Pharmaceutical Products for CDER Research Studies - IDIQ

Active

Contract Opportunity

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Drug Evaluation and Research (CDER), requirement for Pharmaceutical Manufacturer/Supplier to provide brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is- 325412 - Pharmaceutical Preparation Manufacturing; the applicable Small Business Size Standard is 1300 employees.

Statement of Work

Background:

The U.S. Food and Drug Administration (FDA) is engaged in laboratory, animal and human research to develop tools and methodologies to evaluate generic drug equivalence. The Center for Drug Evaluation and Research (CDER), requires a Pharmaceutical Manufacturer/Supplier to provide brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics, drug-device combination products, and contrast agents. FDA collaborates with external investigators in industry and academia as well as internal investigators in various FDA laboratories to conduct research that will advance public health by providing access to safe and effective generic drugs. These research studies include: investigation of the quality of drug products associated with adverse events, comparison of branded and generic products in physicochemical characterization and in vitro release testing, analysis of methods to assay drugs of a particular class and surveillance of marketplace drug quality. Often the quantity and cost of these marketplace drugs exceeds the limit for orders by government credit card and are required as soon as practical. This is particularly true for peptide therapeutics, microsphere formulations, implants and products involving nanotechnology. Extramural and intramural generic drug research projects involve testing the marketed reference product and any marketed generic counterparts. Purchase of marketed drug products at the lowest possible price will enable the FDA to allocate financial resources towards other parts of the research program.

Objective and Scope

To obtain a reliable source of currently marketed pharmaceutical drug products for FDA research studies. This requirement is for the establishment of a five-year IDIQ contract for the purchase of various pharmaceuticals. Specific quantities and type of pharmaceutical will be defined at the delivery order level.

Description of Work

The contractor will fulfill orders from the FDA on an as-need basis for drug products listed in the schedule of items, Drug Products Schedule see attachment 1.

The FDA may request both brand name and any available generic products. Requested drug products may include small molecule and peptide therapeutics, drug-device combination products, and contrast agents. An anticipated list of drug products and the required dosages that will be requested for purchase is given in the Attachment 1. Other drug products not listed in the attachment may also be requested during the IDIQ performance periods. The contractor must be able to supply a comprehensive list of pharmaceutical products to the FDA, including but not limited to those products listed in the Attachment 1. The contractor shall indicate what pharmaceuticals they can provide and the associated pricing.

Drug Product List Refresh: Additional Drug Products may be added to this list at any time throughout the life of the contract. These additional products, prices and descriptions of the products will be negotiated on a case-by-case basis. The additional categories, prices and descriptions quoted, upon determination by the Government that they are necessary for performance and are both fair and reasonable, can be issued in the order. The new product category may be incorporated by modification into the Schedule of Items tables of the IDIQ contract.

The Contractor shall maintain a log of all pharmaceutical products purchased under this Contract and shall supply a copy to the FDA upon request

Immediately upon shipping pharmaceutical products, the Contractor shall provide all tracking information to the FDA COR (Identified at time of task order award).

Location:

Pharmaceutical products shall be delivered to various FDA offices or laboratories; academic and industrial external research collaborators located throughout the U.S. and outside the U.S.

The Contractor shall arrange direct shipment of pharmaceuticals as follows:

Location Delivery Date

Domestic FDA Office/Laboratory Within 7 business days of order

Domestic External Research Site Within 7 business days of order

International External Research Site Within 14 business days of order

Emergency Overnight Delivery

Other FDA Centers and locations may also receive deliveries as needed to meet the mission needs of the FDA and will be identified at the delivery order level.

Delivery Orders/Delivery Schedule:

Particular delivery details will be provided in the delivery order, such as the delivery address, point of contact information, the pharmaceutical required and delivery schedule and any specific local delivery requirements for security or loading dock delivery requirements. Changes to the delivery schedule may occur after issuance of the delivery order at the request of the FDA as long as adequate notice (minimum of two weeks) is given to the contractor and as long as the changes are within the period of performance of the delivery order. Any changes that fall outside the period of performance of the delivery order will require the Contracting Officer to modify the delivery order. No one other than the Contracting Officer is authorized to change the terms and conditions of the Delivery Order.

Contract Period of Performance

The period of performance for this IDIQ contract shall consist of five (5), one-year ordering periods estimated to be:

Ordering period 1: August 1, 2026 through July 31, 2027

Ordering period 2: August 1, 2027 through July31, 2028

Ordering period 3: August 1, 2028 through July 31, 2029

Ordering period 4: August 1, 2029 through July 31, 2030

Ordering period 5: August 1, 2030 through July 31, 2031

FOB Point Destination. All items shall include shipping and handling to the destination identified.

Minimum and Maximum Quantities

The contract guaranteed minimum will be $10,000.

The contract maximum of all orders issued over five (5) years and awarded under this contract is estimated not to exceed $4,000,000 including any shipping costs.

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name, SAM Unique Entity ID number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);

• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

- Technical specification shall be included for each listed item in the minimum required characteristics section in attachment 1.

• Three (3) years of past performance information, where the respondent has provided same or substantially similar product/service solutions on the same or near-same requirements. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include SAM Unique Entity ID number and size status) if not the respondent.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

• Provide information if any of these specifications are too restrictive. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.

• If a large business, identify the subcontracting opportunities that would exist for small business concerns;

• Standard commercial warranty and payment terms;

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed; and

• Though this is not a request for quote, informational pricing is required

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before March 18, 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CDER-2026-132721.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Attachments/Links