Revised RFP 2023-R-92697 CFA Epid Studies 8.9.23.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 78

2. CONTRACT NO.

3. SOLICITATION NO.

Revised

75D301-23-R-72697

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

08/09/2023

07/24/2023

6. REQUISITION/PURCHASE

NO.

0000HCAD-2023-73523

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 2:00p local time

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Tailee C. Tucker

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2812

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 51

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 5 X J LIST OF ATTACHMENTS 62

X D PACKAGING AND MARKING 32 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 33 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 34 X K OTHER STATEMENTS OF OFFERORS 63

X G CONTRACT ADMINISTRATION DATA 35 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 71

X H SPECIAL CONTRACT REQUIREMENTS 38 X M EVALUATION FACTORS FOR AWARD 75

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

75D301-23-R-72697

Section B - Supplies Or Services And Prices/Costs

BASE PERIOD

ITEM SUPPLIES/SERVICES QTY/

UNIT

UNIT PRICE EXTENDED

PRICE

0001 CDC/CFA Epidemiology Studies

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

Period of Performance is 12 months estimated from

8/01/2023-7/31/20249/29/2023-9/28/2024

This is a Firm-Fixed Price/Severable Line Item

1 Job $__________ $__________

OPTION PERIOD ONE

UNIT

UNIT PRICE EXTENDED

PRICE

1001 CDC/CFA CDC/CFA Epidemiology Studies

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2024-7/31/20259/29/2024-9/28/2025

OPTION PERIOD TWO

UNIT

UNIT PRICE EXTENDED

PRICE

2001 CDC/CFA CDC/CFA Epidemiology Studies

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2025-7/31/20269/29/2025-9/28/2026

This is a Firm-Fixed Price/Non-Severable Line Item

OPTION PERIOD THREE

UNIT

UNIT PRICE EXTENDED

PRICE

3001 CDC/CFA CDC/CFA Epidemiology Studies

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2026-7/31/20279/29/2026-9/28/2027

OPTION PERIOD FOUR

UNIT

UNIT PRICE EXTENDED

PRICE

4001 CDC/CFA CDC/CFA Epidemiology Studies

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2027-7/31/20289/29/2027-9/28/2028

B.1 PAYMENT TERMS

Payment will be made subject to receipt of deliverables in accordance with the payment schedule established herein and in accordance with FAR 52.232-25. Prompt Payment, which states that the due date for making invoice payments shall be the 30th day after the designated billing office (see block 25 of the order) has received a proper invoice from the vendor or the 30th day after Government acceptance of the services provided by the vendor, whichever is later.

B.2 Schedule of Milestones for Performance-Based Payments

In accordance with FAR 52.232-32, PERFORMANCE BASED PAYMENTS (April 2012), upon successful completion of an event, the contractor may request performance based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the Contracting Officer’s Representative (COR) that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone. Milestone payments are subject to the terms of FAR

52.232-32 incorporated in this contract.

The COR receives & accepts work associated w/the milestone events.

Milestone Payment Schedule for Base Period (CLIN 0001)

DESCRIBE

PROPOSED

MILESTONE EVENT

PAYMENT

PERCENTAGE

PAYMENT

DUE DATE

PAYMENT AMT

(MONTHLY,

QTLY, ETC.

DOLLAR

AMOUNT

TOTAL 100%

$0.00 $0.00

Milestone Payment Schedule for OPTION PERIOD ONE (CLIN 1001)

DESCRIBE

PROPOSED

MILESTONE EVENT

PAYMENT

PERCENTAGE

PAYMENT

DUE DATE

PAYMENT AMT

(MONTHLY,

QTLY, ETC.

Milestone Payment Schedule for OPTION PERIOD TWO (CLIN 2001)

PROPOSED

MILESTONE EVENT

PAYMENT

PERCENTAGE

PAYMENT

DUE DATE

PAYMENT AMT

(MONTHLY,

QTLY, ETC.

Milestone Payment Schedule for OPTION PERIOD THREE (CLIN 3001)

PROPOSED

MILESTONE EVENT

PAYMENT

PERCENTAGE

PAYMENT

DUE DATE

PAYMENT AMT

(MONTHLY,

QTLY, ETC.

Milestone Payment Schedule for OPTION PERIOD FOUR (CLIN 4001)

PROPOSED

MILESTONE EVENT

PAYMENT

PERCENTAGE

PAYMENT

DUE DATE

PAYMENT AMT

(MONTHLY,

QTLY, ETC.

Section C - Description/Specification/Work Statement

PERFORMANCE WORK STATEMENT

TITLE: CDC/CFA CDC/CFA Epidemiology Studies

SECTION 1 – BACKGROUND

CDC’s Center for Forecasting and Outbreak Analytics (CFA) provides timely analyses relevant to decisions about outbreak control, using a variety of data sources. Each data source has strengths and limitations regarding timeliness, representativeness, geographic scale, level of detail, and other factors.

For this reason, CFA seeks access to a large-scale data source from electronic medical records and health claims in the United States that will enable rapid analyses to assess such quantities as disease incidence and prevalence, severity, sequelae, countermeasure effectiveness, overall and in subgroups of particular interest for reasons of vulnerability or health equity. We refer to the structure for such access as a data analysis environment (DAE), to be defined further below. The primary goal is to acquire the capacity to use the DAE through collaborations with Contractor’s own analysts to conduct analyses in real time to inform decisions about how to respond to outbreaks.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose for this contract is to expand the CFA’s data network and have access to medical records of patients in the data network to investigate trends and to detect, monitor, and characterize emerging infectious and noninfectious threats. The core elements of the contract comprise of data sources, medical records, analytic capabilities, operations and management, and transition services.

SECTION 3 – SCOPE OF WORK

The objectives of this contract are to:

1. Provide CFA with indirect access (via collaborative analysis with contractor’s personnel) to large-scale de-identified United States (US) health care data of millions of patients, including electronic medical records (EMR) (required), and adjudicated and prejudicated administrative claims data (optional) data sources using a distributed data network which may use a common data model (CDM). The data sources shall provide longitudinal health care data for participating patients.

2. Provide access via collaborative analysis after abstraction by the contractor’s personnel to full medical charts of patients, whose health care data are available, for review, abstraction, and adjudication in the context of CFA analytic activities.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Data Analysis Environment and Data Sources

The primary goal of this contract is to provide CFA access to electronic medical records that cover millions of patients in the U.S., providing longitudinal health care data and access to full medical records of participating patients in the data network. The contractor shall:

1. Provide access to a network of large-scale distributed databases transformed into a common data model that include near real-time data with less than 1-month data lag, patient-centered, comprehensive demographic, clinical, and ancillary clinical data in various care settings and cover among others vulnerable populations, such as children, elderly, pregnant women, immunocompromised patients, and others.

2. Provide access to a data network to support analyses of disease trends, including data with linkage between mothers and infants and preferably of individuals residing in the same household, and storage capacity for different versions of databases.

3. Provide access to a common data model that can accommodate a distributed data network and uses a standardized vocabulary to ensure consistency and quality of data across the network.

4. Provide description of data standards that are utilized in data collection, with particular focus on data standards for race/ethnicity and social determinants.

5. Provide demographics of the patient population, type and geographic distribution of participating institutions, types of care settings, average length of follow-up for patients, number of current and historical enrollees in participating health plans.

6. Develop a quality assessment plan for each database with respect to all coding systems used in the database such as ICD9, ICD10, HCPCS, CPT, and others.

7. Develop an action plan to correct any deficiencies or missing data based on the quarterly report results.

Task 2: Analytic Capabilities

The Contractor shall provide the necessary personnel such as epidemiologists, statisticians or data scientists, experts on their databases, computer programmers, and project managers to maintain, update, and interrogate the databases, and run studies in order to develop analytic capabilities to conduct studies as elaborated below:

1. Participate in conducting studies to investigate trends and to detect, monitor, and especially to characterize emerging infectious and noninfectious threats.

2. Provide the capability and capacity in terms of data sources, scientific expertise, medical chart procurement, and operational management to run studies.

3. Provide CFA access to analyses of data, with appropriate safeguards for confidentiality, with the contractor participating in designing and implementing studies and preparing results.

4. Collaborate with CFA to identify studies addressing specific epidemiologic questions for which the Data Analysis Environment is suitable and to establish and meet timelines to prepare study results.

a. Timelines will be dependent upon on complexity of the study and shall be established in the management plan and agreed upon by the contractor and CFA staff.

5. Provide a secure portal for communication and data transfer.

6. Collaborate with CFA in the internal dissemination within the US Government and publication of study results. The Contractor and CFA will form a workgroup for designing and implementing each study in addition to:

a. Developing protocols and final reports for studies.

b. The contractor shall prepare the results in the form of reports in text, graphical, and tabular formats.

c. CFA and the contractor will jointly prepare results for internal briefings, post the results to a public website, publish them in peer-reviewed journals, and/or publicly disseminate them in other ways as determined by CFA.

Task 3: Studies

Studies typically consist of estimating the causal relationship between an exposure and an outcome while minimizing confounding and other sources of bias through design, statistical adjustment, and other approaches (1). Alternatively, studies may be descriptive or predictive, as defined in ref (1).

1. The Contractor shall provide capabilities to use the data sources and analytics to conduct studies, as requested by CFA. CFA has the option to request as many studies as it chooses up to a maximum of 5 studies per period of performance comprising analyses to address questions of interest to CFA.

2. CFA will provide direction and the contractor shall generate a written statement of work (SOW) outlining project-specific activities, deliverables, workgroup members and timelines. These studies may require validation of exposure, outcome, or other components and therefore medical chart access and review.

3. The contractor shall generate a written protocol describing the details of the study.

a. If the protocol requires medical chart review, the contractor shall obtain the charts, provide experts to develop chart abstraction tools, and perform medical record review and adjudication.

b. Once the protocol is finalized and the terms of the protocol, including the timeline, are mutually agreed upon between the contractor and CFA, the study shall comply with the agreed upon timeline.

4. The contractor shall obtain and meet all required review, approval, and standard processes to conduct studies such as Federal Information Security Modernization Act (FISMA), Health

Insurance Portability and Accountability Act (HIPAA), data and information technology security, and any others.

a. These procedures shall address at a minimum the following: data collection, ownership and security, management and tracking, consensus definitions, transfer, and sharing considerations for data summaries.

Task 4: Medical Records

Some studies may include a medical chart review component. This contract requires access to full medical chart of patients whose health care data are available in the databases.

1. The contractor shall have the capability and capacity to obtain patients’ medical charts for certain studies in a timely manner, to abstract the relevant data, and have clinicians adjudicate relevant exposures, outcomes, and covariates.

2. CFA and the contractor will jointly determine a defined number of charts to be reviewed and complexity of review that is commensurate with available resources and study objectives

a. CFA will not have direct access to the medical charts

b. Contractor shall provide the chart review results to CFA as part of study results in a de-identified and aggregate format.

c. The timeline for obtaining and reviewing medical records will vary depending on the type of study and will be agreed upon by CFA and the contractor on a study-by-study basis.

Task 5: Operations and Management

The contractor shall provide Program Management for the CFA Data Analysis Environment. These program management responsibilities shall include what is necessary to plan, coordinate, manage, communicate, report, and steward all respective deliverables and activities throughout the period of performance.

1. The Contractor shall ensure efficient operations between data sources and CFA to safeguard optimal delivery of activities such as telecons and presentations of interim results, and presentations, reports, and manuscripts of study results.

2. The Contractor shall develop a SOP containing written processes and procedures for collaborating with CFA to provide health care data analyses, obtain and review medical charts, and participate in running studies.

3. Collaboration with other stakeholders (defined as CFA personnel and other CDC employees or contractors who may participate in design of Studies and analytic plans) will include the sharing of computer codes and summary and aggregate data, interpretation of findings, review of manuscripts and reports, design of protocols, and co-authorship of reports and publications.

4. Reporting, communicating, presenting, and publishing of all project findings shall be done in coordination with and concurrence of the CFA staff and the CFA COR.

Task 6: Communications and Research

1. The contractor shall conduct and participate in study research and design discussions by virtual meeting or email to facilitate current and future projects.

2. The contractor shall respond to ad-hoc data calls to refine and/or confirm project findings and/or address CFA questions or concerns concerning project findings.

3. The contractor shall create and utilize a secure data transfer capability to allow secure file sharing and document storage for the contractor, subcontractors, CFA staff, and other collaborators.

4. All the data transfer and document storage related to all studies, and other activities shall be carried using the secure portal.

SECTION 5 – REFERENCE MATERIALS

The US government (CFA) will furnish analytic requests to the Data Analysis Environment

Hernán, M. A., et al. (2019). "A Second Chance to Get Causal Inference Right: A Classification of Data

Science Tasks." CHANCE 32(1): 42-49.

SECTION 6 – PLACE OF PERFORMANCE

Work will be primarily at off-site locations.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/ Format

Due Date Deliver To

Kick off meeting (Base Year Only)

One Within 15 days post award

Project Officer;

Technical Monitor

Written report on summary of kick-off meeting

One 10 days post kick-off meeting

Project Officer;

Technical Monitor

1 Report to present results of the data quality assessment plan for each database to include action plan to correct any deficiencies or missing data

One Quarterly Project Officer;

Technical Monitor

1 – 4 Provide documentation of electronic health record data

One 30 days after award Project Officer;

Technical Monitor

2 & 6 Establish secure portal One 60 days after award Project Officer;

Technical Monitor

1 – 6 Provide documentation for available data and refresh schedule with lag less than one month

One Every 60 days, after award

Project Officer;

Technical Monitor

Task Deliverable Quantity/ Format

Due Date Deliver To

2 – 5 Studies On request by CFA

First interim analyses to be available within 21 days; final analyses to be available within 42 days;

unless otherwise agreed

Project Officer;

Technical Monitor

All Written monthly performance report including status of each task

Monthly Monthly at mutually agreed upon time

Project Officer;

Technical Monitor

All Identified risk & mitigation strategies (included as an attachment to the monthly performance report)

Monthly If applicable; Monthly at mutually agreed upon time

Project Officer;

Technical Monitor

SECTION 8 – MINIMUM VENDOR QUALIFICATIONS

Vendor must have at a minimum, access to electronic medical records, including inpatient and outpatient data on a minimum of 3 million persons. Preference will go to proposals with shorter data lags, larger overall sample size, longer duration of coverage for covered persons, and better coverage of vulnerable populations. Preference will also be given to proposals that contain a higher proportion of health care encounters of covered persons and to those that can link individual records to state immunization registries.

SECTION 9 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order

(hereafter “contract”), or portion thereof, includes either or both of the following:

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

(entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) employee will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR)

Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) Safeguarding Information and Information Systems. In accordance with the Federal

Information Processing Standards Publication (FIPS)199, Standards for Security

Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

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

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

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

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

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

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security

Program security requirements, outlined in the HHS Information Security and

Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

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

3) Information Security Categorization. In accordance with FIPS 199 and National

Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II:

Appendices to Guide for Mapping Types of Information and Information Systems to

Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall

Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ ] Low [ X ] Moderate [ ] High

Integrity: [ ] Low [ X ] Moderate [ ] High

Availability: [ ] Low [ X ] 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:

[ ] No PII [ X ] Yes PII

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

[ X ] High http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

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 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. 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) 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.

10) 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.

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

12) 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 [CDC-provided delivery date].

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 keyshttp://csrc.nist.gov/publications/.

Encryption keys shall be provided to CDC Office of Chief Information Security Officer

(OCISO).

13) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://csrc.nist.gov/publications/ 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.

14) 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.

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) 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.

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.

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 PU 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 PU and portable electronic storage media that store PU, the inadvertent disclosure of PU 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 PU 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 without unreasonable delay, 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 cdc@csirt.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.

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).

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.

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.

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.

The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC

Out-Processing Checklist CDC OD OCOO Strategic Business Initiatives Unit (SBI) - In- and Out - Processing of CDC Employees, Non-employees, and Affiliates - All Documents (sharepoint.com) when an employee terminates work under this contract. All documentation shall be made available to the CO and/or COR upon request.

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.

https://cdc.sharepoint.com/sites/SBI/CDCOperationalDocuments/Forms/AllItems.aspx?id=%2Fsites%2FSBI%2FCDCOperationalDocuments%2FCDC%2DGA%2D2007%2D01%2Epdf&parent=%2Fsites%2FSBI%2FCDCOperationalDocuments https://cdc.sharepoint.com/sites/SBI/CDCOperationalDocuments/Forms/AllItems.aspx?id=%2Fsites%2FSBI%2FCDCOperationalDocuments%2FCDC%2DGA%2D2007%2D01%2Epdf&parent=%2Fsites%2FSBI%2FCDCOperationalDocuments

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.

High Value Asset (HVA)

If a system is identified as HVA, the contractor must comply with the HHS Policy for the High Value

Asset (HVA) Program and the DHS HVA Control Overlay in addition to the above requirements.

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.

SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package to the CO and/or COR 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 includes 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. 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.