W911SR23R0009_Amendment 0001_ResponsesToQuestions.pdf

Responses to Contractor Ques ons, W911SR23R0009

1. Would the Government extend the response due date?

Response: Not at this me

2. Who is execu ng this mission/effort currently?

Response: There is no incumbent.

3. Is this a new requirement or a recompete to an exis ng contract?

Response: This is a new requirement.

4. If a recompete, can the government provide the current contract informa on?

Response: This is not a recompete.

a. What company is it?

b. What is the contract number of the current contract?

c. What is the period of performance of the current contract?

d. What is the value of the current contract?

e. How many personnel work on this contract?

i. What are their tles, skills, training and cer fica ons?

ii. How many hours do each of them work?

f. How large is the storage area used for this contract?

g. What are the minimum and maximum requirements for storage by type?

i. Controlled room temperature (+20ºC to +25ºC).

ii. Refrigerated temperature (+2ºC to +8ºC).

iii. Freezer temperature (‐20ºC to ‐10ºC (±10ºC)).

iv. Ultra‐low temperature (‐80ºC (±10ºC)).

h. If it is an IDIQ ‐ What is the throughput/velocity of task orders on the contract?

5. If it is a Government en ty:

Response: There is no incumbent, Government or otherwise

a. What is the number of personnel assigned to this effort?

i. What are their tles, skills, training and cer fica ons?

ii. How many hours do each of them work?

b. How large is the storage area used?

c. What are the minimum and maximum requirements for storage by type?

i. Controlled room temperature (+20ºC to +25ºC).

ii. Refrigerated temperature (+2ºC to +8ºC).

iii. Freezer temperature (‐20ºC to ‐10ºC (±10ºC)).

iv. Ultra‐low temperature (‐80ºC (±10ºC)).

6. Is there a loca on that the USG requires the proposed warehouse to be located?

Response: Contractor facility shall be in the Con nental United States.

7. What is the expected term of this IDIQ? (i.e., is it a 5yr base + 5yr op on period, or how is that broken up?)

Response: As the solicita on states, one base five‐year ordering period and one op onal five‐ year ordering period.

8. What is the expected Period of Performance start date?

Response: The Government is an cipa ng an award in mid‐September

9. On page 15 of the solicita on, under 52.212‐2 EVALUATION‐‐COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021), Past Performance it states, “Past performance

The Government will evaluate past performance. To receive an acceptable ra ng the offeror must demonstrate all of the below items.

a. Past Performance shows experience in storing, distribu ng and disposing of drug or pharmaceu cal materials in each of the condi ons specified in Appendix C.

b. Past Performance evalua ons show no assessments evaluated lower than “Sa sfactory”.”

a. If the contractor does not have specific Past Performance showing experience in storing, distribu ng, and disposing of drug or pharmaceu cal materials but does have broad and expansive experience in storing, distribu ng and disposing of other types of material including HAZMAT, will they s ll be considered viable (i.e., considered “Sa sfactory”) in compe ng for this opportunity?

Response: The Government has reviewed the past performance evalua on criteria and made changes to align with the instruc ons to offerors sec on allowing past performance on similar products to also be included. See revised provision of 52.212‐

2.

10. On page 26 of the Solicita on, Performance Work Statement (PWS), Paragraph 1.0 Background and Purpose, it states, ”The objec ve of this effort is to receive, store, inventory, distribute, and dispose of government owned pharmaceu cal‐related material, such as vaccines and drugs that are subject to regula ons administered by the US Food and Drug Administra on (FDA), the

United States Pharmacopeia (USP), and other federal agencies. Such pharmaceu cal material may include, but is not limited to, vaccines, drugs, biologics, laboratory samples, reagents, or clinical samples.”

On page 27 of the Solicita on, Performance Work Statement (PWS), Paragraph 4.0

Requirements, it states, ”The Contractor shall have all appropriate Drug Enforcement Agency registra ons/ licenses/ permits as well as import/export licenses to store and distribute all vaccines/drugs to include any controlled substances.

a. What are the specific cer fica ons and or training courses the contractor needs to have from the FDA, USP, or other Federal or state agencies to execute this contract?

Response: Go to the following website for cer fica ons, h ps://www.cdc.gov/vaccines/hcp/admin/storage/index.html

b. What are the specific licenses the contractor needs to have from the DEA or other

Federal or state agencies to execute this contract?

Response: Go to the following website for licenses, h ps://deadiversion.usdoj.gov/index.html

c. What are the specific permits the contractor needs to have from the DEA or other

Federal or state agencies to execute this contract

Response: Go to the following website for federal permits, h ps://deadiversion.usdoj.gov/index.html. Offerors shall follow the regula ons of their respec ve state.

d. What are the specific import/export licenses the contractor needs to have from Federal or state agencies to execute this contract?

Response: Go to the following website for federal permits, h ps://deadiversion.usdoj.gov/index.html. Offerors shall follow the regula ons of their respec ve state.

11. On page 26 of the Solicita on, Performance Work Statement (PWS), Paragraph 2.0 Scope, it states, ”Under this Indefinite Delivery/Indefinite Quan ty (ID/IQ) contract the Government will issue task orders for material described above.”

a. Will the Government provide a prospec ve lis ng of task orders they expect to place on this IDIQ?

Response: No. The Government does not have a list of expected task orders.

b. If not, is there an historical lis ng of task orders or material that would likely be placed on this IDIQ as task orders?

Response: This is a new requirement and as such there is no historical lis ng of task orders.

c. What are the expected number of Task Orders per year?

Response: The Government does not have an es mated number of task orders per year.

12. On page 28 of the Solicita on, Performance Work Statement (PWS), Paragraph 4.2. Storage, subparagraph 4.2.4., it states, ”The Contractor’s facili es and/or associated equipment such as refrigera on units/freezers shall be qualified/validated and maintained in a fully opera onal condi on.”

a. To what organiza on should the contractor go to qualify/validate their refrigera on units/freezers?

RESPONSE: In regards to this requirement, qualifying and valida ng equipment refers to ensuring that the equipment maintains the opera onal temperature as specified by the manufacturer. The Government is not manda ng what service or method the

Offeror u lizes to do this and it is the Offeror’s responsibility to seek a service provider that qualifies and validates equipment. The Government is only concerned that the

Offeror’s equipment is func oning to the required temperatures to avoid loss or damage to products due to temperature exceedances.

13. On page 28 of the Solicita on, Performance Work Statement (PWS), Paragraph 4.2. Storage, subparagraph 4.2.5., it states, "The contractor is responsible for ensuring back‐up refrigerators are available..."

a. Is it the governments intent that the contractor have 1:1 backups available on‐hand at all mes, or what is the expected ra o?

Response: The Government is not specifying the number or types of back‐up equipment. The Government requires that the contractor have sufficient capabili es to ensure that the stored product will not be rendered unusable due to equipment breakdowns.

14. Appendix B Storage Temperature and Approximate Annual Space Requirements:

a. What percentage of this space does the government expect to be in use at any given me?

Response: Space requirements provided within the solicita on are the minimum requirements.

b. How confident is the government that these space requirements will hold true for the dura on of the IDIQ?

Response: The Government is confident that the minimum space requirements stated in the solicita on will not change.

c. Should these requirements change and the government end up needing more space, would the government approve of contractor u lizing an alternate site, or is everything required to be maintained at the same site?

Response: We cannot speculate as to what changes could arise and how they would be addressed. If, a er contract award, the Government’s needs change, we will work with the selected awardee to address the changes in accordance with the terms of the contract.