SOLICITATION NOTICE
A -- Pediatric Off-Patent Drug Study (PODS) Center-Sodium Nitroprusside
- Notice Date
- 4/14/2003
- Notice Type
- Solicitation Notice
- 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
- NICHD-2003-09
- Archive Date
- 10/10/2003
- Point of Contact
- Mya Hlaing, Contracting Officer, Phone 301-435-6958, Fax 301-402-3676, - James Quinn, Chief, Contracts Management Branch, Phone 301-435-6964, Fax 301-402-3676,
- E-Mail Address
-
mh89m@nih.gov, quinnja@mail.nih.gov
- Description
- The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) is planning to study off-patent drugs for pediatric use information, based on the Best Pharmaceutical for Children Act process. Federal legislation and the regulations of the Food and Drug Administration (FDA) require that drugs be tested for safety and efficacy before they are approved for clinical use. This testing must take place in all populations in which the drug will be used. Since both the qualitative and quantitative aspects of pharmacodynamics and pharmacokinetics are different in immature individuals, and clinical efficacy and safety may not always be extrapolated from older patient populations to pediatric populations, studies must be conducted in the appropriate pediatric population before pediatric use information may be appropriately incorporated in the label. The contracts will be awarded to entities that have expertise in conducting pediatric clinical trials, including qualified universities, hospitals, Contracts Research Organizations (CROs), federally funded networks (such as the Pediatric Pharmacology Research Unit Network), and other public or private institutions. The study sites will be called Pediatric Off-Patent Drugs Study (PODS) Centers. Lead centers which subcontract to other clinical sites, pediatric clinical trials networks, CROs, and single academic centers are all eligible for contract awards depending on the overall qualifications, experience in drug trials in pediatrics, type of drug under study, specific drug indication and access to target pediatric populations. It is expected that most studies will involve multiple sites. Established pediatric drug trials networks or offerors that include multiple sites are encouraged to apply. Offerors responding to the RFP are requested to develop study protocols involving the use of sodium nitroprusside in pediatric populations according to the specifications listed in the Statement of Work (SOW) in the RFP. Sodium nitroprusside is commonly used for maintaining periods of hypotension during pediatric surgical procedures. However, there is limited information available about dosing, pharmacokinetics, effectiveness and safety in pediatric patients who are maintained in states of controlled hypotension for either short or long periods. In these clinical investigations, studies of safety, pharmacokinetic and pharmacodynamic relationships, and dosing in pediatric patients requiring long-term controlled hypotension will be conducted using randomized, observer-blinded approaches. Investigators will recruit a broad spectrum of patients who require periods of controlled hypotension. It is anticipated that 200 patients must complete the studies specified in the Statement of Work, including the FDA's Written Request. The North American Industry Classification System (NAICS) is 541990. The Request for Proposals (RFP) will be available on or about May 8,2003 at http://FedBizOpps.gov. All responses must be submitted on or before August 10,2003 to: Mrs. Mya N. Hlaing, Contracting Officer, NICHD, CMB, 6100 Building, Suite 7A-07, 6100 EXECUTIVE Blvd., MSC 7510, Bethesda, Maryland 20892-7510 (if sending by overnight carrier, use 6100 Executive Blvd., Suite 7A-07, Rockville, Maryland 20852). Fully electronic copies will not be accepted. The referenced number to use for this announcement is: RFP-NICHD-2003-09. All correspondence must cite the referenced number as provided.
- Record
- SN00302981-W 20030416/030414213330 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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