Reactive Skin Decontamination Lotion
Added: Jun 21, 2012 11:06 am 1. Summary/Introductiona) The Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, is the contracting activity.b) The acquisition will result in a requirements type contract for Reactive Skin Decontamination Lotion (RSDL) and Inactive Skin Decontamination Lotion (ISDL).c) The total duration of this contract will be for a one-year base period and four (4) one-year option periods. The maximum dollar value for all five (5) years is $243,822,950.00.d) The statutory authority for Other than Full and Open Competition is 10 U.S.C. 2304(c)(1): only one responsible source and no other supplies or services will satisfy agency requirements.2. Description of Agency's Need (10 U.S.C. 2304(f)(3)(a)):I) Backgrounda) RSDL is a unique decontaminating lotion designed to reduce morbidity and mortality from chemical, biological, radiological, and nuclear (CBRN) contamination of the skin. RSDL will decontaminate Tricothecen Mycotoxin (T-2), Mustard Gas (HD), SOMAN (GD), and O-Ethyl S-Diisopropyl-aminomethyl Methyphosphonothiolate (VX) agents. RSDL was developed as an improvement to, and replacement of, the M291 Skin Decontamination Kit, manufactured by TrueTech, Inc., Riverhead NY.b) ISDL is a lotion designed to imitate RSDL in color, viscosity, taste, and application. It possesses unique characteristics made to simulate the properties of RSDL in all but active ingredients. ISDL is an essential concomitant to RSDL, and is used by individual Service personnel for training in the application of RSDL.c) The principle technical requirements of RSDL are to reduce toxic effects of warfare agents HD, GD, and VX to a level better that M291. In comparative testing, RSDL performed better than M291 in the following crucial areas:1) Against HD agents, decontamination with RSDL resulted in lesion areas that were 50% smaller than areas treated with M291.2) Animals exposed to lethal doses of GD agents are 3.5 times more likely to survive when decontaminated with RSDL than when treated with M291.3) Animals exposed to lethal doses of VX agents are 7 times more likely to survive when RSDL is used compared to M291.4) An additional unique characteristic of RSDL is its ability to neutralize chemical warfare agents. The M291 lotion does not neutralize the agent, but rather encapsulates it and allows the warfighter to remove the agent. The neutralizing characteristic of RSDL is the key to its superior efficacy.II) Description of Need/Suppliesa) For this acquisition, a firm fixed-price requirements type contract is planned, with an estimated annual requirement of 16,300 packages for RSDL and 3,000 for ISDL. A requirements type contract is preferred to an indefinite quantity type contract because the demand level for RSDL and ISDL has been erratic as the Services have transitioned from M291 to RSDL, and it is difficult to predict with confidence a guaranteed minimum or annual maximum amount. The total duration of this contract will be for a one-year base period and four (4) one-year option periods.b) The previous contract for RSDL and ISDL was awarded by DLA Troop Support to E-Z-EM Canada, Inc. (EZEM) in June 2010. The contract, which was the first contract for these items awarded by DLA, was for a 1-year base period with a 1-year option period. Starting with that contract's pricing and applying an escalation factor of 4.2% (the use of which is based on the Global Insight long range index for pharmaceutical preparations), the total estimated dollar value for the five-year requirement is $104,542,550. The maximum dollar value, including surge, is $243,822,950.3. Authority for Other than Full and Open Competition (10 U.S.C. 2304(f)(3)(B):The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1): only one responsible source and no other supplies or services will satisfy agency requirements. The only known source for the supply of RSDL and ISDL is EZEM, Anjou, Quebec, Canada. EZEM is a division of Bracco Diagnostics, an international pharmaceutical concern. Currently, EZEM is the only source that produces a skin decontaminant that is 1) FDA approved, and 2) has an efficacy that exceeds the standards of M291 Skin Decontamination Kit when decontaminating warfare agents T2, HD, GD, and VX. To date, no other firm has been found to possess the capability to produce these highly specialized items. The resultant contract will be issued to the Canadian Commercial Corporation, which is considered the prime contractor, with EZEM as subcontractor, in accordance with the procedures of DFARS 225.870. The Canadian Commercial Corp. has jurisdiction over a Canadian entity whose operations are in Canada regardless of whether the Canadian entity is a division of an international corporation.4. Price/Cost Considerations (10 U.S.C. 2304(f)(3)(c)):Offers from the Canadian Commercial Corporation are exempt from submission of certified cost and pricing data in accordance with DFARS 215.403-1(c)(4)(C). The undersigned Contracting Officer anticipates that the cost to the Government will be fair and reasonable based on an analysis of other than cost and pricing data, and the analysis performed by the Canadian Commercial Corporation, which certifies the fairness and reasonableness of the proposal it endorses. 5. Market Research/Efforts to Obtain Competition (10 U.S.C. 2304(f)(3)(D) & (E)):a) A Sources Sought notice was published in FedBizOpps on March 28, 2011 describing the requirements and requesting information from potential sources. The notice had a 30-day response period. The notice solicited information on products that are either finished or in the development stage. Two responses were received from manufacturers that have products in development (Albumin Therapeutics LLC and Reliapon Police Products) and were referred to the Joint Project Manager - Protection (JPM), which is the organization at Ft. Detrick responsible for determining the technical requirements of decontamination products such as RSDL.b) Albumin Therapeutics makes a product called Albagen. According to JPM, this product did not meet the requirements stipulated in the synopsis. It was deemed to be a medication to promote the health and maintenance of the skin after chemical/biological/radiological/nuclear exposure and not a decontaminating agent. Additionally, the product is developmental and does not have FDA approval.c) Reliapon makes a product called Bio Rescue. The company claims that this product has many of the same decontaminating properties as RSDL; however, it is not fully developed and not currently approved by the FDA. According to the firm, the product is currently sold in bulk form and used for decontaminating large areas, such as an office building. The firm is developing the product to be used directly on the human body; however, this type application is only in early testing stages. There is no probability that this product would be approved by the FDA in the time allowed to evaluate and award a contract by the target date of June 1, 2012.d) As a result of this research, EZEM is still the only known source for an FDA-approved decontaminating agent with properties specified in Section 2 above.e) In accordance with FAR 6.302-1(d)(2), this requirement was synopsized in FedBizOpps on August 17, 2011.6. Actions Being Taken to Overcome Barriers to Competition (10 U.S.C. 2304 (f)(3)(F):a) Skin decontaminating lotions are items used primarily by the military with very limited use by first responders and other emergency personnel. The items are designed for battlefield use by soldiers under chemical warfare attack. The expenses of capital and technological investments, and compliance with FDA regulations and licensure are prohibitive barriers to entry in this market. There are no known firms other than EZEM that have gone tough this process.b) DLA Troop Support will continue to post Sources Sought notices on a semi-annual basis in the FedBizOpps. Responses to these notices will be forwarded to JPM, who will continue to monitor the development of products that may be suitable alternates to RSDL. A response to these notices does not mean that the sole source status of EZEM will change in the near term. Each new product evaluation will take several months and will require the active participation of the manufacturer. The process of obtaining FDA approval, if even undertaken by the manufacturer, could take several years.c) I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief._______________________________ NEIL McAVINUE Date Contracting Officer SPM2DP11R0006 Defense Logistics Agency Troop Support Medical
6/21/12, 11:06 AM Reactive Skin Decontamination Lotion and Trainer Lotion
Added: Aug 17, 2011 2:14 pm The Defense Logistics Agency Troop Support is soliciting proposals for the supply of Reactive Skin Decontamination Lotion (RSDL), NSN 6505-01-507-5074, and Inactive Skin Decontamination Lotion (ISDL), NSN 6910-01-507-5141. RSDL is used to decontaminate skin exposed to chemical warfare agents. ISDL contains inert ingredients and is used to train in the application of RSDL. This acquisition will be issued under authority of 10 USC 2304 (c) 1, Only One Responsible Source. The type of contract planned is a requirements contract (see FAR 16.503) for an estimated annual amount of 16,300 packages RSDL and 3,000 packages ISDL. Each package contains 60 individual pouches of lotion. Other spec sheet data will be included in the solicitation.The quantities indicated are annual estimates only. The contract will have a base year and include options to extend the contract for four (4) additional 1-year periods.Surge and sustainment requirements, at the rate of 3,340 packages per month, are a requirement for this acquisition.Ordered quantities shall be delivered to the requesting ordering activity within 60 days after receipt of order. Ordering activities will use DLA Troop Support's Electronic Catalog (ECAT) as an ordering venue. SPM2DP-11-R-0006 Defense Logistics Agency Troop Support Medical
8/17/11, 2:14 PM