MODIFICATION
A -- Lithium in the Treatment of Pediatric Mania
- Notice Date
- 2/10/2005
- Notice Type
- Modification
- 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
- Reference-Number-NIHNICHD200507
- Response Due
- 4/12/2005
- 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 Off-Patent Drug Study (PODS) Center to study the use of Lithium for treatment of mania in pediatric patients. NICHD seeks to obtain clinical data on the use of Lithium for treatment of bipolar disorder (BPD) in pediatric populations, which will lead to Food and Drug Administration (FDA)-approved labeling of Lithium 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 pharmacokinetic study of at least 18 patients that will evaluate different sequences of titrations to reach a maximum tolerated dose (the results of this study will be used to select doses for the subsequent efficacy studies); (2) a randomized, double-blind, parallel group, placebo-controlled acute trial that will last a minimum of 6 weeks that will sufficiently detect an distinction in efficacy between lithium and placebo; and (3) a long-term safety study, of no less than 6 months drug exposure, to monitor for adverse events. The final number of patients to be recruited and retained will depend on the final protocols approved by the NICHD and 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 or more cost-reimbursement incrementally funded completion-type contract(s), with a period of performance of 36 months, will be awarded as a result of the RFP. This announcement is not a Request for Proposals (RFP). It is anticipated that the RFP will be available on or before January 31, 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: Susan A. Nsangou, Contracting Officer, Contracts Management Branch, OAM, NICHD, 6100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda, Maryland, 20892-7510 (if sending by overnight carrier, use 6l00 Executive Boulevard, Suite 7A07, Rockville Maryland, 20852). The reference number to be used for this announcement is: NIH-NICHD-2005-07. All correspondence must cite the reference number as provided. Questions may be directed by telephone to Susan A. Nsangou, Contracting Officer, at (301) 435-8867. 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
- SN00749126-W 20050212/050210211815 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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