Amendment 1 to RFP 75A50123R00003 - Questions and Answers.pdf

Reponses to questions for #75A50123R00003.

Amendment 1 to RFP 75A50123R00003

Note: Replaced company name with Vendor in Questions and Answers Replaced subcontractor company names with Subcontractor.

Q1. A key evaluation criterion outlined in the Technical Manufacturing Capabilities of the product is that our product is a “final finished sterile IN formulation of Nalmefene”. Our product is not sterile, do you foresee any issues with the Vendor clarifying this in our technical proposal? [Follow up note: our product meets all FDA criteria for non-sterile solution based intranasal product, as detailed in NDA].

A: There are no issues if the product is FDA approved as a non-sterile solution; however, the Vendor must provide documentation that their product meets FDA criteria for non-sterile solution based intranasal product.

Q2. Where is the location within the excel “Enclosure 8 Budget Spreadsheet” which we present the Commercial costs for 200,000 units per year.

A: The Excel Enclosure 8 Budget Spreadsheet is fully editable and each Vendor should edit it to meet their needs.

Q3. Is there CO guidance information for preparing the various cost elements including the two-step method for G&A overhead rate computation? Another example would be a checklist for all subcontractor awards.

A: Provide vendor budget information in accordance with generally accepted accounting principles.

Q4. Is the maximum annual salary cap for period starting October 1, 2023 available.

A: The maximum salary cap is Senior Executive Service Level II and can be found at the following link: https://www.federalpay.org/ses/level-2. It is applicable on a per annum basis for direct costs.

Q5. Where is the location within the excel “Enclosure 8 Budget Spreadsheet” to present the Commercial costs for 200,000 units per year.

A: The Excel Enclosure 8 Budget Spreadsheet is fully editable and each Vendor should edit it to meet their needs.

Q6. Is there CO guidance information for preparing the various cost elements including the two-step method for G&A overhead rate computation? Another example would be guidance on the requirement for subcontractor awards.

A: Provide vendor budget information in accordance with generally accepted accounting principles.

Q7. Is the maximum annual salary cap for period starting October 1, 2023 available.

A: The maximum salary cap is Senior Executive Service Level II and can be found at the following link: https://www.federalpay.org/ses/level-2.

Q8. Key Personnel (pg.32)

1. Is the Offeror allowed and/or able to add and/or modify the list of FTE’s who are to be considered “essential” to the work being performed?

A: The Vendor is allowed to add and/or modify the list of FTE considered essential, or key, provided that a list of qualifications and resume are submitted for review and approval.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.federalpay.org%2Fses%2Flevel-2&data=05%7C01%7CNellie.Byun%40hhs.gov%7Cb6c6b7f2da5b4411895c08db9f60caba%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C638279010287517134%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=UPejUcBCeeW699Z55mworHl7HSQbR0RH%2BJ91g7fAPDU%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.federalpay.org%2Fses%2Flevel-2&data=05%7C01%7CNellie.Byun%40hhs.gov%7Cb6c6b7f2da5b4411895c08db9f60caba%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C638279010287517134%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=UPejUcBCeeW699Z55mworHl7HSQbR0RH%2BJ91g7fAPDU%3D&reserved=0

Q9. Evaluation Criterion: Project Management (pg.76).

2. What, if any, are the residency requirements for the “essential titles” and/or anyone who might be appointed and/or categorized as “essential”?

A: Essential, or key, personnel are not required to hold US residency.

3. What, if any, are the geographic location requirements for the “essential titles” and/or anyone who might be appointed and/or categorized as “essential”? Or rather, must said individual(s) be based in the US?

A: Essential, or key, personnel are not required to be based in the US.

Q10. BARDA Security Requirements (pg.105)

4. Does the term “facility” refer to the location of where product is stored and/or manufactured, or a headquarters?

A: The term facility refers to the physical location and address of a site where product is stored and/or manufactured, not headquarters.

5. Can the extent of a background check be subject to position? For example, a Corporate Controller having to undergo a more thorough background check than a receptionist is generally standard practice given the latter’s exposure to financial information and/or data.

A: The Vendor's internal practices and procedures on background checks should be followed.

6. Is an independent, contracted security firm sufficient, or, should security be a FTE of the Offeror?

A: Security should be managed by the Vendor having a knowledgeable employee running the program, but the vendor can contract out third-party entities for security guards, alarm monitors, etc.

Q11. Does ASPR have a preferred template for Quality Agreement? How can this be obtained? Will ASPR send us initial draft of Quality Agreement?

A: No, the Vendor should provide the template and initial draft.

Q12: Is there a template for a Quality Management System Plan (p27 F.3.2.E.8)?

A: No, the Vendor should provide one.

Q13. Does every node of the supply chain have to meet all of BARDA's security requirements or is it only the drug substance manufacturer, drug product manufacturer, and warehouse where the VMI is located? Do we need to put security controls in place for the supplier of a unique excipient, or the supplier of drug delivery device.

A: BARDA/ASPR security requirements have to be met by the Vendor and any subcontractors that are on the contract.

Q14. Does a facility have to meet all necessary supply security requirements outlined in Attachment 15 before first supply?

A: Each subcontracted 3PL warehouse, warehouse, and distribution facility in the contract, as applicable, needs to meet ASPR security requirements and should provide the Vendor with their security plans.

Q15. In the event that supply chain sites do not meet the BARDA security requirements, can the contractor include costs into the proposal to close the gaps associated with BARDA's security requirements be included in a grant/award?

A: Yes, the Vendor can include for review and consideration relevant costs associated with closing gaps to meet BARDA/ASPR Security requirements.

Q16. Does BARDA allow stockpiling of materials in leu of sites meeting BARDA security requirements?

A: BARDA allows stockpiling of materials at a facility that meets security requirements until other sites can be brought online.

Q17. Can you provide a copy of the HHS SECTION 508 PRODUCT ASSESSMENT TEMPLATE? The link provided in the Solicitation notice delivers a 'Page Not Found' response.

A: Please disregard. This is not required.

Q18. In response to Subcontractors being utilized for the manufacture of Indivior’s products, do you require Indivior to provide the Subcontractors key resources and their experiences, or just Indivior's resources and experience in managing Subcontractors as per Section L.4.1.1.B?

A: Yes, for subcontractors that are an integral part of the contract, this information on key resources and experiences are required.

Q19. Will there be a need to have BCP location for BARDA in the Distributor’s network?

A: As long as the product can be provided within the timelines stated in the solicitation, there would not need to be a separate Continuity Plan for BARDA product.

Q20. If new account set up is required at the Distributor and they receive the information needed afterhours to set up the account and we are coming up to the 24 hr turnaround requirement

• will the account set up team be required to be on call?

• can the request roll over to the next business day?

A: The Vendor should have system(s) in place to meet the 24 hour turnaround requirement.

Q21. Clarification of Person in Plant - If this program is going to have active shipping there will be receiving/put away activity throughout the year, will they require someone to be onsite for these activities.

A: The need for a Person in Plant most often occurs if or when manufacturing problems are not solvable by the contractor or consultants working on behalf of the contractor and BARDA determined experts are requested to assist in resolving the issue. The Person in Plant does not normally extend to routine receiving and inventory storage activities.

Q22. Physical Inventory count requirement: Is this a report or will BARDA come onsite to physically count?

A: The physical inventory reconciliation can be performed either way.

Q23. Our logistics service provider provides ocean freight and trucking services. The product will never move into their facility. What type of security/ vendor management information should be provided?

A: No security plan is necessary, but we would need to know what their transportation plan is for moving product from one location to the next.

Q24. Do we need to provide air freight rates in addition to road freight?

A: Yes, if air freight is determined acceptable by the Vendor's logistics subject matter expert and absence of low temperature thermal impact on the performance of the product over the expected stability period has been demonstrated.

Q25. Can plastic components from France be shipped without temperature controls?

A: Yes, if air freight is determined acceptable by the Vendor's logistics subject matter expert and absence of low temperature thermal impact on the performance of the component or impact on the drug product over the expected stability period has been demonstrated.

Q26. Are ISO seals acceptable or are high security seals required?

A: Yes, ISO seals are acceptable. The requirement is for “Government products to be secured with tamper resistant seals during transport, and the transport trailer must be locked and sealed.)

• Tamper resistant seals must be verified as “secure” after the product is placed in the transport vehicle. (Check requirements on types of products being moved to ensure they don’t need a higher strength seal)

Q27. Is live GPS monitoring required in transit?

A: GPS seals are not required, but are highly suggested. “Government products should be continually monitored by GPS technology while in transport, and any deviations from planned routes should be investigated and documented.” There should be measures and plans in place to monitor the route to ensure there are no deviations and the product is secure.

Q28. Page 21 states “The USG will be responsible for all shipping costs and handling all shipping/logistics.” This appears to contradict the statements on page 20 (D3).

A: The USG, as opposed to the site of shipping, will be responsible for shipping costs as contracted with the Vendor and the USG will indicate shipping destinations; the destination site shall not be billed by the Vendor.

Q29. Is the same Firm Fixed Price applicable for all option years or will the Firm Fixed Price be re-negotiated for each option year as the years progress?

A: If there is mutual agreement on a negotiated firm fixed price CLIN at the start of a contract then it generally would not be renegotiated later.

Q30. The RFP outlines a specific quantity that needs to be maintained in the VMI. Separately, the RFP further states that this product needs to be used to for the treatment of community opioid/fentanyl overdoses or mass casualty events by satisfying the community availability in hospitals and EMS in minutes, not hours and the creation of a mechanism for replenishing stock.

• Is the expectation that our response to the RFP include a plan to create a distribution model to engage and distribute nasal nalmefene to local EMS/Hospital entities to hold predefined quantities of product?

o Is there an assessed quantity that would be targeted per local entity, or should that be defined by the Offeror?

o Does the Contractor have a defined measure to determine which local entities should be prioritized or should that be defined/suggested by the Offeror?

A: Any submission to this RFP is not expected to include a plan to create distribution model for engaging and/or distributing product to local EMS/hospital entities. No assessed quantity target per local entity or measure to determine local entities is required.

Q31 As that product leaves the VMI to equip those local entities, is it intended that we replenish the stock in the VMI to the listed inventory level?

A: As ordered product leaves VMI, it is not intended to be replenished, or replaced; however, unordered product must be rotated out and replaced as indicated in the RFP.

Q32: Is there a template for Manufacturing Plan (2.4.2)?

A: There is no template provided for the Manufacturing Plan.

Q33. Is there an estimate of how many units will be shipped in any given shipment? An idea of this would be helpful in terms of inventory accounting/management.

A: There should be the capability to ship 1 unit to total inventory in stock.

Q34. Confirming that the invoices for the Commercial units do NOT need to specific batch/lot#s as we may have to rotate stock to maintain the 6month requirement. Lot# was not specified in section G.5.1. Confirmation of interpretation.

A: Invoices for commercial units should specify the specific batch number or lot number and quantities for each batch/lot. Upon rotation of stock, new batch/lot number(s) and quantities as well as batch/lot number of stock rotated out should be provided.