SOLICITATION NOTICE
B -- Manufacture of Oral and Topical Dosage Forms
- Notice Date
- 4/8/2004
- Notice Type
- Solicitation Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-47030-45
- Response Due
- 6/30/2004
- Point of Contact
- Kathy Giuliano, Contract Specialist, Phone (301) 435-3821, Fax (301) 402-6699,
- E-Mail Address
-
kg109o@nih.gov
- Description
- The Pharmaceutical Resources Branch (PRB), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking contractors to furnish services for formulation, manufacture, analysis, packaging and labeling of pharmaceutically acceptable oral and topical dosage forms of new anticancer agents in support of NCI-sponsored clinical trials. The most common dosage forms will include capsules, tablets, enteric-coated tablets, ointment and cream. The contractor will perform formulation and process development, manufacture and controls, packaging and labeling of oral and topical drug products to be used in clinical trials. Batch sizes will range from very small batches required for toxicology studies (e.g. 100s of capsules), to larger batches required for Phase II clinical trials (e.g. several thousand capsules or tablets). Data obtained from the contractors will be used to prepare IND application to submit to the FDA. The Principal Investigator should have at least three years of experience in the development and manufacture of oral and topical dosage forms. Other personnel should possess suitable training and experience to insure satisfactory performance of the contract. The facilities and equipment must be adequate to formulate, manufacture and quality controls of oral and topical dosage forms. The facilities should also have adequate air-handling systems to be suitable for handling highly cytotoxic agents. The Government anticipates that a single, cost-reimbursement, incrementally funded contract will be awarded on or before November 30, 2004, for a base period of five (5) years. NAICS code No.325412 with a size standard of 750 employees. The solicitation is scheduled for electronic release on or about April 23, 2004. An Offeror must meet a mandatory qualification criterion which requires the contractors to be a FDA approved manufacturer of oral and topical dosage forms, must have facilities to handle cytotoxic agents and an Offeror's manufacturing facilities must be in compliance with current good manufacturing practices (cGMP) set forth by the FDA. The incumbent is University of Iowa (NCI Contract No. NO1-CM-07100). The RFP may be accessed through Internet access http://rcb.nci.nih.gov/ . IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE INTERNET SITE FOR THE RELEASE OF THIS SOLICITATION AND AMENDMENTS, if any. POTENTIAL OFFEROR'S WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. ALL QUESTIONS MUST BE SUBMITTED IN WRITING VIA ELECTRONIC MAIL OR BY FAX. Point of Contact: Kathleen Giuliano, Contract Specialist, e-mail giuliank@mail.nih.gov FAX: 301-402-6699; Telephone 301-496-8620. Neither telephone questions nor collect calls will be accepted. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (08-APR-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 20-MAY-2004, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. 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-47030-45/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institute of Health, National Cancer Institute, Research Contracts Branch 6120 Executive Blvd, EPS, Suite 6001, Rockville, MD, 20862
- Record
- SN00590004-F 20040522/040520214717 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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