SOW for new Task Order O_M and GSRS for precisionFDA.docx

DRAFT

DRAFT

IDIQ 75F40119D10041

Task Order SOW PrecisionFDA O&M for Licensing and GSRS precisionFDA precisionFDA

Task Order: PrecisionFDA O&M for Licensing and GSRS Statement of Work (SOW) FDA Office of Health Informatics

1.

Background The Food and Drug Administration (FDA) plays an integral role in precision medicine initiatives, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. To this end, the FDA is developing the tools, standards, and approaches needed to ensure that genomic tests provide reliable and accurate genetic results. This effort is one part of the FDA's commitment to leverage external resources and expertise to advance regulatory science, the science that is essential for product development and evaluation and which underpins the FDA’s regulatory decision-making.

As part of the FDA’s effort to enable innovation in genomic testing, FDA is developing precisionFDA, an open-source, cloud-based regulatory science research space in which community members can share data, ideas and methods that advance the use of next generation sequencing (NGS) technology. PrecisionFDA provides the community with a research and development system that will enable researchers and developers to test, pilot, and validate existing and new bioinformatics approaches for processing NGS data. NGS test developers, researchers, and other members of the community can share and cross-validate bioinformatics pipelines and results against reference materials that are provided on the precisionFDA system.

2. Objectives By completing each task of this Statement of Work (SOW), the FDA will procure:

· The maintenance and continued evolution of the online, cloud-based, high-performance computing FedRAMP moderate secure environment where large datasets can be hosted, managed, shared, and analyzed, as well as the custom, customer facing precisionFDA portal.

· Technologies for the FDA to build and sustain a community of internal FDA scientists and regulators with omics support and a forum to engage with FDA scientists and regulators in areas of evolving science.

· A cadre of tools, applications, and gold standard data as well as a virtual lab environment for collaboration, interactive regulatory review, and scientific exploration.

· Support for the PRISM Project, a research collaboration between FDA (CBER, CDER and ODT) and Industry exploring collaborative regulatory review on precisionFDA to understand opportunities and benefits of a regulatory cloud platform where collaborative and interactive regulatory submission and review can occur.

3. Scope The scope of this task order is the design, development, installation, integration, and testing of operations and maintenance of the precisionFDA system, support for the PRISM Project, support for GSRS Portal enhancements, and the maintenance for the existing operational system including capabilities delivered as part of Increments A, B, C, D, and E, as well as all other Task Orders under this IDIQ.

4. Capabilities and Requirements The FDA requires the next production version of precisionFDA that meets the following capabilities and requirements:

4.1. Platform Characteristics

The Contractor shall provide a cloud-based omics platform for precisionFDA that meets the following salient characteristics:

· Maintains a Federal Risk and Authorization Management Program (FedRAMP) Moderate authorization for a cloud-based Platform as a Service (PaaS)

· Facilitates private collaborations related to the tools and techniques used to analyze large datasets

· Provides capabilities to analyze omics data and test relevant tools and provides a library of reference data and comparative tools

· Provides a framework to facilitate omics scientific community challenges that advances NGS technologies.

4.2. precisionFDA Capabilities The Contractor shall ensure that their solution meets the set of capabilities agreed to with the CCB.

4.3. Security Requirements

The Contractor shall ensure that any part of the solution that uses cloud services continues to meet a FedRAMP moderate authorization. The contractor shall ensure that the overall precisionFDA system continues to achieve a Federal Information Security Management Act (FISMA) moderate certification. See Section 6.1 for detailed security requirements.

4.4. Service Level Agreements

The contractor shall meet the following service level agreements:

· Releases - No unexpected deprecation or modification of existing functionality with any new release. Monthly releases will include standard maintenance for existing features, plus new features as agreed upon in the Change Control Board (CCB). Additional hotfixes may be released to correct errors or temporarily disable functionality if requested by an FDA stakeholder.

· Project management – Within 30 days past the start of a new contract, the DNAnexus Project Manager will create and distribute a project schedule. The Project Manager will provide regular updates to the schedule and provide at least 30 days' notice if there are changes to the feature release schedule. Schedule and resource estimates for each planned schedule delivery shall be within +10%.

· Support - Ticket resolution:

· Initial ticket response time within one business day

· Ticket resolution time within one week unless a code change is required.

5. Description of Task Areas

5.1. Project Management

The Contractor shall provide task order level project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. The Contractor shall hold a task kickoff meeting within 5 days of task award. At the kickoff meeting the Contractor shall review the material that will be part of the management plan and the project schedule. The Contractor shall use internal processes consistent with the FDA’s Enterprise Performance Lifecycle (EPLC) and IT standards.

The Contractor shall provide monthly status reports to the Task Order Contracting Officer Representative (COR). Within the first 30 days after task award, the Government and the Contractor will design and agree upon a standard reporting format that includes the following information at a minimum:

· Activities performed, progress achieved and status for each SOW task

· Metrics report for each applicable SOW task

· Cost and schedule variances against agreed-upon baselines

· Deliverables

· Risks to scheduled deliverables and plans to mitigate each risk

· Issues and recommendations

· Planned Activities for following reporting period.

In addition, the Contractor shall be proactive to inform the designated government Project Managers and Contracting Officer Representatives of any issues, problems and recommendations that should be addressed for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA staff or other Contractors shall be clearly defined and communicated to the responsible party and the FDA, and they shall have identified dates for completion.

5.1.1. Task Schedule

The Contractor shall prepare and deliver a task schedule for the task order, that depicts the implementation and sustainment of precisionFDA. The schedule shall depict all milestones, the major deliverables due, as well as specified schedule features directed by the COR.

5.1.2. Meetings

The Contractor shall support regularly scheduled and impromptu formal and informal meetings including, but not limited to weekly meetings, monthly meeting, informal review meetings, and formal presentations. The Contractor shall facilitate and lead the weekly precisionFDA User’s Group Meeting.

Depending on the type of meeting, the Contractor may be tasked with a variety of activities for meeting planning including:

· Identify facilitator/presentation to be given

· Schedule meeting place and time

· Provide supporting information that may be required including meeting agendas

· Ensure all necessary materials are distributed far enough in advance to allow for review

· Prepare meeting room

· Give presentations

· Facilitate discussions

· Summarize discussions

· Draft notes and/or minutes of the preceding.

5.1.3. Documentation

The Contractor shall provide system documentation in accordance with the FDA EPLC. The FDA EPLC is a tailored version of the Health and Human Services EPLC. The Contractor will work with the COR to determine specific technical document requirements. The Contractor shall ensure that all system documentation is complete and up to date.

5.2. Increment Development

The contractor shall develop the task order of the precisionFDA system. Within this increment and with the approval of the COR, the Contractor shall propose to deploy operational releases throughout the increment’s development.

This task order will build upon the existing operational precisionFDA system and Increments A, B, C, D, and E delivered capabilities, as well as the capabilities delivered by all other task orders in this IDIQ. In addition, it will also meet the requirements of the NEF proposal for GSRS enhancements.

5.2.1. precisionFDA Development The Contractor shall develop and deploy the task order of precision FDA. Development shall include the following tasks:

5.2.1.1. System Design Documentation and Increment Design Reviews The Contractor shall update the precisionFDA System Design Document (SDD) to reflect the system design following integration of the increment. The SDD shall include all supporting data models, a description of all interfaces, and a description of how compliance with laws, regulations, policies and standards applicable to the increment was achieved. The Contractor shall maintain the SDD so that it is current with each operational release. The Contractor shall document the precisionFDA system design in accordance with the FDA EPLC.

According to the Project Schedule, at a date and time agreed to by the COR, the Contractor shall conduct an Increment Design Review (IDR). At the IDR, the Contractor shall describe the increment’s design and demonstrate how the design addresses each of the capabilities allocated to the increment. The Contractor shall describe plans for which capabilities will be deployed in each release in that increment. The Contractor shall provide an approach for how each capability will be tested and/or demonstrated. The Contractor shall also describe the risks that have been identified and the plans to manage them. The IDR shall be considered successfully completed upon resolution of each design-related issue and FDA concurrence with the design plans.

5.2.1.2. Increment Implementation and Delivery

The Contractor shall implement each of their planned releases within the increment. When the release is ready to be deployed, it will be promoted to the precisionFDA staging area for testing. The Contractor shall test the release according to the plan provided during the IDR. Test results shall be documented and presented to the FDA at a Release Readiness Review (RRR). The RRR shall be considered successfully completed upon resolution of each test-related issue, and FDA concurrence with the software meets their expected capabilities. Upon completion of the RRR, that release can be promoted to the production system.

The Contractor shall place all deliverables and all software under configuration control. The Contractor shall support Change Control and Configuration Management in accordance with FDA standards and processes. This includes submitting requests to the CCB for approval prior to the release. The Contractor shall change an artifact under configuration control only if the change is approved by the CCB. The Contractor shall retain a copy of all previous versions of a changed artifact.

5.2.2. Operations and Maintenance (O&M)

The Contractor shall maintain the operational version of precisionFDA and any release of the task order that is deployed. The Contractor shall provide operational support, problem tracking and change management procedures to all operational versions of precsionFDA. Maintenance activities shall include troubleshooting system outages. The Contractor shall provide updates to the system to correct any defects identified in the system. These updates shall be tested in the precisionFDA staging area and promoted to the operational version of precisionFDA with the approval of the CCB. The Contractor shall take all corrective maintenance actions and all preventive maintenance actions necessary to ensure the system meets or exceeds its performance requirements.

The Contractor shall monitor system operations to manage user activities to prevent unintended or excessive use of system resources.

5.3. User Support

The Contractor shall provide user support to precisionFDA users. User support shall include:

· Support for account creation

· General system questions (“how do I…?”)

· Enabling and disabling user accounts

· Development and delivery of precisionFDA training for FDA scientists

· Bioinformatics support for FDA precisionFDA users.

5.4. PRISM Support

The Contractor shall provide support to the PRISM Research Project which will explore the use of an established regulatory cloud platform (precisionFDA) to test if collaboration using the cloud platform would benefit regulatory submission and review processes, improving efficiency while preserving security and data/records retention. The PRISM project will strive to demonstrate optimization of submissions and review of our current eCTD standard by leveraging collaborative regulatory review, including:

· Reduced complexity with a unified FDA regulatory cloud and collaborative environment for submission and review

· Interoperability between current regulatory submission and review processes and an interactive/collaborative regulatory cloud workstation environment

· Mitigated/eliminated complexities of commercial vendor compliance (e.g., 21 CFR 11), security, access, and sustainability/viability due diligence.

The Contractor will serve as a key partner in this collaborative test and shall complete the following tasks:

· Provide an interface for participants of PRISM on precisionFDA

· Deploy regulatory applications such as the Lorenz validator in the precisionFDA environment

· Support use cases

· Create a minimum of three videos to instruct industry and FDA reviewers on the use of the environment

· Link to FDA’s Electronic Systems Gateway (ESG) for submission of validated submissions

· Build a tool to index International Council for Harmonization (ICH) documents.

5.5. GSRS Pipeline and Functionality Enhancements

The Contractor shall provide support to the GSRS Portal Project which will receive some enhancements to improve data security, performance, interoperability, and standardization of the critical data elements to establish a modernized and more secure data architecture, improve data pipelines and develop key features that enhance the portal’s ability to format data. These requirements are in line with NEF funding awards for this project.

The Contractor will serve as a key partner in this collaborative test and shall complete the following tasks:

· Enhance GSRS portal on PrecisionFDA to allow creation of synthetic scheme JSON files, batch substance registrations and enhanced structured data editing. Adapting, where possible, existing AI tools to help convert previously unstructured data into structured data.

· Purchase software licenses which allow for managing ontologies that support structured data management and structured data submissions, especially as they pertain to in-vitro pharmacology.

· Enhance the GSRS platform’s ability to meet higher demand by making a more elastic on-demand scaling for the web application while also improving cybersecurity through modernization of software stack.

· Create automated data pipelines to expedite the integration, curation, and dissemination of critical substance data within the GSRS ecosystem.

6. Constraints

6.1. Security

6.1.1. 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:

[ ] No PII [ X ] 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.

6.1.2. 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.

6.1.3. 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.

6.1.4. 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.

6.1.5. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: Tier 2.

6.1.6. 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.

6.1.7. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, EPLC processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract.

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.

6.1.8. 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.

6.1.9. 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).

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 proposal 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 calendar days and all medium weaknesses must be mitigated within 60 calendar days 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, including remote authentication, is in-place in accordance with the assurance level determined by the E- Auth (when required) in accordance with HHS and FDA policies.

b. Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, and FDA IS2P. The following are the minimum requirements for ISCM:

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

· Asset Management - Using an FDA-approved Security Content Automation Protocol (SCAP)-compliant automated tool for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing FDA-owned information/data. It is anticipated that this inventory information will be required to be produced at least annually to facilitate management/oversight efforts). IT asset inventory information shall include IP address, machine name, operating system level, security patch level, and SCAP- compliant format information. The contractor shall maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools.

· Configuration Management - Use FDA-approved SCAP-compliant automated tools, per NIST IR 7511, for authenticated scans to provide visibility into the security configuration compliance status of all IT assets, (computers, servers, routers, databases, operating systems, application, etc.) that store and process government information. Compliance will be measured using IT assets and standard HHS and government configuration baselines at least annually. The contractor shall maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

· Vulnerability Management - Use FDA-approved SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets (computers, servers, routers, Web applications, databases, operating systems, etc.) that store and process government information. Contractors shall actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS and FDA policy. Automated tools shall be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor shall maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least monthly.

· Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and FDA specified timeframes (follow the FDA patch management policy).

· Secure Coding - Follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

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

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

a. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government’s direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing…