1213431_Sample_Management_Software_FBO_Synopsis_9.20.19.docx

New Sample Management Software Solicitation # 1213431

Combined Synopsis/Solicitation

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 and 13. This procurement is a 100% small business set-aside.

ii. The solicitation number is 1213431 This is a Request for Quotes.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2019-04, Effective 7 August 2019.

iv. The associated North American Industry Classification System (NAICS) Code is 541511, Custom Computer Programming Services; Small Business Size Standard is $27.5M.

v. Line Items:

Price Amount

Consists of sub-Line Items 0001AA – 0001AC

0001AA

Sample Management Software Section 1.3 Part # Type License:

Quantity:

Duration:

Section 1.4 - Configuration, Customization, Installation and Validation.

Section 1.5

Section 1.6 - Licenses/Maintenance for Sample Management Software Start Date:

Section 1.6 - Support/Maintenance for Sample Management Software

Licenses for additional users

vi. The requirements is a software product suitable for management of test samples to support the Division of Pharmaceutical Analysis’s Sample Management Program and per ISO 17025. The Contractor will be responsible for customization, installation, validation, and provide training and support of their software.

See 1. Description of Requirement.

vii. Delivery Address:

US Food and Drug Administration Division of Pharmaceutical Analysis 645 S Newstead Avenue Saint Louis, Missouri 63110

viii. The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition, with addenda.

See 2. Instructions

ix. The provision at 52.212-2, Evaluation -- Commercial Items applies to this acquisition. Factors considered are:

a. Meets requirements / Compliance

b. Provides additional benefit to FDA

c. Price Price is less important than the combined non-price factors.

Evaluation Procedure: The Government will determine whether the items and services offered are compliant with the requirements in the solicitation. Then the Government determine which contractor is best-suited by considering price and the extent to which the offer provides any additional benefits. Once the government determines the contractor that is the best-suited (i.e., the apparent successful contractor), the government reserves the right to communicate with only that contractor to address any remaining issues, if necessary, and finalize an order with that contractor. These issues may include technical and price. If the parties cannot successfully address any remaining issues, as determined pertinent at the sole discretion of the government, the government reserves the right to communicate with the next best-suited contractor based on the original analysis and address any remaining issues.

x. Offerors verifies that by summiting an offer their annual representations and certifications are complete and accessible in SAM, per FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (Oct 2018).

xi. The clause 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition.

See 3. For additional clauses.

xii. The clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition.

See 3. additional clauses.

xiii. Additional contract requirement(s) or terms and conditions are included.

xiv. DPAS does not apply.

xv. Questions due Tuesday 3 PM ET to jacob.ohatnick@fda.hhs.gov

xvi. Quotes due Thursday 3 PM ET to jacob.ohatnick@fda.hhs.gov

xvii. For additional information contact Jacob O’Hatnick Contract Specialist Division of Information Technology Acquisition Office of Acquisition and Grants Services U.S. Food and Drug Administration Tel: 240-402-7545 jacob.ohatnick@fda.hhs.gov Addenda Description of Requirement Sample Management Software Background The Division of Pharmaceutical Analysis (DPA) is a pharmaceutical testing laboratory within the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) that conducts regulatory research to uphold FDA’s mission to ensure human drug safety and efficacy for consumers in the US. As such, the DPA is responsible for receiving, testing, and reporting findings in support of investigations and enforcement actions to its customers. Due to the nature of work, chain of custody, sample integrity, and data integrity are paramount. The DPA has established and refined its procedures for sample management over the years with the aid of in-house computer databases used as management tools, but truly a pen and paper system.

Succumbing to both internal and external forces such as the increasing intake of projects and the Paper Reduction Act, the DPA is in need of a revamped, modern, and reliable software solution. A new sample management software system will improve efficiency from intake, retrieval, and updating of electronic records pertaining to samples without the need for printing, signing, and retrieving hard copy records in an antiquated filing system. A new system will ensure that the data and inventories generated are accurate, authentic, reliable, and accessible.

The DPA has searched for suitable software solutions and found a vast array of products ranging from Inventory Management Systems to Laboratory Information Management Systems (LIMS) that are commercial-off-the-shelf (COTS) customizable software that can fulfill this requirement. Many of the products employ barcoding technology that is cost effective and DPA needs to ensure accurate record keeping. Furthermore, web-based COTS software will ensure accessibility and optimize available information technology (IT) resources. The DPA needs to acquire a suitable software for management of samples to modernize conduct of laboratory processes and streamline inventories.

Objective The objective is to procure a software product suitable for management of test samples to support the DPA’s Sample Management Program and per ISO 17025. The Contractor will be responsible for customization, installation, validation, and provide training and support of their COTS software.

Software Requirements

1. 15 Users initially. Up to a maximum of 50 additional user.

2. Shall be customizable Commercial-Off-the-Shelf (COTS) and suitable for managing the lifecycle of samples in a defined workflow.

3. Simplified Workflow:

3.1. Request for Analysis (new project) -> New Sample -> Transfer to person/location -> Manipulation of Sample (sub sampling) ->Analysis->Transfer to permanent location (sample custodian) -> Destruction of Sample (archive record).

4. Shall be capable of recording information pertaining to project that can be carried over to the sample, once received. Project ID (assigned outside of this system), Project Title, user identified as Point of Contact (PoC), and products associated.

5. Shall be suitable for recording sample information, including but not limited to, unique barcode (sample ID), project ID, date received, receiver, name (ex. drug), National Drug Code (NDC), lot/batch, expiry, type, ingredients, sender’s name and address, manufacturer, quantity, container type, storage condition, storage location, description, safety data sheet (SDS), methods, links and other attachments (including, but not limited to, .pdf, .docx, .jpg, .png, xlsx).

6. Shall be predefined as a catalog and may be associated with other attributes: Project, name (drug), type, sender’s name and address, manufacturer, container type, storage condition, storage location.

7. Shall allow new catalog entries within the form where catalog selection is required by means of a popup window or other mean that does not interrupt completion of the form.

8. Receiver and date received shall be recorded.

9. Shall be customizable to choose what fields are required for entry

10. Shall generate and print unique barcodes labels for the following: Sample ID, Project ID and storage locations. Label format shall be customizable

11. Shall be able to associate parent/children samples and be able to split or derive child samples from parent sample. Child sample shall have unique ID.

12. Shall be suitable for tracking chain of custody of sample: Personnel accountability and location changes.

13. Shall use barcode scanning to Transfer and Update locations and accountability.

14. Shall require users to use electronic signature to acknowledge samples that are being transferred and taking custody of sample.

15. Shall be suitable for recording analytical testing information pertaining to testing performed, including summary, review, and approvals.

16. Shall be able to generate reports such as sample description, chain of custody, inventory reports by location, status of sample, samples checked out by user, sample processing metrics (i.e number and time for samples pending, received, awaiting next step etc.), and list for destruction. Reports shall be in PDF format.

17. Shall generate notifications by email and within software for status changes or actions to be completed in the workflow.

18. Shall be able to search/query on any individual or multiple field/attributes to find, select, open record, and take action dictated by the workflow.

19. Shall maintain non-editable Audit Trail for system, sample, and workflow.

20. Shall assign roles, groups, and permissions to all users.

21. Shall have customizable fields that only system administrator can customize.

22. Shall be multi-tier for development, testing, and production instances.

23. Shall allow user accounts for at least 100 users with a minimum of 15 concurrent users.

24. Shall provide pricing for additional concurrent user licenses that may be purchased as Options during entire period of performance.

25. Shall utilize single-sign-on (SSO) authentication for user sign-in.

26. Shall use electronic signature.

27. Shall be web-based and installed on-premises at place of performance.

28. Interface shall work with current versions of internet browsers such as Internet Explorer, Firefox, and Chrome.

29. Shall have graphical user interface (GUI) that uses trees and menus. A dashboard, or commonly accessed reports/ processes, that are customized to roles of users.

30. Shall be able to print and scan barcodes.

31. Shall allow users to update one or more fields to multiple samples on the same screen/page simultaneously contingent on their roles and permissions (item 9). This includes, but not limited to, receipt of multiple samples under same study, transfer of multiple samples to user or location, retention/destruction of multiple samples by user.

32. Shall be able to integrate with other software systems, such as electronic lab notebook (ELN), to facilitate electronic data handling and the ability to maintain chemical inventories to streamline the laboratory’s sample and chemical inventories.

33. Shall have ability to record analytical results and be capable of integrating with laboratory test instruments.

Service Requirements

34. Shall provide services to configure/customize forms and fields to customer’s needs, import all room and cold storage locations, set up initial user accounts, and upload data from legacy sample database.

35. Shall develop workflow(s) (involving ten (10) steps or less for the customer’s process. Responsibilities and access within workflow must be dependent on user role and assignment. Dependent on the user’s roles and combination of assignment, the user must have ability to interface the steps in workflow independently

36. Shall build five (5) Custom reports that may be in addition to the COTS standard reports

37. Visual representation of workflow and reports shall be provided by contractor as PDF prior to execution of IQ/OQ. Approval of workflow and reports will be made by customer.

38. Shall provide and execute Installation Qualification and Operational Qualification (IQ/OQ) validation service of software for on premise installation at place of performance. Shall assist drafting Performance Qualification (PQ) protocol for customer. IQ/OQ/PQ shall consist of the standard software installation as well as the customized workflow and reporting

39. Shall provide remote technical support for the software and the configurations rendered above by means of telephone, email, and video conference (such as WebEx or Adobe Connect) during base year contract.

Training Requirements

40. Shall provide a one (1) day in-depth training for four (4) super users, and two (2) —one (1) hour classroom sessions—for up to twenty-five (25) users per session, at place of performance.

41. In-depth training shall include at minimum:

41.1. how to log in samples, create projects, transfer samples, configure workflows, set up locations and catalogs, and how to manage user accounts within the software.

41.2. Alternative locations/methods of training may be considered, though evaluated on effectiveness and cost.

Follow-On Service Requirements

42. Shall provide maintenance support and validation service with at least one (1) upgrade per year.

42.1. Maintenance support shall include telephone and email technical support accessible Monday-Friday during regular business hours, excluding federal holidays.

42.2. Includes remote support for desktop sharing.

42.3. Validation Services for software upgrades shall include IQ/OQ and customer assistance with PQ and risk assessment of upgrade.

43. Shall provide access to software patches and updates upon each release.

44. Covers additional users may be added during performance through exercising options for additional quantity.

Deliverables

When fully authorized, installed, and validated.

Services

Services

Services

Training

IT Security and Privacy Standards A. Baseline Security Requirements

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

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

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

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

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

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

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

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

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

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

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

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

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

[ ] 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: [ ] Low [ x ] 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.

6) 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).

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

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

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

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

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

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use are compliant with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

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

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

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

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

B. Training

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

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

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

C. Rules of Behavior

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

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual FDA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

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

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

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

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

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

3) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “other stakeholders.”) including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour of discovery/detection, and consistent with the applicable FDA and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

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

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

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

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

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation demand.

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

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

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

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

G. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here: http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.aspx HHS EA requirements may be located here: https://www.hhs.gov/about/agencies/asa/ocio/index.html

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with FDA OAGS SMGs to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media

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

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

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm as soon as it is known that an employee will terminate work under this contract within days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

H. Records Management and Retention 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.

I. Security & Privacy Deliverables

Contractor Employee Non- Disclosure Agreement (NDA) Prior to performing any work on behalf of HHS/FDA

Assist in the completion of a PTA/PIA form Per timeline as specified by the FDA Privacy POCs. after contract award

Copy of training records for all mandatory training Within 3 days after each training session

Incident Report (as incidents or breaches occur) Within 1 hour from discovery of incident

Incident and Breach Response Plan Upon request from Government

List of Personnel with defined roles and responsibilities Within a time directed by the COR that is before an employee begins working on this contract.

work on behalf of HHS/FDA

Off-boarding documentation, equipment and badge when leaving contract The last day that work is being performed after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Additional Terms and Conditions Travel Travel is not a separate expense.

Order of Precedence The contractor shall follow the terms and conditions of this order. 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 of the contract. Any indemnification language indemnifying the contractor of any liability and governing law language in the contractor’s terms and conditions shall be invalid and shall be stricken and removed from this order. 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.

Additional Clauses & Provisions 52.252-2 -- Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):www.acquisition.gov.

52.212-4, Contract Terms and Conditions—Commercial Items (Oct 2018), 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Aug 2019) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) 52.222-3, Convict Labor (June 2003) (E.O.11755).

52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) (E.O.13126).

52.222-21, Prohibition of Segregated Facilities (Apr 2015).

52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

52.217-6 -- Option for Increased Quantity (Mar 1989) 52.217-9 -- Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 7 days]; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 14 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 Years.

HHS Class Deviation 17-01 applies to this acquisition.

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Appropriate Scoping Requirement from Appendix A E207 Software (Appendix A, Application and Scoping Requirements) Appropriate Technical Performance and Technical Requirement from Appendix C Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements) Provisions FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): www.acquisition.gov.

352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

Instructions Instructions follow provision 52.212-1 Instructions to Offerors-Commercial Items. Follow these instructions for the submission and content of offers, rather than the provision’s paragraph (b).

Submission of offers consists of a signed and dated offer to the email addresses specified in this solicitation at or before the exact time specified in this solicitation.

The email must contain the subject “Response to solicitation 1213431” As a minimum, offers must consist of:

i. The solicitation number 1213431 on all documents.

ii. A signed and dated offer letter, with contact information.

iii. Pricing for all line items.

a. Offerors may modify the line items to reflect their business, and may add additional optional services.

iv. A technical description of the items and services offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature or other documents. Also:

a. Software license description (term vs. perpetual, etc.)

b. All software Terms of Service or End User Licensing Agreement, in full text.

c. All additional terms and conditions.

v. If re-seller, must be authorized by Original Equipment Manufacturer (OEM) to sell and service the software.

vi. For accessibility compliance review, submit an Accessibility Conformance Report (ACR) for software.

image1.png