Attachment_J6___Section_B_and_Performance_Work_Statement_Opioid_-_Task_Order_2_-_Final_8_9_2019.docx

ATTACHMENT J6

Task Order 0002 - Section B & Performance Work Statement

Section B - Supplies Or Services And Prices/Costs

Offeror shall enter your proposed prices in the table below and copy and paste the table into your Proposal.

Contract Line Items

(NTE)

PRICE (NTE)

Work performed in accordance with the Performance Work Statement (PWS) entitled “Opioid Certified Reference Material Product to Expand National Laboratory Capacity to Measure Exposures to Synthetic Opioids”

Opioid CRM Kits

This is a Firm Fixed Price Line Item This is a non-severable line item

Estimated Period of Performance:

12 Months

1 Job

Opioid CRM Kits Contractor shall provide 1,000 Kits in accordance with the Option for increased quantity

This is a Firm Fixed Price Line Item This is a non-severable line item

OPM Kit

This is a Firm Fixed Price Line Item This is a non-severable line item

Estimated Period of Performance:

12 Months

OPM Kit

Contractor shall provide 1,000 Kits in accordance with the Option for increased quantity.

This is a Firm Fixed Price Line Item This is a non-severable line item

Performance-Based Work Statement

Title: Opioid Certified Reference Material Product to Expand National Laboratory Capacity to Measure Exposures to Synthetic Opioids

C.1 BACKGROUND AND NEED:

The opioid epidemic has created the need for the CDC’s design of an Opioid Polysubstance Mix (OPM) Kit and further support of the CDC’s designed Opioid Certified Reference Material (CRM) Kit. This work will allow CDC to Expand National Laboratory Capacity to Measure Exposures to Synthetic Opioids. These Opioid Certified Reference Material Products are part of the CDC’s newly launched Traceable Opioid Material* Kits product line (TOM Kits*).

C.2. PROJECT OBJECTIVE:

CDC’s Division of Laboratory Science will use its awarded funds toward Expanding National Laboratory Capacity to Measure Exposures to Synthetic Opioids to establish non-severable service contracts when executed in their entirety will achieve an expanded national laboratory capacity to measure exposure to synthetic opioids. The contractor’s final evaluation of the products’ distribution will provide CDC with the information it needs to report the current national laboratory capacity and show how this capacity has expanded following this work.

C.3 SCOPE OF WORK:

The objective of this task order will be achieved using a multi-Task approach assuring a quality product and service. In the completion of the tasks outlined below, the contractor shall provide all labor, materials, and equipment using current infrastructure and in-house logistics. Shipping costs will be included in the awardee’s kit price and will not be any added cost to the kit recipients or CDC. All deliverables will meet or exceed the accredited, commercial quality metrics of the awardee.

C.4 TECHNICAL REQUIREMENTS:

The contractor shall have the ability to make and distribute the Opioid CRM Kit products and CDC-newly-designed OPM Kit products. Distribution of the Opioid CRM Kit will begin at task order award, and distribution of the OPM Kit will begin within 6 months of task order award. Each product will include accompanying certificates of analysis information for each material, a CDC-provided citation on how to cite the use of these products, customer service contact information, and a shipping manifest with directions on where to access electronic resources such as safety information. The contractor shall provide supplemental marketing drafts for CDC approval prior to dissemination electronically or at in-person conferences/meetings/displays. The contractor shall host HHS/CDC approved survey questions on the host ordering site for CDC’s prioritization of kit requests. The contractor will maintain an electronic platform to support the CDC in reviewing and approving order requests. This platform should be able to adapt to simple data analytics requests. For instance, the CDC may need to see a U.S. map of where shipments are going and where they are requested.

Task 1 – Opioid CRM Kit– CDC’s designed Opioid CRM Kit products will be distributed, supported, and evaluated so that the nation’s laboratories have access to the first series of neat and accompanying carbon-13 and nitrogen-15 isotopically-labeled certified reference materials for illicit opioids identified in part by the Drug Enforcement Administration and CDC in FY2018.

1.1 The Contractor shall distribute, support, and evaluate the distribution of the Opioid CRM Kit designed by CDC in FY2018 (roughly 3,000 each)..

1.2 For distribution, the contractor shall send out CDC-approved kits to laboratories who have the appropriate DEA registration to receive them.

1.3 For support, the contractor shall provide customer service and technical service for laboratories in receipt of the kits.

1.4 For evaluation, the contractor shall be responsive to CDC analytics and update request and submit a final report to the CDC-COR upon this tasks completion which will include at minimum a log of all laboratory/customer feedback, a log of where and to whom kits were distributed, and summary of the Task workflow and findings. This report will be used by the CDC to evaluate the nation’s expanded laboratory capacity following this Task completion. More information on this work can be found at:

http://www.cerilliant.com/ShopOnline/CDC.aspx

Task 2 – OPM Kit CDC-designed OPM Kit products will be developed, produced, distributed, supported, and evaluated so that the nation’s laboratories have access to the first series of neat and accompanying carbon-13 and nitrogen-15 isotopically-labeled certified reference materials for 22 substances that can be found in exposure specimens in conjunction with illicit opioids (including the 14 most common found). The OPM Kit will newly expand the nation’s laboratories to measure exposure to synthetic opioids and the polysubstances most often identified in exposure specimens in part by the Drug Enforcement Administration and CDC as of FY2019.

2.1 The contractor shall develop, produce, distribute, support, and evaluate the distribution of an Opioid Polysubstance Mix (OPM) Kit (2,000 each).

2.2 For development, the contractor shall review the kit they propose with the CDC-COR to ensure that it meets the CDC’s design.

2.3 For production, the contractor shall manufacture the kits to the agreed specification of the CDC’s design.

2.4 For distribution, the contractor shall send out CDC-approved kits to laboratories who have the appropriate DEA registration to receive them.

2.5 For support, the contractor shall provide customer service and technical service for laboratories in receipt of the kits.

2.6 For evaluation, the contractor shall be responsive to CDC analytics and update request and submit a final report to the CDC-COR upon this Task’s completion which will include at minimum a log of all laboratory/customer feedback, a log of where and to whom kits were distributed, and summary of the Task’s workflow and findings. This report will be used by the CDC to evaluate the nation’s expanded laboratory capacity following this Task’s completion. Each OPM kit will contain 1 milligram of 1 mg/mL of each item in methanol.

2.7 The contractor shall also maintain the ability to provide larger quantities in varying matrices in unique instances (for example, a CDC-approved laboratory may require 10 milligrams of powder instead of the aforementioned kit packaging design).

2.8 Since emerging needs may change quickly during the U.S. opioid overdose crisis, the contractor shall confirm the below list of kit items with the CDC-COR after the award is executed and before production is begun. The awardee is expected to have flexibility to substitute 5 of the below items (not to exceed a kit total of 22 items). The OPM Kit will contain the below list of compounds and their respective carbon-13 and nitrogren-15 isotopically-labeled (greater than or equal to 5 heavy isotopes per item) analogues:

C.5. DELIVERABLES (Base Period and any Exercised Options/Optional Tasks):

SubTask Reference

As necessary

C.6 Special Considerations

· The contractor shall maintain their ISO accreditation and DEA registration throughout the duration of the contract.

· All kits will refer recipients to a CDC provided citation for use when citing findings reported from using the kits.

C.7 Government Furnished Property N/A C.8 References For scope of work, the awardee should review the FAS products found on the CDC URL: https://www.cdc.gov/nceh/dls/erb_opioid_kits.html

C.9 Period of Performance 12 Months C.10 Place of Performance Contractor’s Facility

C.11 SCHEDULE OF MILESTONES FOR PERFORMANCE-BASED PAYMENTS

In accordance with FAR 52.232-32, PERFORMANCE BASED PAYMENTS (April 2012), upon successful completion of an event, the contractor may request performance based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the Contracting Officer’s Representative (COR) that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone. Milestone payments are subject to the terms of FAR 52.232-32 incorporated in Section I of this contract.

The COR receiving and acceptance of performance based payments is based on verification that work on the contract was satisfactorily performed.

CDC proposes the Milestone Payment Schedule for this contract as outlined below. As part of the negotiated process, however, the contractor may provide a different Milestone Schedule. If you decide to agree with the milestone schedule as outlined below, you should provide your proposed payment percentage allocation for each scheduled payment below based upon your total proposed price. The final Milestone Payment Schedule will be negotiated between the parties and included in the contract award.

This table below represents the proposed milestones for the Base Period and Option Periods as the options are exercised.

GOVERNMENT PROPOSED CONTRACTOR PROPOSED

MILESTONE EVENT

AMOUNT

C.11 Reporting Schedule/Performance Requirements Summary Since this is a Performance Based Services contract, CDC must effectively validate in a timely manner the performance of the Contractor in meeting the services required. This Performance Matrix provides a systematic surveillance method for the services and describes the methodology by which the contractor’s performance will be monitored.

The contractor is responsible for management and quality control actions necessary to meet the quality standards set forth by this contract. The below listed Performance Standards and Surveillance Methods shall be used by the COR in the technical administration of this Performance Matrix. The Government will evaluate the contractor’s performance at least annually, if not more frequently, in the Contractor’s Assessment Performance Reporting System (CPARS), www.cpars.gov

Not more than 2 documented complaints of performance within a one month period (may be corrected to COR comments) Documented customer complaints as they occur The COR will perform a quarterly and annual assessment of the quality, instrument performance, and business relations. The assessment will consist of the COR contacting the end users, reviewing customer complaints, and other reports documenting the contractor’s level of service.

Contractor’s performance is documented as past performance using CPARS which is considered for future awards.

Performance is considered in determining whether to exercise the option periods Repeated complaints on different events/tasks but the same issue will be elevated for higher level resolution (senior management and/or PGO)

Contractor is prepared to discuss relevant work performance, is responsive to performance issues, and documents quarterly meetings as described in PWS 100% review of events (by the COR) Unacceptable quarterly reporting will be documented as customer complaints, contractor may be allowed to correct any insufficiences to CDC satisfaction

C.12 SPECIAL CONSIDERATIONS

HHSAR Provision 352.239-73 Electronic and Information Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any Contractor responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, Contractors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows Contractors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, Contractors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a Contractor claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of Provision) Information Security Requirements

1. 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:

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.

c. 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.

d. 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.

e. 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, 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:

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

[X] No PII [ ] Yes PII 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.” 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: [X] 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 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.

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.

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

7.) 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).

8.) 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.

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

10.) 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 CDC-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 COR and ISSO within 30 days of contract award.

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 keyshttp://csrc.nist.gov/publications/. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

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 CDC non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

12.) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy (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 the CDC SOP or designee with completing a PIA for the system or information within 30 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

b. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

A. 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/CDC 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 CDC specific 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.

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 policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

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 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.

B. 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, and any CDC-specific rules, as applicable.

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 CDC Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

C. 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)/CDC CSIRT 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 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 CDC approved notifications to affected individuals following CDC’s designated process.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the CDC’s Computer Security Incident Response Team (CSIRT) [CSIRT@CDC.gov], COR, CO, CDC 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 CDC 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 HHS and CDC’s 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.

D. 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 1 Non Sensitive E. 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. For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12) 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 the CDC Specified timeline of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 7 days of the change. 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.

F. 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 CDC EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012). CDC EPLC requirements may be located here: https://www2a.CDC.gov/CDCup/library/other/eplc.htm.

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 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.

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 7 days before an employee stops 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 CDC policies.

6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Contractor Employee Separation Checklist when an employee terminates work under this contract within 7 days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

G. 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/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

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/CDC policies.

* TRACEABLE OPIOID MATERIAL, TOM KITS, and the TOM KITS logo are marks of the U.S. Department of Health and Human Services.