine and mAb to inform market forecast analyses, including number of doses, timing of administration, duration of immunity, total cost of the product, among other characteristics.

The contractor will assess the current standard of care, unmet medical need, and clinical development landscape; evaluate regulatory pathways and potential policy considerations; and conduct stakeholder analyses, including interviews or structured engagement with public health officials, clinicians, payers, and patient representatives. Demand forecasting models will be developed using demographic, epidemiologic, and coverage assumptions to estimate potential uptake under multiple scenarios.

In parallel, the contractor will perform commercial and access assessments for each product, including pricing benchmarks, reimbursement considerations, procurement pathways (e.g., public and private sector), distribution channels, and competitive landscape analyses. The work will include segmentation of target populations, evaluation of implementation considerations (e.g., integration with existing immunization or prophylaxis programs), and sensitivity analyses to assess key uncertainties. Findings will be synthesized into two standalone market analysis reports—one for the WNV vaccine and one for the WNV mAb—each providing evidence-based estimates of market size, adoption potential, and key risks and opportunities to inform strategic decision-making.

Technical Requirements

4.1 Market forecast analysis for human WNV vaccine

4.1.1 Use available target product profiles to inform the market forecast analysis Existing target product profiles will be reviewed and synthesized to define key assumptions regarding vaccine indications, efficacy, dosing regimen, and delivery characteristics that will underpin all subsequent market forecasting analyses.

4.1.2 Market launch and timing of introduction

The analysis will estimate expected timelines for regulatory approval, market entry, and geographic rollout, incorporating development pipelines, approval pathways, and country-specific introduction dynamics.

4.1.3 Target population forecast

A forecast of the eligible target population will be developed using epidemiological data, demographic trends, and risk stratification to estimate annual vaccine demand over the analysis period.

4.1.4 Private market coverage rate

Projected vaccination coverage within private markets will be estimated based on healthcare access, willingness to pay, provider practices, historical uptake patterns for comparable vaccines, and anticipated public market coverage.

4.1.5 Public market coverage rate

Public market coverage assumptions will be developed by analyzing national immunization programs, funding mechanisms, procurement strategies, and historical vaccination coverage benchmarks.

4.1.6 Vaccine presentation and cost

The analysis will assess vaccine presentation formats (e.g., single-dose vs. multi-dose vials) and associated cost implications, including manufacturing, cold chain, storage, and administration considerations.

4.1.7 Vaccine price

Pricing scenarios will be developed based on benchmarking against comparable vaccines, tiered pricing strategies, and anticipated variations across public and private markets.

4.1.8 Financial analysis

An investment return analysis will be completed regarding the development, commercialization, production, and distribution of a WNV vaccine. A comprehensive financial model will be constructed to estimate revenues, costs, and profitability under multiple scenarios, incorporating sensitivity analyses to reflect key uncertainties. The contractor shall include explicit declarations of assumptions made in the analyses; technical descriptions of models; parameter specifications and justifications for any analyses conducted or model used; and links to and/or availability of all data, literature cited, and code.

4.1.9 Publication of peer-reviewed manuscript

The contractor shall synthesize findings from the analysis into a manuscript suitable for peer-reviewed publication—including methodology, assumptions, results, and policy-relevant implications—and submit it to a mutually agreed-upon journal before the end of the period of performance, providing documentation of submission and responding to any peer-review comments received during that period.

4.2 Market forecast analysis for anti-WNV mAb used as pre-exposure prophylaxis

4.2.1 Use available target product profiles to inform the market forecast analysis Existing target product profiles will be reviewed and synthesized to define key assumptions regarding mAb indications, efficacy, dosing regimen, and delivery characteristics that will underpin all subsequent market forecasting analyses.

4.2.2 Market launch and timing of introduction

The analysis will estimate expected timelines for regulatory approval, market entry, and geographic rollout, incorporating development pipelines, approval pathways, and country-specific introduction dynamics.

4.2.3 Target population forecast

A forecast of the eligible target population will be developed using epidemiological data, pharmaceutical use data (e.g., patients prescribed B-cell depleting therapies), demographic trends, and risk stratification to estimate annual mAb demand over the analysis period.

4.2.4 Private market coverage rate

Projected mAb coverage within private markets will be estimated based on healthcare access, willingness to pay, provider practices, historical uptake patterns for comparable mAb products, and anticipated public market coverage.

4.2.5 Public market coverage rate

Public market coverage assumptions will be developed by analyzing public insurance programs, funding mechanisms, procurement strategies, and historical public market coverage for comparable mAb products.

4.2.6 mAb presentation and cost The analysis will assess mAb presentation formats (e.g., single injection, infusions, etc.) and associated cost implications, including manufacturing, cold chain, storage, and administration considerations.

4.2.7 mAb price Pricing scenarios will be developed based on benchmarking against comparable mAb products, tiered pricing strategies, and anticipated variations across public and private markets.

4.2.8 Financial analysis

An investment return analysis will be completed regarding the development, commercialization, production, and distribution of a mAb used for WNV pre-exposure prophylaxis. A comprehensive financial model will be constructed to estimate revenues, costs, and profitability under multiple scenarios, incorporating sensitivity analyses to reflect key uncertainties. The contractor shall include explicit declarations of assumptions made in the analyses; technical descriptions of models; parameter specifications and justifications for any analyses conducted or model used; and links to and/or availability of all data, literature cited, and code.

4.2.9 Publication of peer-reviewed manuscript

The contractor shall synthesize findings from the analysis into a manuscript suitable for peer-reviewed publication—including methodology, assumptions, results, and policy-relevant implications—and submit it to a mutually agreed-upon journal before the end of the period of performance, providing documentation of submission and responding to any peer-review comments received during that period.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

The Government will provide CDC subject matter-related and/or resources, if available and needed, that will be used for the market forecast analyses.

SECTION 6 – PERIOD OF PERFORMANCE

The period of performance shall be a period of 12 months from 9/30/2026 to 9/29/2027.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

The table below presents all required deliverables organized by project phase. Unless stated specifically, the deliverables apply to both the WNV vaccine market forecast analysis and the WNV mAb pre-exposure prophylaxis market forecast analysis. Dates are expressed relative to the contract Period of Performance start date (Day 1 = Date of Award).

PHASE 1: Project initiation and planning | Months 1–2

PHASE II: Market Research & Data Analysis | Months 3–5

PHASE III: Forecast Model Development | Months 6–8

PHASE IV: Scenario Analysis & Report Development | Months 9–10

PHASE V: Final Deliverables & Closeout | Months 11–12

SECTION 9 – TRAVEL

Travel is authorized for two trips (e.g., two travelers to attend one meeting, one traveler to two meetings) with prior government approval.

All travel must be in accordance with the Federal Travel Regulations (FTR). Contractor shall obtain COR preapproval of estimated travel expenses prior to occurrence. Charges will be submitted for actual costs as incurred. The contractor shall ensure that the requested travel costs shall not exceed the amount authorized in this task order.

SECTION 10 – PAYMENT TERMS

This contract is a time and materials contract with monthly invoicing.

SECTION 11 – REFERENCE MATERIALS

1. Gould CV, Staples JE, Guagliardo SAJ, Martin SW, Lyons S, Hills SL, Nett RJ, Petersen LR. West Nile virus: a review. JAMA. 2025;334(7):618-628. doi: 10.1001/jama.2025.8737.

2. Gould CV, Staples JE, Huang CY, Brault AC, Nett RJ. Combating West Nile virus disease — time to revisit vaccination. N Engl J Med. 2023;388(18):1633-1636. doi: 10.1056/NEJMp2301816.

3. Calvert AE, Miazgowicz KL, Atkinson B, Long AH, Thrasher E, Brault AC, Nett RJ. A scoping review of preclinical research on monoclonal antibody development for prophylaxis and treatment of West Nile virus infections. Viruses. 2025;17(6):845. doi: 10.3390/v17060845.

4. Nett RJ, Brault AC, Lambert AJ, Agnihothram S, Barrett ADT, Barzon L, Clements DE, Durbin A, Kretschmer M, Monath TP, Mura M, Pierson TC, Prutzman K, Slifka MK, Suthar MS, Whitehead SS, Staples JE. Summary of human West Nile virus vaccine meeting, 2024: Investigating barriers to development. Vaccine. 2025;68:127938. doi: 10.1016/j.vaccine.2025.127938.

5. Curren EJ, Shankar MB, Fischer M, Meltzer MI, Erin Staples J, Gould CV. Cost-effectiveness and impact of a targeted age- and incidence-based West Nile virus vaccine strategy. Clin Infect Dis. 2021;73(9):1565-1570. doi: 10.1093/cid/ciab540.

6. Shankar MB, Staples JE, Meltzer MI, Fischer M. Cost effectiveness of a targeted age-based West Nile virus vaccination program. Vaccine. 2017;35(23):3143-3151. doi: 10.1016/j.vaccine.2016.11.078.

7. Zohrabian A, Hayes EB, Petersen LR. Cost-effectiveness of West Nile virus vaccination. Emerg Infect Dis. 2006;12(3):375-80. doi: 10.3201/eid1203.050782.

SECTION 12 –INFORMATION SECURITY AND COMPLIANCE

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

1. Baseline Security Requirements

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

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

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

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

i. Protect the:

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

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

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

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

· Confidentiality:

[ x ] Low [ ] Moderate [ ] High

· Integrity:

[ x ] Low [ ] Moderate [ ] High

· Availability:

[ x ] Low [ ] Moderate [ ] High

· Overall Impact Level:

[ x ] Low [ ] Moderate [ ] High

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

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

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

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

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

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

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

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

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

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

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

i. Marked appropriately;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

2. Training Requirements

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

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

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

3. Rules of Behavior

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

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

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.

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:

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 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and CDC Policy for Records Management and HHS policies and must not dispose of any records unless authorized by CDC Program.

b. If a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with CDC policies.

10. High Value Asset (HVA):

If a system is identified as HVA, the contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the Department of Homeland Security (DHS) HVA Control Overlay[22] in addition to the above requirements.

11. Deliverables

Personnel Security Responsibilities

Off-boarding documentation, equipment and badge when leaving contract

Within 5 days or less after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Background Investigation

Certification of Sanitization of Government and Government Activity-

Related Files, Information, and Devices.

Standard-2 Requirements for Procurements Involving Privacy

Appropriate security controls and Rules of Behavior should be incorporated to protect the confidentiality of information, proprietary, sensitive, and Personally Identifiable…