Notice of Intent to Sole Source - Allergen Extracts.pdf

NOTICE OF INTENT TO SOLE SOURCE

The Medical Readiness Contracting Office - East is issuing this Notice of Intent (NOI) to inform industry contractors of the Government’s intent to execute a Sole Source Award under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements under the authority of 10 U.S.C. 3204 (c)(1).

The contractor shall supply allergen extract stock solutions for a wide variety of allergens, including but not limited to trees, grasses, weeds, molds, food, animals and miscellaneous antigens; vials, syringes and other related ancillary supplies in support of the United States Army Centralized Allergen Extract Laboratory (USACAEL), Kimbrough Ambulatory Care Center (KACC), Fort Meade, MD.

This procurement is being conducted using FAR Part 15, Contracting by Negotiation, allowing the Contracting Officer (KO) to solicit from one source. This will be a Firm Fixed Price (FFP) award and an anticipated award date is set for April 15, 2025.

The period of performance, six-month contract estimated from 15 April 2025 – 14 October 2025. Total estimated value is $2.5M.

The North American Industry Classification System (NAICS) for this requirement is, NAICS 325414 Biological Product Manufacturing. The Small Business Administration (SBA) size standard for this sector is 1,250 employees.

This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available, and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government.

All inquiries and concerns must be addressed in writing via e-mail to jessie.g.hart.civ@health.mil and copy ricardo.a.corderocruz.civ@health.mil with the following information referenced in the subject line, Respond to Notice of Intent (NOI) – Allergen Extract Supplies. A determination by the Government not to compete this proposed procurement based on the responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

All interested parties must be able to meet the following specifications:

1. The contractor/manufacturer must be approved and licensed by the FDA and have no current outstanding violations with respect to appropriate FDA procedural and regulatory guidelines or policies.

2. The contractor/manufacturer’s facility will be compliant with USP regulations and recommended USP 797 guidelines. Manufacturer USP 797 adherence policies and procedures shall be made available to USACAEL upon request. Issues and concerns involving USP 797 guidelines will be addressed promptly.

mailto:ricardo.a.corderocruz.civ@health.mil

3. The manufacturer/contractor shall supply the allergen extract products and ancillary supplies as specified with respect to concentrations dosage form (Aqueous or Glycerinated) and annual USACAEL volume usage requirements, there will be no deviations authorized.

4. The manufacturer/contractor must be able to supply at least 80% of requested allergen extract products without substitutions, see attached listing of requested allergen extracts.

All interested parties who are responsible, certified, and capable may identify their interest by responding back to this notice no later than 11:00 AM, Eastern Standard Time (EST) on April 9, 2025, to Mr. Jessie Hart at jessie.g.hart.civ@health.mil and also email a copy to Mr. Ricardo Cordero Cruz at ricardo.a.corderocruz.civ@health.mil The interested parties bear full responsibility to ensure complete transmission and timely receipt.

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