Attach_01b_General_Requirements.docx

RFP No. 277-19-0531 Attachment 1b: General Requirements

General Requirements

Section C: Services to be Performed The Contractor shall account for project funding necessary to meet all requirements specified in Section C, including but not limited to activities supporting IT security and privacy, Section 508 compliance, and web content development, management, and migration.

1. Independently, and not as an agent of the Government, the Contractor shall furnish the necessary personnel, labor, equipment, software, services, materials, and supplies, except as otherwise noted specifically herein to perform the work set forth below.

2. All work under this contract/task order will be monitored by the Contracting Officer’s Representative (COR).

Part 1. SAMHSA INFORMATION TECHNOLOGY (IT) CONTRACT REQUIREMENTS

I. Federal and SAMHSA Standards and Terminology A. Data and copyrights

1) “Data” means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information.

2) Before development of any software for SAMHSA, the contractor shall understand and communicate any questions to SAMHSA regarding FAR Subpart 27.4 – Rights in Data and Copyrights.

3) The contractor shall not integrate any proprietary or commercial licensed software that cannot be severable at close out without the government incurring licensing costs or loss in functionality.

B. Systems

1) The term “information system” means a discrete set of information resources organized for the collection, processing, maintenance, transmission, and dissemination of information, in accordance with defined procedures, whether automated or manual.

2) For additional guidance, see OMB Circular A-130.

C. Major investments

1) An Earned Value Management System (EVMS) is required for major acquisitions that include development activities, in accordance with OMB Circular A-11.

2) The Government may also require an EVMS for other acquisitions, in accordance with agency procedures. See FAR Subpart 52.234-2 – Notice of Earned Value Management System for additional guidance.

D. SAMHSA technology standards

1) SAMHSA’s Capital Planning Investment Control (CPIC), Enterprise Architecture, Mobile, Privacy and Security and Website technology standards are available, see: SAMHSA Technology Standards.

E. Federal records

1) “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, function, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record:

i. includes SAMHSA/HHS records;

ii. does not include personal materials;

iii. applies to records created, received, or maintained by Contractors pursuant to their SAMHSA contract; and

iv. may include deliverables and documentation associated with deliverables.

2) Library and museum material made or acquired and preserved solely for reference or exhibition purposes or duplicate copies of records preserved only for convenience are not included (44 U.S.C. 3301).

F. Electronic records

1) Any information that is recorded in a form that only a computer can process, and that satisfies the definition of a federal record in 44 U.S.C. 3301.

2) Electronic records include numeric, graphic and text information, which may be recorded on any medium capable of being read by a computer and which satisfies the definition of a record.

G. Federal Reporting Requirements

1) The Contractor shall provide any required information on systems, applications, or IT investments as needed to support SAMHSA’s compliance with federally mandated reporting.

Information Technology (IT) Plan A. The Contractor shall prepare an IT Plan that addresses and describes the Design, Development, Implementation, and Maintenance for all IT Systems in the contract/ task order. The IT Plan shall include:

1. Functional requirements (e.g., data, workloads, user interface, reliability, security, and maintenance

2. Technical requirements (e.g., hardware, software, and telecommunications)

3. Operational requirements

4. Any additional requirements that are needed to accurately address design, development, implementation, and maintenance

5. System architecture

6. Iterative development approach for software development

7. IT milestones and implementation dates of the project.

B. A draft IT plan shall be included as part of the proposal. The final IT Plan (Electronic Version) shall be submitted as a deliverable to the COR and DTM (through the COR) for review and approval 60 calendar days after award.

C. Full acceptance of the Contractor’s IT Plan is required before implementation and contingent upon the review and approval of DTM.

D. The IT Plan will be reviewed on an annual basis, and updated as necessary if major modifications are made to the system.

E. The contractor shall follow the Health and Human Services Enterprise Performance Lifecycle (EPLC) policy/templates or equivalent with an iterative and/or agile development approach to manage IT projects.

F. The proposal, project, schedule, and work products should clearly demonstrate an agile or iterative approach to software development.

SAMHSA’s Division of Technology Management (DTM) Standards A. The Contractor shall develop, test, and deploy all new systems and applications into the SAMHSA AWS GovCloud environment.

B. If the contract/task order is for an existing system that is not currently in the SAMHSA AWS GovCloud environment, the Contractor shall include a plan within their proposal to migrate the system to the SAMHSA AWS GovCloud within the base year of the awarded contract/task order. The contractor shall contact and meet DTM at least 60 calendar days or earlier if have a need to migrate sites from the third-party hosted service to the SAMHSA AWS GovCloud.

Note: This may not apply to systems that store and process highly sensitive data C. The Contractor shall use software that meets SAMHSA Technology Standards and has achieved the Federal Risk and Authorization Management Program (FedRAMP) authorization, where applicable. For SAMHSA technology standard, see: SAMHSA Technology Standards.

D. The Contractor shall at all times maintain compliance with current DTM standards, which may change over the duration of this contract/task order. Any deviation from the SAMHSA standards shall be negotiated with SAMHSA and approved by the SAMHSA CIO prior to contract/task order award.

Federal Information Technology Acquisition Reform Act (FITARA) Requirements H. IT Cost Reporting Contractor shall comply with OMB, HHS, and SAMHSA requirements on reporting IT costs. Contractor shall submit reports of actual and future estimated IT costs to the COR twice a year (July and November). It is the responsibility of the COR to submit the reports to DTM. A reporting template shall be provided to the Contractor upon award of contractor/task order.

I. Contract Factsheet Contractor shall work with the COR to submit or update the contract factsheet annually. For a new contract, a factsheet should be submit to the DTM FITARA team (fitara@samhsa.hhs.gov) within 90 calendar days of contract start.

J. Website Domain Registration Contractor shall work with the COR to submit domain registration information to DTM FITARA team when a new website domain name is registered or website information is requested by the DTM FITARA team.

K. Contractor shall work with COR to provide contract-related software and hardware license or registration information to the DTM FITARA Team.

L. Contractor shall work with COR to provide all project information requested by HHS data calls and the DTM FITARA Team.

Security and Privacy Requirements for SAMHSA IT Systems M. General Information Security Requirements 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 including Government-Owned/Contractor-Operated (GOCO) or Contractor-Owned/Contractor-Operated (COCO) systems. 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) Information Security Laws, Regulations, Policies

a. Federal Policies. The Contractor (and/or any subcontractor) shall comply with applicable federal laws that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P), and SAMHSA Security Policy; 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 (current version), 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.

b. Comply with all new and existing cybersecurity OMB circulars, memorandums and the President’s signed Executive Orders. The Contractor shall perform periodic reviews to ensure compliance with existing information security and privacy requirements. The Contractor shall make all system information and documentation produced in support of the contract/task order available to the agency and agency auditors upon request. All questions concerning IT security should be directed to the IT Security Team (through the COR) at infosecurity@samhsa.hhs.gov.

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

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

i. 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;

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

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

b. Perimeter defense: Contractor shall ensure that the system and the information it contains or stores are secured; using appropriate perimeter defense technologies and that these technologies are monitored for anomalous traffic behavior. Contractor shall provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS and SAMHSA 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 HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P) and SAMHSA Security Policy by contacting the SAMHSA Security team emailing infosecurity@samhsa.hhs.gov and/or emailing fisma@hhs.gov.

4) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, 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:

Overall Risk Level and Data Classification of the Current Contract Systems:

[ ] Low [ ] Moderate [ ] High

5) Protection of Personally Identifiable Information (PII). Per the Office of Management and Budget (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.”

a. Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) - All SAMHSA systems subject to the Privacy Act of 1974, 5 U.S.C. § 552A are required to conduct Privacy Impact Assessments (PIAs) before developing IT systems that contain personally identifiable information or before collecting personally identifiable information electronically. The PIA shall be completed in accordance with HHS PIA guidance, see: http://www.hhs.gov/ocio/securityprivacy/privacyresources/ pias.html.

b. The Contractor must conduct a Privacy Threshold Analysis (PTA). PTAs are used to determine if a full Privacy Impact Assessment (PIA) is needed, and is due within 30 calendar days after contract award.

c. Contractor must provide entity relationship diagrams, data types and related relationship diagrams for the data that is being stored, processed and transmitted within the system no later than 30 calendar days after the contract/task order award date to the SAMHSA Privacy Officer and SAMHSA Security through the COR by emailing at Info.Privacy@samhsa.hhs.gov.

d. The Contractor shall assist the Senior Agency Official for Privacy (SAOP) or designed representative with conducting a PTA (using the PIA form) for the information system and/or information collection project to determine whether a full PIA needs to be completed.

e. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the SAOP (or his or her designee) and other designated authorities with completing a PIA for the system or project.

i. The PIA shall be completed in accordance with HHS policy OMB M-03-22 Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002 and shall be revised at each milestone during the system development lifecycle (SDLC), see: OMB M-03-22

ii. PIAs and PTAs are required in the early stages of system development. PIAs must be reviewed within 3 years of the last PIA approval date and/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. All systems should have a PIA or PTA approved by HHS Privacy.

f. The Contractor shall create and submit draft System’s PIA no later than 45 calendar days after the contract/task order effective date (CED) to the SAMHSA Privacy Officer through the COR. All questions related to SAMHSA PIA form template and submission should be emailed to Info.Privacy@samhsa.hhs.gov through the COR.

g. Periodic reviews shall be conducted to determine if a major change to the system has occurred, and if a PIA update is subsequently required.

h. The impact of privacy violations should consider any adverse effects experienced by individuals or organizations as a result of the loss of Personally Identifiable Information (PII) confidentiality.

i. PII shall receive a level of protection commensurate with the risk associated with the loss or compromise of sensitive information.

j. The Contractor shall abide by all requirements of the Privacy Act of 1974 and FAR Clause 52-239-1, FAR 48 CFR §52.224-2 Privacy Act (includes definition of operation of a system of records), FAR 48 CFR §52.239-1 Privacy or Security Safeguards, and HHSAR 48 CFR §352.224-70 Privacy Act.

k. The Privacy Act requires Federal agencies to notify the public of systems of records by publishing SORNs to the Federal Register, see: SAMHSA SORNs.

l. Pursuant to those requirements, the Contractor shall create and publish a System of Records Notice (SORN) in the Federal Register when required and shall publish an updated SORN following a major change to the system, as directed by OMB Memorandum (M) 03-22, OMB Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002, or subsequent replacement guidance.

6) 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. See National Archives CUI” 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, see CUI Marking Handbook;

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

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

d. Returned to SAMHSA/HHS control before close of the contract, 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.

7) Protection of Sensitive Information

a. The Contractor shall ensure that sensitive information is protected by information security and privacy controls commensurate with the risk associated with the potential loss or compromise of the information.

b. 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. (See the HHS Standard for the Definition of Sensitive Information, for additional information in defining and protecting sensitive information.)

c. Sensitive information on public systems. The Contractor shall ensure that sensitive information is not stored, processed or transmitted on any system (via the Internet) without the appropriate Security controls in place and specific authorization from the SAMHSA Chief Information Officer (CIO) and/or Chief Information Security Officer (CISO).

d. Website Privacy Policy: The Contractor shall assure each page of the website, including the homepage, contains a link to SAMHSA's Website Privacy Policy, see SAMHSA Website Privacy.

· DHHS and SAMHSA policy does not allow for persistent cookies on any SAMHSA or SAMHSA-funded websites.

· Forms on the site asking users to enter personal information must first be approved through SAMHSA channels and DTM.

· Questions or assistance required for SAMHSA websites should be directed to the SAMHSA webmaster (webmaster@samhsa.hhs.gov) through the COR.

8) Secure Web Connection Requirements

a. The Contractor must comply with the secure web connection requirement. OMB requires that all publicly accessible Federal websites and web services only provide service through a secure connection using https not http; OMB Binding Operational Directive (BOD) 18-01. Additional OMB’s mandatory requirement can be found at OMB M-15-13.

b. Requirement on using Internet Protocol Version 6 (IPv6): All acquisitions using Internet Protocol must comply with FAR sections: FAR 7.105(b) (5), FAR 11.002(g), and FAR 12.202(e) (Federal Acquisition Regulation).

9) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by SAMHSA/HHS or collected by the contractor on behalf of HHS 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 SAMHSA/HHS 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 SAMHSA policies. Unauthorized disclosure of information will be subject to the HHS/SAMHSA sanction policies and/or governed by the following laws and regulations:

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

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

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

10) Standard for Encryption

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

b. The Contractor shall use FIPS 140-2 (as amended) compliant encryption (4) to protect all instances of SAMHSA/HHS information during storage and transmission.

c. The Contractor shall verify that the selected encryption product has been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2 (as amended), see: Cryptographic Module Validation Program. The Contractor shall provide a written copy of the validation documentation to the COR and SAMHSA Security team before obtaining the Authorization to Operate (ATO).

d. The Contractor shall securely generate and manage encryption keys to prevent unauthorized decryption of information, in accordance with FIPS 140-2 (as amended).

e. The Contractor shall ensure that this standard is incorporated into the Contractor’s property management/control system or establish a procedure to account for all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive SAMHSA/ HHS information.

f. The Contractor shall ensure that all of its employees, subcontractors (at all tiers), and employees of each subcontractor, who perform work under this contract/subcontract, comply with the above requirements.

g. 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.

h. 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 shall be provided to the COR and SAMHSA Security team upon request and at the conclusion of the contract.

i. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS 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).

j. Mobile device encryption

i. The Contractor shall:

· Encrypt all laptop computers, mobile devices and portable media which store or process, or may store or process, sensitive information using FIPS 140-2 compliant encryption technology

· Verify that encryption products have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2, see: Cryptographic Module Validation Program

· Establish key recovery mechanisms to ensure the ability to decrypt and recover sensitive information by authorized personnel

· Generate and manage encryption keys securely to prevent unauthorized decryption of information.

ii. For more information, reference the HHS Encryption Standard for Mobile Devices and Portable Media. (A copy of the document is available upon request.)

11) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the SAMHSA non-disclosure agreement. A copy of NDA shall be obtained from, signed and witnessed, and submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

Security Incidents Response

1) The Contractor shall immediately (within 1 hour of discovery) report all security and Personally Identifiable Information (PII) incidents to the agency COR and/or System Owner, SAMHSA’s Security Officer at infosecurity@samhsa.hhs.gov, and the Department of Health & Human Services (DHHS) Computer Security Incident Response Center (CSIRC) at CSIRC@HHS.gov or 1-866-646-7514. The Contractor (and/or subcontractor) shall provide full access and cooperation for all activities determined by the Government to be required to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. Incident response activities determined to be required by the Government may include, but are not limited to, the following:

a. Inspections

b. Investigations

c. Forensic reviews

d. Containment and damage assessment

e. Data analysis and processing

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

3) 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.

4) A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (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”.

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

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

b. 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 SAMHSA/HHS approved notifications to affected individuals after consulting with the CISO and CIO.

6) 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 shall:

a. co-operate 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.

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

8) 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. The Contractor must follow the agency reporting procedures and document the steps it takes to contain and eradicate the incident, recover from the incident, and provide a post-incident report that includes at a minimum the following:

a. Company and point of contact name;

b. Contract information;

c. Impact classifications/threat vector;

d. Type of information compromised;

e. A summary of lessons learned; and

f. Explanation of the mitigation steps of exploited vulnerabilities to prevent similar incidents in the future.

9) The Contractor (and/or any subcontractor) must implement a program of inspection to safeguard against threats and hazards to the security, confidentiality, integrity, and availability of federal data; and afford HHS access to its facilities, installations, technical capabilities, operations, documentation, records, and databases within 72 hours of notification.

Security/Privacy 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 HHS/SAMHSA Contractor Information Security Awareness and Privacy, (provided upon contract award) within thirty (30) calendar days after the award of the contract or a new employee’s start date. Thereafter, the employees shall complete HHS/SAMHSA Information Security Awareness and Privacy at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies. The Contractor shall send training records to the COR.

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 within thirty (30) calendar days after the award of the contract and annually thereafter to commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. The Contractor shall send training records to the COR.

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with SAMHSA/HHS policy. A copy of the training records shall be provided to the COR within thirty-five (35) calendar days after contract award and annually thereafter or upon request.

Rules of Behavior (ROB)

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, and sign and provide a copy to the COR within thirty-five (35) calendar days after contract award. A copy of ROB can be obtained from the COR.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department 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 Information Security Awareness Training. If the contractor provides the training, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

Homeland Security Presidential Directive (HSPD)-12

1) 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. For additional information, see HSPD-12 policy at: Presidential Directive 12.

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 shall be submitted to the COR and/or CO within thirty (30) calendar days of the effective date of this contract. Any revisions to the roster because of staffing changes shall be submitted within ten (10) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member

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

Contract Closeout

1) 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 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.

2) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system CISO as soon as possible before an employee stops working under this contract.

3) 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 SAMHSA policies. If a system needs to be decommissioned, the contractor shall request the system decommission procedures from DTM through the CO and or COR. NOTE: Request Project Closeout/System Decommission Meeting with DTM and Division of Operational Support (DOS) representatives at least 30 calendar days before the completion of the contract.

B. Security Requirements for Government Information Processed on GOCO or COCO Systems The Federal Information Security Modernization Act (FISMA of 2014, (44 U.S.C. 101)22, Office of Management and Budget (OMB Circular A-130, Managing Information as a Strategic Resource23, and Federal Procurements Regulation (FAR) 39.10124 mandate that contractor systems, including Government-Owned/Contractor-Operated (GOCO) or Contractor-Owned/Contractor-Operated (COCO) be at least as secure as government systems operated by the government.

1. Federal Policies. See baseline security requirements section.

2. Security Assessment and Authorization (SA&A). A valid authority 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 HHS IS2P/and SAMHSA Security Policy, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision). NOTE: SAMHSA’s acceptance of the ATO does not alleviate the Contractor’s responsibility to ensure the system security and privacy controls are implemented and operating effectively.

1) Contractor must be able to implement the Federal Information Security Management Act (FISMA), NIST 800-53 (current version) required security controls at the FIPS-199 Low and/or Moderate data classification level.

2) The Contractor shall assist in the security assessment and authorization (SA&A) of all systems developed for support of the contract/task order in conformance with the standards set forth by the FISMA and NIST SP800-37 (current revision), Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach.

3) Contractor must reach out to SAMHSA Security through the COR (infosecurity@samhsa.hhs.gov) to initiate the SA&A process (Authorization to Operate) within 30 days after the contract/task order effective date (CED), categorize the system and information hosted on the system in accordance with:

a. FIPS-199, see NIST FIPS PUB 199

b. Federal Information Processing Standard NIST SP 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, Table C-2 at Vol 2, see: NIST SP800-60 Vol2 Rev1.

4) The security categories and risk level shall be documented in the designated System Security Plan (SSP) for all systems within the proposal and must obtain Authorization to Operate (ATO) from SAMHSA CIO and CISO prior to system goes live into the production or becomes operational.

5) SA&A Package Deliverables - Contractor shall develop and submit ATO package (SA&A Checklist) to SAMHSA Security through the COR along with related documentation and supporting artifacts to meet applicable security controls before obtaining ATO. SAMHSA has created the checklist and SA&A package to facilitate compliance with the OMB-mandated SA&A process. The SA&A Checklist will be provided to the Contractor after contract/task order award and upon request to DTM through the COR.

6) ATO package artifacts & of deliverables are but not limited to this list:

a. Privacy Threshold Analysis (PTA)/Privacy Impact Analysis (PIA)

b. SAMHSA provided Information System Security Plan (ISSP) template along with evidences to backup compliance descriptions; 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 SAMHSA policies and other guidance.

c. Each of the 17 NIST control families prescribed in NIST Special Publication (SP) 800-53 (current version) Recommended Security Controls for Federal Information Systems, and the specific ways in which those controls are implemented must be addressed, if applicable, in the ISSP and pertinent to the function the system is designed to provide. The system security plan must be reviewed on at least an annual basis. The version numbers must be employed and revised to record when changes are made to the document.

d. System Contingency Plan: 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 policies.

e. CP Test Report

f. CP Test Lessons Learned report

g. System Account Management Plan

h. System Categorization (Low, Moderate, High)

i. System Risk Assessment

j. Evidence related to security controls implementation i.e. artifacts, supporting documentation or references to appropriate sources and other risk or security-related documents

k. Interconnection Security Agreement, where applicable

l. Vulnerability and Compliance Scan report: The Contractor shall address all “Critical” and “high” deficiencies and vulnerabilities before submitting the package to the Government for acceptance

7) This activity shall be performed in conjunction with the initial development of the system, updated when a major change occurs to the system, and renewed no less than every three years. Contractor will be responsible for ATO re-assessment if they add or delete Hardware or Software to the current ATO baseline or system accreditation boundary.

8) The SAMHSA ATO package will be provided to the Contractor after contract award and upon request to DTM through the COR. All system authorization to operate (ATO) packages shall be compliant with all Public Law (PL)-107-347, OMB mandates, FIPS, and additional applicable NIST guidance. This guidance includes, but is not limited to FIPS 199, FIPS 200, NIST SP 800-18, NIST SP 800-30, NIST SP 800-37, NIST SP 800-53 (current version), NIST SP 800-53A, and NIST SP 800-60. All NIST and FIPS documentation can be found at the NIST website.

9) 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, Rev. 2, Electronic Authentication Guidelines. 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 policies. Answers to the questionnaire shall be submitted to CISO and infosecurity@samhsa.hhs.gov within 30 calendar days after CED.

10) Contractor shall remediate security weaknesses resulting from a security authorization (ATO) process in a timely manner (Plan of Action and Milestones or POA&Ms). All Critical security findings must be addressed within seven (7) calendar days. Security relevant patches, service packs and hot fixes must be promptly installed. All High-risk findings must be addressed within 30 calendar days. All Moderate risk findings must be addressed in 60 calendar days and Low risk findings in 90 calendar days. Depending on the severity of the risks, SAMHSA may require designated POAM weaknesses to be remediated before an ATO is issued.

11) Contractor must be able to appoint a security resource on the contracting staff with at least 3 years of professional IT Security experience in FISMA & NIST. Security resource must act as liaison between SAMHSA Security & Contractor. That person must be capable of providing the services and expertise to the contractor to implement and maintain the IT security requirements and completing ATO package at the appropriate data classification level or contractor must hire a 3rd party contractor (s) who has the expertise and is capable of implementing NIST based IT security requirements at least at the Moderate data classification level.

12) The Contractor shall ensure all staff has the required level of security clearance commensurate with the sensitivity of the information being stored, processed, transmitted or otherwise handled by the System or required to perform the work stipulated by the contract/task order.

13) Contractor shall comply with all Federal and Department of Health and Human Services (HHS) security and privacy guidelines in effect at the time of the award of this contract, see HHS Cybersecurity website.

14) Contractor must establish Interconnection Security Agreement (ISA), Memorandum of Understanding (MOU), or MOU with entities external to SAMHSA and outside of their defined accreditation boundary except for connections to infrastructure general support systems that provide inherited security controls.

15) Contractor shall perform Annual Penetration Testing on the system, provide test report to SAMHSA COR and the DTM security team, and plan to remediate findings. The contractor can perform the test anytime during a contract year.

16) Contractor must have separate and segregated development, test and production environments, and must not use production data or PII date on the test environment.

17) System shall employ multi-factor authentication for access to the system.

18) Baseline Configuration Standards: Contractor IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices etc.) containing or processing information on behalf of HHS/SAMHSA data shall be configured with the applicable security configuration baselines established by the United States Government Configuration Baselines (USGCB).

a. The following actions are recommended when configuring operating systems, applications, IT products and devices:

i. Consult HHS-approved security configuration standard baselines for configuring IT products, hardware and software.

ii. If an HHS-defined configuration standard baseline is not available, select the checklist maintained on the NIST NCP (National Checklist Program Repository).[footnoteRef:2] Select the source of each checklist in the following order depending on their availability: [2: NCP is a publicly available resource that contains information on a variety of security configuration checklists for specific IT products or categories of IT products. Browse and search the repository to locate a particular checklist using a variety of criteria, including the product category, vendor name, and submitting organization.]

· NIST-produced checklists and/or the United States Government Configuration Baseline (USGCB);

· Agency-produced checklists (e.g. Defense Information Systems Agency [DISA] or the National Security Agency [NSA]);

· Vendor-produced checklists;

· Other checklists; Refer to page 15 of NIST SP 800-70 rev.3 and NIST Special Publication 800-73-4. Other checklists are those that are posted on the NCP other than the government-authorized checklists (USGCB, DISA, and NSA) and vendor-produced checklists.

19) System components shall have and maintain the latest operating systems and applications patch level and anti-virus software level.

20) All exceptions and deviations from the standard baseline configurations shall be documented and approved by the HHS or SAMHSA Chief Information Officer (CIO) or designated official.

21) Contractor must design the system using proper architecture to ensure system security and document the system architecture as a part of the IT plan.

22) The Contractor shall ensure all its subcontractors that perform work under this contract (at all tiers) comply with the above requirements.

23) All privileged access system accounts to the system, application and or database must be approved and requested using SAMHSA Privileged Access Request Form. Request for the blank copy of form can be sent to COR and SAMHSA Cyber Security team. All privileged users shall employ multi-factor authentication for access to the system

24) Must comply with the HHS End of Life Policy and promptly retire or update end-of-life systems and products. Updated end-of-life systems and products must be configured in accordance with this guidance. (A copy of the HHS End of Life Policy is available upon request.)

3. Continuous Monitoring

1) Maintenance of the security authorization to operate (ATO) will be through continuous monitoring of security controls (based on guidance from NIST 800-37/800-137, and OMB Ongoing authorization memo 14-03) of the system and its environment of operation to determine if the security controls in the information system continue to be effective over time in light of the inevitable changes that occur.

2) Security controls should be re-assessed as recommended by the SAMHSA Security Continuous Monitoring…