Allergen Extract Vaccines

This is a Sources Sought notice of the Government's intent to award an unrestricted delivery order to provide Venom, AP Dog and histamine allergen extract vaccine products in support The United States Army Centralized Allergen Extract Laboratory (USACAEL), Kimbrough Ambulatory Care Center, Fort Meade, MD, 12 month base period, 28 September 2023 - 27 September 2024, 4 - 12 month option periods, 28 September 2024 - 27 September 2028. This acquisition will be solicited under North American Industry Classification System (NAICS) code 325412 - Pharmaceutical Preparation Manufacturing with a size standard of 1,250. The contractor shall provide freeze dried venoms (Honey bee, White faced hornet, Yellow hornet, Wasp, Yellow Jacket and Mixed Vespid) AP Dog allergen extract, prick histamine and any other additional or related ancillary supplies. 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. 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 upon request. The contractor shall supply the allergen extract products and ancillary supplies as specified with respect to concentrations and annual usage requirements. Allergen Extract Product Specifications: 1. Venom (Freeze Dried) Patient Treatment and Testing Products (freeze dried), to include the treatment and diagnostic testing vials, shall be supplied in the appropriate vial sizes (5.5 ml, 5 dose vials or multi 12 dose vials) with the appropriate mcg/ml concentrations as specified in the itemized contract listing. The diagnostic or venom maintenance sets are 6 vials each of 2ml venom product vials (100 mcg/ml). Substitutions may be made, if the vial size ordered is not available, for the same comparable ml amount of the same product in another vial size. 2. AP Dog product will be supplied in 50 ml vial size at a 1:100 W/V concentration. Substitutions may be made if a vial size is not available, for the same comparable ml amount in another vials, for example, five 10 ml vials may be substituted for a 50 ml vial of AP Dog extract, or a comparable vial volume of another size vial if the product is not available. The U.F. Dog Hair Dander product (1:650 w/v, 50 ml) product will be substituted as necessitated and available. 3. Histamine Phosphate for Prick Skin Testing will be supplied at 6 mg/ml histamine base, 10 mg/ml Histamine Dihydrochloride in 50% glycerin. Parties interested in future announcements on this procurement shall provide detailed information of their capabilities and certifications to clearly meet the requirements stated above. Interested parties must be registered in the System for Award Management (SAM) https://www.sam.gov/portal/public/SAM/. Responses(s) may be via email or on company letterhead: include company's name, point of contact, address, phone number, DUNS number, Tax ID, business size. All responses must be received by 9:00 a.m. EST 29 May 2023. Responses may be emailed to myissha.n.tompkins.civ@health.mil.