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FBO DAILY ISSUE OF MAY 14, 2008 FBO #2361
SOLICITATION NOTICE

A -- OPPB-BPCA Repository

Notice Date
5/12/2008
 
Notice Type
Presolicitation
 
NAICS
541711 — Research and Development in 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
NIH-NICHD-OPPB-08-26
 
Point of Contact
Lisa L Coleman,, Phone: 301-435-6963, Ross Kelley,, Phone: 301-435-6960
 
E-Mail Address
lc304t@nih.gov, rk17a@nih.gov
 
Small Business Set-Aside
N/A
 
Description
THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) intends to solicit proposals for sources to provide repository services for pediatric pre-clinical and clinical trial activities being conducted under the authority of the Best Pharmaceuticals for Children Act (BPCA) through full and open competitive procedures under NAICS 541711. It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 7-year period of performance beginning on or about September 30, 2008. The services being sought by this notice are related to the establishment and operation of a large repository to receive, store, process, and ship biological, chemical and drug formulation samples that will be collected throughout multiple studies (as described below). NICHD anticipates that the repository will periodically distribute portions of stored samples to laboratories at the direction of the Government. Since the inception of the BPCA 2002, NICHD has awarded approximately fifteen (15) individual projects to organizations for the purposes of gathering information to improve pediatric therapeutics and inform pediatric labeling. Samples from these ongoing studies may be integrated into the samples collected and processed from future studies described in this notice. Further information relating to the BPCA can be found at: http://bpca.nichd.nih.gov/. In September 2007, BPCA was reauthorized as part of the FDA Amendments Act (FDAAA). The legislation directs NICHD to initiate studies of critical importance to specific pediatric therapeutic areas to obtain results that will be submitted to FDA for consideration of labeling changes, and used to improve pediatric therapeutics. NICHD anticipates that the clinical studies conducted under BPCA 2007 will focus on the PK/PD, safety and efficacy of therapeutics (including drugs, biologics, and therapeutic lifestyle modifications) used in children, and the pre-clinical studies will provide vital information to the pediatric therapeutics development processes. NICHD anticipates that thousands of diverse biological specimens and chemical specimens will be collected from the preclinical (including samples from experimental animals and humans) and clinical (including samples from humans) studies conducted in 5 to 10 therapeutic areas (with multiple therapeutic approaches within each therapeutic area). Approximately 6,000 (six thousand) samples per year from phase 1 clinical studies Approximately 15,000 (fifteen thousand) samples per year from phase 2 clinical studies Approximately 500 (five hundred) samples per year from preclinical animal studies Approximately 100 (one hundred) samples per year from formulation development studies Biological samples may include, but are not limited to, tissue and organ samples, blood, urine, hair, nails, saliva, buccal cells, breast milk, placentas, umbilical cord, vaginal swabs, cord blood, and meconium from experimental animals as well as human participants, with studies conducted in vivo and in vitro. Chemical and drug samples may include, but are not limited to, the active ingredient and excipients used in the formulation of a drug, solvents, vehicles, drug metabolites and breakdown products. Samples from biologics may include materials used in preparing these therapeutic approaches, as well as samples from animals or humans treated with these therapies. Additionally, prepared ampulated samples, such as digestates or extracts, and residual drug, chemical or biologic samples may be required to be stored. Plans for a repository for the multiple therapeutic studies being considered are evolving. Technical requirements for the repository include shipping all samples directly from specific study sites to a central receiving repository where they will be processed, alliquotted and stored. It is anticipated that some studies will be conducted outside of the United States, predominantly in European Union (EU) countries. All sample processing, shipping and storage activities will be conducted under Good Laboratory Procedures (GLP) and other relevant regulatory requirements for studies conducted in the EU and US with Data being submitted for regulatory consideration (FDA, EMEA). Periodically, at the direction of the Government, the repository will send aliquots to analytic and clinical laboratories. Alternatively, some samples may be shipped first to the primary analytic and clinical laboratories for analysis with remaining material sent to the main repository. The ability to move a fraction of the biological and drug samples to a separate geographic location is required to mitigate the risk of sample loss in a disaster. The repository shall be located in facilities with specific space allocated from the purpose of this contract, including back-up electrical supplies for computers and storage resources. The RFP will be available electronically on or about May 27, 2008 and may be accessed through the FedBizOpps. All responsible sources may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. See Government-wide Numbered Note 26.
 
Web Link
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=cc99ba64ab6bf7743758bd92abf92613&tab=core&_cview=1)
 
Record
SN01571324-W 20080514/080512220215-cc99ba64ab6bf7743758bd92abf92613 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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