SOLICITATION NOTICE
A -- Use of Oral Baclofen for Treatment of Spasticity of Cerebral Palsy in Children
- Notice Date
- 3/4/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- RFP-NIH-NICHD-2005-13
- Response Due
- 5/24/2005
- Archive Date
- 6/8/2005
- Description
- As part of its contract program for the Best Pharmaceuticals for Children Act (BPCA), the Centers for Research on Mothers and Children (CRMC) of the National Institute of Child Health and Human Development (NICHD) has a contract requirement to establish a Pediatric Drug Study Center to study the use of oral Baclofen for the treatment of spasticity of cerebral palsy in pediatric patients. The NICHD seeks to obtain clinical data on such pediatric use, which will lead to Food and Drug Administration (FDA)-approved labeling of oral Baclofen for this purpose. The NICHD already has awarded contracts for several BPCA studies, including a contract for a BPCA Coordinating Center. Additional information on BPCA and NICHD can be found at http://www.nichd.nih.gov/oppb/bpca/index.htm. The Studies will include the following: (1) a Pediatric Pharmacokinetic/Pharmacodynamic Study to determine the pharmacokinetics of oral Baclofen in pediatric patients, investigate the relationship between plasma concentrations of oral Baclofen and clinical measures of spasticity and to determine optimal dosage range and interval for administration of oral Baclofen for use in a randomized clinical trial of efficacy and safety; (2) a Retrospective Chart Review of Safety to describe the pediatric patient population using oral Baclofen to manage spasticity of cerebral palsy, estimate the patient population size needed to result in a sample of 100 children using oral baclofen continuously for 1 year or more (in preparation for safety study), use the data to describe the safety of oral baclofen in 200 pediatric patients using oral Baclofen (under the assumption that one out of two patients continue for a full year), and use the data to describe treatment course and reasons for treatment changes, withdrawal, and adverse events associated with treatment and withdrawal; (3) a Randomized Controlled Clinical Trial (upon completion of PK/PD Study and Chart Review) to evaluate efficacy of oral Baclofen in children under age 16, and describe safety, adverse events, and withdrawal experiences in children under age 16 using oral Baclofen for spasticity of cerebral palsy; and (4) a Safety Follow-up Study (upon completion of first three studies and review of their data) to describe neurodevelopmental outcomes after 1 year of continuous treatment with oral Baclofen for spasticity of cerebral palsy. The final number of patients to be recruited and retained will depend on the final protocols approved by the NICHD and the FDA. This contract requirement is defined as code 541710 under the North American Industry Classification System (NAICS). As such, the applicable Small Business Size Standard for this announcement is 500 employees. It is anticipated that one cost-reimbursement incrementally funded completion-type contract, with a period of performance of 48 months, will be awarded as a result of this RFP. This announcement is not a Request for Proposals (RFP). It is anticipated that the RFP will be available on or before 03/22/2005 through the website at http://FedBizOpps.gov. All proposals must be submitted on or before the due date and time stated in the RFP to: Jason S. Williams, Contracting Officer, Contracts Management Branch, OAM, NICHD, 6100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda, Maryland, 20892-7510 (if sending by overnight carrier such as FedEx, use 6100 Executive Boulevard, Suite 7A07, Rockville, Maryland, 20852). The reference number to be used for this announcement is: RFP-NIH-NICHD-2005-13. All correspondence must cite the reference number as provided. Questions may be directed by e-mail or telephone to Jason S. Williams, Contracting Officer, at willjas@mail.nih.gov, Ph: 301-402-6775. The Government does not intend to release hard copies of the RFP. The Government also reserves the right to cancel this procurement at any time prior to contract award.
- Record
- SN00762841-W 20050306/050304211950 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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