SOLICITATION NOTICE
R -- Regulatory Support for Cancer Prevention Agent Development
- Notice Date
- 1/14/2004
- 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 Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CN-45004-39
- Point of Contact
- Theresa Shroff, Contracting Officer, Phone (301) 435-3796, Fax (301) 402-8579, - Theresa Shroff, Contracting Officer, Phone (301) 435-3796, Fax (301) 402-8579,
- E-Mail Address
-
ts44t@nih.gov, ts44t@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) is seeking a contractor to provide regulatory and technical support in gathering, interpreting and summarizing a vast amount of preclinical and clinical data associated with cancer preventive agents. These data are generated by the scientific community and NCI funded projects. The contractor will be responsible for regulator submissions to support the DCP?s chemoprevention development and clinical research program. The contractor will develop and implement procedures for accessing, reviewing and compiling scientific, safety and clinical data for possible inclusion in Investigational New Drug (IND) and other regulatory submissions. The task areas of the statement of work include support for 1) regulatory submissions; 2) regulatory correspondence and administrative tracking; 3) safety activities; 4) maintenance of collaborating research agreement records; 5) coordination and documentation of regulatory meetings; 6) document management; 7) regulatory review, reporting and advisory activities; 8) process and quality assurance/quality control (QA/QC) standard operating procedures (SOPs) and 9) information management system. The contractor will prepare and maintain documents required by the Food and Drug Administration (FDA) for clinical trials of investigational agents. The proposed acquisition is a recompetition of contract N02-CN-05008 awarded to CCS Associates, Inc. Any award resulting from this solicitation will be made on the basis of a cascading evaluation preference approach. It is anticipated that one (1) level of effort, TERM type contract will be awarded and that the period of performance will consist of a base period of five (5) years plus two (2) option years for a possible total of seven (7) contract years. This applicable NAICS Code is 541519. The award will be made to an eligible business concern included in one of the following three (3) cascading preference tiers, provided that adequate competition is received and award can be made at fair market price (see definition at FAR part 19). Adequate competition is defined as the receipt of at least two (2) competitive proposals in a tier from companies that are qualified, technically acceptable, cost reasonable and responsible business concerns. The cascading evaluation is to be applied in the following manner: First Tier Competition - is defined by competition among eligible HUBZone small business concerns providing 51% or more of the direct labor dollars proposed for the required contract effort. In the event that competitive and price requirements cannot be met under the First Tier Competition and there is only one technically qualified firm offering a fair market price, then competition for this Tier will stop. However, the one qualified firm from this Tier will become eligible to compete in the Second Tier Competition. Second Tier Competition is defined by competition among eligible small business concerns providing 51% or more of the direct labor dollars proposed for the required contract effort. If no proposal received for the First Tier Competition is determined to be eligible for award and only one proposal received for the Second Tier Competition is determined to be eligible for award, the Government will consider a Third Tier Competition. Third Tier Competition is defined as an unrestricted, full and open competition with selection of an awardee based upon a best value determination pursuant to FAR 15.3. This solicitation will be available electronically on or about February 1, 2004. The RFP may be accessed through Internet address: http://rcb.nci.nih.gov/. It is the offeror?s responsibility to monitor this Internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO CONTRACTING OFFICER THERESA SHROFF at ts144t@nih.gov. Point of contact: Theresa H. Shroff, Contracting Officer, at e-mail address: ts144t@nih.gov; telephone: 301-35-3796 and fax: 301-402-8579. No collect calls will be accepted.
- Record
- SN00503632-W 20040116/040114211916 (fbodaily.com)
- Source
-
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