National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

A -- PRIORITIZATION AND REVIEW OF MARKETED DRUGS WITHOUT PEDIATRIC LABELING THAT ARE OFF PATENT OR WITH PATENT THAT WILL EXPIRE IN LESS THAN ONE YEAR SOL NICHD-CRMC-99-03 POC Mya N. Hlaing, Contracting OfficerContracts Management Branch, (301)435-6958 WEB: National Institute of Health, http://www.nih.gov. E-MAIL: National Institutes of Health, mh89m@nih.gov. The National Institute of Child Health and Human Development (NICHD) plans to award a contract to The United States Pharmacoloeis (U.S.P), using other than full and open competition to prioritize and review marketed drugs without pediatric labeling that are off patent or with patent that will expire in less than one year. The determination to use other than full and open competition was made in accordance with USC 253 (c)(1) and is based upon the following factors: The organization operates transparent information development processes with public review and comment and maintains strict conflict of interests safeguards. The U.S.P has been designated as a source of unbiased information for off-label use, drun utilization review and patient consultation under Omnibus Budget Reconcilation Act of 1990 and Omnibus Budget Reconcilation Act of 1993. The U.S.P information development is rests on evidence-based consensus of experts. Particularly germane to the performance of this project the U.S.P. has a standing pediatrics advisory panel of experts from the major U.S. Medical Schools and standing clinical specialty panels with pediatric representation. The strength of the USP drug and the therapeutics information database is a result of the development process and the people who determine its final content. Not only is the database a comprehensive collection of clinically relevent, established information about drug therapies, but it also is a continuously updated collection of the current judgments of experts in the use of medications. The information includes is the result of an organized, nationwide evidence-based consensus-generating system with worldwide input. This system has been designed to involve not only the experts but also all interested parties through open public review and comment. The purpose of this synopsis is to determine whether there are other sources with the above capabilities to perform the work described above. Capability statements should be submitted within 45 days of the publication ofthis synopsis to Mrs. Mya N. Hlaing, Contracting Officer, CMB, NICHD,NIH, 6100 Executive Blvd., Suite 7A-07, MSC 7510, Bethesda, MD20892-7510, telephone number (301) 496-4611 and FAX number (301)402-3676. (See Numbered Note 22) Posted 02/26/99 (W-SN302759). (0057)

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