SOURCES SOUGHT
A -- Evaluation of the Ex Vivo Release Profile - FDA SS 1146505
- Notice Date
- 6/26/2015
- Notice Type
- Sources Sought
- 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-SS-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 TITLE: Sources Sought Notice FDA SS-1146505 This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. The North American Industry Classification System (NAICS) code for the proposed acquisition is 325413, In‑Vitro Diagnostic Substance Manufacturing, with a small business size standard of 500 employees. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND: The Food and Drug Administration's Office of Acquisitions and Grants Services have a requirement for detailed description and Evaluation of the ex vivo release profile.. The project will investigate the ex vivo release rate of a long-acting biodegradable periodontal dosage form in a canine periodontal disease model to help the Agency in understanding the in vivo release kinetics of this product and in developing recommendations to determine bioequivalence of generic long-acting periodontal drug products. 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. Estimated timeline: Task 1: Approximately 2 months following the kick-off meeting. Task 2: Sometime between month 6 and month 12 following the kick-off meeting. Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to provide the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses must be received not later than 9:00 AM EST, July 06, 2015. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Telisha.Wilson@fda.hhs.gov with subject line titled "Sources Sought 1146505".
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1146505/listing.html)
- Record
- SN03778531-W 20150628/150626235437-9cc750fb0ae760f8c2e3a97dc850d63d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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