Statement of Work.docx

Statement of Work / Performance Work Statement Title: Annual Maintenance Agreement for Peak Scientific Nitrogen Gas Generators

Period of performance of this contract is: September 10, 2026 to September 09, 2030 Base Period: September 10, 2026 to September 09, 2027 Option Period One: September 10, 2027 to September 09, 2028 Option Period Two: September 10, 2028 to September 09, 2029 Option Period Three: September 10, 2029 to September 09, 2030

SECTION 1 – BACKGROUND

The Biotechnology Core Facility Branch (BCFB) within the Division of Core Laboratory Services and Response (DCLSR) is a service core for CDC researchers. The mission of BCFB is to provide various analytical services to CDC. Within the branch, there are three teams – DNA synthesis, Peptide Synthesis, and Proteomics – which use mass spectrometer systems for proteomics analysis and analytical quality control (QC) of the branches synthetic products. The branch maintains several kinds of mass spectrometers which perform various QC and analytical roles. A critical support piece of equipment for the mass spectrometers is nitrogen gas generators. Currently, BCFB maintains two nitrogen gas generators. Two Peak Scientific Genius XE35 are operated as a bank and support multiple systems including the Thermo Scientific Lumos Orbitrap, the Bruker timsTOF Pro, and the Pacific Bioscience Sequel II. This acquisition is for the maintenance contract for both of the Peak Scientific Genius XE35 units.

SUBSECTION A – DEFINITIONS

BCFB –Biotechnology Core Facility Branch DCLSR – Division of Core Laboratory Services and Response nanoLC – nanoliter per minute flow liquid chromatograph QMS – Quality Management System QC – Quality Control

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this procurement is to obtain an equipment maintenance agreement for the two Peak Scientific Genius XE35 nitrogen gas generators used within BCFB to support mass spectrometers and DNA sequencers.

SECTION 3 – SCOPE OF WORK

The contractor will provide a Complete Plan 48/72 Service Plan (SL3a-Teir-NA) support service for the following systems:

SECTION 4 – TASKS TO BE PERFORMED

1. Provide equipment maintenance of

2. Provide on-site service visits with a maximum 48-hour response

3. Provide unlimited parts for any service

4. Includes Engineer labor and travel

5. Provide priority status for technical support inquiries

6. Conduct one Scheduled Preventative Maintenance visit

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

No Government Furnished Materials

SECTION 6 – PERIOD OF PERFORMANCE

Period of Performance is September 10, 2026 to September 09, 2030.

Optional Periods of Performance:

Option Period One: September 10, 2027 to September 09, 2028 Option Period Two: September 10, 2028 to September 09, 2029 Option Period Three: September 10, 2029 to September 09, 2030

SUBSECTION A – PLACE OF PERFORMANCE

Performance for this contract will be entirely onsite, within the United States, at the Centers for Disease Control and Prevention, Roybal Campus, 1600 Clifton Rd., NE, Bldg 23, 12th Floor.

SUBSECTION B – CONTRACT SUPPORT HOURS

Contract support hours will be scheduled during normal business hours of the Biotechnology Core Facility Branch, Monday-Friday, 6:30 a.m. – 5:30 p.m. EST, depending on the business hours of the laboratory receiving the services.

SECTION 7 – TRAVEL

Government funded travel is not applicable to this contract.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

SECTION 9 – REFERENCE MATERIALS

Not applicable

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

Technician shall be vendor certified on instrument(s) being serviced.

SECTION 11 – ADDITIONAL REQUIREMENTS

Not applicable

Information Security and Privacy

1. Baseline Security Requirements:

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

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 CDC 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 System Security and Privacy Officer (previously referred to as 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: [ ] Low [ X ] Moderate [ ] High

· Availability: [ X] Low [ ] Moderate [ ] High

· Overall Impact Level: [ ] Low [ X ] Moderate [ ] High

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

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

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

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

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable CDC Component 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 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 timeline specified in CDC Assessment and Authorization (A&A) Standard Operating Procedure 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. According to the CDC Web policy, all CDC web content must reside on a CDC.gov domain and must be hosted on CDC or CDC-authorized information systems .

k. Contract Documentation. The Contractor must use CDC-provided templates, policies, forms, and other agency documents 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 CDC and CDC-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. 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 Information 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 the 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)29, 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).30"

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-approved notifications to affected individuals in accordance with CDC privacy breach response policies, including the CDC/OCIO Standard for Responding to Breaches of Personally Identifiable Information (PII).

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) at csirt@cdc.gov or telephone at 1-866-655-2245, 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 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.

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.

· Not Applicable X Level 1: Non-sensitive

· Level 2: Non-critical Sensitive

· Level 3: Critical Sensitive

· Level 4: Special Sensitive

· Level 5: Public Trust/Moderate Risk

· Level 6: Public Trust/High Risk

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; HHS/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 by the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon 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 Security and Privacy Officer (previously referred to as ISSO) 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 HHS and/or CDC policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the CDC Out-Processing Checklist when an employee terminates work under this 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 Records Management Policy and must not dispose of any records unless authorized by CDC.

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 in addition to the above requirements.

11. Security Requirements for GOCO and COCO Resources:

a. Federal Policies. The Contractor (and/or any subcontractor) must comply with applicable federal laws, directives and CDC policies that include, but are not limited to, HHS Information Security and Privacy Policy (IS2P), the CDC IT Security Program Implementation Standards, Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, latest revision, Security and Privacy Controls for Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and agency policies.

b. Security Assessment and Authorization (SA&A). A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO prior to any use of the system in a production capacity, i.e., its intended users able to collect, store, process or transmit data to fulfill the system’s function. The Contractor must conduct the SA&A requirements in accordance with HHS IS2P/CDC IT Security Program implementation standard and Appendix K: CDC Organizationally Defined Minimum Numbers and Time Periods Derived from NIST SP 800-53 Revision 5 , NIST SP 800-37, Guide for Applying the Risk Management Framework to Information Systems: A Security Life Cycle Approach (latest revision), NIST SP 800-53B, Control Baselines for Information Systems and Organizations, and the NIST SP 800-53A (latest revision).

CDC acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

i. SA&A Package Deliverables - The Contractor (and/or any subcontractor) must provide an SA&A package timeline, process, and formats prescribed for a Full system authorization in the CDC Security Assessment and Authorization Standard Operating Procedure (CDC SA&A SOP). The following SA&A deliverables are required to complete the SA&A package:

· Baseline System Information (BSI) – The Contractor will document a system overview, in accordance with the timeline, process and formats described in the CDC SA&A SOP. The BSI will include information concerning: system identification and ownership; system data, information types, impact levels and system categorization; system functional description / general purpose; system authorization boundary and environment; system user descriptions; and system interconnections and dependencies. The Contractor shall update the BSI at least annually thereafter.

· Privacy Threshold Analysis / Privacy Impact Analysis – The Contractor (and/or any subcontractor) shall provide a PTA/PIA (as appropriate), in accordance with the timeline, process and formats described in the CDC SA&A SOP, if applicable. Also see the sections of this contract concerning “Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)” and “Requirements for Procurements Involving Privacy Act Records.” NOTE: If social security numbers (SSN) are expected to be handled by the system, the program and Contractor must include an SSN Elimination or Usage Approval Request along with the PTA/PIA. That request will be processed in accordance with the CSPO Standard for Limiting the Use of Social Security Numbers in CDC Information Systems.

· System Security Plan (SSP) – due in accordance with the timeline prescribed in the CDC A&A SOP. The SSP must comply with the NIST SP 800- 18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as CDC policies and other guidance. The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor must review and update the SSP at least annually thereafter and if requested, provide a copy of the updated SSP.

· Risk Assessment Report (RAR)- The initial security assessment shall be conducted by the Contractor in conjunction with the program’s Information System Security Officer, consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and CDC policies. The assessor will document and submit the assessment results in the RAR, in accordance with the process and formats described in the CDC SA&A SOP. The Contractor shall address all “High” deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M) for CDC CSPO approval in accordance with the CDC SA&A SOP. Thereafter, the Contractor, in coordination with CDC, shall conduct an assessment of the security controls and update the RAR within 365 days.

· POA&M - The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and CDC policies. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the Security or Risk Assessment Report (SAR/RAR), shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, CDC may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

· Contingency Plan and Contingency Plan Test - The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS/CDC policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, must test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor must update and test the Contingency Plan at least annually.

· E-Authentication Assessment - The Contractor (and/or any subcontractor) must collaborate with government personnel to ensure that the E- Authentication requirements are implemented in accordance with OMB 04- 04 and NIST SP 800-63-3, NIST SP 800-63A, NIST SP 800-63B, and NIST SP 800-63C . Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with CDC CSPO Standard for Electronic Authentication (E- Authentication), and the CDC SA&A SOP.

ii. Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)- owned/operated systems that input, store, process, output, and/or transmit government information, must meet, or exceed, the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, HHS ISCM Strategy, and CDC IT Security Program implementation standard and Appendix K: CDC Organizationally Defined Minimum Numbers and Time Periods Derived from NIST SP 800-53 Revision 5.

iii. Annual Assessment/Penetration (Pen) Test - Assess the system security and privacy controls (or ensure an assessment of the controls is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (this involves penetration testing conducted by the agency or independent third-party In addition, review all relevant SA&A documentation (SSP, POA&M, Contingency Plan, etc.) and provide updates by specified due date.

iv. Asset Management - Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing CDC- owned information/data. It is anticipated that this inventory information will be required to be produced at least annually. IT asset inventory information must include IP address, machine name, operating system level, security patch level, and SCAP-compliant format information. The Contractor must maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools in accordance with the HHS Policy for Information Technology Asset Management (ITAM) and any other applicable HHS/CDC policy.

v. Configuration Management - Use available SCAP-compliant automated tools as per NIST IR 7511 and CDC Organizationally-Defined Minimum Numbers and Time Periods Derived from NIST SP 800-53, to scan all IT assets, including but not limited to: computers, servers, routers, databases, operating systems, application, etc., that store and process government information. Provide scan reports to CDC upon request. The Contractor must maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

vi. Vulnerability Management - Contractors must actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with CDC Policy for Vulnerability Management. Automated tools must be compliant with NIST-specified SCAP standards for vulnerability identification and management. The Contractor must maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least annually.

vii. Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and agency specified timeframes per CSPO Vulnerability Remediation Framework Standard.

viii. Secure Coding - Follow the HHS Policy for Software Development Secure Coding Practices and the CDC Secure Software Development Standard for secure coding best practice requirements, as directed by 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.

ix. Boundary Protection - The Contractor must ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities is routed through a Trusted Internet Connection (TIC).

c. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) must afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of CDC, including but are not limited to:

i. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract.

The Government includes but is not limited to the U.S. Department of Justice, U.S. Government Accountability Office, and the CDC Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

ii. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the Contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

· Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited. Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information.

· Cooperate with inspections, audits, investigations, and reviews.

d. End of Life Compliance. The Contractor (and/or any subcontractor) must use Commercial off the Shelf (COTS) software or other software that is supported by the manufacturer. In addition, the COTS/other software need to be within one major version of the current version; deviation from this requirement will only be allowed via the CDC waiver process (approved by CDC CISO). The Contractor must retire and/or upgrade all software/systems that have reached end-of-life in accordance with HHS End of Life Operating Systems, Software and Application Policy.

e. Desktops, Laptops, and Other Computing Devices Required for Use by the Contractor. The Contractor (and/or any subcontractor) must ensure that all IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices, etc.) used to process information on behalf of CDC are deployed and operated in accordance with approved security configurations and meet the following minimum requirements:

i. Encrypt equipment and sensitive information stored and/or processed by such equipment in accordance with HHS/CDC encryption standard and current FIPS 140 validation certificate from the NIST CMVP;

ii. Configure laptops and desktops in accordance with the latest applicable United States Government Configuration Baseline (USGCB) and HHS Minimum Security Configuration Standards33;

iii. Maintain the latest operating system patch release and anti-virus software definitions;

iv. Validate the configuration settings after hardware and software installation, operation, maintenance, update, and patching and ensure changes in hardware and software do not alter the approved configuration settings; and

v. Automate configuration settings and configuration management in accordance with CDC security policies, including but not limited to:

· Configuring its systems to allow for periodic CDC vulnerability and security configuration assessment scanning; and

· Using Security Content Automation Protocol (SCAP)-validated tools with capabilities to scan its systems at least on a monthly basis and report the results of these scans to the CO and/or COR, Project Officer, and any other applicable designated POC.

f. Change Management. Once a system is authorized, all changes must be approved by CDC in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations; the HHS IS2P; and the timeline, process and formats prescribed in the CDC CSPO Change Management Standard Operating Procedure.

g. Retirement / Decommissioning. When the CDC program and Contractor determine the system is no longer required, it must be decommissioned in accordance with NIST SP 800- 88, Guidelines for Media Sanitization; the HHS IS2P; and the timeline, process and formats prescribed in the CDC CSPO System Retirement Standard Operating Procedure.34

h. Rights to Data. All contracts that require data to be produced, furnished, acquired, or used in meeting contract performance requirements, must contain terms that delineate the respective rights and obligations of the Government and the Contractor regarding the use, reproduction, and disclosure of that data. Data rights clauses do not specify the type, quantity or quality of data that is to be delivered, but only the respective rights of the Government and the Contractor regarding the use, disclosure, or reproduction of the data. Accordingly, the contract must specify the data to be delivered.

i. Information and Communications Technology (ICT) Cybersecurity Supply Chain Risk Management (C-SCRM) requirements. The Contractor (and/or any subcontractor) must secure their ICT supply chain in compliance with HHS Policy for Cyber Supply Chain Risk Management and Public Law 115-232 § 889. At a minimum, they must implement the following:

i. Develop rules for suppliers' development methods, techniques, or practices;

ii. Use of secondary market components;

iii. Prohibit counterfeit products;

iv. Dispose and/or retain elements such as components, data, or intellectual property securely;

v. Ensure adequate supply of components;

vi. Require external providers handling federal information or operating systems on behalf of the federal government to meet the same security and privacy requirements as federal agencies;

vii. Require external providers to express security and privacy requirements (including the controls for systems processing, storing, or transmitting federal information) in contracts or other formal agreements;

viii. Establish Service Level Agreements (SLAs), patching vehicles and disclosure requirements in the case of a security incident or new vulnerability being discovered;

ix. Ensure that the supplier applies same contractual requirements to any sub- contractors/suppliers that they involve in the provision of the product or service to the customer; and,

x. Prohibit the use of covered telecommunications and video surveillance equipment or services.

Human Subjects Protections in Research Not applicable

Paperwork Reduction Act (PRA) Not applicable

Section 508 Compliance Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have…