Service: in vivo pharmacokinetic (PK) study of antibody-lectin conjugates, etc 75N94025Q00182

This notice is modified to change the Naics business size standard to $19m, there are no other changes to this notice. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation number is 75N94025Q00182 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2025-05. The North American Industry Classification (NAICS) Code is 541380 and the business size standard is $19m. However, this solicitation is not set aside for total small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is seeking a vendor who can provide the following services/tasks: OBJECTIVE The objective of this requirement is to procure one (1) in vivo pharmacokinetic (PK) study of antibody-lectin conjugates to determine the sera half-life of the labs antibody-lectin conjugates. The NIH lab is seeking a vendor who is a leader in biomedical research, with services offering cutting-edge preclinical services with a strong emphasis on translational science. Have exceptional capabilities in handling complex in vivo models, including genetically engineered mice (eg, transgenic FcRn mice), which are essential for accurately assessing antibody or drug pharmacokinetics. Have integrated analytical support and customizable study design that will enable a lab at the National Institutes of Health (NIH) to address specific research questions with the highest efficiency. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS The required features for the pharmacokinetic study (240234_IVFC) are: Contractor shall provide 35 (21 female and 14 male) transgenic FcRn mice between the ages of 6-8 weeks old. The mice (N=35) will be split into 7 groups of 5 mice each. All mice will be treated with seven different optimized antibody-lectin conjugates on SD 0 through intravenous (IV) injection. In-life blood collections will occur at 5m, and 1d, 3d, 5d, 7d, 10d, 14d, 17d, 24d, and 28d (end-point). A terminal blood collection will be conducted on day 28 for all mice. Blood processing and serum preparations will be conducted on all samples. Additionally, ELISAs will be conducted. A full pharmacokinetic report with analysis will be provided 3 weeks after the end of the experimental work. TASK AREAS Task Area 1 Serum Data - The Contractor shall provide data from ELISA from each bleed to the NPCS by either electronic transfer or hard copy mail as needed. Task Area 2 Final Report The Contractor shall provide a final report via email (to be scheduled by Project Officer); billed upon receipt of the first draft. Task Area 3 Testing - The Contractor shall provide the services contingent upon test system availability. PURCHASE ORDER TYPE This purchase order will be a Firm Fixed Price. ACCREDITATION The Contractor/facility shall be Association for Assessment and Accreditation of Laboratory Animal Care accredited and have rigorous Institutional Animal Care and Use Committee review procedures to ensure the highest quality animal use and care. PERIOD OF PERFORMANCE AND PAYMENT BREAKDOWN The period of performance is: September 2, 2025 September 1, 2026 (Estimate) The period of performance should not start until the purchase order is awarded and will be valid for one year. When applicable, amounts for animal purchases are due upon purchase order award/acceptance, procedures and per diem will be billed monthly in arrears and Administration/Management will be billed monthly on a prorated basis until the end of in-life. INSPECTION AND ACCEPTANCE The Project Officer, Alternate Project Officer, or the Project Officer Supervisor will review and monitor the services provided to ensure services conform with the requirements, TIMELINE Study folders containing raw data and other study-related documents shall be archived by the Contractor for 1 year. At the end of that time, NIH shall be contacted to determine whether documents should be destroyed or shipped to NIH or other designated location. Any samples will be disposed of unless prior arrangements for their return have been made. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Products and Commercial Services (May 2024) (Deviation Feb 2025) with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors Commercial Items; FAR Clause 52.212-2, Evaluation Commercial Items - The Government will award a procurement resulting from this solicitation to the responsible offeror whose offer, conforming to the solicitation, based on lowest price and technically acceptable. FAR Clause 52.212-4, Contract Terms and Conditions Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (Jan 2025) (Deviation Feb 2025); FAR Clause 52.204-8 Annual Representations and Certifications (Jan 2025) (Deviation Feb 2025) Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. Note: The contractor/offeror must provide a completed copy of FAR 52.204-24, "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment" with their quote in response to this solicitation. The clauses are available in full text at http://www.acquisition.gov/far/. Interested vendors capable of furnishing the government with the items specified in this synopsis should submit a copy of their quotation via email to robinsti@mail.nih.gov. Responses to this solicitation must include enough information to establish the interested parties bona-fide capabilities of providing all services and or products needed as per this solicitation. Responses must be accompanied by descriptive literature, warranties, delivery timeframe and/or other information that demonstrates that the offer meets all the foregoing requirements. Quotations will be due on August 22, 2025, before 5:00pm eastern daylight time via email to robinsti@mail.nih.gov. Attn: Tina Robinson. The quotation must reference Solicitation number 75N94025Q00182. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Any questions must be sent via email to robinsti@mail.nih.gov and must include solicitation# 75N94025Q00182 in the subject line of email. Note: In order to receive an award, contractors must maintain an active SAM registration for all awards throughout the entire contract/order lifecycle, from offer submission to final payment. Failure to maintain an active SAM registration can jeopardize the award or result in non-payment. Lack of valid registration in SAM will make an offeror ineligible for award. Note: System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations, including 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals Representation, and paragraph (t) of 52.212-3, Offeror Representations and Certifications Commercial Products and Commercial Services. Agencies will not consider or use these representations. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.