SOLICITATION NOTICE
B -- Percutaneous Absorption of Drugs Study
- Notice Date
- 5/13/2008
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- FDA1041476
- Point of Contact
- David - Kordel,, Fax: 301-827-7151
- E-Mail Address
-
david.kordel@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Requisition Number: FDA1041476 The Food and Drug Administration (FDA) is seeking a Total Small Business Set-Aside for vendors to write an analytical report on the Effect of Occlusion (Overlays) on the Percutaneous Absorption of Drugs Description of Work/Statement of Work. i) Background Occlusion and subsequent hydration of the stratum corneum, which is the uppermost layer of the skin consisting of dead cells, increases the absorption through the skin (percutaneous absorption) for many drugs. This could result, for example, from the use of water-impermeable tape over a transdermal patch. Generally, hydration of the skin causes a decrease in the stratum corneum resistance and an increase in the delivery rate of drugs that have the stratum corneum as the rate limiting step to drug diffusion. It is possible that a drug that is not rate-limited by the stratum corneum, but by the viable epidermis, may not be as significantly affected by skin hydration as other drugs. It might also be possible that with more water in the stratum corneum that a very hydrophobic drug might even have a decreased delivery rate. ii) Vendor Objectives The objective of this research is to examine percutaneous absorption of model compounds with different hydrophobicities, occluded and non-occluded, using the human skin in vitro diffusion model and pre-clinical studies. Cadaver skin or abdominal reduction surgical waste skin and a diffusion cell system shall be used for permeation studies. Different drugs shall be applied, and movement across the skin shall be determined by measuring drug concentration on either side of skin layer in the diffusion cell. The diffusion experiment is initiated by applying an appropriate amount of formulation to the skin, unoccluded or occluded (with or without an impermeable cover). Bioclusive cover can be used to mimic the occlusion condition in later stage experiments. The diffusion samples shall be analyzed according to modified extraction and chromatography methods found in the scientific literature. Based on the results, permeability studies shall be conducted in the appropriate animal model (hairless guinea pig). Candidate drugs shall be applied with and without occlusion to the skin of hairless guinea pigs. Blood samples shall be collected over time, and analyzed for drug concentrations using validated analytical methods. Using plasma concentrations vs. time profiles, the pharmacokinetics of each drug shall be determined following transdermal application. Finally, in vitro-in vivo correlations shall be developed, using results from the diffusion studies in vitro, and the in vivo study in animals. Specific Aim 1: Vendor shall test the hypothesis that the significant effect of occlusion on triamcinolone acetonide (or a similar drug) percutaneous absorption can be measured in human skin in vitro; Specific Aim 2: Vendor shall test the hypothesis that occlusion will also have a significant effect on a more hydrophilic molecule (triamcinolone) and not have an effect on two very hydrophobic molecules (fentanyl and oxybutynin) in human skin in vitro. Specific Aim 3: Vendor shall develop predictive models using in vitro and in vivo data from animal studies. Reporting Requirements and Deliverable Items. A written progress report shall be provided to the FDA six months after award in both paper and electronic formats. Receipts for expenditures should be submitted and will be reimbursed on a monthly basis. In addition to labor, supplies and overhead costs, expenditures include travel economy class to one conference, and reimbursement for hotels, meals, and transportation. Thirty days before 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, in both paper and electronic format, shall be provided to the FDA. Data may be shared with the institution where the research is conducted. Duration of Project. The FDA anticipates a one year period of performance. Evaluation Criteria for Competitive Proposals. 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. 25% Quality of the proposal as assessed by its ability to meet the requirements in the statement of work Site Visit Schedule. FDA scientists will visit the vendor’s site two times during the period of performance. The performance period shall be one year from the time of award. The NACIS code for this work is 541690. Vendor’s response to this RFQ must be limited to no more than 10 pages. This is a REQUEST FOR QUOTATION (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 5:00 pm (1600) EST on May 20, 2008. All responsible sources must be registered in the Central Contractor Registry System (CCR) at www.ccr.gov to be considered. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 10:00 AM (1000) EST on 28 May 2008 to the attention of David Kordel, david.kordel@fda.hhs.gov. Evaluation/Award will be based on the technically acceptable quote that offers the best value to the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
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- Record
- SN01572448-W 20080515/080513221540-57609503a09802a36beeecd69c280cfd (fbodaily.com)
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