Questions and Answers 75A50120R00008 final.pdf

RFP 75A50120R00008

Questions & Answers: NIOSH approved (and/or FDA cleared) N95 respirators or other surgical masks/facemasks

1. Question: What does the government deem fair and reasonable pricing and will this be awarded to multiple companies?

Answer: Fair and Reasonable Pricing. Award will be made to offerors proposing prices that the agency can conclude are fair and reasonable. This is a commercial acquisition and offerors will be expected to utilize their established and published commercial market prices for the N95 Respirators as a baseline for any prices offered to the agency in this acquisition. All proposals must reference each offeror’s current established and published commercial market prices. In the event that prices offered to the agency exceed ten percent (10%) of the offeror’s current established and published commercial market prices, the offeror must submit a detailed explanation of the price increase and sufficient information to enable the agency to determine that the proposed prices are fair and reasonable. The agency reserves the right to reject any offer for which the agency has determined that the prices are not fair and reasonable. See Section L.3-52.212-1- Instructions to Offerors-Commercial Items (Oct 2018)

Awarded to multiple companies: It is the intention of the Government to evaluate proposals and award a contract or contracts without conducting discussions with contractors. The Government anticipates making a split award resulting in multiple contracts- See Section L.5- Notice of Intent to award without discussions and make multiple awards.

2. Question: How many units do you all need immediately and when do you all expect to have the 500m units available?

Answer: Offerors are to provide a proposal schedule for items that can be delivered quickly without overwhelming the supply chain during a national emergency, the Government is anticipating a split award for incremental delivery of items over a period not to exceed 18 months. See Section C.4 Contract Period.

3. Question: Apart from the reseller permit and DUNS number, are there any other special requirements for the offeror?

Answer: Offeror must be registered in SAM.gov in order to do business with the Government. Offeror is strongly encouraged to read and completely understand Sections L & M of the solicitation

4. Question: We plan to provide a quote for immediate US-based stock as well as the soon to be manufacturing, the price most likely will be different. Will you accept two separate quotes?

Answer: YES, along with an explanation for the difference in quotes.

5. Question: Are BFE99 Mask acceptable?

Answer: See the statement of work outlined in the solicitation. Also you can go to Section J- which further describes the requirements of the Mask

6. Question: Are Surgical Disposable 3 Ply Face Mask. HSN Code: 62101000?

Answer: ASPR requirement is identified in Section B of the solicitation as outlined in the

RFP#75A50120R00008.

7. Question: Are KN95 Masks FDA approved or rather approved for this procurement?

Answer: Please refer to the solicitation for requirements for an approved masks.

8. Question: In preparing proposal to submit for solicitation # 75A50120R00008, should we use the attached form or submit on our own letterhead?

Answer: You are to use the Standard Form 1449 for your response. Please refer to Section L of the solicitation for further proposal submission guidance.

9. Question: Also assuming we should state the quantities up to the amount we can supply and we may be considered for a lower quantity if not the full quantity we state can supply?

Answer: The Government's required quantity is 500,000,000.

10. Question: Do the masks have to be from TAA compliant countries even if they have the certifications? Can you explain the statement below? L.7 Trade Agreement Compliance (TAA).

The offeror must certify that the N95 Respirators are in compliance with TAA in accordance with the Federal Acquisition Regulation (FAR) 52.225-6 and are domestically manufactured.

Answer: The N95 masks must originate from countries that are TAA Compliant

11. Question: Are Non-domestic manufacturers in China eligible for this opportunity?

Answer: No

12. Question: Are Authorized resellers of N95 respirators that are manufactured in China eligible for this opportunity?

Answer: No

13. Question: Regarding three types of respirators namely, 1) NIOSH approved, 2) NIOSH approved and FDA cleared, 3) NIOSH approved with protections as described in FDA/NIOSH MOU; is there any preference or allocation of quantity for each type?

Answer: Approval and Clearances. The offeror shall provide sufficient documentation supporting the item(s) proposed are:

1) NIOSH approved,

2) NIOSH approved and FDA cleared, and

3) NIOSH approved with protections as described in FDA/NIOSH MOU

14. Question: What is the address for delivery of the respirators?

Answer: To be provided at time of award

15. Question: Based on your experience per most recent previous procurement and contracts, what cost per unit of N95 respirators is the government expecting?

Answer: The contractor is to propose a cost per unit of the N95 Respirators.

16. Question: In Section M, Page 25, subparagraph (b) states that the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. This suggests that there may be options in the requirements, but in Section B – Supplies and Services Schedule, there are no option requirements listed. Please advise how the Government intends to evaluate price?

Answer: There are no options with this requirement. Please reference sections L and M of the solicitation for price evaluation

17. Question: While we understand that the Technical volume is limited to 10 pages, does the page limit include the business proposal cover page in the count?

18. Question: On SF1449, block 10 of this solicitation, the box was checked “unrestricted” indicating it was not set-aside for small businesses, but Section I, Page 12, Clause FAR 52.219-6 has been checked indicating a total small business set aside. This creates a conflict. Kindly advise.

Answer: This solicitation is unrestricted. FAR Clause 52.219-6 was inadvertently checked and will be removed at award time

19. Question: The Solicitation appears to erroneously apply both the Buy American Act and the Trade Agreements Act to this procurement. In Section I, Page 13 FAR 52.225-1, Buy American-Supplies is checked as an incorporated clause. However, in several other places, the Solicitation states correctly that the Trade Agreements Act applies to this procurement. Section § L.7 of the Solicitation states that “[t]he offeror must certify that the N95 Respirators are in compliance with TAA in accordance with [FAR] 52.225-6 and are domestically manufactured. The Solicitation confirms that non-domestically produced supplies are eligible as long as the offeror certifies that “the N95 Respirator(s) proposed are compliant with TAA in accordance with [FAR] 52.225-6.”

Because the value of this supply contract exceeds $182,000, the TAA applies per FAR 25.402. Will the Agency correct the erroneous incorporation of FAR 52.225-1 by deleting the incorporation of that clause in Section i?

Answer: FAR Clause 52.225-1 is not applicable to this requirement and will be removed at award time. FAR clause 52.225-6 is applicable to this requirement.

20. Question: Section § L.7 of the Solicitation states that “[t]he offeror must certify that the N95

Respirators are in compliance with TAA in accordance with [FAR] 52.225-6 and are domestically manufactured. The Solicitation confirms that non-domestically produced supplies are eligible as long as the offeror certifies that “the N95 Respirator(s) proposed are compliant with TAA in accordance with [FAR] 52.225-6.” Although not an eligibility requirement, the Solicitation says that TAA-compliant products manufactured in designated countries may be evaluated as a risk factor: “The agency will also evaluate any risks of potential disruptions to the manufacturing capability based upon the location of proposed manufacturing facilities for the end product N95 Respirators, the location of proposed manufacturing facilities for critical components and the location of all supply chains and capability such as raw materials sourced, or manufacturing performed outside of the United States and the potential ramifications a pandemic may have on the supply chains or on nondomestic manufacturing sources.” Some offerors may have manufacturing facilities located both domestically and in TAA-compliant “designated countries.” May an offeror with manufacturing facilities located both domestically and in designated countries propose a hybrid approach, which includes a specific quantity subject to the certification at § L.7 and the remaining quantity manufactured in a designated country in compliance with TAA in accordance with FAR 52.225-6? If so, will the Agency revise the solicitation instructions and evaluation criteria accordingly?

Answer: See this provision L.7 Trade Agreement Compliance (TAA). The offeror must certify that the N95 Respirators are in compliance with TAA in accordance with the Federal Acquisition Regulation (FAR) 52.225-6 and are domestically manufactured. The government will accept both domestic and TAA compliant products. There is no need to revise the solicitation.

21. Question: The Solicitation requests a massive quantity (500 million) of N95 Respirators for the Strategic National Stockpile (“SNS”) at the time that the COVID-19 pandemic is impacting the United States. An order of this quantity will likely occupy substantially all of the manufacturing capacity of the contractor who receives award, making it impracticable for the contractor to accept substantial orders from other Federal agencies and state and local governments responding to the COVID-19 pandemic. Section C.1 of the Solicitation states: “When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during an emergency.” Section C.1 acknowledges that N95 Respirators are “one part of an infection control strategy” and further states that the SNS is “a national repository of large quantities of medicines, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.” A contractor whose manufacturing capacity is depleted by award of this contract may refer other Federal agencies and state, local, tribal, and territorial public health and medical systems with requirements for N95 Respirators in response to the COVID-19 emergency to submit their requirements to the Agency for fulfillment out of the SNS. Will the Agency confirm that it will consider fulfilling from the SNS requests for N95 Respirators received from other Federal agencies and state, local, tribal, and territorial governments responding to the COVID-19 pandemic? Will the Agency confirm that, after delivery of N95 Respirators by the contractor to the SNS, the Agency is responsible for the allocation, deployment, and distribution of N95 Respirators from the SNS to requesting Federal agencies and state, local, tribal, and territorial governments?

Answer: SNS will make an agency determination of allocation regarding the N95 Respirators.

22. Question: What weighting will be given to medical respirators with ASTM-rated fluid protection

(via ASTM F1862, which are identified by AORN and similar bodies as appropriate for fluid-risk procedures) vs. industrial or consumer non-medical respirators?

Answer: None

23. Question: What portion, if any, will industrial or consumer respirators (non-medical) be scoped for purchase in the bid?

Answer: None

24. Question: For the larger self-manufactured N95 producers who may produce in North America but distribute globally into front-line healthcare in dozens of countries affected by the COVID-19 outbreak, how should we prioritize the rapidly rising international demand with global healthcare workers relative to our existing US healthcare distribution and the pending potential SNS stockpile purchases?

Answer: The government does not tell a vendor how to prioritize requirement. Hence, this is a contractor’s decision.

25. Question: What is the desired timeline and stages (desired quantities and delivery timing) of the SNS, understanding that supply may need to be taken from the commercial healthcare distribution channel depending on this desired timing?

Answer: The desired timeline is 18 months to delivery 500,000,000 N95 Masks

26. Question: Will there be an opportunity to limit the award to two or three awarded companies if sufficient surge capacity is demonstrated by existing in-market companies with widely accepted N95 use in medical supplies distribution and contracting today?

Answer: The Government anticipates making multiple awards

27. Question: What will be the weighting of current market acceptability of products via national healthcare Group Purchasing Organizations and having pre-approval of their clinical approval teams for use in healthcare facilities that are members of such GPOs?

Answer: There is no weighting of current market acceptability of products. The contractor is required to fulfill the Government’s requirement.

28. Question: Will prevalence of common use among healthcare workers today be a significantly weighted decision factor? In particular, will preference be given to market leaders whose products are used in many or most hospitals and healthcare facilities, potentially limiting massive burden of fit testing products that are relatively new or underpenetrated in the healthcare facilities today?

Answer: No preference will be given

29. Question: With 3M so prominently and publicly engaged with the White House task force, what steps will be taken to demonstrate balanced merit scoring of competitive bids?

Answer: All proposals will be evaluated in accordance with Sections L and M.

30. Question: Is it feasible to win a sole source award if one company can demonstrate it can provide the entire volume in a market-acceptable format (e.g. surgical N95 respirators), thus standardizing the national formulary?

Answer: The Government anticipates multiple awards.

31. Question: Do the N95 respirators need to contain a vent or will the Respirators without a vent suffice?

Answer: Please refer to the Statement of Work and the Memorandum of Understanding located in Section J of the solicitation.

32. Question: Due to the current inflation of these masks, is there a ceiling price that the government is willing to pay for a box (100 count) of masks?

Answer: The government is willingly to pay a fair and reasonable price as outlined in Sections L and M of the solicitation.

33. Question: What is the address for delivery of the respirators?

Answer: The address for delivery will be provided at time of award.

34. Question: How many vendors will be selected for such procurement of N95 respirators?

Answer: The government anticipates multiple awards

35. Question: Would the government take a lower volume than the requested 500million?

36. Question: Are Surgical Disposable 3 Ply Face Mask. HSN Code: 62101000 acceptable?

Answer: Refer to the Statement of Work and Section J- Memorandum of Understanding for acceptable N95 masks

37. Question: Will the government consider extending the lead-time of 12-18 months to allow domestic manufacturers of N95 respirators time to build required automated manufacturing equipment in order to increase overall capacity to produce these respirators?

38. Question: What is the difference between the FDA cleared respirator listed in the description in 2i and the Surgical N95 listed in 2i bullet number 1?

Answer: Refer to the Statement of Work and Section J- Memorandum of Understanding for acceptable N95 mask

39. Question: Section B of the solicitation calls out a fixed price line item. It is not possible to provide various types of respirators in fixed price line item format. We will provide costing for each item we submit.

Answer: This is a firm fixed price contract

40. Question: Will longer use by dates (shelf life) be important considerations when selecting the vendor?

Answer: Please refer to Section L and M

41. Question: In the description in C2a you call out a single use N95 FFR. Single use can be interpreted as one time use or the use of a single respirator in a typical 8 hour day. What consideration will be given if a respirator can be shown to last longer over an 8 hour day thereby saving costs thru lower overall consumption?

Answer: No consideration will be given.

42. Question: Is the RFI worksheet still required to be submitted with the proposal? It was referenced in the RFI Personal Protective Equipment (Notice ID 75A50120R9999)? Or is this a completely difference notice?

Answer: No. 75A50120R00008 is the official solicitation for this requirement.

43. Question: Can product be bought in non-domestic/non-TAA if enough product is not available for purchase in compliant countries approved by SNS?

44. Question: It is stated on page 4 paragraph C.5 that mixed lots will not be accepted unless approved by SNS. Question: If approval is granted will SNS state their approval for mixed lots in the original contract award?

Answer: Yes.

45. Question: As listed on page 4 C.5 are TyHi stack pattern an industry known form of stacking?

Answer: Yes it is a pattern known for logistical pallet configuration. Your pallet configuration data is composed of: the type and the size of the pallet you are using, the stacking pattern as well as the rotation of layers you will opt for, the type of packaging of your product (boxes or bags) and finally the number of items per row and per pallet

46. Question: According to page 20 section E, #3 NIOSH approved, NIOSH approved and FDA cleared, NIOSH approved with protections as described in FDA/NIOSH MOU are all three different type of mask and either of the three can be provided by the vendor?

Answer: Approval and Clearances. The offeror shall provide sufficient documentation supporting the item(s) proposed are:

1) NIOSH approved,

2) NIOSH approved and FDA cleared,

3) NIOSH approved with protections as described in FDA/NIOSH MOU