FDA-SS_Notice_1160590.pdf

TITLE: Sources Sought Notice FDA SS-1160590

This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below.

The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing, with a small business size standard of 500 employees. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract.

BACKGROUND:

The Food and Drug Administration’s Office of Acquisitions and Grants Services have a requirement to exchange 8 telemetry implantable catheters for an upgrade to the HD-X11 implantable catheters and accessories. The following exchange 8 telemetry implantable catheters technical specifications are as follows:

1. Quantity 8 implantable telemetry HD-X11 probes from DSI with the following :

a. Able to monitor the bio parameters :

i) ECG, EEG and EMG

ii) Systemic blood pressure via the carotid artery

iii) Core and systemic body temperatures.

iv) Animal activity

b. Intuitive, easily understood/used software.

c. Weighs no more than 2.5gms, transducer can’t be no larger than 1.5 cc, must have ONE bio potential lead for ECG, temperature and animal activity

2. Quantity 2: Data Exchange Matrix

a. Dataquest A.R.T Data Exchange Matrix (20 channel) for use with implantable HD-X11 probes equivalent to DSI part number #271-0117-001

b. Include 4 meter cable

c. Include power supply with US power cord equivalent to part number #370-0102-001

i) Should be 120V

3. Delivery & warranty

a. Must include installation and delivery

Please provide the follow Business information:

1. DUNS Number

2. Company Name

3. Company Address.

4. Company Point of Contact, phone number and email address

5. Type of company under NAICS, as validated via the System for Award Management (SAM).

Additional information on NAICS codes can be found at www.sba.gov. Any potential http://www.sba.gov/ government contract shall be registered on the SAM located at http://www.sam.gov/index.asp.

6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.);

7. Current GSA Schedules appropriate to this Sources Sought

8. Current Government Wide Agency Contracts (GWACs)

9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses.

Interested parties having the capabilities necessary to provide the stated requirements may submit capability statements via email or regular mail to the point of contact listed below.

Responses shall be received not later than 10:00 AM EST, January 14, 2016. Capability statements will not be returned and will not be accepted after the due date.

Documentation should be emailed to: Telisha.Wilson@fda.hhs.gov with subject line titled “Sources Sought 1160590”.

http://www.sam.gov/index.asp