SOLICITATION NOTICE
A -- Best Pharmaceuticals for Children Act Pediatric Drug Study: Use of Oral Baclofen for Treatment of Spasticity of Cerebral Palsy in Children
- Notice Date
- 7/29/2010
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- BPCA-267-2006-03421
- Archive Date
- 8/31/2010
- Point of Contact
- Lynn L Salo, Phone: 301-435-6962
- E-Mail Address
-
ls59u@nih.gov
(ls59u@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Obstetric and Pediatric Pharmacology Branch (OPPB), within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Health, intends to negotiate on a sole source basis, under the authority of 42 U.S.C. 253- (1) and FAR 6.302 – 1(a) (2) (ii) a modification to its current contract with the Washington University, St Louis, Missouri, entitled, Baclofen for Management of Spasticity. A 12 month study extension is necessary for study completion. This modification will allow the Washington University and its subcontractors the needed time to recruit enough patients such that significant study endpoints will be adequately powered, as well as time to process the data. The modification is to continue this study until September 30, 2011. Baclofen is a drug used to treat spasticity in children (and adults) with brain injury such as cerebral palsy. While the drug is quite old, having been developed more than 40 years ago, there are only a handful of children in which the drug has been carefully studied for dosing, safety, and efficacy. Despite this lack of information health care providers are using Baclofen every day to treat children with spasticity. This study was funded by the OPPB of NICHD (under the auspices of the Best Pharmaceuticals for Children Act) to provide crucial information regarding the use of Baclofen and to characterize the efficacy and safety of this drug in children. Congress enacted the Best Pharmaceuticals for Children Act (BPCA) in 2002 and again in 2007 to specifically address gaps like these in knowledge concerning the treatment of children. The Baclofen for Management for Spasticity Study commenced on June 16, 2006 and was designed to have two components; initial chart reviews and following the review, utilizing gleaned information, design, implementation, conduct and analysis of the pk/pd studies. While the study is almost complete, following interim data analysis (pk/pd), it was ascertained that to ensure adequate powering of the pharmacodynamic data an additional 10 – 15 children will be needed to be added. The startup researcher training requirements, particularly those needed for the measurement of the primary and secondary endpoints, are time consuming and require an expertise that is lacking in many academic centers. There is no other source presently known to NICHD that has access to the currently accrued data that would be in position to complete this study without starting from scratch. Those required skills include highly sophisticated clinician and computer/ instrumented measurements of spasticity and strength. It would cost the Government significant time and effort to train, recruit, and duplicate the expertise acquired by Washington University and its subcontractors over the past 4 years. If any contractor believes it can perform the above requirement, it may submit, within 15 days of publication of this notice, three (3) copies of a capability statement, which will be considered by this agency (plus an electronic copy to ls59u@nih.gov) to: Lynn Salo, Contracting Officer, NICHD CMB, NIH, 6100 Executive Building, MSC 7510, Bethesda, Maryland 20892-7510 (or overnight courier: 6100 Executive Blvd., Rockville, Maryland 20852). Phone number: 301-435-6962, and FAX number: 301-402-3676. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Authority: 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1(a)(2)(ii). No collect calls will be accepted. This requirement is defined as code 541712 under the North American Industry Classification System (NAICS).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/BPCA-267-2006-03421/listing.html)
- Record
- SN02222194-W 20100731/100729235404-6b1994d665b9d01a2f1492d2070663e8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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