Attachment 1d Schedule of Deliverables.pdf

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HRSA/MCHB Newborn Screening Systematic Evidence Review IDIQ and Task Order 1
Solicitation number
75R60226R00026
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Task Order 1 Schedule of Deliverables Summary

This is a Schedule of Deliverables document for Task Order 1 under the MCHB IDIQ Solicitation #75R60226R00026, titled "Support for Evidence Reviews and Newborn Screening Processes." The document outlines all required deliverables, formats, due dates, and distribution/approval requirements across eight primary task categories plus three optional tasks. All digital deliverables must comply with Section 508 Standards (WCAG 2.0 Level A and AA) and be accompanied by the HHS Section 508 Accessibility Compliance Checklist.

The deliverables span organizational tasks, evidence review processes, and clinical documentation. Key deliverables include Records Management Training Certificates (within 30 days of contract start), Draft and Final Clinical Evidence Review Reports for Biliary Atresia (within 4-5 months), consumer-friendly summaries (within 4 months, 8th grade reading level, maximum 12 pages), a Manual of Procedures and accompanying training materials (within 3-4 months), comprehensive evidence protocols for rare genetic conditions (within 3 months), and condition-specific evidence review reports covering 10-15 conditions (within 6-12 months). Additional critical deliverables include a Project Timeline for Concurrent Evidence Reviews (within 6 months), Environmental Scan Summary (within 30 days), and security-related documentation including an Incident Report (within 1 hour of discovery), Device Encryption FIPS 140 Validation Documentation, AI Compliance and Risk Management Plan (if applicable, before implementation), and HRSA Disposition Plan & Media Sanitization Certification (at contract closeout). Optional tasks address policy briefs, meeting materials, and journal supplement manuscripts. The Contracting Officer's Representative (COR) serves as the primary approval authority for most deliverables, with some requiring additional stakeholder working group or national NBS working group input.

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Attachment 1d – Task Order 1 Schedule of Deliverables 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 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

Written Reports

Within 10 months of

EDOC

COR (Review & Comment)

Reports (Up to 10 Conditions)

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

Task 8.0

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

Written Plan Before implementing any AI tools

CO / COR (Approval Required)

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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