Presolicitation Notice - FDA NCTR Pathology Services.pdf
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- Attached to
- FDA NCTR On-Site Pathology Services Federal contract opportunity
- Solicitation number
- 75F40125R00059_Presolicitation
About this file
This document is a Presolicitation Notice for comprehensive on-site pathology services issued by the U.S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR). The solicitation (75F40125R00059) seeks a contractor to provide extensive pathology support services for animal research, including necropsy, histopathology, special staining, hematology, clinical chemistry, and specialized techniques such as teratology, reproductive toxicology, respiratory pathology, sperm analysis, and mammary whole mounts.
The anticipated contract is a Labor Hour (LH) type with a base period and up to four 1-year option periods, expected to be released on April 30, 2025, with a 30-calendar-day submission window. The procurement is classified under NAICS code 541990 with a small business size standard of $19.5 million, and will be conducted as a full and open competition allowing responses from businesses of all sizes. The contract will support NCTR's internationally recognized toxicological research activities that partner with FDA, other government agencies, industry, and academia to protect public health.
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Text version
Notice Type: Presolicitation Solicitation #: 75F40125R00059 PSC Code: Q515 – Medical-Pathology Services
Comprehensive On-Site Pathology Services The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires comprehensive on-site animal pathology services to support the Center’s animal research program. NCTR is an internationally recognized FDA research center that conducts toxicological research studies and activities designed to support the FDA’s mission to protect the public’s health.
NCTR investigators partner with researchers elsewhere in the FDA as well as other government agencies, industry, and academia.
Pathology support services are ongoing and determined by research protocols written by Center Principal Investigators (PI’s), and range from necropsy of a few animals and collection of a few tissues to complete necropsy of hundreds of animals requiring special handling of tissues, histopathology, special staining or other techniques (immunohistochemistry, digital imaging, etc.), hematology, urinalysis, and/or clinical chemistry. Other required techniques include, but are not limited to, teratology techniques, reproductive and developmental toxicology techniques, respiratory pathology techniques (inhalation toxicology studies), sperm morphology and motility analysis, vaginal cytology, vaginal smears for sperm evaluations, and mammary whole mounts.
Additional Information The associated North American Industry Classification System (NAICS) code for this acquisition is 541990 – All Other Professional, Scientific and Technical Services; the applicable Small Business Size standards is $19.5 million. This requirement is solicited as full and open competition; any business, regardless of size, may submit a response.
FDA solicitation number 75F40125R00059 is expected to be released on or about April 30, 2025, with a closing date of thirty (30) calendar days subsequent to posting. Any resultant contract is expected to be a Labor Hour (LH) contract, and will consist of a base period plus up to four (4) 1-year option periods. It is the contractor's responsibility to monitor SAM.gov/contract opportunities for further information relevant to this solicitation.
Note: The closing date referenced above is contingent upon the expected release date of April 30, 2025 for the solicitation, and serves only as a placeholder field required for publication of this Notice.
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