SOURCES SOUGHT
R -- Central Institutional Review Board (CIRB) Initiative
- Notice Date
- 12/2/2004
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-57006-48
- Response Due
- 12/20/2004
- Point of Contact
- John Manouelian, Contract Specialist, Phone (301) 435-3813, Fax (301) 402-6699, - Richard Hartmann, Contracting Officer, Phone (301) 496-8620, Fax (301) 402-6699,
- E-Mail Address
-
jm486p@nih.gov, rh75f@nih.gov
- Description
- Sources Sought Notice N02-CM-57006-48 “Central Institutional Review Board (CIRB) Initiative” 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 under the North American Industry Classification System (NAICS) code 541690, with a size standard of $6.0M 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 NIH, NCI 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: 1) provide administrative and technical support to operate the two national Central IRBs currently in place for review of selected NCI multi-center trials (an estimated 50-75 protocols per year, per board); 2) provide support to the local IRBs enrolled in the Initiative; 3) organize, recruit and manage the integration of an estimated 2,000 new sites into the Initiative; 4) interface with 9 national cooperative groups with 2 separate offices each, around the country; and 5) administer and support a third Board, if necessary, to handle growth. Major tasks required of the Contractor include the following: • Manage and provide administrative/regulatory support for two Central IRBs, one for adult trials and one for pediatric trials; • Manage and support current and newly enrolled participating local sites; • Conduct the recruitment and integration of new sites into the Initiative; • Provide informatics support and system integration; • Support NCI’s internal and external communications efforts regarding all aspects of the Initiative; • Implement and manage an Initiative-wide Quality Improvement Plan; • Provide support for the formal accreditation of both CIRBs in contract year 2 or 3, as determined by NCI; • Develop and implement a system for utilizing central review for sites that do not have a local IRB; and • Establish and support a second Board for adult trials if it is needed to handle the growth in the menu of Phase 2 protocols. As these tasks indicate, the Contractor’s responsibilities are more complex than simply the routine management of two central IRBs. One unusual feature of this Initiative is that every decision the CIRBs make have an impact on a national trial development and distribution system; consequently, all Standard Operating Procedures (SOPs) must be integrated with the relevant administrative procedures of the NCI, the Cooperative Group Operations offices and the Cancer Trials Support Unit (CTSU). Also, due to the high profile of this Initiative, sophisticated data management, analysis and presentation reflecting all activities in the above tasks is required. 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. Basic information about the CIRB Initiative can be obtained from the following website at www.ncicirb.org . There will be a technical question and answer session on December 14, 2004 in the NCI Research Contracts Branch Conference Room at 6120 Executive Boulevard, Bethesda, MD 20892, Room 6005 of Suite 6001, from 10:00AM until 12:00PM local time, to help you in preparation of your capability statement. If you plan to attend the question and answer session, please send an e-mail or fax to the person listed under Point of Contact, along with all questions you may have, by December 9, 2004, 3:30PM EST. Please note, all submitted questions will not be answered until the actual question and answer session on December 14, 2004. 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, Contract Specialist, at manouelj@mail.nih.gov in either WordPerfect or Microsoft Word OR faxed to (301) 402-6699 by December 20, 2004, 3:30PM EST. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (02-DEC-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 19-JUL-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/RCB/N02-CM-57006-48/listing.html)
- Record
- SN00850589-F 20050721/050719213309 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |