SOLICITATION NOTICE
R -- Drug Development Support for CTEP
- Notice Date
- 9/26/2001
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Room 604, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-27022-32
- Response Due
- 11/16/2001
- Point of Contact
- Richard Hartmann, Contracting Officer, Phone (301) 496-8620, Fax (301) 402-6699,
- E-Mail Address
-
rh75f@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for administration and coordination of most of the extramural clinical trials supported by the DCTD. It is also responsible for the ongoing clinical development of more than 100 agents on which the Division has filed more than 150 Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA). The CTEP must prepare, file and manage INDs for the investigational agents it sponsors in clinical trials, including the agents from the NCI's intramural clinical programs. As the sponsor of these agents, DCTD must design a plan for the efficient evaluation and development of these agents and monitor the safety, efficacy and drug distribution of the agents in the trials, tracking the progress of the studies both administratively and scientifically, review and transmit adverse events in a timely manner and preparing IND annual reports for submission to the Food and Drug Administration (FDA), investigator brochures for agents and other special reports and manuscripts. The CTEP must also submit amendments to the INDs it sponsors including new protocols, protocol amendments, adverse events, updated chemistry and manufacturing information, compassionate exemptions and responses to FDA communications. At least annually, federal law requires that an IND sponsor analyze and summarize all results from the investigational agent?s development in an Annual Report submitted to the FDA on the anniversary of the IND filing. These results are reported to the CTEP by, quarterly and annual data updates (Clinical Data Update System, CDUS), biweekly by the Clinical Trials Monitoring System, by publications, Cooperative Group reports and periodic meetings with clinical investigators. Annual Reports are reviewed and used by the Program Medical Staff who develop future plans for the agent. IND sponsors have the obligation to inform investigators, the Office of Biotechnology Activities (OBA), NIH (for gene transfer studies) and the FDA of any serious or unexpected Adverse Events (AEs) that have been observed. When AE reports are made to the CTEP, Program staff analyze and categorize them according to severity. The Contractor shall provide support to the CTEP, Investigational Drug Branch (IDB) and Regulatory Affairs Branch (RAB) for a wide range of services related to these responsibilities. These services include assistance with Investigational New Drug Applications (INDs), investigational agent development and clinical research information management; assessment of adverse events, logistical and clerical support. It is anticipated that one award will be made and that the resulting contract will be awarded on an incrementally funded basis for a period of 6 years. The Government?s requirement is 67,000 hours per year for a total of 405,600 total hours over the 6 years. RFP N02-CM-27022-32 will be available on or about 10/15/01 with a due date for receipt of 11/16/01. For further information, the Request Proposals will be available on the NCI Research Contracts Branch web site at: http://rcb-inter.nci.nih.gov/appl/rfp/rfps_published.jsp on or about 10/15/01.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/RCB/N02-CM-27022-32/listing.html)
- Record
- SN00034415-F 20020302/020301083922 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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