B -- Manufacture of Bulk Chemical and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies

The Pharmaceutical Resources Branch, Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking offerors for the purpose of procurement of bulk chemicals and drugs that are needed by the Drug Treatment Programs (DTP) for preclinical and clinical use. Assigned compounds are not readily available in the quality or quantities required from the original source, other suppliers or the open market. The compounds could be known or new chemicals with a wide variety of chemical structures. Multi-step preparation sequences will generally be involved and process development for scale-up preparation will be expected using provided investigator's procedures. The quantity of a given material synthesized may range from multi-grams to multi-kilograms. All materials prepared will be fully characterized for high purity and the preparative cost will also be calculated. Most of assigned projects should be performed under the current good manufacturing practice (cGMP) complied with the Food and Drug Administration (FDA) rule and regulations. The following MANDATORY QUALIFICATION CRITERIA must be met at the time of receipt of initial proposals by the Contracting Officer in order to be considered for award: (A) All offerors shall be registered with the United States Food and Drug Administration (FDA) as a manufacturer of bulk drugs; and (B) The facilities shall conform to the applicable regulations of the U.S Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), U.S. Department of Transportation (DOT), and those of state and local regulatory agencies. All chemicals handled during the project should be considered to be potentially hazardous and/or toxic and, thus, should be handled accordingly. Offerors will be instructed to describe their safety program and their proposed approach for the handling of hazardous and toxic agents. Submission of safety manuals will be required. In addition, offerors must have facilities to handle cytotoxic agents because most projects involve preparation of potentially carcinogenic compounds (e.g., adequate air-handling system). Multiple awards of cost reimbursement, incrementally funded completion type contracts are anticipated. The contracts will be competed and awarded at two levels, Level I and Level II. Level I awardees are expected to complete 8 to 12 deliveries each year excluding reports and Level II awardees are expected to complete 15 to 25 deliveries each year excluding reports. Monthly progress reports describing work performed and annual project reports will be submitted, but additional reports may be required. Laboratory notebooks containing raw data should be maintained at the contract site for reviewing at the discretion of the Government. Prepared compounds are shipped to the NCI or the NCI repositories along with data sheets. Synthetic procedures and cost information should also be submitted for each compound when available. It is anticipated that resulting awards will be made for a five year base period with two option years. The solicitation is scheduled for release approximately December 2, 2005. Proposals will be due 45 days following the actual date of RFP issuance. This is a 100% small business set-aside under the NAICS Code No. 54171 and a size standard of 500 employees. (See Number Note 1.) The RFP may be accessed through the Research Contracts Branch home page by using the following Internet address: http:/rcb.nci.nih.gov/rfp.htm. It is the offeror's responsibility to monitor the above internet site for the release of the solicitation and any amendments. Point of contact is Diane H. Stalder; electronic mail address ds88b@nih.gov/; phone 301-435-3822; and fax 301-402-6699. NO COLLECT CALLS WILL BE ACCEPTED.