SOLICITATION NOTICE
B -- NIH-RAID Project "Developing SRX246 for Stress Related Affective Illness"
- Notice Date
- 6/24/2008
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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-80103-MM
- Archive Date
- 7/18/2008
- Point of Contact
- Melissa P Marino, Phone: 301-402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
marinome@mail.nih.gov, cr214i@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD) plans to procure on a sole source basis for services regarding the NIH-RAID project "Developing SRX246 for Stress-related Affective Illness" with Frontage Laboratories, Inc., 105 Great Valley Parkway, Malvern, PA 19355. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-(b)(1) and 13.501-(a)(1) to use simplified procedures for commercial acquisitions. The North American Industry Classification System Code is 541990 and the business size standard is $6.5M. Period of Performance: Performance shall be two months from date of award. 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 investigators at academic and not for profit institutions are designated as RAID programs (Rapid Access to Interventional Development). DTP is seeking an organization to prepare three strengths of SRX246 capsules, one batch per strength and one batch of placebo so that SRX246 can be evaluated clinically. Contractor Requirements 1)Qualify NCI provided analytical HPLC methods used to assay SRX246 drug substance alone and in capsules. 2)Adapt the HPLC method to monitor the dissolution of SRX246 in capsule dosage forms. 3)Manufacture three strengths of SRX 246 capsules: 20, 50 and 100 mg, one lot/strength, and one batch of placebo capsules under current Good Manufacturing Practices (cGMP). Each batch of SRX246 active is of sufficient size to deliver 5000 capsules. Two thousand capsules of placebo are required. The capsule will need to be opaque and identical in size and appearance across the range of strengths of active and for the placebo. Since the capsules will be identical in appearance manufacture of a particular strength must be completed before initiating preparation of the next strength. The contractor is responsible for providing capsule shells, excipients if needed, packaging materials, and labels. Certificates of testing are required for all product contact materials, e.g. capsule shell, desiccant, cotton or equivalent plug, containers and closures. Where compendial specifications are available, the materials must conform to those requirements. 4)Batch records are prepared by the contractor and approved by NCI prior to manufacture. 5)Contractor is responsible for packaging of clinical trial material, i.e. units of 50 capsules/HDPE container with desiccant and cotton plug. NCI provides the text information for label and approves final label. 6)Test the three batches of SRX246 capsules and one batch of placebo capsules according to specifications provided by NCI. SRX246 contains a beta lactam moiety, in common with penicillins or cephalosporins. However, SRX246 is highly stable to chemical or enzymatic hydrolysis of the four membered azetidinone ring and does not behave biologically as a penicillin or cephalosporin with respect to allergic potential. Thus, manufacturing in a facility that already handles penicillin or cephalosporin products is not an option. See Guillon et al. Bioorg Med Chem 15:2054-2080 2007 Azetidinones as Vasopressin V1a antagonists (compound 50, p 2062, 2064) for the chemical structure of SRX246. Market research done by the program shows that there is only one known vendor who is capable of meeting all the scientific specifications required by NCI, Frontage Laboratories. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office by 1:00 PM ET on July 3, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at marinome@mail.nih.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-80103-MM on all correspondence.
- Web Link
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- Record
- SN01599963-W 20080626/080624220240-794b21425e8f42f2e91ca3a1473e26f7 (fbodaily.com)
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