SOLICITATION NOTICE
A -- Evaluation of the Ex Vivo Release Profile - FDA-SOL-1146505
- Notice Date
- 7/21/2015
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- 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
- FDA-SOL-1146505
- Point of Contact
- Telisha Wilson, Phone: 2404027572
- E-Mail Address
-
telisha.wilson@fda.hhs.gov
(telisha.wilson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Evaluation of the Ex Vivo Release Profile Following are the two tasks proposed for the current project: Task 1. Development of Animal Protocol This task is divided into three steps: • The contractor shall develop an animal protocol based on the following study design: "PerioChip, Chlorhexidine Gluconate Tablet/Dental 2.5 mg, will be applied to a naturally occurring periodontal pocket (with a depth of 5-12 mm) in adult (5-7 years old) beagle dogs. At predetermined time points (i.e. 0.5, 1, 2, 4, 7, 14, 28, 45, 60, 75, 90, 105 and 120 days post implantation, the product will be removed, and the residual chlorhexidine gluconate content in the product will be analyzed. By estimation, a total number of 60 animals (i.e. 5 dogs × 12 time points) with a minimum of 3 eligible periodontal pocket sites at nonadjacent teeth is needed for this project. The time points may be adjusted and/or additional time points may be investigated depending on the observed degradation rate of the polymer matrix of the tablet. The estimated number of animals may change from the proposed budget due to the number of eligible sites upon screening. The study will not be terminated until the product is completely degraded in the periodontal pockets." • The contractor shall obtain IACUC approval. • After obtaining the IACUC approval, the contractor shall submit the approved animal protocol to the FDA for review prior to conducting the animal studies. Please note that FDA will only review the IACUC approved animal protocol. Deliverable of Task 1: IACUC approved animal protocol. Task 2 Ex vivo evaluation of Periochip This task is divided into two steps: • After obtaining the FDA's approval on the animal protocol, the contractor shall conduct the animal study. The contractor shall purchase PerioChip and apply this drug product to a naturally occurring periodontal pocket (with a depth of 5-12 mm) in adult (5-7 years old) beagle dogs. At predetermined time points as defined in the animal protocol, the contractor shall remove the products and analyze the residual chlorhexidine gluconate content in each removed product. • Upon completion of analyzing the last group of samples (when the product fully degrades in vivo), the contractor shall prepare a detailed written report to present the experimental results to the FDA. In addition, please also submit all the raw data that are generated by this contract. Deliverable of Task 2: All the experimental raw data and a detailed written report on the study results.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1146505/listing.html)
- Record
- SN03804518-W 20150723/150721235226-9c40d84c760a6ec903d656bebee9c957 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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