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FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 26, 2015 FBO #5116
DOCUMENT

65 -- Orthopedic Implants (Hips and Knees) Adult Surgical Procedures - Attachment

Notice Date

11/24/2015
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Fredericksburg VA 22408
 

ZIP Code

22408
 

Solicitation Number

VA11916N0086
 

Response Due

12/8/2015
 

Archive Date

2/6/2016
 

Point of Contact

Henry T. Wells
 

E-Mail Address

304-4514<br
 

Small Business Set-Aside

N/A
 

Description

Description Subject: Request for Information (RFI/Sources Sought, Synopsis for Orthopedic Implants (Hips & Knees) adult surgical procedures, for the Department of Veterans Affairs, Veterans Healthcare Administration's (VHA) Prosthetic Clinical Management Program (PCMP). The Department of Veterans Affairs; Office of Acquisition Operations, Strategic Acquisition Center (SAC) is issuing this Request for Information (RFI) in accordance with Federal Acquisition Regulations (FAR) 15.201(e) for market research purposes. The Strategic Acquisition Center is requesting responses from qualified businesses capable of providing Orthopedic Implants (Hips & Knees) to the Department of Veterans Affairs. This notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, or request for proposals. This Sources Sought effort is intended to gain knowledge of potential qualified sources, their knowledge of the Medical Surgical Prime Vendor program (MSPV) and solicit feedback for acquisition planning purposes. Potential vendors are encouraged to submit a minimum two, no more than three page non-binding statement of interest that includes the requested responses demonstrating their capabilities. Responses to this Sources Sought are not considered adequate responses to a solicitation announcement. The applicable qualifying NAICS code for this effort is 339113 Surgical Appliance and Supplies Manufacturing. Small Business size standard for the specified NAICS code is 500 employees. The SAC is issuing this Sources Sought as a means of conducting market research to identify qualified vendors with the capability and the resources to provide Orthopedic Implants for total hip and knee replacements. According to 21 Code of Federal Regulations (CFR) Part 807 Subpart E, a manufacturer cannot commercially distribute medical devices in the United States until FDA authorization is obtained. The subject vendors should have the ability to provide these devices throughout the VA enterprise wide (i.e. VA facilities in the U.S., U.S. Territories, Puerto Rico, and the Philippines). Business concerns must demonstrate the ability to meet the requirement for the following: PRODUCT IDENTIFICATION AND MINIMUM TECHNICAL REQUIREMENTS (MTR's) PRODUCT LINE - HIPS 1.Primary Total Hip Cemented 2.Primary Total Hip Uncemented 3.Primary Total Hip Hybrid 4.Hemi Arthroplasty Hip 5.Uni Polar Hip 6.Bi Polar Hip 7.Primary Total Hip Cemented 8.Primary Total Hip Uncemented 9.Primary Total Hip Hybrid 10.Hemi Arthroplasty Hip 11.Uni Polar Hip 12.Bi Polar Hip PRODUCT LINE - KNEES 1.Primary Total Knee Cemented 2.Primary Total Knee Uncemented 3.Primary Total Knee Hybrid 4.Primary Total Knee Cemented 5.Primary Total Knee Uncemented 6.Primary Total Knee Hybrid REQUESTED INFORMATION: If your business can provide Orthopedic Implants (Hips & Knees), as a distributor or manufacturer, please submit a non-binding statement of no more than three pages providing the following information. 1. Company Name: 2. Capability Statement. Provide a tailored capability statement, specific to this RFI. The response should clearly describe business capabilities to deliver their full product line of Hip and Knee Implants. 2.Socio-economic status and business size. Specifically, indicate whether your business is a certified Service Disabled Veteran Owned Small Business (SDVOSB) and registered in VetBiz Registry at http://www.vetbiz.gov, or a Veteran Owned Small Business (VOSB) 3.If Small Business (SB), indicate if your firm qualifies as a (a) small, emerging business, or small disadvantage business, (b) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act 4.If SB are you a distributor or a manufacturer 5.If Large Business (LB) who are your authorized distributors 6.Provide the DUNS number of your business 7.State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov 8.Provide current pricing for items listed reference product Line MTR table. 9.Whether or not the company is currently affiliated or familiar with the Med Medical Surgical Prime Vendor program 10. If yes to #9, Provide the link to the Veterans Affairs Federal Supply Schedule (FSS) information including schedule/contract number, point of contact and commodity schedule listing the specified items reference product ID # MTR table 11.State explicitly whether or not the required commodities are on your GSA Federal Supply Schedule and that they meet the Minimum Technical Requirements (FSS Holders only) 12.Provide the link to the General Services Administration (GSA) schedule information including schedule/contract number and commodity schedule listing the specified items reference product Line MTR table (FSS Holders only) 13.Product information, literature, or electronic catalog information. 14.Are the product(s) made in the United States 15.Please answer all of the following additional questions: a.Can you provide National Coverage of Services (VA facilities in the U.S., U.S. Territories, Puerto Rico, and the Philippines)? b.Can you provide a listing of Qualification and Certification of potential Reps? c.Do you currently have a Training Program for Operating Room (OR) personnel? d.Do you currently have Procedures and Policies on tracking trends and failure of products? e.Can you provide a Declaration that manufacturing meets the Trade Agreement Act? 16.Provide comments, questions and/or recommendations on the above MTRs Responses are due by 3:00 PM EST, December 8, 2015. Please submit email responses to Contract Specialist, Henry Wells, at Henry.Wells@va.gov please include in the subject line of your email the following: "Attention: Orthopedic Implants." This notice is to assist the VA in market research identifying potential sources only. Issuance of this notice does not constitute an obligation on the part of the Government to procure these commodities or to issue a solicitation nor to notify respondents of the results of this notice. No solicitation document exists at this time. The VA is neither seeking proposals nor accepting unsolicited proposals, and responses to this notice cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The Government will not pay for any information or administrative costs incurred in response to this Sources Sought Notice.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/db7778c792f80670f8d348f29ea899a1)
 

Document(s)

Attachment
 

File Name: VA119-16-N-0086 VA119-16-N-0086_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2433120&FileName=VA119-16-N-0086-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2433120&FileName=VA119-16-N-0086-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03954523-W 20151126/151124235159-db7778c792f80670f8d348f29ea899a1 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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