Attachment 1 - Statement of Work (draft).docx

Statement of Work / Performance Work Statement Title: Clinic Consortium for HIV Implementation Research and Prevention (CCHIRP)

Period of performance of this contract is: July 1, 2024 to June 30, 2029 Base Period: July 1, 2024 to June 30, 2025 Option Period One: July 1, 2025 to June 30, 2026 Option Period Two: July 1, 2026 to June 30, 2027 Option Period Three: July 1, 2027 to June 30, 2028 Option Period Four: July 1, 2028 to June 30, 2029

SECTION 1 – BACKGROUND

To achieve the goals of the Ending the HIV Epidemic in the U.S. and the National HIV/AIDS Strategy to decrease new HIV infections, access to and use of high-quality clinical HIV preventive care services must be increased.1-3 CDC guidelines for HIV prevention include routine opt-out HIV testing and more frequent risk-based HIV testing in clinical settings4, and prescribing of preexposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) for persons who might benefit.5,6 However, provision of these services has been suboptimal in the United States and large and worsening disparities exist in PrEP use by Black or African American (Black) men and women and Hispanic or Latino men who have sex with men (MSM).7 Persons in these populations comprise most new HIV infections each year,8 and these infections could have been prevented with PrEP use. To increase HIV preventive measures by persons in populations with the greatest need, it is imperative to develop, implement, and evaluate strategies that support healthcare systems and clinical practices to more effectively and efficiently implement HIV testing PrEP and PEP.9 Effective interventions need to be scaled-up and implemented using strategies found effective and acceptable to both providers and patients in implementation research studies and that can be adapted to varying clinical settings and requirements.

SECTION 2 – PURPOSE/OBJECTIVE

An Indefinite Delivery, Indefinite Quantity (IDIQ) contract with a term of 60 months will support increased PrEP and other HIV prevention measure use by persons in priority populations by funding individual task orders for conduct of implementation research in healthcare systems and clinical care setting (e.g., academic clinic networks, retail clinic networks, integrated healthcare systems). Research will assess strategies to increase the reach, effectiveness, and efficiency of biomedical HIV preventive care. Biomedical prevention includes PrEP, nPEP, and associated healthcare services such as HIV and STI testing and patient education and support counseling provided in clinical care settings.

SECTION 3 – SCOPE OF WORK

This IDIQ research contract provides a mechanism for NCHHSTP/DHP to acquire HIV prevention research services. This includes conduct of PrEP and other HIV biomedical intervention prevention and implementation research, development of scientific and technical expertise, and acquisition of support services to increase the impact of HIV prevention interventions that increase HIV-related health equity.

(a) Implementation research to increase PrEP prescribing in healthcare systems and clinics

(b) Implementation research to increase HIV testing in healthcare systems and clinics.

(c) Development, implementation, and evaluation of clinical decision support (CDS) to increase HIV testing and PrEP initiation and persistence in healthcare systems and clinical practices.

(d) Development, implementation, and evaluation of interventions to increase PrEP adherence.

(e) Development, implementation, and evaluation of novel formulations and delivery models for HIV prevention in healthcare systems and clinical practices.

As an independent organization and not as an agent of the Government, the Contractors shall furnish all necessary personnel, facilities, supplies, and equipment, as appropriate, to provide NCHHSTP/DHP with required research services within the general work parameters set forth in this Statement of Work. Contractor performance and all resulting deliverables must adhere to Federal, HHS, and/or CDC IT security policies and procedures.

The Contractors are advised that it is not possible to determine the precise types or amounts of services, supplies, and/or equipment that will be ordered during the term of the contract. The Contractors shall be obligated to perform within the minimum and maximum order limitations set forth in clauses 52.216-19, Order Limitations. The time of issuance and amount of work in task orders cannot be accurately predicted. The Government will make every effort to give the Contractors advance notice of requirements, but the services for which this contract will be used could address an immediate need involving an emergency or short notice requirement. Services to be performed shall be non-personal and not inherently governmental services. Supplies and equipment are incidental to the required services to be performed.

SECTION 4 – TASKS TO BE PERFORMED

Task 1.1: Kick-off meetings and regular progress meetings

a) The Contractor shall schedule and convene a kick-off meeting within 10 business days of the award.

b) The Contractor shall schedule and convene regular meetings for progress update and discussion.

Task 1.2: HIV PrEP CDS enhancement

a) The contractor shall direct its information technology specialists to enhance an existing HIV testing CDS that uses information in the patient electronic medical record (EMR) to identify patients who need to be tested for HIV and who are eligible to be prescribed PrEP and to provide options for provider prompts and automatic (a) HIV testing, (b) provider notification of PrEP eligibility, and (c) provider PrEP order sets. This shall require the Contractor to modify the code in the existing HIV testing CDS.

b) The Contractor shall identify a brief sexual and injection behavioral risk assessment questionnaire and shall program it to allow real-time integration with the CDS at a patient visit.

c) HIV prevention educational materials shall be identified and integrated into the CDS and clinical workflow to facilitate automatic dissemination to patients with indicators of risk identified using the CDS.

d) The Contractor shall develop a Fast Health Interoperability Resources (FHIR) implementation guide and application for the PrEP CDS to allow easily adaptation across various EMR systems

Task 1.3: Healthcare system recruitment

a) The Contractor shall recruit at least three or more healthcare systems that with capacity to develop CDS, to program existing CDS to include PrEP services described in Task 1.2.a, to program/integrate the CDS in the healthcare system EM, to extract data from their EMR, and willingness to modify clinical workflow to accommodate the integrated tools and automated services.

Task 1.4: HIV PrEP CDS implementation

a) The Contractor shall implement the PrEP CDS and sexual risk assessment questionnaire in the EMR of the healthcare systems.

b) The Contractor shall develop a user guide for the CDS implementation and make needed adjustments to ensure the CDS can be integrated into various EMR systems.

Task 1.5: HIV PrEP CDS evaluation

a) The Contractor shall collect deidentified pre- and post-implementation EMR data from the recruiting sites. The retrospective EMR data shall include information predetermined by CDC, including but not limited to patient sex at birth, current sex/gender, year of birth, race and ethnicity, payer, and clinical records such as diagnoses, procedures, laboratory tests and results, and prescriptions.

b) The Contractor shall clean, organize, and standardize the extracted EMR data and submit to CDC through a secured data transfer system (Enterprise Data Exchange (DEX)) at intervals required by CDC.

c) The Contractor shall evaluate the effectiveness of the tool by analyzing pre- and post-implementation EMR data.

Task 1.6: Annual progress reports

a) The Contractor shall produce a progress report that describes the project progress by the end of the period of performance.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

The government will furnish a secure VPN for annual transmission of data to CDC and will monitor timely and complete receipt of quality data according to CDC specifications.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Place of performance is not at a government facility. It is estimated that approximately 0% of the contract will be performed on-site at CDC facilities and 100% will be performed off-site at the Contractor’s facilities.

SUBSECTION B – CONTRACT SUPPORT HOURS

The specific hours required to support these tasks shall be days Monday through Friday, starting no later than 9am and ending no earlier than 3:30pm. There is no specific time zone.

SECTION 7 – TRAVEL

Travel will be in accordance with / and not to exceed the Federal Travel Regulation rates. Travel costs need to be approved in advance by the COR. The Contractor shall be required to provide their travel policy to the Government for review.

Travel does not include conference travel.

SECTION 8 – PERFORMANCE MATRIX

PERFORMANCE OBJECTIVE

Kick-off meetings and regular progress meetings

100% Inspection

100% Inspection

100% Inspection

100% Inspection

100% Inspection

100% Inspection

SECTION 9 – REFERENCES

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

Contractors must be a healthcare system network or clinical practice network such as an academic clinic network, retail clinic network, or integrated healthcare system(s). The Contractors must have experience conducting clinical trials and implementation research, including HIV prevention research. The Contractors must have expertise and experience developing code for clinical decision support tools and programming it in EMR systems. The Contractors must have experience conducting evaluation of clinical services using information in patients’ EMRs. The Contractors must include healthcare systems or clinical practice networks that provide care to a patient population comprised of at least 50% Black persons.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy The Contractor shall develop a Data Management Plan (DMP) and commit to update the DMP throughout the life cycle of the public health data collected or generated during the performance period. CDC requires awardees of contracts that involve the collection or generation of public health data with federal funds to develop, submit, and comply with the requirement of a DMP for each collection or generation of public health data undertaken. A DMP should include the following:

· A description of the public health data to be collected or generated in the contract period of performance.

· Mechanisms for or limitations to providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights) or justification for why data cannot be made accessible. This section should address access to identifiable and de-identified data (see below for additional information about access).

· Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use.

· Plans for archiving and long-term preservation of the data, or explanation of why long-term preservation and access are not justified. This section should address archiving and preservation of identifiable and de-identified data (see Public Access to CDC Funded Digital Public Health Data) for additional information regarding archiving).

· Plans for addressing security/privacy considerations, plans for data sharing and release and references the data storage location. (CDC Note that the STARS data management plan should be used, if applicable. The Data Use Agreement Template Module should be used, if applicable. If data are made available for public use, use enterprise data services such as data.cdc.gov. EDAV use is required for all data storage, analysis, and visualization activities.)

[Source for text below: CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0; Draft Standard Acquisition Language Guide - FINAL (cdc.gov). Sections 2, 3, 4 and 6 of this HHS/CDC document applies to this procurement.}

Procurements Requiring Information Security and/or Physical Access Security (Section 2)

Baseline Security Requirements

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

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

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

2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

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

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

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

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ ] Low [ ] Moderate [ ] High Integrity: [ ] Low [ ] Moderate [ ] High Availability: [ ] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [ ] Moderate [ ] High

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

[ ] No PII [ ] Yes PII

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

4) Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ ] Low [ ] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 32 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

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

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

7) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and [CDC] policies. Unauthorized disclosure of information will be subject to the HHS/[CDC] sanction policies and/or governed by the following laws and regulations:

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

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

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

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

9) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

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

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

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

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and CDC-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to CDC Office of Chief Information Security Officer (OCISO).

12) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the CDC non-disclosure agreement, as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition. See Appendix C for the Contractor Non-Disclosure Agreement.

13) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract in accordance with HHS policy and OMB M03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

a. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of PII are collected that could introduce new or increased privacy risks), whichever comes first.

B. Training

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

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training (RBT) within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least annually in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

All HHS employees and contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

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

C. Rules of Behavior

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

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

D. Incident Response

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally Identifiable Information” (03 January 2017) states:

Definition of an Incident: An occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.

Definition of a Breach: The loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose.

It further adds: A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment. A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII for an other than authorized purpose.

The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII”.

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

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

2) All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

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

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

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

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

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

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

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

E. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR).

The requiring activity representative, in conjunction with Personnel Security, shall use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

F. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2. . For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidentialdirective-12) Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO by the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted immediately upon change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

G. Contract Initiation and Expiration

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

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html CDC EPC Requirements: https://www2a.CDC.gov/CDCup/library/other/eplc.ht

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

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

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Out-Processing Checklist (http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract. All documentation shall be made available to the CO and/or COR upon request.

H. Records Management and Retention The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS policies and shall not dispose of any records unless authorized by HHS. In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS policies.

Requirements for Procurements involving the Privacy Act (Section 3)

A. 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 on individuals.

The System of Records Notice (SORN) that is applicable to this contract is: Insert SORN number if one exists. Applicable SORNs are found at https://www.hhs.gov/foia/privacy/sorns/index.html, and may be chosen from CDC, or HHS, or Government-wide. If there is no SORN, indicate that a SORN will be developed].

The design, development, or operation work the Contractor is to perform is: [Insert description of design, development, and/or operation work; see definitions in the FAR at 24.101 - Definitions].

The disposition to be made of the Privacy Act records upon completion of contract performance is: [Insert records disposition instructions and as applicable, the corresponding Records Schedule that the contractor and any subcontractor must follow upon completion of contract performance].

Procurements Involving Government Information Processed on GOCO or COCO Systems (Section 4)

A. Security Requirements for GOCO and COCO Resources

1) Federal Policies. The Contractor (and/or any subcontractor) shall comply with applicable federal directives 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, Security and Privacy Controls for Federal Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Departmental policies.

2) Security Assessment and Authorization (SA&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) shall 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. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P/ CDC Protection of Information Resources; the CDC IT Security Program Implementation Standards; the CDC Security Assessment and Authorization (SA&A) Standard Operating Procedure; and NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

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. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package to the C/I/O Information System Security Officer (ISSO) in accordance with the timeline, process and formats proscribed for a Full system authorization in the CDC Security Assessment and Authorization Standard Operating Procedure (CDC SA&A SOP). The following SA&A deliverables are required to complete the SA&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 shall update the BSI at least annually thereafter.

· Privacy Threshold Analysis / Privacy Impact Analysis – The Contractor (and/or any subcontractor) shall 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 OCISO Standard for Limiting the Use of Social Security Numbers in CDC Information Systems.

· System Security Plan (SSP) – 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 shall 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 Federal 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 shall 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 shall provide an overview of the system environment (including an inventory of all devices and software contained within the system boundary) 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 shall update the SSP at least annually thereafter.

· Risk Assessment Report (RAR) The initial security assessment shall be conducted by the Contractor in conjunction with the program’s Information System Security Officer, consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and CDC policies. The assessor will document and submit the assessment results in the RAR, in accordance with the process and formats described in the CDC SA&A SOP. The Contractor shall address all “High” deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M) for CDC OCISO approval in accordance with the CDC SA&A SOP. Thereafter, the Contractor, in coordination with CDC shall conduct an assessment of the security controls and update the RAR within 365 days.

· POA&M –The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and CDC policies. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the Security Assessment Report (SAR), shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, CDC may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

· Contingency Plan and Contingency Plan Test –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, shall 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 shall update and test the Contingency Plan at least annually.

· E-Authentication Assessment – The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04; NIST SP 800-63, Digital Identity Guidelines; the OCISO Standard for Electronic Authentication (E-Authentication); and the CDC SA&A SOP.