SOURCES SOUGHT
B -- Histopathology of Stented Minipig Iliac Arteries
- Notice Date
- 8/12/2013
- Notice Type
- Sources Sought
- 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
- FDA-SS-1122666
- Archive Date
- 8/31/2013
- Point of Contact
- Tomeka Evans, Phone: 3018277168
- E-Mail Address
-
Tomeka.Evans@fda.hhs.gov
(Tomeka.Evans@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to perform histopathology services for a total of 16 explanted stented arteries from minipigs. The Contractor's capability statement shall demonstrate the company's ability to meet the following requirements. Please provide a detailed description of your company's (including its teammates/subcontractors, if applicable) experience and demonstrated abilities to deliver the following: Background The Food and Drug Administration is conducting a research study to understand the ramifications of corrosion in nickel containing cardiovascular stents. Through FDA's Critical Path Program, the FDA has initiated an animal study to assess whether current pre-clinical corrosion testing accurately captures observed in-vivo corrosion and nickel leaching. To understand the effects of corrosion on local tissue response, the FDA seeking sources that has capabilities and expertise to perform histopathology on cardiovascular stents implanted within minipig iliac arteries. This work must be performed by an entity that has expertise in histopathology, including soft tissue dehydration, processing, embedding arteries in plastic or paraffin, sectioning of stented arteries, staining for morphology, imaging of sections, and histological analysis. Objective The FDA is seeking local sources (facility within 50 miles of Silver Spring, MD) that have an excellent record of conducting and publishing quality histopathology of stented arteries to perform histopathology services for a total of 16 explanted stented arteries from minipigs. The following services are required: 1. Provide histopathology and analysis on sixteen (16) stented minipig iliac arteries (8 single stented arteries and 8 overlapped stented arteries). The contractor will be provided sixteen (16) stented arteries from the FDA/CDRH/OSEL/DSFM to perform the histopathology services. 2. For all nitinol stented arteries, histological processing that includes soft tissue trimming, dehydration, processing, embedding stented arteries in plastic and non-stented sections in paraffin, sectioning of stented arteries, and staining of sections. 3. For single nitinol stented arteries (n=8), provide at minimum the following: a. 2 paraffin sections proximal and distal to stented region (3-5 microns each) b. 3 plastic (MMA) cross sections of stented tissue region (approximately 50 microns each) equally spaced through 30 mm length of stented artery stained with Toluidine Blue-Basic Fuchsin c. 3 plastic (MMA) cross sections of stented tissue region (approximately 4-6 microns each) stained with Hematoxylin and Eosin (H&E) and modified Movat Pentachrome 4. For overlapped nitinol stented arteries (n=8), provide at minimum the following: a. 2 paraffin cross sections proximal and distal to stented region (3-5 microns each) b. 5 plastic (MMA) cross sections (approximately 50 microns each) of stented tissue region (1 in proximal single stented region, 3 in overlapped stented region, and 1 in distal single stented region) stained with Toluidine Blue-Basic Fuchsin c. 5 plastic cross sections (approximately 4-6 microns each) of stented tissue region (1 in proximal single stented region, 3 in overlapped stented region, and 1 in distal single stented region) stained with Hematoxylin and Eosin (H&E) and modified Movat Pentachrome 5. Digital optical imaging of all sections with histopathology analysis for inflammation, vessel damage, lumen area, and stenosis. 6. Preparation of a technical report that will be submitted after histopathology analysis. The following needs to be included in the report a. Images of all stained sections b. Semi-quantitative scoring of inflammation c. Quantitative metrics such as percent stenosis and lumen area d. Any qualitative observations of injury, inflammation, thrombosis, restenosis, or remarkable features The deliverables (technical report, histology slides, and remaining embedded tissue) will be as follows: a. First 3 stented arteries  Nov 4th (stents are anticipated to be delivered to contractor week of Sep 3rd 2013) b. Next 5 stented arteries  Jan 14th 2104 (stents are anticipated to be delivered on week of Nov 11th 2013) c. Next 4 stented arteries  May 15th 2014 (stents are anticipated to be delivered on week of March 10th 2014) d. Last 4 stented arteries  Aug 15th 2014 (stents are expected to be delivered on week of June 16th 2014) 5. Duration of Project The period of performance will be 1.5 years from awarding of contract. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and Fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541712 (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) to be considered as potential sources. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email to Contract Specialist Tomeka Evans at email address Tomeka.Evans@fda.hhs.gov no later than 1:00 PM Eastern Standard time on August 16, 2013 for consideration. Responses to this announcement will not be returned, nor any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1122666/listing.html)
- Place of Performance
- Address: within 50 miles of Silver Spring, MD, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03145134-W 20130814/130812234635-1b5499285a0b4a01a0d40bf1bae5675b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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