SPECIAL NOTICE
65 -- Solicitation for the Creation of Formulations of Vitamins and Minerals for the Treatment of Age-Related Macular Degeneration
- Notice Date
- 8/26/2004
- Notice Type
- Special Notice
- NAICS
- 424210
— Drugs and Druggists' Sundries Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Division of Research Acquisition, 6100 Executive Boulevard, Room 6E01, MSC 7540, Bethesda, MD, 20892-7540
- ZIP Code
- 20892-7540
- Solicitation Number
- Reference-Number-NIH-NEI-01
- Response Due
- 9/30/2004
- Archive Date
- 10/15/2004
- Point of Contact
- Valerie Pickett, Contracting Officer, Phone 301-496-8505, Fax 301-402-0178,
- E-Mail Address
-
vp5v@nih.gov
- Description
- The National Eye Institute of the National Institutes of Health is seeking proposals from pharmaceutical companies to create 4 formulations to be tested in a clinical trial of participants at risk of developing age-related macular degeneration in one or both eyes. The formulations will be as follows: Formulation 1 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 15 mg Beta Carotene; 80 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 2 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 0 mg Beta Carotene; 80 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 3 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 0 mg Beta Carotene; 25 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 4 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 15 mg Beta Carotene; 25 mg Zinc Oxide; 2 mg Cupric Oxide. The company must demonstrate the ability to make these formulations with previous products that have similar components. The company must demonstrate the willingness to produce these formulations for a large multi-centered trial involving 4000 subjects for at least 7 years. The formulation should be produced with the minimal number of tablets or gel capsules possible to enhance compliance of the study subjects. The company must produce these formulations in a timely fashion to begin the clinical trial by June 2005 and have the ability to remain solvent throughout the next 7 years. Responses to this synopsis are due September 30, 2004. Electronic submission is preferred. Send all submissions directly to: Emily Y. Chew, MD echew@nei.nih.gov NIH Building 31, Room 6A52 31 Center Drive, MSC-2510 Bethesda, MD 20892-2510 310 496 6583 (tel) 301 496 2297 (fax) Please note that this is not a solicitation for contract proposals and no contract award is planned from the submissions received.
- Record
- SN00655270-W 20040828/040827093523 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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