A19. 75D301-26-Q-78781 Combined Synopis_Solicitation_CO Reviewed.pdf

Subject: Transmission Electron Microscope Service (TEM) Agreement - Infectious Diseases Pathology Branch (IDPB)

Solicitation Number: 75D301-26-Q-78781

ISSUANCE DATE: January 23, 2026

QUESTIONS DUE DATE/TIME: NLT Noon EST February 9, 2026

Response DUE Date/time: NLT 3:30PM EST February 10, 2026

Section A – Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.603, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

The solicitation number for this requirement is 75D301-26-Q-78781 and is hereby issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2025-06 dated August 27, 2025.

The associated North American Industrial Classification System (NAICS) code for this procurement is 811210 – Electronic and Precision Equipment Repair and Maintenance with a Standard Size of $34 million in annual revenue.

This is an RFQ to procure a service agreement that maintains the functionality of the transmission electron microscope used for diagnostics, case investigations, and research. The Government intends to award a single Firm-Fixed Price purchase order as a result of this solicitation that will include the terms and conditions that are set forth herein.

The provision at 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition. FAR 52.212-2, Evaluation-Commercial Items, is not included.

Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Items, with its offer or indicate if it is available online at SAM.gov. FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition; there are no addenda to the clause. FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and the additional FAR clauses cited in the clause that are applicable have been noted.

There are no additional contract requirement(s) or terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. No telephonic quotes will be processed. All responses must be received no later than the date stated above. Contact, Alyssa Thomas at ah78@cdc.gov, Contracting Specialist, for any questions regarding this solicitation. Questions must be submitted in writing; no telephonic questions permitted.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

CLIN 0001 will be funded at time of award.

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 TEM Service (Base) provide a service agreement to provide annual maintenance and calibration for the TEM to ensure that the equipment remains current, operational, and functional Custodial Account #: 91707 Firm Fixed Priced

Base Year:

PoP: 02/XX/2026 – 02/XX/2027

1 Job $

CLINs 1001, 2001, 3001, and 4001 are Optional Priced Line Items, as described in FAR 52.217-5. Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

https://www.acquisition.gov/far/part-17#FAR_17_206

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

Option Period 1 1001 TEM Service (OY1) provide a service agreement to provide annual maintenance and calibration for the TEM to ensure that the equipment remains current, operational, and functional Custodial Account #: 91707

Firm Fixed Priced

PoP: 02/XX/2027 – 02/XX/2028

1 Job $

Option Period 2 2001 TEM Service (OY2) provide a service agreement to provide annual maintenance and calibration for the TEM to ensure that the equipment remains current, operational, and functional Custodial Account #: 91707

Firm Fixed Priced

PoP: 02/XX/2028 – 02/XX/2029

1 Job $

Option Period 3 3001 TEM Service (OY3) provide a service agreement to provide annual maintenance and calibration for the TEM to ensure that the equipment remains current, operational, and functional Custodial Account #: 91707

Firm Fixed Priced

PoP: 02/XX/2029 – 02/XX/2030

1 Job $

Option Period 4 4001 TEM Service (OY2) provide a service agreement to provide annual maintenance and calibration for the TEM to ensure that the equipment remains current, operational, and functional Custodial Account #: 91707

Firm Fixed Priced

PoP: 02/XX/2030 – 02/XX/2031

1 Job $

SECTION C – PERFORMANCE WORK STATEMENT (PWS)

Title: Transmission Electron Microscope Service (TEM) Agreement – Infectious Diseases Pathology Branch

(IDPB)

Period of performance of this contract is: February XX, 2026 to February XX, 2031 Base Period: February XX, 2026 to February XX, 2027 Option Period One: February XX, 2027 to February XX, 2028 Option Period Two: February XX, 2028 to February XX, 2029 Option Period Three: February XX, 2029 to February XX, 2030 Option Period Four: February XX, 2030 to February XX, 2031

SECTION 1 – BACKGROUND

Investigating unexplained illnesses and deaths is a major part of IDPB's work, and the transmission electron microscope is a critical and valuable tool for these unique diagnostics, especially for cases with suspected infectious diseases. IDPB’s key functions include conducting electron microscopic evaluation of tissues from patients with confirmed or suspected infectious diseases, and providing support for investigations from which tissue samples might be obtained for laboratory evaluation. IDPB provides ultrastructure reference and diagnostic support to state and local health departments, other federal agencies, and national and international health organizations. IDPB develops, improves, evaluates, and applies ultrastructural technologies for detecting and visualizing microbial agents in tissue specimens and/or tissue culture. Additionally, IDPB provides electron microscopy evaluation of research and surveillance specimens for CDC. All of this work relies on the transmission electron microscope, which was purchased in fiscal year 2023 from Field Electon and Ion Company (FEI) under contract 75D30123P18201 and fully installed on the Centers for Disease Control and Prevention (CDC) campus in Atlanta, Georgia within the Electron Microscopy dedicated laboratory room in Laboratory Building 18 in fiscal year 2025.

SUBSECTION A – DEFINITIONS

CDC - Centers for Disease Control and Prevention FEI Company - Field Electon and Ion Company FFPE - Formalin Fixed Paraffin Embedded IDPB - Infectious Diseases Pathology Branch TEM - Transmission Electron Microscope

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this contract is to provide a service agreement that maintains the functionality of the transmission electron microscope used for diagnostics, case investigations, and research.

SECTION 3 – SCOPE OF WORK

Annual Service Maintenance contract including one in-person preventative maintenance (PM) service on the Transmission Electron Microscope for one year. Service includes PM, software updates and any needed troubleshooting to provide annual maintenance and calibration for the TEM to ensure the equipment remains current, operational, and functional for laboratory use.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: The contractor shall provide a standard equipment service agreement for the Thermo Fisher Talos L120C, SN: 9960670 (Transmission Electron Microscope) with a 48-hours response time that will include unlimited labor, travel and Original Equipment Manufactured (OEM) parts coverage to ensure that the equipment remains current, operational, and functional. Service/maintenance must be performed by an authorized personnel/engineer specially trained to maintain the TEM.

Task 2: The contractor shall provide software coverage, including updates and fixes to installed software.

Task 3: The contractor shall provide one scheduled preventive maintenance visit each year in accordance with an established maintenance schedule requested by the Government that will include labor, travel and parts coverage.

This visit will cover any repairs and adjustments arising from normal usage of the equipment and will use Original Equipment Manufactured (OEM) replacement or repair parts.

Task 4: The contractor shall provide targeted telephone support within 4-hours for repair and maintenance of the equipment during business hours, exclusive of Federal holidays.

Task 5: The contractor shall submit quarterly reports, identifying all work performed and any relevant details or findings. If no work was completed during the reporting period, the contractor shall state within the report.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

N/A

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Contract will be performed entirely at the Centers for Disease Control and Prevention (CDC), Roybal Campus, Laboratory Building 18, Atlanta, GA 30329.

SUBSECTION B – CONTRACT SUPPORT HOURS

Contractor support hours for service calls shall be Monday through Friday between 8:00AM and 5:00PM EST.

There is unlimited phone and email support.

SECTION 7 – TRAVEL

The contractor shall travel to CDC campus in Atlanta, GA to perform (1) scheduled preventative maintenance service per period of performance, and if needed, any potential unforseen repair services throughout the period of performance. Travel costs are already included in the contract and no formal modification will be required. Service Update Reports from any travel will be required per the Deliverable Schedule.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/Format Due Date Deliver To Quarterly Service Report

Report identifying the work performed and any noted details or findings.

Word or PDF Within 10 business days of the completed quarter

COR: Lisa Angel (vin3@cdc.gov) and PO: Hannah Bullock (ocr3@cdc.gov)

SECTION 9 – REFERENCE MATERIALS

N/A

SECTION 10 – MINIMUM CONTRACTOR QUALIFICATIONS

The contractor shall have successful experience providing service for Transmission Electron Microscopes, which is a highly sensitive and valuable piece of laboratory equipmentthe contractor.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy Security 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 mailto:vin3@cdc.gov mailto:ocr3@cdc.gov 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 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf 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 http://csrc.nist.gov/publications/ 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 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

1 Memorandum is available at: https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf 2 Standard is available at: https://cdc.sharepoint.com/teams/OCIO-CSPO- PUBDOCS/Standards/CSPO%20Responding%20to%20Breaches%20of%20Personally%20Identifiable%20Informati on.pdf

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 Deliverable Title/Deliverable Type

Description Due Date

Roster Roster Within 30 days of the effective date of this contract

Contractor Employee Non- Disclosure Agreement (NDA)

Contractor Employee Non- Disclosure Agreement (NDA)

Prior to performing any work on behalf of HHS http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf https://login.max.gov/cas/login?service=https%3A%2F%2Fcommunity.max.gov%2Flogin.action%3Fos_destination%3D%252Fpages%252Fviewpage.action%253FspaceKey%253DHHS%2526title%253DHHS%252BCyberSecurity%252BPolicy%252BCollaboration%252BPage

Privacy Threshold Analysis (PTA)/ Privacy Impact Assessment (PIA)

Assist in the completion of a PTA/PIA form

Within 60-90 days after contract award

Training Records Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Rules of Behavior Signed ROB for all employees Initiation of contract and at least annually thereafter

Incident Response Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Personnel Security Responsibilities

List of Personnel with defined roles and responsibilities

Within 7 days; that is before an employee begins working on this contract.

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

Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

Certification of Sanitization of Government and Government Activity- Related Files, Information, and Devices.

Form or deliverables required by

CDC

At contract expiration.

Contract Initiation and Expiration

If the procurement involves a system or cloud service, additional documentation will be required, such as Disposition/Decommission Plan

At contract expiration.

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 Information (PII) the Contractor may come in contact with during the performance of this contract.

Standard-5. Other IT Procurements

1. Hardware Procurements

a. Card Readers. The Contractor (and/or any subcontractor) must include Federal Information Processing

Standard (FIPS) 201-compliant smart card readers (referred to as LACS Transparent Readers) with the purchase of servers, printers, desktops, and laptops.

b. Mobile Devices. The contractor must follow NIST 800-124, Rev. 1, Guidelines for Managing the Security of Mobile Devices in the Enterprise and comply with Public Law 115-232 § 889, when purchasing mobile devices that process or store CDC data.

2. Non-Commercial and Open-Source Computer Software Procurements The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by the United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP) that will limit system software vulnerability exploits. The contractor will be liable for malicious or defective code or failure to reduce risk.

3. Information Technology Application Design, Development, or Support

a. The Contractor (and/or any subcontractor) must ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

https://www.idmanagement.gov/approved-products-list-pacs-products/ https://www.idmanagement.gov/approved-products-list-pacs-products/

b. The contractor must consult the guidelines from NIST SP 800-160 volume 1, Systems Security Engineering: Considerations for a Multidisciplinary Approach in the Engineering of Trustworthy Secure Systems, NIST SP 800-160 volume 2, Systems Security Engineering: Considerations for a Multidisciplinary Approach in the Engineering of Trustworthy Secure Systems, and NIST SP 800-53 to implement security during the development of all applications and throughout the life cycle stages of software development.

c. The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards, the Open Web Application Security Project (OWASP), System Admin, Audit, Network and Security (SANS), HHS Policy for Software Development Secure Coding Practices and CDC Secure Software Development Standard that will limit system software vulnerability exploits.

d. The Contractor (and/or any subcontractor) must ensure that computer software developed on behalf of CDC or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor must test applicable products and versions with all relevant and current updates and patches updated prior to installing in the CDC environment. No sensitive data must be used during software testing.

e. The contractor must, at a minimum, segregate physically or logically, all test and development systems from production systems as applicable in accordance with the HHS Standard for Segregation of Dev/Test Environments from Production.

f. The Contractor (and/or any subcontractor) must protect information that is deemed sensitive from unauthorized disclosure to persons, organizations or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by CDC must be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

4. Physical Access to Government Controlled Facilities (NOTE: For procurements involving physical access to government facilities, selected language from Appendix B:

Standards may apply. This includes, but not limited to security awareness, incident response, and HSPD-12. Consult with the CDC Component Information Systems Security Officer (ISSO), CDC CPO, and other relevant stakeholders to select applicable language.)

Additionally, due to the COVID-19 Epidemic of 2020 (Effective as of March 30, 2020), The below contract language must be included in all COVID-19 contract actions until such time the CDC Director makes a determination to issue rated contracts related to items used for allowing CDC employees/contractors to physically use and/or operate in CDC facilities and spaces.

"CDC reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System."

1. Deliverables Deliverable Title Description Due Date

Other IT Procurements (Non- Commercial and Open-Source Computer Software Procurements)

Computer software, including the source code.

Prior to performing any work on behalf of HHS

Standard-6: Installation and Servicing of Equipment Contractor shall scan all media (CDs, DVDs, portable hard drives, thumb drives, etc.) used for upgrading and installing the the contractor’s software/firmware with antivirus software that has the latest virus signatures. The scans shall occur before using the media in a CDC computer/device and when moving the media between CDC computers/devices.

If in the performance of this contract, the contractor must replace an information storage device (hard drive, non-volatile flash memory module, etc.) or service equipment offsite, the contractor must remove the information storage device(s) from the equipment and provide it to CDC to be either destroyed or erased. The contractor shall not bring off-site any part of the equipment they are servicing that contains CDC data.

Human Subjects Protections in Research DOES NOT INCLUDE activities or tasks that meet the definition of research

Paperwork Reduction Act (PRA) PRA does not apply

Section 508 and Accessibility Requirements Part A – Provision Reference HHSAR 352.239-73[8] Electronic Information and [Communication] Technology Accessibility Notice.

[(Deviation)] [(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the Template are available at https://www.section508.gov/.

(e) Additionally, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(End of provision)] Part B - Clause 352.239-74[9] Electronic, Information, and Communication Technology Accessibility.

[(Deviation)]

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services, or support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R.