B -- SHELF LIFE EVALUATION OF INVESTIGATIONAL DOSAGE FORMS

Notice Date

July 30, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Room 608G, Rockville, MD, 20852

ZIP Code

20852

Solicitation Number

N02-CM-27005-19

Response Due

October 5, 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, Diagnosis, and Centers, National Cancer Institute (NCI) is seeking a contractor experienced in analysis and evaluation of clinical pharmaceuticals to provide testing and evaluation of shelf life samples of investigational clinical drug formulations, including both injectable products and oral dosage forms, and report the results of such testing. Data in these reports will provide NCI and its investigators with information regarding the proper storage and handling of various drug products under investigation, for determining appropriate expiration dates for the products, and to support NCI's Investigational New Drug Applications (INDs) files with the Food and Drug Administration (FDA). The Contractor will be responsible for evaluating each of the analytical methods in compliance with FDA requirements prior to use. Currently there are approximately 100 lots of NCI drug products on stability testing. It is anticipated that there will be 10 to 15 new chemical entities each year requiring analytical method evaluation and shelf life determination. These will require approximately 150 separate evaluation per year. The NAICS Code for this acquisition is 54171. It is anticipated that one Performance Based contract will be awarded for a five (5) year period. The proposed contract project represents a re-competition of Contract N02-CM-77013-28. The solicitation is scheduled for electronic release on or about August 30, 2001. The RFP may be accessed through the Internet at http://rcb.nic.hin.gov. It is the offerors responsibility to monitor the above Internet site for solicitation release and any amendments. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. No collect calls will be accepted. =20

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/RCB/N02-CM-27005-19/listing.html)

Record

Loren Data Corp. 20010801/BSOL006.HTM (D-211 SN50T3U0)