Attachment 5 - Information and Physical Access Security.pdf

Attachment 5 – Information and/or Physical Access Security

Information and/or Physical Access Security

For the duration of the contract for Bioactivity Assay Development Consultant Services, the Contractor is required to conform to the following provisions, clauses, and terms to maintain information systems and information security with respect to the requirement:

FAR clause 52.239-1, Privacy or Security Safeguards - https://www.acquisition.gov/far/52.239-1

HHSAR Clause 352.224-71, Confidential Information - https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71

HHSAR Clause 252.224-70, Privacy Act - https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-70

FAR Subpart 4.1300, Personal Identity Verification - https://acquisition.gov/content/41300-scope-subpart

FAR Subpart 52.204-9, Personal Identity Verification of Contractor Personnel -https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel

The Contractor must ensure that any computer used in the course of performing work for this requirement include the following features:

• Must be patched with most updated IT Security Patches.

• Must have virus protection loaded and running with definition files that are updated at least daily.

• Must be backed up to an external hard drive, which is password-protected.

• Any hard drives and portable media used for this requirement must be encrypted using the FIPS

140-2 standard.

• Must be assessed for vulnerabilities prior to use.

• Must have auditing enabled such that if an incident occurred then that event could be reconstructed.

• Must employ at a minimum user name and password authentication or if possible two factor authentication.

• must employ at a minimum username and password authentication, and if possible, two factor authentications.

• Must be password-protected. Passwords must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters:

(a) capital letters; (b) lower case letters; (c) numeric characters; and (d) special characters (!@#$%

Contractor is required annually to complete NIH Security and Privacy Training accessible at http://irtsectraining.nih.gov/.

Contractor is required to sign the NIH non-disclosure agreement accessible at http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf.

Contractor is required to report any lost or stolen NIH data to the NINDS Information Systems Security Officer (ISSO) within one hour of knowing of the loss or theft even if the data is on Contractor’s furnished computer.

Contractors is required to adhere to the NIH IT Rules of Behavior, published at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx.

https://www.acquisition.gov/far/52.239-1 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-70 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-70 https://acquisition.gov/content/41300-scope-subpart https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

Applicability: The below 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.

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 HHS network, or operated by the Contractor on behalf of HHS 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.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS

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), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with Privacy Act and Confidential Information requirements.

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, Contractor Non-Disclosure Agreement and based on information provided by the Information Systems Security Officer (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:

mailto:fisma@hhs.gov

Confidentiality: [ ] Low [ X] Moderate [ ] High Integrity: [ ] Low [ X ] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High

Personally Identifiable Information (PII): Based on information provided by the ISSO, CISO, Privacy Officer, system/data owner, or other security or privacy representative, it has been determined that this acquisition involves:

[ ] No PII [ X] Yes 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." 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.

Privacy Act Requirements: It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals. The System of Record Notice (SORN) applicable to this requirement is SORN 09-25-0118 Contracts: Professional Services Contractors, published at https://www.federalregister.gov/documents/2002/09/26/02-23965/privacy-act-of-1974-annual-publication-of-systems-of-records.

The design, development, or operation work the Contractor is to perform is: The Contractor is expected to provide support services in a collaborative way. Lead Development Teams to which the Contractor is assigned may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

Records disposition instructions apply to the contract/order as follows: Destroy PII after processing and retain sanitized records under schedule DAA-0443-2012-0007-0003 for a period of 7 years after cutoff.

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. 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 and handled under the contract shall be:

a. Marked appropriately;

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

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

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

d. Returned to HHS 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.

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 https://www.federalregister.gov/documents/2002/09/26/02-23965/privacy-act-of-1974-annual-publication-of-systems-of-records https://www.federalregister.gov/documents/2002/09/26/02-23965/privacy-act-of-1974-annual-publication-of-systems-of-records

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 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 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 NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH 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).

Each employee, including subcontractors, having access to non-public Department information n shall in relation to this acquisition shall complete the "Commitment to Protect Non-Public Information - Contractor Employee Agreement" accessible at https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

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. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-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 have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative within 15 days of the validation.

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 shall be provided to the COR upon request and at the conclusion of the contract.

f. 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.

Mandatory Training for All Contractor Staff: All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information

Security Awareness, Privacy, and Records Management training course at https://irtsectraining.nih.gov/public.aspx before performing any work under this contract. Thereafter, the employees shall complete NIH 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 training policies.

1. Training Records- The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS 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.

Rules of Behavior: The Contractors (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and comply with the NIH Information Technology General Rules of Behavior at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx, which are also contained in the NIH Information Security Awareness Training Course.

The Contractor (and/or any subcontractor) 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 NIH Information Security Awareness Training. If the training is provided by the contractor, the signed Rules of Behavior must be provided as a separate deliverable to the CO and/or COR per the above defined timelines.

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)/NIH 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 cyber security 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 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"

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 so as 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 NIH approved notifications to affected individuals individuals in accordance with https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx https://irtsectraining.nih.gov/public.aspx https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx

3. Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT) via email at IRT@mail.nih.gov , COR, CO, the NIH Office of the SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable NIH and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor 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 HHS and NIH 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 within an hour of discovery.

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:

Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with MBI or LBI).

Contractor employees assigned to a Level 5 position with no previous investigation and approval shall undergo a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

List of Information Security Deliverables: The following table details a listing of possible deliverables to be completed by the contractor (at a minimum) and included in the Schedule of Deliverables.

mailto:IRT@mail.nih.gov

Document Section Deliverable Title/Description Due Date

Roster and Personnel Security Responsibilities

Roster Changes Onboarding Offboarding List of Personnel with definedroles and responsibilities

Onboarding- Prior to performing any work on behalf of NINDS, and monthly thereafter.

Offboarding- documentation, equipment and badge when leaving contract within 3 business days.

Background Investigation Onboarding documentation when beginning contract performance.

Prior to performing any work on behalf of NIH/NINDS.

Contractor Employee Non-Disclosure Agreement (NDA)

Contractor Employee NDA Prior to performing any work on behalf of NIH/NINDS.

Training Records Copy of NIH training recordsfor all mandatory training

In conjunction with contract award and annually thereafter or upon request.

Rules of Behavior (ROB) Signed ROB for all Contractor employees

Initiation of contract and annually thereafter.

Incident Response Incident Report (as incidents or breaches occur)

Per NIH/NINDS policy, as soon as possible or no later than 1 hour of discovery.

Incident Response Incident and Breach Response Plan Upon request from Government.