SOLICITATION NOTICE
B -- Shelf Life Evaluation of Investigational Dosage Forms
- Notice Date
- 7/30/2001
- Notice Type
- Solicitation Notice
- 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
- 10/5/2001
- Point of Contact
- Diane Stalder, Contract Specialist, Phone (301) 435-3822, Fax (301) 402-6699, - MaryAnne Golling, Contracting Officer, Phone (301) 435-3819, Fax (301) 402-6699,
- E-Mail Address
-
ds88b@nih.gov, mg345x@nih.gov
- Small Business Set-Aside
- N/A
- 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. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (30-JUL-2001). IT ACTUALLY FIRST APPEARED ON THE FEDBIZOPPS SYSTEM ON 17-APR-2002. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/RCB/N02-CM-27005-19/listing.html)
- Place of Performance
- Address: Contractor facility
- Record
- SN00061977-F 20020419/020417214550 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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