Attachment 1c -Task Order 1 Statement of Work.pdf

Attachment 1c – Task Order 1 Support for Evidence Reviews and Newborn Screening Processes SOW

MCHB IDIQ Solicitation #75R60226R00026

STATEMENT OF WORK (SOW) -Support for Evidence Reviews and Newborn Screening Processes

I. BACKGROUND

Newborn screening (NBS) is a critical public health program that enables early identification of infants affected by serious, life-threatening, or disabling conditions before the onset of clinical symptoms. The Health Resources and Services Administration/Maternal and Child Health Bureau (HRSA/MCHB) provides coordination, management, and operational services that support the maintenance of the Secretary of Health and Human Service’s Recommended Uniform Screening Panel (RUSP). The RUSP is a national guideline for newborn screening (NBS) that includes a list of conditions recommended for screening by the U.S. Secretary of Health and Human Services. The RUSP also serves as a guide for states to implement their newborn screening programs.

Systematic evidence-based reviews are conducted for all nominated conditions considered for inclusion on the RUSP.

HRSA/MCHB provides support to a newborn screening stakeholder group that provides subject matter expertise, recommendations and technical information on the most appropriate application of technologies, policies, guidelines, and standards for: (a) effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders; and (b) enhancing the ability of state and local health agencies to provide newborn and child screening, counseling, and health care services for newborns and children having, or at risk for, heritable disorders.

II. PURPOSE

The purpose of this Task Order (TO) is to obtain contractor support to conduct condition-specific scoping and systematic evidence reviews for newborn screening.

This TO shall conduct other activities as described below in the scope of work to support the work of the NBS Stakeholder Workgroup evidence review process.

III. SCOPE OF WORK

The Contractor shall:

1. Conduct a clinical evidence review to determine best approaches to screen for biliary atresia in the newborn period.

2. Develop a framework or manual of procedures for determining readiness of a condition for state newborn screening (e.g., evidence scans, scoping reviews, evidence reviews).

3. Complete evidence scans for ten (10) to fifteen (15) candidate conditions to evaluate evidence.

4. Conduct simultaneous systematic evidence reviews for up to ten (10) candidate conditions.

5. Conduct economic analysis for candidate conditions.

6. Develop and publish reports for each candidate condition reviewed.

7. Develop consumer summary reports for reviewed conditions.

8. Complete optional tasks as instructed by COR related preparing reports, convening meetings, and travel.

IV. PERIOD OF PERFORMANCE

The period of performance shall be a base of twelve (12) months and one (1) twelve (12) month option period from the effective date of contract (EDOC).

V. PLACE OF PERFORMANCE

Primarily Contractor facility, with occasional CONUS travel for expert panel convenings, subject to COR approval.

VI. TASK AREAS

Independently, and not as an agent of the Government, the Contractor shall furnish all personnel, material, services, and equipment as needed to perform the requirements.

BASE and OPTION YEAR 1 (OPY1)

Task 1: Federal Records Management

1.1: Records and Information Regulation Guidelines

MCHB IDIQ Solicitation #75R60226R00026

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

1.2: Records and Information Management

The contractor shall manage and maintain Federal records and/or information, including electronic records and/or information, ensuing from this contract in accordance with all applicable records management laws and regulations, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33); 36 CFR § 1236.20 What are appropriate recordkeeping systems for electronic records? & 1236.22 What are the additional requirements for managing electronic mail records? (http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25); NARA Bulletin 2013-02, August 29, 2013, Guidance on a New Approach to Managing Email Records

(https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html); and NARA Bulletin 201005 September 08, 2010 (http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html), Guidance on Managing Records in Cloud Computing Environments.

Managing the records includes maintaining records to retain functionality and integrity throughout the records' full lifecycle including: (1) maintenance of links between records and metadata, and (2) categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

1.3: Records Management Training

The contractor (and/or subcontractor) shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HHS Records Management Training before performing work under this contract, and thereafter completing the annual refresher course during the life http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25 https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html

MCHB IDIQ Solicitation #75R60226R00026 of the contract. The training is located at https://www.hhs.gov/sites/default/files/trainings/recordsmanagement/01_ind ex.html. At the end of the Records Management training, the “Congratulations" slide is considered your certificate of completion. Please send the completion certificates to the Contracting Officer Representative (COR) of the contract within 30 days of EDOC Base/EDOC OPY1 and upon new staff onboarding. The listing of completed training shall be included in the first progress report. Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report. Task 1 - Federal Records Management

Task 1.1 - Records and Information Regulation Guidelines

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

Task 1.2 - Records and Information Management

The contractor shall manage and maintain Federal records and/or information, including electronic records and/or information, ensuing from this contract in accordance with all applicable records management laws and regulations, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33); 36 CFR § 1236.20 What are appropriate record keeping systems for electronic records? & 1236.22 What are the additional requirements for managing electronic mail records? (https://www.ecfr.gov/current/title-36/section-1236.22); NARA Bulletin 2013-02, August 29, 2013, Guidance on a New Approach to Managing Email Records (https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html); and NARA Bulletin 2010-05 September 08, 2010 (http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html), Guidance on Managing Records in Cloud Computing Environments.

Managing the records includes, maintaining records to retain functionality and integrity throughout the records' full lifecycle including: (1) maintenance of links between records and metadata, and (2) categorization of records to manage retention and disposal, either https://www.hhs.gov/sites/default/files/trainings/recordsmanagement/01_index.html https://www.hhs.gov/sites/default/files/trainings/recordsmanagement/01_index.html https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ecfr.gov%2Fcurrent%2Ftitle-36%2Fsection-1236.22&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653266553%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6ExZcO7iVYQB9ejELL5eq7lZwXJEQQPjHm96JwoqBcs%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.archives.gov%2Frecords-mgmt%2Fbulletins%2F2013%2F2013-02.html&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653304205%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=zq6OkJGz23GY0L1krt2YRUG65%2F6qXxBH9IenpdEyNZE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.archives.gov%2Frecords-mgmt%2Fbulletins%2F2010%2F2010-05.html&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653326075%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=MD8ZrAePnFyAX031%2BRjfmUsbMIE1gGaiEsGTUkxaRAE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.archives.gov%2Frecords-mgmt%2Fbulletins%2F2010%2F2010-05.html&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653326075%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=MD8ZrAePnFyAX031%2BRjfmUsbMIE1gGaiEsGTUkxaRAE%3D&reserved=0

MCHB IDIQ Solicitation #75R60226R00026 through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

Task 1.3 - Records Management Training

The contractor (and/or subcontractor) shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HHS Records Management Training before performing work under this contract, and thereafter completing the annual refresher course during the life of the contract. The training is located at https://www.hhs.gov/sites/default/files/trainings/recordsmanagement/01_index.html. A t the end of the Records Management training, the “Congratulations" slide is considered your certificate of completion. Please send the completion certificates to the Contracting Officer Representative (COR) of the contract. The listing of completed training shall be included in the first progress report. Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report.

Task 2 – Program Management

2.1 Kickoff Meeting.

The Contractor shall:

• Meet with the Contracting Officer’s Representative (COR) and other HRSA staff invited by the COR within two (2) weeks of EDOC Base/EDOC OPY1 to discuss the project plan and timeline for all phases of the project, scope of work, schedule of deliverables, priorities, and identify any potential challenges and solutions.

• Submit draft meeting agenda in Microsoft Word and any materials to be reviewed and discussed during the meeting within ten (10) business days of EDOC Base/EDOC OPY1.

• Take meeting minutes and submit with the revised contract timeline to the COR within fourteen (14) business days of Kickoff Meeting. The timeline shall include a checklist of all activities and anticipated deadlines reflecting all agreed upon outcomes of the discussion.

2.2 Project Management

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fsites%2Fdefault%2Ffiles%2Ftrainings%2Frecordsmanagement%2F01_index.html&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653348220%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=pU4%2BVdvAKG3dCrSD9q5GPd3UqIQMUBA3g%2FJIoGc880g%3D&reserved=0

• Meet with the COR and other HRSA staff monthly to discuss the status of the contract and other pertinent issues.

• Develop an agenda for the meeting and electronically submit to the COR for review and acceptance three (3) business days before each meeting.

• Provide meeting notes and electronically submit the draft summary and, if needed, revised project timeline to the COR in Microsoft Word within two (2) business days of each meeting.

• Use a centralized project management information system to systematically track, monitor, and report on the status of all tasks, milestones, and deliverables outlined in this Statement of Work (SOW). The system should support real-time performance monitoring, facilitate cross-team coordination, ensure adherence to timelines, and enable transparent documentation of progress, risks, and corrective actions to support effective program oversight and accountability.

BASE YEAR Only

Task 3 - Conduct a clinical evidence review for Biliary Atresia

The contractor shall:

3.1 Conduct a clinical evidence review of biliary atresia to determine best approaches to screen for biliary atresia in the newborn period, including measuring direct bilirubin. The evidence review shall include:

• An overarching framework and key questions;

• An analysis of biliary atresia including the latest medical studies, existing clinical guidelines, and proven clinical practices;

• Quality and strength of evidence;

• Expected health benefits;

• Potential harms;

• Feasibility during routine preventive visits;

• Appropriate ages and intervals for screening or counseling;

• Consistency with other national recommendations (ex. other evidence-based guidance, policy statements, Center for Disease Control, American Academy of Pediatrics)

3.2 Convene and manage a team of experts, to provide objective input on the overall clinical evidence review as described above. This clinical evidence review group (cERG)

MCHB IDIQ Solicitation #75R60226R00026 shall consider the benefits and health outcomes of population level screening for biliary atresia. The COR must approve all experts on the team.

• Prior to initiating substantive review activities, the Contractor shall conduct a conflict of interest (COI) screening for all personnel and SMEs involved in the evidence review.

• All personnel (including subcontractors) and SMEs must sign a non-disclosure agreement (NDA) to ensure all sensitive information regarding the evidence reviews remains confidential until the HRSA COR confirms public release.

• Promptly disclose to the HRSA COR any new COI that arises during the period of review.

3.3 Convene and manage a multidisciplinary panel of independent, subject matter experts that have expertise in biliary atresia. (SMEs) on biliary atresia to review. Provide a list for approval of the SMEs to the COR.

• Confidential screening and NDA requirements apply to the technical expert panel.

3.4 Develop final clinical evidence review of biliary atresia within four (4) months of EDOC.

A. Develop a draft clinical evidence review report synthesizing the findings from the evidence review.

B. Incorporate comments and feedback from HRSA, the NBS Stakeholder Workgroup, and public comments into the final report and submit the final report within five (5) months of EDOC.

3.5 Develop a consumer-friendly summary for the public at the 8th grade reading level of the evidence-based condition reviewed. The summary shall be a maximum of 12 pages. The draft shall be submitted to the COR for review within four (4) months of EDOC. Incorporate COR comments and edits and submit the final consumer summary fourteen (14) days after receiving comments.

Task 4 – Develop a framework or manual of procedures (MOP) for conducting scoping and systematic evidence reviews for multiple conditions simultaneously.

4.1 Conduct an environmental scan of the following: processes and procedures for evidence scans and systematic evidence-based reviews; prior evidence reviews; and legislative mandates that require evidence reviews. The environmental scan shall consist of current and past federal, state, and private organizations. The Contractor shall submit a brief summary of the environmental scan to the COR within 30 days of EDOC.

MCHB IDIQ Solicitation #75R60226R00026

4.2 Draft a framework or manual of procedures (MOP) for determining readiness of a condition for state newborn screening (NBS) based on specific criteria as determined by HRSA within three (3) months of EDOC. The criteria may include items such as (a) the condition causes serious morbidity/mortality in childhood; (b) there is a screening test with acceptable sensitivity/specificity; (c) treatment initiated after newborn screening detection is superior to treatment initiated after clinical ascertainment. The MOP shall account for the simultaneous review of multiple candidate conditions. The framework/MOP shall:

a. Describe the procedure for gathering evidence from the published and gray literature for NBS candidate conditions.

b. Outline procedures to identify relevant experts and stakeholders, convene condition-specific expert opinion panels, identify key questions and issues, and develop a methodology for assessing this supporting information.

c. Explain how information from 2a. and 2b. will be evaluated to determine strength of evidence for decision-making.

d. Outline how information above (a and b), including strength of evidence (c), will be used to place an NBS candidate condition into a category for readiness for state NBS based on predetermined criteria.

e. Describe how steps 2a-2d can be done simultaneously for up to 10 NBS candidate conditions.

f. Describe guidelines and methodology for determining financial value, cost-effectiveness, and budget impact of treatments for rare genetic diseases and newborn screening.

4.3 Solicit feedback and comments on draft MOP and standardized evidence review framework from the National NBS Stakeholder Workgroup. Incorporate feedback into draft MOP and submit final for COR approval within four (4) months of EDOC.

4.4 The Contractor shall use the Final MOP to develop accompanying training materials within (4) months of EDOC to inform the National NBS Stakeholder Workgroup and facilitate the implementation of the MOP among the evidence review teams and technical evaluation panels.

MCHB IDIQ Solicitation #75R60226R00026

BASE and OPTION YEAR 1

TASK 5: Evidence Scans for Newborn Screening Conditions

The Contractor shall:

5.1 Develop a comprehensive evidence protocol for rare genetic conditions detailing the research questions, search strategy, inclusion/exclusion criteria, and data extraction framework within three (3) months of EDOC. The protocol must be submitted to the COR for approval prior to initiating the scan.

5.2 Conduct searches of peer-reviewed literature, rare disease and newborn screening registries, and relevant grey literature (e.g., patient advocacy organization data) to identify evidence relevant to each condition's epidemiology, natural history, diagnostic pathways, and treatment landscape.

Execute the approved literature search strategy across multiple electronic databases (e.g., PubMed, Embase, Cochrane Library). The literature search must include peer-reviewed literature and, if approved in the protocol, relevant grey literature.

5.3 Synthesize extracted findings into condition-specific summary reports within six (6) months of EDOC that characterize the current evidence base and identify key evidence gaps, with attention to the criteria established in the MOP (Task 3.2). Include a complete bibliography and documented search strategy.

5.4 Incorporate feedback from the COR and the Newborn Screening Stakeholder

Workgroup and submit the final version of the summary reports within two (2) weeks of receipt of feedback.

5.5 Synthesize the extracted data into a cohesive final narrative report. The report must objectively map the available evidence with the outlined criteria (established in the MOP) without making definitive clinical recommendations.

TASK 6: Conduct Evidence-based Reviews for Conditions Nominated for Inclusion on the RUSP

The Contractor shall:

6.1 Conduct systematic, evidence-based reviews of rare conditions nominated for the Recommended Uniform Screening Panel (RUSP). The COR will assign the

Contractor up to 10 medical/genetic condition(s) to review. The evidence-based reviews will be considered when determining the recommendation of including the nominated conditions to the RUSP. The evidence-based review shall include:

• An overarching framework and key questions;

• An analysis of the condition including, the case definition and clinical history;

o Population characteristics, including age, birth prevalence, and genetic/biochemical subtype

• The corresponding newborn screening test(s), confirmatory test(s), and treatment(s);

o Screening test characteristics (sensitivity, specificity, positive predictive value, negative predictive value, false positive rate, cutoff values)

• Clinical outcomes (short- and long-term), including mortality, morbidity, developmental outcomes, and quality of life

• An analysis of the benefits and harms of newborn screening (including diagnosis and treatment) for the condition at a population level;

• Assessment of the impact and cost of State public health newborn screening programs' ability to implement screening of new conditions;

• An economic analysis specifically related to the newborn screening condition(s) under review.

• Public health system and family/psychosocial impacts.

6.2 The Contractor shall develop and deliver a project timeline to support the planning and implementation of concurrent evidence reviews for multiple rare conditions. The timeline shall identify all major activities, milestones, deliverables, decision points, and task dependencies necessary to complete the reviews in a coordinated and efficient manner. The timeline must be submitted to the COR for approval prior to beginning the evidence reviews within six (6) months of EDOC.

6.3 Convene and manage a team of experts, the Evidence Review Group (ERG), to provide objective input on the systematic evidence reviews including providing expertise on the overarching framework and key questions; reviewing published and gray literature; and abstracting data and weighing the quality and quantity of the data.

The team of experts will also provide input into the assessment of the benefits and harms of screening for a condition at a population level as well as input on state public health newborn screening programs’ ability to implement the screening of a new condition and the cost implications of implementing population-based screening of the condition. The COR must approve all experts on the team.

• Prior to initiating substantive review activities, the Contractor shall conduct a COI screening for all personnel and SMEs involved in the evidence reviews.

• All personnel (including subcontractors) and SMEs must sign a non-disclosure agreement (NDA) to ensure all sensitive information regarding the evidence reviews remains confidential until the HRSA COR confirms public release.

• Promptly disclose to the HRSA COR any new COI that arises during the period of reviews.

6.4 Convene and manage a Technical Expert Panel of up to 10 subject matter experts (SMEs) that have expertise in the rare conditions that are under review. Provide a list for approval of the SMEs to the COR.

• Confidential screening and NDA requirements apply to the technical expert panel.

6.5 Develop draft condition specific reports and submit to the COR within ten (10) months of EDOC.

6.6 Incorporate feedback and comments from the COR and the National NBS Stakeholder Workgroup and submit final reports within twelve (12) months of EDOC. If applicable, work with COR to publish final reports in peer reviewed journals.

6.7 Develop a consumer-friendly summary for the public at the 8th grade reading level of the evidence-based condition reviewed. The summary shall be a maximum of 12 pages within twelve (12) months of EDOC.

Task 7: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

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

i. 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.

ii. 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.

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

i. 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.

ii. 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).

iii. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/HRSA 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 HHS/HRSA security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/OpDiv privacy policies, and complete all the requirements below:

i. 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.

e. 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:

i. Marked appropriately;

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

iii. 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

iv. Returned to HHS 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.

f. 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.

g. 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 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 HHS 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 and HRSA policies. Unauthorized disclosure of information will be subject to the HHS/HRSA sanction policies and/or governed by the following laws and regulations:

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

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

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

h. Contract Documentation. The Contractor must use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate. See Appendix A for baseline deliverables.

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

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

ii. 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.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and HRSA-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).

iv. 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.

v. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

2. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/HRSA Computer Security Incident Response Team (hrsacsirt@hrsa.gov) 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), 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 HHS breach response http://csrc.nist.gov/publications/ mailto:hrsacsirt@hrsa.gov process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

ii. 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 must send HRSA approved notifications to affected individuals following specific instructions from the HHS Privacy Incident Response Team (PIRT).

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the HRSA Computer Security Incident Response Team (hrsacsirt@hrsa.gov) or 301-443-3333, COR, CO, HRSA SOP (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 HRSA 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, 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.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS and HRSA privacy breach response policies when handling PII breaches.

v. 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.

3. Position Sensitivity Designations

a. 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: non-sensitive moderate risk Tier 2 background investigation.

b. Homeland Security Presidential Directive (HSPD)-12

c. 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 HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

4. Contract Initiation and Expiration

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

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS 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.

c. 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, including HRSA Disposition Plan 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.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within 14 days before an employee stops working under this contract.

e. 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 HRSA policies.

Appendix A: Deliverables

Policy Section Deliverable Title/Description

Due Date

Incident Response Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Incident Response Incident and Breach Response Plan

Upon request from government

Incident Response

• Incident reports (as needed)

• Incident Response Plan

Incident Reports – must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/HRSA Computer Security Incident Response Team (hrsacsirt@hrsa.gov) within 24 hours

Report all suspected and confirmed information security and privacy incidents and breaches to the HRSA Computer Security Incident Response Team as soon as possible and without unreasonable delay, no later than one (1) hour

Incident Response Plan – Upon request from government

Task 8: Artificial Intelligence

Unknown Use of AI by the Contractor in Contract Performance

Disclosure Requirement

The contractor must disclose any planned or potential use of AI, including Generative AI (GenAI) tools) in the performance of this contract.

If the contractor plans to use, or may use, AI technologies at any point during contract performance, the contractor must submit an AI compliance and risk management plan, in accordance with the Deliverables section of this contract.

8.1 Required Elements of the AI Compliance and Risk Management Plan Deliverable

The plan must:

• Identify the specific tasks or functions where AI will be used.

• Explain how AI-generated data will be stored, used, retained, or deleted.

• State whether the AI technologies are open-source, proprietary, or any other type.

• Include applicable model cards or system documentation describing the AI technologies used.

• Describe how bias in AI models and outputs will be identified, monitored, and mitigated, including the origin, quality, and weighting of data.

• Explain the AI safeguards in place, including compliance and risk management practices, protections against unauthorized data access, and steps taken to manage bias and reduce risk in alignment with applicable AI policies and directives.

• Describe internal policies governing AI use, including transparency, accountability, data integrity, accuracy, protection of sensitive or proprietary information, foreseeable risks, and potential social impacts.

• Explain how the contractor will assess and prevent unfair or disparate impacts, address privacy, civil rights, and civil liberties concerns, and prevent misuse, unauthorized use, or corruption of AI systems.

• Confirm that the AI solution will not make or support decisions based on unlawful discrimination in violation of federal civil rights laws, including Title VII of the Civil Rights Act, the Americans with Disabilities Act (ADA), and the Age Discrimination in Employment Act (ADEA).

• Describe how applicable technological or voluntary consensus standards will be incorporated to reduce acquisition and operational risk.

8.2 Review and Approval

The Government reserves the right to review and approve or disapprove the proposed use of AI technology under this contract. The contractor must obtain written approval from the contracting officer for the AI compliance and risk management plan before using any AI tools or technologies.

Deliverable Timeline

MCHB IDIQ Solicitation #75R60226R00026

The contractor must submit the AI compliance and risk management plan before implementing any AI technologies under the contract. The Government will review the plan prior to authorizing AI use. If the contractor later proposes to use new or different AI technologies, an updated plan must be submitted and approved by the Contracting Officer before those technologies are implemented.

VII. Deliverables

Section 508 Language for Solicitations and Contracts with Information and Communications Technology (ICT)

The contractor shall ensure all products and services delivered under this contract are compliant with Section 508 in accordance with the Health and Human Services Acquisition Regulation (HHSAR). These Section 508 Standards were issued by the United States Access Board (https://www.access-board.gov/) and published in the Federal Register, on January 18, 2017, as the final rule (https://www.access-board.gov/ict/). The final rule updates the Section 508 Standards along with accessibility guidelines for telecommunication products and equipment covered by section 255 of the Communications Act.

The Section 508 Standards applicable to this contract are:

Section 508 Standards and Guidelines (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines)

• Web Content Accessibility Guidelines (WCAG) 2.0

• Success Criteria, Level A and AA

• Chapter 3: Functional Performance Criteria (FPC)

• Chapter 4: Hardware (If Applicable)

• Chapter 5: Software

• Chapter 6: Support Documentation and Services

Section 508 requires that all external public facing content and non-public facing official agency communications be accessible. Regardless of format, all digital content or communications materials produced as deliverables under this contract must conform to https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2F&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653367284%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=8G%2B1RVWkuJFOM33oZOgm6HULGZOpHy9XWp3npvNs7ZE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2F&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653367284%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=8G%2B1RVWkuJFOM33oZOgm6HULGZOpHy9XWp3npvNs7ZE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2F&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653385629%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=36jbS8Fe1z03Q9TueJweod2VYNdHGxL2Lyfhy%2FeaEjE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2Fict%2F&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653403987%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=FJfhVSIO4hvYE%2FAemgMAJWaXPH5Z9UjN3l2brH%2FxZAY%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acce%2F&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653421764%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=hMkQPM1rWpo7tv6ufRUTmDWYr1pE%2Byacgv7Vdswxo54%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2Fguidelines-and-standards%2Fcommunications-and-it%2Fabout-the-ict-refresh%2Ffinal-rule%2Ftext-of-the-standards-and-guidelines&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653439947%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2H0kJ8ivPaBgRgMph7qWir6j84ws429Uo0SMXEndTsc%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2Fguidelines-and-standards%2Fcommunications-and-it%2Fabout-the-ict-refresh%2Ffinal-rule%2Ftext-of-the-standards-and-guidelines&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653457874%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ESNIun9au7WjZCGVxoH86xPcbg9A8iq6tR2fCIS2iMg%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2Fguidelines-and-standards%2Fcommunications-and-it%2Fabout-the-ict-refresh%2Ffinal-rule%2Ftext-of-the-standards-and-guidelines&data=05%7C02%7CLManning%40hrsa.gov%7C7e0ac8066a534e25b70a08def4af3e15%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639217230653457874%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ESNIun9au7WjZCGVxoH86xPcbg9A8iq6tR2fCIS2iMg%3D&reserved=0…