A -- DEVELOPMENT OF DOSAGE FORMS AND DELIVERY SYSTEMS FOR ANTITUMOR AGENTS

Notice Date

November 9, 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

N01-CM-27004-19

Response Due

January 7, 2002

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 to develop acceptable dosage forms for compounds to be subsequently evaluated in cancer patients. NCI will select and provide the compounds to be studied. In addition to solubility studies, the projects may require analytical work, particularly the development of a stability-indicating assay to monitor the integrity of the parent compound during the formulation studies. These investigations will be directed toward a pharmaceutical dosage form that will meet certain solubility and stability targets determined by the Government. Data will be submitted to the Project Officer primarily in the form of progress reports but additional reports may be required. The Contractor will be required to maintain laboratory notebooks containing raw data at the contract site. The data will remain at the contract site but copies may be requested at the discretion of the Government. The Contractors may be assigned compounds covered by a discreet agreement. Therefore, the contract will contain the current confidentiality clause in accordance with HHSAR 352-224-70. The Principal Investigator on this project should possess a Ph.D. in Pharmaceutics or Medicinal Chemistry and should also have at least three years experience in the development of injectable formulations. It is anticipated that three (3) cost-reimbursement term (level of effort) type contracts will be awarded for five (5) years. The proposed contract project represents a re-competition of the following contracts: NO1-CM-77109 (University of Arizona), NO1-CM-77017 (University of Kansas), and NO1-CM-77108 (University of Utah). All responsible offerors will be considered. The solicitation is scheduled for electronic release on or about November 29, 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 Staider, 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/N01-CM-27004-19/listing.html)

Record

Loren Data Corp. 20011114/ASOL004.HTM (D-313 SN5127D2)