SOURCES SOUGHT
A -- Hip Simulator Study of Mal-Positioned Metal-on-Metal Hip Replacements - Description of Requirements
- Notice Date
- 8/20/2013
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies 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-1119682
- Archive Date
- 8/24/2013
- Point of Contact
- Joy Garnett, Phone: 3018270469
- E-Mail Address
-
joy.garnett@fda.hhs.gov
(joy.garnett@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Description of Requirements CONTRACTING OFFICE U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) / Office of Acquisitions and Grants Services (OAGS) 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 a hip simulator research study of mal-positioned metal-on-metal hip replacements in accordance with the attached Statement of Work. The Contractor's capability statement shall demonstrate the company's ability to meet the FDA's requirements as defined in the attached Statement of Work (SOW). Please provide a detailed description of your company's experience (including its teammates, if applicable) and demonstrated abilities to meet the requirements of this research study. ANTICIPATED PERIOD OF PERFORMANCE The period of performance shall be for a period of one (1) year from the date of award. Capability Requirement: The Contractor should have the following qualifications in order to participate in this project: 1. Already owns at least n=20 virgin (unused) large diameter (greater than 45 mm) MoM total hip bearings for study in hip simulators. 2. The Contractor shall have expertise and be considered an expert in implant analysis and hip joint simulation. The Contractor must be able to show published studies on explant analysis and hip join simulation, specifically with reference to MoM hip bearings, wear rates, debris and metal ion analyses. 3. Have a demonstrated publication record to include a significant number of peer reviewed journals elated to tribological and biomaterial studies of hip joint replacements. 4. The Contractor shall have a significant number of publications and presentations (peer review journal articles, conference abstracts, book chapters) related to MoM hip bearings and explant analysis (wear rates, debris, and metal ion analyses). 5. Contractor shall have a good working relationship with industry member(s) that may be able to assist in this project. 6. The Contractor shall have demonstrated collaborations with orthopedic surgeons with experience in MoM hip surgery. 7. The Contractor shall immediate access to hip joint simulators with a capacity of at least 12 stations. At least one of these hip simulators is required to have: (1) microseparation fixtures capable of simulating 3mm of joint laxity, and (2) accept fixtures large enough to mount 60mm diameter MoM cups. 8. Have immediate access to an analytical facility that includes, (1) a coordinate measuring machine (CMM) with an accuracy of approximately 1 micron, and (2) a 3D modeling software package capable of discriminating linear and volumetric wear magnitudes of MoM devices. 9. The Contractor must have immediate access to the following laboratory equipment: (1) surface roughness interferometer, (2) a reflective-light microscope (RLM), (3) a scanning electron microscope/EDS combination (SEM), (4) a high precision (0.1mg) micro-balance capable of measuring large MoM bearings, and (5) wear particle extraction equipment/expertise, including centrifuges/filtration systems, etc. 10. Contractor shall abide by Good Laboratory Practices (GLP) when conducting all applicable testing and analyses and is conversant with standard guidelines (ISO 17025). 11. Contractor shall be actively involved with standards groups, such as American Society for Testing and Materials (ASTM) on topics relating to MoM hip bearings. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FASCIMILE 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 Code 339113 and classification such as an 8(a) firm, Small Disadvantaged Business (SDB), Woman-Owned Small Business (WOSB), HUBZone firm, and/or Service-Disabled Verteran-Owned Small Business (SDVOB). If qualified as an 8(a) firm, SDB, or HUBZone, your form must be certified by the Small Business Administration. If qualified as a SDVOB, your firm must be listed in the VetBiz 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 Special Item Numbers (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 that 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 Ms. Joy Garnett at Joy.Garnett@fda.hhs.gov no later than 2:00 PM EST on Friday, August 23, 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 for the purposes of conducting market research and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
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