This is a notice of the Government's intent to solicit, negotiate and award a 100% small business set aside competitive delivery order, 1 year base period (09 July 2012 - 08 July 2013), 4 -12 month option periods (09 July 2013 - 08 July 2017) and a potential 6 month extension of services (09 July 2017 - 08 December 2017), IAW FAR 52.217-8, to facilitate services to the United States Army Centralized Allergen Extract Laboratory, Department of the Army, Kimbrough Ambulatory Care Center, Fort Meade, MD. Contractor/Manufacturer: 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. 3. The contractor shall supply the allergen extract products and ancillary supplies as specified with respect to concentrations and annual USACAEL usage requirements. Allergen Extract Product Specifications: 1. Weight per Volume items will be supplied in the desired 1:20 W/V, 1:10 W/V or 1:100 W/V concentrations as specified in the itemized contract listing for allergen extract products (trees, weeds, grasses, molds, miscellaneous antigens, foods and special processed antigens). If the desired concentration for an item is not available, the highest available strength for that item shall be provided by the contractor. 2. The PNU/ml content shall be provided for requested Weight per Volume allergen extract products. The PNU/ml content shall be clearly labeled for all Alum-Precipitated slow release allergen extract products. 3. The mg/ml content shall be made available by the contractor, if at all possible, for requested items. 4. It is preferable that Weight per Volume items be supplied as 50% glycerinated solutions. In instances where this is not possible, aqueous solutions are acceptable. (Concentrate stock solutions contain soluble extracts from source material, 0.5% sodium chloride and 0.54% sodium bicarbonate in water for injection or 50% glycerin. (Aqueous allergen extract solutions contain 0.4% phenol as a preservative. 50% glycerinated stock solutions contain 0.2% phenol). 5. Food items (Weight per Volume) are to be provided in 1:20 W/V or 1:10 W/V concentrated solutions. These items shall be supplied as 50% glycerinated solutions. 6. Standardized (BAU/ml and AU) allergen extract products to include cat, mite products and grass solutions must be provided in the following desired concentrations: a. Cat 10,000 BAU/ml b. Mites 10,000 BAU/ml c. Grasses: Standardized grasses are to be supplied at a 100,000 BAU/ml concentration except for Bermuda which is available only at 10,000 BAU/ml. 7. All allergen extract products shall be labeled with the appropriate genus/species name as well as the common name of the product as applicable. 8. All requested allergen extract stock solutions shall be provided in the appropriate vial sizes (10 ml, 50 ml) as specified in the itemized contract listing. Substitutions may be made if a vial size is not available, for example, five 10 ml vials may be substituted for a 50 ml vial of a particular allergen extract product if the 50 ml vial size of the product is not available. 9. Diluents shall be provided in the specified vial sizes. Annual volume requirements for diluent products are indicated in the itemized contract listing. a. Sterile albumin saline (HSA) diluent products (9 ml, 1.8 ml and 100 ml) contain 0.9% sodium chloride, 0.03% normal human serum albumin and 0.4% phenol as a preservative in water for injection. b. Sterile phenol saline (normal saline) diluent products (9 ml and 100 ml) contain 0.9% sodium chloride and 0.4% phenol as preservative in distilled water. c. Sterile 50% glycerin solution (100 ml) contains 50% glycerin, 0.09% sodium bicarbonate, and 0.166 sodium chloride in distilled water. d. Sterile 10% glycerin solution contains 10% glycerin, 0.9% sodium chloride and 0.4% phenol. 10. Venom products shall be supplied in the appropriate vial sizes (5.5 ml or multi dose 10 ml) and mcg/ml concentrations as specified in the itemized contract listing. 11. Vial labels for stock allergen extract solutions will have bar coding capability to assist in capturing information (lot number, expiration dating, and item #). Related Ancillary Supply Items: 1. Related ancillary supply items to include syringes, empty vials, vial caps, tamper proof seals, biohazard containers and jiffy bags are to be supplied in the desired annual amounts as specified in the detailed itemized contract listing. 2. Sterile empty vials and scratch dropper vials to include 10 ml empty vials, 30 ml empty vials, 50 ml empty vials and 5ml scratch dropper vials are to be supplied in the volume indicated as detailed in the itemized contract listing. Allergen Extract Product Availability: 1. USACAEL must be notified immediately as to the availability of an allergen extract product. Bio-equivalent or cross reacting species substitutions for an allergen extract product that is no longer available or discontinued, will be made so as not to necessitate a cut back in the patient's treatment regimen. Cross-reactivity data or information will be made available if possible. 2. USACAEL must be notified for any allergen extract product that will have a shortened expiration dating (less than 1 year). 3. New allergen extract antigens that are to be added to the itemized contract listing, during the course of the contract (base year and four option years), shall be priced accordingly with respect to manufacturer pricing for current option year. The Request for Proposals (RFP) for this contract will be published at a later date. This notice is an urgent requirement for the United States Army Centralized Allergen Extract Laboratory, Department of the Army, Kimbrough Ambulatory Care Center, Fort Meade, MD. 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 Central Contractor Registration, https://www.bpn.gov/ccr/default.aspx. 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 30 May 2012. Responses may be emailed to
[email protected].