SOW corrected.pdf

RFQ 75F40124Q00407 corrected

FDA Cloud Interconnect Services and Support

Statement of Work (corrected)

July 2024

Version 4.0

Statement of Work (SOW)

FDA Cloud Interconnect Services and Support Version Date: July 25, 2024

1. Background In Fiscal Year 2019, the Office of Digital Transformation (ODT) Division of Infrastructure Operations

(DIO) entered into a five-year contract with Equinix Incorporated to acquire 2 EA 10Gbps Interconnect

Circuits, associated equipment, rack space, power, and associated technical support required to host the circuits at their DC 1 and DC 3 Data Center Platforms located in Ashburn, VA.

ODT currently uses Equinix Fabric to connect the FDA White Oak Datacenter (WODC) and Ashburn

Datacenter (ADC) to multiple CSPs, including AWS (US East & Gov West), Azure for Government.

ODT leases rack space from Equinix in their DC1 & DC3 datacenters in Ashburn, VA, and has an ODT owned and operated Cisco router in each location. Equinix provides 10G Ethernet Private Line (EPL) circuits from DC1 to ADC, and DC3 to WODC, which ODT secures using MACSEC end-to-end encrypted cross connects between the ODT DC1/DC3 racks, and the nearest AWS Direct Connect interconnection points in Equinix DC2/DC11.

ODT uses an AWS Public VIF, and multiple IPSEC VPN tunnels for encrypted connections to the CSPs via the 10G Equinix Fabric service at both DC1 & DC3.

2. Purpose The purpose of this contract is to acquire continued access to secure, high‐speed direct connections at or above 10 Gbps from the FDA on-premises to the Cloud Service Providers (CSPs) via of an

Interconnect Service Provider (ICSP).

3. Objectives This contract shall allow ODT / DIO to achieve the following objectives:

• Fulfill security controls for the AWS GovCloud to operate under FISMA high categorization;

FISMA high categorization requires high availability (HA), and HA is one of the benefits of the

Interconnect Service.

• Increase network performance and reduce latency issues between the FDA network and CSPs;

the Interconnect Service enables real‐time access to cloud resources and services.

• Provide increased network bandwidth needed to migrate large applications and to transfer large data sets from FDA on‐premises data centers to the cloud in high speed.

• Provide secure connections to the CSPs which comply with all Federal cloud computing regulations and security standards that are specified in Section 3.1; improve security by bypassing the public internet with a direct connection to the CSPs.

• Support the monitoring and inspection of cloud traffic between the FDA network and the CSPs.

• Increase communication reliability since faster data transfers with high‐speed connections are less vulnerable to system timeouts.

• Facilitate diverse location high speed direct and simultaneous connections to multiple CSPs.

• Minimize resources required to acquire, implement, and manage individual connections from the FDA to each CSP.

• Extend the FDA network infrastructure footprint with greater reach and flexibility to manage network resources in the ICSP infrastructure facilities/data centers.

• Increase security and performance through direct connections that are more secure and reliable and have lower latency than public internet connections.

4. Technical Constraints

• The ICSP shall allow an unlimited number of incidents tickets to be submitted to resolve/troubleshoot issues and to provide technical support and guidance.

• The ICSP shall not restrict the number of FDA staff named as authorized contacts to initiate support calls.

• The ICSP shall not restrict the number of FDA staff named to have physical access to the government furnished equipment installed in secured enclosure.

• The ICSP shall provide access to on‐line technical documentation and self‐help resources such as knowledge bases and analysis tools.

• Vendor interconnection solution must provide for redundancy along diverse fiber paths (if applicable).

• Vendor solution shall support the existing Equinix Datacenter & Fabric solution until it can be fully migrated to the new MACSEC or alternate interconnection solution.

• The ICSP infrastructure facilities/data centers (if applicable) shall comply with the following security standards: FISMA high, NIST 800/53, SOC 1 Type II, SOC 2 Type II, ISO 27001, HIPAA, and PCI DSS.

• The ICSP infrastructure shall support fault tolerant operations across cloud environments and

FDA’s Data Centers (WODC and ADC). In case of system failure in one CSP/Data Center, the system shall support failover to the second CSP/Data Center.

• PCI DSS – All US IBX Data Centers shall be compliant with the latest version of PCI DSS.

• ISO 27001 Certification

• HIPAA Compliant

• LEED Certification -

• The ICSP shall support HA by allowing two or more redundant 10 or more Gbps uplink connections from FDA Data Centers (ADC and WODC) to the ICSP’s infrastructure.

• The ICSP infrastructure shall be compatible and able to integrate with FDA network equipment that will be hosted/installed in their facilities. The network equipment includes Cisco ASR 1000 series routers, Cisco Catalyst switches and/or the most up to date Cisco router models.

• The ICSP vendor shall not impose a limit (data cap) on the amount of data transferred at a specified level of throughput over a given time period or throttle the data transfer rate.

• The ICSP shall allow multiple layers of encryption to meet Federal guidelines for secure data communications.

• Ethernet Private Line (EPL) Circuits shall support:

o QinQ Trunking (802.1ad) o Jumbo Frame Support

5. General Requirements

5.1 10 Gbps Interconnect Circuits The contractor shall provide access to 2 EA 10 Gbps interconnect network circuits without interruption in service. FDA currently has 2 EA 10 Gbps Interconnect circuits leased by Equinix Incorporated. The technology of the current interconnect circuits is Wavelength Ethernet Private Lines (EPL). The circuits are considered “Local” and currently connect to Cloud Service Providers (CSP) locations – AWS

GovCloud US‐ East (Ohio), AWS GovCloud US‐West (Oregon), and AWS US East (Northern Virginia), Azure for Government. Currently FDA has virtual circuit access via 1 unlimited port via Equinix Cloud

Fabric but intends to potentially purchase additional Single-mode Cross-Connects to replace the unlimited port access in the future. The first circuit originates from the FDA Ashburn Data Center (ADC) and interconnects at Equinix DC1 in Ashburn, VA. The second circuit originates at FDA White Oak Data

Center (WODC) and interconnects at Equinix DC3 in Ashburn, VA.

5.2 Equinix DC1 and DC3 Cabinets, Ports, Space, Single Mode Fiber Cross Connects, and Power

FDA currently has Government Furnished Equipment (GFE), “Secure Cabinets” installed at Equinix’s DC1 and DC3 Data Centers to support the 10 Gbps interconnect circuits. FDA pays a monthly fee for the cabinet space and power at each Data Center. It is anticipated the current cabinets and power will support any future increases in bandwidth. Both DC1 and DC3 have virtual circuit access via 1 unlimited port. Equinix’s port access is not an end-to-end MACsec enabled solution. In the future, the FDA reserves the unilateral right to replace the Equinix Fabric with multiple Single Fiber Cross Connects to achieve MACsec compliance (see the Optional Line Item section).

To support the Secure Cabinets currently installed a Equinix Data Centers:

• DC1 has a minimum power requirement of 3 kVA.

• DC3 has a minimum power requirement of 2.4 kVA.

5.3 Technical Support

The contractor shall provide 24/7 technical support of FDA’s 10 Gbps DC1 and DC3 Interconnect Circuits. This includes but is not limited to the following:

• Provide 24/7 technical support 365 days a year at FDA origination sites, Equinix DC1 and DC3 data centers, and cloud service provider termination locations.

• Provide online access to the Equinix Customer Portal all-day, every day to place incident tickets, report problems and / or obtain SmartHands support at any time of the day or night.

• Provide a technical support Point of Contact name, phone number, and email.

• Test and troubleshoot configurations to ensure connection and circuit meets Quality of Service

(QoS) standards.

• Work with FDA network engineers to perform end‐to‐end connectivity testing to verify operability from the FDA data centers to the CSP.

• Conduct testing of peering metrics (i.e., RDP, Ping and Traceroute, and file transfers) to an accessible service such as AWS S3.

• Conduct route table examination on FDA provided edge equipment and the CSP to verify expected routes.

• Provide content and recommendations for troubleshooting guides for FDA operational support technicians.

• Perform technology upgrades, maintenance releases, patches, and bug fixes on their infrastructure facilities/data centers to comply with Federal and FDA technology and security standards.

• Smart Hands Technical Support – The FDA will purchase up to 24 hours of dedicated Equinix

Support or equal to. SmartHands or equal to support shall include a range of services by a highly trained International Business Exchange (IBX) data center staff to include but not limited to complex installations, configurations, and troubleshooting services. Incident tickets may be placed by an authorized FDA personnel that has received written authorization from the COR or

COR supervisor via email to place a request for SmartHands support. The contractor must submit an incident report within 1 business day that details SmartHand services provided, hours billed, and actions taken to resolve the issue. Other administrative detail on the incident report shall include:

o The time and date the services were ordered;

o The FDA Technical Point of Contact (POC) that requested services to include name / phone / and email;

o The IBX Personnel POC information to include name / phone / and email;

o The time and date the issue was resolved.

At no time during an active POP shall the contractor provide or bill for more than 24-hours of

SmartHands service annually. The contractor may only invoice for hours reported in incident reports and accepted by the COR.

5.4 Optional Line Item(s)

5.4.1 Optional Line Item - Increased Bandwidth:

The contractor shall provide additional pricing for increased bandwidth in the Option Periods as follows (inclusive of deinstall fees, 1 time install fees, and new secure cabinets (if applicable)).

• Increased Bandwidth Option 1: 10Gbps to 20 Gbps

• Increased Bandwidth Option 2: 10Gbps to 40 Gbps

• Increased Bandwidth Option 3: 10Gbps to 100 Gbps

Pricing for optional line items to increase bandwidth shall separately price out 1x de-install fees, Service Related Equipment (SRE) fees, and 1 x non-recurring install fees for new equipment (if applicable).

The Government may process a unilateral modification to increase Bandwidth at the FFP identified in the contract at any time during the POP with the intent of decommissioning the lower bandwidth circuit once the new circuit is activated. Once the lower bandwidth is deactivated the vendor will cease charging the monthly fee for that circuit. The Optional Period amounts will be adjusted to reflect the changes in price.

5.4.2 Optional Line Item: Single Mode Fiber Cross Connects

The FDA is investigating alternative solutions to the current Equinix Fabric Virtual Circuit Access via an Unlimited Port to a networks technology that supports end-to-end MACsec encryption. FDA intends to review alternative solutions in the future and will reduce this feature in the Option Period once the viable technology is identified, purchased, and implemented. The FDA reserves the right to unilateral remove the Unlimited Port feature at the negotiated Firm Fixed Unit Price during any

Option Period exercise. The Option Period amount will be adjusted accordingly.

5.5 Service Level Agreements (SLAs)

The contractor shall ensure the Active Circuits and Technical Support are within the following Service

Level Agreements (SLAs):

• Ensure ICSP data centers, infrastructure, technologies, circuits, and services have an average minimum uptime of 99.999%.

• Contractor shall respond within 1-hour of an incident ticket being placed.

• The contractor shall provide on-site support within 4-hours.

• The contractor shall replace failed equipment at the DC1 and DC3 Equinix Data Centers within 4-hours of the equipment failure.

6. Deliverables The ICSP vendor shall provide the deliverables in the format, delivery mechanism, and by the completion date specified in the following table:

Deliverabl e

Description Qty Format and Delivery Mechanism

1 DC1 10Gbps Circuit

1 EA Notification to the COR that the Circuit is activated effective 09/02/2024

2 DC1 Port for up to 2- 4 Cloud Service Providers or Unlimited

2-4 CSPs or Unlimited

Notification to the COR that the Ports to CSPs are active

3 DC1 Secure Cabinet Space and Power

2.4 kVa

1 EA Notification to the COR that GFE is currently functional and connected to FDA circuits

4 Single Mode Fiber Cross-Connect

1 EA Notification to COR via email that the Single Mode Fiber Cross Connects are available effective 09/02/2024

5 DC3 10Gbps Circuit Notification to the COR that the Circuit is activated effective 09/02/2024

6 DC3 Port for up to 2- 4 Cloud Service Providers or Unlimited

Notification to the COR that the Ports to CSPs are active

7 DC3 Secure Cabinet Space and Power

3.0 kVa

Notification to the COR that GFE is currently functional and connected to FDA circuits

8 DC3 Single Mode Fiber Cross- Connect

Notification to COR via email that the Single Mode Fiber Cross Connects are available effective 09/02/2024

9 SmartHands Technical Support

– up to 24 hours annually

The contractor shall provide an incident report to the COR within 1- business day of an authorized request for SmartHands Services.

10 Option Line Item:

Additional Single- Mode Fiber Cross- Connects up to 10

EA

FDA may order up to 10 EA Single Mode Cross Connects at the FFP unit price identified in the contract.

11 DC1: Optional Line Item for Increased Bandwidth – 20 Gbps Configuration

Circuit must be delivered within 60-days of a unilateral modification ordering the circuit.

12 DC1: Optional Line Item for Increased Bandwidth 40 Gbps

Circuit must be delivered within 60-days of a unilateral modification ordering the circuit.

13 DC1: Optional Line Item for Increased Bandwidth 100 Gbps

Circuit must be delivered within 60-days of a unilateral modification ordering the circuit.

14 DC3: Optional Line Item for Increased Bandwidth – 20 Gbps Configuration

Circuit must be delivered within 60-days of a unilateral modification ordering the circuit.

15 DC3: Optional Line Item for Increased Bandwidth 40 Gbps

Circuit must be delivered within 60-days of a unilateral modification ordering the circuit.

16 Optional Line Item for Increased Bandwidth 100 Gbps

Circuit must be delivered within 60-days of a unilateral modification ordering the circuit.

17 Develop monthly status report

Frequenc y 12 Months

10th of each month delivers Monthly Status Report (MSR) to COR

18 Submit monthly financial report in eSTARS

Frequenc y 12 Months

5th of each month delivers to COR

Monthly Status Report

The Contractor shall submit a Monthly Status Report (MSR) to the COR on the 10th of each month for the prior month’s work. If the 10th falls on a non-working day the MSR shall be due the next business day after the 10th. The Contractor shall obtain approval from the COR before using the MSR format. The MSR shall cover all work completed during the preceding month and shall describe the work to be accomplished during the subsequent month. This report shall also identify any issues/problems identified and a statement explaining how the issue/problem was resolved. The Contractor shall not wait until the Weekly Status Meeting, MFR, or MSR to notify the COR of any identified or anticipated issues/problems. The MSR shall include the following information on tasks within this SOW:

• Work completed during each billing period

• Changes or updates to the Project Management Plan to include changes to project schedules for each activity (if applicable)

• Problems or issues that may impact successful contract performance and risk mitigation strategies taken

• List of change requests submitted during the billing period and issue resolution process

• List of Data Calls for the month and actions taken

• Action Items - which includes personnel to whom the Actions Items are assigned, date assigned, due date, and status (i.e., open, closed) by task

• Planned Activities for the next (month) reporting period by task

• Running total of sprints completed, along with the sprint #, month of the sprint, and the velocity for each sprint. For example, and for the purposes of this Task Order, the velocity should be constant as it represents the workload capacity of the Contractor.

• Organization chart that lists the task order team members, their roles, and their management, noting Key Personnel with an asterisk

Monthly Financial Report

The Contractor shall submit Monthly Financial Report (MFR) in eSTARS and inform the COR before the 5th of each month for the prior month’s work. If the 5th falls on a non-working day, the MFR shall be due to next business day after the 5th. The Contractor shall obtain approval from the COR before using the MFR format and enter data in eSTARS. The MFR shall include the following information on tasks within this SOW:

• For T&M and Labor Hour Service tasks - Resources (contractors’ names and their labor categories) assigned to each project/task, level of effort expended per resource on activities for the billing period, and amount billed per resource against the obligated amount.

• For Firm Fixed Price (FFP) tasks – Amount billed for the billing period.

7. Government-Furnished Equipment (GFE) This section identifies GFE provided to support FDA’s 2 EA 10Gbps Interconnect Circuits.

FDA currently has GFE – “Secure Cabinets” at Equinix Data Centers DC1 and DC3. FDA intends to rent space at the Equinix Data Centers for the Secured Cabinets currently installed at each location.

The FDA will acquire outside of this contract any network equipment required to increase bandwidth in the outyears. This may include the following equipment:

• Routers/switches to be hosted the ICSP data centers.

• New Cabinets for increased bandwidth

• Upgraded Firewalls

8. Place of Performance

Originating Circuit Locations FDA Ashburn Datacenter (ADC) 44480 Hastings Dr Ashburn, VA 20147

FDA White Oak Datacenter (WODC) 10903 New Hampshire Ave

WO2-0053

Silver Spring, MD 20903

Equinix Data Center Interconnect Locations Interconnect Location for FDA’s ADC 10Gbps:

Equinix DC1 21711 Filigree Court Ashburn, VA 20147

Interconnect Location for FDA’s WODC 10Gbps:

Equinix DC3 44470 Chilum Place Ashburn, VA 20147

9. Period of Performance The Period of Performance of the contract will include a 12‐month Base Year and Four (4) 12‐month

Option Years.

Years Start End

Base Year

September 2, September 1, 2025

Option Period 1

September 2, September 1, 2026

Option Period 2

September 2, September 1, 2027

Option Period 3

September 2, September 1, 2028

Option Period 4

September 2, September 1, 2029

10. Inspection and Acceptance The Contracting Officer Representative (COR) shall perform inspection and acceptance of the

Interconnect Services, support, and deliverables specified in Sections 3, 1, and 6. Inspection and

Acceptance will primarily be based on the performance, timely delivery, and meeting the requirements within the POP or established completion dates.

The acceptance criteria for the Interconnect Services and support are the requirements specified in

Section 3 must be fulfilled. The acceptance criteria for the deliverables is they must be reviewed, approved, completed, and delivered to the COR in the format by the completion date specified in Table

2: Deliverables in Section 6. The Government will provide written notification of rejection within four (4) hours of receipt. The Government will reject non‐conforming services and deliverables. The Contractor shall correct any deficiencies within three (3) calendar days when the Government issues the rejection notices. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within one (1) business days.

11. Security and Privacy Requirements

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

2) 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.

a. 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 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.

3) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• 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.

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA 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 the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

4) Information Security Categorization. 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, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

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

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[ X ] No PII [ ] Yes PII

5) Controlled Unclassified Information (CUI). CUI is defined 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. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need‐To‐Know basis;

c. protected in accordance with NIST SP 800‐53, Security and Privacy

Controls for Federal 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

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed.

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800‐88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer‐Related Storage Media.

6) 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) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M‐06‐16, Protection of

Sensitive Agency Information by securing it with a FIPS 140‐2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall 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 shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall 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.

802.1 x Requirements

Any system requiring wired or wireless connectivity to the FDA Enterprise network shall support the Institute of Electrical and Electronics Engineers (IEEE) 802.1X protocol and shall provide 802.1x authentication “supplicant” software. All systems shall support X.509 Public Key Infrastructure (PKI) and accept FDA issued device certificates as a method of authentication. If the system does not support the 802.1X protocol, a waiver will be required to document and justify the exemption with the Information System Security Officer (ISSO), and the FDA system owner shall provide a device MAC (Media Access Control) address identifying the end point network device and its associated role the device will perform when connected to the FDA network. (e.g. Printer, Scientific Instrument, Telephone)

The following Extensible Authentication Protocols (EAP) Methods are supported under 802.1x for wired access, EAP-TLS, EAP-PEAP, and EAP-TTLS. All Government Systems connected via wireless shall use EAP-TLS as defined by National Institute of Standards and Technology (NIST) Special Publication 800-53

- AC-18(1) - Wireless Access – (Authentication and Encryption).

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

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

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

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

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M‐05‐22, Transition Planning for

Internet Protocol Version 6 (IPv6).

8) 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 shall 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, the HTTPS is not required, but it is highly recommended.

9) Contract Documentation. The Contractor shall use FDA‐provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

10) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

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

b. 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 FIPS 140‐2 validated encryption solution.

c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non‐public FDA information should utilize FDA‐ provided or FDA information security authorized devices that meet HHS and FDA‐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).

d. Verify that the encryption solutions in use are compliant with FIPS 140‐2.

The Contractor shall provide a written copy of the validation documentation to the COR.

e. 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. Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract.

Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

11) Contractor Non‐Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non‐public government information under this contract shall complete the FDA non‐disclosure agreement (3398 Form), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

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

The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M‐03‐22, Guidance for Implementing the Privacy Provisions of the E‐ Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /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.

B. Training

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

2) 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 and FDA policy and FDA Role‐Based Training (RBT) of Personnel with

Significant Security Responsibilities Standard Operating Procedures

(SOP).

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA 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.

C. Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology

General Rules of Behavior.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA 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 FDA 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.

D. Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA SMC /Incident Response Team (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.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as 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. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

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

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract to avoid a secondary sensitive information incident with FIPS 140‐2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting

Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send FDA approved notifications to affected individuals as directed by FDA’s SOP.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, including incidents 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 of discovery/detection, and consistent with the applicable FDA 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 information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

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

b. not include any sensitive information in the subject or body of any reporting e‐mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M‐17‐12, Preparing for and Responding to a Breach of Personally Identifiable Information and HHS and FDA incident response policies when handling PII breaches.

5) 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 demand.

E. 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 I and Tier 2

F. Homeland Security Presidential Directive (HSPD)‐12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)‐12, Policy for a Common Identification Standard for Federal Employees and Contractors;

OMB M‐05‐24; FIPS 201, Personal Identity Verification (PIV) of Federal

Employees and Contractors; HHS HSPD‐12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. The Contractor (and/or any subcontractor) shall 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 and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes. 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 shall provide a position description and the Government will determine the appropriate suitability level.

G. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall 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 shall follow the FDA EPLC framework and methodology in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here:

https://www.hhs.gov/ocio/ea/documents/proplans.html

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800‐64, Security Considerations in the

System Development Life Cycle, 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.

http://www.hhs.gov/ocio/ea/documents/proplans.html

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with FDA OAGS SMGs 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 and FDA IS2P

Appendix T: Sanitization of Computer‐Related Storage Media

4) Notification. The Contractor (and/or any subcontractor) shall notify the

CO and/or COR as soon as it is known that an employee will stop working under this contract.

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall 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 shall 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 FDA policies.

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, coping the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartur eSystem/de fault.htm as soon as it is known that an employee will terminate work under this contract within days of the employee’s exit from the contract.

All documentation shall be made available to the CO and/or COR upon request.

H. Records Management and Retention The Contractor (and/or any subcontractor) shall 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/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

12. Contractor-Owned/Contractor-Operated Security Requirements

A. Security Requirements for GOCO and COCO Resources

1) Federal Policies. The Contractor (and/or any subcontractor) shall comply with applicable federal laws that include, but are not limited to, the FDA 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.

2) Security Assessment and Authorization (SA&A). A valid authorization 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) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s). The Contractor shall conduct the SA&A requirements in accordance with FDA IS2P, NIST SP 800‐ 37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, FDA must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

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

a. SA&A Package Deliverables ‐ The Contractor (and/or any subcontractor) shall provide an SA&A package within a timeline directed by the COR, per to FDA EPLC process, to the CO and/or

COR. The following SA&A deliverables are required to complete the SA&A package:

• System Security Plan (SSP) – due a week prior to the start of the annual security assessment. The SSP shall 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 Federal 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 HHS and FDA policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor’s bid or quotation that resulted in the award of this contract. The SSP shall 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 shall update the SSP at least annually thereafter. Security Assessment Plan/Report (SAP/SAR) – due before the system is made available to standard users. The security assessment shall be conducted by FDA’s team of security assessors, unless otherwise noted and be consistent with NIST SP 800‐53A, NIST SP 800‐30, and HHS and FDA policies.

The assessor will document the assessment results in the SAR.

• Independent Assessment – This shall be coordinated through the FDA Information Security program.

• POA&M – due as part of the SAR. The POA&Ms shall be documented consistent with the HHS and FDA Standard for Plan of Action and Milestones and FDA policies. All high‐risk weaknesses must be mitigated within 30 and all medium weaknesses must be mitigated within [60 from the date the weaknesses are formally identified and documented. FDA’s assessors will determine the risk rating of vulnerabilities.

Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as noted in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, FDA may require designated POA&M 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 – due before the start of the annual security assessment. 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 and FDA policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall 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 shall update and test the Contingency Plan at least annually.

• E‐Authentication Questionnaire – The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E‐Authentication Threshold Analysis (E‐Auth TA) is completed to determine if a full E‐Authentication Risk Assessment (E‐Auth RA) is necessary. System documentation developed for a system using E‐ Auth TA/E‐Auth RA methods shall follow OMB 04‐04 and NIST SP 800‐63 Digital Identity Guidelines document suite.

Based on the level of assurance determined by the E‐Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system,…