RFP ATTACHMENT 2- Pegfilgrastim Q and A Template (Government Comments) 10.02.2024.pdf

ATTACHMENT 2

SOLICITATION Q & A Sheet

REQUIREMENT TITLE:

SOLICITATION NO.

Note: Use this sheet to submit Questions. The government will consolidate all questions received and will provide responses to all vendors in blue.

1. CONTRACTOR’S QUESTION:

RFP Section

Question Document Name Section Paragraph Page Solicitation Language

RFP

75A50324R00004

C.4 e. 10 The Contractor shall have the ability to service the continental United States and must possess an inventory system capable of providing up to date information on all Government owned inventory, including quantity and location.

Is the Government expecting access to inventory systems or to be able to receive reports from said system that confirms the quantity and locations of goods?

GOVERNMENT’S RESPONSE:

The Government does not require access to the Contractor’s inventory systems, the Contractor shall submit the required reports as outlined in the Statement of Work and ensure that the Government is provided 24/7 availability of the product(s) and 24/7/365 access to the Contractor’s vendor managed inventory facility.

2. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

C.4 g. 11 The contractor shall provide a detailed description of the organization’s production capacity, scalability for increased demand, and lead times across all ordering periods. Include production plans, historical performance data, and a strategy for ramping up production when necessary. Identify potential risks to delivery and outline comprehensive risk mitigation strategies, including a thorough risk assessment, mitigation approaches, and contingency plans to ensure a continuous and reliable supply. Describe the approach to inventory management, detailing how sufficient stock levels will be maintained for both regular and emergency demands, including replenishment procedures and the use of backup manufacturing sites. Supporting documentation should include inventory reports, replenishment strategies, and backup plan documentation.

Do we need full quantity on hand immediately with inventory control parameters fully aligned by the effective date or a particular percentage of the full amount? Is there a ramp-up period?

There is no requirement for the Contractor to have the full quantity on hand immediately with inventory control parameters fully aligned by the effective date of award. Each Offeror is required to submit a detailed delivery schedule, monthly manufacturing and ramp-up capabilities, and a strategy for continuous Pegfilgrastim supply and these requirements will be evaluated as part of Subfactor 2: Technical Approach.

3. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

C.5 Task 2: b 11 The Contractor shall store, hold, inventory, perform quality control management, replenish, What is the notice period we would have in advance of needing to deploy inventory? Would we only be deploy, and rotate, and transport pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) that has the FDA approved indication for treatment of hematopoietic subsyndrome of acute radiation syndrome. The Contractor is responsible for the secure safe keeping of the finished drug product. The Contractor must have the ability to deploy all Government product across the continental United States upon request.

deploying inventory to the Government’s facilities (SNS facilities) or other? If other, where would it be deployed to?

As stated in the Background Section of the Statement of Work, these assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that depletes local supplies during an emergency operation. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, the SNS ensures that the right pharmaceuticals, supplies, and equipment get to those who need them most during a public health emergency or pandemic event. It is anticipated that inventory could not only be deployed to Government (SNS) facilities but could also be deployed directly to other CONUS locations in direct support of an event. Upon notification of an emergency event, the Contractor shall deliver product within twelve (12) hours of the initial notification and make final delivery of the product within one (1) business day from the date of shipment as directed by the Government. The Government may also pickup and transport the finished drug product from the Contractor’s facility withing (2 business days) of advanced written notification to the Contractor.

4. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

C.5 Task 2: c 11 The Contractor shall possess and maintain inventory, adhere to shelf-life criteria, and provide quality control of the finished drug product as necessary in accordance with cGMP federal regulations to ensure that the Government is provided 24/7 availability of the product(s).

What is the notice period we would have to provide the Government access to the stock?

The Government shall provide at least a twenty-four (24) hours advance written notification to the Contractor prior to conducting a site visit. Statement of Work Task 3 para (a) language has been update to specify timeframe. Please refer to updated Statement of Work in RFP 75A50324R00004 Amendment 2.

5. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

C.5 Task 3: c 12 The Contractor shall be able to deliver product to a SNS identified location within the continental United States within twelve (12) hours of notification.

Is there any flexibility with the timeline?

The 12-hour notification will be doable only for certain Government locations.

All other locations would require additional time depending on the location.

As stated in the Background Section of the Statement of Work, these assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that depletes local supplies during an emergency operation. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, the SNS ensures that the right pharmaceuticals, supplies, and equipment get to those who need them most during a public health emergency or pandemic event. Due to critical nature of responding to emergency events, the Contractor shall ship the product within twelve (12) hours of the initial notification and make final delivery of the product within one (1) business day from the date of shipment as directed by the Government. Statement of Work Task 3 para (c) language has been updated to specify 12 hours “ship” and the one business day “delivery” timeframe can be located in Task 4 para (d). Please refer to updated Statement of Work in RFP 75A50324R00004 Amendment 2.

6. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

C.5 Task 4: c&d 12 c. The Contractor must store the finished drug product within the continental United States (CONUS) in one location that enable shipping to emergency sites within twelve (12) hours

These paragraphs in Task 4 seem to contradict Task 3.

of notification from the Government. The Contractor must coordinate with the receiving location, load, and start transporting the finished drug product to ASPR/SNS designated sites within twelve (12) hours of receiving a distribution directive from ASPR/SNS. The Contractor must identify, pick, package, and process paperwork for the finished drug product identified for distribution.

d. The Contractor shall make final delivery of the finished drug product to the local site(s) within the continental United States (CONUS) within one (1) business day from the date of shipment as directed by the Government.

Do we have to deliver within 12 hours of notification or shipment within 12 hours to deliver within 1 business day?

The Contractor shall ship the product within twelve (12) hours of the initial notification and make final delivery of the product within one (1) business day from the date of shipment as directed by the Government. Statement of Work Task 3 para (c) language has been updated to specify 12 hours “ship” and the one business day “delivery” timeframe can be located in Task 4 para (d). Please refer to updated Statement of Work in RFP 75A50324R00004 Amendment 2.

7. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

C.5 Task 6: n 15 The Contractor shall contact the designated SNS point of contact to schedule delivery appointments no later than forty-eight (48) hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:00

PM ET).

Solicitation language states that we are to reach out to the designated SNS contact 48 hours prior to shipping any product, but language in prior tasks state shipment within 12 hours or one business day. Which is the accurate instruction?

Statement of Work Task 6 para (n) applies to shipments destined for SNS warehouse locations. The language associated with the requirement has been updated to specify timeframe. Please refer to updated Statement of Work in RFP 75A50324R00004 Amendment 2.

8. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

C.9 c 17 Product shall have 90% of Shelf-Life remaining at time of delivery (not applicable to VMI deployment).

Solicitation language states product should have 90% of Shelf life remaining at time of delivery but previous language states 50%. Can this be clarified?

The 90% Shelf Life requirement stated in the Statement of Work C.9 para (c) relates to the Shelf Life requirement upon the procurement by the government prior to transitioning product into the VMI (as in procured under CLINs 0001, 1001, 2001, 3001 and 4001). The 50% shelf life requirement relates to the minimum shelf life of the product if/when product is ordered to be delivered out of the VMI and/or if the VMI is no longer necessary and the Government takes possession.

9. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

Please advise if amendment needs to be signed and acknowledged.

GOVERNMENT’S RESPONSE: Offerors are required to sign amendments to the subject RFP (refer to Section L.1.8, Subpart 1 of the RFP).

10. CONTRACTOR’S QUESTION:

Question Document Name Section Paragraph Page Solicitation Language

I 52.217-6 49 The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within fifteen (15) business days prior to contract expiration. Delivery of the added items shall continue at the same rate as the like items called for under the contract unless the parties otherwise agree.

Option for increased quantity doesn’t give a timeframe in which the increased quantity must be supplied. What is the expected timeline?

If the Government has a need to exercise FAR 52.217-6, the Government will notify the Contractor as specified in the clause to provide the Government with a delivery schedule and production timeline that meets the Government’s need for increased quantity.