Ondansetron 4MG and 8MG

Amendment / Modification

• This amendment cancels the subject solicitation in its entirety.

• The entire solicitation is affected.

• All previous deadlines and requirements for proposal submission are nullified due to the cancellation of the solicitation.

Amendment / Modification

This amendment modifies solicitation SPE2D223R0007 to update packaging and extend the closing date.

• Packaging Update: The Unit of Measurement for CLINs 0005AA-0005AE and 0007AA-0007AE has been changed from "BX" (Boxes) to "BX/BT" (Boxes/Bottles).

• Trade Agreements Chart Update: The Trade Agreements chart on page 38 has been updated for CLIN 0005 and CLIN 0007 to reflect "unit dose box/bottle" instead of "unit dose box."

• Price Proposal Updates: The Price Proposal section (Volume 2, page 40) has been updated to reflect pricing for "bottles" instead of "boxes" for CLIN 0002, 0005, and 0007.

• Line Item Updates: Line Items 0002, 0005, and 0007 on page 71 have been updated to include "BOX/BOTTLE" in their descriptions.

• Closing Date Extension: The closing date for the solicitation has been extended to December 20, 2023, at 3:00 PM.

• Solicitation pages 6, 38, 40, and 71.

• Schedule of Supplies (updated via attachment).

• The proposal submission deadline has been extended to December 20, 2023.

• Bidders should ensure their proposals reflect the updated packaging and unit of measure information.

Solicitation / RFP / RFQ

This solicitation, SPE2D2-23-R-0007, is for the procurement of pharmaceutical products to be distributed through the Defense Logistics Agency (DLA) and Department of Veterans Affairs (VA) Pharmaceutical Prime Vendor (PPV) programs. The objective is to establish a national supply source for the drugs listed in the schedule, ensuring product availability, consistency, and volume-based pricing.

• Procurement of various Ondansetron formulations (HCL 4MG Tablets, HCL 8MG Tablets, ODT 4MG Tablets, ODT 8MG Tablets) in different counts and unit dose packaging.

• Products must be compatible with automated dispensing units (e.g., Baxter ATC Canisters, OptiFill).

• Unit of use packaging must include a child-proof closure and a minimum 100cc cylindrical bottle with a 5.75" circumference.

• Bar code labeling at the unit-of-use package level is required, conforming to GS1-128 or HIBC standards, and must include the NDC, lot number, and expiration date.

• Products must be FDA approved with a Therapeutic Equivalence Code (TE Code) of "A", unless all drugs in the family group are "B" rated.

• Offerors must have FDA approval (NDA, ANDA, or Biologic License) for offered drugs by the solicitation closing date.

• Manufacturing facilities must have current acceptable cGMP status with the FDA.

• Contract type: Firm-fixed-price requirements contract.

• Period of Performance: One base year with four option years, for a maximum term of five years.

• Contract Price Effective Date: No more than 60 calendar days after award.

• Contract Performance Date: 45 calendar days (or sooner upon mutual agreement) after award.

• Pricing effective: 15 calendar days after contract performance date.

• Offers must be submitted electronically via the Defense Logistics Agency Internet Bid Board System (DIBBS).

• Offer due date: July 27, 2023, 3:00 PM EST.

• Evaluation criteria: Lowest Price Technically Acceptable (LPTA) acquisition. Proposals will be evaluated for technical acceptability and lowest evaluated aggregate price.

• Proposals must include a Non-Price Proposal (Volume 1) and a Price Proposal (Volume 2).

• Offerors must provide historical sales data, delivered quantities, and Points of Contact for past performance.

• The acquisition is UNRESTRICTED.

• Offerors must comply with FAR 52.219-9 (OCT 2022) regarding subcontracting plans if they are large business concerns.

• Awardee must enter into business-to-business agreements with DLA and VA PPV contractors.

• Payments will be received from PPV contractors, not directly from the Government.

• Offerors must provide pricing information for all items and option years.

• National Drug Code (NDC) must be provided for each product.

• Trade Agreements Act (TAA) and Country of Origin information is required for end products and APIs.

Amendment / Modification

• The quantity for Line Item 0007 (Ondansetron ODT 8MG Tablets, DIS unit dose 30 count) has been updated from 67,404 to 14,034.

• The closing date for the solicitation has been extended from July 13, 2023, at 3:00 PM EST to July 27, 2023, at 3:00 PM EST.

• Line Item 0007 quantity.

• Solicitation closing date.

• The proposal submission deadline has been extended to July 27, 2023, at 3:00 PM EST.

• All other terms and conditions of the original solicitation remain unchanged.

Amendment / Modification

• The closing date for the solicitation has been extended.

• Original closing date: June 29, 2023, 3:00 PM EST

• New closing date: July 13, 2023, 3:00 PM EST

• Solicitation closing date.

• The deadline for proposal submissions has been extended to July 13, 2023, 3:00 PM EST.

• All other terms and conditions of the original solicitation remain unchanged.

Amendment / Modification

• The closing date for the solicitation has been extended.

• The new closing date is June 29, 2023, at 3:00 PM EST.

• The opening/closing date has been modified.

• The proposal submission deadline has been extended to June 29, 2023, at 3:00 PM EST.

Solicitation / RFP / RFQ

This solicitation (SPE2D2-23-R-0007) is for Ondansetron HCL and ODT tablets in various quantities and dosage forms. The Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel, is procuring these pharmaceutical products through its Pharmaceutical Prime Vendor (PPV) program to supply the Department of Defense (DoD), Department of Veterans Affairs (VA), Indian Health Service (IHS), and Bureau of Prisons (BoP).

• The solicitation covers multiple line items for Ondansetron HCL and ODT tablets in 30-count bottles, 500-count bottles, and 30-count unit dose boxes, with dosages of 4MG and 8MG.

• Products must be compatible with automated dispensing units (e.g., Baxter ATC Canisters, OptiFill).

• Unit of use packaging must include a child-proof closure and a bottle with a minimum size of 100cc.

• Bar code labeling at the unit-of-use package level is required, conforming to GS1-128 or HIBCC standards.

• Product information must be registered with RXNorm, First Data Bank, and Medi-Span prior to contract performance.

• Therapeutic equivalents will be considered only if they are FDA-approved with a "A" TE Code, unless all drugs in the family group are "B" rated.

• Offerors must have FDA approval (NDA, ANDA, or Biologic License) for the offered drugs by the solicitation closing date.

• Manufacturing facilities must have current acceptable cGMP status with the FDA.

• This is a firm-fixed-price requirements contract.

• The contract will have a one-year base period and four option years, for a maximum term of five years.

• The Contract Price Effective Date shall be no more than 60 calendar days after award.

• The contract performance date shall be 45 calendar days after award.

• Offers must be submitted electronically via DIBBS by June 8, 2023, 3:00 PM EST.

• The evaluation will be based on Lowest Price Technically Acceptable (LPTA).

• Proposals must include a Non-Price Proposal (Volume 1) and a Price Proposal (Volume 2).

• Offerors must complete representations and certifications electronically via SAM or provide them with the offer.

• Past performance will be evaluated based on historical sales data, delivered quantities, and points of contact for three relevant contracts within the last three years.

• The acquisition is unrestricted.

• Offerors must provide their Unique Entity Identifier (UEI) and CAGE code.

• The contract awardee will receive payments from the PPV contractors, not directly from the Government.

• Business-to-business agreements with DLA and VA PPV contractors are required.

• A 0.5% cost recovery fee is embedded in contract prices and must be reported quarterly.