HCOREHPOP24

The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) HHS Coordination Operations and Response Element (HCORE) has a requirement to maintain a response/product agnostic web-based order and distribution Software as a Service (SaaS) application deployed within Oracle Cloud Infrastructure as a service/Platform as a Service (IaaS/PaaS) for managing, monitoring, and reporting key metrics associated with the ordering and distribution of MCMs and public health resources to address public health threats. The Contractor shall be responsible to ensure that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part 11 compliant and are validated as per Software Development Life Cycle (SDLC) concept.

The purpose of Amendment 0001 was to extend the response due date and provide instructions to all offerors to submit an email notification to the Contracting Officer of their intent to submit an offer at least 24 hours prior to the solicitation closing.

The purpose of Amendment 0004 is to:

1. 1. Update NAICS Code Title
   2. Extend the proposal due date.
   3. Update the CLIN Description in table B.3
   4. Update to section C.2
   5. Update to section C.4.1.7, C.4.1.8, C.4.1.9, C.4.1.10
   6. Section C.5 Deliverables updated from SOW to PWS
   7. Update to section C.6.4 Key Personnel Program Manager
   8. Remove section C.6.6 Onsite presence
   9. Remove section C.7 Quality Assurance Surveillance Plan (QASP)
   10. Remove section C.11 TRAVEL REQUIREMENTS (T&M, CLIN 0006, 1006, 2006, 3006)
   11. Add clarifying language to the Performance Work Statement (PWS)
   12. Updated Section H.4 Key Personnel
   13. Extend the questions, past performance, and response due dates
   14. Update imbedded price break down document Section L
   15. Update technical approach evaluation Section L

Proposal are due no later than 9/27/2024 at 12pm noon eastern standard time.

The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) HHS Coordination Operations and Response Element (HCORE) has a requirement to maintain a response/product agnostic web-based order and distribution Software as a Service (SaaS) application deployed within Oracle Cloud Infrastructure as a service/Platform as a Service (IaaS/PaaS) for managing, monitoring, and reporting key metrics associated with the ordering and distribution of MCMs and public health resources to address public health threats. The Contractor shall be responsible to ensure that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part 11 compliant and are validated as per Software Development Life Cycle (SDLC) concept.

The purpose of Amendment 0001 was to extend the response due date and provide instructions to all offerors to submit an email notification to the Contracting Officer of their intent to submit an offer at least 24 hours prior to the solicitation closing.

The purpose of Amendment 0002 is to:

1. Extend the questions, past performance and response due dates.
2. Add the instructions to all offerors to submit an email notification to the Contracting Officer of their intent to submit an offer at least 24 hours prior to the solicitation closing to Section L.1 Addendum to FAR 52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (Sep 2023)
3. Add clarifying language to the Performance Work Statement (PWS)
4. Add technical approach evaluation rating definitions to Section M.1 52.212-2 Evaluation – Commercial Products and Commercial Services (Nov 2021), and
5. Make administrative edits (formatting edits throughout the combined synopsis/solicitation, deletion of instructional text to Government personnel in Section C.12 Requirements for Handling Sensitive/Proprietary Information, updating the Amendment 0001 file attachment name).

All changes in the Amendment 0001 and 0002 attachments, except formatting edits and deletions, are highlighted in yellow.

The purpose of Amendment 0003 is to attach the J&A Attachment 1. No extension to the response due date is anticipated.

The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) HHS Coordination Operations and Response Element (HCORE) has a requirement to maintain a response/product agnostic web-based order and distribution Software as a Service (SaaS) application deployed within Oracle Cloud Infrastructure as a service/Platform as a Service (IaaS/PaaS) for managing, monitoring, and reporting key metrics associated with the ordering and distribution of MCMs and public health resources to address public health threats. The Contractor shall be responsible to ensure that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part 11 compliant and are validated as per Software Development Life Cycle (SDLC) concept.

The purpose of Amendment 0001 was to extend the response due date and provide instructions to all offerors to submit an email notification to the Contracting Officer of their intent to submit an offer at least 24 hours prior to the solicitation closing.

The purpose of Amendment 0002 is to:

1. Extend the questions, past performance and response due dates.
2. Add the instructions to all offerors to submit an email notification to the Contracting Officer of their intent to submit an offer at least 24 hours prior to the solicitation closing to Section L.1 Addendum to FAR 52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (Sep 2023)
3. Add clarifying language to the Performance Work Statement (PWS)
4. Add technical approach evaluation rating definitions to Section M.1 52.212-2 Evaluation – Commercial Products and Commercial Services (Nov 2021), and
5. Make administrative edits (formatting edits throughout the combined synopsis/solicitation, deletion of instructional text to Government personnel in Section C.12 Requirements for Handling Sensitive/Proprietary Information, updating the Amendment 0001 file attachment name).

All changes in the Amendment 0001 and 0002 attachments, except formatting edits and deletions, are highlighted in yellow.

The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) HHS Coordination Operations and Response Element (HCORE) has a requirement to maintain a response/product agnostic web-based order and distribution Software as a Service (SaaS) application deployed within Oracle Cloud Infrastructure as a service/Platform as a Service (IaaS/PaaS) for managing, monitoring, and reporting key metrics associated with the ordering and distribution of MCMs and public health resources to address public health threats. The Contractor shall be responsible to ensure that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part 11 compliant and are validated as per Software Development Life Cycle (SDLC) concept.