B -- ANALYSIS OF ANTI-CANCER CHEMICALS AND PHARMACEUTICAL FORMULATIONS

Notice Date

October 2, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Room 604, Rockville, MD, 20852

ZIP Code

20852

Solicitation Number

N02-CM-27008-19

Response Due

November 30, 2001

Point of Contact

Diane Stalder, Contract Specialist, Phone (301) 435-3822, Fax (301) 402-6699, Email ds88b@nih.gov -- MaryAnne Golling, Contracting Officer, Phone (301) 435-3819, Fax (301) 402-6699, Email mg345x@nih.gov

Description

The Pharmaceutical Resources Branch of the Developmental Therapeutics Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (PRB/DTP/DCTD/NCI) is seeking contractors experienced in the analytical assessment of bulk drug substances and clinical drug products to provide analytical services. Analytical information generated under these contracts will be used for pre-clinical and clinical development of drug candidates. Data provided in the analytical reports will be supplied to the Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) filings for anti-tumor agents. Historical summaries of the data are used in preparing specifications for the various bulk drug substances. These specifications are used in procurement actions as well as for the routine control of these materials. The Contractors selected should be experienced in the analytical assessment of bulk drug substances and will be expected to have operational equipment and capabilities. All materials to be analyzed will be assigned and usually supplied by the NCI Project Officer. The Project Officer will transmit with each sample a Request for Analysis. Each Contractor shall complete and deliver approximately 40 to 50 Requests for Analysis assignments each year. The Contractors shall consider the chemicals and drugs to be analyzed under the proposed contract as proprietary in nature. The Contractors shall maintain laboratory notebooks containing raw data at the contract site. All data generated under the proposed contract are property of the Government and must be supplied to the Government upon request. All chemicals and drugs handled during the project should be considered potentially toxic, and thus, handled accordingly. Offerors will be instructed to describe their safety program and their proposed approach for the handling of toxic agents. Proposals will be evaluated as to the adequacy of their facilities and their proposed methods of handling these agents. It is anticipated that three (3) cost-reimbursement, completion type contracts will be awarded for a period of five (5) years. The proposed contract project represents a re-competition of the following contracts: Midwest Research Institute (NO1-CM-77014), Research Triangle Institute (NO1-CM-77103), and SRI International (Nol-CM-77104). All responsible offerors will be considered. The solicitation is scheduled for electronic release approximately October 19, 2001. The proposals will be due approximately 30 days following the actual date of RFP issuance. The RFP may be accessed through the Research Contracts Branch Home Page by using the following internet address: http://rcb.nci.nih.gov/ It's the offeror's responsibility to monitor the above Internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Diane Stalder, Contract Specialist, at e-mail: ds88b@nih.gov; FAX: 301-402-6699; Telephone: 301-435-3822. No collect calls will be accepted.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/RCB/N02-CM-27008-19/listing.html)

Record

Loren Data Corp. 20011004/BSOL004.HTM (A-275 SN50Z708)