SOLICITATION NOTICE
A -- Dry Power Inhalers (DPIs)
- Notice Date
- 8/7/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- PRE-09-223-01-00153
- Point of Contact
- Jacqueline Richardson, , Doreen Williams ,
- E-Mail Address
-
jacqueline.richardson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jacqueline.richardson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: The Food and Drug Administration intends to issue a Request for Proposal (RFP) for Evaluating the Effects of Formulation and Device Changes on In-vitro Performance for Dry Powder Inhalers (DPIs). Dry powder inhalers (DPIs) are used by a large number of patients for the delivery of medications to effectively treat asthma and chronic obstructive pulmonary disease (COPD). In coming years, patents will expire on innovator DPIs. Thus, there is an urgent need for establishing regulatory requirements for approval of safe and effective generic DPIs. The objective of this contract is to provide a quality by design (QbD) approach to identify formulation and device critical quality attributes (CQAs) of a test DPI product that could be adjusted to achieve equivalent in-vitro performance to the reference product. This project will systematically evaluate the extent to which changes in formulation and device influence in vitro performance of a test DPI product and lead to equivalent in vitro performance of test and reference DPI products. Therefore, the results of this project will 1) help to establish a systematic approach in developing a generic DPI product that has increased likelihood of establishing equivalence, and 2) help to accelerate the generic development of DPI products. The solicitation number for the procurement will be 09-223-01-00153 and the resultant award is expected to be a combination Time and Material (T&M) contract with a period of performance of three (3) years. The requirements under the solicitation will be designated for Full and Open Competition. This will be is an unrestricted solicitation being conducted under FAR Part 15. The RFP will be posted on FedBizOpps (FBO) website: http://www.fbo.gov on or about August 21, 2009. All responsible sources may submit proposals which shall be considered by the agency. No bidder's list will be maintained. It is the offerors' responsibility to monitor the FedBizOpps for release of this acquisition and any associated amendments. Offeror must be registered in the Central Contract Registration (CCR) database before an award can be made to them. If the offeror is not registered in the CCR, it may done so through the CCR website at http://www.ccr.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/PRE-09-223-01-00153/listing.html)
- Place of Performance
- Address: 5630 Fishers Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01903631-W 20090809/090808000517-62bdf1a701f2959e0dfc3b329a4bc71d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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