Atropine Auto-Injectors (0. 5 mg, 1 mg, and 2 mg)

Closed Pre-Solicitation Posted

Solicitation number
AA-I08192025
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Jerusalem 97770 Israel
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to award a sole source contract for Atropine auto-injectors in three dosages: 0.5 mg, 1 mg, and 2 mg. These FDA-approved pharmaceutical products are essential for treating nerve agent or organophosphate poisoning and will support the Strategic National Stockpile (SNS) and CHEMPACK mission for national emergency preparedness. The procurement is being conducted under FAR 6.302-1 authority as a sole source acquisition, citing that only one responsible source exists and no other supplies will satisfy the agency's requirements. The contract will be structured as a firm fixed price agreement with Rafa Laboratories LTD of Jerusalem, Israel, which is identified as the sole manufacturer of these specific auto-injectors. The notice was posted on August 19, 2025, with a due date of September 3, 2025, though this appears to be for informational and planning purposes rather than a formal solicitation.

This procurement does not utilize any set-aside designations and identifies Rafa Laboratories LTD as both the intended sole source contractor and current sole manufacturer, noting they have no relationships with resellers or distributors for this product. The contract structure includes a base year ordering period for 2025 requiring 394,050 auto-injectors (187,250 units of 0.5 mg, 172,800 units of 1 mg, and 34,000 units of 2 mg), followed by two optional ordering periods for 2026 and 2027, each requiring 212,000 auto-injectors with different quantity distributions. Each optional year would include 72,000 units each of the 0.5 mg and 1 mg dosages, plus 68,000 units of the 2 mg dosage. The total potential procurement across all three years could reach 818,050 auto-injectors if all options are exercised. The products will be staged in CHEMPACK forward deployed operations at the local level to enable swift emergency response by personnel during chemical attacks or accidental exposures.

Notice text

This is a NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

The Office of the Administration for Strategic Preparedness and Response (ASPR), Center for the Strategic National Stockpile (SNS) intends to award a sole source firm fixed price contract to:

Manufacturer Name

Rafa Laboratories LTD

Jerusalem, Israel 97770

The purpose of this acquisition is to provide the United States Government (USG) with pharmaceutical required to support the SNS/CHEMPACK mission. Atropine auto-injectors (0.5 mg, 1 mg, and 2 mg) are essential for future readiness and response to nerve agent or organophosphate poisoning. For emergencies like chemical attacks or accidental exposures, immediate treatment is vital, emphasizing the need for readily available auto-injectors to enable swift response by emergency personnel.

The USG has a need to procure Atropine auto-injectors (0.5 mg, 1 mg, and 2 mg), a U.S. Food and Drug Administration (FDA)-approved and FDA-approved Emergency Use Authorization (EUA) and commercial pharmaceutical, to be utilized during national emergencies and staged in CHEMPACK forward deployed operations at the local level.  The USG intends to procure the following: Base Year Ordering Period (1): 2025 - 394,050 EA auto injectors (187,250 ea. of 0.5 mg, 172,800 ea. of 1 mg, and 34,000 ea. of 2 mg)

Optional Ordering Period Year (2): 2026 - 212,000 EA auto injectors (72,000 ea. of 0.5 mg, 72,000 ea. of 1 mg, and 68,000 ea. of 2 mg)

Optional Ordering Period Year (3): 2027 - 212,000 EA auto injectors (72,000 ea. of 0.5 mg, 72,000 ea. of 1 mg, and 68,000 ea. of 2 mg)

Rafa Laboratories is currently the sole manufacturer of Atropine auto-injectors (0.5 mg, 1 mg, and 2 mg).  They have no relationships with resellers or distributors for this product.

This notice is for informational and planning purposes and does not constitute a solicitation. This notice of intent is NOT a request for competitive proposals. A determination by the Government not to compete this procurement based upon response(s) to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement must submit in writing their name, address, telephone number, email, UEI/CAGE code, business size, National Drug Code (NDC), and a statement of capability demonstrating their abilities to meet this requirement. The Government will not be responsible for any costs incurred in responding to this notice. All responses must be received by September 03, 2025, at 12:00 PM Eastern Standard Time. All responses must be in writing and must be sent via email to OSContracting.hhs.gov. Reference Atropine Auto-Injectors (0.5 mg, 1 mg, and 2 mg) Acquisition in the subject line. No other submissions will be accepted.

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