SOURCES SOUGHT
R -- N/A
- Notice Date
- 6/25/2007
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- N02-CM-81000-48
- Response Due
- 7/10/2007
- Archive Date
- 7/25/2007
- Small Business Set-Aside
- Total Small Business
- Description
- TITLE: "Drug Development Support For The Cancer Therapy Evaluation Program (CTEP)" The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is seeking capability statements from all eligible small business concerns [particularly Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB)] under the North American Industry Classification System (NAICS) code 541990, with a size standard of $6.5M per annum. Based on the responses received from this SOURCES SOUGHT announcement, the proposed acquisition may be solicited as a Total Small Business Set-Aside. THIS IS NOT AN RFP AND DOES NOT COMMIT THE NCI, NIH TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO RFP PACKAGE IS AVAILABLE AT THIS TIME. All eligible small business concerns responding to this Sources Sought Announcement must have the capabilities to provide support to the Investigational Drug Branch (IDB) and Regulatory Affairs Branch (RAB), CTEP. The support required encompasses a wide range of services, including: 1) providing assistance with Investigational New Drug Applications (INDs); 2) information management; 3) assessment of Adverse Events (AEs); and 4) logistical and clerical support. In addition, the Contractor shall furnish all services, qualified personnel, material, equipment (including secure computers and computer support) and facilities not otherwise provided by the Government under the terms of the contract, including maintenance of appropriate software licenses, as needed, to perform the clinical research support tasks required by the contract. Major tasks required of the Contractor include the following: A. Provide support for investigational agent development, clinical research information management, adverse event reporting and assistance in writing and organizing INDs and Master Files (MFs), which includes the following subtasks: 1. Assist in the preparation of approximately ten to twenty (10-20) INDs and MFs per year; 2. Assist in the preparation and submission of up to five (5) Investigational Device Exemptions (IDEs) with the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) per year; 3. Maintain Investigational New Drug (IND) files; 4. Update NCI MFs from data provided by RAB (e.g., clinical protocols, preclinical toxicology, chemistry and manufacturing information); 5. Monitor and maintain collaborative research agreement records; 6. Prepare, for IDB staff on a quarterly basis, or in some cases on an as needed basis, summary tables from information in the CTEP informatics databases updating clinical trial status, accrual, response results and AEs; 7. Prepare and edit IND FDA Annual Reports for each active IND for submission to the FDA in accordance with FDA requirements; 8. Prepare approximately five (5) Investigator's Brochures per year--from information provided in the INDs, the CTEP enterprise systems including the Clinical Data Update System (CDUS), appropriate literature and other sources--when the IND does not have a CTEP or pharmaceutical collaborator; 9. Attend scientific meetings, meetings with pharmaceutical collaborators and/or meet periodically with Clinical Investigators and Data Managers involved in the conduct of CTEP-sponsored clinical trials to organize and discuss study results and data retrieval; 10. Draft written responses--for IDB physicians to investigators who have submitted protocols or Letters of Intent (LOIs)--reflecting the discussions of the Protocol Review Committee regarding the protocols and LOIs; B. Monitor and Support Adverse Event Reporting, which includes the following subtasks: 1. Provide telephone answering services on the CTEP AE reporting telephone line (called AdEERsMD) Monday through Friday from 7am-8pm (except for holidays); 2. Receive, prioritize and direct all incoming queries from clinical investigators regarding AE reporting and use of Adverse Event Expedited Reporting System (AdEERS) to appropriate CTEP or Contractor staff during business hours; 3. Receive, analyze, organize and prepare AE reports from information received via AdEERS in accordance with IDB Senior Investigator instructions and FDA requirements; 4. Enter and maintain AE data in appropriate computerized databases; 5. Set up an electronic mail (e-mail) mailbox to receive adverse event reports from pharmaceutical collaborators and review/share with appropriate IDB drug monitor; 6. Provide written review of the adverse event reporting section of clinical protocols submitted to the Protocol Review Committee (PRC), CTEP; C. Track information regarding investigational anti-cancer agents, which includes the following subtasks: 1. Maintain IDB drug development plans and prepare quarterly/annual reports for project planning; 2. Maintain the Informatics Project for Agents and Diseases (iPAD) database and enter information into iPAD regarding pivotal non-NCI studies performed by pharmaceutical collaborators; 3. Maintain project plans for each investigational agent in development; 4. Maintain an up-to-date Drug-Disease Matrix which tracks investigational agents available for study in standard diseases; 5. Survey, retrieve and assemble clinical and supportive data on each IND agent; 6. Conduct literature searches, establish and maintain comprehensive reference databases of articles pertinent to the investigational agent and monitor published literature relevant to investigational agents; 7. Prepare quarterly/annual reports regarding agent and disease development plans using data in the CTEP enterprise system; D. Provide general administrative support for investigational agent development and regulatory activities, which includes the following subtasks: 1. Distribute (electronically) relevant investigational agent development information to investigators; 2. Prepare slides for presentations from data made available to the Contractor; 3. Organize and maintain supplemental investigational agent information files by investigational agent; 4. Maintain, store and provide to CTEP, Investigator's Brochures, Annual Reports, active and inactive INDs, including all amendments to the IND and other archived material; 5. Store electronic copies of IND Annual Reports, prepared in mandated electronic formats (read-only MS Word or PDF) and provide electronic delivery of these reports within 1 hour upon request; and E. Establish, implement and maintain a Quality Control Program, which includes the following subtasks: 1. Establish and put into place written procedures to allow the effective continuation of work in the event of personnel changes/absences; 2. Establish Standard Operating Procedures (SOPs) for performing the tasks outlined in the Statement of Work and utilize those SOPs as part of a comprehensive plan to demonstrate the Contractor's compliance with FDA regulations and CTEP requirements. In addition to the above, all eligible small business concerns must document the ability of their staff to meet frequently/or on short notice (within the workday), face-to-face with CTEP Program Staff. Sources possessing experience and demonstrated capability to accomplish the aforementioned requirements are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information furnished must not exceed 10 pages and should include an outline of previous or similar projects and other available literature for the NIH to perform a proper evaluation of your capability statement. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses to this SOURCES SOUGHT/REQUEST FOR INFORMATION notice may be submitted electronically to John R. Manouelian, Contracting Officer, at manouelj@mail.nih.gov in either MS Word, Wordperfect or Adobe Portable Document Format (PDF), by July 10, 2007, 3:30PM, EST. All related questions shall be in writing and may be submitted electronically to the aforementioned email address as well.
- Place of Performance
- Address: To Be Negotiated
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01326874-W 20070627/070625220345 (fbodaily.com)
- Source
-
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