Attachment A - Statement of Work .pdf

Food and Drug Administration (FDA)

Office of Facilities Engineering and Mission Support Services (OFEMS)

Attachment A: Statement of Work

Facility Management System (FMS) Systems Administration and Data Management

1. Background

In response to Executive Order 13327, Federal Real Property Asset Management, the Food and

Drug Administration (FDA) implemented an automated Facility Management System (FMS) to track facilities and report to the Department of Health and Human Services (HHS) quarterly. U.S.

population growth and demographic trends continue toward an increasingly aged and longer-lived population, with attendant increasing health care expectations and needs. Consequently, the volume and scope of FDA services continues to increase. FDA staff increases to meet these needs continue to grow year after year, with the immediate cause being user fee legislation and other drivers. Simultaneously, government policy in the interest of budget limitation, space use efficiency, and environmental stewardship limits the FDA’s ability to acquire additional space to house staff. FDA relies on the FMS data to support requests for additional space and for daily space management in existing facilities.

The current FMS is called ARCHIBUS. FDA currently uses the following ARCHIBUS modules:

Real Estate Portfolio Management, Space Planning & Management, Building Operations, and

Extensions & Frameworks. FDA may implement additional modules in the future. The FMS has become the system of record for personnel location and is an integral part of facilities strategic planning for the Agency. ARCHIBUS has a 2-way information flow with FDA’s enterprise personnel system.

FDA is currently using version 26.2 in ARCHIBUS Smart Client, ARCHIBUS Web Central, and the Smart Client Extension for AutoCAD. After the award of this contract, FDA may upgrade to new versions as they are released.

2. Objectives

The objectives of this contract, for which the Contractor shall be responsible for fulfilling, are to work in coordination with, and under the direction of, OFEMS staff to: provide continual FMS administration and support with minimal system lag; meet FDA information technology (IT) system and reporting requirements; meet FDA information technology security system and reporting requirements; ensure accurate and timely responses to Federally mandated reporting;

provide real-time end-user assistance, trouble shooting, and any requested data; communicate system changes and provide training; provide comprehensive project plans for FMS solutions;

and complete additional FMS tasks, as required.

3. Requirement

The Contractor shall provide support services in the form of system administration, software installation and implementation, data maintenance, user guides, user training, and continued implementation of an automated facility management system (i.e., ARCHIBUS); support project teams involved in space planning, alteration, construction, and repair projects for facilities owned and/or operated by FDA; provide the computer-aided design (CAD)/computer-aided facility management (CAFM) administration for FDA; and provide helpdesk support to end users.

4. Specific Task Requirements/Qualifications/Deliverables

The Contractor shall perform the following tasks in support of facilities and FDA components, as assigned:

I. GENERAL

A. Support Services - The Contractor shall provide support services in the form of system administration, data maintenance, user training, and continued implementation of an automated FMS (i.e., ARCHIBUS); supporting project teams involved in space planning, alteration, construction, building operations, and repair projects for facilities owned and/or operated by FDA; and serving as the CAD/CAFM Administrator for FDA.

1. The Contractor must be a current authorized ARCHIBUS business partner in good standing, who can demonstrate the appropriate skills in the current version of the software which includes all modules and consoles within the ARCHIBUS product line, especially with the features and functionality the FDA is deploying (i.e., the real property and lease management, space management, building operations, overlay with design management for AutoCAD, hoteling, preventive maintenance, on-demand work, service desk, strategic master planning, project management, and portfolio forecasting modules).

2. In providing the required services, the Contractor shall apply its familiarity with the reporting requirements imposed by the Federal Real Property Council (FRPC); work with other Federal agencies, as necessary, in the areas of space management and real property asset inventory management; and work with Federal clients using the

ARCHIBUS product.

B. Customer Service – OFEMS is a customer service organization. The Contractor shall provide the highest level of professional customer service to customers in OFEMS and in other organizations within FDA.

C. Communication – The Contractor shall keep the FDA program manager continually informed of project status, system changes, data requests, meeting outcomes, and IT requirement changes.

D. Independence - The Contractor is expected to work pro-actively and independently, and to schedule and manage work effectively.

E. Reporting – The Contractor shall provide meeting minutes and project reports, as requested.

F. Mandatory Training – The Contractor’s staff shall complete any and all FMS-related training required by FDA, within set timeframes, at the Contractor’s expense.

G. Security Clearance – All Contractor staff shall be required to pass FDA security requirements, including a background check, so they can be officially badged to work in

FDA space and access the FDA network. See Attachment E, FDA Personnel Security

Requirements, for requirements related to Security Clearance of all contractor staff.

H. Travel – The Contractor may be required to travel as needed. If travel is required, it must be pre-approved in writing by the COR. Actual travel costs may be reimbursed by FDA at the Government rate and are subject to the limitations contained in the Federal Travel

Regulations.

I. Alternate Work Location

1. The FMS Systems Administrator/Data Manager may work at a contractor provided alternate location (e.g. telework) if they are able to perform all tasks/requirements and responsibilities stated within this SOW. If the COR or FMS Program Manager finds that the FMS Administrator/Data Manager is unable to perform these tasks at an alternate location (e.g. telework) it will be expected that the duties must be performed on-site within OFEMS’ designated area.

II. The FMS SYSTEMS ADMINISTRATOR/DATA MANAGER shall perform the following tasks (minimum of 10 years of experience is required):

A. System Administration – Perform all tasks necessary to maintain a functional database, including but not limited to:

1. Complying with FDA IT and IT Security requirements – represent OFEMS in IT discussions, report on meetings, and advise OFEMS for IT related actions.

2. Assist with data migration – includes any new systems/databases related to the FMS implemented at FDA or HHS for reporting purposes.

3. Software:

a. Manage and execute FMS software installation.

b. Create and maintain software installation guides.

c. Provide system and module information, as requested.

d. Demonstrate available modules for possible use by FDA.

e. Implement new modules.

f. Manage, execute, and document version upgrades.

4. User Accounts:

a. Create new user accounts.

b. Maintain user accounts and access – including periodic review of usage, identifying inactive accounts, deleting accounts, as necessary, provide reports, as needed.

c. Create and manage user navigation.

d. Maintain and create user roles and user restrictions for different levels of access.

5. Reporting:

a. Provide any required reporting in a timely manner.

6. Documentation:

a. Create and maintain system procedures.

b. Create and maintain system upgrade procedures.

c. Draft and deliver information for data calls.

d. All documentation must be stored on a shared network drive accessible to the FMS

Program Manager.

7. User guides – Draft, finalize, maintain, disseminate.

8. Initiate and monitor communication and data flow between FMS and other systems.

9. Reset the system when failure occurs; communicate status via system notifications to

OFEMS and end users.

10. CAD Integration – The FMS Administrator must have expert level ability (i.e., the ability to perform the tasks with ease and independence) with ARCHIBUS, AutoCAD, and Auto

CAD Architecture (experience with Revit will be considered a strength):

a. Maintain integrations with AutoCAD.

b. Maintain and develop AutoCAD toolbars and menus related to the integration of the

FMS.

c. Ensure all FMS capabilities in AutoCAD are functional and the AutoCAD user can perform the necessary changes to, but not limited to:

i. Room Category

ii. Room Type

iii. Room Standard

iv. Seating Capacity

v. Center assignment

vi. Office/Branch assignment

vii. Floor and Room number assignment

viii. Prorate assignment

11. ARCHIBUS Views – Utilize knowledge and understanding of FDA’s requirements;

creating, testing, and publishing views, as appropriate.

12. Maintain ARCHIBUS Background data and resolve all data integration issues.

13. Create ARCHIBUS Web view definitions.

14. Create ARCHIBUS JAVA and JAVA Script programs.

15. Link new CAD drawings to the ARCHIBUS database.

16. Maintain ability to view floor plans in the FMS that includes FDA standards, Center restrictions, and specified room data specific to each Center/Office.

B. Data Manager – Perform all tasks necessary to maintain data accuracy and integrity, including, but not limited to:

1. Real Property Inventory Reporting updates, additions, and data maintenance – ensure FMS continues to meet information management and reporting requirements imposed by FRPC, HHS, and FDA.

2. Assist with FRPC data elements:

a. Inventory.

b. Existing Reports/New Reports.

c. Views – maintenance and additions.

d. History files – maintenance.

3. HHS Automated Real Property Inventory System (ARIS) Data:

a. Identify data elements; perform data mapping and migration between FDA ARIS table and HHS automated system of record.

b. Upload data, as required by FRPC, HHS, and FDA.

c. Perform verification and validation to confirm transferred data is accurate.

d. Assist with migration of ARIS data to additional systems, including those used by

HHS, OMB, GSA, etc. (includes any new systems that come online and require input from ARIS data).

4. Preventive Maintenance and On-Demand:

a. Load and maintain data lists; which includes, but not limited to, equipment and parts.

b. Act as point of contact for end users.

c. Maintain staff lists and roles.

d. Implement features and additional maintenance modules, as appropriate.

e. Maintain scheduling updates.

f. Develop Work Requests.

g. Maintain equipment SOPs.

5. Location and Personnel Data:

a. Maintain personnel data – updates, changes, adding additional fields.

b. Maintain location data – building, floor, and room data for all facilities.

i. Manage and assign room categories, capacity and types.

ii. Manage and assign room center and office/branch.

iii. Load and review room and employee data.

6. Assist with developing reports and provide various reporting data to support the Agency’s

Cost Allocation Team and Working Capital Fund.

IV. OTHER REQUIREMENTS:

1. A kickoff meeting shall occur within 10 business days after the contract effective date.

2. A transition meeting shall occur within 10 business days after the kickoff meeting to review current projects and set deadlines.

5. Place of Performance

The majority of project locations will be in the Washington, D.C./ National Capital Region/FDA

Headquarters (HQ), including, but not limited to, locations in Montgomery County and Prince

George’s County, Maryland. Additional project locations may include FDA owned or leased facilities throughout the United States. ARCHIBUS software is to be provided for FDA locations throughout the United States. Administration will be managed within the FDA Headquarters offices located at: 10903 New Hampshire Ave, Silver Spring, MD 20903

6. Period of Performance

Base Year is 03/24/2025 – 03/23/2026

Option Year 1 is 03/24/2026 – 03/23/2027

Option Year 2 is 03/24/2027 – 03/23/2028

Option Year 3 is 03/24/2028 – 03/23/2029

Option Year 4 is 03/24/2029 – 03/23/2030

7. Contract Type

It is anticipated a Firm Fixed Price order.

8. Security

All Contractor staff shall be required to pass FDA security requirements, including a background check, so they can be officially badged to work in FDA space and access the FDA network.

INFORMATION SECUIRTY REQUIREMENTS

I. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification

(hereafter "contract"), or portion thereof, includes either or both of the following:

i. 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.

b. 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.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor

FAR and HHSAR clauses as needed.

d. 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:

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.

e. 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:

i. Marked appropriately;

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

iii. 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

iv. 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.

f. 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.

g. 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.

h. 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).

i. 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).

j. 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.

k. 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.

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

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

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

ii. 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.

iii. 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).

iv. 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.

v. 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.

n. 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.

1. Training Requirements

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.

2. 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.

3. Incident Response

o. 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.

p. 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.

4. 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: Tier 1 Low Risk, Non-Sensitive, including HSPD-12 Credentialing

5. 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.

6. 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.

7. 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/EPLCHome.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.

q. 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.

r. 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.

s. 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.

t. 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/default.h tm 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.

8. 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.

b. 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.

Government Information Processed on GOCO or COCO Systems

A. Security Requirements for GOCO and COCO Resources

1) Federal Policies. The Contractor (and/or any subcontractor) shall comply with applicable federal laws that include, but are not limited to, the FDA Information Security and Privacy Policy

(IS2P), Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101);

National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, Security and Privacy Controls for Federal Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Departmental policies.

2) Security Assessment and Authorization (SA&A). A valid authorization to operate (ATO) certifies that the Contractor’s information system meets the contract’s requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s). The Contractor shall conduct the SA&A requirements in accordance with FDA IS2P, NIST SP 800- 37, Guide for Applying the Risk Management

Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, FDA must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

FDA acceptance of the ATO does not alleviate the Contractor’s responsibility to ensure the system security and privacy controls are implemented and operating effectively.

a. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within a timeline directed by the COR, per to FDA EPLC process, to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package:

• System Security Plan (SSP) – due a week prior to the start of the annual security assessment. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security

Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and FDA policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the

Contractor’s bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system, as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter. Security

Assessment Plan/Report (SAP/SAR) – due before the system is made available to standard users.

The security assessment shall be conducted by FDA’s team of security assessors, unless otherwise noted and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and FDA policies. The assessor will document the assessment results in the SAR.

• Independent Assessment – This shall be coordinated through the FDA Information

Security program.

• POA&M – due as part of the SAR. The POA&Ms shall be documented consistent with the HHS and FDA Standard for Plan of Action and Milestones and FDA policies. All high-risk weaknesses must be mitigated within 30 and all medium weaknesses must be mitigated within

[60 from the date the weaknesses are formally identified and documented. FDA’s assessors will determine the risk rating of vulnerabilities.

Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as noted in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, FDA may require designated POA&M weaknesses to be remediated before an ATO is issued. Thereafter, the

POA&M shall be updated at least quarterly.

• Contingency Plan and Contingency Plan Test – due before the start of the annual security assessment. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and

FDA policies. Upon acceptance by the System Owner, the Contractor, in coordination with the

System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed.

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

• E-Authentication Questionnaire – The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-

Auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-Auth RA) is necessary. System documentation developed for a system using E-Auth TA/E-Auth RA methods shall follow OMB 04-04 and NIST SP 800-63 Digital Identity Guidelines document suite.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E- Auth (when required) in accordance with HHS and FDA policies.

b. Information Security Continuous Monitoring. Upon the government issuance of an

Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and

NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information

Systems and Organizations, and FDA IS2P. The following are the minimum requirements for

ISCM:

• Annual Assessment/Pen Test - Assess the system security and privacy controls (or ensure an assessment of the controls is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (this may involve penetration testing conducted by the agency or an FDA-authorized independent third-party for all high impact systems. In addition, review all relevant SA&A documentation

(SSP, POA&M, Contingency Plan, etc.) and provide updates by specified due date.

• Asset Management - Using an FDA-approved Security Content Automation Protocol

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

• Configuration Management - Use FDA-approved SCAP-compliant automated tools, per

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

• Vulnerability Management - Use FDA-approved SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets

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

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

• Secure Coding - Follow secure coding best practice requirements, as directed by United

States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web

Application Security Project (OWASP), that will limit system software vulnerability exploits.

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

3) Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to the

Contractor’s facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

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

(whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract.

The Government includes, but is not limited to, the U.S. Department of Justice, U.S. Government

Accountability Office, the HHS Office of the Inspector General (OIG), and FDA Information

Security. The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include, but not be limited to, such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

b. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity.