SOLICITATION NOTICE
B -- Development and Production of Parenteral Dosage Forms for Clinical Studies - Statement of Work
- Notice Date
- 7/18/2012
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- N02CM37000-11
- Archive Date
- 8/20/2012
- Point of Contact
- Brenda Oberholzer, Phone: 301-624-8750
- E-Mail Address
-
oberholzerb@mail.nih.gov
(oberholzerb@mail.nih.gov)
- Small Business Set-Aside
- Partial Small Business
- Description
- Statement of Work as referenced in body of Presolicitation Notice. The Development Therapeutics Program (DTP) of the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is soliciting organizations to develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, DCTD will be as¬signed for development and production as parenteral products. Batch sizes shall range from small batches (100 - 200 units) to intermediate size batches to be used in Phase I and II trials (1,000 - 5,000 or more units). The capability to develop and manufacture other pharmaceutical dosage forms (i.e. sterile emulsions, liposomes and sterile micro-dispersions) is desirable. Data obtained from resulting contract(s) may 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration as well as foreign agen¬cies, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, nurses, and other medical personnel handling these products in a clinical setting. The contract type is multiple award, five (5) year, Indefinite Delivery Indefinite Quantity (IDIQ) type contract. Task Orders will be either cost reimbursement completion or fixed price completion. Offerors will be invited to submit proposals for approximately 6 Development Task Orders and 12 Productions Task Orders as described in the Statement of Work (SOW). The following mandatory qualification criteria will apply: The Offeror must be registered with the FDA as a pharmaceutical manufacturing facility for sterile products. The Offeror should show proof of routine FDA inspection(s) within the last two years. The Offeror must be in compliance with FDA requirements during the course of contract performance, and will be required to notify the COR and CO/CS of any outstanding FDA form FD 483's resulting from routine inspection and proposed timetable for corrective action during the course of contract performance. The NAICS code for this acquisition is 325412. The solicitation is scheduled for electronic release on or about August 30, 2012. The RFP may be accessed through the NCI Office of Acquisitions, NCI homepage by using the following address: http://rcb.cancer.gov/rcb-internet/index.jsp; or through FedBizOpps.gov https://www.fbo.gov/. It is the offeror's responsibility to monitor the above internet sites for the release of this solicitation and amendments if any. ALL OFFERORS WILL BE RESONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN ADDITION, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO FAX SUBMISSIONS WILL BE ACCEPTED. NO COLLECT CALLS WILL BE ACCEPTED. Point of Contact: Brenda Oberholzer oberholzerb@mail.nih.gov Phone: 301-624-8750
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/N02CM37000-11/listing.html)
- Place of Performance
- Address: Contractor Site, United States
- Record
- SN02807298-W 20120720/120718235658-c4e8bb3e61cb8967e6f1e0c6cc60ac11 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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