Attachment 1d-TO Deliverables-A1.pdf

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HRSA/MCHB Newborn Screening Systematic Evidence Review IDIQ and Task Order 1
Solicitation number
75R60226R00026
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This is a Schedule of Deliverables for Task Order 1 under the MCHB IDIQ Solicitation #75R60226R00026, titled "Support for Evidence Reviews and Newborn Screening Processes." The document outlines specific deliverables, formats, due dates, and distribution/approval requirements across multiple task categories spanning approximately 12 months from the Effective Date of Contract (EDOC).

Core deliverables include Records Management Training Completion Certificates (due within 30 days of EDOC); project management materials such as Kickoff Meeting Agendas and Minutes (due within 10-14 business days); monthly meeting agendas and notes; and an AI Compliance and Risk Management Plan if AI/GenAI tools are used (approval required before implementation). Clinical evidence review work includes a Draft Clinical Evidence Review Report on Biliary Atresia (due within 4 months) and Final Report (due within 5 months), with associated consumer-friendly summaries at 8th-grade reading level. Supporting deliverables encompass an Environmental Scan Summary (30 days), a Manual of Procedures (MOP) framework with training materials (3-4 months), and a Comprehensive Evidence Protocol for rare genetic conditions (3 months). Additional evidence reviews include 10-15 condition-specific summary reports (6 months for draft; 2 weeks for final), up to 10 condition-specific evidence review reports (10 months for draft; 12 months for final), and corresponding consumer-friendly summaries. Security and compliance deliverables include Incident Reports (within 1 hour of discovery), an Incident and Breach Response Plan, Device Encryption FIPS 140 Validation Documentation, and HRSA Disposition Plan & Media Sanitization Certification at contract closeout. All digital deliverables must comply with Section 508 Standards (WCAG 2.0 Level A and AA) with accompanying accessibility checklists. Optional tasks include Policy/Research Briefs and Reports to Congress, Briefing Books and Meeting Materials, and Journal Supplement manuscripts, each with timelines to be executed separately. The Contracting Officer's Representative (COR) or Contracting Officer (CO) approves most deliverables, with some requiring stakeholder workgroup input.

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Attachment 1d – Task Order 1 Schedule of Deliverables-A1 Support for Evidence Reviews and Newborn Screening Processes

MCHB IDIQ Solicitation #75R60226R00026

Note: All digital deliverables must conform to Section 508 Standards (WCAG 2.0 Level A and AA) and be accompanied by the HHS Section 508 Accessibility Compliance Checklist.

Task / Ref Deliverable Name Format Due Date (From EDOC unless noted) Distribution / Action

Task 1.3

Records Management Training Completion Certificates

Certificates / Listing

Within 30 days of EDOC (and upon new staff onboarding; annually)

COR (Review & File)

Task 2.1

Draft Kickoff Meeting Agenda & Materials MS Word Within 10 business days of EDOC COR (Review & Accept)

Task 2.1

Kickoff Meeting Minutes & Revised Contract Timeline

MS Word Within 14 business days of Kickoff Meeting COR (Approval)

Task

2.2 Monthly Meeting Agenda Electronic 3 business days before

each meeting COR (Review & Accept)

Task 2.2

Meeting Notes & Draft Summary / Revised Project Timeline

MS Word Within 2 business days of each meeting COR (Review & File)

Task 2.3

AI Compliance and Risk Management Plan (If AI/GenAI is used)

Written Plan Before implementing any AI tools

CO / COR (Approval Required)

Task 3.2/3.3

Proposed cERG Members & SME Panel List (Biliary Atresia)

Written List Prior to initiating substantive review activities

COR (Approval)

Task 3.2/3.3

Conflict of Interest (COI) Screenings & Signed NDAs

Signed Forms Prior to initiating substantive review activities

COR (Review & File)

Task 3.4

Draft Clinical Evidence Review Report (Biliary Atresia)

Written Report Within 4 months of

EDOC

COR & Stakeholder

WG

Task 3.4

Final Clinical Evidence Review Report (Biliary Atresia)

Written Report Within 5 months of

EDOC

COR (Approval & Public Release)

Task 3.5

Draft Consumer-Friendly Summary (8th Grade Level, Max 12 pages)

Written Summary

Within 4 months of

EDOC

COR (Review & Comment)

Task 3.5

Final Consumer-Friendly Summary (Biliary Atresia)

Written Summary

Within 14 days of receiving COR comments COR (Approval)

Task 4.1

Environmental Scan Summary (Evidence Review Processes)

Brief Written Summary Within 30 days of EDOC COR (Review &

Accept)

Task 4.2

Draft Framework or Manual of Procedures

(MOP)

Written Document

Within 3 months of

EDOC

COR & National NBS

WG

Task 4.3

Final MOP (Incorporate Stakeholder Feedback)

Written Document

Within 4 months of EDOC COR (Approval)

Task 4.4

Accompanying MOP Training Materials

Training Materials

Within 4 months of

EDOC

COR & National NBS

WG

Task 5.1

Comprehensive Evidence Protocol (Rare Genetic Conditions)

Written Protocol

Within 3 months of

EDOC

COR (Approval Required)

Task 5.3

Draft Condition-Specific Evidence Summary Reports (10–15 Conditions)

Written Reports

Within 6 months of

EDOC

COR & Stakeholder

WG

Task 5.4

Final Summary Reports (Incorporate WG Feedback)

Written Reports

Within 2 weeks of receipt of feedback COR (Approval)

Task 5.5

Final Cohesive Narrative Report (Map Evidence to

MOP)

Written Narrative

Following synthesis of Tasks 5.3–5.4

COR (Review & Accept)

Task 6.2

Project Timeline for Concurrent Evidence Reviews

Written Timeline

Within 6 months of

EDOC

COR (Approval Required)

Task 6.3/6.4

Proposed ERG and Technical Expert Panel (TEP) Lists

Written Lists Prior to initiating substantive review activities

COR (Approval)

Task 6.5

Draft Condition-Specific Evidence Review Reports (Up to 10 Conditions)

Written Reports

Within 10 months of

EDOC

COR (Review & Comment)

Task 6.6

Final Condition-Specific Evidence Review Reports

Written Reports

Within 12 months of

EDOC

COR (Approval / Publication)

Task 6.7

Consumer-Friendly Summary per Condition Reviewed

Written Summary

Within 12 months of EDOC COR (Approval)

Task 7.0

Incident Report (If security/privacy breach occurs)

Immediate Report

Within 1 hour of discovery hrsacsirt@hrsa.gov, COR, CO

Task 7.0

Incident and Breach Response Plan Written Plan Upon request from government COR / CO

Task 7.0

Device Encryption FIPS 140 Validation Documentation

Written Verification

Upon contract initiation / request COR

Task 7.0

HRSA Disposition Plan & Media Sanitization Certification

Written Certificate

At contract closeout/expiration CO / COR

Opt.

Task 1

Policy/Research Briefs, Toolkits, Reports to Congress (RTCs)

508 Compliant Deliverable

Per executed Optional Task timeline

COR (Review & Approve)

Opt.

Task 2

Briefing Books, Meeting Materials, & Minutes

508 Compliant Docs

Minutes within 10 days of convening COR

Opt.

Task 2

Draft & Final Meeting Summary/Next Steps Report

Written Report Following meeting conclusion COR (Approval)

Opt.

Task 3

Journal Supplement Timelines, Concepts, Outlines & Manuscripts

Written Deliverables

Per executed Optional Task timeline

COR & Journal Editors

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