FDA_NOI__1169147.doc

PRESOLICITATION NOTICE: INTENT TO AWARD A SOLE-SOURCE CONTRACT

INTENDED SOURCE: Quo Data: Kaitzer Str. 135 Dresden, SA 01187 ANTICIPATED PERIOD of PERFORMANCE: September 30, 2016 – September 29, 2017

DESCRIPTION OF REQUIREMENT:

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, the U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) intends to award a sole source contract to Quo Data, Kaitzer Str., Dresden , SA 01187 for Technical services to incorporate International Organization for Standardization (ISO) standards and methods to FDA’s Proficiency Testing (PT) program.

The applicable North American Industry Classification System (NAICS) code for this acquisition is 541611 "Administrative Management and General Management Consulting Services.”

FDA has a need to obtain technical services to incorporate International Organization for Standardization (ISO) standards and methods to FDA’s Proficiency Testing (PT) program.

In order to successfully perform the services, the Government requires qualified Contractor personnel who have:

· mathematician and statistician skills with strong experience in data science, advanced programming skills and experience in food microbiological and chemical analysis;

· long-term experience in validation and standardization of methods and in the conduct, analysis and interpretation of collaborative studies;

· publications in peer-reviewed journals on statistical methods for validation of both quantitative and qualitative methods; and

· expertise in international standards of such as ISO 13528, 16140, 5725, Guide 34 and similar.

The Government intends to solicit and negotiate directly with Quo Data and no solicitation will be issued. This notice of intent is not a request for competitive proposals or quotations; however, if any interested party believes they can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities must be submitted in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. All interested parties must express their interest and capabilities in writing via email to Robert.Maydwell@fda.hhs.gov within fifteen (15) days after the date of publication of this notice. No faxed documents will be accepted. If no responsive statements are received within fifteen (15) days, an award will subsequently be made to Quo Data.

This is a Federal contract opportunity; FDA-NOI-1169147 for services at Food and Drug Administration Office of Acquisitions and Grants Services - Rockville, MD. Response Due NLT 2:30 PM EST August 17, 2016.

Due

08/17/16

Solicitation Number

FDA-NOI-1169147

Set-Aside

No Set-Aside Used

Contact(s)

Robert Maydwell

Category Technical services to incorporate International Organization for Standardization (ISO) standards and methods to FDA’s Proficiency Testing (PT) program.

Agency

Department of Health and Human Services

Office

Food and Drug Administration

Location

Office of Acquisitions and Grants Services - Rockville