SOW Send Explore Warehouse License and Support.docx

VERSION HISTORY

Version Number Implemented By Revision Date Approved By Approval Date Description of Change

FY26 Annual Send Explorer Warehouse and Technical Support, or an equal to solution

1. General

1.1 Background

The Center for Drug Evaluation and Research (CDER) of the U.S. Food And Drug Administration (FDA) requires software to support the nonclinical review of CDISC- SEND submissions. The Office of Computational Sciences (OCS) has purchased and deployed SEND Explorer Warehouse in order to fully support CDER’s Office of New Drugs (OND) with regulatory review.

1.2 Scope

The contract shall provide OCS with a Send Explorer Warehouse license on Development Environment, Test Environment, Production, and Pre-production, or equal to software solution with technical support. Comment by Sahoo, Sanjay: Please add some clarity on the scope.

How many licenses we are procuring? Is it one or two (for Preprod and Prod)? Can we provide the details somewhere? Does this license include upgraded version release in between the contract cycle?

I saw in IGCE it's one license cost. Is it true? One license works in two environments?

If this is true, then ignore this comment. Comment by Kang, Jing: @Sahoo, Sanjay We are not buying SEND licenses. This acquisition is just for support and maintenance. Should I remove "Send Explorer Warehouse license" for clarity? Comment by Chang, Isaac A.: My understanding was that the amount was for the Send Explorer license renewal which comes with support and maintenance. Since this is a COTS product, the support is for help support should we have questions regarding the COTS product... and maintenance means that we get upgrades of the software when it becomes available. This does not cover labor cost for installation which is done by our team. Is this correct?

Separately, I too have questions as to whether there needs to be clarification on implementation in Pre-Prod and Prod environments and whether that is included in the license cost. Comment by Kang, Jing: @Chang, Isaac A. Where can I find out the answers? Please advise. Thank you. Comment by Sahoo, Sanjay: Please work with Divine... Comment by Kang, Jing: Updated per Sanjay and Isaac's comments Comment by Chang, Isaac A.: I think this should be Production and Pre-Production. Can you clarify also whether there is a separate Test environment, or are you planning on using the Pre-Production server for testing purposes as well. (Not generally recommended) Comment by Kang, Jing: I will check this with Matt next week and finalize it. Comment by Wiley, Matthew: We have Dev, Test, PP, and Prod environments for SEW. I would recommend using the general language of "SEND Explorer Warehouse licensing to support Dev, Test, Pre Prod, and Production environments, along with ongoing technical support."

2 Description of Work

2.1 The Send Explorer Warehouse, or equal to software solution, shall have the following salient and software update characteristics: Comment by Chang, Isaac A.: At this point, do you really mean "or equal" to software solution? What happens if it is not Send Explorer Warehouse? Comment by Sahoo, Sanjay: This is contractual term, Karen confirmed in past to include. Truly, I would prefer to say only SEND explorer. If it's a standard practice - it's okay. Comment by Chang, Isaac A.: OK.

2.1.1 Salient characteristics:

· Summary view for numeric data to visualize patterns and trends in numeric data with summary statistics, scatterplot, out-of-concurrent-control range indicator, and % control mean calculations

· Summary view thumbnail plots to display distribution of subject data across groups

· Line graphs to visualize patterns of group means and individual subject data over time

· Clinical observations time course to reveal dose-related patterns and trends in clinical observations over the course of a study

· Severity heatmap to visualize patterns and trends in both incidence and severity of pathology findings

· Cross-domain subject view to put a subject’s data into perspective as compared to its own group and control group, on a single day or over time

· Single-study survival plot to plot survival in long-term studies

· Correlations matrix to reveal pairwise correlations of endpoints for selected subjects, identifying those with histopathology findings in tissues of interest

· Multi-study scatterplot time course to compare dose-response and time course relationships in a selected endpoint for a group of related studies with the ability to overlay historical control reference range values

· Multi-study histopathology bar chart to visualize prevalence and severity of histopathology findings across studies or in untreated control subjects

· Historical control distribution to reveal the distribution of numeric data in control subjects across studies, stratified by selected fields of interest

· Multi-study line graph to compare study-specific time course patterns in group means and individual subject data for one or more selected endpoints across studies

· Supports a variety of source data formats including direct connection to data collection systems

· Handles custom domains and provides term reconciliation functionality

· Override records and create and populate ad hoc study metadata fields for querying data and filtering visualizations

· A robust data grid that merges subject and group metadata with associated results Comment by Sahoo, Sanjay: What is the source of these information? Does the vendor provide this information? If yes or no - this doesn't align with the vendor published website https://www.certara.com/data-and-informatics/send-explorer-software/

Confirm!

Also, the site talks about enhancements such as Single-Study, Multi-Study enhancements, visual pattern recognition, trend analysis, and multi-study visualization capabilities/features

Make sure we are aligned with latest releases. Comment by Kang, Jing: @Sahoo, Sanjay We might not have all the services and support described on Certara's website, because we are not their only customer. I've sent email to Shawn Hasan who is the Certara SEND project manager, to ask for up-to-date information. Comment by Sahoo, Sanjay: You answered by questions. Thanks. Comment by Kang, Jing: Updated per Sanjay and Isaac's comments based on SEND Explorer Warehouse Service Description provided by Shawn Hasan Comment by Chang, Isaac A.: Should be compatible with the database... not sure we can say that it has to be compatible with the environment. (As that is not within the vendor's control.)

· Advanced data management and query features such as column hiding/showing, sorting, and filtering

· Ability to export all or filtered data to Excel

· Pivoting of data by time-point, test code, and/or subject

· Group summary and incidence calculations based on a user-specified group definition

· Scientifically-relevant data visualizations including scatterplots of subject data, group mean bar charts, and Severity Heatmaps™

· Reference range highlighting and calculated % change from control group mean

· Hyperlink to comments and supplemental qualifiers

· Hyperlink to multi-domain subject view with tabular and graphical displays of data

· Multi-study Correlations Matrix visualization with tissue-finding indicators and drill-down to subject data

· Multi-study Timecourse Grid visualization permitting comparison of endpoint across studies and over time

· Straight-forward load interface and study dashboard

· Bulk studies loading to watchfolder from the front end

· Fully-compliant SEND-based data model

· Multi-study/multi-domain data query grid

· Hyperlinked related records

· Ability to integrate data by easily registering new source systems and connectors regardless of how the data was collected

· Ability to view and interact with data visualizations before data is converted into SEND, allowing for quick response to questions during or after a study from internal departmental teams or regulators

· Administrative tool to allow term reconciliation, to view/modify mapped terms, to specify unit transformations, and to identify number of decimal places for display

· Ability to load, reload, or delete individual domains or an entire study

· Ability to review load history and load history details to help identify and correct data errors

· Ability to load data on-demand or according to a specified schedule

· Bulk load studies from Dashboard to Watchfolder

· Ability to flag dosing timepoints in line graph

· Support hierarchical x-axis in multi-study visualizations

· Add numeric endpoints from BW, OM PP, and VS domains to Scatterplot Timecourse View

· Include %Change from Baseline in selected multi-study visualizations

2.1.2 Software update characteristics:

· All software new version release during the contract performance period. Comment by Sahoo, Sanjay: I see it here. but it's not a salient feature. We need to separate the salient features vs. software upgrade and delivery methods.

Suggestion to keep two sections: (1) Software Salient Features; (2) Software Management (which must cover Versioning, Fixes, deployment schedule, installation documents so on...)

Comment by Kang, Jing: @Sahoo, Sanjay Once I get answers from Certara, I will reorganize this section. Comment by Chang, Isaac A.: I'm wondering whether a salient characteristic is that it must be compatible with Send Explorer Warehouse database. You already have it in existence so you are claiming compatibility to something you already have. This is not a sole-source justification. That could be done by Cetera or another SEW reseller. My concern is if the technology platform is anything else, you have to rebuild your SEW database all over again. Comment by Chang, Isaac A.: I checked with Karen... this approach should be allowable. Comment by Kang, Jing: Updated per Isaac's comments

· All software version must be compatible with FDA’s existing SEND Explorer database.

· All software bug fix patches during the contract performance period.

· All usual manual updates due to the software upgrade during the contract performance period.

· All Deployment and installation documents due to the software upgrade during the contract performance period.

· Refresh of technology to Oracle 19c Enterprise Edition, .NET v10, and D3v6

· Point releases are made available between point releases to address high priority bug fixes and performance issues

2.2 The technical support shall provide the following:

· Answering questions regarding SEND Explorer Warehouse, or equal to solution, from FDA Users

· Help OCS and FDA OIMT Deployment team to modify vendor’s technical documents for software upgrade, installation and system configuration in FDA’s develop, test, pre-production and production environments

· Provide real time consulting for FDA deployment team when FDA asks for help and technical insight of software upgrade

· Provide online training classes for users and administrators

· Provide troubleshooting Comment by Chang, Isaac A.: When you say "providing study loading support" that sounds like Labor hours that exceed support that comes with the standard bundled license. Do you need this line? I would recommend rewording (or deleting) Not sure that isn't covered by the last bullet.

· Consultation on performance tuning and additional needs

3. Deliverables

3.1 Service and Maintenance Delivery

The software and license file shall be delivered either by secure electronic file transfer or a physical media such as a CD.

The physical delivery shall be considered an alternative method when electronic delivery is not available due to the unforeseen technical difficulties. The physical delivery shall be shipped to:

Office of Computational Science ATTN: Jing Kang 10903 New Hampshire Avenue Silver Spring, MD 20993 Email: jing.kang@fda.hhs.gov

4. Administrative Details

4.1 Performance Period

The period of performance is 09/15/2026-09/14/2027.

4.2 Contract Type

This will be a firm-fixed price contract type.

4.3 COR Information

Jing Kang - jing.kang@fda.hhs.gov

5. 508 Standards

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 and new revision are available at http://www.section508.gov/.

All deliverables must meet HHS 508 compliance formatting based on the criteria available on HHS’s Making Files Accessible web page: https://www.hhs.gov/web/section-508/index.html The following Section 508 provisions apply to the content or communications material identified in this SOW:

· Must meet WCAG 2.0 A and AA

· 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, Application and Scoping 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.

· E207 - Software (Appendix A, Application and Scoping Requirements)

· E208 - Support Documentation and Services (Appendix A, Application and Scoping Requirements)

· Chapter 5 - Software (Appendix C, Functional Performance Criteria and Technical Requirements)

· Chapter 6 - Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

6. FDA IT Privacy and Security

A. Baseline Security Requirements

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

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

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

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

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

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

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

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

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

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

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

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

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

[ x ] No PII [ ] Yes PII

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

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

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

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

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

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

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

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

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 a full PIA needs to be completed.

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

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

B. Training

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

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

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

C. Rules of Behavior

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

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

D. Incident Response

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

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

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

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

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

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

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

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

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

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

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

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

E. Position Sensitivity Designations

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

F. Homeland Security Presidential Directive (HSPD)-12

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

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

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

G. Contract Initiation and Expiration

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

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html

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

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

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

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

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, coping the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/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.