SOW_sam.gov.pdf

Statement of Work / Performance Work Statement

Title: Non-medical cost of injury morbidity.

Period of performance of this contract is: September 1, 2024- August 31, 2028

Base Period: September 1, 2024 - August 31, 2025

Option Period One: September 1, 2025 – August 31, 2026

Option Period Two: September 1, 2026 – August 31, 2027

Option Period Three: September 1, 2027 – August 31, 2028

SECTION 1 – BACKGROUND

NCIPC’s WISQARS Cost of Injury website includes a new non-medical cost of injury morbidity element:

quality of life loss costs for nonfatal injuries. This addition is consistent with health economics scholarship and guidance from the US HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE, 2016).

This new WISQARS cost element was described in an MMWR report (Peterson et al. 2021). The current data source for this cost element (PIRE, 2020) is limited for indefinite future use because some of the contributing data sources are decades old and employ methodology (clinician assessments of injury impairments) that is increasingly displaced in favor of other methods; specifically, affected patients’ own assessments of their impairments, or general population surveys in which respondents rank health descriptions (“vignettes”) leading to health utility loss estimates (UK NICE, 2020 and Wolowacz, 2016). Therefore, it is relevant to consider updated data sources for non-medical injury morbidity costs (“Quality of life loss costs”) reported in

WISQARS Cost of Injury. Market research by the NCIPC Economics Team has identified that collaboration with the University of Washington Institute for Health Metrics (IHME) to integrate Global Burden of Disease study (GBD) disability weights with WISQARS nonfatal injury data is a desirable next step, based on:

• Cost-effective for CDC: Building from previous funded work to crosswalk underlying GBD data on the non-medical health burden injury morbidity, there is an opportunity to produce new comprehensive U.S.

health and economic burden estimates for an NCIPC priority topic for injury and violence prevention.

SUBSECTION A – DEFINITIONS

• Global Burden of Disease study (GBD): Provides a tool to quantify health loss from hundreds of diseases, injuries, and risk factors, so that health systems can be improved and disparities can be eliminated. Coordinated by IHME, an independent population health research organization based at the University of Washington School of Medicine. GBD Results Tool publicly available data:

https://vizhub.healthdata.org/gbd-results/

• Disability weights: Represent the magnitude of health loss associated with specific health outcomes, are used to calculate years lived with disability for these outcomes in a given population.

The weights are measured on a scale from 0 to 1, where 0 equals a state of full health and 1 equals death. GBD disability weights available online at: https://ghdx.healthdata.org/record/ihme-data/gbd-2019-disability-weights

• Health utility: A number ranging from zero (death) to one (full health) that describes the health state or outcome of a patient.

• Injury classification by mechanism and intent versus body region and nature of injury.

Described here: https://www.cdc.gov/nchs/injury/injury_tools.htm

• International Committee of Medical Journal Editors (ICMJE). Authorship criteria for peer-review journal articles (https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html).

• National Electronic Injury Surveillance System – All Injury Program (NEISS-AIP):

WISQARS Cost of Injury nonfatal injury counts are hospital ED injury visits (including transferred and admitted patients) from the nationally representative NEISS-AIP. Dataset years 2000-2019 available online (as of November 2022) at: https://www.icpsr.umich.edu/web/NACJD/series/198

• NCIPC priority topic for injury and violence prevention. Described here:

https://www.cdc.gov/injury/prevention-topics-a-z-index.html

• Web-based Injury Statistics Query and Reporting System (WISQARS) Cost of Injury:

Website managed by CDC, reports medical and non-medical cost of injuries by intent (e.g., unintentional) and mechanism (e.g., cut/pierce). https://www.cdc.gov/injury/wisqars/cost/

SECTION 2 – PURPOSE/OBJECTIVE

• Purpose: Produce new comprehensive U.S. health and economic burden annual estimates for an

NCIPC priority topic for injury and violence prevention.

• Parties the project involves: CDC National Center for Injury Prevention and Control, Division of

Injury Prevention, Data Analytics Branch (NCIPC/DIP/DAB); Institute for Health Metrics and

Evaluation at the University of Washington (IHME).

• Overall Objectives: Use GBD data to produce new health and economic burden estimates for an

NCIPC priority topic for injury and violence prevention (e,g, traumatic brain injury, drowning/submersion, etc.).

• General Period of Performance: Period of performance is 12 months (starting September 1, 2024).

• General Place of Performance: Usual work location for participating staff from

NCIPC/DIP/DAB and IHME.

• Performance Objectives or Required Results:

1. Base period: GBD Economic burden of injuries and violence subject #1

Produce new comprehensive US health and economic burden annual estimates of the medical and non-medical burden of an NCIPC priority topic area for injury and violence prevention in terms of fatal/nonfatal, sex, age group, and injury mechanism and intent (e.g., self-harm cut/pierce injury). Priority topic area:

traumatic brain injury.

Primary deliverable: Draft biomedical format journal article for peer review

(1,200-3,000 words) describing new estimates. Author order for participating staff

IHME and NCIPC/DIP/DAB based on level of effort.

2. Option Period 1: US medical expenditures on injuries by mechanism and intent

Replicate approach described in Dieleman et al. “US Health Care Spending by

Payer and Health Condition, 1996-2016” (2020) JAMA (PMID: 32125402) to produce novel estimates of total medical spending on injuries by mechanism and intent (e.g., unintentional cut/pierce), payer (e.g., private, etc.), patient sex, age, and other characteristics (as possible), health care setting (e.g., nursing home, etc.).

As possible: Incorporate multiple data years in addition to most recent available data years; differentiate fatal and nonfatal events; and incorporate prevalence (case count) data to produce unit cost estimates (e.g., per injured person).

Primary deliverable: Draft biomedical format journal article for peer review

(1,200-3,000 words) describing new estimates. Author order for participating staff

IHME and NCIPC/DIP/DAB based on level of effort.

3. Option Period 2: GBD Economic burden of injuries and violence subject #2

Produce new comprehensive US health and economic burden annual estimates of the medical and non-medical burden of an NCIPC priority topic area for injury and violence prevention in terms of fatal/nonfatal, sex, age group, and injury mechanism and intent (e.g., self-harm cut/pierce injury). Priority topic area: will be determined based on most recent available GBD data and NCIPC prevention priority topics list, potentially will include: self-harm, burns, or drowning.

Primary deliverable: Draft biomedical format journal article for peer review

(1,200-3,000 words) describing new estimates. Author order for participating staff

IHME and NCIPC/DIP/DAB based on level of effort.

4. Option Period 3: Improving non-medical cost of injury morbidity for WISQARS #2

Building from previous funded work to crosswalk underlying GBD data on the non-medical health burden injury morbidity (FY23), use GBD disability weight source data to improve injury morbidity burden estimates for priority CDC injury surveillance injury types in the NEISS-AIP data source.

Primary deliverable: Draft biomedical format journal article for peer review

(1,200-3,000 words) describing new estimates. Author order for participating staff

IHME and NCIPC/DIP/DAB based on level of effort.

• Operating Constraints: None.

SECTION 3 – SCOPE OF WORK

Start-up and ongoing support: CDC will provide background references and ongoing content area expertise to inform planning and implementation. This includes:

1) Provide a list of NCIPC priority topics for injury and violence prevention

(https://www.cdc.gov/injury/prevention-topics-a-z-index.html),

2) Provide journal article examples of past similar NCIPC health and economic burden studies (e.g., adverse childhood experiences—forthcoming Dec 2023),

3) Provide guidance for using CDC’s publicly available annual surveillance data on fatal and nonfatal injuries (e.g., https://www.cdc.gov/injury/wisqars),

4) At least 1 participating CDC staff person will be a named collaborator on each public-facing product

(e.g., peer reviewed journal article) based on contributions commensurate with authorship as described by the International Committee of Medical Journal Editors (ICMJE).

Performance objectives and required results: Successful completion of this project will be indicated by:

A draft journal article cleared by CDC for peer review journal submission describing new U.S. health and economic burden annual and per-person estimates of an NCIPC priority topic for injury and violence prevention.

Parties the project involves: The vendor will have demonstrated research experience in: 1) Generating original estimates of nonfatal injury and disease quality of life values (such as disability weights, disability-adjusted life years, quality-adjusted life years, health utilities) from general population respondent samples, and 2) Access to and extensive experience with an existing comprehensive data source for such original estimates that can facilitate direct or calculated quality of life values for the broad range of injury types

(mechanism, intent, body region, and/or nature of injury) that comprise the NEISS-AIP data source, including treated-and-released and transferred/hospitalized patients.

SECTION 4 – TASKS TO BE PERFORMED

The contractor will:

Task 1: Project Management

Attend monthly online project meetings arranged by participating CDC staff (using

MS Teams or similar) and submit brief written progress updates on those meeting dates.

a) Kickoff meeting- A kickoff meeting shall be held 10 work days after the initial award is made to discuss plans and timelines and clarify roles and responsibilities, to be held through a web conference.

b) Work Plan- Following the kick-off meeting, the contractor shall develop a written work plan that minimally includes all essential interim and final deliverables, key staff responsible for tasks (including contractor, CDC or other partners), schedule of key deadlines (including review cycles and absolute No

Later Than (NLT) dates for key activities and deliverables) and clarifications or updates specific to each task in greater detail than may have been included in the original proposal (for COR review and correction before acceptance). The work plan shall contain:

i. a series of specific reports and activities proposed by the contractor following the kick-off meeting to be developed by the contractor during the course of the project, inclusive of the contractor’s plan for ongoing monitoring and evaluation of services to assure high-quality performance and customer satisfaction

ii. hours of operation,

iii. contractor plan for employee management.

iv. The work plan shall be a distributable document for sharing with key CDC management/staff impacted by this project, as needed. The work plan shall be due no later than 10 workdays following the kickoff meeting. The work plan may be revised according to CDC acceptance of the updated work plan by the COR during the project, with the restriction that these changes must not impact the overall period of performance, scope, or specifications of the award or otherwise impinge on the authority of the contracting officer. Development of the work plan may result in modifying the contract to revise the deliverables. Still, it shall only change the terms of the contract or performance work statement with a modification.

Task 2: Monthly Work Plan

Provide a month-level workplan identifying dates for interim deliverables (e.g., drafts to participating staff) within 2 months of project start date. Deliver to the CDC Project Lead and CDC COR within 5 business days after the monthly meeting.

Task 3: Draft Exhibit “Shells” for Journal Article Manuscript

Draft exhibit shells (i.e., no final data) for approval within 4 monts of the project start date and deliver drafts to the CDC Project Lead and CDC COR

Task 4: Daft Manuscript

Draft manuscript in biomedical journal format (1,200-3,000 words) text and final exhibits within 10 months of the project start date and deliver to the CDC Project Lead and CDC

COR.

Task 5: Final Manuscript

Prepare final version of manuscript drafted in Task 4. This task shall be completed at least two weeks before the last workday with in the contract perfromance period and delivered to the CDC Project Lead and CDC COR.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

None.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Work will be performed off-site at the contractor’s place of business, with video conference as the primary means of meeting with CDC staff.

SUBSECTION B – CONTRACT SUPPORT HOURS

Contract support hours will be established as part of the requirment under Task 1b) ii.

SECTION 7 – TRAVEL

Travel is not included in this contract. Contractor travel for in-person meetings, Smartcard new issuance or renewal, or government-furnished equipment will be at the contractor's expense.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task Numer

Items

Description

Quantity or

No.

of Copies

Delivery Date

Deliver

To

Task 1

Kick of meeting and ongoing monthly meeting summary and progress updates

Online project meetings to start-up project and provide monthly progress updates against workplan.

Within 10 workdays after contract award date and then monthly

COR and

Project Lead

Task 2 Month-level workplan

Identifies dates for interim deliverables (e.g., drafts to participating staff).

Within 2 months of project start date

COR and

Project Lead

Task 3

Draft exhibit

“shells” for journal article

Draft exhibit shells (i.e., no final data) for approval.

Within 4 months of project start date

COR and

Project Lead manuscript

Task 4 Draft manuscript

Biomedical journal format

(1,200-3,000 words) text and final exhibits.

Within 10 months of project start date

COR and

Project Lead

Task 5

Manuscript prepared to submit to CDC clearance

Final version of Task 4. 1

Two weeks before the last workday within the performance period

COR and

Project Lead

SUBSECTION A – PERFORMANCE MATRIX

The Performance Matrix is the portion of the performance-based SOW that explains to the contractor what the Government’s expectations are, and how (and how often) deliverables or services will be monitored and evaluated. It also spells out any incentives that would encourage the contractor to exceed the performance standards. It also imposes negative incentives when the outputs/outcomes are below the performance standards.

Desired

Outcomes

Acceptable Quality Level

(AQL)

Monitoring Method

Incentives/ Disincentives

Task 1.a

Kick off meeting

• Occurs at regularly scheduled times

• Contractor is prepared to discuss relevant project issues, is responsive to project planning issues/project improvments, and documents meetings as described in PWS (may be corrected to COR comments)

• 100% review of event (by the COR)

• Unacceptable meetings will be documented as customer complaints, contractor may be allowed to correct any insufficiences to CDC satisfaction

• Contractor’s performance is documented as past performance using CPARS which is considered for future awards.

• Performance is considered in determining whether to exercise the option periods

• Repeated complaints on different events/tasks but the same issue will be elevated for higher level resolution (senior management and/or OAS)

Task 1.b

Work Plan

• Appropriate content is included as outlined in the PWS (may be corrected to COR comments)

• 100% review of plan by CDC Project Manager and COR

• Late delivery of work plan will be documented as customer complaints, contractor shall correct any errors or edits required by CDC

Task 2-

Monthly Work

Plan

• Delivered at regular scheduled time.

• Appropriate content is included as outlined in the PWS (may be corrected by CDC COR comments)

• CDC Project Manager and COR review

• 100% review of plan by CDC Project Manager and COR

• Late delivery of work plan will be documented as customer complaints, contractor shall correct any errors or edits required by CDC

Task 3- Draft

Exhibit

“Shells” for

Journal

Article

Manuscript

• High quality draft should be submitted for review and approval.

• 90% of information is represented accurately.

• CDC Project Manager and COR Review

Desired

Outcomes

Acceptable Quality Level

(AQL)

Monitoring Method

Incentives/ Disincentives

• Approved “shells” are delivered within specified time period

Task 4- Draft

Manuscript

• High quality draft should be submitted for review and approval.

• 90% of information is represented accurately.

• Approved draft is delivered within specified time period

CDC Project

Manager and COR

Review

• Contractor’s performance is documented as past performance using CPARS which is considered for future awards.

• Repeated complaints on different events/tasks but the same issue will be elevated for higher level resolution (senior management and/or OAS)

• Favorable or Unfavorable Performance Evaluation

• Full payment according to payment schedule

Task 5- Final

Manuscript

• High quality final draft should be submitted for review and approval.

• 100% of information is represented accurately.

• Approved final draft is delivered within specified time period

• CDC Project Manager and COR Review

• Contractor’s performance is documented as past performance using CPARS which is considered for future awards.

• Repeated complaints on different events/tasks but the same issue will be elevated for higher level resolution (senior management and/or OAS)

• Favorable or Unfavorable Performance Evaluation

• Full payment according to payment schedule

SECTION 9 – REFERENCE MATERIALS

• ASPE 2016. Guidelines for regulatory impact analysis. Washington, DC: US Department of Health and

Human Services.

• James et al. (2020). Estimating global injuries morbidity and mortality: methods and data used in the

Global Burden of Disease 2017, Injury Prevention Supp 1:i125-i153.

• Lawrence B, Miller T. Quality of life loss estimation methods for the WISQARS Cost of Injury Module.

Calverton, MD: Pacific Institute for Research and Evaluation; 2020.

https://www.cdc.gov/injury/wisqars/pdf/PIRE_WISQARS_cost_injury_quality_life_loss_estimation_met hods-508.pdf

• Peterson C, Miller GF, Barnett SBL, Florence C. Economic cost of injury—United States, 2019. MMWR

Morb Mortal Wkly Rep 2021;70:1655–9.

• Salomon JA, Haagsma JA, Davis A, Maertens de Noordhout C, Polinder S, Havelaar AH. 2015.

Disability weights for the Global Burden of Disease 2013 study. Lancet Global Health, 3 (11): E712-

E723.

• UK NICE. “Measuring and valuing health-related quality of life when sufficient data is not directly observed.” Sheffield, UK: University of Sheffield; 2020.

• Wolowacz SE, Briggs A, Belozeroff A, Clarke P, Doward L, Goeree R, Lloyd A, Norman R. 2016.

Estimating Health-State Utility for Economic Models in Clinical Studies: An ISPOR Good Research

Practices Task Force Report. Value Health 19(6):704-719.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

The vendor must demonstrate research experience in: 1) Generating original estimates of nonfatal injury and disease quality of life values (such as disability weights, disability-adjusted life years, quality-adjusted life years, health utilities) from general population respondent samples, and 2) Access to and extensive experience with an existing comprehensive data source for such original estimates that can facilitate direct or calculated quality of life values for the broad range of injury types (mechanism, intent, body region, and/or nature of injury) that comprise the NEISS-AIP data source, including treated-and-released and transferred/hospitalized patients.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

1. Baseline Security Requirements:

i.Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

• Access (Physical or Logical) to Government Information: A

Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

• Operate a Federal System Containing Information: A Contractor

(and/or any subcontractor) will operate a federal system and information technology containing data that supports the CDC 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.

ii.Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

• Protect the:

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

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

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

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

CDC/NCIPC and information systems that store, process, and/or transmit

CDC information in accordance with FIPS 199 and National Institute of

Standards and Technology (NIST) Special Publication (SP) 800-60, Volume

II: Appendices to Guide for Mapping Types of Information and Information

Systems to Security Categories. Based on information provided by the

System Security and Privacy Officer (previously referred to as ISSO), CISO, CDC CPO, or other representative, the impact level for each Security

Objective (Confidentiality, Integrity, and Availability) and the Overall

Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

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

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

Availability: [ X] Low [ ] Moderate [ ] High

Overall Impact Level: [X] Low [ ] Moderate [ ] High

• Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of CDC/NCIPC regardless of location or purpose.

• Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

• Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC/NCIPC Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or CDC/NCIPC security and/or privacy officials.

iii.Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor

FAR and HHSAR clauses as needed.

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

• Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual."

Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

• To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's PII.

• The Contractor must support the agency with conducting a Privacy

Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the

Contractor must support the agency with completing a PIA for the system or information after completion of the PTA and in accordance with CDC policy and OMB M-03-22, Guidance for

Implementing the Privacy Provisions of the E-Government Act of

2002.

The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle

(SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

v.Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The

Contractor (and/or any subcontractor) must comply with 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. The requirements below apply only to nonfederal systems that process, store, or transmit

CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

• Marked appropriately;

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

• Protected in accordance with NIST SP 800-53, Security and Privacy

Controls for Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP

800-171, Protecting Controlled Unclassified Information in Nonfederal

Information Systems and Organizations if handled by internal Contractor system; and,

• Returned to HHS/CDC control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

vi.Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

vii.Confidentiality and Nondisclosure of Information. Any information provided to the

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

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

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

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

and

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

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

Version 6 (IPv6).

ix.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.

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

Policy for Internet and Email Security for additional information. According to the

CDC Web policy, all CDC web content must reside on a CDC.gov domain and must be hosted on CDC or CDC-authorized information systems .

xi.Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents NCIPC specify which documents/forms will be provided to contractor] to comply with contract deliverables as appropriate.

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

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

• Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

• Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet CDC and CDC

Component-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

• Verify that the encryption solutions in use have been validated under the

Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR

[CDC Component- provided delivery date].

• Use the Key Management system on the CDC personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

xiii.Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the CDC non-disclosure agreement, https://intranet.cdc.gov/ofr/documents/contracts/Non-Disclosure-Agreement-

Con.docx, as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO

Representative (COR) prior to performing any work under this acquisition.

2. Training Requirements:

i.Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable CDC Contractor Information Security Awareness, Privacy, and Records

Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete CDC Information

Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with CDC training policies.

ii.Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role- based training annually commensurate with their role and responsibilities in accordance with HHS/CDC policy and the CDC Role-Based

Training (RBT) of Personnel with Significant Security Responsibilities.

iii.Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with CDC policy. A copy of the training records must be provided to the CO and/or COR within

30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior:

i.The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.

ii.All Contractor employees performing on the contract must read and adhere to the

Rules of Behavior before accessing agency 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

Information 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.

4. Incident Response:

i.The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of

Compromise (IOCs) provided by CDC Computer Security Incident Response Center

(CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a

Breach of Personally Identifiable Information (PII)29, an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information

(PII).30"

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

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

• 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, with encryption solution that is validated with the current FIPS 140 validation certificate from the NIST CMVP.

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

• NOT notify affected individuals unless so instructed by the Contracting

Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send NCIPC approved notifications to affected individuals within 60 days.

• Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) at csirt@cdc.gov or 866-655-2245, COR, CO, CDC CPO (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC Component and CDC policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

Not include any sensitive information in the subject or body of any reporting e-mail; and

Encrypt sensitive information in attachments to email, media, etc.

iii.Comply with OMB M-17-12, Preparing for and Responding to a Breach of

Personally Identifiable Information, and CDC Component and CSPO privacy breach response policies when handling PII breaches.

iv. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

29 Memorandum is available at: https://www.whitehouse.gov/wp content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf 30 Standard is available at: https://cdc.sharepoint.com/teams/OCIO-CSPO-

PUBDOCS/Standards/CSPO%20Responding%20to%20Breaches%20of%20Personally%20Identifia ble%20Information.pdf v.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.

vi.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.

vii.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.

5. Position Sensitivity Designations:

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

6. Homeland Security Presidential Directive (HSPD)-12:

The Contractor (and/or any subcontractor) and its employees must comply with Homeland

Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for

Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal

Identity Verification (PIV) of Federal Employees and Contractors; HHS/CDC HSPD-12 policy;

and Executive Order 13467, Part 1 §1.2.

7. Roster:

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the

Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO by the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

8. Contract Initiation and Expiration:

i.General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance

Life Cycle (EPLC) processes, CDC Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the Contractor must follow the CDC EPLC framework and methodology in accordance with the CDC

Office of Financial Resources (OFR) Contract Closeout Guide and HHS Closeout

Guide: Contracts and Orders.

ii.System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals

(specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

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

Sanitization.

iv.Notification. The Contractor (and/or any subcontractor) must notify the CO and/or

COR and System Security and Privacy Officer (previously referred to as ISSO) within

[CDC Component-specific timeline] before an employee stops working under this contract.

v.Contractor Responsibilities upon Physical Completion of the Contract. The

Contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR.

Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

vi.The Contractor (and/or any subcontractor) must perform and document the actions identified in the NCIPC Contractor Employee Separation Checklist when an employee terminates work under this contract within [insert CDC Component-specific timeline] days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention:

i.The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and CDC Policy for Records Management and NCIPC policies and must not dispose of any records unless authorized by CDC/ NCIPC.

ii.If a Contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with CDC/ NCIPC policies.

10. High Value Asset (HVA):

If a system is identified as HVA,31 the Contractor must comply with the HHS Policy for the High

Value Asset (HVA) Program and the Department of Homeland Security (DHS) HVA Control

Overlay[22] in addition to the above requirements.

31 HVA, Federal information or a federal information system that relates to one or more of the following categories:

• Informational Value - The information or information system that processes, stores, or transmits the information is of high value to the Government or its adversaries.

• Mission Essential - The agency that owns the information or information system cannot accomplish its Primary Mission Essential Functions (PMEF), as approved in accordance with

Presidential Policy Directive 40 (PPD-40) National Continuity Policy, within expected timelines without the information or information system.

• Federal Civilian Enterprise Essential (FCEE) - The information or information system serves a critical function in maintaining security and resilience of the Federal civilian enterprise

(OMB M-19-03).

Section 508 Compliance

Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the

Workforce Investment Act of 1998 and the Architectural and Transportation Barriers

Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part

1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at https://www.access-board.gov/ict/.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section

508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508

Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

Offerors may alternatively provide a Section 508 Accessibility conformance report (ACR) as described at www.section508.gov.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services…