Accreditation of CBER’s Laboratory Quality System and Reference Materials Production

Amendment 01:

Question: We are in process of providing a quotation for accreditation services for this contract and have a question. It mentions that there is a possibility of adding up to 30 or so RMPS or tests on the reassessment years. Are you looking for a quotation for that on top of what is currently accredited or is this an informative statement so we are aware modifications of the contract may occur every 2 years because of these requests?

Answer: This is an informative statement that additional test methods and/or reference materials may be added to the current scope of standing accredited methods and reference materials. Currently there are 19 Test Methods accredited, and 3 reference materials. I would like to begin by seeking clarification on the type of procurement document in question. Specifically, I am uncertain whether it is categorized as an RFQ or an RFP.

Answer: The requirement is a Request for Proposal (RFP). Could you present us with more details on how we should fill this attachment. Are you requesting monthly prices or yearly costs ?

Answer: Annual Costs Solicitation number FDA-RFP - 75F40124R00024 is issued as a Request for Proposal (RFP). This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13 and included in this notice. The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2023-03.

The North American Industrial Classification System (NAICS) code for this procurement is 541380, Testing Laboratories. The PSC Code will be PSC Q301 Medical—Laboratory Testing. The objective of this contract is to renew accreditation of CBER’s pharmaceutical testing and reference material production activities to international standard ISO 17025 “General requirements for the competence of testing and calibration laboratories” and ISO 17034 “General requirements for the competence of reference material producers”.

After accreditation is granted, an alternating schedule of biennial on-site assessments and alternating year document reviews is required.

Independently, and not as an agent of the Government, the Contractor shall assess CBER’s 17025 and 17034 Quality System and LQS including previously accredited biological, microbiological, and chemical test methods (currently 21) with no additional new test methods being put forward for the base year but CBER reserves the right to expand its scope in the upcoming option years (approximately 10 per year) along with approximately 30 reference materials. These activities are conducted at only one location in Silver Spring, Maryland. No off-site or mobile testing is performed.