Name | Type | Posted | Actions |
|---|---|---|---|
05. Solicitation Amendment # 0002.pdf | Apr 6, 2021 | ||
05. Solicitation Amendment # 0001.pdf | Mar 31, 2021 | ||
01. Price Schedule.xlsx | XLSX | Mar 31, 2021 | |
01. RFQ - HHSN-21-Q-000048.pdf | Mar 8, 2021 | ||
04. Baseline Equipment and Calibration Needs.xlsx | XLSX | Mar 8, 2021 | |
04. Current and Future APF Room and PEC Needs.xlsx | XLSX | Mar 8, 2021 | |
04. Attachment C001 - CCE 2J Duct Layout East HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C002 - CCE 2J Duct Layout West HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C009 - PET GMP Lab B3 Layout HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C004 - DLM Sterility Lab Reflected Ceiling Plan HEPA.pdf | Mar 8, 2021 | ||
04. Attachment C005 - NCI TIL Modular Ceiling Plan HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C006 - NCI TR-10B Reflected Ceiling Plan HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C007 - NCI 1B42 Reflected Ceiling Plan HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C012 - Pharmacy P-IVAU - Reflected Ceiling Plan HEPA 65. pdf.pdf | Mar 8, 2021 | ||
04. Attachment C011 - Pharmacy IIVAU Reflected Ceiling Plan HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C003 - CCE Terrace Modular Reflected Ceiling Plan HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C010 - Pharmacy E-IVAU Reflected Ceiling Plan HEPA Locations.pdf | Mar 8, 2021 | ||
04. Attachment C008 - NCI 3W MECH Layout.pdf | Mar 8, 2021 |
NIH CC Aseptic Processing Facility (APF) Certification and Testing Program
Contact and place of performance
Anthony Q. Hawley
Bethesda, MD 20814
USA
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 rese...
View moreThe National Institutes of Health (NIH) Clinical Center, Office of Research Support and Compliance, requires an APF certification and testing program to support sterile compounding preparations in Bethesda, Maryland. This requirement includes cleanroom certification services, high efficiency particulate air (HEPA) filter testing and maintenance, air visualization studies, equipment calibration, and a controlled temperature unit qualification program. These services ensure the facility meets regulatory requirements established by the Food and Drug Administration, International Organization for Standardization, and United States Pharmacopeia. The government intends to award a firm-fixed-price, indefinite-delivery indefinite-quantity contract with a one-year base period starting May 1, 2021, followed by four one-year option periods ending April 30, 2026.
This acquisition, identified under solicitation number HHSN-21-Q-000048, is being conducted via full and open competition following a previous small business set-aside attempt that yielded no responses. The requirement is classified under NAICS 541380 for Testing Laboratories and Services and PSC H966 for Other QC/Test/Inspect- Instruments and Laboratory Equipment. Evaluation for award is based on best value, considering technical qualifications, past performance, and price, where technical and past performance factors are more important than price.
Quotes are due by April 16, 2021, and must be submitted via email to the primary point of contact, Contracting Officer Anthony Q. Hawley. The solicitation includes 18 attachments, such as price schedules, equipment and calibration needs, and multiple solicitation amendments. The question and answer period for this notice concluded on March 22, 2021. All performance will take place at the NIH APF facilities in Bethesda, Maryland.
Generated by Lumen AI
Scoped analysis and attachments—go beyond the summary when you need detail from the solicitation package.