SOURCES SOUGHT
A -- Absorbable Stent Sub-Unit Testing
- Notice Date
- 7/20/2011
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1088874
- Archive Date
- 8/13/2011
- Point of Contact
- Marcia O Park, Phone: (870) 543-7405
- E-Mail Address
-
marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified small businesses, woman owned small businesses, small disadvantaged businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the items below. The North American Industry Classification System (NAICS) code is 541990 - All Other Professional, Scientific and Technical Services with a small business size standard of $7.0 million dollars. The FDA is interested in finding a Contractor to assist with Absorbable Stent Sub-Unit Testing. Background The Food and Drug Administration is experiencing increased Submissions for cardiovascular stents that are fully bioabsorbable. This device area represents a novel use of bioabsorbable materials and their application to create a fully absorbable cardiovascular stent poses unique preclinical challenges that need to be assessed. These preclinical challenges address safety concerns related to degradation of this device in the presence of mechanical loading, fatigue resistance, and the risk of embolic particle generation prior to complete endothelialization. This project is intended to evaluate the effecs of mechanical loading on the degradation behavior and performance of bioabsorbable materials and medical device forms, specifically stents. Statement of Work The contractor provide fatigue life or fatigue testing "S-N" testing, monitoring, and long term testing on a minimum of multiple specimens to satisfactory completion. Deliverables shall be S-N testing results on bioabsorbable specimens (minimum n-16 specimens) with report; Complete set up of long term fatigue testing; Interim long term fatigue testing reports a 2 distinct pre-specified end points to include information on sample dimensions, weight pre- and post- test, load and displacement monitoring during testing, and other mechanical testing parameters as appropriate; Completion of long term fatigue testing such that a minimum of 12 specimens survive testing over the course of distinct pre-specified endpoints with final report from long term fatigue testing at 3rd and final pre-specified endpoint. End of test information shall include data on sample dimensions, weight pre- and post-, load and displacement monitoring during testing, and other mechanical testing parameters as appropriate. Period of performance is expected to be 15 months. Potential contractors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number and email address of point of contact. Capability statement must provide enough information to determine if company can meet requirements stated above by including technical specifications, descriptive literature, brochures and other information that demonstrates the capabilities of the contractor to meet the requirements. Provide two contact names, email and phone numbers for user of the proposed system that may be contacted by the Government. Identify availability under GSA contract if applicable. Contractors must also be ISO 17025 certified and have expertise with GLP practices. Responses are due in person, by postal mail or by email to the point of contact listed below on or before July 29, 2011 by 1:00 P.M. CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR, 72079-9502. Reference 1088874. Questions regarding this posting shall be submitted via email no later than 1:00 P.M. CDT on July 27, 2011. 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 the 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 solicitation may be published in the 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 a resultant solicitation that may result from this market survey. For information regarding this notice, contact Marcia Park, 870/543-7405, FAX 870543-7990 or email marcia.park@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1088874/listing.html)
- Place of Performance
- Address: Food and Drug Administration, White Oak Campus 10903 New Hampshire Avenue, Building 63, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02504606-W 20110722/110721002459-559cb140aa9e66c0b7f2a8eecb9e9e70 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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