NIH CC Aseptic Processing Facility (APF) Certification and Testing Program

This is a Combined Synopsis/Solicitation for commercial supplies/services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. The NIH CC is the Clinical Research Facility of the NIH. As a national resource, the NIH CC provides the protocol-specific patient care, services, training, and environment needed to initiate and support the clinical research sponsored by the individual NIH Institutes. To meet regulatory requirements in accordance with the Food and Drug Administration (FDA), International Organization for Standardization (ISO) and United States Pharmacopeia (USP) standards for sterile compounding preparations, the National Institutes of Health (NIH), Clinical Center (CC), Office of Research Support and Compliance (ORSC) requires an APF certification and testing program including cleanroom certification services with high efficiency particulate air (HEPA) filter testing and maintenance, air visualization studies (AVS), equipment calibration, and controlled temperature unit (CTU) qualification program at the NIH APF facilities located in Bethesda, Maryland. The Federal Government intends to award a Firm-Fixed Price (FFP) Indefinite-Delivery Indefinite-Quantity (IDIQ) Contract in accordance with FAR 16.504. Period of Performance The Period of Performance for this requirement shall entail a Base Period of twelve (12) months and four (4) one (1) year Option Periods as is listed below: PERIOD OF PERFORMANCE DATES BASE PERIOD May 01, 2021 through April 30, 2022 OPTION PERIOD 1 May 01, 2022 through April 30, 2023 OPTION PERIOD 2 May 01, 2023 through April 30, 2024 OPTION PERIOD 3 May 01, 2024 through April 30, 2025 OPTION PERIOD 4 May 01, 2025 through April 30, 2026 A Request for Quote (RFQ) for the services outlined in this solicitation was issued via GSA eBuy on Friday, January 08, 2021 under Solicitation Announcement # RFQ1470623 implementing a total (100%) Small Business Set-Aside in accordance with FAR 19.502-2. The solicitation closed on Friday, February 12, 2021 with no responses received from Small Business concerns. Therefore, in accordance with FAR 6.102 - Use of Competitive Procedures, this solicitation is being issued using Full and Open Competition (Unrestricted) without giving preference to the Small Business Programs outlined in FAR 19 and FAR 26. All concerns may submit a response to this solicitation. The North American Industry Classification System (NAICS) Code for this requirement is 541380 (Testing and Laboratories) and the Small Business Size Standard is $16.5 Million Dollars in Annual Receipts. Award of this requirement shall be predicated on - Best Value. The Contracting Officer (CO) will determine - Best Value to the Government based on the highest technically rated Offeror whose price is found to be fair and reasonable. A comparative evaluation of offers shall be conducted in accordance with FAR Subpart 13.106-2 (3). The following factors, listed in descending order of importance will be used to evaluate offers: (1) Technical Qualifications, (2) Past Performance, and (3) Price. Technical Qualifications and Past Performance when combined are more important than Price. Quotes are due no later than Friday April 16, 2021 at 12:00 p.m. (EDT) as it is the intent of the Federal Government to make a Contract Award for this requirement by May 01, 2021. The Point of Contact for this acquisition is: NAME: Anthony Q. Hawley TITLE: Contracting Officer (Section Chief) ADDRESS: National Institutes of Health Clinical Center Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892 EMAIL: anthony.hawley@nih.gov All Quotes and Subsequent Quote Materials must be submitted via email to the Contracting Officer. Late or incomplete Quotes will not be considered. The question and answering period for this solicitation commences on Monday, March 08, 2021 and concludes on Monday, March 22, 2021 at 5:00 P.M. (EDT). All questions pertaining to this RFQ shall be submitted in writing to the Contracting Officer at the email address listed above. No telephone calls will be accepted. Any questions received after the aforementioned date and time may not be answered.