20-FDA-SOL-1221384 Attachment C TO1 FDA OIMT-OIS Risk and Vulnerability Assessment SOW.pdf

RFP # 20-FDA-SOL-1211384 Cybersecurity IDIQ

Attachment C

Task Order #1 FDA OIMT-OIS Risk and Vulnerability Assessment

TASK ORDER # 1

STATEMENT OF WORK

Food and Drug Administration (FDA)

Office of Information Management and Technology (OIMT) Office of Information Security (OIS)

Risk and Vulnerability Assessment Contract

1.0 Background

The United States Food and Drug Administration is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, and veterinary products. The FDA’s primary mission is to protect and promote the public health of U.S. consumers and individuals around the world.

FDA’s scientific and regulatory health mission is facing increased internal and cyber threats to FDA information and IT infrastructure. These new and sophisticated threats call for a more dynamic information security program.

The FDA is required to protect vast quantities of sensitive information:

▪ Intellectual Property

▪ Trade Secrets

▪ Proprietary Information

▪ Company Confidential Information

▪ Personally Identifiable Information

▪ Protected Healthcare Information

▪ Classified and Acquisition Information

The FDA Office of Information Management and Technology (OIMT), Office Information Security (OIS), headed by the Chief Information Security Officer (CISO), directs and implements the FDA Information Security Program to ensure security controls are appropriately applied to FDA systems for the protection of privacy and to ensure confidentiality, integrity, and availability of information. The CISO leads the OIS Staff in meeting security compliance requirements in accordance with the Federal Information Security Modernization Act (FISMA) 2014, HHS, GSA, OMB, and other federal IT security-related statues.

▪ Computer Security Act, PL 100-235

▪ Federal Information Security Modernization Act (FISMA) of 2014, part of the E-Government Act of 2002

▪ OMB Circular A-130 and Appendix III, Security of Federal Automated Information Resources

▪ Presidential Decision Directive 63 (PDD 63)

▪ Department of Health and Human Services, Policy for Information Systems Security and Privacy

▪ E-Government Act of 2002

▪ Clinger-Cohen Act of 1996

▪ Computer Fraud and Abuse Act of 1986

▪ FDA Information Resources Management – IT Security Staff Manual Guides - 3250 Series

▪ FIPS PUB 199, Standards for Security Categorization of Federal Information and Information

Systems

▪ FIPS PUB 200, Minimum Security Requirements for Federal Information and Information

Systems

▪ NIST Special Publications – 800 Series

▪ Executive Order 13636, Improving Critical Infrastructure Cybersecurity

▪ Executive Order 13800, Strengthening the Cybersecurity of Federal Networks and Critical

Infrastructure

2.0 Objective

The FDA requires a Risk and Vulnerability Assessment. The contractor must demonstrate a high degree of expertise and experience in the Cyber/IT Security fields. The contractor shall be well versed in conducting testing, assessment, and analysis of target systems with state-of-the-art tools and highly trained security experts. The contractor shall specifically provide this support in accordance with the Federal Information Security Modernization Act of 2014 (FISMA) (44 U.S.C. 3541) to assess the FDA enterprise network and evaluate the cybersecurity posture when compared to best practices, regulations, policies and standards relating to IT and cybersecurity.

The contractor shall plan, execute, coordinate, and conduct vulnerability assessments. The contractor shall perform exploitation of identified vulnerabilities with the use of automated tools and scripts as well as manual attempts to access the FDA network, systems, and/or applications. The Risk and Vulnerability Assessment shall include:

▪ Rules of Engagement Agreement

▪ Network Penetration Test

▪ Assessment Finding Reporting

▪ Transition Out

The level of effort to complete the Risk and Vulnerability assessment shall include a minimum of 1,000 targets endpoints or as defined by FDA.

3.0 Requirements

3.1 Task – Rules of Engagement (RoE)

As the initial task of the Risk and Vulnerability Assessments, the contractor shall coordinate with the Contracting Officer’s Representative (COR) and FDA’s Technical Representative(s) to prepare a Rules of Engagement (RoE) agreement which identifies key aspects and terms for a network penetration test as outlined by the FDA Chief Information Security Officer (CISO).

At minimum, the Rules of Engagement shall include:

1. Methodology

2. Assessment Period, schedule and duration

3. Communications

a. Points of contact for both the FDA and the penetration team.

b. Communication process of activities, issues and concerns while the Network Penetration Testing is actively in progress.

c. Network Penetration Test Report Outline

4. Network Penetration Tools used

5. List of FDA Target systems and network segments.

6. Risks and limitations including how critical and high-risk events will be coordinated with the FDA team as well as criteria for suspension of the Network Penetration Testing to resolve an event.

7. Schedule and duration of the Network Penetration Test.

8. Transition In and Out approach including information on:

a. Tool installation and removal

b. Briefing of the results

c. Final Results Report.

9. Signatures (FDA and Network Penetration Test Team) accepting the terms of the RoE.

The Government will provide a previous example of a Rules of Engagement, if requested.

3.2 Task – Network Penetration Tests

The contractor shall perform Network Penetration Testing that consist of evaluating the security of the FDA Information Technology Infrastructure by attempting to gain unauthorized access to the computer network, systems, and/or applications. The process shall involve an active analysis for any potential vulnerability that could result from poor or improper configuration, known and unknown software/hardware flaws, and/or operational weaknesses in processes and technical countermeasures.

The analysis shall be carried out from the position of an advisor/hacker and involves active exploitation of vulnerabilities where the contractor attempts to compromise the FDA assets.

The Network Penetration Tests shall attempt to exploit vulnerabilities that have been identified in the FDA hosts, applications, databases, or other computer related resources. The test results shall detail the risk exposure and demonstrate how vulnerabilities can be exploited to gain access to FDA systems. The contractor shall include recommendations and remediation actions necessary to lower the agency’s risk exposure.

During the Network Penetration Tests, the contractor shall not delete, replace, or move any data, make every attempt not to disrupt current operations, and shall not perform denial of service attacks.

3.3 Task – Assessment Finding Reporting

The contractor shall:

1. Provide a post Risk and Vulnerability Assessment briefing that outlines the network penetration test results and is no longer than 90 minutes (including questions and answers).

2. Provide a written report of the results of the Network Penetration Test. At a minimum, the report shall include the following sections:

a. Executive Summary of the Host Exploitation Success and Failures.

b. Summary of the Network Penetration Test executed.

c. Findings Report which includes the recommended remediation steps which are founded in industry standard best practices, i.e. CVE, NIST, etc.

3.4 Task – Transition Out

The contractor shall provide a written report the outlines the penetration tools installed onto the FDA environment and validates the removal of any installed penetration tools or configuration changes. This written report shall also validate that no FDA data has been removed or unsecured during testing and that the vendor has purged all FDA related data upon completion of all testing and reporting at the end of the assessment FDA may accept configuration changes that were identified as improving the FDA cybersecurity posture.

4.0 Contract Deliverables

The contractor shall provide the following deliverables to the designated Contracting Officer Representatives (COR) for acceptance.

1. Rules of Engagement (ROE) As defined in Task 3.1

a. Schedule: Determined by FDA Points of Contact, COR or designated FDA expert

b. Format: Adobe Acrobat

c. Delivery Method: Email as attachment

d. Deliver To: COR and FDA Technical Points of Contract

2. Network Penetration Test As defined in Task 3.2

a. Schedule: Determined by RoE Agreement

b. Format: Not Applicable

c. Delivery Method: Not Applicable

3. Risk and Vulnerability Assessment Report As defined in Task 3.3

a. Schedule: within 30 day upon completion of Network Penetration Testing.

b. Format: Microsoft Word or Adobe Acrobat PDF

c. Delivery Method: Email as attachment

4. Formal Post Assessment Briefing. As defined in Task 3.3

a. Schedule: within 5 days after the completion of the Network Penetration Test

b. Format: Microsoft Word, PowerPoint or Adobe Acrobat PDF

c. Delivery Method: Presentation

5. Tool Removal Validation. As defined in Task 3.4

The vendor will provide written proof that the FDA environment was restored to the state prior to

a. Schedule: After acceptance Formal Post Network Penetration Test Briefing

b. Format: Microsoft Word or Adobe Acrobat PDF

c. Delivery Method: Presentation

5.0 Government Furnished Property/Information

The Government will provide the Rules of Engagement (ROE) for the Risk and Vulnerability Assessments, if requested. The Government may provide a laptop, if required.

6.0 Period of Performance

The period of performance is for one (1) year from award.

7.0 Place of Performance

The contractor shall perform the primary work onsite at:

Food and Drug Administration (FDA) 3 White Flint North (3WFN) Building 11601 Landsdown Street North Bethesda, MD 20852

Work may also be required at the FDA White Oak Campus in Silver Spring, MD.

All meetings with agency staff will be held at various FDA offices in the Washington, D.C. metropolitan area unless otherwise specified. No local travel will be reimbursed.

FDA Site Requirements

All contractors are required to wear personal protection equipment (PPE) in FDA facilities until otherwise directed. At a minimum, the contractor shall wear a face covering at all times. Guidance may change at any time during the performance of this task order.

8.0 Service Level Agreement

This statement of work establishes the understanding that the contractor will plan, execute, coordinate, and conduct the risk and vulnerability assessment process as outlined in the guidance set forth in FISMA, NIST Special Publications 800-30, 800-37, 800-53 Rev. 4, 800-115 and other NIST 800 series publications as required.

9.0 Information and Communication Technology Requirements – Section 508

Section 508 standards are applicable to this contract. See clause HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015) in the Applicable Clauses and Conditions section.

10.0 Security and Privacy

See Appendix 1 (attached)

11.0 Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017)

This is applicable for this task order. Reference base contract terms and conditions for complete requirements.

The contractor shall provide staff who have an active Public Trust, Moderate Level Tier 2S (previously Level 5) background investigation.

12.0 Order Type

This task order is firm fixed price.

13.0 Points of Contact

Contract Specialist Contracting Officer Michelle Dacanay Phillip Frame 4041 Powder Mill Road 4041 Powder Mill Road Room 41025B Room 42053 Beltsville, MD 20705 Beltsville, MD 20705 Phone: 301-796-0447 Phone: 240-402-7578 Email: Michelle.Dacanay@fda.hhs.gov Email: Phillip.Frame@fda.hhs.gov

Contracting Officer’s Representative Provided at award

14.0 Clauses

352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements) mailto:Michelle.Dacanay@fda.hhs.gov mailto:Michelle.Dacanay@fda.hhs.gov mailto:Phillip.Frame@fda.hhs.gov mailto:Phillip.Frame@fda.hhs.gov

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

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

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

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

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the contractor at its own expense.

(End of clause)

APPENDIX A

Procurements Requiring Information Security and/or Physical Access Security

A. Baseline Security Requirements

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

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

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

2) Safeguarding Information and Information Systems. In accordance with the Federal

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

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

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

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

and

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

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location.

In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

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

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

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

Confidentiality: [ ] Low [ ] Moderate [ ] High Integrity: [ ] Low [ ] Moderate [ ] High Availability: [ ] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [ ] Moderate [ ] High

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

[ X ] No PII [ ] Yes PII

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

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

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

a. marked appropriately;

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

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal 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

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

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

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

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

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

The confidentiality, integrity, and availability of such information shall be protected in accordance with //HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

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

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

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

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

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

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

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

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

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

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

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

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

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

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

http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf

b. The Contractor shall assist the procuring activity representative, program office and the

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

B. Training

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

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

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

C. Rules of Behavior

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

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

D. Incident Response

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

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system;

or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or

(2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

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

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

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

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

company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

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

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

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

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

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

E. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

F. Homeland Security Presidential Directive (HSPD)-12

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

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

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

G. Contract Initiation and Expiration

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

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

HHS EA requirements may be located here:

https://www.hhs.gov/about/agencies/asa/ocio/index.html

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

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

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

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

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

H. Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm