A1. b Statement of Work - SAM.gov.docx

SECTION C -DESCRIPTION/SPECIFICATION/WORK STATEMENT

Title of Project: ToxIC (Toxicology Investigators Consortium) Registry Access for CDC’s National Center for Injury Prevention and Control

C.1. Background and Need The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) is engaging in efforts to better understand drug overdose trends in the United States by using timely and comprehensive data from emergency departments, death certificates, and medical examiner/coroner reports including toxicological results. In order to complement surveillance data currently being collected by CDC’s Overdose Data to Action (OD2A) program, NCIPC is interested in access to datasources that document drug adverse events and toxicity that may result from overdose and treatment, particularly for nonfatal events.

One such datasource is the Toxicology Investigators Consortium or ToxIC Registry collected by the American College of Medical Toxicology (ACMT). The ToxIC Registry is a nationwide repository of clinical toxicology data. The registry was established 12 years ago and includes data from approximately 40 unique sites, including three international sites. Data come from approximately 63 facilities in these sites with medical toxicologist who participate in the registry. De-identified data obtained by medical toxicologists during bedside encounters are entered prospectively into the database. A range of information is included in the registry including the drugs taken or generally used, symptoms and side effects, treatment provided, and other risk and protective factors.

NCIPC staff access to this registry can be another data source in the analysis of nonfatal drug overdoses including the combination of drugs used and other risk and protective factors. As the database continues to mature trend analyses will be possible. Investigators have also created sub-registries in which additional supplemental data is collected prospectively on cases – for example, the outbreak of e-cigarette, or vaping, associated illness (EVALI).

C.2 PROJECT OBJECTIVE

The objective is to acquire one (1) Single Seat User License to access the ToxIC Registry to view emerging drug toxicity data in overdose cases as recorded in this registry.

c.3 SCOPE OF WORK Independently and not as an agent of the Government the contractor shall furnish the necessary personnel and services, except as provided in the schedule, and otherwise do all things necessary for the performance of the work as described below:

3.1 The contractor shall work with NCIPC staff to develop any necessary elements to maintain access to their IT infrastructure currently in place that is required to carry out the inquiries. Access to the contractor’s infrastructure will be from the CDC network.

3.1.1 Continue to allow infrastructure access from a minimum of one (1) individual NCIPC staff workstation.

3.2 Provide technical, analytical and scientific support, including software documentation and notices of updates and changes, as agreed upon in writing.

3.3a Provide annually (2) two (1)-hour online training sessions, to NCIPC program personnel on data entry and data search within the infrastructure. These training sessions will be held yearly via webcast, skype (or other CDC approved).

3.3b Improve data interpretation and data entry by conducting a continous needs assessment and indentifying areas for improvement. Develop vigorous training program,establish routing training schedule, and host routine training sessions for participating providers based on identified needs to improve data quality, consistency, and timelines.

3.4a Provide (1) one data quality report every 6 months following award. – (Base year, Option Years, if exercised)

This is an ongoing activity and is expected to be renewed, at the option of the Project Officer (PO), for up to two (4) consecutive years (base + 3 option years).

3.4b Work to maintain data quailty, detail, and completeness of the registry data by refining or adding needed elements and improve data quality procedures. Expected improvements include but are not limited to enhanced quality checks and inclusion of additional data fields in the final dataset related to opioids overdose and treatment to allow CDC users of ToxIC Registry data to better analyze the data. Contractor will assist in identifying areas of improvement of data and implementing improvements identified.

3.5. Expanded focused data collection on the public health impact of substance use disorders related to opioid use and withdrawl.

c.4 TECHNICAL REQUIREMENTS

· Provide licensing to access to the ToxIC registry for one (1) NCIPC user.

· Provide technical, analytical and scientific support and discussion on best practices for using the registry.

· Provide two (2), one (1) hour online training sessions yearly via webcast, skype (or other CDC approved)

· Provide one (1) data quality report every 6 months to describe changes in data completeness, site data entry into the registry, and other issues that may impact the ability to use the data.

· Provide enhanced data collection and data quality improvement of the ToxIC Core Registry.

· Provide expanded focused data collection on the public health impact of substance use disorders related to opioid use and withdrawl.

c.5 REPORTING SCHEDULE (Base + Option years, if exercised)

Kick-Off Meeting: Within 2 weeks of the award date, meet with the CDC Contracting Officer’s Representatiave (COR) or her designee to review the scope of work, delivery schedule and technical requirements, and establish communication protocols. This meeting shall take place via teleconference, Zoom or Teams.

Summary notes of the meeting will be provided by the contractor within 3 days after the meeting to the COR.

Training dates to be agreed upon in writing At least once every 6 months for the funding period, based on participant availability.

Meeting dates to be agreed upon in writing Every 6 weeks c.6 Place of Performance It is estimated that approximately 0% the contract will be performed on-site at CDC facilities and 100% will be performed off-site at the contractor’s facilities. Contractor shall not be required to travel domestically or internationally on this contract.

C.7 Government Furnished Property No-Government Furnished Equipment or Government Furnished Information will be provided C.8 REfERENCES None C.9 deliverables

Training dates to be agreed upon in writing At least once every 6 months for the funding period, based on participant availability.

Meeting dates to be agreed upon in writing Every 6 weeks

C.10 period of performance

The period of performance is:

C.11 Special Considerations (Section 508) (Start of verbiage) Electronic and Information Technology Accessibility Notice

(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 offeror 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/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors 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 offerors or developers to self-evaluate their supplies and documentation 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 Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror 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 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.

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

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C.12 information security requirements A. Baseline Security Requirements

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

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

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

2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall: a. Protect government information and information systems in order to ensure:

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

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

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

b. Provide security for any Contractor systems, and information contained therein, connected to an 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 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:

Confidentiality: [x ] Low [ ] Moderate [ ] High Integrity: [ ] Low [x ] Moderate [ ] High Availability: [ x] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [ x] Moderate [ ] High 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 Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

4) 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.

5) 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 32 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.

6) 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.

7) 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).

8) 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). .

9) 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.

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

See Appendix D for baseline deliverables.

11) 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.

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 Cybersecurity Program Office (CSPO).

12) 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, as applicable. 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.

See Appendix C for the Contractor Non-Disclosure Agreement.

13) 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 in accordance with HHS policy and OMB M03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

a. 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 CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of PII are collected that could introduce new or increased privacy risks), whichever comes first.

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable 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 Security Awareness Training (SAT), 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 (RBT within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least annually in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. All HHS employees and contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

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.

C. Rules of Behavior

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

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior 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 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.

D. Incident Response 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 another than authorized purpose.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally Identifiable Information” (03 January 2017) states:

Definition of an Incident:

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 Definition of a Breach:

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 another than authorized purpose.

It further adds:

A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment. A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII for another 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”. Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC shall include the following requirements:

1) The contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage a suspected or confirmed breach.

2) All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall 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. 3) All contractors and subcontractors shall participate in regular training on how to identify and report a breach.

4) All contractors and subcontractors shall report a suspected or confirmed breach in any medium as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC and incident management policy, and United States Computer Emergency Readiness Team (US-CERT) notification guidelines. To this end, the Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC) or CDC Computer Incident Response Team (CSIRT) within 24 hours via email at csirt@cdc.gov or telephone at 866-655-2245, whether the response is positive or negative.

5) All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

6) All contractors and subcontractors shall allow for an inspection, investigation, forensic analysis, and any other action necessary to ensure compliance with HHS/CDC Policy and the HHS/CDC Breach Response Plan and to assist with responding to a breach.

7) Cloud service providers shall use guidance provided in the FedRAMP Incident Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

8) Identify roles and responsibilities, in accordance with HHS/CDC Breach Response Policy and the HHS/CDC Breach Response Plan. To this end, the Contractor shall NOT notify affected individuals unless and until so instructed by the Contracting Officer or designated representative. If so, instructed by the Contracting Officer or representative, all notifications must be pre-approved by the appropriate CDC officials, consistent with HHS/CDC Breach Response Plan, and the Contractor shall then send CDC- approved notifications to affected individuals; and,

9) Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the contractor or its subcontractor failed to provide adequate safeguards for PII.

E. Position Sensitivity Designations All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The requiring activity representative, in conjunction with Personnel Security, shall use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

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

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidentialdirective-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 by the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted immediately upon 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.

G. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

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 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 Out-Processing Checklist (http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract. All documentation shall be made available to the CO and/or COR upon request.

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

HHS EA requirements may be located here:

https://www.hhs.gov/ocio/ea/documents/proplans.html CDC EPC Requirements: https://www2a.CDC.gov/CDCup/library/other/eplc.htm 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 policies.

The following criteria shall be utilized in evaluation of the technical proposal.

Staffing Plan- Pass/Fail The Offeror shall be evaluated on their ability to demonstrate how they will provide qualified technical labor resources in numbers adequate to address the technical and administrative requirements and deliverable schedules outlined in the task order. The contractor will be evaluated on the following:

a. A staffing matrix showing type and number of staffing resources readily available, including breakdowns by skill sets, security clearances and any related certifications. The matrix of proposed personnel shall also include their experience, education, skills, and qualifications to do the job. The backgrounds of the personnel will reflect the length and variety of experience and expertise in tasks similar to the tasks required by this project and any relevant training. The percentage of time each staff member shall contribute to the program will be adequately identified. The extent to which outside consultants or specialists will be used and evidence of availability shall be indicated.

b. A description of the Offeror’s approach to rapidly obtain and/or replace qualified staffing resources to support existing and new task order work and to meet changing workload requirements.

c. Document the decision-making authority of the project director as related to other elements of the organization. Including a description of how the Offeror will interface with CDC, as well a clear delineation of staff authorities and line of responsibility with special emphasis on relationships with subcontractors, other Contractors, and CDC partners.

d. If subcontractors are proposed, provide information to support their qualifications as well. The Offeror shall identify any portions of the task that will be performed by subcontractors. This information must include the subcontracting firm and the specific duties and labor categories that will be performed by the subcontractor. The Offeror shall also furnish a written copy of the draft subcontracting agreement. The Offeror shall also provide copies of any Service Level Agreements.

Management Plan- Pass/Fail

The Offeror shall be evaluated on their ability to demonstrate an overall understanding of the project and adequacy and feasibility of plans to address all items in the task order statement of work. In addition, the offeror will be evaluated on their detailed description of specific tasks to be performed, methods and resources (not staffing) to be used and a discussion of problems likely to occur and plans for addressing them.

The offeror will be evaluated on the below:

a. The offeror’s ability to describe their organizational structure and how they propose to manage this task, including a discussion of timelines and issues.

b. The Offeror’s ability to provide rationale for their management approach.

c. The Offeror’s ability to describe the methodology for managing the task, performance measures they will use to monitor performance, any management tools they will use, how they will ensure quality products are delivered, how they will mitigate risk and how they will communicate. Offeror shall adequately describe the resources they propose to complete the work described in the PWS and a rationale for their proposed approach. The Offeror shall identify any resources (facilities, hardware, software, communications, etc.) that would be required above and beyond that already addressed as part of this task order.

d. Their ability to provide (1) a detailed description of how conflicts are managed; (2) a plan to ensure client satisfaction; and (3) a measurement of fiscal responsibility and accountability paying particular attention to the deliverable timeline in this task order.

e. The Offeror’s ability to identify anticipated management barriers and risks. The Offeror shall provide a description of their approach to risk management during the task order from a management perspective and the planned actions to mitigate or eliminate risk.

C.13 Contracting Officer REpresentative (COR)

TBD