Amendment 2 RFQ 75F40124Q00232 .pdf

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

REQUEST FOR QUOTE

FDA OCS TECHNOLOGY TRANSFER KNOWLEDGE

MANAGEMENT SYSTEM

RFQ 75F40124Q00232

This is a combined/synopsis solicitation issued under FAR Part 12 and 13.5 procedures. This is a Full and Open procurement. The NAICS code is 513210.

The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote.

1. PRODUCT LIST AND DELIVERY INFORMATION

The U.S. Food and Drug Administration (FDA), Office of the Chief Scientist (OCS), Technology Transfer Program (TTP) has a requirement for a Technology Transfer Knowledge Management System. Due to the FDA current IT Strategy of “Zero Data Center”, this solution requires a cloud-based Software as a Service (SaaS) that is a Federal Risk Authorization Management Program (FedRAMP) authorized at moderate level.

FedRAMP must be available and accredited at the time of this solicitation.

FDA requires a Commercial-Off-The-Shelf (COTS) solution to manage multiple aspects of the intellectual property (IP) portfolio, including invention disclosures, patent portfolios, trade secrets, trademarks, and copyrights, as well as the operational activities associated with patent prosecution, partnerships, agreements, marketing, and licensing. This SaaS will replace the current TTP Knowledge Management System, Knowledge Sharing System (KSS) TechTracS. TechTracS is an intellectual property database which the OCS/TTP uses to manage, track, and maintain FDA Intellectual Property (IP).

1.1 PRODUCT LIST

The Contractor shall provide the following that meets the delineated salient functional characteristics for this requirement:

Description Qty Unit Price Extended Price

Technology Transfer Knowledge Management System 1

A. The Technology Transfer Knowledge Management System shall consis of the following salient characteristics :

1. This solution requires a cloud-based Software as a Service (SaaS) that is a Federal Risk Authorization Management Program (FedRAMP) authorized at moderate level.

FedRAMP must be available and accredited at the time of this solicitation.

2. Easily configured for country law updates that does not require additional funding or development

3. Provide a Technology Transfer Knowledge Management System using Software as a Service (SaaS) licensing and delivery model on an authorized FedRAMP cloud hosted environment.

4. Securely migrate data to the FedRAMP hosting environment; One-time setup includes migration of data, field values, forms, reports, and workflows to externally-hosted system

5. Allow for electronic storage, workflow, document management, secure digital signature, document extraction and redaction, and records management.

6. Support the entire FDA technology transfer community of users (approximately 12 concurrent users).

7. Be scalable and configurable allowing FDA the flexibility to meet current and future requirements in terms of number of concurrent users, storage space, processing capacity, and business processes.

8. Comply with the HHS/FDA Technical Reference Model, Federal Acquisition Regulation, Management Directive, and Section 508, and other FDA standards.

9. Includes access to records retention and destruction after contract closeout.

10. Compatible with FDA information technology including put not limited to FDA laptops and desktop computers, PIV Card sign-on, and Microsoft 365

B. The Technology Transfer Knowledge Management System User Interface shall consist of the following salient characteristics :

1. The system shall provide a customizable dashboard for each users with access to information pertinent to their system role.

2. The system shall provide users the capability to search the database as well all attachments.

3. The system shall be able to send users notifications to their dashboard or email for events and deadlines.

4. The system shall provide users the ability to import and export data between files and database tables that is compatible with Microsoft Excel, Microsoft Word, Microsoft Access and/or Adobe PDFs.

C. The Transfer Knowledge Management System Invention Disclosure Tracking shall consist of the following salient characteristics:

1. Online invention disclosure forms for inventors/researchers with customizable review and approval levels for either direct entry by researchers into database or requiring approval

2. Store, edit, and review information on invention disclosures, including inventors, key dates, abstracts, descriptions, presentations, and notes

D. The Transfer Knowledge Management System Intellectual Property Management shall consist of the following salient characteristics:

1. Tracking of multiple patents and trademarks

2. Automated population of critical filing and annuity due dates

3. Automated email reminders to ensure compliance with maintenance fees, office actions, patent filing requirements.

4. Tracking of attorney information and associated patent expenses

5. Ability to group inventions and patents by inventor and technology area.

6. Track and calculate expenses and payments related to reimbursable funded agreements, contracts with vendors, patent prosecution, maintenance fees, and outside patent firm expenses ; Receive emails from patent attorneys to a single designated email inbox, which are then accepted into an IP Notifications system;

7. Projects module(s) for work both inside and outside of traditional inventions, agreements, and intellectual property filings;

8. Web-based invention disclosure and agreement submissions tool.

a. Accepted submissions automatically create agreement records in the System;

b. Must enable fully customizable workflows and questions that can be set-up by customer. Questions must include “hierarchy” questions (e.g., if A, then show question 2; if B, then show question 3);

9. Create various document forms related to TTP workflows to include, but not limited to invention evaluation, notification to stakeholders, invoices, and determination of rights;

10. Employ a business intelligence tool to automate TTP and relevant stakeholder processes and workflows;

11. DocuSign (or equivalent) electronic signature of documents;

12. User customizable design of workflows/tasks.

a. Customized fields, field views, and inputs to reflect TTP preference and workflows. System administrators have the capability to further customize without additional cost to TTP.

b. Individual users can define their personal view of each record type, including order of information displayed, ability to hide information, and ability to collapse a summary view of the information on screen.

c. Document forms are routed to various stakeholders dependent upon workflows for signature approval;

E. The Transfer Knowledge Management System Commercialization shall consist of the following salient characteristics:

1. Search existing IP and patents to get company specific profiles

2. Maintain company contacts and information

3. Ability to group inventions and patents by inventor and technology area.

F. The Transfer Knowledge Management System Reporting shall consist of the following salient characteristics:

1. The system shall be able to generate weekly, monthly and annual standard and adhoc reports. These reports shall be accessible in excel and pdf formats.

2. The system shall provide a wizard to to support SQL queries for specialized reports.

G. The Transfer Knowledge Management System Support shall consist of the following salient characteristics:

1. Provide Support for system configuration and setup.

2. Provide support in migrating data from current system to new system.

3. Provide a complete solution that meets the standard required for the HHS/FDA

Enterprise Architecture.

4. Provide a solution that complies with the FDA Information Security Systems

Program Directive.

5. Provide training for TTP and non-TTP personnel through online video tutorials and live help support for the number of users.

6. Provide System Configuration Documentation.

7. Provide User and System Administration Training.

2. DELIVERABLES

The above items shall be delivered according to the below Period of Performance in Section

4. The Contractor shall notify the COR via email when the above items are available.

The Contractor shall deliver all software with appropriate license keys, proof of entitlement certificates, maintenance support confirmation to the FDA COR within 7 days after contract award or the Period of Performance start date which ever comes first, as well as the on-time delivery of maintenance and support.

The vendor shall deliver all software as detailed in Section 1 of this delivery order as follows:

The Contractor shall deliver or make available to the COR updates, patches, and new versions of the required software within ten (10) business days of release.

3. INSPECTION AND ACCEPTANCE

All items specified to be delivered under this order are subject to final inspection and acceptance by an authorized representative for the Government. The authorized representative of the Government is the Government’s COR/TPOC, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

This section describes how the product will be inspected and the acceptance criteria:

• Software must be able to install correctly on the range of FDA server and operating system types in accordance to those specified as being supported in the vendor’s documentation (or equivalent).

• Software must operate on FDA servers if the servers meet the vendor recommended hardware and system requirements specified in the vendor’s documentation (or equivalent).

• Software must operate on FDA workstations that are connected through the FDA VPN.

• Software must contain all features specified in the user guide of the product

• Software must be free of major defects that would halt major functions and operations of the software from performing

• The Contractor shall remediate any problems with delivery identified by the COR/TPOC within ten (10) calendar days from the COR/TPOC’s notification of a problem. If the Contractor cannot implement changes within that time frame, the Contractor shall notify the COR/TPOC immediately to establish a reasonable agreed upon timeline.

• The performance criteria for this order shall be that all software with appropriate license keys, proof of entitlement certificates, etc. has been delivered to the COR/TPOC within ten (10) business days after award, as well as the timely delivery of maintenance and support in accordance with the service level agreements (SLAs) and terms and conditions of this order.

4. PERIOD OF PERFORMANCE

The period of performance table that includes the base period and all option periods for software subscription licensing and vendor support & maintenance.

Period of Performance Date

Base 10 days from date of award

Option Year 1 12 months

Option Year 2 12 months

Option Year 3 12 months

Option Year 4 12 months

5. PLACE OF PERFORMANCE

All providing of licensing and support shall be completed at the Vendors location. No onsite support or visits are required.

The software will reside in FedRAMP vendor cloud environment, delivered to FDA as a Software as a Service (SaaS). Training sessions shall occur virtually and in person as directed by the COR.

Any and all travel required for deliverables shall be at the expense of the contractor/vendor.

6. POINTS OF CONTACT

CONTRACT MANAGEMENT:

Contract Specialist (CS):

Tiffany Hatcher 4041 Powder Mill Rd.

Beltsville, MD 20705

(240) 402‐8856 Tiffany.Hatcher@fda.hhs.gov

7. CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

8. CONTRACT TYPE

The contract type of this order is firm‐fixed price (FFP)

9. AUTHORIZED RESELLER/SERVICING AGENT

The Contractor shall be the software Original Equipment Manufacturer (OEM) or an authorized reseller/servicing agent of the software OEM.

The Contractor shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the OEM.

mailto:Tiffany.Hatcher@fda.hhs.gov

10. ORDER OF PRECEDENCE

The Contractor shall follow the terms and conditions of this contract. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4. The Contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract. Any auto-renewals are at the risk of the Contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

Any additional terms and conditions shall not be prohibited by applicable laws and regulations.

Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from this order.

11. PROCUREMENTS REQUIRING INFORMATION SECURITY AND/ OR

PHYSICAL ACCESS SECUIRTY

Baseline Security Requirements

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

Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

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 FDA 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.

Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with FDA policies and level of risk.

At a minimum, the Contractor (and/or any subcontractor) must

i. Protect the:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

ii. Categorize all information owned and/or collected/managed on behalf of FDA and information systems that store, process, and/or transmit FDA information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories.

Based on information provided by the System/Data Owner, ISSO, privacy representative, or other POC, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

(i) Confidentiality: ☐Low ☒Moderate ☐High

(ii) Integrity: ☐Low ☒Moderate ☐High

(iii) Availability: ☐Low ☒Moderate ☐High

(iv) Overall Impact Level: ☐Low ☒Moderate ☐High

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

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s). This includes notifying the FDA Cybersecurity and Infrastructure Operations Coordination Center (CIOCC) within one (1) hour of discovery/detection in the event of a cybersecurity or privacy incident.

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the 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 Protection (IS2P) policy, by contacting the CO/COR or emailing your ISSO.

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

Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable FDA privacy policies and complete all the requirements below:

http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. Based on information provided by the ISSO, System/Data Owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

☐ No PII ☒ PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed.

1. If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information 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).

2. The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

Marked appropriately;

Disclosed to authorized personnel on a Need-To-Know basis;

Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Information Systems and Organizations applicable baseline if handled by a contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

Returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800- 88, Guidelines for Media Sanitization.

Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

Government Furnished Equipment (GFE) for Foreign Travel. FDA personnel are prohibited from taking GFE when participating in personal, unofficial travel to foreign countries. FDA personnel are strictly prohibited from teleworking using GFE in foreign countries. FDA personnel must also request loaner GFE from the FDA Foreign Travel program for official travel to any foreign country. Please see the FDA IS2P, Appendix T Government Furnished Equipment for Foreign Travel.

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 must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein. The confidentiality, integrity, and availability of such information must be protected in accordance with HHS and FDA policies.

Unauthorized disclosure of information will be subject to the HHS and FDA sanction policies and/or governed by the following laws and regulations:

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

18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

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

Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115- 232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR

52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents to comply with contract deliverables as appropriate.

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

Comply with the HHS Standard for Encryption of Computing Devices and

Information to prevent unauthorized access to government information.

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 an encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices 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).

Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificates from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the FDA non-disclosure agreement (3398 Form)], as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

Training Requirements http://csrc.nist.gov/publications/

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable FDA information security awareness, privacy, and records management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete FDA information security awareness, privacy, and records management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users, and FDA policies and standards.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Agency data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual 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 above.

Incident Response

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

FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. In accordance with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the FDA IS2P Appendix F: Incident Response and the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

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

ii. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so, instructed by the Contracting Officer or representative, the Contractor must send FDA approved notifications to affected individuals as directed by FDA’s SOP.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the FDA CIOCC, COR, CO, FDA SOP (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable 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, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

Not include any sensitive information in the subject or body of any reporting e- mail; and

Encrypt sensitive information in attachments to email, media, etc.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of

Personally Identifiable Information, and HHS and FDA breach response policies when handling PII breaches.

v. 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 on demand.

Position Sensitivity Designations

a. 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:

☐ Does not apply

☐ Tier 1 Low Risk, Non-Sensitive, including HSPD-12 Credentialing

☒ Tier 2 Moderate Risk Public Trust (MRPT)

☐ Tier 3 Non-Critical Sensitive, National Security, including SECRET & "L" access eligibility

☐ Tier 4 High Risk Public Trust (HRPT)

☐ Tier 5 Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility

Homeland Security Presidential Directive (HSPD)-12

a. The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD- 12 policy; and Executive Order 13467, Part 1 §1.2.

Roster

a. The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes must 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.

i. If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the 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/EPLCHo me.as px and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation in accordance with SMGs published by FDA’s Office of Acquisitions and Grant Services (OAGS) 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.

Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO as soon as it is known that a contract employee will stop working under this contract.

Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and FDA policies.

The Contractor (and/or any subcontractor) must perform and document the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/def ault.htm as soon as it is known that a contract an employee will terminate work under this contract. 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. All documentation must be available to the CO and/or COR upon request.

Records Management and Retention

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS Policy for Records Management and HHS and FDA policies and must not dispose of any records unless authorized by HHSFDA.In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with HHS and FDA policies.

http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.as http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.as

High Value Asset (HVA). If a system is identified as HVA,24 the contractor must comply with the FDA IS2P Appendix AB: High Value Asset (HVA) Program, the HHS Policy for the High Value Asset (HVA) Program, and the DHS HVA Control Overlay25 in addition to the above requirements.

Privacy Act

a. It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records about individuals from which records are retrieved by name or other identifying particular.

The System of Records Notice(s) (SORN(s)) that is applicable to this contract is:

New SORN will be developed.

The system of records design, development, or operation work the Contractor is to perform is:

The contractor will be configured and deploy application in FDA environment.

The disposition to be made of the Privacy Act records upon completion of contract performance is:

Contractor and subcontractor will adhere to the Privacy Act for all records at the completion of the contract.

Security Requirements for GOCO and COCO Resources

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

Assessment and Authorization (A&A). A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s): [Within 30 days]. The Contractor must conduct the A&A requirements in accordance with HHS IS2P/ FDA IS2P NIST SP 800- 37, Guide for Applying the Risk Management Framework to Information Systems: A Security Life Cycle Approach (latest revision), NIST SP 800-53B, Control Baselines for Information Systems and Organizations, and the NIST SP 800-53A (latest revision). 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&A Package Deliverables - The Contractor (and/or any subcontractor) must provide an A&A package within a timeline directed by the COR, per the FDA Enterprise Performance Lifecycle (EPLC) process, to the CO and/or COR. The following A&A deliverables are required to complete the A&A package:

System Security Plan (SSP) - due a week prior to the start of the annual security assessment. The SSP must comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Information Systems, and NIST SP 800-53, Security and Privacy Controls for Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and FDA policies and other guidance.

The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor must review and update the SSP at least annually thereafter and if requested, provide a copy of the updated

SSP.

Security Assessment Plan/Report (SAP/SAR) - due before the system is made available to standard users. The security assessment must 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.

Thereafter, the Contractor, in coordination with FDA, must assist in the assessment of the security controls and update the SAR at least annually. A copy of the updated SAR should be provided if requested.

Independent Assessment - The Contractor (and/or subcontractor) must have an independent third party validate the security and privacy controls in place for the system(s) commensurate with the risk levels per NIST SP 800-53B. The independent third party must review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor must address all "high" deficiencies and enter all other deficiencies that require mitigation by Contractor before submitting the package to the Government for acceptance and document all remaining deficiencies in a system Plan of Action and Milestones (POA&M).

POA&M - as part of the SAR All high-risk weaknesses must be mitigated within 30 calendar days moderate weaknesses must be

Author Note to the Requiring Activity Representative: The FDA should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by contractor, government, or third parties, with third-party verification considered the strongest. If independent assessment is required, include statement below.

mitigated within 60 calendar days and low weaknesses must be mitigated within 180 calendar days from the date the weaknesses are formally identified and documented. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, flaws and security defects in a system (that require to create a patch for remediation), and other security reviews and sources, as documented in the SAR, must be documented and tracked by the Contractor for mitigation in the POA&M document consistent with the HHS Standard for Plan of Action and Milestones, FDA POA&M Management Guide, and FDA IS2P policies. Depending on the severity of the risks, FDA may require designated POA&M weaknesses to be remediated before an ATO is issued. Thereafter, continue to remediate weaknesses throughout the contract. The POA&M document must be updated at least quarterly

Contingency Plan and Contingency Plan Test - due during 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, must test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed.

Thereafter, the Contractor must update and test the Contingency Plan at least annually.

E-Authentication Questionnaire - The contractor (and/or any subcontractor) must collaborate with government personnel to ensure that the E-Authentication requirements are implemented in accordance with OMB 04-04 and NIST SP 800- 63 B.

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 Guidance for Selection of e-Authentication Assurance Levels and any other applicable HHS and FDA policies.

Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, must meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, HHS ISCM Strategy, and HHS and FDA IS2Ps.

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

Asset Management – Using FDA-approved Security Content Automation Protocol (SCAP)- compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing 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 must include IP address, machine name, operating system level, security patch level, and SCAP-compliant format information. The contractor must maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools in accordance with the HHS Policy for Information Technology Asset Management (ITAM) and any other applicable HHS and FDA policies.

Configuration Management - Use FDA-approved SCAP-compliant automated tools as per NIST IR 7511 and HHS Minimum Security Configurations Standards Guidance to scan all IT assets, including but not limited…