SOLICITATION NOTICE
65 -- IV Bags or Syringes with Sterile Powdered or Aqueous concentrate chemicals
- Notice Date
- 8/7/2009
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, 77AESG -Aeronautical Systems Group, 2300 D Street, Wright-Patterson AFB, Ohio, 45433, United States
- ZIP Code
- 45433
- Solicitation Number
- RFI77AESGB2009
- Archive Date
- 9/30/2009
- Point of Contact
- Terry Wilkinson, Phone: 2105364109, 1Lt Jacob McDermott, Phone: 210-536-2367
- E-Mail Address
-
terry.wilkinson@brooks.af.mil, jacob.mcdermott@brooks.af.mil
(terry.wilkinson@brooks.af.mil, jacob.mcdermott@brooks.af.mil)
- Small Business Set-Aside
- N/A
- Description
- Request for Information on Manufacturing Capabilities for IV Bags Preloaded with Sterile Chemicals (Dry Powder or Aqueous Concentrates) and/or Syringes Prefilled with Sterile Chemical Concentrates Background and Purpose: The Government has awarded a contract to develop a medical combination product, known as Field Intravenous Fluid Reconstitution (FIVR), to produce the following routine intravenous (IV) solutions for patient administration in field medical treatment facilities supporting military operations worldwide: • Normal saline (NS); • Half normal saline (HNS); • 5% dextrose in normal saline (D5NS); and • Lactated Ringers (LR) The FIVR device will produce these sterile IV-bagged solutions (as listed above) by reconstituting (mixing) single-use prepackaged sterile powdered chemicals (or concentrated aqueous solutions) in IV bags, or highly concentrated sterile chemical solutions in prefilled injectors (syringes), with FIVR's internally-generated sterile water for injection (SWFI). The final product, upon reconstitution, is intended to be functionally equivalent and chemically identical to commercially available ready-to-use IV bags containing sterile drug solutions. The government is seeking to identify FDA-experienced and compliant contract pharmaceutical manufacturers who could prepare and package the chemical components (drugs) to be used with the FIVR device, which will ultimately yield (upon reconstitution) the desired sterile drug solutions in IV bags. Sterile drug chemicals shall be in the IV bags in powdered form or highly concentrated aqueous solutions for reconstitution with SWFI to yield standard IV solutions in FIVR-compatible 1000ml IV bags. The government is seeking manufacturers who can deliver the packaged chemicals via methods such as: (a) sterile IV bags preloaded with sterile powdered chemicals for subsequent reconstitution; (b) sterile IV bags preloaded with sterile drugs in concentrated solution for subsequent reconstitution and/or (c) other admixture approaches (e.g. highly concentrated sterile chemical solutions in prefilled syringes, suitable for insertion into FIVR-compatible IV bags containing SWFI) to yield standard 1-liter IV solutions as described above. Manufacturers may consider sterilizing the chemicals before or after packaging them, as long as the fabrication process yields packaged drug products the FDA would consider as certifiably sterile. The process of reconstituting these packaged drugs with SWFI shall result in sterile, ready-to-use products. The government would require a minimum shelf-life of six months for the prepackaged drugs, with a desired target of 18 months or more, and would ultimately require the product be FDA approved prior to fielding. Preliminary discussions indicate the FDA would consider FIVR a combination product, which includes both the device and the packaged drugs. This RFI is for information and planning purposes only and is not to be construed as a commitment by the government. This is NOT a Request for Proposal, Invitation for Bid, or an announcement of a solicitation. Response to this RFI is strictly voluntary and will not affect any corporation's ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement. The purpose of this document is to identify potential sources and technological capabilities. Any requests for a solicitation package will be disregarded. The Government does not intend to award a contract on the basis of this RFI or otherwise pay for the information solicited. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of preparing submissions in response to this RFI and the Government's use of such information. Submittals will not be returned to the sender. Respondents of this RFI may be requested to provide additional information/details based on their initial submittals. For submissions to be considered developers/sponsors must electronically supply (.doc or.pdf format) the requested information in the order and format in which it is presented to terry.wilkinson@brooks.af.mil, cc: jacob.mcdermott@us.af.mil no later than 1700 hrs, 15 September 2009. Respondents may also contact 1Lt Jacob McDermott, FIVR program manager, at (210)536-2367. Electronic Media can also be mailed to 77 AESG/PSK, 7980 Lindbergh Landing, Brooks City-Base TX 78235-5119, ATTN: Mr. Terry Wilkinson. The Government recognizes that proprietary data may be part of this effort. If so, clearly mark such restricted or proprietary data and present it as an addendum to the non-restricted/non-proprietary information. The Government shall not be liable for or suffer any consequential damages for any improperly identified proprietary information. Proprietary information will be safeguarded in accordance with the applicable Government regulations. The Government reserves the right to select one, some, or none of the submissions for further investigation. Submissions shall not exceed twenty (20) 8.5 X 11 inch, single-sided pages per product. Product MSDS, independent technical reports, and laboratory reports may be attached in an appendix and will not count against the length requirement. Vendors who submit packages for review do so with the understanding that U.S. Government personnel as well as their support contractors will review their material and data. Respondents will not (necessarily) be contacted regarding their submission or information gathered as a result of this notice nor the outcome of the Government's review of the solicited information. Submitted information packages will be retained by the Government and not returned to the contractor. Contracting Office Address: Department of the Air Force, Air Force Materiel Command, 77th AESG/PSK, 7980 Lindbergh Landing, Brooks City-Base, TX, 78235-5119 Point of Contact(s): Mr. Terry Wilkinson, Contracting Specialist, Phone 210 536-4109, Fax 210 536-4109, Email terry.wilkinson@brooks.af.mil. RESPONSE GUIDANCE Request comment from interested parties to the following questions: FIVR Focus Questions 1. Can your company prepare USP grade chemical constituents of NS, HNS, D5NS and/or LR, in a powdered or concentrated aqueous solution form, sterilize the product and load into empty IV bags? The resulting preloaded bags would need to be verifiably sterile and would be part of a submission application to the Food and Drug administration (FDA) for approval. 1.1. What sterilization method would you use on the drugs and the IV bags? 1.2. Would the drugs be sterilized prior or subsequent to loading in the IV bag? If prior, how would verification of a sterile fill be performed on the powdered chemicals? 2. Can your company prepare USP grade chemical constituents of NS, HNS, D5NS and/or LR, in a powdered or concentrated aqueous solution form, pre-loaded into syringes, yielding a sterile product, that when reconstituted with SWFI, would yield the desired IV solutions? The resulting drug-filled syringes would need to be verifiably sterile and would be part of an application submission for FDA approval. 2.1. What sterilization method would be used on the drugs and the syringe or combination thereof? 2.2. Would the drugs be sterilized prior or subsequent to loading in the syringe? If prior, how would verification of a sterile fill be performed on the powdered chemicals? 3. Is there an alternate method by which your company could produce either (a) sterile preloaded IV bags containing chemical constituents of the listed compounds or (b) some combination of container(s) and chemicals to yield the targeted sterile injectables in IV bags upon reconstitution with sterile water? 4. Where would the products be manufactured (processed)? Please identify city, state and/or country. 5. Is your manufacturing facility FDA approved, cGMP certified and/or GLP compliant? 6. Please provide, if possible, a Rough Order of Magnitude (ROM) of the cost to produce the following quantities of each chemical product: 100; 500; 1,000; 2,000; 5,000; 10,000. FIVR would require initial (small) orders of the packaged drugs to support system testing and validation as a prelude to FDA certification, with follow-on (large) quantities to supply and sustain the operation of the FIVR systems in field medical treatment facilities supporting military operations worldwide. 7. Does your company have previous experience with the FDA certification process? Has your company submitted any applications or been involved with the submission of any drug products for FDA approval? Has your company received FDA approval for any submissions (if applicable)? 8. Please specify if your company is rated as a large or small business. If the company is a Small Business, does it also qualify under any of the sub-categories (8(a), Small Disadvantaged Business, Woman Owned Small Business, Veteran Owned Small Business, HubZone Small Business, Service Disabled Veteran Owned Small Business, and HBCU/MI)?
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