SOW_0514 Smart Mfg demo line v4-1.docx

Statement of Work Modeling, simulation and demonstration capabilities to facilitate evaluation of smart design and manufacturing processes for shortage mitigation and supply chain resilience

United States Food and Drug Administration (FDA) Office of Counterterrorism and Emerging Threats (OCET)

Background As part of its regulatory science mission, The FDA Office of Counterterrorism and Emerging Threats (OCET) is tasked with supporting the development of safe and effective medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear agents and emerging threats, such as threats posed by the SARS-CoV-2 virus. This mission space includes preparing the agency to evaluate and foster use of new technologies that can help increase supply chain resilience and improve shortage mitigation. The COVID-19 pandemic has exemplified the possibility that existing manufacturing supply chains and infrastructures can be disrupted by severe events, something that has also been demonstrated in the aftermath of hurricanes in recent years. This can and has elevated risks to public health and created shortages in the U.S.

To that end, there is a critical question about how advanced design and manufacturing technologies can increase US manufacturing capacity, increase supply chain resilience, or decrease time to market for medical diagnostics, therapies, and vaccines that are needed for public health emergency response. Moreover, smart and digital manufacturing technologies can help retrofit older manufacturing equipment to enable improvements in quality, efficiency, and reduce supply chain uncertainty. These solutions can also include automation, optimizing design and manufacturing computational modeling, and digital monitoring and analysis of production. Applicable across the industries regulated by FDA, the Agency needs experience with and understanding of the processes and technologies to provide appropriate guidance to industry, develop the regulatory science to evaluate incoming submissions, and prepare for the potentially disruptive changes to design and production norms. The FDA could become a stumbling block to implementing these technologies without increased experience, communication, and clarity.

An advanced digital design and manufacturing line from Siemens Industry Software Inc. (Siemens) was designed for use at a federal public private partnership called MxD was identified to meet FDA needs for a digital design and manufacturing platform for research and training. Their system is already designed, built, and operational. It includes both physical and virtual manufacturing lines along with simulations and optimization use cases. This demonstration line is a functional manufacturing process assembled with hardware from multiple vendors, tied together with control and automation systems by Siemens and other automation vendors. It is also duplicated in virtual space with a “digital twin”. This system can replicate digital uses cases similar to those provided by Siemens as part of a previous award to the Center for Devices and Radiological Health (CDRH). In that project (FDA-RFQ-1230746), CDRH commissioned several computational modeling and simulation for several device-related use cases. This proposal would leverage the work done in those use cases and the experience gained by CDRH. It expands the research and training opportunities with a broader set of computational functions and access to a working miniature manufacturing line installed in an FDA Innovation laboratory.

Objectives Acquire a complete, digitally-enabled design and manufacturing platform capable of demonstrating and recreating use cases across medical products areas with simulation and modeling paired with physical (hardware) demonstration capabilities. A physical production line that can demonstrate digital integration, automation, and the ability of manufacturers to rapidly convert a manufacturing line to address a pandemic threat (e.g. ventilator part production) is an ideal use case. Modeling and simulation software, training, and services should demonstrate and allow FDA to research the full range of capabilities available to modern manufacturers who adopt digital design and manufacturing processes.

Tasks Areas CAPABILITIES: The following capabilities are required for the new Digital enterprise, SMART automated manufacturing demonstration line, demonstrating flexible production of medical products, (Demonstration line) to be used in the FDA Laboratory for Advancing Science and Public Health (FLASH).

Task 1: Provide a complete miniature digital enterprise manufacturing demonstration line for ventilator parts construction and assembly. To include:

a. Conveyor system

i. Manual part inspection and rework station

ii. Manual part assembly station

iii. Automated Conveyor movement based on manufacturing execution system (MES) inputs

iv. Options for automated/robot assembly in future

v. Proven and flexible hardware that can be molded to fit a wide variety of stories

vi. Premade cartons to move parts around the conveyor

vii. Interaction with the system via preconfigures human-machine interfaces (HMI’s)

b. Availability of 3D printable parts in the complete assembly

c. Testing and monitoring

i. Detailed textual and visual instructions for guided testing and assembly instructions

ii. Radiofrequency Identification (RFID) sensors to gather data from on container content

iii. Barcode scanner to collect unique data on specific parts

iv. Photoelectric sensors to collect detailed position data

v. Multiple Emergency Stops to allow hard stops of the system from a variety of locations

vi. Light curtain for safety division between equipment and operators

vii. View real time hardware data via preconfigured HMI

d. Computing and data

i. If applicable, local computational resources, storage, and network interfacing for short term storage of production data and long-term processing to a networked storage device

ii. Computing systems to control conveyor, inspection, and assembly processes

iii. Data capture capabilities for - agreed upon use cases related to production

iv. All control software to set and monitor production on the demonstration line.

v. Interfacing software to transfer and maintain a database of production data.

vi. Preset settings for running a standard production cycle of the demonstration line.

Task 2: Digital manufacturing and Software requirements

a. Digital twin of manufacturing line, replicating physical production in digital space

i. Simulates full production of the demonstration line (including manual and automated steps)

ii. Collects data to replay production runs from physical demonstration line

iii. Allows modifications to digital production to optimize physical demonstration line

iv. Analyzes production for efficiency, waste, and other performance factors

v. Allow feedback from production data to a design optimization element

b. Software – The unit should include all software required to run and maintain the digital twin, perform modeling for product and process design, modeling and simulation for manufacturing and its associated processes as well as analytics. Software capabilities should include:

i. Computer aided design modeling, exploration, and optimization

ii. Product and service lifecycle management

iii. Closed loop manufacturing quality

iv. Design control and risk management

v. Design aid (CAD) and Multiphysics simulation

vi. Generative design processes

vii. Model based enterprise (includes Model Based Systems Engineering and Model Based Quality)

viii. MES, Device History Records and documentation

ix. Quality and Compliance

x. Plant and Process simulation

xi. Supplier collaboration

Task 3: Training and demonstration optimization

a. Flexible training program for multiple teams

i. On Demand virtual training on software for “power” and “frequent” users of the system

ii. Demonstrations and training in the developed use cases

iii. Team-specified training in specialty areas related to FDA research needs.

iv. Specified number of hours of technical and operational support for the system

b. Optimization of product line and simulations to effectively demonstrate state-of-the-art manufacturing

i. Consultation with FDA to continue development of use cases

ii. Modification of existing use cases to meet public health needs.

Task 4: Shipping, Installation and setup

a. Total shipping costs

b. Riggers and technicians (e.g. electrical, mechanical, automation) to deliver and install the hardware. FDA responsibility includes electrical drop and air feed at conveyor’s final destination and any certifications required to perform work (ex: operating fork lift).

c. Software installation and support interactions with the Office of Information Management and Technology

Task 5: Software certification and documentation

a. An IT Project Manager who will organize documentation and tasks for integration into FDA systems

b. Completion of software assessments (e.g. Authorization to Operation)

Task 6: Service and Maintenance

a. Support

i. Technical support for physical demonstration line - On-site maintenance and repair for programmable logic controller (PLC) code related – up to 3 one-week services in 1st year

ii. 1 year of licensing on all subscription software products

iii. 1 year of updates and service on perpetually licensed software products

iv. Virtual technical support sessions

v. Same day availability for virtual technical support

b. Warranty and preventive maintenance schedule

i. Onsite maintenance and repair

ii. Included service calls for preventive maintenance

iii. No warranty on conveyor hardware parts or assembly components. Hardware is provided “AS IS” without warranty of any kind.

iv. Renewable annually

Task 7 (Optional): Managed Cloud Services

a. If software will be housed and accessed from a cloud service such as FedRAMP approved AWS

i. Provision of all cloud services necessary to use the system described above

ii. Maintenance and management of licenses, user accounts, and FDA access portal

b. Managed services and maintenance for up to 4 years (option years)

Key Personnel The contractor shall provide the following as key personnel to assure completion of this task:

Role: Information Technology Project Manager

Deliverables Format of Deliverables Software deliverables and data will be provided in the appropriate format for the digital tools outlined in the acquisition. Final format of deliverables will be mutually agreed upon prior to completion of the period of performance.

Deliverables Submission Procedure The Contractor shall submit all deliverables and documentation of completed tasks to the FDA COR/TPOC, unless otherwise stated. The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives.

All deliverables shall be developed using Microsoft Office products that are compatible with the versions currently utilized by the FDA (i.e., Office 2016). Daily, weekly, interim, informal, and working-copy products shall be provided by email upon request by the Technical Point of Contact (TPOC) designated herein.

Summary of Deliverables The contractor shall ensure the accuracy and completeness of all deliverables as described in this section. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction by the Contractor at no additional cost to the Government. Unless specified otherwise, the TPOC will review and approve all deliverables, which may require multiple revisions prior to being finalized.

Inspection and Acceptance The COR, as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services and products provided by the Contractor, and performing final inspection and acceptance of all deliverables.

The Government will closely monitor the Contractor’s performance in terms of accuracy, quality and timeliness of deliverables, and responsiveness to requests.

The COR may inform the Contractor of any rejections verbally, electronically, or in writing. Unless otherwise noted, the COR will accept or reject deliverables within fourteen (14) workdays.

Contract Type This is a Time and Materials and Firm Fixed Price Contract.

Period of Performance One year from the date of award.

Government Points of Contact Contracting Officer (CO):

Name: Steven Gagnon Email Address: Steven.Gagnon@fda.hhs.gov

Contract Specialist:

Name: Peter Lee Email Address: Peter.Lee@fda.hhs.gov

Contracting Officer’s Representative (COR):

Name: Christopher Le Telephone Number: 240‐402‐9239 Email Address: Christopher.Le@fda.hhs.gov

Technical Point of Contact (TPOC) Name: James Coburn Telephone Number: 301-796-0286 Email Address: James.Coburn@fda.hhs.gov

Contracting Officer's Authority The Contracting Officer (CO) identified in this SOW has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the government in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the CO shall be interpreted as modifying the terms and conditions of this BPA. It is the contractor’s responsibility to contact the CO immediately if there appears to be any technical direction that is, or may be, outside the scope of the contract. The government will not reimburse the contractor for any work not authorized by the CO including work outside the scope of the contract.

Contractor Performance Evaluation During the life of the order, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be accessed at https://www.cpars.gov/index.htm.

Procurements Requiring Information Security and/or Physical Access Security 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:

a. 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.

b. 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.

2) 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.

3) 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:

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

Personally Identifiable Information (PII). Per the OMB Circular A-130, “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.

PII Confidentiality Impact Level has been determined to be: [X] Low [ ] Moderate [ ] High

4) 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.

5) 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.

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).

6) 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).

7) 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.

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

9) 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.

10) 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.

11) 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, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “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: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

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 shall be submitted within a timeline as directed by the COR and/or CO. 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 FDA EPLC Project documentation, located here: http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.aspx HHS EA requirements may be located here: https://www.hhs.gov/about/agencies/asa/ocio/index.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.

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, copying 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/eDepartDepartureSystem/default.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

1. 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.

2. 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.

Three-Way Matching Invoice Instruction The below instructions included in this task order supersede the ones in the Article G.7, Invoice Submission, of the base contact:

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Office of Financial Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

a. list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

b. total amount of all payments received to date under the subject contract or order

c. and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the contract/order award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address or phone number provided above in Section A.

(Amend as necessary) INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE REQUIREMENTS SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND 52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER. SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

FAR / HHSAR Clauses

FAR Clauses The below Federal Acquisition Regulation (FAR) Clauses apply. FAR Clauses can be viewed in full text at: https://www.acquisition.gov/far/part-52

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204–23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab or Other Covered Entities (Jul 2018) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020) 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.217-8 Option to Extend Services (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at any time within the period of performance.

(End of clause)

HHSAR Clauses The below Health and Human Services Acquisition Regulation (HHSAR) Clauses apply. HHSAR Clauses can be viewed in full text at: http://www.hhs.gov/policies/hhsar/subpart352.html