CISA IDIQ SOW - Final with IT clauses.docx

CLINICAL IMMUNIZATION SAFETY ASSESSMENT (CISA)

Section B - Supplies Or Services And Prices/Costs

Improving vaccine safety at the individual patient level and meeting public health priorities for CDC. Work performed will be based on CISA project clinical review, consultation, and evaluation activities. Ordering Period for Task Orders is April 1, 2023 – March 31, 2028. Contract Type will be determined at the Task Order Level. This CLIN is not funded. If required, this CLIN will be used to fund the Guaranteed Minimum on a fixed price basis. IDIQ amount of $5,000.00.The maximum amount for all task orders under all CISA Project IDIQ contracts shall not exceed $86,000,000.00 1 Job

$86,000,000.00

B.1 GENERAL

The purpose of this indefinite delivery, indefinite quantity (IDIQ) contract is to provide the Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), Immunization Safety Office (ISO), an “as needed” mechanism to obtain required services through the issuance of individual task orders in support of vaccine safety monitoring and evaluation that meet public health priorities for CDC. The Contractor independently, and not as an agent of the United States Government, shall furnish personnel, facilities, supplies and equipment (except that specifically addressed within the individual task order) necessary to perform the individual Task Orders under the contract.

B.2 TYPE OF CONTRACT

This is a multiple award, IDIQ type contract. At the discretion of the Contracting Officer, the government may use a variety of task order types under this contract, including Firm Fixed Price (FFP), Labor Hours (LH), Time and Materials (T&M), and Cost-Plus Fixed Fee (CPFF) contracts. Unless otherwise stated, the terms, conditions, technical requirements, administrative data, and special contract requirements of the IDIQ contract are applicable to any and all task orders issued under this IDIQ. The clearances obtained for this IDIQ are applicable to all task orders under the IDIQ.

B.3 MINIMUM GUARANTEE

The contract guarantees that task orders amount to a minimum of $5,000. In the event that during its contract term the contractor receives obligations of less than this minimum, the Government will fund the difference between the actual obligation and the guaranteed minimum.

B.5 MAXIMUM CONTRACT AMOUNT

The contract ceiling amount is $86,000,000.

B.6 Ordering Period

The IDIQ contract provides a single 5-year ordering period, during which the Government may issues task orders as needed to meet program needs. The Ordering period is May 1, 2023 – April 30, 2028. No task order may be issued with a period of performance end date later than September 30, 2030.

B.7 SERVICE CONTRACT ACT

The contract labor categories are executive, administrative, professional labor and specifically noted in the task order, are exempt from the Service Contract Act.

Section C - Description/Specification/Work Statement C.1 Background and Need

Vaccines are one of the most effective means of reducing or eliminating morbidity and mortality from selected infectious diseases.[endnoteRef:1] However, no vaccine is completely effective or safe and concerns about vaccine safety may lead to decreased uptake of vaccine.[endnoteRef:2] The licensed vaccines currently in routine use in the United States have been judged by the Food and Drug Administration (FDA), with input from its advisory committee, to be safe and effective.[endnoteRef:3] Serious adverse events following immunization (AEFI), which may or may not be causally related to vaccines, are rare. However, clinical trials may not be large enough to detect these rare events and AEFI may not be observed until the vaccine is widely used in populations after clinical trials are complete.[endnoteRef:4] Similarly, special populations, such as persons with autoimmune diseases or immunodeficiency, may be excluded from or not be adequately represented in clinical trials; AEFI in these populations may not be detected until after licensure. [1: ] [2: ] [3: ] [4: CISA BASIC STATEMENT OF WORK REFERENCES

Salmon D, Pavia A, Gellin B. Editor’s Introduction: Vaccine Safety throughout the Product’s Life Cycle. Pediatrics;2011; May;127 Suppl 1:S1-4. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S1.full, accessed on December 5, 2022.

DeStefano F, Bodenstab HM, Offit PA. Principal Controversies in Vaccine Safety in the United States. Clinical Infectious Diseases. 2019; Aug 1;69(4):726-731, available at https://academic.oup.com/cid/article/69/4/726/5316263, accessed on December 5, 2022.

Marshall V and Baylor N. Food and Drug Administration Regulation and Evaluation of Vaccines, Pediatrics;2011; May;127 Suppl 1:S23-30. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/early/2011/04/18/peds.2010-1722E.full.pdf+html, accessed on December 5, 2022.

Ball R, Horne D, Izuriet H et al. Statistical, Epidemiologic, and Risk Assessment Approaches to Evaluating Safety of Vaccines throughout the lifecycle at the Food and Drug Administration, Pediatrics. 2011; May;127 Suppl 1:S31-8. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S31.full, accessed on December 5, 2022.

CDC. About the Immunization Safety Office (ISO), available at https://www.cdc.gov/vaccinesafety/iso.html, accessed on December 5, 2022.

Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015 Aug 26;33(36):4398-405. Epub 2015 Jul 22, available at, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/, accessed on December 5, 2022.

McNeil MM, Gee J, Weintraub ES et al. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety. Vaccine. 2014 Sep 22;32(42):5390-8. Epub 2014 Aug 6, available at https://stacks.cdc.gov/view/cdc/81251, accessed on December 5, 2022.

HHS, Vaccine Adverse Event Reporting System, available at https://vaers.hhs.gov/index, accessed on December 5, 2022.

Food and Drug Administration. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005, available at https://www.fda.gov/media/71546/download, accessed on December 5, 2022.

Kelly WN, Arellena FM, Barnes J et al. Guidelines for submitting adverse event reports for publication, Pharmacoepidemiology and drug safety 2007; 16: 581–587, available at https://onlinelibrary.wiley.com/doi/epdf/10.1002/pds.1399, accessed on December 5, 2022.

Institute of Medicine (IOM). 2012l Adverse Effects of Vaccines: Evidence and Causality, available at https://www.nap.edu/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality, accessed on December 5, 2022.

Miller, E, Batten B, Hampton L, et al. Tracking Vaccine Safety Inquiries to Detect Signals and Monitor Public Concerns. Pediatrics. 2011;127;S1, available at https://publications.aap.org/pediatrics/article/127/Supplement_1/S87/30146/Tracking-Vaccine-Safety-Inquiries-to-Detect, accessed on December 5, 2022.

CDC. Clinical Immunization Safety Assessment (CISA) Project, available at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html, accessed on December 5, 2022.

Salmon D, Akhtar A, Mergler M et al. Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program. Pediatrics 2011. 127:S78-S86, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S78.full, accessed on December 5, 2022.

LaRussa P et al. Understanding the Role of Human Variation in Vaccine Adverse Events: The Clinical Immunization Safety Assessment (CISA) Network. Pediatrics. 2011;127 Suppl 1:S65-73, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S65.long, accessed on December 5, 2022.

US Department of Health and Human Services. Vaccines. National Strategic Plan fo the United States: 2021-2025, available at https://www.hhs.gov/sites/default/files/HHS-Vaccines-Report.pdf, accessed on December 5, 2022.

CDC, Advisory Committee on Immunization Practices (ACIP), available at https://www.cdc.gov/vaccines/acip/index.html, accessed on December 5, 2022.

CDC. Clinical Care Considerations for COVID-19 Vaccination, available at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/index.html, accessed on December 5, 2022.

CDC COVID-19 Response Team. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020. Morbidity and Mortality Weekly Report (MMWR)2021; 70(2);46–51.

See I, Su JR, Lale A et al. US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021. JAMA. 2021;325(24):2448-2456.

Walter EB, Klein N, Wodi P et al. Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations. Pediatrics. 2020 Mar;145(3):e20191909. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055925/, accessed on December 5, 2022.

Schmader KE, Liu C, Harrington T et al. Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2031266.

Fortner KB, Swamy GK, Broder KR et al. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018 Oct 8;36(42):6354-6360. Available at https://pubmed.ncbi.nlm.nih.gov/30219367/, accessed on December 5, 2022.]

A comprehensive vaccine safety system exists in the United States.5 The Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office (ISO) and FDA co-manage the Vaccine Adverse Event Reporting System (VAERS).[endnoteRef:5],[endnoteRef:6] The main goal of VAERS is to identify potential vaccine safety problems (“signals”) that can be further assessed in other systems, such as CDC’s Vaccine Safety Datalink.[endnoteRef:7] The VAERS form collects information on demographics, health history, vaccine(s) received, and signs and symptoms of the adverse events experienced.6,8 Information from the reports is entered into a database that is maintained by the VAERS contractor. Medical records are requested for all reports coded as serious,8 which includes adverse events resulting in death or hospitalization, and for other reports of special interest. [5:

Information Security ] [6: Standard-1: Procurements Requiring Information Security and/or Physical Access Security Baseline Security Requirements Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

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.

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

Safeguarding Information and Information Systems. 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:

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.

Note to the Requiring Activity Representative: Complete the following section using the information obtained from the Information Security and Privacy Certification Checklist.

Categorize all information owned and/or collected/managed on behalf of HHS/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:

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 HHS/CDC regardless of location or purpose.

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).

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

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

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

Note to the Requiring Activity Representative: This information may be included after award in the event it is not yet available at the time of acquisition. Section d must be included in all contracts regardless of whether or not personally identifiable information (PII) is involved.

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.

To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, HHS uses a privacy analysis process to assess the risks associated with HHS'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 HHS collects, disseminates, maintains, or disposes of the public's PII.

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 60-90 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.

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.

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 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:

Marked appropriately;

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

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 Returned to HHS 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.

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.

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 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 HHS 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 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:

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

18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

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).

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.

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 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, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

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

Note to the Requiring Activity Representative: See Appendix C for baseline deliverables. Do NOT include in procurement documentation.

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

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

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.

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).

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.

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

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.

Note to the Requiring Activity Representative: See Appendix D for the HHS Contractor Non-Disclosure Agreement. Do NOT include in procurement documentation.

Training Requirements Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must 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 must complete CDC Security Awareness Training (SAT), Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

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.

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

Rules of Behavior The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users.

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 (SAT). 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.

Incident Response The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/CDC Computer Incident Response Team (CSIRT) within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), 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 HHS breach response process, please see the “HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

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 must send CDC approved notifications to affected individuals.

Report all suspected and confirmed information security and privacy incidents and breaches to the CDC Computer Incident Response Team (CSIRT), 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 and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor 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.

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

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 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:

Note to the Requiring Activity Representative: The Requiring Activity Representative, in conjunction with Personnel Security, must 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.

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

Note to the Requiring Activity Representative: For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12) 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 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.

Contract Initiation and Expiration General Security Requirements. The Contractor (and/or any subcontractor) must 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 must follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS 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.

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.

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

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 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 HHS and/or CDC policies.

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 30 days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

Records Management and Retention 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 HHS Policy for Records Management and HHS policies and must 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, he/she must document and report the incident in accordance with HHS policies.

High Value Asset (HVA) If a system is identified as HVA,[23] the contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the DHS HVA Control Overlay[24] in addition to the above requirements.

Deliverables

Standard-2 Requirements for Procurements Involving Privacy Privacy Act It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records about individuals from which records are retrieved by name or other identifying particular.

The System of Records Notice that is applicable to this contract is: 09-20-0136 and 09-90-2001.

The system of records design, development, or operation work the Contractor is to perform is: The design, development, or operation work the Contractor is to perform is described in this Statement of Work and includes data collection and data management.

The disposition to be made of the Privacy Act records upon completion of contract performance is: VAERS does not have an individual record schedule in NCEZID record schedule document. According to CDC MASO website, VAERS compliance with CDC record schedule “CDC-04-4-66” which is maintain at least six years, but no longer than ten years after the retirement of the system depending upon program need for scientific, legal, or business reference then delete/destroy .

Standard-3 Procurements Involving Government Information Processed on GOCO or COCO Systems Security Requirements for GOCO and COCO Resources Federal Policies. The Contractor (and/or any subcontractor) must comply with applicable federal laws and HHS policies that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P), the CDC Protection of Information Resources policy; Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, latest revision, Security and Privacy Controls for Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; President Biden issued Executive Order 14017 Presidential Actions February 24, 2021 Executive Order on America’s Supply Chains, and other applicable federal laws, regulations, NIST guidance, and Departmental policies.

Assessment and Authorization (A&A). A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO prior to any use of the system in a production capacity, i.e., its intended users able to collect, store, process or transmit data to fulfill the system’s function. within the specified timeline(s). The Contractor must conduct the A&A requirements in accordance with HHS IS2P/ the CDC Security Assessment and Authorization (SA&A) Standard Operating Procedure, NIST SP 800-37, Guide for Applying the Risk Management Framework to Information Systems: A Security Life Cycle Approach (latest revision), NIST SP 800-53B, Control Baselines for Information Systems and Organizations, and the NIST SP 800-53A (latest revision).

Note to the Requiring Activity Representative: For an existing ATO, the OpDiv must make a determination if the system needs to be re-authorized to ensure all necessary safeguards are in place to protect the system and information for the performance of the contract and state as such.

CDC acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

A&A Package Deliverables - The Contractor (and/or any subcontractor) must provide an A&A package within 120 days of the system planned go-live date to the CO and/or COR. The following A&A deliverables are required to complete the A&A package.

Baseline System Information (BSI) – The Contractor will document a system overview, in accordance with the timeline, process and formats described in the CDC SA&A SOP. The BSI will include information concerning system identification and ownership; system data, information types, impact levels and system categorization; system functional description / general purpose; system authorization boundary and environment; system user descriptions; and system interconnections and dependencies. The Contractor must update the BSI at least annually thereafter.

Privacy Threshold Analysis / Privacy Impact Analysis – The Contractor (and/or any subcontractor) must provide a PTA/PIA (as appropriate), in accordance with the timeline, process and formats described in the CDC SA&A SOP, if applicable. Also see the sections of this contract concerning “Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)” and “Requirements for Procurements Involving Privacy Act Records.”

NOTE: If social security numbers (SSN) are expected to be handled by the system, the program and Contractor must include a SSN Elimination or Usage Approval Request along with the PTA/PIA. That request will be processed in accordance with the CSPO Standard for Limiting the Use of Social Security Numbers in CDC Information Systems.

System Security Plan (SSP) – due in accordance with contract. The SSP must be provided in a digital format supporting copy or export of all content into the HHS/CDC automated SA&A tool. The SSP must comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and CDC policies and other guidance. The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor must review and update the SSP at least annually thereafter and if requested, provide a copy of the updated SSP.

Security Assessment Plan/Report (SAP/SAR) – within 120 days. The security assessment must be conducted by the Contractor in conjunction with the program’s Information System Security Officer, and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and CDC policies. The assessor will document the assessment results in the SAR.

Note to the Requiring Activity Representative: CDC should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with CDC must conduct and/or assist in the assessment of the security controls [insert specific timeline(s) if applicable] and update the SAR at least annually. A copy of the updated SAR should be provided if requested.

Independent Assessment – due after 120 days after contract award. The Contractor (and/or subcontractor) must have an independent third-party validate the security and privacy controls in place for the system(s) commensurate with the risk levels per NIST SP 800-53B. The independent third party must review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor must address all "high" deficiencies before submitting the package to the Government for acceptance and document all remaining deficiencies in a system Plan of Actions and Milestones (POA&M).

POA&M – due 120 days. All critical-risk weaknesses must be mitigated within 15 days, high-risk weaknesses must be mitigated within 30 days, medium weaknesses must be mitigated within 60 days, and low weaknesses must be mitigated within 360 days from the date the weaknesses are formally identified and documented. CDC will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, flaws and security defect in a system (that require to create a patch for remediation), and other security reviews and sources, as documented in the SAR, must be documented and tracked by the Contractor for mitigation in the POA&M document consistent with the HHS Standard for Plan of Action and Milestones and CDC policies. Depending on the severity of the risks, CDC may require designated POA&M weaknesses to be remediated before an ATO is issued. Thereafter, continue to remediate weaknesses throughout the contract. The POA&M document must be updated at least quarterly.

Contingency Plan and Contingency Plan Test – due 120 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and CDC policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, must test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor must update and test the Contingency Plan at least annually.

E-Authentication Questionnaire - The contractor (and/or any subcontractor) must collaborate with government personnel to ensure that the E-Authentication requirements are implemented in accordance with OMB 04-04 and NIST SP 800-63 B.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS Guidance for Selection of e-Authentication Assurance Levels and any other applicable HHS policies.

Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, must meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, HHS ISCM Strategy, and HHS IS2P.

Annual Assessment/Penetration (Pen) Test - Assess the system security and privacy controls (or ensure an assessment of the controls is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (this involves penetration testing conducted by the agency or independent third-party. In addition, review all relevant A&A documentation (SSP, POA&M, Contingency Plan, etc.) and provide updates by specified due date Asset Management - Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. It is anticipated that this inventory information will be required to be produced at least annually. IT asset inventory information must include IP address, machine name, operating system level, security patch level, and SCAP-compliant format information. The contractor must maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools in accordance with the HHS Policy for Information Technology Asset Management (ITAM) and any other applicable HHS policy.

Configuration Management - Use available SCAP-compliant automated tools as per NIST IR 7511 and HHS Minimum Security Configurations Standards Guidance to scan all IT assets, including but not limited to: computers, servers, routers, databases, operating systems, application, etc., that store and process government information. Provide scan reports to HHS/CDC upon request. The contractor must maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

Vulnerability Management - Contractors must actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS Policy for Vulnerability Management. Automated tools must be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor must maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least annually.

Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and agency specified timeline per CSPO Vulnerability Remediation Framework Standard.

Secure Coding - Follow the HHS Policy for Software Development Secure Coding Practices and secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits. The Contractor (and/or any subcontractor) shall perform both static and dynamic code testing.