Pharmaceutical Products for CDER Research Studies - IDIQ

Amendment / Modification

This document is Amendment 1 to the combined synopsis/solicitation 75F40126Q132721.

This amendment does not appear to modify specific sections of the original solicitation but rather provides additional details and clarifications.

No changes to proposal deadlines or submission requirements are explicitly stated in this amendment. Bidders should refer to the original solicitation for these details.

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet containing a comprehensive list of drug products, likely for procurement or forecasting purposes. It details various pharmaceutical items, their strengths, packaging, and NDC numbers where available.

• Product Name: Lists the names of various drugs, including generic and brand names.
• Strength: Specifies the dosage or concentration of the active ingredient(s).
• Size/Packaging: Indicates the quantity or format of the product (e.g., tablets/bottle, inhaler/unit).
• NDC Number: Provides the National Drug Code for identification, if available.
• Manufacturer/Distributor: Lists the source of the drug product.
• Quantity for evaluation purposes only: A column indicating a quantity, explicitly stated as for evaluation only and subject to change.
• Ordering Period Prices: Columns for unit prices for five different ordering periods.
• Notes: A column for any additional relevant information.

This attachment provides a detailed list of specific drug products that may be part of the government's requirement. Bidders should review this list to understand the types and quantities of pharmaceuticals involved in the opportunity. The pricing columns indicate potential cost structures, and the "Quantity for evaluation purposes only" note suggests that this list is a basis for understanding the scope rather than a fixed order quantity. Bidders may need to use this information to prepare their pricing and confirm their ability to supply these specific items.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products or services, issued as a Request for Quote (RFQ) for multiple types of pharmaceutical drugs. The U.S. Food and Drug Administration (FDA) requires a reliable source of currently marketed pharmaceutical drug products for its research studies. The research involves laboratory, animal, and human studies to evaluate generic drug equivalence, and includes work on small molecule and peptide therapeutics, drug-device combination products, and contrast agents.

• Procurement of brand name and/or generic pharmaceuticals, including small molecule and peptide therapeutics, drug-device combination products, and contrast agents.

• An anticipated list of drug products is provided in Attachment 1, but other products may also be requested.

• Contractor must be able to supply a comprehensive list of pharmaceutical products and indicate pricing.

• Contractor shall provide a firm fixed-price quote for pharmaceuticals listed in Attachment #1.

• Contractor shall maintain a log of all purchased pharmaceutical products and supply a copy to the FDA upon request.

• Immediate shipment of pharmaceutical products requires providing tracking information to the FDA COR.

• All products must comply with Section 508 of the Rehabilitation Act regarding accessibility standards for information and communication technology.

• Contract Type: Commercial Item - Firm Fixed Price (FFP) Indefinite Delivery/Indefinite Quantity (IDIQ).

• Contract Maximum: Estimated not to exceed $4,000,000 over five (5) ordering periods.

• Guaranteed Minimum: $25,000.

• Period of Performance: Five (5) one-year ordering periods, from September 1, 2026, through August 31, 2031.

• Delivery: Within 7 business days to domestic FDA offices/laboratories and domestic external research sites; within 14 business days to international external research sites. Emergency overnight delivery is also an option.

• FOB Point: Destination.

• Offers are due by email to nick.sartain@fda.hhs.gov on or before May 15, 2026, by 1:00 P.M. Central Time.

• Evaluation Criteria: Technical Capability, Past Performance, and Price. Technical capability and past performance combined are more important than price. Price becomes more important if non-price factors are essentially equal.

• Offerors must complete Attachment 1 with pricing, manufacturer/distributor information, and NDC number if available.

• Offerors must include their SAM Unique Entity ID (UEI) with the quotation.

• Technical Capability requires submission of sufficient technical information and specifications to demonstrate products meet requirements.

• Past Performance requires recent (within 3 years) relevant experience information.

• This acquisition is not set-aside for small business concerns; it is an unrestricted, full and open competition.

• NAICS Code: 325412 - Pharmaceutical Preparation Manufacturing.

• Small Business Size Standard: 1300 employees.

• Small businesses are exempt from submitting a small business subcontracting plan.

• Other than small business offerors must submit a subcontracting plan via the HHS Small Business Customer Experience (SBCX) system.

• The solicitation incorporates provisions and clauses by reference; full text may be accessed electronically.

• Offerors must not include macros in submitted documents.

• A single award IDIQ contract is anticipated.

• World Trade Organization Government Procurement Agreement and Free Trade Agreements apply.

• Offerors agree to hold prices firm through September 30, 2026.