Attachment A_ SOW.pdf

Food and Drug Administration (FDA)

Office of Facilities Engineering and Mission Support Services (OFEMS)

Attachment A: Statement of Work

For

Facility Management System (FMS) 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 limit 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 C, 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 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.

2. The Developer/CAD Technician 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

Developer/CAD Technician 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 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/CAFM – 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. Review 3rd party architectural and engineering construction documents.

b. Utilize knowledge and understanding of space standards and methodologies, including, but not limited to, the BOMA office space standard.

c. Formulate utilization rates for FDA facilities using appropriate formulas.

d. Document and communicate CAD/CAFM changes.

e. Develop and communicate drawing standards.

f. Maintain master drawings electronically.

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.

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.

a. Interface with GSA to provide rent and leased operating costs.

b. Perform thorough analyses of leased and owned operating costs and variables associated with those costs.

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.

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.

III. The DEVELOPER\CAD TECHNICIAN (minimum 5 years of experience is required) and shall perform the following tasks:

1. Login difficulties:

. Create new user accounts.

2. Create, test, and publish views, as appropriate per FDA requirements

3. Create ARCHIBUS Web view definitions.

4. Create ARCHIBUS JAVA and JAVA Script programs.

5. Preventive Maintenance and On-Demand:

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

b. Maintain staff lists and roles.

c. Maintain scheduling updates.

6. 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.

7. Report requests – Data calls.

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

9. System Notification backup.

10. Review architectural and engineering construction documents.

11. Utilize knowledge and understanding of space standards and methodologies, including, but not limited to, the BOMA office space standard.

12. Respond to ad hoc requests from end users for specifically prepared drawings.

13. Convert CAD drawings to meet FDA layering standards.

14. Link new CAD drawings to the ARCHIBUS database.

15. Develop polylines and link polylines to the Archibus database.

16. Update Archibus room data within the associated CAD drawing.

17. Perform other drawing needs, as assigned by OFEMS.

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 related to office space 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.

9. Inspection and Acceptance Criteria

The FDA COR is responsible for the inspection and acceptance of the deliverables for this requirement.

10. Other Pertinent Information or Special Considerations

The Contractor should be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools.

11. Post-Award Administration

Completion of all deliverables, quality and timeliness of delivery, as well as incidents and types of defects, will be used to evaluate the Contractor’s progress and suitability.

12. Point of Contact

Contract Specialist: TBD at time of Solicitation

FDA, Office of Acquisitions and Grants Services

Email:

Contracting Officer’s Representative:

William Wirt

FDA, OFEMS

Email: William.Wirt@fda.hhs.gov

13. Contracting Officer Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this contract/order and notwithstanding any provisions contained elsewhere in the contract/order, the said authority remains solely with the CO. In the event the

Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract/order and modify any term or condition of the contract/order. The CO is the only individual who can legally obligate Government funds.

The COR or Project Officer is not authorized to make any commitments or otherwise obligate the

Government or authorize any changes which affect the order price, terms or conditions. The

COR/Project Officer is responsible for the technical aspects of the project and serves as technical http://www.section508.gov/ mailto:William.Wirt@fda.hhs.gov liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the delivery order.

14. Authorized Reseller/Servicing Agent

Offeror must certify that it is a current ARCHIBUS Business Partner in good standing as of the date of the submission of its bid.

15. 508 Requirements and Security Requirements

Deliverables will conform to 36 CFR Part 1194.41, "Information, Documentation and Support," and 36 CFR Part 1194.24 "Video and Multimedia Products" which are of particular importance with regard to all written, graphical or broadcast, video materials or products produced for HHS

(to include training). 36 CFR Part 1194.41 outlines the requirements supporting services for products accommodating the communication needs of end-users with disabilities.

C.A. Section 508

This language is applicable to Statements of Work (SOW) or Performance Work Statements

(PWS) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a

Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards.

This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access

Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR)

Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition

Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable

Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable

Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

• § 1194.21 - Software applications and operating systems.

• § 1194.22 - Web-based intranet and internet information and applications.

• § 1194.31 - Functional performance criteria.

• § 1194.41 - Information, documentation, and support.

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

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

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/EPLC

Home.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.htm as soon as it is known that a contract an employee will terminate work under this contract. The Contractor (and/or any subcontractor) shall coordinate with the

COR via email, copying the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system. All documentation must be available to the CO and/or COR upon request.

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

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.