Solicitation Amendment _ Sec. D PWS - RFP 75D301-22-R-72117.docx

RFP 75301-22-R-72117 – SOLICITATION aMENDMENT

SECTION D – PERFORMANCE WORK STATEMENT

TITLE: MASS-C Study New Contract: Multistate Assessment of SARS-CoV-2 Seroprevalence (Commercial Laboratories)

PERIOD OF PERFORMANCE:

Base Year 02/21/2022 - 01/20/2023; 10 months of sample testing (5 total testing periods, each of 8 week duration), and 1 month to finalize final report prior to submission.

Option Period 12/05/2022* - 12/04/2023; 11 months of sample testing (6 total testing periods, each of 8 week duration), and 1 month to finalize final report prior to submission.

*Note: The start date overlaps the Base Year period of performance so that data collection will remain continuous, as the final data collection date of the Base Year is 12/04/2022

I. BACKGROUND:

Several U.S. seroprevalence studies have suggested that the majority of persons have not been infected with SARS-CoV-2. However, there has been wide variability in seroprevalence estimates due to several factors including the use of different assays, participant selection methods, time period conducted, and regional differences in the burden of disease. In this work, CDC will enter into a new contract for a repeat cross sectional serologic survey using convenience samples collected from commercial laboratories across the United States.

II. PROJECT OBJECTIVE:

The CDC’s work in this contract will use offeror(s) residual/remnant/excess, deidentified blood specimens to obtain laboratory testing toward determining U.S. seroprevalence by geographic region, pediatric age group, and time period.

III. DESCRIPTION OF WORK (organized by TASK):

CDC reserves the right to award multiple contracts to multiple offerors to achieve the geographic reach needed for studying seroprevalence across 50 states, Washington DC and Puerto Rico. Offeror(s) shall complete and include with their technical proposals Attachment A which includes questions on offeror(s) capabilities, geographic coverage, ability to obtain pediatric specimens, ability to monitor and adjust for geographic representativeness of sample, and residual specimen descriptions. Offeror(s) shall include in their technical proposal an appendix of all offered test protocols. CDC will not be able to provide residual samples to contractors.

IV. TASKS:

TASK 1: COVID-19 PAN-IG ELISA TESTING

Task 1.1 Residual Specimen Selection

a. Contractor(s) shall identify excess, remnant, or residual blood specimens from remaining volumes of previously obtained blood specimens for non-COVID-19 diagnostic or antibody testing or otherwise obtained specimens.

b. From this list, the contractor shall choose sufficient samples from each jurisdiction (50 US States, DC, and Puerto Rico) to achieve the target sample size within each age group.

Base Period:

i. Age groups and sample sizes below:

ii. Totaling ~650 samples over each 8-week period per jurisdiction

iii. Time Periods for Collection:

· Collection Period 30: Feb 28, 2022 – Apr 24, 2022

· Collection Period 31: Apr 25, 2022 – Jun 19, 2022

· Collection Period 32: Jun 20, 2022 – Aug 14, 2022

· Collection Period 33: Aug 15, 2022 – Oct 9, 2022

· Collection Period 34: Oct 10, 2022 – Dec 4, 2022

Option Period 1:

i. Age groups and sample sizes below:

ii. Totalling ~650 samples over each 8-week period per jurisdiction

iii. Time Periods for Collection:

· Collection Period 35: Dec 5, 2022 – Jan 29, 2023

· Collection Period 36: Jan 30, 2023 – Mar 26, 2023

· Collection Period 37: Mar 27, 2023 – May 21, 2023

· Collection Period 38: May 22, 2023 – Jul 16, 2023

· Collection Period 39: Jul 17, 2023 – Sept 10, 2023

· Collection Period 40: Sept 11, 2023 – Nov 5, 2023

Optional CLINs 1005 and 1006

iv. Age groups and sample sizes below:

v. Totalling ~1100 samples over 8-week period per jurisdiction

vi. Time Periods for Collection: CDC will determine which Collection Period(s) upon exercise of optional CLINs 1005 and 1006

Task 1.2 Residual Specimen Testing

a. The Contractor(s) shall test specimens to include CLIA-approved and/or EUA-approved ELISA, COVID-19 IgG and/or IgM serological assays. The required sample matrix and sample volume should be specified for each offered test name. One anti-S quantitative assay and one anti-N qualitative assay will be performed on each specimen.

i. Required assay characteristics to ensure consistency of assay characteristics across labs:

[potential for inclusion of newly developed assays designed to optimize sensitivity in detection for Omicron and/or future variantsif validated and calibrated to WHO standards]

ii. Any anticipated remnant handling costs such as accessioning work should be part of the testing cost estimated in the price proposal.

b. The Contractor(s) shall ship any CDC-selected seropositive or seronegative specimens to CDC- designated facilities for reflexive testing described under task 2 (see Task 1.6) if the Contractor(s) cannot perform reflexive testing or was not awarded Task 2.

Task 1.3 Data Report and Review Meeting

a. Contractor(s) shall create sample draft data report and schedule meeting for review and to address any questions.

Task 1.4 Data Reporting

a. Contractor(s) shall provide data report to CDC within 2 weeks after each sample collection and testing period

Task 1.5 Identification of Specimens for Reflexive Testing

a. Offeror(s) will identify seropositive specimens from task 1.2 for further reflexive testing. Contractor(s) shall complete testing under task 2.1 or prepare and send shipments under task 1.6 to another offeror(s) facilities. Reflexive testing under task 2.1 should be performed within 5 days of the quantitative anti-S assay performed under Task 1.2 to ensure comparable results. A small subset of seronegative specimens may also be requested for reflexive testing.

Task 1.6 Specimen Shipping

a. If the remnant/excess/residual specimens selected under task 1.1 exceeds the Contractor(s)’ specimen testing capacity under task 2.1, the Contractor(s) shall ship the selected residual specimens that exceed its testing capacity to another testing facility designated by CDC.

b. Contractor(s) with any COVID-19 seropositive specimens identified from task 1.2 and selected for reflexive testing in tasks 2.1 shall ship those samples to a CDC designated facility for reflexive testing, if different than the facility where specimens were tested under task 1.2, meaning that the Contractor(s) cannot perform reflexive testing or was not awarded Task 2.

c. In general, Contractor(s) should pack and ship suspected and confirmed SARS-CoV-2 specimens, as UN 3373 Biological Substance, Category B, in accordance with the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulations and U.S. Department of Transportation’s (DOT) Transporting Infectious Substances Safely. Personnel must be trained to pack and ship according to the regulations and in a manner that corresponds to their function-specific responsibilities.

i. The estimated sample volume to plan for reflexive testing is 0.5 mL

ii. The estimated shipping temperature to plan for this work is -20 ˚C

iii. If shipping is projected to be required, the contractor will notify the CDC as soon as possible; the CDC will provide the U.S. shipping address for reflexive testing and required timelines

Task 1.7 Draft Final Report and Review Meeting

a. Contractor(s) shall create and submit a sample final report and schedule a draft final report meeting with CDC to discuss. The draft final report should be submitted at least 10 days in advance of the meeting.

Task 1.8 Final Report

a. Contractor(s) shall create and submit a final report

TASK 2: REFLEXIVE COVID-19 MICRONEUTRALIZATION ASSAY TESTING

Task 2.1

a. The Contractor(s) shall provide microneutralization testing for seropositive specimens. Specimens from individuals from whom a date of previous positive PCR are available are preferred. Reflexive testing under task 2.1 should be performed after the quantitative assay performed under Task 1.2. Samples undergoing reflexive microneutralization testing should be frozen within one (1) week of collection, and then stored frozen to be batched monthly for testing. Tests (with specific test names) will be selected from offeror(s) proposals and identified in the contract award. Sample sizes for this task by age group are:

i. Positive serology samples (on qualitative anti-nucleocapsid antibody test): 200 samples tested per 8-week collection period; these may be batched as agreed upon after award between contractor and CDC to maximize efficiency.

1. 100 samples from persons aged 0 – 11

2. 100 samples from persons aged 12 – 17

3. As many as possible with a previous positive PCR date should be selected (20-50% of specimens undergoing microneutralization testing should be from individuals from whom there is a dated prior positive PCR result for SARS-CoV- 2 infection, unless that sample size is not available from specimen pool)

b. As needed, the Contractor(s) may use specimens identified in Task 1.2, or they may identify excess, remnant, or residual blood specimens from samples submitted for COVID-19 antibody testing. Any anticipated remnant handling costs such as accessioning work should be part of the testing cost estimated in the price proposal. If residual specimens are not available, the contractor(s) will test specimens shipped from CDC or other contracted labs.

Task 2.2 Draft Data Report and Meeting

a. Contractor(s) shall create sample draft data report and schedule meeting for review.

Task 2.3 Data Reporting

a. Contractor(s) shall provide data report bi-weekly to CDC.

Task 2.4 Draft Final Report and Review Meeting

a. Contractor(s) shall create and submit a sample final report and schedule a draft final report meeting with CDC to discuss. The draft final report should be submitted at least 10 days in advance of the meeting.

Task 2.5 Final Report

a. Contractor(s) shall create and submit a final report

V. DELIVERABLES:

See Attachment B for Deliverables Table. Offeror(s) should also use the list of deliverables provided in Attachment B as a guide for the preparation of technical and price proposals in addition to the PWS. Offeror may propose revised language for the Deliverables Table and attach as an appendix to their proposal

Laboratory Reporting

In accordance with deliverables and tasks as listed, the Contractor(s) shall transmit data to CDC within 2 weeks following every 8 week data collection period by either a CDC-designated secure email or SFTP. The Contractor(s) shall submit aggregate information on age and gender by jurisdiction for all samples available for selection for this study. Additionally, labs shall submit sample-level data for all tested specimens. Files will be submitted as: 1) a locked Excel file, 2) an unlocked Excel file, and 3) a .CSV file.

In addition to the specifmen information requested in Attachment A, the following data elements (if available) are wanted at the sample level and should also be included in the data report deliverables described in Attachment B:

· Race and ethnicity (if available)

· 5-digit zip code of patient residence; provider zip code if residence not available

· The name of the original laboratory test (e.g., basic metabolic panel, lipid panel)

· ICD10 diagnosis associated wit hthe original laboratory test

· Results (including collection date) of any previous COVID-19 testing on the same patient, including previous PCR testing for SARS-CoV-2 infection or previous testing for SARS-CoV-2 antibodies (antibody assay type should be included, if available)

· Information on if the specimen came from an outpatient or inpatient facility (if available)

· Information on payer by category (e.g., private insurer/HMO, Medicaid, Medicare, self-pay, military health system), if available

· Unique patient identifier to allow for deduplication of sample results from the same patient

Time Schedule

The proposed time schedule for this work is as follows. Offerors must clarify whether testing can begin on the first sample cycle start date in their technical proposal.

BASE YEAR

Period (numbered continuously from previous study for clarity)

Start date

OPTION PERIOD 1

Period (numbered continuously from previous study for clarity)

Start date

VI. SPECIAL REQUIREMENTS/CLAUSES:

A. HUMAN SUBJECTS

The test results are not intended to be used as a diagnostic tool and instead identify a marker for past infection with SARS-CoV-2 at some previous undetermined time. It will not be useful to the health or well-being of any individual. Remnant/excess/residual specimens will have all personal identifying information removed. Final results will be presented in aggregate, stratified by location and age group, and it will not be possible to link results to an individual.

B. SECURITY AND PRIVACY COMPLIANCE

Baseline Security Requirements

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

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

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

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

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

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

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

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

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

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

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

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

Confidentiality: [X] Low [ ] Moderate [ ] High Integrity: [ ] Low [X] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [X] Moderate [ ] High Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X] No PII [ ] Yes PII Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

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

PII Confidentiality Impact Level has been determined to be: [X] N/A [ ] 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.

CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0 Page 12 Office of the Chief Information Security Officer (OCISO) 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], CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0 Page 13 Office of the Chief Information Security Officer (OCISO) 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 M-03-22, 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.

Part 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) CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0 Page 14 Office of the Chief Information Security Officer (OCISO) 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.

Part 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.

Part 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.

CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0 Page 15 Office of the Chief Information Security Officer (OCISO) 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 CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0 Page 16 Office of the Chief Information Security Officer (OCISO) 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.

Part 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.

Part 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-presidential-directive-12) Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO 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 CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0 Page 17 Office of the Chief Information Security Officer (OCISO) Government will determine the appropriate suitability level.

Part G. Contract Initiation and Expiration

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

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

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

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

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

6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Out-Processing Checklist (http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract. All documentation shall be made available to the CO and/or COR Part H. Records Management and Retention The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS policies and shall not dispose of any records unless authorized by HHS.

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html CDC EPC Requirements: https://www2a.CDC.gov/CDCup/library/other/eplc.htm CDC Implementation of HHS Security and Privacy Language for Information and Information Technology Procurements Language, Version 1.0 Page 18 Office of the Chief Information Security Officer (OCISO) 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.

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