SOLICITATION NOTICE
A -- Science Moving TowArds Research Translation and Therapy (SMARTT) - Coordinating Center
- Notice Date
- 8/6/2009
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HV-10-10
- Archive Date
- 9/11/2009
- Point of Contact
- Scott A. Bredow, Phone: 301-435-0333
- E-Mail Address
-
bredowsa@nhlbi.nih.gov
(bredowsa@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute is seeking a Coordinating Center (CC) for a new six-year program, Science Moving TowArds Research Translation and Therapy (SMARTT). The purpose of the SMARTT program is to assist translation to the clinic of novel synthetic, natural, or biologic therapeutic interventions arising in the scientific community for the treatment of heart, lung, and blood diseases. SMARTT will provide resources in the areas of preclinical and clinical-grade production and testing for biologics, non-biologics and small molecules in accordance with Good Manufacturing Practices (GMP), and in the conduct of pharmacology/toxicology studies. In addition, SMARTT will provide regulatory assistance to investigators wishing to conduct early stage clinical trials. SMARTT will consist of a Production Facility (PF) for biologics; a PF for non-biologics and small molecules; a Pharmacology/Toxicology Center (PTC); and a Coordinating Center (CC). SMARTT will provide consulting, manufacturing, pharmacology and toxicology testing, preclinical and early phase clinical study design support, and administrative and regulatory expertise. The CC will monitor and coordinate organizational and regulatory aspects of the SMARTT program. One award is anticipated under a Request for Proposal (RFP). The CC will 1) perform annual site visits and ensure that production and testing facilities (PFs and PTC) continually possesses all required certifications, inspections, and assurances needed to comply with United Stated Food and Drug Administration (US FDA) and 21 CFR Parts 210 and 211 governing cGMP at PFs; and to comply with US EPA Good Laboratory Practices (GLP) guidelines, NIH OLAW, and IACUC guidelines for small and large animal use at the PTC; 2) develop and maintain a Manual of Procedures (MOP) for all SMARTT services, 3) receive and process investigators’ requests for manufacturing, testing, and consulting services, 4) assist research investigators in preparing and submitting to the US FDA and other regulatory entities all necessary materials, 5) develop a program marketing plan and market the program to the research community, 6) develop, maintain, and update public and private web sites with pages for each of the program facilities (PFs and PTC), 7) establish, in collaboration with the SC, and maintain an electronic database for use in capturing information conveyed to and from groups associated with the study, 8) participate in the Steering Committee (SC), subcommittees, and teleconferences, 9) schedule, coordinate the logistics and provide minutes for teleconferences, site visits and other face-to-face meetings between groups associated with conduct of the program, 10) develop, in collaboration with the SC, request for services application, a format for feasibility assessment and customer satisfaction survey for products and services, and 11) handle travel-related expense reimbursements for program-associated group members to attend meetings and site visits. This is not a request for proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about August 28, 2009. This advertisement does not commit the Government to award a contract.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HV-10-10/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions, 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01902701-W 20090808/090807001401-1e789fdda3043e0c2d9575427e193714 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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