W911SR23R0009_Amendment 0001_ResponsesToQuestions_Revised08.29.2023.pdf

Responses to Contractor Questions, W911SR23R0009

1. Would the Government extend the response due date?

Response: Not at this time

2. Who is executing this mission/effort currently?

Response: There is no incumbent.

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

Response: This is a new requirement.

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

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 titles, skills, training and certifications?

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 entity:

Response: There is no incumbent, Government or otherwise

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

i. What are their titles, skills, training and certifications?

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 location that the USG requires the proposed warehouse to be located?

Response: Contractor facility shall be in the Continental United States.

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

Response: As the solicitation states, one base five‐year ordering period and one optional five‐ year ordering period.

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

Response: The Government is anticipating an award in mid‐September

9. On page 15 of the solicitation, 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 rating the offeror must demonstrate all of the below items.

a. Past Performance shows experience in storing, distributing and disposing of drug or pharmaceutical materials in each of the conditions specified in Appendix C.

b. Past Performance evaluations show no assessments evaluated lower than “Satisfactory”.”

a. If the contractor does not have specific Past Performance showing experience in storing, distributing, and disposing of drug or pharmaceutical materials but does have broad and expansive experience in storing, distributing and disposing of other types of material including HAZMAT, will they still be considered viable (i.e., considered “Satisfactory”) in competing for this opportunity?

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

2.

10. On page 26 of the Solicitation, Performance Work Statement (PWS), Paragraph 1.0 Background and Purpose, it states, ”The objective of this effort is to receive, store, inventory, distribute, and dispose of government owned pharmaceutical‐related material, such as vaccines and drugs that are subject to regulations administered by the US Food and Drug Administration (FDA), the

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

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

Requirements, it states, ”The Contractor shall have all appropriate Drug Enforcement Agency registrations/ 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 certifications 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 certifications, https://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, https://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, https://deadiversion.usdoj.gov/index.html. Offerors shall follow the regulations of their respective 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, https://deadiversion.usdoj.gov/index.html. Offerors shall follow the regulations of their respective state.

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

a. Will the Government provide a prospective listing 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 listing 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 listing of task orders.

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

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

12. On page 28 of the Solicitation, Performance Work Statement (PWS), Paragraph 4.2. Storage, subparagraph 4.2.4., it states, ”The Contractor’s facilities and/or associated equipment such as refrigeration units/freezers shall be qualified/validated and maintained in a fully operational condition.”

a. To what organization should the contractor go to qualify/validate their refrigeration units/freezers?

RESPONSE: In regards to this requirement, qualifying and validating equipment refers to ensuring that the equipment maintains the operational temperature as specified by the manufacturer. The Government is not mandating what service or method the

Offeror utilizes 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 functioning to the required temperatures to avoid loss or damage to products due to temperature exceedances.

13. On page 28 of the Solicitation, 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 times, or what is the expected ratio?

Response: The Government is not specifying the number or types of back‐up equipment. The Government requires that the contractor have sufficient capabilities 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 time?

Response: Space requirements provided within the solicitation are the minimum requirements.

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

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

c. Should these requirements change and the government end up needing more space, would the government approve of contractor utilizing 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, after 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.

15. The workbook Excel has lines asking for pricing for refrigerated, freezer and ultra‐low temperatures in addition to the controlled room temperature. However, the storage for TPOXX is at controlled room temperature. Are we only supposed to complete the TPOXX worksheet out of the 3 worksheets?

Response: Offerors shall complete all three worksheets for the response to this solicitation.

The Price Evaluation Worksheet will be used to establish the total evaluated price for evaluation purposes. The TPOXX worksheet will be used to establish the initial task order issued under the resultant ID/IQ. The IDIQ Price Sheet will be used to establish baseline pricing for storage distribution and disposal orders issued under the ID/IQ.

16. Should we also provide pricing for other temperatures based on Appendix B?

Response: No. The Government pricing will be based on the temperature ranges listed in Appendix B only.

17. Will Army personnel be picking up the shipments from our facility or should be assume we will use a courier.

Response: Each task order issued will specify the method of distribution.

18. The shipping box we use is more advanced than the Sonoco box with gel packs. Our proposed box can maintain temperature better than the Sonoco box. Is this acceptable?

Response: The Government has amended the TPOXX Task Order SOW to accommodate equivalent shipping boxes to the one specified by the Government.