REQUEST FOR INFORMATION Bethanechol – CMC Formulation

Solicitation
Person of Contact Bernadette Davis (bernadette.davis@nih.gov)
Proposal Due Date Monday, July 6, 2026 (Closed 1 week ago)
NAICS Codes 541714, 541715
  • Research Category Research & Development Services & Subcontracts
  • Solicitation Number S26-XX52
  • NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

The Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC), currently operated by Leidos Biomedical Research, Inc. (Leidos Biomed) for the National Cancer Institute, is seeking information regarding validation of analytical methods of Drug Product (DP) manufacturing of a feasibility batch of the inhalation capsule formulation for a 6-month accelerated stability study.

The goal of this project is to support the manufacturing of the clinical GMP batches of the DP and corresponding stability studies.

Bethanechol Chloride powder will be supplied by the GMP API manufacturer, as well as the certificate of analysis, preliminary HPLC method, material safety data sheet and stability data for the API. All excipients should be compendia grade (USP or NF).

As part of this Request for Information, the following information is being requested:

• A Rough-Order-of-Magnitude (ROM) estimate of the above elements inclusive of labor, services fees, materials and supplies, other pass-through costs, and any other costs needed to complete the requested tasks.

• Projected timelines and anticipated period of performance to complete the tasks outlined above.


This Request for Information (RFI) is for INFORMATIONAL PURPOSES ONLY and SHALL NOT be construed as a solicitation or as an obligation on the part of Leidos Biomedical Research, Inc. (Leidos Biomed). All information received will be handled as Proprietary Information. Based on responses, a formal Request for Proposal (RFP) may be issued.



Proposal Instructions

For a copy of the abbreviated scope of objectives, please contact Ms. Bernadette Davis at bernadette.davis@nih.gov

Specific questions about this RFI are due by 3:00 PM ET, on Monday June 29, 2026.

RFI Responses due date by 3:00 PM ET, on Monday, July 6, 2026