RFP 75A50326R00007 - Qs and As.pdf

ATTACHMENT 2 – QUESTIONS AND ANSWERS

Solicitation 75A50326R00007 – FY26 SNS Pharmaceutical Logistic Replenishment

No. Solicitation Reference Offeror Questions Government Answers 1 RFP §D.3.2(C); Section E, M-3 May an Offeror satisfy the requirement to be a manufacturer or authorized distributor/reseller through a licensed pharmaceutical subcontractor that will procure, store, and ship the offered products directly, or must the prime Offeror itself be licensed/authorized as the manufacturer, distributor, or reseller?

The reseller, distributor, subcontractor, and Prime Offeror must be a licensed/authorized manufacturer, distributor, or reseller, as applicable to the role and regulated activities each entity will perform under the contract.

The Prime Offeror remains responsible for ensuring that all entities performing under their proposed arrangement maintain the licenses, registrations, and authorizations required by the solicitation and applicable law.

2 RFP §D.3.2(C); Section E, M-3 The solicitation refers to an authorized distributor/reseller having a “current FDA license.”

Please identify the specific license, registration, state wholesale drug distributor license, FDA wholesale drug distributor reporting evidence, or other documentation the Government will accept as satisfying this requirement.

The reference to a “current FDA license” means evidence of the applicable, current FDA establishment registration and/or drug listing required for the activities and pharmaceutical products being offered.

Where FDA registration or listing applies to an Offeror, manufacturer, authorized distributor/reseller, or other entity performing the regulated activity, the Government will accept documentation demonstrating the applicable current registration and/or listing. Where an entity or activity is not subject to FDA establishment registration, the Offeror should provide documentation demonstrating authorization to distribute or resell the offered pharmaceutical product and any applicable federal or state licenses, registrations, or other authorizations required for the activities it will perform.

State wholesale drug distributor licensing requirements are separate from FDA registration requirements.

Offerors and their proposed distributors/subcontractors remain responsible for maintaining all licenses, registrations, and authorizations required by applicable federal, state, and local law for the activities they perform under the contract.

3 RFP §D.3.2(C); Section E, M-3 Because final Strategic National Stockpile delivery locations will not be disclosed until after award, what state wholesale drug distributor licenses must an Offeror possess at

Because final Strategic National Stockpile (SNS) delivery locations will not be disclosed until after award, Offerors are not expected to possess wholesale drug distributor licenses in every potential

No. Solicitation Reference Offeror Questions Government Answers proposal submission and/or award?

May applicable destination-state licenses be held by the performing pharmaceutical distributor/subcontractor?

destination state solely for purposes of proposal submission or contract award.

The Contractor is responsible for ensuring that all required federal, state, and local licenses, registrations, permits, and other authorizations applicable to the distribution and delivery of pharmaceutical products are in place before performing the regulated activity in the applicable jurisdiction. Where permitted by applicable law and the terms of the solicitation/contract, required destination-state wholesale drug distributor licenses may be held by the pharmaceutical distributor or subcontractor that will actually perform the licensed distribution activity. The Prime Contractor remains responsible for ensuring that its proposed distribution arrangement and all entities performing regulated activities comply with applicable licensing requirements throughout contract performance.

4 RFP Controlled Substance Requirements; Section E, M-3

If a DEA-registered pharmaceutical subcontractor will procure, store, and ship all controlled substances directly and the prime Offeror will never take physical possession of those products, must the prime Offeror separately hold the applicable DEA distributor registration(s)? Please also confirm that an Offeror proposing only non-controlled pharmaceutical CLINs is not required to hold a DEA registration for this procurement.

A DEA registration is required for a manufacturer, reseller, distributor, subcontractor, or Prime Offeror only to the extent that the entity's activities involving controlled substances require that registration. An Offeror proposing only non-controlled pharmaceutical CLINs is not required to hold a DEA registration solely for those items.

5 Section E – Factor 2, Past Performance; Attachment 4

May the Government consider relevant past performance of a major pharmaceutical subcontractor and/or relevant pharmaceutical stockpile, inventory-management, and logistics experience of the Offeror’s principals/key personnel when evaluating Factor 2, or is Factor 2 limited solely to contracts performed by the legal Offeror?

Reference Section E, Factor 2, Past Performance

The Offeror that is providing the proposal should submit two recent and relevant contract or project examples that they have performed within the three years preceding the solicitation closing date.

If an Offeror has no relevant past performance, state "None." An Offeror without relevant past performance will receive a Neutral rating and will not be evaluated favorably or unfavorably on that basis.

6 Attachment 3; Section E.6; FAR 52.225-1 and 52.225-2

Attachment 3 requests information concerning both Trade Agreements Act (TAA) and Buy American Act (BAA) compliance, while the

The Government acknowledges the questions regarding the applicability of the Trade Agreements Act (TAA) and Buy American Act (BAA) requirements.

solicitation expressly includes the Buy American provisions/clauses.

Please confirm whether TAA compliance/certification applies to this solicitation and identify the controlling clause(s).

We see that FAR 52.225-1 and FAR 52.225-2 are mentioned.

Please confirm that the government will only accept products that are Made in America and does not want TAA-compliant?

In light of the value of this solicitation and any contracts to be awarded pursuant to it, please provide the basis for the inclusion of RFO FAR 52.225-1 and RFO FAR 52.225-2 in the solicitation, instead of RFO FAR 52.225-5 and RFO FAR 52.225-6.

RFP Attachment 3 asks offerors to state whether their products are both Trade Agreement Act (TAA) and Buy American Act (BAA) compliant.

Please provide the basis for asking offerors to apply both the TAA and BAA requirements to their offered products—as opposed to either the TAA or the BAA.

FAR 52.225-1, Buy American—Supplies, and FAR 52.225-2, Buy American Certificate, are included in the RFO and govern the Buy American requirements applicable to this solicitation.

The references in Attachment 3 to TAA and BAA compliance are intended to obtain information regarding the country of origin and compliance status of the products being offered and should not be interpreted as imposing an additional TAA requirement unless applicable TAA requirements are expressly incorporated into the RFO.

Offerors should identify the country of origin and applicable BAA/TAA compliance status for the products proposed, as requested in Attachment 3.

The Government will amend the solicitation, if necessary, to address any inconsistency between Attachment 3 and the clauses incorporated into the

RFO.

7 Section B.3, Table B.3-1;

Attachment 5

Section B.3 identifies CLINs 0001 through 0021, while Attachment 5 contains pricing lines numbered 1 through 26. Please confirm that only the 21 CLINs identified in Table B.3-1 are applicable and advise how pricing lines 22 through 26 should be completed.

Only the 21 CLINs identified in Table B.3- 1 are applicable. Attachment 5 has been updated to remove lines 22 through 26.

8 Section B.5; FAR 52.217-6;

Attachment 5

Section B.5 states that the solicitation contains no option periods and permits an increase of up to 20 percent under FAR 52.217- 6; however, Attachment 5 contains four separate Optional Quantity sections. Please clarify how Optional Quantity 1 through 4 should be completed and whether a revised pricing template will be issued.

This solicitation is for a one-year contract and does not include any option periods. The Optional Quantity sections in Attachment 5 do not represent additional periods of performance or option years.

In accordance with Section B.5 and FAR 52.217-6, the Government may increase the quantity of supplies ordered by up to 20 percent during the contract period.

Offerors should complete the base quantity pricing in Attachment 5.

Optional Quantity 1 through 4 are not applicable and should be left blank.

9 Section B / Delivery Requirements; FOB Destination

Because exact SNS delivery locations and allocation quantities will not be disclosed until after award, please explain how Offerors should develop firm-fixed FOB Destination pricing, particularly for potential deliveries to Hawaii. Will the Government provide an estimated geographic distribution, delivery allocation, or other pricing assumption?

Will the Government provide estimated allocation percentages/ shipment volumes among the nine SNS locations as well as general locations? Can ASPR clarify whether deliveries to Hawaii are expected under every awarded CLIN or only selected products?

Hawaii is one of the potential SNS delivery locations; however, the Government is not stating that Hawaii will receive product under every award.

Offerors shall submit firm-fixed-price, FOB Destination pricing that accounts for the possibility of delivery to Hawaii. No separate post-award shipping charge will be permitted solely because the Government directs delivery to Hawaii.

The Government will not provide estimated allocation percentages or shipment quantities among the nine SNS locations for proposal-pricing purposes.

Exact ship-to locations and quantities will be provided after award, as applicable.

Unless a particular CLIN specifically states otherwise, Offerors should develop their pricing assuming that any awarded product may be directed to Hawaii.

10 Section B.3; Packaging and Shipping Requirements

The Government states quantities in the lowest unit of measure while also requiring shipment in full cases and prohibiting partial cases. If a manufacturer’s standard case configuration does not divide evenly into the stated Basic Required Quantity, should the Offeror propose the next full-case quantity, or will another method be permitted?

Offerors shall provide the case configuration for the NDC being proposed, including the number of individual units (“eaches”) contained in each full case.

The Government recognizes that a manufacturer's standard case configuration may not divide evenly into the Basic Required Quantity the vendor should round down into next full case quantity.

11 CLIN 0014; Table B.3-1 For CLIN 0014, Midazolam HCl Injection 5 mL, the Basic Required Quantity is stated as 31,285 with UOM “BX,” although the product description identifies a multidose vial. Please confirm whether 31,285 represents individual vials, manufacturer boxes, or another packaging configuration, and identify the required number of vials per box if “BX” is the intended unit of measure.

For CLIN 0014, the intended Lowest Unit of Measure is the individual vial, with 10 vials per box. Then we would need the case count of how the boxes are in each case. Offerors shall provide the manufacturer's case configuration for the NDC proposed, including the number of boxes contained in each full case.

12 CLIN 0005; Table B.3-1 For CLIN 0005, Morphine Sulfate Injection, the product is described as a prefilled syringe but the UOM is shown as “VI.” Please confirm

Yes. For CLIN 0005, Morphine Sulfate Injection, prefilled syringe, the intended Lowest Unit of Measure (UOM) is “SYR.”

The Basic Required Quantity of 137,000 whether the Basic Required Quantity of 137,000 represents individual prefilled syringes and whether “VI” is the intended UOM code.

represents 137,000 individual prefilled syringes. Offerors should provide the case configuration for the NDC proposed, including the number of individual prefilled syringes contained in each full case.

13 Section D – Shelf-Life Requirements; Attachment 3

The solicitation requires pharmaceutical products to have at least 90 percent of total FDA-approved shelf life remaining upon receipt at the SNS location. Please confirm how the Government will calculate the 90-percent requirement for products whose FDA-approved or manufacturer-labeled shelf life may vary by NDC/manufacturer, and what documentation the Offeror must submit with the proposal or shipment to demonstrate compliance.

Products shall be delivered to the designated SNS location with no less than 90 percent of the total FDA-approved or manufacturer-labeled shelf life remaining at receipt. The requirement will be calculated using the total approved/labeled shelf life applicable to the specific NDC and manufacturer offered.

When 90 percent does not result in a whole number of months, the minimum required remaining shelf life will be rounded down to the nearest whole month. For example:

36-month total shelf life × 90% = 32.4 months, rounded down to 32 months.

Therefore, the product must have at least 32 months of shelf life remaining at receipt.

24-month total shelf life × 90% = 21.6 months, rounded down to 21 months.

Therefore, the product must have at least 21 months of shelf life remaining at receipt.

Offerors shall identify the proposed NDC and manufacturer and provide any shelf-life documentation expressly required by the solicitation. At delivery, product labeling, expiration date, lot information, and/or applicable shipment documentation must demonstrate compliance.

14 Section D – Delivery/Logistics Requirements

Please confirm whether an Offeror may use its licensed pharmaceutical distributor/subcontractor and qualified third-party logistics carriers to perform direct-to-SNS delivery, temperature-controlled transportation, lot/expiration controls, recall support, and related fulfillment activities, while the prime remains responsible for overall contract management and compliance. If permitted, please identify any specific subcontractor, carrier, or logistics documentation

Yes. Offerors may utilize appropriately licensed and qualified pharmaceutical distributors, subcontractors, and third-party logistics (3PL) carriers to support direct-to-SNS delivery and related fulfillment activities, including temperature-controlled transportation, lot and expiration-date controls, recall support, and other required distribution activities, provided such arrangements comply with the requirements of the solicitation and all applicable federal, state, and local laws and regulations.

that must be included with the proposal.

The Prime Contractor remains responsible for overall contract performance and for ensuring that its subcontractors, distributors, and carriers comply with all applicable contract requirements, including product integrity, storage and transportation conditions, chain of custody, lot and expiration-date traceability, delivery requirements, and recall support.

Offerors shall identify proposed distributors, subcontractors, or logistics providers and submit the documentation expressly required by the solicitation (Reference SOW Section D.6.s). Unless otherwise specifically required by the solicitation, detailed carrier-specific documentation for individual shipments is not required with the proposal.

Specific SNS delivery addresses will be provided by the Government as applicable. The Contractor is responsible for ensuring that all required licenses, registrations, permits, transportation capabilities, and other authorizations necessary to perform delivery to the designated SNS locations are maintained throughout contract performance.

15 B.3 Schedule of Pharmaceutical Items

Table B.3-1

CLIN 0015 specifies “0015 O Oxycodone hydrochloride/ acetaminophen, 5mg/325mg (tablet, bottle, 100s)

BT 2,162,550”

CLIN 0017 Q

Amoxicillin/Clavulanate 500mg/125mg tablets (100 tablets/bottle)

BT 570,000

Please confirm that the government is asking for 2,162,550 bottles, with each bottle containing 100 tablets?

(Which would be 216,255,000 tablets)

Please confirm if the volumes stated for these two CLINs are in tablets, or are in Finished Dose Bottles of 100’s.

For CLINs 0015 and 0017, the Lowest Unit of Measure (UOM) is a tablet, and the Basic Required Quantities are stated in tablets, not bottles. Each bottle contains 100 tablets. Offerors shall provide the manufacturer’s case configuration for the NDC proposed, including the number of 100-tablet bottles contained in each full case.

Accordingly, the Basic Required Quantities for CLINs 0015 and 0017 should be interpreted as 2,162,600 tablets and 570,000 tablets, respectively.

16 RFP Section B.3

The Government may make separate awards by item, and the basic required quantity of an individual item will not be split among multiple contractors.

Given the Government's intent to make awards by individual pharmaceutical item and potentially make multiple awards, can ASPR clarify whether the acquisition strategy is intended to encourage direct manufacturer participation, or whether authorized distributors/resellers will be evaluated on an equal basis provided

The Government does not intend to limit participation to direct manufacturers.

Authorized distributors and resellers may submit offers, provided they meet all applicable solicitation requirements, including technical, regulatory, supply, and other stated requirements. Offers will be evaluated in accordance with the evaluation criteria established in the solicitation.

they meet all technical, regulatory, and supply requirements?

17 RFP Section B.3

For each item offered, the Offeror shall submit a firm-fixed unit price and extended price in RFP Attachment 5 – Price/Business Template. The awarded unit price will apply to the basic quantity and to any increased quantity exercised under Section B.5 and

FAR 52.217-6.

Given the 12-month ordering period and the possibility of deliveries occurring throughout contract performance, would ASPR consider incorporating an Economic Price Adjustment (EPA) provision for products subject to documented manufacturer price increases that occur after contract award and are beyond the contractor's control?

ASPR does not intend to incorporate an Economic Price Adjustment (EPA) provision. Offerors should submit pricing that accounts for the 12-month ordering period and the anticipated timing of deliveries throughout contract performance.

18 SOW Section D.3

The contractor must provide brand name or equal product for the pharmaceuticals listed in Table B.3-1 above.

May offerors propose alternative NDCs for the same active ingredient, strength, dosage form, and package configuration during performance if market shortages occur?

Yes, subject to prior Government review and approval. The primary NDC proposed by the Offeror and accepted by the Government must be used initially upon award.

If the awarded NDC becomes unavailable or is affected by a market shortage or other supply constraint, the Contractor may request approval to provide an alternate NDC. The alternate NDC must be approved before delivery and satisfy all applicable solicitation and contract requirements, including product specifications, FDA approval/status, packaging, shelf life, storage, and transportation. Until the Government authorizes a substitution, the Contractor remains obligated to provide the primary NDC accepted at award.

19 Proposals are due by September 18, 2026, at 5:00 p.m. (EST).

Considering the size and scope of this requirement, would ASPR consider extending the proposal deadline to allow offerors adequate time to develop a response?

The proposal submission deadline will be extended to 22 September 2026 at 1:00pm EST.

20 B – Supplies or Services and Prices/Costs

Basic Required Quantity (Lowest UoM)

For CLIN 0021, the Government requests 140,000 tablets; however, the product is packaged and sold in cases containing 6,000 tablets.

Because the requested quantity is not divisible by the case quantity, would the Government accept a quantity based on full-case increments? If so, should vendors quote 138,000 tablets (23 cases) or 144,000 tablets (24 cases)?

Does the basic required quantity identified under the “Lowest UoM” represent the quantity required at each individual SNS delivery site, or the total quantity required across all nine SNS sites?

The Basic Required Quantity identified under after award:

Offerors shall provide the case configuration for the NDC being proposed, including the number of individual units (“eaches”) contained in each full case. The Government recognizes that a manufacturer's standard case configuration may not divide evenly into the Basic Required Quantity the vendor should round down into next full case quantity.

For example, for CLIN 0021, is the requested quantity of 140,000 tablets the total requirement to be allocated among the nine sites, or should vendors anticipate providing approximately 140,000 tablets to each site?

21 For each item offered, the Offeror must provide a proposed month-by-month delivery schedule and corresponding quantities using RFP Attachment 3 – Technical Template Tab.

The Government will evaluate the proposed schedule in accordance with Section E.

The final delivery schedule for each awarded item will be incorporated into the resulting contract or established through written delivery instructions consistent with the awarded schedule. All basic and increased quantities must be ordered within the 12-month ordering period and delivered within the applicable delivery dates established by the contract or written delivery instruction.

Will the Government permit a production or ramp-up period before deliveries begin? Specifically, would delivery commencing within 90 days after receipt of order (ARO) be acceptable?

To comply with the requirement that products have at least 90% of their shelf life remaining upon receipt, manufacturers may need to produce new inventory, which could take up to 90 days. After this ramp-up period, the vendor would have sufficient inventory to fulfill the basic required quantity and any exercised quantity increase of up to 20%.

Offerors may propose a production or ramp-up period, including a proposed delivery schedule under which initial deliveries commence within 90 days after receipt of award. The proposed ramp-up period and delivery schedule will be evaluated by the Government in accordance with Section E.

If accepted, the Offeror’s proposed delivery schedule will serve as the basis for the final delivery schedule for the awarded item and will be incorporated into the resulting contract or established through written delivery instructions, as applicable.

Accordingly, a proposed schedule providing for initial delivery within 90 days award may be acceptable, subject to the Government’s evaluation and acceptance of the proposed schedule and the Offeror’s ability to meet all applicable solicitation requirements.

Products must still meet the solicitation’s requirement for no less than 90 percent of the total FDA-approved or manufacturer-labeled shelf life remaining at receipt.