SOLICITATION NOTICE
65 -- Phenformin HCl Manufacture
- Notice Date
- 5/21/2010
- 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, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-100089-TG
- Archive Date
- 6/22/2010
- Point of Contact
- Terry Galloway, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
gallowaytl@mail.nih.gov, cr214i@nih.gov
(gallowaytl@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, EPS Suite 600, Room 6068, Rockville, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI) plans to procure the manufacturing services to produce Phenformin HCl capsules to be used in Building 37 on the Main Campus of The National Institutes of Health (NIH). This acquisition will be conducted under the procedures for acquiring commercial buys as authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501 (a)(1)(ii). The North American Industry Classification System code is 325412 and the business size standard is 750 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The Developmental Therapeutics Program (DTP) is located in the Division of Cancer Treatment and Diagnosis (DCTD), NCI, NIH, HHS. The NCI's DTP supports pharmaceutical development of novel therapeutic agents identified in its own drug development program as well as through several initiatives arising from investigator initiated research programs in the academic and not for profit sector. Drug development for lead compounds identified by the NCI investigators is done by the Pharmaceutical Resources Branch through various Contractors. This requirement is for the manufacture of 7,000 capsules of Phenformin HCl. NCI will provide the pharmaceutical active ingredient (API), manufacturer's certificate of analysis (if any), and independent analysis by NCI analytical contractor, HPLC method for the API, product specifications and Material Safety Data Sheet. The contractor shall: 1) Qualify NCI provided validated analytical HPLC method to use to assay drug substance (phenformin HCl) and drug product (phenformin HCl in capsules). 2) Adapt the above HPLC method to monitor the dissolution of phenformin HCl in capsule dosage forms. 3) Manufacture twenty five (25) mg strengths of phenformin HCl capsules under current Good Manufacturing Practices (cGMP). The batch shall be of sufficient size to deliver 7,000 capsules. 4) Prepare Batch records for approval by NCI Contract Officer Technical Representative (COTR) prior to manufacture. 5) Package clinical trial material, at fifty (50) capsules per HDPE container with desiccant, cotton plug, and label the containers. 6) Prepare required labels. NCI will provide text information for label and approve final label. 7) QC Test the product according to provided specifications by NCI COTR. 8) Ship the packaged and released product to the sites designated by the NCI for storage and shelf life studies. The assay method for the capsule formulation shall be adapted from the assay for the drug substance and must have sufficient sensitivity to accurately measure the active ingredient at 0.1% of the assay concentration (for application to impurities testing). Potential offerors may request a copy of the solicitation from Terry Galloway, Contract Specialist via electronic mail at gallowayt@mail.nih.gov or fax (301) 402-4513. Interested parties shall include the name of company; complete mailing address; point of contacts, phone, fax numbers, and email address; company DUNS number and business size. All questions shall be in writing and addressed to the Contract Specialist noted above. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference: RFQ-NCI-100089-TG on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-100089-TG/listing.html)
- Record
- SN02157579-W 20100523/100522000038-2e034a46e037b858986b68607a24ae62 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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