SSN 75F40125SSNFLUVAX.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought Notice (SSN) in order to determine if there are existing small business or other qualified sources capable of providing the Seqirus (or equal) seasonal influenza vaccine doses to FDA Occupational Health Units (OHUs) at the White Oak Campus in Silver Spring, MD, and the Jefferson Laboratories Campus in Jefferson, AR.

The Food and Drug Administration (FDA) is responsible for enforcing the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws that safeguard public health. As part of its commitment to employee health and regulatory compliance, the FDA’s Occupational Health Services (OHS) delivers a comprehensive, work-related medical program. This program includes critical services such as immunizations. The annual influenza vaccination effort supports FDA’s workforce health initiatives and aligns with Center for Disease Control (CDC) recommendations for influenza prevention.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code is 325412 – Pharmaceutical Preparation Manufacturing; with a Small Business Size Standard of 1,300 employees, and you believe that your firm would be able to provide the FDA with the products described below, please submit an email to suzanne.martella@fda.hhs.gov. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

Minimum Requirements:

1. Contractor shall provide 4,100 units of seasonal influenza vaccine (Product #: SADSYR24 for the FLUAD TIV 0.5mL Prefilled Syringe (65yrs+) and (Product #: SCELSYR24 for the Flucelvax TIV 0.5mL Prefilled Syringe) or equal products that meet the following specifications:

a. Vaccines shall be FDA-approved and recommended for the 2025–2026 influenza season.

mailto:suzanne.martella@fda.hhs.gov

b. All doses shall be provided in single-dose pre-filled syringes.

c. Vaccines shall be shipped, stored, and handled in compliance with CDC cold chain requirements.

d. Each unit’s packaging shall clearly indicate the manufacturer, National Drug Code (NDC) number, lot number, and expiration date.

2. The total order shall consist of:

a. 4,000 units formulated for adults under 65 years of age.

b. 100 units formulated for adults 65 years of age and older.

The following services are not part of this requirement:

• On-site storage or refrigeration,

• Inventory or tracking systems,

• Clinical staffing or administrative services,

• Logistical planning or coordination, and

• Recordkeeping or documentation support

Delivery Terms: FOB Destination to the addresses listed below. Guaranteed delivery of the vaccines must be before October 1, 2025.

Place of Delivery

White Oak Campus:

Deliver 3,900 total units: 3,800 units for adults under 65 years of age and 100 units for adults 65 and older to:

US FDA

White Oak Campus 10903 New Hampshire Ave.

Building 52/72 loading dock Silver Spring, MD 20993

Jefferson Laboratories Campus:

Deliver 200 total units (all 200 units will be for adults under 65 years) to:

US FDA/NCTR

3900 NCTR Rd.

Jefferson AR 72079

The Contractor shall provide proof of shipment (e.g., tracking, packing slip). Upon receipt, shipments will be inspected for quantity, condition, adherence to cold chain compliance, and accuracy of lot documentation. Non-conforming deliveries may be rejected at the Contractor’s expense.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of flu vaccines. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, Unique Entity ID (SAM) 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 again if responding to provide a vaccine offered by another firm.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of business which the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and/or delivery time identified above can be met.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product to include date of sale, description of product provided, contract dollar value, client name, client address, client 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 Unique Entity ID (SAM) number and size status) if not the respondent.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products meet the technical requirements identified above.

• The offeror’s capability to provide the required flu vaccines and how long after receipt of award the vaccines can be delivered.

• If applicable, identification of the firm’s GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the vaccines may be available on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Provide place of product manufacture or 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.

• Letter of Supply. Offerors who are authorized resellers and not the manufacturer of any offered vaccine shall provide a copy of their letter of supply or other documentation substantiating their relationship as an authorized reseller of the proposed manufacturer’s product. The documentation shall be on the manufacturer’s letterhead and include contact information for the individual who has signed the letter.

• Though this is not a request for quote, informational pricing for the vaccines would be helpful for market research purposes.

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

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 3:00pm (Central Time in Jefferson AR) on July 10, 2025 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40125SSNFLUVAX.

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.

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 or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the vaccines would be helpful.

mailto:suzanne.martella@fda.hhs.gov