SOLICITATION NOTICE
A -- In Vitro Characterization of Dry Powder Inhalers
- Notice Date
- 5/18/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-RQN1017403
- Response Due
- 6/14/2006
- Archive Date
- 9/30/2006
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation, a simplified acquisition under FAR part 13 and a total small business set-aside. The Food and Drug Administration (FDA), Office of Generic Drugs (OGD) is investigating in vitro characterization of Dry Powder Inhalers (DPIs) as a component in the demonstration of their bioequivalence. A set of in vitro tests would be used as part of the determination of product equivalence. These include the emitted dose evaluated at different flow rates and the particle size (measured by cascade impactor) produced at different flow rates for development of a product with potentially different ratios of carrier to drug from those found in the reference product. The purpose is to evaluate the proposed in vitro equivalence tests for DPIs to identify the sensitivity to differences in product formulations; evaluate the variability to be expected in the in vitro tests; and investigate the extent to which the device can be changed to counteract differences in formulation and provide equivalent in vitro performance. In this project, products with known differences (which should include ratios of drug substance (DS) to carrier, particle size (carrier or DS), surface roughness, and different manufacturing steps) would be manufactured and then tested at multiple flow rates for emitted dose and for particle size by cascade impactor. Monthly progress reports will be required. At the completion of the project, a report analyzing the results of the study shall be provided to the FDA. In addition, all of the raw data from the experiments shall be provided to the FDA. Offerors shall submit technical proposals to demonstrate their ability to perform the work. Offerors shall propose 1 or 2 model drugs to be studied and shall justify these selections for generalizability. Technical merit will be assessed on the following factors: 50% Qualification of the PI as assessed by education, publications, and previous research projects relevant to the project; 25% Quality of the facilities required including laboratory space and analytical instrumentation; and 25% Quality of the proposal as assessed by its ability to meet the requirements set forth above. A separate pricing proposal must be submitted itemizing projected costs required to complete the work. Cost realism will be analyzed to determine the offeror?s understanding of the requirement as well as to evaluate the reasonableness of the proposed price. A firm fixed price award is anticipated, with a monthly payment schedule corresponding to the offeror?s anticipated monthly costs or cash flow or corresponding to progress achieved, except that not less than 5 percent of the negotiated price shall be withheld pending acceptance of the final report and all raw data. Payment of monthly invoices will depend on acceptance by the Project Officer of the monthly progress report. This is a best buy acquisition in which technical factors are significantly more important than all other factors including price and past performance. Award will be made using SF1447 as a bilateral purchase order in accordance with FAR Part 13, Simplified Acquisition Procedures; all relevant required clauses will apply. FAR clause 52.212-1 at http://acquisition.gov/comp/far/current/html/52_212_213.html shall be included as well as 52.212-3, Offeror Representations and Certifications?Commercial Items and 52.212-4, Contract Terms and Conditions?Commercial Items. Proposals must be submitted in electronic form to Robert.Julia@fda.hhs.gov. Hardcopy proposals will be accepted at the contracting office address set forth above, marked for Robert Julia, but electronic versions of all documents must be provided unless physically impossible (drawings or designs that cannot be created electronically or scanned). Proposals are due not later than 4:30pm Wednesday June 14, 2006. Questions concerning this acquisition should be submitted by email to Mr. Julia within ten days following this announcement; answers will be provided as an amendment to this combined synopsis/solicitation.
- Record
- SN01052775-W 20060520/060519133757 (fbodaily.com)
- Source
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