Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF MAY 06, 2016 FBO #5278
SOURCES SOUGHT

66 -- THRESHOLD TOTAL SYSTEM DNA STARTER KIT - THRESHOLD TOTAL SYSTEM, DNA STARTER KIT

Notice Date

5/4/2016
 

Notice Type

Sources Sought
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-SS-1165423
 

Archive Date

5/27/2016
 

Point of Contact

NAOMI CARTER,
 

E-Mail Address

NAOMI.CARTER@FDA.HHS.GOV
(NAOMI.CARTER@FDA.HHS.GOV)
 

Small Business Set-Aside

N/A
 

Description

THRESHOLD TOTAL SYSTEM, DNA STARTER KIT TITLE: Sources Sought Notice FDA SS-1165423 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 1000 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 and OPQ is seeking to conduct analytical studies addressing the quantitation and characterization of host cell DNA impurities in complex drug products of biological origin and biologics. Adopted methodologies must be highly sensitive and non-sequence specific in order to detect low levels of potentially unknown DNA sequences in biologically sourced drug products. Requirement for System and service maintenance agreement with four option years for the following: •THRESHOLD TOTAL SYSTEM, DNA STARTER KIT, ENTERPRISE ADMINISTRATOR V1 1, THRESHOLD ENTERPRISE V1 0 2 LICENSE, THRESHOLD ENTERPRISE V1 01 VAL package, and Onsite assurance digital IQ OQ service site for Threshold. Scope: The scope of work covers the purchase of a DNA quantification system that is sensitive at the low picogram level and is not sequence specific. Technical Requirements: -The system shall detect and quantify total DNA within a drug sample on a non-sequence specific basis. -The system shall have a lower limit of detection at or below 10 picograms. -The system shall be easy to use. -The system shall have a reasonably short total assay time (less than one day). -The system package shall include associated workstation, software and installation. -The system shall be furnished with start-up supplies including assay reagents and any necessary consumables. -The system shall be able to fit easily on a laboratory benchtop (i.e. two cubic feet or less, 50 pounds or less). -The system shall have minimal waste that can be redirected into a waste container. Vendor Tasks: -The vendor shall deliver a system that meets the above specifications to the DPA laboratory in St. Louis, MO. -The vendor shall perform and document IQOQ including installation and testing. -The system package shall include a one year limited warranty for parts and labor. -The system package shall include application training for key personnel. 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 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 3:00 PM EST, May 12th, 2016. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Naomi.Carter@fda.hhs.gov with subject line titled "Sources Sought 1165423".
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1165423/listing.html)
 

Place of Performance

Address: Food and Drug Administration, St. Louis, Missouri, 63110, United States

Zip Code: 63110
 

Record

SN04105160-W 20160506/160504234212-aff6e0f4ad93a2730f5db6738aab804d (fbodaily.com)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |