Questions and Answerd Attachment 3-Q A 9-5-2022 Post.docx

Leidos Proprietary

ATTACHMENT 3

SOLICITATION Q & A Sheet

REQUIREMENT TITLE: SNS Pharmaceutical Bulk Buy

SOLICITATION NO. 75A50322Q00019

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:

I noticed that the “(50) 52.225-5 Trade Agreements” box is unchecked, but at the same time the “(48) 52.225-1 Buy American Supplies” is checked.

Can you confirm if this bid is only for U.S. made end products? Or are all products eligible that meet the other criteria specified in the bid?

Depending on your answer to my first two questions, will there be a preference for U.S. end made products in the award determination?

GOVERNMENT’S RESPONSE: Should be TAA compliant.

2. CONTRACTOR’S QUESTION:

On Line 17 - Oxycodone HCL 5mg/Acetaminophen 325mg Tab / 2,315,500 Eaches – there is no specific quantity noted as in other line items. Will this be for this quantity of tablets? If it is a bottle request, what is the size bottle required?

GOVERNMENT’S RESPONSE: The quantity is for tablets, and vendor can provide bottle size for determination of acceptability.

3. CONTRACTOR’S QUESTION:

· Are the quantities for each item expected to be purchased all at once or via multiple orders? All at once but shipments can be delivered at different times during the awarded period of performance.

· Does the government anticipates placing single or multiple orders for each of the items listed? The government anticipates placing a single order for each item listed.

· Does the government have a preference for unit of measure (UoM) or pack size? No preference as long as partials are not delivered.

· Will the government be open to receive items in Unit Dose (UD) form? No.

· Are the commodities and services envisioned/to be provided under this RFP expected to meet requirements under the United States Trade Agreements Act of 1979 (TAA Compliant)? Should be TAA compliant only.

GOVERNMENT’S RESPONSE:

4. CONTRACTOR’S QUESTION:

In response to RFP 75A50322Q00019 purchase of bulk pharmaceuticals, we formally request an extension to the bid due date currently set at 08/23/2022 at 2:00 pm, EST to 08/31/2022 at 2:00 PM EST.

GOVERNMENT’S RESPONSE: Updated

Due date changed to 9/30/2022.

5. CONTRACTOR’S QUESTION:

Can you please clarify the number of ship to locations?

GOVERNMENT’S RESPONSE: 7 (seven).

6. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

later than July 26, at 2 pm EST. Late submissions shall be treated in accordance with thesolicitation provision at FAR 52.212-1(f).

The RFP states that bids must be submitted by July 26. Please clarify the intended submission date.

GOVERNMENT’S RESPONSE: updated to 9/30/2022.

7. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

B.1 D.2 Pharmaceuticals List SOW Table A Pharmaceutical Product

Please provide an example NDC for the Methylprednisolone sodium succinate for injection,125mg, 2ml powder/diluent 2 chamber vial products. We only see single vial products currently available in the pharmaceutical supply chain.

GOVERNMENT’S RESPONSE: NDC: 0009-0047-22

8. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

GOVERNMENT’S RESPONSE: Should be TAA compliant only.

9. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

GOVERNMENT’S RESPONSE: No

10. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

GOVERNMENT’S RESPONSE: No.

11. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

C.5

GOVERNMENT’S RESPONSE: This Clause should not be included.

12. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

approved shelf-life remaining.

Please confirm that for purposes of this procurement expiration date is the date provided by the manufacturer on the product labeling or in its Certificate of Analysis.

GOVERNMENT’S RESPONSE: It is 80% of the expiration date per the mfr’s label on the product.

13. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

D.2 & D.3.2 D.3.3

Has Government obtained any provisional agreement from or discussed the possibility of exemptions from requirements with DEA and / or state agencies?

Has Government successfully obtained such exemptions previously?

GOVERNMENT’S RESPONSE: This language should be removed. Appears to be a copy/paste error. Deleted.

14. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

E.6 Appendix A

This acquisition is subject to the requirements of FAR Subpart 19.7 (The Small Business Subcontracting Program). A Subcontracting Plan shall be submitted by offerors who are large business concerns only. Offerors must comply with FAR 52.219-9 Small Business Subcontracting Plan (Nov. 2021).

HHS SUBCONTRACTING PLAN TEMPLATE

A Subcontracting Plan is required if the estimated cost of the contract may exceed $750,000 ($1,500,000 for construction) Small businesses are excluded.

The RFP provides two different sets of subcontracting goals. The first set is set forth in section E.6.

The second set is in Appendix A.

Can the agency clarify which set applies?

GOVERNMENT’S RESPONSE: updated

15. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

E

26-27

SECTION E - INSTRUCTIONS, CONDITIONS, AND NOTICES TO BIDDERS

SECTION E - EVALUATION FACTORS FOR AWARD

The RFP includes two Section E’s. The second version, at pages 26-27.

Is it possible to revise the RFP to eliminate the second version of Section E?

GOVERNMENT’S RESPONSE: Removed

16. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

Section E.6.b requires the offeror to provide “a breakdown of the end product demonstrating that the cost of domestic components is 100% of the cost of all components.” We have seen this language in solicitations for PPE as required by the “Make PPE in America Act.” This law is not applicable to the procurement of pharmaceuticals and request that the agency remove it from the RFP.

GOVERNMENT’S RESPONSE: This is IIJA requirement language not relevant to pharmaceuticals.

17. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

E.6

The contract form found in Section B, and the Representations and Certifications contained in Section E, of this Request for Proposal must be executed by an official authorized to bind the offeror.

This acquisition is subject to the requirements of FAR Subpart 19.7 (The Small Business Subcontracting Program). A Subcontracting Plan shall be submitted by offerors who are large business concerns only. Offerors must comply with FAR 52.219-9 Small Business Subcontracting Plan (Nov. 2021).

The HHS current subcontracting goal is 33.25% for Small Business (hereafter referred to as SB), 5.00% for Small Disadvantaged Business, including 8(a) Program Participants, Alaska Native Corporations (ANC) and Indian Tribes (hereafter referred to as SDB), 5.00% for Women-Owned Small Business and Economically Disadvantaged. Offerors shall provide past experience in meeting proposed subcontracting goals along with processes that have been implemented to correct inabilities to meet subcontracting goals will also be evaluated. Past performance in meeting or exceeding SB subcontracting goals shall be demonstrated utilizing copies of Electronic Subcontracting Reporting System (eSRS) reports. Offerors shall include most recent eSRS reports covering the last three (3) years.

The eSRS reports shall include contracts of similar size and scope to this requirement. In order to be considered for award the “successful offeror”, SHALL have a subcontracting plan that comply with HHS Agency subcontracting goals for each socioeconomic category in order to receive award. If the apparent successful offeror fails to negotiate a subcontracting plan acceptable to the contracting officer within 30 days or the time limit prescribed by the contracting officer, the offeror will be ineligible for award.

We have an approved Commercial Subcontracting Plan that already covers the legal entity that would respond to this solicitation. Our understanding is that the approved Commercial Subcontracting Plan satisfies the subcontracting plan obligation in the RFP. Please confirm that we do not need to submit an individual plan.

GOVERNMENT’S RESPONSE: That is correct.

18. CONTRACTOR’S QUESTION:

Attachment 1&2

Attachment 1&2

Can an offeror bid on a select group of items?

GOVERNMENT’S RESPONSE: The offeror may bid on as many or as few items as desired.

19. CONTRACTOR’S QUESTION:

Attachment 1&2

Attachment 1&2

Can an offeror bid less than the full quantity of a given item?

GOVERNMENT’S RESPONSE: Yes. We should ensure this is also addressed in the evaluation factors to include assumptions for administrative costs, etc. For multiple awards and also our preference is more so is quantity proposed in correlation with our requirement a factor? If not should include.

20. CONTRACTOR’S QUESTION:

Attachment 1&2

Attachment 1&2

Is it possible to clarify the product volumes as some seem exceedingly low and others exceedingly high? Albuterol volumes (total of $400 when purchased at WAC) are insignificant compared to typical market demand while others’ (e.g. Ciprofloxacin (total value of $580 million at WAC), Clindamycin (total value of $6million at WAC) requirements are well above typical market demand.

GOVERNMENT’S RESPONSE: The volumes are correct and in eaches/tabs/capsules/etc.

21. CONTRACTOR’S QUESTION:

Solicitation 75A50322Q00019

COMBINED SYNOPSIS SOLICITATION

GOVERNMENT’S RESPONSE: We agree to September 30th.

22. CONTRACTOR’S QUESTION:

D.2 Scope of Work

· Solicitation states “The quantities listed in the below table are in the lowest unit of measure, each, which is defined as a single tablet, capsule, vial, bag, tube, bottle, packet, ampule, etc.. “

· Several products have a bottle size specified in the description. Please confirm when a bottle size is specified, are eaches expressed still in tabs, mLs, grams, etc., or do the eaches now refer to number of bottles of the stated package size?

or is this expressed in tabs and requirement is 3,168 bottles of 100ct

or is this expressed in mLs and requirement would be 44,401 bottles of 100mL

· If the required package size is not stated, is there a preference for package size? No. Package size information would be required to list an NDC number and provide information on Qty in UoM

· Prefer Largest available? No preference.

· Prefer Smallest Available? No preference.

· Can we add lines to express multiple package sizes/NDCs? Yes.

23. CONTRACTOR’S QUESTION:

Attachment 1 – Business Attachment

Please provide clarity as to if units and costs expressed on the Business attachment are expressed as the lowest unit of measure (each) for all columns, or as the package price for specified size of finished good offered? (UoM Price per Product)

Is below sample correct format? Please provide pricing per tab or each. If it were to only come in bottles as lowest UoM please provide cost and state that.

Bactrim sulfamethoxazole, 800mg/trimethoprim 160mg tablets in 100 bottle

Ciprofloxacin, 250mg/5ml oral suspension, powder, 100ml bottle

Performance Period anticipated to begin September 30, 2022.

· How soon after award is SNS requesting merchandise (begin to) be received? Delivery dates can be discussed after award with the respective COR’s.

· Does SNS anticipate one PO/Shipment, if possible, or will they be issuing multiple POs throughout the year? We anticipate one delivery but multiple deliveries are acceptable.

Delivery: Delivery address on Form 1449 states Atlanta, GA

· Is this the actual delivery location? No. Delivery locations could be as many as 7 (seven) different locations (spanning from the east to the west coasts).

· Is there only one delivery location or are there multiple locations? See above.

· Will the government Prime Vendor(s) be involved in this purchase or is it a direct purchase from the manufacturer to the specified ASPR warehouse? Yes.

Packaging and Shipping Requirements

· For products with an issued NSN, product cases shall have applicable NSN annotated on case and inner packages' labels.

· These numbers are not on standard commercial bottle labels or shipper labels. Can this provision be waived if selected product will be allocated from commercial merchandise? Yes. This provision can be waived.

· NDC numbers (National Drug Code numbers must also be annotated on case and inner package labels. NDCs must use the 5+4+2 standard digit methodology (xxxxx-yyyy-zz). Leading zeros may be utilized on the 5-digit section and/or the 4-digit section and/or the 2-digit section within the NDC methodology.

· For billing or other purposes, customer, government, CMS and reimbursement software adapts and appends the NDC as required to display in an 11-digit format in computer systems by adding leading zeros where necessary. However, the 11 digit NDC numbers are not displayed on the label or within the barcode as standard manufacturer practice, and may not be technically possible without erroring-out SPL software. Please advise if this requirement can be amended to follow standard industry/FDA accepted practices. Yes. It can be amended to follow standard industry/FDA accepted practices. However, request confirmation from the Science team.

E.4 TECHNICAL EVALUATION CRITERIA; FACTOR 1 – TECHNICAL CAPABILITY: Subfactor 3: Shelf Life:

· Section D.3 Special Requirements states at time of delivery, product shall have no less than 80% of total FDA approved shelf-life remaining. In Subfactor 3, it states product shall have been manufactured within the prior three months. If these timelines do not coincide, which takes precedent? Should revise language to be consistent with the manufactured within the prior 3 months.

· What is considered “sufficient documentation” to support shelf-life claims? The vendor should state what their shelf life is upon manufacturing so we have that information.

E.6 BUSINESS PROPOSAL INSTRUCTIONS; (b) Business Proposal Cover Sheet

· How is the following requirement to be expressed? “A breakdown of the end product demonstrating that the cost of domestic components is 100% of the cost of all the components.” See response above. This should be removed.

· What is the significance of the 100% requirement? BAA- minimum standards cite domestic content threshold is currently 55% (increasing to 60% in October, 2022) See response above, BAA is not applicable.

24. CONTRACTOR’S QUESTION:

ATTACHMENT 1 Schedule, Additional Clauses, Performance Work Statement, Instructions & Evaluation Criteria (in SF 1449 format)

In other words is it all or nothing?

GOVERNMENT’S RESPONSE: No, you may bid on one or more items.

25. CONTRACTOR’S QUESTION:

ATTACHMENT 1 Schedule, Additional Clauses, Performance Work Statement, Instructions & Evaluation Criteria (in SF 1449 format)

Are all the list items to be offered needed to be “Manufactured in USA”?

What if the American manufacturer does not have capacity to supply for this requirement?

GOVERNMENT’S RESPONSE: No. Must be TAA compliant.

26. CONTRACTOR’S QUESTION:

ATTACHMENT 1 Schedule, Additional Clauses, Performance Work Statement, Instructions & Evaluation Criteria (in SF 1449 format)

> FACTOR 1-TECHNICAL CAPABILITY

> Subfactor 1: Manufacturer/Producer >C. Offerors must provide current DEA License Information.

Is DEA licensure needed, if we don’t bid on controlled medications in the list?

GOVERNMENT’S RESPONSE: DEA license is only required for controlled items.

27. CONTRACTOR’S QUESTION:

RFQ-75A50322Q00019 FY22- SNS Pharma Buy SAM.gov 8-9-2022

GOVERNMENT’S RESPONSE: POP changed to 12/15/2022-12/14/2023. If product is available immediately, it can be shipped. If not, it can be coordinated with the respective COR.

28. CONTRACTOR’S QUESTION:

Table A In reviewing the statement of work, I am confirming that there isn’t a requirement for 1L bags of saline.

Do you anticipate adding or a future solicitation for this product?

GOVERNMENT’S RESPONSE: That product is not a requirement of this solicitation.

29. CONTRACTOR’S QUESTION:

Are alternate delivery methods/presentations of these molecules accepted?

(Example: sodium chloride 100 mL bag is requested; however, our business may be able to offer the same presentation but in a vial delivery method)

GOVERNMENT’S RESPONSE: No.

30. CONTRACTOR’S QUESTION:

PR-BUSINESS ATTACHMENT 2- FY22 Bulk Pharma Buy 7-25-2022

Attachment 2 lists products with pack sizes. Can you clarify the Eaches/Quantities for the products? For example, the description for Voriconazole is “Voriconazole 200mg 30 Tablet Bottle.” Are the Quantities/Eaches listed a bottle quantity or tablet quantity? Is ASPR asking for 197,640 tablets, or 197,640 30-count bottles?

GOVERNMENT’S RESPONSE: ASPR is asking for 197,640 tablets. For items listed in Eaches the vendor shall provide the UOM for those items.

31. CONTRACTOR’S QUESTION:

PR-ATTACHMENT 1-TECHNICAL-Product and Organization Details 7-25-2022

Item 14

GOVERNMENT’S RESPONSE: Yes the Government will accept phased product delivery. Yes we are ok with phased delivery. Also the product we are seeking is the 1:100,000.

32. CONTRACTOR’S QUESTION:

PR-ATTACHMENT 1-TECHNICAL-Product and Organization Details 7-25-2022

(CLARIFY ACCEPTABLE FORMULATION)

Sterile cartridge units with Luer Lock is exclusively manufactured by Hospira. There is a national shortage of this product (https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Morphine%20Sulfate%20Injection&st=c) due to commercial demand increase for 10 mg/mL (10 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1893-01). Will government accept a 10mg/ml vials if syringes are unavailable?

GOVERNMENT’S RESPONSE: NexJect 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock (10mg/ml), NDC 0409-1893-23 to Science.

CONTRACTOR’S QUESTION:

PR-ATTACHMENT 1-TECHNICAL-Product and Organization Details 7-25-2022

GOVERNMENT’S RESPONSE: Vials (powder for solution) only.

33. CONTRACTOR’S QUESTION:

PR-ATTACHMENT 1-TECHNICAL-Product and Organization Details 7-25-2022

(CLARIFY ACCEPTABLEFORMULATION)

Does “flexi” refer to latex-free container? Will government accept only Baxter “Via- flex” package? Viaflex plastic containers contain polyvinyl chloride (PL 146) plastic. BD offers a “Free-Flex” package composed of a multi-layer polyolefin film that contains no PVC, DHEP, or natural rubber latex.

34. CONTRACTOR’S QUESTION: Not brand specific. Seeking a 100ml piggyback bag of 0.9% sodium chloride solution for injection.

Are eaches in this case individual tablets for the Clindamycin and grams for the Bacitracin? Individual tablets for the Clindamycin and Tubes for the Bacitracin. I just wanted to clarify, because typically I think of an each as a bottle or tube.

Would this volume be purchased weekly/monthly throughout the year? Possibly all at once? It will be a one-time purchase; however, the product can be delivered over the period of performance.

Would any of these units go through the prime vendor? No.

GOVERNMENT’S RESPONSE: See above.

35. CONTRACTOR’S QUESTION:

Section E page 24

The RFP states that offerors are to submit the “Representations and Certifications contained in Section E”. However, Section E of the RFP contains no such representations and certifications. Can the agency clarify what it desires offerors to submit?

GOVERNMENT’S RESPONSE: (See attached)