R -- RFI Foreign Registration Verification program

Description: The Food and Drug Administration (FDA), 5600 Parklawn Drive, Rockville, MD 20857 announces its intention to procure, on a competitive basis, support services for the verification of the registration data of foreign firms shipping regulated products to the US. Potential firms would act as agents of the FDA. This sources sought is a market research tool being used to determine potential and eligible business firms capable of providing the services described herein prior to determining the method of acquisition and issuance of a Request for Proposal (s). All interested businesses are encouraged to respond. The Government is not obligated to and will not pay for any information received from potential sources as a result of this synopsis. The Contractor will support the FDA FY08 Foreign Registration Verification program in multiple world wide locations. We want to be able to utilize this program in any country/continent. A capabilities statement, containing the following, should be sent to Roberta Richardson via email at Roberta.richardson@fda.hhs.gov. Submissions must be received at the office/email cited no later than 2:00 p.m. Eastern Time on November 1, 2007. Questions or comments regarding this notice may be addressed to Ms. Richardson via email. The capabilities statement for interested businesses should contain the following information and is limited to no more than 10 pages in length, single spaced, and 12 point font minimum that demonstrates the company?s ability to perform the services in the attached SOO (attached). This documentation must address, at a minimum, the following: (1) prior/current corporate experience performing efforts of similar size and scope within the last three years, including contract number, organization supported, indication of whether as a prime or subcontractor, contract value, Government point of contact with current telephone number, and a brief description of how the referenced contract relates to the services described herein; (2) company profile to include number of employees, annual revenue history, office location (s), the DUNS number, (3) a statement regarding current small business status; (4) the company?s strategy for adjusting their staffing to accommodate levels of effort over and above their current levels, including possible subcontract/teaming arrangements, (5) the company name; the company address, and Point-of-Contact (name, phone number, fax number, and e-mail address). The capability statement package may be sent by mail to, Roberta Richardson Contract Specialist, 5630 Fishers Lane; HFA -500; Rockville, MD 20857 or by email to Roberta.richardson@fda.hhs.gov. Responses are considered business-sensitive and will not be shared outside of the Government. Place of Performance: Contractors Facility and Other sites as designated by the Government Statement of Objectives The overarching goal of this requirement is to establish a contract relationship with a non-government organization that would conduct an onsite verification of the registration data and product listing information, previously submitted to the FDA, of foreign firms shipping regulated products to the U. S. as Agents of the Food and Drug Administration. This registration verification process would include visiting foreign firms, verifying and documenting submitted registration information and that they exist and manufacture the products that Agency import records indicate they export to the U.S. It would also be necessary for this firm to establish and maintain an internet based database that contains information about the foreign facilities visited, as well as allow FDA internet access to this database. This company would need to provide an electronic report to FDA within 30 days for each firm visited that includes the following: Hard copy reports would also be acceptable when examples of products were collected and could not be scanned. 1. On site Verification and documentation of the facility?s existence (or absence thereof),including photos of the location. 2. Description of attempts to verify the company?s business activities through direct contact with company employees, company materials, or local individuals with relevant knowledge; people interviewed. 3. Samples/examples of labeling of the company?s products and product packaging obtained from the facility location (if any). 4. Identity of the company employee who traveled to, and reported on, the requested location; 5. Participate in a briefing by FDA on expectations 6. Maintain a database of inspected firms and employees Note: All travel will be at the expense of the private organization and should be incorporated in cost per verification activity.