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A -- Monitoring Clinical and Research Laboratories for Good Manufacturing Practice for the Laboratories Currently Supporting the BPCA Pediatric Clinical Trials Network

Notice Date
Notice Type
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
Solicitation Number
Archive Date
Point of Contact
Daniel Federline, Phone: 301.435.6972, Elizabeth J. Osinski, Phone: 301-435-6947
E-Mail Address
daniel.federline@nih.gov, eo43m@nih.gov
(daniel.federline@nih.gov, eo43m@nih.gov)
Small Business Set-Aside
The Obstetric and Pediatric Pharmacology Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), intends to negotiate, under the authority of 41 U.S.C. 253(c) (1) and FAR 6.302-1, a modification to its current contract no. HHSN275200900012C entitled "Best Pharmaceuticals for Children Act Data Coordinating Center (BPCA)." The purpose of this modification is to acquire the services capable of implementing, managing, directing and coordinating all monitoring of clinical and research laboratories for Good Manufacturing Practice for the laboratories currently supporting the BPCA Pediatric Clinical Trials Network. The services will include audits of clinical and research laboratories for data quality, assay validation, and quality control measures for all equipment necessary to perform laboratory tests applicable to the clinical studies conducted under the Best Pharmaceutics for Children Act Program. The NICHD anticipates that their services are congruent with the current services provided by the BPCA Data Coordinating Center and the monitoring reports from these laboratories will be incorporated into the already existing infrastructure for regulatory reporting to the FDA for BPCA studies. Background The BPCA Data Coordinating Center (DCC) provides the requisite personnel, facilities and services to support aspects of data collection, analysis and reporting in support of regulatory reporting for the pediatric clinical trials conducted under the authority of the Best Pharmaceuticals for Children Act (BPCA). BPCA was initially authorized by Congress in 2002 and reauthorized in September 2007, to improve labeling information for drugs used to treat children. Currently, the functions of the BPCA Data Coordinating Center are being performed by the EMMES Corporation. The BPCA DCC responsibilities include the management and coordination of all clinical trials data management and analyses and all regulatory activities for the clinical and preclinical studies conducted under the BPCA. The scope of responsibilities include: data management and clinical trial monitoring; coordinating and maintaining a BPCA Data Safety Monitoring Plan, to including maintaining and supporting the BPCA Data Monitoring Committee; provide site monitoring and training necessary for protocol implementation in all clinical and preclinical sites; provide leadership in statistical and data analyses of all protocols submitted to the FDA; submission of all regulatory submissions to the FDA including Investigational New Drug (IND) applications, abbreviated New Drug Applications (aNDA), and Final Study Reports for each protocol; and the development and support of all public use data sets designed to inform the science and the labeling of drugs used in children. The NICHD anticipates that the services described above can only be done as part of the existing infrastructure of the BPCA DCC. Awarding a new contract to another contractor would require them to duplicate the infrastructure for regulatory reporting that already exists and would require the new contractor to develop an electronic system that is compatible with the system that has already been developed. This would result in unacceptable delays, substantial duplication of effort, and increased costs to the government. This is not a request for proposals. However, if any responsible source believes it can perform the above requirement, they may submit three (3) copies of their capability statement for consideration by the NICHD to Daniel Federline, Contract Specialist, NICHD, CMB, NIH, 6100 Executive Boulevard, MSC 7510, Bethesda, Maryland, 20892-7510 (or overnight courier: 6100 Executive Boulevard, Rockville, Maryland, 20852). Phone number (301) 435-6972, and fax number (301) 402-3676. Secondary point of contact is Elizabeth Osinski, Contracting Officer, NICHD, CMB, NIH, 6100 Executive Boulevard, MSC 7510, Bethesda, Maryland, 20892-7510 (or overnight courier: 6100 Executive Boulevard, Rockville, Maryland, 20852). Phone number (301) 435-6947, and fax number (301) 402-3676. All responses must be received in writing and must contain material in sufficient detail to allow the NICHD to determine if the party can perform this requirement. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. 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.
Web Link
FBO.gov Permalink
Place of Performance
Address: Rockville, Maryland, 20850, United States
Zip Code: 20850
SN02739454-W 20120506/120504234956-e7d237525dbde81461b6496cbfdd1907 (fbodaily.com)
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