Attachment 1 - Statement of Work.pdf

Statement of Work

Title: PRAMS Cognitive and Field Testing of Two Modified Survey Questions on

Maternal Vaccination

Period of Performance: September 20, 2024 - December 29, 2024

SECTION 1 – BACKGROUND

CDC’s Division of Reproductive Health (DRH), Women’s Health and Fertility Branch (WHFB), Pregnancy

Risk Assessment Monitoring System (PRAMS) is a surveillance project of the Centers for Disease Control and Prevention (CDC) and health departments. Developed in 1987, PRAMS collects jurisdiction-specific, population-based data on maternal attitudes and experiences before, during, and shortly after pregnancy.

PRAMS surveillance currently covers about 81% of all U.S. births. PRAMS provides data not available from other sources. PRAMS data are used by researchers to investigate emerging issues in the field of reproductive health and by state, territory, and local governments to plan and review programs and policies aimed at reducing health problems among mothers and babies.

Prior to field implementation of PRAMS surveys, new and modified survey questions must first undergo cognitive testing to ensure that the questions can accurately capture the intended domains and fulfill specific analytic objectives. Cognitive testing is followed by field testing of the questions. Cognitive testing of

PRAMS survey questions is conducted to evaluate interpretive and cognitive processes used by respondents when responding to survey questions. Analysis of cognitive interviews will determine the types of experiences or perceptions that respondents include in their answers, difficulties experienced by respondents when answering the questions, as well as identify potential response error. Survey questions then may be revised based on cognitive testing results. Once cognitive testing is completed and survey questions are finalized, field testing is needed to assess overall question comprehension, appropriateness of response options, accuracy of instructions, and overall impression of the questions. This assessment is needed to further ensure that the survey questions are understood and generally accepted by new mothers.

SECTION 2 – PURPOSE/OBJECTIVE

To provide support for consultation, independent cognitive and field testing, and analysis of two Pregnancy

Risk Assessment Monitoring System (PRAMS) Phase 9 core questions for the National Center for Chronic

Disease Prevention and Health Promotion (NCCDPHP), Division of Reproductive Health (DRH), Women’s

Health and Fertility Branch (WHFB), PRAMS Team.

SECTION 3 – SCOPE OF WORK

The contractor shall be responsible for conducting cognitive and field testing of two current PRAMS Phase 9 questions on maternal vaccination, modified to include response options for RSV vaccination, in English and Spanish, for mail and phone questionnaires, to further ensure that the modified survey questions on maternal vaccination are understood by new mothers. Recruitment and testing procedures must follow the specifications outlined in the Section 4 (TASKS TO BE PERFORMED) and all tasks must be completed according to the timeline noted in Section 7 (DELIVERABLES/REPORTING SCHEDULE).

The contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation and perform all tasks as specified in this contract.

SECTION 4 – TASKS TO BE PERFORMED

• Contractor shall be responsible for obtaining any Institutional Review Board (IRB) exemptions/approval as needed to 1) identify and recruit eligible participants for conducting cognitive interview and field testing of PRAMS survey questions, 2) provide participation incentives as appropriate, 3) prepare cognitive interviewing materials for testing as needed, 4) train testing interviewers, 5) conduct the interviews, 6) perform interview analysis, and 7) write a report documenting findings.

• Contractor shall be responsible for recruiting 18 participants, 9 for cognitive interview and 9 for field testing whose characteristics represents the following target population requirements:

o Interviewees who delivered a live born infant and who are ≤12 months postpartum.

o 10 English speakers and 8 Spanish speakers (bi- and mono-lingual), with diverse race, education, and reading level representation.

o Recruitment must be done from a pediatrician’s office or health department (including WIC and

Medicaid offices), as these venues have been approved by CDC for testing.

• Contractor shall be responsible for developing cognitive interviewing protocol and conducting cognitive interviews of PRAMS survey questions in English and Spanish, for mail and phone questionnaire, with 9 participants.

• Contractor shall be responsible for conducting field testing of the PRAMS survey questions, in

English and Spanish, for mail and phone surveys with 9 participants according to the recruitment and interview instructions provided by CDC.

• Contractor shall communicate preliminary question performance to CDC via email or conference calls as testing progresses so adjustments may be made to revise questions wording, as needed.

• Contractor shall provide CDC with a final report summarizing recruitment process, cognitive interview and field testing description, testing results, and any recommendations at project completion.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

N/A

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Work will be performed entirely off site.

SECTION 7 – TRAVEL

No travel involved.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

The vendor shall provide the following deliverables to the Project Officer by the dates reflected below.

All electronic files should be delivered in MS Word format and provided via e-mail.

Deliverables Date Required Deliver To

Obtain any required IRB exemptions or approvals to conduct field testing for the purpose of public health surveillance improvement (e.g., IRB exemption as non-research), prior to the project start date.

10/04/2024 COR and

PRAMS Staff

Identify 18 interviewees, 9 for cognitive testing and 9 for field testing.

10/25/2024 COR and

PRAMS Staff

Complete cognitive and field testing according to the following specifications.

1. Survey Version (2)

a. English mail (3 interviewees)

b. English phone (2 interviewees)

c. Spanish mail (2 interviewees)

d. Spanish phone (2 interviewees)

11/29/2024 COR and

PRAMS Staff

SECTION 9 – POINT OF CONTACT INFORMATION

The Contract Officer Representative (COR) for this procurement is:

Mirelys Rodriguez

Centers for Disease Control and Prevention National Center for Chronic Disease Prevention and Health Promotion Division of Reproductive Health

4770 Buford Highway, NE

Chamblee, GA 30341

Telephone Number: 770.498.5355

E-mail Address: jwo4@cdc.gov

SECTION 10 – PAYMENT TERMS

Payment will be made in accordance with the line items 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 30 th day after the designated billing office (see block 21 of the order) has received a proper invoice from the vendor or the 30th day after Government acceptance of the services performed by the vendor, whichever is later.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

(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 Accessibility Standards (36

CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology (ICT), 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 conform to established HHS EIT accessibility standards. Information about Section 508 is available at https://508.hhs.gov/ . The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/.

(c) The Section 508 accessibility standards applicable to this solicitation are :

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

503 Applications

504 Authoring Tools

602 Support Documentation

603 Support Services

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable

Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate

Complete report of cognitive and field testing findings 12/29/2024 COR and

PRAMS staff mailto:jwo4@cdc.gov https://508.hhs.gov/ http://www.access-board.gov/ their supplies and document - in 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 at https://Section508.gov/ .

In order to facilitate the Government's determination whether proposed ICT services meet applicable Section

508 accessibility standards, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(e) Respondents to this solicitation must identify any inability to conform 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 delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(f) Items delivered as Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/ or from the OPDIV Section 508 Program. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Procurements Requiring Information Security and/or Physical Access Security

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) 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 https://section508.gov/ http://508.hhs.gov/ 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: [X] Low [ ] Moderate [ ] High

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

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

[ ] No PII [X] Yes PII

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

4) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3

CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

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

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified

Information in Nonfederal Information Systems and Organizations if handled by internal

Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed.

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

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-

88, Guidelines for Media Sanitization.

5) 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.

6) 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).

7) 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).

8) 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.

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

10) 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 and ISSO within 30 days of contract award.

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 the COR upon request and at the conclusion of the contract.

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

11) 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. 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.

12) 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 to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the CDC SOP or designee with completing a PIA for the system or information within 30 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for

Implementing the Privacy Provisions of the E-Government Act of 2002.

b. 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 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.

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

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

Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

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, and any CDC-specific rules, as applicable.

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 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.

Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/CDC CSIRT teams within 24 hours, whether the response is positive or negative.

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 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”.

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) 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.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send

CDC approved notifications to affected individuals following CDC’s designated process.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the

CDC’s Computer Security Incident Response Team (CSIRT) [CSIRT@CDC.gov], COR, CO, CDC

SOP (or his or her designee), and other stakeholders, including incidents 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 and HHS 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, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

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

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

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable

Information HHS and CDC’s incident response policies when handling PII breaches.

5) 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.

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 may apply to this solicitation/contract: Not Applicable and Level 1: Non-sensitive, depending on roles and responsibilities.

Homeland Security Presidential Directive (HSPD)-12

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

Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and

Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and

Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2. For additional information, see

HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12)

Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within the CDC Specified timeline of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 7 days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the

Government will determine the appropriate suitability level.

Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, and HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. The EPLC framework provides a standard structure for planning, managing, and governing IT projects from concept to disposition. The framework consists of ten phases to review the project’s management quality, soundness, and technical feasibility remain adequate, and the project is ready to move forward to the next phase.

Within each phase, the activities, responsibilities, reviews, and deliverables are defined. All new information systems development or major enhancement tasks supported by the contractor should utilize CDC’s North Star Architecture as a “blueprint” to guide any decisions on technologies and processes and projects must be reviewed and approved by NCCDPHP’s local governance, the CDC

Information Technology and Data Governance (ITDG) Board and the CDC Architectural Review

Team (ART). All IT projects must follow the CDC EPLC framework and methodology, pass each review as appropriate, and meet all conditions outlined during the stage gate, ITDG, ART reviews, and attend all required meetings. The contractor shall use NCCDPHP approved stage gate templates, adhere to tailored processes, and utilize the NCCDPHP Project Process Agreement (PPA). The contractor shall produce all required EPLC documentation per project phases. The work must be in accordance with the HHS Contract Closeout Guide (2012). CDC EPLC requirements may be located here: https://www2a.CDC.gov/CDCup/library/other/eplc.htm.

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST

SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

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

88, Guidelines for Media Sanitization.

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system

ISSO within 7 days before an employee stops working under this contract.

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

HHS and/or CDC policies.

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

CDC Contractor Employee Separation Checklist when an employee terminates work under this contract within 7 days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

Records Management and Retention https://www.dhs.gov/homeland-security-presidential-directive-12 https://www2a.cdc.gov/cdcup/library/other/eplc.htm

The Contractor (and/or any subcontractor) shall maintain all information in accordance with

Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records

Administration (NARA) records retention policies and schedules and HHS/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with

HHS/CDC policies.

Privacy Act

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals. The System of Records

Notices (SORN) that is applicable to this contract is: “09-20-0160, Records of Subjects in Health Promotion and Education Studies”. The design, development, or operation work the Contractor is to perform is: See

Section 4, “Tasks to be Performed” (above). The disposition to be made of the Privacy Act records upon completion of contract performance is: Records are managed in accordance with CDC’s Scientific and

Research Project Records Control Schedule (N1-442-09-01). Personal identifiers may be deleted from records when no longer needed, as determined by the program manager. Records are maintained at least eleven years, but no longer than twenty years, after the retirement of the system, depending upon program needs for scientific, legal, or business references. CDC will follow the National Archives Disposal of Records

(44 USC Chapter 33) guidance once retention has ended.

Data Analysis: CDC’s Enterprise Data and Visualization (EDAV) Platform should be used for projects with analytics and visualization needs. For NEW data collection, management, analysis, and visualization projects, the project team must meet with local governance for review of the business need then with the

EDAV team to determine if the business need can be met by the enterprise capabilities for data management, analysis, and/or visualization. For new or ongoing data activities, CDC (or CDC contractors) must avoid building new or duplicative analytic or visualization tools or purchasing licenses (e.g., Tableau resources).

The project team must: 1. Identify the existing analytic or visualization solution or tool in use or planned to use. 2. Avoid purchasing or building new or duplicative analytic or visualization tools or licenses, unless an exception is granted by CDC; 3. Consult with the EDAV team to identify opportunities for integration or use of enterprise services; and 4. If appropriate, prepare a migration plan and timeline to shift away from siloed solutions to enterprise services (e.g., plan for migrating to the EDAV platform, including technical and workforce development components); 5. When appropriate, catalog all datasets in CDC’s Enterprise Data

Catalog.

Artificial Intelligence (AI): Any uses of artificial intelligence tools or technology should follow CDC’s

Guidance for Generative Artificial Intelligence which establishes principles and practices for the responsible use, development, and procurement of generative artificial intelligence technology by CDC staff, to support the agency’s public health mission to equitably protect the nation’s health, safety, and security. CDC data cannot be stored into a non-CDC tool with AI capabilities. Contractor’s may not utilize non-CDC AI technology to transcribe calls with CDC staff.

Requirements for Government Information Processed on Government or Contractor Owner Systems

A. Security Requirements for Government Information Processed on Government or Contractor Owner

Systems

1) Federal Policies. The Contractor (and/or any subcontractor) shall comply with applicable federal laws that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P);

Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National

Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, Security and

Privacy Controls for Federal Information Systems and Organizations; Office of Management and

Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other https://www.hhs.gov/foia/privacy/sorns/09200160/index.html applicable federal laws, regulations, NIST guidance, and Departmental policies.

2) Security Assessment and Authorization (SA&A). A valid authority to operate (ATO) certifies that the Contractor’s information system meets the contract’s requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the

ATO within the specified timeline(s). The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, CDC’s SA&A Standard Operating Procedures, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security

Life Cycle Approach (latest revision).

CDC’s acceptance of the ATO does not alleviate the Contractor’s responsibility to ensure the system security and privacy controls are implemented and operating effectively.

a. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an

SA&A package to the C/I/O Information Systems Security Officer. The following SA&A deliverables are required to complete the SA&A package.

• System Security Plan (SSP) – The SSP shall comply with the NIST SP 800-18, Guide for

Developing Security Plans for Federal Information Systems, the Federal Information

Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information

Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information

Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and CDC policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

• Security Assessment Plan/Report (SAP/SAR) – The security assessment shall be conducted by a CDC assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and CDC policies. The assessor will document the assessment results in the SAR.

Thereafter, the Contractor, in coordination with CDC shall assist in the assessment of the security controls and update the SAR at least annually.

• Independent Assessment - When applicable, the Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all “high” deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

• POA&M – The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and CDC policies. All high-risk and medium weaknesses must be mitigated within CDC defined timeframes from the date the weaknesses are formally identified and documented. CDC will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, CDC may require designated POAM weaknesses to be remediated before an ATO is issued.

Thereafter, the POA&M shall be updated at least quarterly or as requested by CDC.

• Contingency Plan and Contingency Plan Test – The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal

Information Systems, and be consistent with HHS and CDC policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the

Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

• E-Authentication Questionnaire – The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold

Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment

(E-auth RA) is necessary. System documentation developed for a system using E-auth

TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic

Authentication Guidelines. Based on the level of assurance determined by the E-Auth, the

Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

b. Information Security Continuous Monitoring. Upon the government issuance of an Authority to

Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP

800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, and HHS IS2P. The following are the minimum requirements for ISCM:

• Annual Assessment/Pen Test - Assess the system security and privacy controls (or ensure an assessment of the controls is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results

(this may involve penetration testing conducted by the agency or independent third-party.)

In addition, review all relevant SA&A documentation (SSP, POA&M, Contingency Plan, etc.) and provide updates by specified due date provided by CDC.

• Asset Management - Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. It is anticipated that this inventory information will be required to be produced at least annually. IT asset inventory information shall include IP address, machine name, operating system level, security patch level, and SCAP-compliant format information. The contractor shall maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools.

• Configuration Management - Use available SCAP-compliant automated tools, per NIST

IR 7511, for authenticated scans to provide visibility into the security configuration compliance status of all IT assets, (computers, servers, routers, databases, operating systems, application, etc.) that store and process government information. Compliance will be measured using IT assets and standard HHS and government configuration baselines at least annually, if not more often. The contractor shall maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

• Vulnerability Management - Use SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets

(computers, servers, routers, Web applications, databases, operating systems, etc.) that store and process government information. Contractors shall actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS policy. Automated tools shall be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor shall maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least monthly.

• Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and CDC specified timeframes. CDC specific timeframes can be provided after contract award.

• Secure Coding - Follow secure coding best practice requirements, as directed by United

States Computer Emergency Readiness Team (US-CERT) specified standards and the Open

Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

• Boundary Protection - The contractor shall ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities is routed through a Trusted Internet Connection (TIC).

3) Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to the

Contractor’s facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

a. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government’s direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation

(whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract.

The Government includes but is not limited to the U.S. Department of Justice, U.S. Government

Accountability Office, and the HHS Office of the Inspector General (OIG).