SOLICITATION NOTICE
B -- Manufacture of Bulk Chemicals and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies - FedBizOpps_Presolicitation_Announcement
- Notice Date
- 2/9/2017
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CM77007-98
- Archive Date
- 2/27/2017
- Point of Contact
- Stephen C. Shaffer, Phone: (301) 624-8759, C. Timothy Crilley, Phone: (301) 624-8743
- E-Mail Address
-
Stephen.Shaffer@nih.gov, tcrilley@mail.nih.gov
(Stephen.Shaffer@nih.gov, tcrilley@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- FedBizOpps_Presolicitation_Announcement Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments that may be issued. This acquisition is being advertised as a 100% set-aside for small businesses. The Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), supports the NCI's Experimental Therapeutics (NExT) to facilitate the transition of novel drug discoveries into clinical trials of new cancer therapeutic agents. One of essential parts of the program involves the manufacture and supply of bulk chemicals/drugs that are prepared under the current Good Manufacturing Practice (cGMP). The bulk materials will be used to support pre-clinical studies and to prepare clinical products that are necessary to support human clinical trials under the NCI sponsorship or investigator initiated Investigational New Drug Applications (IND). The Pharmaceutical Resources Branch (PRB), DTP/DCTD/NCI is seeking a contractor that will provide services, personnel, equipment, and facilities as required to perform process development and synthesis of bulk materials under cGMP conditions. The quantity of a given material to be synthesized may range from multi-grams to multi-kilograms. The materials are required to be highly pure and well characterized. They are intended for use in formulation development, pharmacology, toxicology and clinical trials. These materials are not readily available in the quality or quantities needed from the original supplier or on the open market. Major aspects of the contract work scope will include: (1) cGMP process development to transform laboratory-scale procedures to large-scale process; (2) synthesis of bulk chemicals/drugs on multi-grams to multi-kilograms scale as needed; (3) analysis for ensuring the purity, identity and quality of the prepared compounds including QA/QC for the cGMP batches; and (4) additional studies such as solubility/stability as needed. Technical reports submitted by the contractors may be used to support the filing of IND applications to the Federal Drug Administration (FDA). Request for Proposal (RFP) N02CM77007-98 will be available on/or about February 28, 2017 and receipt of proposals will be due at 3:00 PM EDT on/or about March 30, 2017. The RFP will only be available electronically and must be accessed through the FedBizOpps website or the National Cancer Institute homepage at http://rcb.cancer.gov/rcb-internet/index.jsp. Once there, click on solicitations. All information required for submission of a proposal will be contained in the electronic RFP package. Potential offerors will be responsible for downloading their own copy of the RFP and any amendments, failure to do so will be at your firm's own risk. It is the offeror's responsibility to monitor the above websites for the release of this RFP and amendments, if any. All responsible sources may submit a proposal which will be considered by the agency. This solicitation is anticipated to result in one award to an offeror capable of performing all aspects of the work described in the Statement of Work (SOW). It is anticipated that a single award, cost reimbursement type contract will be awarded. To be awarded on or before July 31, 2017, for a period of performance of one-year with four one-year options, for a total of five years if all options are exercised. The Government's estimated effort for this project is 4,350 hours annually or 21,750 hours over the five-year period of performance, if all options are exercised. This advertisement does not commit the United States Federal Government to award any contract. The North American Industry Classification System (NAICS) code is 325412, with a current size standard of 1,250 employees. This is a recompetition of contract numbers HHSN261201200020C and HHSN261201200021C, awarded to Alchem Laboratories, Inc. and Starks Associates, Inc. respectively. Both contracts were for the five-year period of performance. Freedom of Information Act (FOIA) requests regarding the current contract's should be directed to Suzy Milliard at milliars@mail.nih.gov. This notice does not commit the Government to award a contract. No collect calls will not be accepted. No facsimile or email transmissions will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CM77007-98/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN04397263-W 20170211/170209234434-b23ee4521b4f891e8998306dc024ba8d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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