RFQ-Attachment7_Additional Terms-Conditions.pdf

RFQ No. 75N95024Q00194 Additional Terms and Conditions

Request for Quotation No.: 75N95024Q00194 Title: Reference Clinical Laboratory Services for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) Study

ADDITIONAL TERMS AND CONDITIONS

Notwithstanding the requirements as described in the Request for Quotation (RFQ) and the described in the Statement of Work, the following are applicable to this requirement.

A. DELIVERY - PERIOD OF PERFORMANCE

The anticipated period of performance is July 24, 2024, through July 23, 2025, and will include four 4 additional Optional Periods as follows:

Base Period: July 24, 2024, thru July 23, 2025 Optional Period 1: July 24, 2025, thru July 23, 2026 Optional Period 2: July 24, 2026, thru July 23, 2027 Optional Period 3: July 24, 2027, thru July 23, 2028 Optional Period 4: July 24, 2028, thru July 23, 2029

B. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

TO BE SPECIFIED AT AWARD.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the contract.

The Government may unilaterally change its COR designation.

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C. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluations will be prepared Annually as follows on the anniversary award date of the contract.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

D. SPECIAL CONTRACT REQUIREMENTS

I - PRIVACY ACT

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals. The System of Records Notice (SORN) that is applicable to this contract is: 09-25-0200. The design, development, or operation work the Contractor is:

Clinical, Basic and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.

The SORN describing the types of information contained in the records, the legal authority for collecting and maintaining the records, how the records are used within HHS, and the purposes (referred to as "routine uses") for which HHS may disclose the records to non-HHS parties without the individual record subject's consent is found at: https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html.

The Contractor and any Subcontractor must follow disposition to be made of the Privacy Act records upon completion of contract performance shall be in accordance with agency policy, and by direction of the Contracting Officer/Contracting Officer Representative.

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II - HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or order (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) employee 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 technology containing data that supports the HHS 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/NIH 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 HHS/NIH 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, OpDiv SOP, 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 [ ] Moderate [X] High Availability: [ ] Low [ ] Moderate [X] High Overall Risk Level: [ ] Low [ ] Moderate [X] High javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','') 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

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 HHS/NIH 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 HHS/NIH 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 HHS/NIH security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/OpDiv 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. Based on information provided by the ISSO, system/ data owner, or other security or privacy representative, it has been determined that this solicitation/ contract involves:

[ ] No PII [X] 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 a full Privacy Impact Assessment (PIA) needs to be completed.

o 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 HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002.

o 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.

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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 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 HHS or collected by the contractor on behalf of HHS 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 HHS 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 and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

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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. 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, 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.

i. 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 assume HTTPS at all times 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 the HHS Policy for Internet and Email Security for additional information.

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

k. 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 HHS and NIH-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 within 15 days of the validation.

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v. Use the Key Management system on the HHS 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 the COR upon request and at the conclusion of the contract.

l. 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 OpDiv non-disclosure agreement, Contractor Non-Disclosure Agreement (nih.gov) 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 shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS 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 policy and the HHS Role- Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. Read further guidance about the NIH Role-based Training at: Security Awareness and Training | HHS.gov.

c. Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall 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 HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department 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 NIH Information Security Awareness Training. If the training is javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','') http://csrc.nist.gov/publications/ https://ocio.nih.gov/sites/external/files/2024-01/Nondisclosure04082020.pdf http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/ https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/security-awareness-training/index.html provided by the Contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per the defined timelines above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/NIH IRT teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as "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. In accordance with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII) , an incident is "an occurrence that

(1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

b. In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) must:

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

ii. NOT notify affected individuals unless instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor must send NIH approved notifications to affected individuals in accordance with https://wiki.ocio.nih.gov/wiki/index.php/US-CERT_Federal_Incident_Notification_Guidelines

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the OpDiv Incident Response Team (IRT) via email at IRT@mail.nih.gov , COR, CO, OpDiv SOP (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 OpDiv and HHS 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 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','') https://wiki.ocio.nih.gov/wiki/index.php/US-CERT_Federal_Incident_Notification_Guidelines https://wiki.ocio.nih.gov/wiki/index.php/US-CERT_Federal_Incident_Notification_Guidelines mailto:IRT@mail.nih.gov information, 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.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS/NIH and NIH privacy breach response policies when handling PII breaches.

vi. 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 within an hour of discovery.

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:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and "L" access eligibility.

[ ] Tier 3SR: Reinvestigation.

[ ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[X] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

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 HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','') https://www.dhs.gov/homeland-security-presidential-directive-12 https://www.dhs.gov/homeland-security-presidential-directive-12

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 within fourteen (14) calendar days of the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for Contractor use at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

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, HHS 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 HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Directive (2018) located at:

HHS-Closeout-Directive-2018.pdf (nih.gov). HHS EA requirements are located at: HHS Policy for Enterprise Architecture (EA) | HHS.gov and NIH EA requirements are located at: Enterprise Architecture | Office of the Chief Information Officer (nih.gov).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS 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 in accordance with the NIH Media Sanitization and Disposal Policy 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 fifteen days before an employee stop 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 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','') https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html https://ocio.nih.gov/enterprise-architecture https://ocio.nih.gov/enterprise-architecture 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 NIH policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the NIH Employee Separation Checklist Employee Separation Checklist (nih.gov) when an employee terminates work under this contract within 2 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 HHS Policy for Records Management and NIH policies and must not dispose of any records unless authorized by HHS/NIH.

b. In the event that 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 HHS/ NIH 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 DHS HVA Control Overlay in addition to the above requirements.

GOVERNMENT INFORMATION PROCESSED ON GOCO OR COCO SYSTEMS

1. SECURITY REQUIREMENTS FOR GOVERNMENT-OWNED/CONTRACTOR-OPERATED (GOCO) AND

CONTRACTOR-OWNED/CONTRACTOR-OPERATED (COCO) RESOURCES

a. Federal Policies- The Contractor (and/or any subcontractor) shall comply with applicable federal laws that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P), 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, Security and Privacy Controls for Federal 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 Departmental policies.

b. Government Access for Security Assessment - In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall 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 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','') https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, 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 HHS 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.

c. 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 HHS waiver process (approved by HHS CISO). The Contractor shall retire javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','') and/or upgrade all software/systems that have reached end-of-life in accordance with HHS End-of- Life Operating Systems, Software, and Applications Policy.

d. Desktops, Laptops, and Other Computing Devices Required for Use by the Contractor- The Contractor (and/or any subcontractor) shall ensure that all IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices, etc.) used to process information on behalf of HHS 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 and FIPS 140-3 encryption standards.

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

iii. Maintain the latest operating system patch release and anti-virus software definitions within 15 days.

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 HHS security policies, including but not limited to:

Configuring its systems to allow for periodic HHS vulnerability and security configuration assessment scanning; and Using Security Content Automation Protocol (SCAP)-validated tools with USGCB Scanner 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.

e. 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.

f. 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.

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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; and

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.

HARDWARE PROCUREMENTS

a. Card Readers- The Contractor (and/or any subcontractor) must include FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors | CSRC (nist.gov) 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 HHS data.

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.

E. ADDITIONAL CONTRACT PROVISIONS AND CLAUSES INCLUDED IN FULL TEXT

Notwithstanding the FAR/HHSAR provisions and clauses included in the RFQ by reference and the provisions and clauses provided in full text and attached to the RFQ, additional provisions and clauses are applicable to this acquisition and are hereby incorporated in full text.

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I - FEDERAL ACQUISITION REGULATION CLAUSES

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

1. FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

a. Definitions. As used in this clause--

"Covered contractor information system" means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

"Federal contract information" means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

"Information" means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

"Information system" means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C.

3502).

"Safeguarding" means measures or controls that are prescribed to protect information systems.

b. Safeguarding requirements and procedures.

1. The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

i. Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

ii. Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

iii. Verify and control/limit connections to and use of external information systems.

iv. Control information posted or processed on publicly accessible information systems.

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v. Identify information system users, processes acting on behalf of users, or devices.

vi. Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

vii. Sanitize or destroy information system media containing Federal Contract

Information before disposal or release for reuse.

viii. Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

ix. Escort visitors and monitor visitor activity; maintain audit logs of physical access;

and control and manage physical access devices.

x. Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

xi. Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

xii. Identify, report, and correct information and information system flaws in a timely manner.

xiii. Provide protection from malicious code at appropriate locations within organizational information systems.

xiv. Update malicious code protection mechanisms when new releases are available.

xv. Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

1. Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

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2. FAR 52.204-29 Federal Acquisition Supply Chain Security Act Orders—Representation and Disclosures (Dec 2023)

(a) Definitions. As used in this provision, Covered article, FASCSA order, Intelligence community, National security system, Reasonable inquiry, Sensitive compartmented information, Sensitive compartmented information system, and Source have the meaning provided in the clause 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition.

(b) Prohibition. Contractors are prohibited from providing or using as part of the performance of the contract any covered article, or any products or services produced or provided by a source, if the prohibition is set out in an applicable Federal Acquisition Supply Chain Security Act (FASCSA) order, as described in paragraph (b)(1) of FAR 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition.

(c) Procedures.

(1) The Offeror shall search for the phrase “FASCSA order” in the System for Award Management (SAM)( https://www.sam.gov) for any covered article, or any products or services produced or provided by a source, if there is an applicable FASCSA order described in paragraph (b)(1) of FAR 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition.

(2) The Offeror shall review the solicitation for any FASCSA orders that are not in SAM, but are effective and do apply to the solicitation and resultant contract (see FAR 4.2303(c)(2)).

(3) FASCSA orders issued after the date of solicitation do not apply unless added by an amendment to the solicitation.

(d) Representation. By submission of this offer, the offeror represents that it has conducted a reasonable inquiry, and that the offeror does not propose to provide or use in response to this…