Laboratory Accreditation

MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a sources sought to determine the availability and capability of businesses, both small and large, in providing nationally recognized Laboratory Accreditation. The associated North American Industry Classification System (NAICS) Code is 541990 All Other Professional, Scientific and Technical Services; Small Business Size Standard is $7.0 million.

Part I: General Information (Introduction/Background/Scope)

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisitions Programs (DAP) is conducting market research to support the FDA's requirement for third party laboratory accreditation services by an internationally recognized i.e. International Laboratory Accreditation Cooperation (ILAC) and/or International Accreditation Forum (IAF).

The contractor shall be an International Standards Organization (ISO) 17011 conforming accrediting body to maintain accreditation status of FDA laboratories in compliance with the ISO 17025 and the Association of Official Agricultural Chemists (AOAC) Food and Pharmaceutical Program.

The objective of an accreditation assessment is to establish whether or not a laboratory complies with the accrediting body's requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of the AOAC Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals.

Part II: Supporting Information

A. The Government anticipates issuing an Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle with the issuance of firm-fixed priced task orders for the duration of one (1) base year and four (4) option years.

B. Place of Performance
Locations requiring laboratory accreditation certification services include, but are not limited to the following locations:

FDA Office of Regulatory Affairs
Pacific Regional Lab South West
19701 Fairchild
Irvine, CA 92612

FDA Office of Regulatory Affairs
San Juan District Laboratory
466 Fernandez Juncos Ave
San Juan, PR 00901

FDA Office of Regulatory Affairs
Winchester Engineering and Analytical Center.109 Holton St
Winchester, MA 01890

FDA Office of Regulatory Affairs
Detroit Laboratory
300 River Place, Suite 5900
Detroit, MI 48207

FDA Office of Regulatory Affairs
Kansas City Laboratory
11630 West 80th St.
Lenexa, KS 66214

FDA Office of Regulatory Affairs
Northeast Regional Laboratory
158-15 Liberty Avenue
Jamaica, NY 11433-1034

FDA Office of Regulatory Affairs
Southeast Regional Laboratory
60 Eighth Street NE
Atlanta, GA 30309

FDA Office of Regulatory Affairs
Pacific Regional Laboratory NW
2201 23rd Dr. SE
Bothel, WA 98021

FDA Office of Regulatory Affairs
Denver Laboratory
6th Ave. & Kipling St
DFC-Bldg 20

Denver, CO 80225
FDA Office of Regulatory Affairs
Arkansas Regional Laboratory
3900 NCTR Rd
Jefferson, AR 72079-9501

FDA Office of Regulatory Affairs
Philadelphia Laboratory
US Customs House, Room 900
200 Chestnut St
Philadelphia, PA 19106-2973

FDA Office of Regulatory Affairs
San Francisco Laboratory
1431 Harbor Bay Pkwy
Alameda, CA 94502-7070

Part III: Instructions to Prospective Respondents

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above.

~At a minimum provide: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Indicate whether the organization is the manufacturer of the items or authorized reseller. If reseller, include the manufacturer's name, address and DUNS number.

~Business name and bio, DUNS number, business address, business website, business size status (i.e., LB, SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address;

~Past performance information for the same or substantially similar items, to include date of services, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent;

~Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing;

~If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement;

~Although this is not a request for quote, informational pricing is encouraged;

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested parties must respond with capability statements, which are due in person, by postal mail or email to the point of contact listed below on or before December 23, 2014 by 9:00 AM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, Bldg 50/Room 421, HFT‐320, Jefferson, AR 72079‐9502 or email sondea.blair@fda.hhs.gov. Reference Number 1142466 in all correspondence with the point of contact listed above.

Notice of Intent
Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures.

Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a combined synopsis/solicitation (No. FDA-15-223-SOL-1142466) may be published via FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).