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FBO DAILY ISSUE OF AUGUST 28, 2004 FBO #1006
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
(may not be valid after Archive Date)

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