SOURCES SOUGHT
A -- Prioritization and Review of Marketed Drugs without Pediatric Labeling
- Notice Date
- 4/7/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NO1-HD-9-3305
- Archive Date
- 9/30/2003
- Point of Contact
- Mya Hlaing, Contracting Officer, Phone 301-435-6958, Fax 301-402-3676, - Lynn Salo, Contract Specialist, Phone 301-435-6962, Fax 301-402-3676,
- E-Mail Address
-
mh89m@nih.gov, ls59u@nih.gov
- Description
- The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) is planning to extend and negotiate the ongoing contract with United States Pharmacopeial Convention, Inc.(USP.Inc), in Rockville, Maryland, using other than full and open competition to continue to review the off-patent drugs in the FDA list and those drugs with patents that will expire in less than a year. Evidence tables will be constructed according to a criteria developed by the USP summarizing the available information. The USP Pediatric Expert Panel will determine the significance of the information contained in the evidence tables. Drugs will then be prioritized according to a system developed jointly by the NICHD, FDA, and the U.S. Pharmacopeial (U.S.P). Those drugs with a high priority score will be reviewed in detail. All pediatric published studies as well as data volunteered by sponsors will be analyzed in regard to suitability for the support of labeling according to the Guidelines for Industry for Performance of Clinical Trials (FDA May 1998). Any organization capable of performing the above without a costly and significant break in work should submit a statement of capabilities with documentation supporting its ability to meet the Government's requirements as described above. Capability statements (Five copies plus original) should be submitted within 45 days of the publication of this synopsis to: Mya N. Hlaing, Contracting Officer, CMB, NICHD, NIH, DHHS, 6100 Executive Bldg., Suite 7A-07, MSC 7510, Bethesda, Maryland 20892-7510. Overnight courier address: 6100 Executive Blvd., Suite 7A-07, Rockville, Maryland 20852 (No electronic copies will be accepted).
- Record
- SN00297300-W 20030409/030407213348 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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