SOURCES SOUGHT
A -- SMALL BUSINESS SOURCES SOUGHT NOTICE: LISTERIA CHALLENGE MODEL FOR MICE PRE-DOSED WITH NANOPARTICLES
- Notice Date
- 2/13/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in 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
- SBSSNoFDA-SOL-13-ListeriaChallengeModelforMicePre-DosedwithNanoparticles
- Archive Date
- 3/13/2013
- Point of Contact
- Daniel Gregory Laidlaw Feldman, Phone: 3018270359
- E-Mail Address
-
daniel.g.feldman@fda.hhs.gov
(daniel.g.feldman@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTE: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition (541711, Research and Development in Biotechnology, Size Standard: 500 employees). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). BACKGROUND The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), Division of Drug Safety Research conducts research on the safety, efficacy, metabolism, and other aspects of the mechanisms and effects of pharmaceuticals. The Division of Drug Safety Research has a need to host resistance model using listeria and a Balb/C mouse model pre-dosed with nanoparticles (NPs). Systemic administration of NPs leads to particle accumulation in macrophages of the reticuloendothelial system independent of NP core composition, size, or mode of administration. There is, however, little to no information on whether NP accumulation affects macrophage function in vivo. CDER would like to use the listeria host resistance assay to evaluate the function of macrophages in vivo to determine if the systemic administration of nanoparticles suppresses macrophage function to the point of producing observable disease effects. PURPOSE/OBJECTIVE The purpose of this requirement is to host resistance models using listeria and a Balb/C mouse model pre-dosed with nanoparticles. The listeria host resistance models shall be used to evaluate the immune response of Balb/C mice after they have been pre-dosed with nanoparticles. The Contractor shall determine if nanoparticles cause a delayed immune response to the listeria challenge or cause the mice to have a more severe infection/longer clearance times for the bacteria. The Contractor shall make this determination through an analysis of bacterial titers, blood and serum analysis, animal observations, early death findings, and histopathology analysis. PROJECT REQUIREMENTS To meet the purpose and objective of this requirement, the Contractor shall perform all aspects of this study, including being responsible for animal model set-up, preparation, dosing, and handling, the listeria challenge, necropsy, and all post-dosing tests and analysis. In particular, the Contractor shall perform the following tasks and provide the following deliverables: • Provide a comprehensive written study plan to the FDA project manager (PM) prior to testing, which shall include an outline of all animal handling, the host resistance model, dosing and post-dosing analysis (including bacterial titers, animal observations, blood and serum analysis, and histopathology analysis), and all endpoint and interim data collected during the study, including protocols, such as validation protocols. The Contactor shall discuss with the PM the appropriate handling and disposal of test samples and compounds prior to the initiation of testing and only follow a study plan approved by the PM. • Inject Balb/C mice with vehicle, nanoparticle, or positive control once per week for up to four weeks. The Contractor shall discuss and get approval from the PM concerning the appropriate handling of dosing materials prior to initiation of this study. The Contractor shall perform the injections only in accordance with approved instructions provided by the PM. • Challenge mice with a five to 35% lethal dose of listeria via intravenous injection or vehicle. The Contractor shall use approximately 180 mice with 10 mice per group, six groups, and three time points. The exact number of mice may change based on discussions between the Contractor and the PM and determined by the PM. • Perform bacterial titers during a specified time course: approximately on day one, day four, and day seven of testing. The Contractor shall determine titers in peripheral blood, spleen, liver, and lungs. In addition, the Contractor shall conduct peripheral blood draws for monitoring of cell count and cytokine/chemokine production at appropriate time intervals to be discussed with and approved by the PM. The Contractor shall observe mice daily and record body weights weekly. • Perform a necropsy and histopathology analysis of organs including, but not limited to, the liver, spleen, lung, brain, kidney, and bone marrow. • Dispose of both biological and non-biological samples after analysis in accordance with applicable Federal and state laws. As requested by the PM, the Contractor shall return any unused materials to the PM, including biological samples. • Complete a report delineating the study results. The report shall be a formal written report containing summary, background, methodology, results, and conclusion sections, including summary information as to bacterial models and histopathology results. The Contractor shall include the raw data as an appendix to the report. The Contractor shall provide a draft report to the PM, who will provide feedback to the Contractor within one month of receipt of it. The Contractor shall incorporate the PM's feedback in a final report. All tasks and deliverables will be approved by the PM. All written deliverables, such as study plans and analysis, shall be delivered to the PM electronically in a commonly used format, such as Microsoft Word or pdf. The Contractor must ensure all deliverables and tasks in this requirement meet the requirements of Sections 504 and 508 of the Rehabilitation Act of 1973, as amended, (Rehabilitation Act). The Rehabilitation Act, among other things, requires all electronic products prepared for the Federal Government be accessible to persons with disabilities, including those with vision, hearing, cognitive, and mobility impairments. The Rehabilitation Act insures Federal employees with disabilities will be able to use information technology to do their jobs and that members of the public with disabilities who are seeking information from Federal sources will be able to use information technology to access the information on equal footing with people who do not have disabilities. Information on Section 508 standards can be viewed at www.section508.gov. Work performed in this requirement shall be subject to compliance with the standards in effect as of the award date of the action. ANTICIPATED PERIOD OF PERFORMANCE The FDA anticipates a base period of one year with three one year options. For each option period, the Contractor shall perform the same tasks and produce the same deliverables as delineated in the base period, except the Contractor shall study a different particle for each option period. The FDA anticipates an award date on or around May 1, 2013. OTHER IMPORTANT CONSIDERATIONS Contractor Facility: In accordance with U.S. Department of Health and Human Services Acquisition Regulation (HHSAR) Subpart 370.4, Acquisitions Involving the Use of Laboratory Animals, the Contractor must perform the listeria testing following all applicable rules, regulations, procedures, and protocols, including performing this testing in a certified facility for animal testing. Government Furnished Property: The FDA expects to provide to the Contractor sterile, endotoxin-free nanoparticles for the host resistance model in sufficient quantities for complete dosing of the animals as well as post-dosing analysis. As requested by the PM, the Contractor shall return any unused materials to the PM, including biological samples. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement electronically to Dan Feldman at daniel.g.feldman@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement shall be no more than five pages, excluding a cover page and table of contents, and shall include examples of successfully completing similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, DUNS number and size and business type (e.g. 8(a), HUBZone, etc.) based on the applicable NAICS code for the proposed acquisition (541711, Research and Development in Biotechnology, Size Standard: 500 employees). Potential offerors have until 7:30 am ET, Tuesday, February 26, 2013 to respond to the FDA.
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