36C24826Q0962.docx

SUBJECT*

Pharmacokinetic Studies

GENERAL INFORMATION

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Ste 160A Tampa FL 33637

POINT OF CONTACT*

N/A

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Special Notice Special Notice

DESCRIPTION

Special Notice

James A. Haley VA Medical Center, 13000 Bruce B. Downs Blvd., Tampa, Florida 33612, intends to solicit emergency sole source to Charles River Laboratories for CRO services for pharmacokinetics and toxicity studies of NPC86.

Charles River Laboratories will perform a pharmacokinetic study and develop a High Performance Liquid Chromatography Mass Spectrometry/Mass Spectrometry (HPLC-MS/MS) method for quantifying the labs in house-drug NPC86.

Each respondent must have an established business, with an office and full time staff to include a "fully qualified" field service engineer (FSE) and a "fully qualified" FSE who will serve as backup. "Fully qualified" is based upon training and on experience in the field on VIIA7 instruments. The contractor shall provide written assurance to the competency of their personnel and a list of credentials of approved FSEs for VIIA7 specifically must demonstrate 3 years’ experience on each instrument. The Contracting Officer (CO) may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VA equipment.

SERVICES TO BE PROVIDED:

1. Development of an HPLC - MS/MS Method for the Quantification of NPC86 in Mouse Plasma:

a. Method Development and pre-validation testing will be conducted over 7 days. Archival of data is included for a period of 1 year(s).

b. Matrix ordered in method development will be used as blank (control) matrix and will also be used in method validation.

2. Optimization and Qualification of an LC-MS/MS RGA2 Method for the Quantification of NPC86 in Mouse Tissues:

a. An LC-MS/MS Research Grade 2 (RGA2) method will be optimized to determine appropriate conditions for the quantification of test article in mouse tissues. Method optimization will include infusion of test article to determine appropriate mass spectral settings, development of LC conditions that produce acceptable chromatography, and assessment of whether instrument sensitivity (based on matrix-free test injections) is suitable for the target assay range.

b. Method optimization will be conducted by the laboratory for up to 1 day.

c. A stable labeled internal standard is preferred for LC-MS/MS methods and if not supplied, the laboratory will assess a provided analog and/or generic compound for this purpose.

d. A RGA2 method is intended to run a standard curve and quality control samples in tissue homogenate and can be used to support non-regulated studies.

e. A previously optimized LC-MS/MS method will be qualified to support non-clinical, non-GLP studies. Method qualification will include a single run containing 2 standard curves prepared in tissue or appropriate surrogate matrix and at least 5 replicate QCs at Low,Mid, and High levels prepared in Mouse tissue homogenate. Pricing includes QCs prepared in one tissue type. May include up to1 additional tissue type at one level. Additional QCs by tissue type may be added at additional cost.

f. Tissue will be purchased from commercial sources and will be used as the blank (control) matrix.

g. Data tables will be provided. 3.

3. A Pharmacokinetic and Biodistribution Study of NPC86 by Intranasal Administration or Intraperitoneal Injection in the C57BL/6 Mouse:

a. Ensure animal welfare compliance through approved procedures, veterinary oversight, and appropriate housing and monitoring.

b. Monitor animals for clinical signs, body-weight changes, adverse effects, or dosing complications.

c. Administer NPC86 consistently by the selected route, such as oral, intravenous, intraperitoneal, or intranasal dosing.

d. Preparing and documenting the NPC86 dosing formulation, including concentration, homogeneity, and stability checks when required.

e. Collect blood and tissue samples at defined time points.

f. Calculating PK parameters such as Cmax, Tmax, AUC, half-life, clearance, volume of distribution, and tissue-to-plasma ratios.

5. Qualifications: The qualifications of the contractor’s personnel shall require expertise uniquely suited to the following:

a. Bioanalytical scientists must be experienced with HPLC/LC-MS method development, tissue extraction, calibration curves, assay qualification, and regulated documentation and must have a B.S, M.S, or Ph.D.

b. The animal research technicians must be trained in husbandry, handling, dosing, sample collection, tissue harvest, and humane care. They must also have experience working under IACUC-approved protocols, animal welfare standards, SOPs, and audited laboratory processes.

The North American Industry Classification System (NAICS) code is 541714, Research and Development in Biotechnology (except Nanobiotechnology).

Any information regarding this requirement must be received no later than 8/17/2026 @ 10:00 AM EST. Please provide a letter from the manufacturer stating authorization to work with Lovell Government Services.

DISCLAIMER

This request for information is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this request for information that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.