75N95021Q00423

Submitted by NIDA_Section on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Develop manufacturable tablet formulation of CD206 Compound NCG72 for Use in Dog Sarcoma Studies
Contracting Office
National Center for Advancing Translational Sciences (NCATS)

Contact Points

Primary Contract Specialist

Andrew
Varley
Andrew.Varley@nih.gov

Secondary Contracting Officer

Kenneth
Goodling
kenneth.goodling@nih.gov
NAICS Code Number
325414
The National Institute on Drug Abuse (NIDA) intends to award a sole source contract under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1 (b) Soliciting from a single source. For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.

This contract will be awarded to University of Kansas Bio Center McCollum Laboratories, 2907 Constant Avenue, Lawrence, KS, 66047 to procure:
• Over 1000 tablets (500-700) tablets of each dosage strength – 200mg, 100mg, 25mg) as required by clinical protocol.
• The compound, NCG00413972 will be administered as a tablet at 3 different dosages to determine its efficacy against sarcomas.
Small Business Size Standard
1,250 employees
FPDS Classification Code
N/A
Estimated Period of Performance
Up to 6 months depending on clinical results
Delivery of Goods
As soon as the order is placed
Competition Status
Non-Competitive
Vendor Name
Kansas University Biopharmaceutical Innovation and Optimization Center
Vendor Address
McCollum Laboratories, 2097 Constant Avenue, Lawrence, KS 66047
Single-Sole Source Determination
The essential characteristics limit the availability to a single source.
Background/Description of Requirement

Non-GMP manufacture of over 1000 tablets (500-700 tablets of each dosage strength - 200mg, 100mg, 25mg) as required by “clinical” protocol. This will require milling of about 300 gms of drug, mixing the milled drug with excipients, tableting three dosage strengths with different size tablets and then insuring appropriate analytical characterization for their release to be used in “clinical” studies. Adequate number of tablets will be made to provide retained samples and place on stability to support at least one year storage. Supplies will be packaged for shipment to sites.  
The compound, NCGC00413972, will be administered as a tablet at 3 different dosages to determine its efficacy against sarcomas.

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.