75D30124Q78216_SOW.pdf

Statement of Work Title: Rabies Serology Proficiency Testing Program

Period of performance of this contract is: September 16, 2024 to September 15, 2026 Base Period: September 16, 2024 to September 15, 2025 Option Period One: September 16, 2025 to September 15, 2026

SECTION 1 – BACKGROUND

Rabies is a disease that is almost always fatal and ~95% of human cases arise from infected dog bites. While the US is free of canine rabies, it still circulates in many other countries and dogs are frequently imported from around the world. There have been multiple importations of rabid dogs over the past 5 years; each one raising the potential of the re-introduction of canine rabies virus variant in the US.

To prevent dog rabies importations, US importation regulations will require a rabies vaccination and an adequate antibody titer to be listed on the importation documents. This regulation requires the US to ensure that the testing laboratory is capable of reliable testing. Often this occurs through proficiency testing; where an external third party sends a laboratory a blinded set of positive and negative samples to ensure their test is accurate. The laboratory will test the samples, record their results, and send back to the third party for grading. A laboratory with a well-functioning test will pass the proficiency test, while a tests with quality issues will fail. Proficiency testing will allow the CDC to identify laboratories with accurate tests for detecting rabies antibody titers. These laboratories will then be added to a CDC website for importers and pet owners to find high quality laboratories for rabies antibody testing.

The ability for the CDC to support a proficiency test will both fill an urgent gap in the global campaign to eliminate rabies and help prevent rabid canine importation into the US. The program will help identify laboratories that can accurately test for rabies vaccination and reduce trafficking of rabid animals. Further, by identifying where these laboratories exist, we can then identify areas to increase rabies serology capacity.

SUBSECTION A – DEFINITIONS

Antibody titer: A measure of the level of antibodies in an animal.

Fluorescent Antibody Virus Neutralization (FAVN) test: One of the two approved serology tests for determining rabies antibody titers in animals after vaccination.

IU/mL: The international unit for the antibody titer that is calculated by normalizing the animal titer by a known standard.

Animals must have a rabies titer of ≥0.5 IU/mL.

Proficiency test: An external assessment of a laboratory assay where unknown samples are tested and graded to determine the laboratory’s ability to accurately perform a test.

Proficiency test panel: A set of blinded samples that are sent to a laboratory for a proficiency test. The panel contains several positives and negative samples.

Rapid Fluorescent Focus Inhibition Test (RFFIT): One of the two approved serology tests for determining rabies antibody titers in animals after vaccination.

SECTION 2 – PURPOSE/OBJECTIVE

A contracted laboratory shall develop, distribute, and grade results from serum panels. The panels shall contain serum with several concentrations of rabies neutralizing antibodies and serum that does not contain neutralizing antibodies. The overall objective will be to aid in proficiency testing to laboratories across the world to allow the importation of dogs into the U.S.

Performance objectives include: 1) The development of proficiency panels suitable for demonstrating laboratories that can detect rabies antibody titers. 2) Distribution of panels, receipt of results and grading the laboratory results. 3) Sharing the results with the CDC for the purpose of determining which laboratories should be added or removed from the list of laboratories that can test for importation purposes.

SECTION 3 – SCOPE OF WORK

The CDC’s Poxvirus and Rabies Branch will provide the contracted laboratory serum from rabies vaccinated animals. The contracted laboratory shall then develop proficiency test (PT) panels for distribution. The contracting laboratory shall contact laboratories for participation in the proficiency testing and send them PT panels. The contracting laboratory shall then grade the results, notify laboratories of their scores, and send the results and scores to the CDC.

The production of the PT panels will allow the CDC to determine which laboratories are able to accurately detect anti-rabies antibodies from vaccinated dogs. The participating laboratories will test the PT panels, which are a set serum samples that are either positive or negative for anti-rabies antibodies. The results of the PT will be used by the Poxvirus and Rabies Branch to determine which laboratories can perform accurate testing. After the PTs are graded, laboratories that passed will be added to a website that allows importers to identify laboratories for obtaining a rabies titer.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Test Serum

1. Test at least 20 serum samples from rabies vaccinated animals to determine FAVN/RFFIT titers and report the results to the CDC.

a. Ensure the serum aliquots are stable and give consistent results between lots using ISO 17043 requirements.

Task 2: Construct PT Panels

1. Construct the PT panels, to include a mixture of positive and negative specimens.

a. Enroll 5-25 participants into the PT program.

b. Receive and resolve issues that participating laboratories may have in testing the PT panels

c. Score the results from participating laboratories.

d. Send the scored results report to the CDC’s Poxvirus and Rabies Branch

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

The CDC’s Poxvirus and Rabies Branch will provide serum from vaccinated animals to the contracted laboratory and RFFIT titers from theses samples.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

All contractor laboratory responsibilities shall be performed at their laboratory, unless there is prior notification and review of the change.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/Format Due Date Deliver To Initial Analysis of serum

A FAVN test will be performed to determine the titer

1 1/15/2025 PM and COR

Statement of suitability for the serum panels

The statement will describe how the serum specimens were selected and prepared for the panels. The panel will be listed with their results.

Stability data and FAVN titer for the panels will be included. The statement will list the dates of the PT testing period and the process for scoring.

1 1/15/2025 PM and COR

PT panels A set of serum samples with known titers for RFFIT and FAVN. The panel shall include at least 1 sample that is negative, positive and >0.5 IU/ml and positive <0.5 IU/ml.

100-150 depending on the number of participating laboratories

1/15/2025 PM and COR

Draft Report of Scores from submitted laboratories

The contracting laboratory will send a draft report to PRB of the participating laboratories’ PT scores and whether they passed the PT.

# of draft reports based on the # of participating labs

6/15/2025 PM and COR

Scores from submitted laboratories

The contracting laboratory will send a report to PRB of the participating laboratories’ PT scores and whether they passed the PT.

# of reports based on the # of participating labs

9/05/2025 PM and COR

Initial Analysis of serum

A FAVN test will be performed to determine the titer

1 1/15/2026 PM and COR

Statement of suitability for the serum panels

The statement will describe how the serum specimens were selected and prepared for the panels. The panel will be listed with their results.

Stability data and FAVN titer for the panels will be included. The statement will list the dates of the PT testing period and the process for scoring.

1 1/15/2026 PM and COR

PT panels A set of serum samples with known titers for RFFIT and FAVN. The panel shall include at least 1 sample that is negative, positive and >0.5 IU/ml and positive <0.5 IU/ml.

100-150 depending on the number of participating laboratories

1/15/2026 PM and COR

Draft Report of Scores from submitted laboratories

The contracting laboratory will send a draft report to PRB of the participating laboratories’ PT scores and whether they passed the PT.

# of draft reports based on the # of participating labs

6/15/2026 PM and COR

Scores from submitted laboratories

The contracting laboratory will send a report to PRB of the participating laboratories’ PT scores and whether they passed the PT.

# of reports based on the # of participating labs

9/05/2026 PM and COR

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

Laboratories or their directors shall need to be recognized as experts in rabies serology. The laboratories shall be accredited by an external party to ensure the elements of a quality management system are in place. These external accreditations can include ISO17025 and the American Association of Veterinary Diagnosticians (AAVLD).

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy Compliance

Standard-1: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO.

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

ii. 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 CDC 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.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

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.

ii. Categorize all information owned and/or collected/managed on behalf of CDC and information systems that store, process, and/or transmit HHS information 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. Based on information provided by the ISSO, CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Table 1: Information Types and Risk Ratings

Information Type Title Confidentiality Integrity Availability http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

Impact Level Impact Level Impact Level C.2.1.3 Program Monitoring Low Low Low C.3.4.4 Services Acquisition Low Low Low

Table 2: Information/System Categorization and Overall Risk

Information Type Title

Confidentiality (Low, Moderate, High)

Integrity (Low, Moderate, High)

Availability (Low, Moderate, High)

Security Objectives Impact Level: (NIST SP 800-60) Low Low Low Security Objectives Impact Level: (If System / Information Owner need to downgraded / upgraded risk)

Overall Impact Level: (Low, Moderate, High) Low Low Low

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of CDC regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC 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 all applicable security and privacy policies by contacting the CO/COR or CDC security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable CDC privacy policies, and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (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.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's PII.

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with CDC policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

The Contractor must support the agency 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.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

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

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

iv. Returned to HHS/CDC control, destroyed when no longer needed, or held until otherwise directed.

Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by CDC or collected by the contractor on behalf of CDC must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any CDC records may be made available or disclosed must 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 must be protected in accordance with HHS/CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

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

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

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

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

i. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

j. 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 must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to always assume HTTPS to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult HHS/CDC Policy for Internet and Email Security for additional information.

k. Contract Documentation. The Contractor must use provided templates, policies, forms and other agency documents specify which documents/forms will be provided to contractor] to comply with contract deliverables as appropriate.

l. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

ii. 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 encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

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

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. Use the Key Management system on the CDC 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 http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

m. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the CDC non-disclosure agreement, as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

2. Training Requirements

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

b. 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/CDC policy and the CDC Role- Based Training (RBT) of Personnel with Significant Security Responsibilities.

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

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing agency 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.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding http://csrc.nist.gov/publications/ to a Breach of Personally Identifiable Information (PII)1, an incident is "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" and a privacy breach is "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." For additional information on the CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information (PII).2"

b. Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC must include in the following requirements:

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

ii. 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, with encryption solution that is validated with the current FIPS 140 validation certificate from the NIST CMVP.

iii. All contractors and subcontractors shall participate in regular training on how to identify and report a breach

iv. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send [CDC Component] approved notifications to affected individuals [insert CDC Component Specific timeline, process, and format].

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) [CDC Component inserted contact information should be cited here], COR, CO, CDC CPO (or his or her designee), and other stakeholders, including breaches 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 Component and CDC 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, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

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

Encrypt sensitive information in attachments to email, media, etc.

vi. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and CDC Component and CSPO privacy breach response policies when handling PII breaches.

vii. 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 [CDC Component insert timeline if required].

viii. 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.

1 Memorandum is available at: https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m- 17-12_0.pdf 2 Standard is available at: https://cdc.sharepoint.com/teams/OCIO-CSPO- PUBDOCS/Standards/CSPO%20Responding%20to%20Breaches%20of%20Personally%20Identifiable%20Information.pdf

ix. 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.

x. 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.

5. 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:

6. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors;

CDC HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster

The Contractor (and/or any subcontractor) must 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 must be submitted to the COR and/or CO 30 days prior to the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon the 30 days 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 must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, CDC 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 must follow the CDC EPLC framework and methodology and in accordance with the CDC Office of Financial Resources (OFR) Contract Closeout Guide and HHS Closeout Guide: Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC System Development Life Cycle requirements, 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.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must 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.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within 15 days before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must 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

Investigation Position Requirement NAC National Agency Check

X Tier 1 Low-Risk Non-Sensitive, including HSPD-12 Credentialing Tier 2 Moderate-Risk Public Trust (MRPT) Tier 3 Non-Critical Sensitive, National Security, including Secret and “L” access eligibility Tier 4 High-Risk Public Trust

Tier 5 Critical Sensitive and Special Sensitive, National Security, including Top Secret, SCI, and “Q” access eligibility

Not Applicable No Requirement and/or COR. Additionally, the Contractor must 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 CDC policies.

f. The Contractor (and/or any subcontractor) must 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 within 15 days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention

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

b. If a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with CDC policies.

10. High Value Asset (HVA):

If a system is identified as HVA, the contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the Department of Homeland Security (DHS) HVA Control Overlay[22] in addition to the above requirements.

11. Deliverables

Deliverable Title/Deliverable Type

Description Due Date

Roster Roster Within 30 days of the effective date of this contract

Contractor Employee Non- Disclosure Agreement (NDA)

Contractor Employee Non- Disclosure Agreement (NDA)

Prior to performing any work on behalf of HHS

Privacy Threshold Analysis (PTA)/ Privacy Impact Assessment (PIA)

Assist in the completion of a PTA/PIA form

Within 60-90 days after contract award

Training Records Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Rules of Behavior Signed ROB for all employees Initiation of contract and at least annually thereafter

Incident Response Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Personnel Security Responsibilities

List of Personnel with defined roles and responsibilities

Within 7 days; that is before an employee begins working on this contract.

Personnel Security Responsibilities

Off-boarding documentation, equipment and badge when leaving contract

Within 5 days or less after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Background Investigation Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

Certification of Sanitization of Government and Government Activity-

Form or deliverables required by

CDC

At contract expiration.

http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf https://login.max.gov/cas/login?service=https%3A%2F%2Fcommunity.max.gov%2Flogin.action%3Fos_destination%3D%252Fpages%252Fviewpage.action%253FspaceKey%253DHHS%2526title%253DHHS%252BCyberSecurity%252BPolicy%252BCollaboration%252BPage

Related Files, Information, and Devices.

Contract Initiation and Expiration

If the procurement involves a system or cloud service, additional documentation will be required, such as Disposition/Decommission Plan

At contract expiration.

Standard-2 Requirements for Procurements Involving Privacy

Appropriate security controls and Rules of Behavior should be incorporated to protect the confidentiality of information, proprietary, sensitive, and Personally Identifiable Information (PII) the Contractor may come in contact with during the performance of this contract.

Section 508 Compliance 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 402 Closed Functionality 403 Biometrics 404 Preservation of Information Provided for Accessibility 405 Privacy 406 Standard Connections 407 Operable Parts 408 Display Screens 409 Status Indicators 410 Color Coding 411 Audible Signals 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 an 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 http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://hhs.gov/web/508 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.

http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html