RFP 2023-R-92696 CFA DSCT 24 Jul.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 83

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-23-R-72696

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

07/24/2023

6. REQUISITION/PURCHASE NO.

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

40 DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 56

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

X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 67

X D PACKAGING AND MARKING 37 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 38 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 39 X K OTHER STATEMENTS OF OFFERORS 68

X G CONTRACT ADMINISTRATION DATA 40 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 76

X H SPECIAL CONTRACT REQUIREMENTS 43 X M EVALUATION FACTORS FOR AWARD 80

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 FACILIT

Y

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

Section B - Supplies Or Services And Prices/Costs

BASE PERIOD

ITEM SUPPLIES/SERVICES QTY/

UNIT

UNIT PRICE EXTENDED

PRICE

0001 CDC/CFA Demographic Social Comorbidities Table

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

Period of Performance is 12 months estimated from

8/01/2023-7/31/2024

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

1 Job $__________ $__________

OPTION PERIOD ONE

UNIT

UNIT PRICE EXTENDED

PRICE

1001 CDC/CFA Demographic Social Comorbidities Table

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2024-7/31/2025

1002 Optional - Additional DSCT see Task 5 of Section C

– Performance-Base Work Statement (PWS)

8/01/2024-7/31/2025

OPTION PERIOD TWO

UNIT

UNIT PRICE EXTENDED

PRICE

2001 CDC/CFA Demographic Social Comorbidities Table

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2025-7/31/2026

2002 Optional - Additional DSCT see Task 5 of Section C

– Performance-Base Work Statement (PWS)

8/01/2025-7/31/2026

OPTION PERIOD THREE

UNIT

UNIT PRICE EXTENDED

PRICE

3001 CDC/CFA Demographic Social Comorbidities Table

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2026-7/31/2027

3002 Optional - Additional DSCT see Task 5 of Section C

– Performance-Base Work Statement (PWS)

8/01/2026-7/31/2027

OPTION PERIOD FOUR

UNIT

UNIT PRICE EXTENDED

PRICE

4001 CDC/CFA Demographic Social Comorbidities Table

To be performed as outlined in the Section C –

Performance-Base Work Statement (PWS)

8/01/2027-7/31/2028

4002 Optional - Additional DSCT see Task 5 of Section C

– Performance-Base Work Statement (PWS)

8/01/2027-7/31/2028

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 contract) 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)

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 Demographic Social Comorbidities Table (DSCT)

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.

When outbreaks of new diseases arise, it is often desirable to focus interventions at the highest-risk groups. While these groups may be defined by demographic, social, geographic, and health factors, we currently lack robust estimates of the number of persons in the United States who have the specific characteristics that place them at high risk. In anticipation that the specific risk factors for future outbreaks may differ, this contract will create a Demographic, Social, and Comorbidities Table (DSCT) that can be queried to obtain estimates of the number of persons in specific jurisdictions with a defined set of characteristics. The Contractor will create a tool that takes as input a set of geographic, demographic, health-related, and social characteristics and provides an estimate of the number of persons meeting combinations of these criteria. Extensive research has shown that targeting of vaccination, testing, treatment, and other interventions to those at higher risk for incidence, severity, and

/or transmission can improve aggregate outcomes and/or can enhance health equity. A key challenge to implementing such strategies has been estimation of the number of persons at high risk for one or more of these outcomes, in part because the specific composition of high-risk groups is different for each health emergency, outbreak, or other event. This tool will advance health equity by facilitating the efforts of public health jurisdictions to offer interventions to those at greatest risk and in whom the interventions may be most effective, importantly including efforts to reach underserved communities.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose for this contract is to expand the CFA’s data network and provide CFA with a comprehensive table that can be queried for estimates of the number of persons in specific jurisdictions with a defined set of characteristics. The tool created in this contract will aid planners in estimating resource needs, evaluating intervention coverage, identifying groups in need of additional efforts to provide interventions, and providing such outreach in an efficient fashion.

SECTION 3 – SCOPE OF WORK

For pandemic preparedness, it is of value to CFA to have a cross-tabulation, for each state and territory in the United States, ideally by county, and by demographic factors (minimally age group and sex, ideally to include race/ethnicity, primary language, occupation, residence in nursing home or other congregate facility, and a measure of socioeconomic status) of estimated numbers of individuals currently alive and meeting certain criteria that may make them eligible, ineligible, or falling into a particular priority group for medical countermeasures or other interventions. For example, COVID-19 vaccines were prioritized in the United States by age group, occupation (health care worker), residence in a nursing home or other congregate facility, and presence of varying numbers of comorbidities from a defined list. In general, countermeasures may be needed for persons with combinations of demographic characteristics (as defined above) and medical conditions, in each state or county of the United States.

To this end the Contractor will:

1. Produce a DSCT, in consultation with CFA staff, that provides estimates for the number of persons in specific jurisdictions with certain defined sets of characteristics.

2. Re-produce DSCT one time during contract period to include an alternative set of characteristics that are deemed of interest for CFA and public health activities, based on existing outbreaks or emergency activities.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Demographic, Social, and Comorbidities Table (DSCT) for COVID-19

1. The Contractor shall propose a means of making estimates using a combination of data sources, including the contractor’s own data in addition to other data sets that are publicly available

(hereafter, referred to as Contractor’s database).

2. The Contractor shall describe data standards that are utilized in data collection for all data sets utilized for making estimates. The Contractor shall include a description of any data elements that will be provided to CDC in addition to the minimum core data set of elements.

3. The Contractor shall document representativeness of populations included in data set(s) that are used for making estimates, including percent minority, percent on public insurance and other social services, percent with disabilities.

4. The Contractor shall obtain the CDC’s list of comorbidities conferring high risk for COVID-19 severity (here).

5. The Contractor shall propose a list of criteria for identifying individuals having and/or not having each comorbidity in the Contractor’s database.

6. The Contractor shall propose and implement a process for scaling estimate from the sample included in the Contractor’s database to the population of covered jurisdictions, which may be county, state, or US-wide population, accounting for the nonrandom selection of individuals in the database.

7. The Contractor shall identify in what jurisdictions of the United States, at what geographic scale, it is possible to make population estimates for numbers of individuals having zero, one, or two or more such comorbidities, with what demographic and occupational information.

8. The Contractor shall document correlations between prevalent health conditions and demographic/geographic/socio-contextual variables.

a. Where possible, add specific demographic or sociocontextual variables as a dimension of the table, for example race/ethnicity.

b. Where such correlations are not directly obtainable from data, propose sensitivity analyses to account for such correlations.

9. The Contractor shall define a process for adding additional comorbidities to a query should they be identified as risk factors for infection or severity of a future disease.

10. The Contractor shall document population estimates stratified by insurance type, i.e., Private

(optionally to include insurer), Medicare, Medicaid and Uninsured.

11. The Contractor shall provide a Table that contains estimates of the numbers of individuals by geographic subdivision with zero, one, and two-or-more of the COVID-19 comorbidity risk factors, by age group and other variables as defined above, and a means of querying this Table.

a. Contractor shall make this data object table and the means of querying it as US government property so that is can be use after the contract ends

Task 2: Demographic, Social, and Comorbidities Table (DSCT) for Influenza or Condition of

CFA’s Choice

1. The contractor shall produce one (1) additional DSCT replicating the procedure in Task 1 but focused on the risk factors for an additional disease of CFA’s choosing, to be discussed at the

Kickoff meeting. As a default, this DSCT will replicate the procedure in Task 1 but for the list of risk factors relevant to the 2009 pandemic influenza, which are listed here. At CFA’s discretion, CFA may supply an alternative list of risk factors for a different disease for this DSCT.

2. The Contractor shall obtain the list of comorbidities from CFA for the second DSCT.

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html#:~:text=Like%20adults%2C%20children%20with%20obesity,very%20sick%20from%20COVID%2D19.)

3. The Contractor shall propose a list of criteria for identifying individuals having and/or not having each comorbidity in the Contractor’s database.

4. The Contractor shall propose and implement a process for scaling estimate from the sample included in the Contractor’s data set to the population of covered jurisdictions, which may be county, state, or US-wide population, accounting for the nonrandom selection of individuals in the data set.

5. The Contractor shall identify in what jurisdictions of the United States, at what geographic scale, it is possible to make population estimates for numbers of individuals having zero, one, or two or more such comorbidities, with what demographic and occupational information.

6. The Contractor shall document correlations between prevalent health conditions and demographic/ geographic/ socio-contextual variables.

a. Where possible, add specific demographic or sociocontextual variables as a dimension of the table, for example race/ethnicity.

b. Where such correlations are not directly obtainable from data, propose sensitivity analyses to account for such correlations.

c. Define a process for adding additional comorbidities to a query should they be identified as risk factors for infection or severity of a future disease.

7. The Contractor shall provide a Table that contains estimates of the numbers of individuals by geographic subdivision with zero, one, and two-or-more of the 2009 H1N1 influenza comorbidity risk factors, by age group and other variables as defined above, and a means of querying this Table.

Task 3: Operations and Management

1. The contractor shall provide Program Management for the environment in which the DSCT can be queried. 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.

2. The contractor shall ensure efficient operations between data sources and CFA to safeguard optimal delivery of activities such as Common Data Model Extract Transform Load (CDM ETL) data transfer meetings, telecons, and study results.

3. The Contractor shall develop a SOP and comprehensive description of methods used to make

DSCT to serve as technical documentation for DSCT users.

4. The contractor shall produce a data management plan that addresses any security/privacy considerations, includes plans for data sharing and release, and references the data storage location.

a. Collaboration with other stakeholders must 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.

5. All custom developed code shall be provided to CDC and hosted on a CDC-recognized source code repository (e.g., GitHub), to include data preparation, data transformation, and analytic code.

6. The contractor shall identify a point of contact that will be available for technical assistance for

CFA or CDC throughout the duration of the contract.

7. Contractor shall report all reporting, communications, presenting, and publishing drafts to CFA.

Task 4: Communications and Research

1. The contractor shall schedule and conduct an annual virtual meeting with CFA personnel to discuss Contractor’s performance.

2. The contractor shall participate in preparing drafts of protocols, reports, presentation materials

(e.g., presentation slides and posters), and manuscripts describing and analyzing the contents of each DSCT.

3. The contractor shall make available on a publicly accessible website a tool to query each Table produced under this contract for individual entries or through an Application Programming

Interface (API) for bulk queries.

4. 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.

5. 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.

a. All the data transfer and document storage related to all queries shall be carried using the secure portal.

Optional Task 5: Demographic, Social, and Comorbidities Table (DSCT) – (Optional Periods 1 thru 4)

1. The contractor shall produce one (1) additional DSCT, per option year, within 60 days when requested from CFA. This table shall be created replicating the procedure in Task 1 but focused on the risk factors for that additional disease of CFA’s choosing.

2. The contractor shall obtain the list of comorbidities from CFA for the additional DSCT.

3. The contractor shall propose a list of criteria for identifying individuals having and/or not having each comorbidity in the Contractor’s database.

4. The contractor shall propose and implement process scaling estimate from the sample included in the Contractor’s data set to the population of covered jurisdictions, which may be county, state, or US-wide population, accounting for the nonrandom selection of individuals in the data set.

5. The contractor shall identify in what jurisdictions of the United States, at what geographic scale, it is possible to make population estimates for numbers of individuals having zero, one, or two or more such comorbidities, with what demographic and occupational information.

6. The contractor shall document correlations between prevalent health conditions and demographic/ geographic/ socio-contextual variables.

a. Where possible, add specific demographic or sociocontextual variables as a dimension of the table, for example race/ethnicity.

b. Where such correlations are not directly obtainable from data, propose sensitivity analyses to account for such correlations.

c. Define a process for adding additional comorbidities to a query should they be identified as risk factors for infection or severity of a future disease.

7. The contractor shall provide a Table that contains estimates of the numbers of individuals by geographic subdivision with zero, one, and two-or-more of the comorbidities identified for this

DSCT, by age group and other variables as defined above, and a means of querying this Table.

SECTION 5 – REFERENCE MATERIALS

The US government (CFA) will furnish guidance on the development of the prioritization tool.

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

1.11 & 2.7 Completed

DSCTs (1 for

COVID-19, 1

for second

Written report and description of its use;

downloadable and query able data object

Yearly COR/ Technical

Monitor (TM) disease of

CFA

choosing)

2.1 Kick-off

meeting (base only)

Kick-off meeting with CDC and CFA Subject Matter

Experts to identify required data elements for DSCT and identify condition for second DSCT

14 days after award

COR/TM

4.1 Annual

Virtual

Meeting

Annually One per year COR/TM

4.3 Draft of Final

Table and API on public forum

Draft Table in the format of at least one complete API on public forum for each DSCT produced (2 in year 1, optionally 1 in each successive year)

120 days prior to end of each period of performance

(POP).

COR/TM

4.3 Final Table

and API on public forum

Final Table in the format of at least one complete API on public forum for each DSCT produced (2 in year 1, optionally 1 in each successive year)

60 days prior to end of of each period of performance

(POP).

COR/TM

4.5 Secure portal Monthly progress reports on

preliminary findings, including any reports, interpretations, recommendations, and other communication products.

2 months after award

COR/TM

5 Optional task:

Updated

DSCT tool (up to 1 time)

Written report and description of its use;

downloadable and query able data object

Yearly; as needed

COR/TM

ALL Status Reports Monthly progress reports on preliminary findings, including any reports, interpretations, recommendations, and other communication products.

Monthly through contract completion

COR/TM

ALL Consultation with CFA on design of

DSCT

Monthly progress reports on preliminary findings, including any reports, interpretations, recommendations, and other communication products.

Once monthly in months 5, 6, & 7; Progress reports due on the last Friday of every month.

COR/TM

All deliverables should be sent in electronic format (i.e., Microsoft

Word or

Adobe PDF)

Final reports due by contract completion

COR/TM

SUBSECTION A – PERFORMANCE MATRIX

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

Task 1, #2:

The Contractor shall describe data standards that are utilized in data collection for all data sets utilized for making estimates. The

Contractor shall include a description of any data elements that will be provided to CDC in addition to the minimum core data set of elements.

The Contractor shall adhere to data standards set by the Office of

Management and Budget in the United States Core

Data for Interoperability.

100% Compliance

Zero Deviation from standard

Periodic Inspection

Task 1, #3:

Document representativeness of populations included in data set(s) that are used for making estimates, including percent minority, percent on public insurance and other social services, percent with disabilities.

utilize datasets that encompass complete representativess of populations.

100% Compliance Periodic Inspection

Task 1, #11:

Contractor shall provide a data object.

The Contractor shall provide complete data object that contains estimates of the numbers of individuals by geographic

100% Compliance Periodic Inspection https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi#draft-uscdi-v4 https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi#draft-uscdi-v4

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

subdivision with zero, one, and two-or-more of the COVID-19 comorbidity risk factors, by age group and other variables as defined above, and a means of querying this data object.

Task 2, #7:

Contractor shall provide a data object.

provide complete data object that contains estimates of the numbers of individuals by geographic subdivision with zero, one, and two-or-more of the 2009 H1N1 influenza comorbidity risk factors, by age group and other variables as defined above, and a means of querying this data object. At CFA’s discretion, CFA may supply an alternative list of risk factors for a different disease for this DSCT.

100% Compliance Periodic Inspection

Task 3, #3:

Develop a SOP and comprehensive description of methods used to make DSCT to serve as technical documentation for DSCT users.

provide an SOP and comprehensive description of methods.

100% Compliance Periodic Inspection

Task 3, #4:

The contractor shall produce a data management plan.

provide a data management plan that addresses any security/privacy

100% Compliance Periodic Inspection

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

considerations, includes plans for data sharing and release, and references the data storage location.

Collaboration with other stakeholders must 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.

Task 3, #5:

All custom developed code shall be provided to

CDC.

provide all custom developed code to

CDC, hosted on a

CDC-recognized source code repository

(e.g., GitHub), to include data preparation, data transformation, and analytic code.

100% Compliance Periodic Inspection

Task 4, #1:

The contractor shall schedule and conduct an annual virtual meeting with CFA personnel to discuss Contractor’s performance.

The contractor shall schedule and conduct annual virtual meetings to discuss performance with CFA.

100% Compliance Periodic Inspection

Task 4, #3:

The contractor shall make available on a publicly accessible website a tool to query the tables for individual entries or through an

Application

The contractor shall make DSCT available on publicly accessible website for individual queries and through an

API for bulk queries.

100% Compliance Periodic Inspection

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

Programming Interface

(API) for bulk queries.

SECTION 8 – MINIMUM VENDOR QUALIFICATIONS

Applicants must have access to electronic health record or claims data for a minimum of 33 million US residents, over the past 5 years (2018 – 2023).

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 [ X ] 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 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:

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

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 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.

http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://csrc.nist.gov/publications/

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.