B -- CLINICAL GENETICS BRANCH SUPPORT SERVICES

Notice Date

March 20, 2001

Contracting Office

National Cancer Institute, Research Contracts Branch, ESS, Executive Plaza South, Rm. 620, 6120 Executive Blvd., MSC 7224, Bethesda, MD 20892-7224

ZIP Code

20892-7224

Solicitation Number

N02-CP-11019-50

Response Due

May 13, 2001

Point of Contact

Karen L. McFarlane, Contracting Officer, (301) 435-3782

E-Mail Address

Karen L. McFarlane (km63k@nih.gov)

Description

ELECTRONIC RFP ANNOUNCEMENT, POTENTIAL OFFERORS WIL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. The Clinical Genetics Branch (CGB), Division of Cancer Epidemiology and Genetics (DCEG), of the National Cancer Institute (NCI) is competing a new contract for support services for interdisciplinary studies in clinical cancer genetics. The contract will establish a mechanism to provide all the services required to conduct a wide variety of domestic and international family studies and field (case-control and cohort) studies. The projected level-of-effort for this contract is 14,170 direct labor hours for Year 1, 20,870 direct labor hours for Year 2, and 34,000 direct labor hours per year for Years 3 through 5, for a total of 137,040 direct labor hours for the entire contract period. Although the scientific design and oversight of the activities are the responsibility of the Clinical Genetics Branch professional staff, the major activities of the contract provide: 1) nursing support including contacting family members, explaining the studies, enrolling family members, obtaining clinical information and records, requesting pathology slides for diagnosis confirmation, arranging for family members to be evaluated by CGB investigators in the Cancer Genetics Clinic at the NIH Clinical Center, performing phlebotomy, obtaining other biologic specimens as necessary, arranging and conducting field trips to evaluate family members, verifying information for the family registry database, maintaining tracking systems for data and biologic specimens, developing and providing educational materials for participants, and participating in genetic counseling and risk notification; 2) maintenance of a locked medical record room to which CGB investigators have immediate access; 3) supporting the development and conduct of chemoprevention trials to be conducted at the NIH Clinical Center, targeting subjects at increased genetic risk of cancer, including assistance related to maintenance of the IND for investigational agents, monitoring and reporting of adverse events, and related FDA regulatory matters; 4) development of coordination and liaison at a local or international level with collaborating investigators or institutions whose cooperation is needed for the conduct of a study; 5) assistance in the design and pilot testing of forms required for field investigations (e.g., questionnaires, abstracting forms, coding forms, manuals for field procedures and other documents); 6) hiring, training and supervision of field personnel (interviewers, abstractors, and others); 7) identification of study subjects, including locating cancer patients and/or their relatives, selection of controls through such methods as random digit dialing and acquisition of appropriate study population rosters or files; 8) supervision and management of field operations; 9) collecting data (interviewing/record abstraction, biologic specimen collection and processing); 10) data reduction activities (coding, keying, and editing) of data collected into a format suitable for computer analysis; 11) quality control and standardization so that appropriate and valid data result. The maintenance of a secure record room which allows CGB investigators access to the medical records within 15 minutes is a mandatory qualification requirement. There are also mandatory qualification requirements of the capability of nearly daily face to face meetings with the CGB staff; and NIH Clinical Center Credentialing of contractor staff. A uniform budget assumption shall be included in the RFP to require that all offerors propose a line item of $80,000 per year of the contract for required subcontracts. It is anticipated that the Request for Proposal (RFP) package will be available on or about April 13, 2001, with responses due within 30 calendar days following the actual date of issuance of the RFP. The RFP may be accessed via the NCI Research Contracts Branch (RCB) website: http://rcb.nci.nih.gov/ under "Current Request For Proposals". Award of this project is anticipated by September 30, 2001. All responsible sources may submit a proposal which shall be considered by the NCI. No collect calls will be accepted. National Cancer Institute, Research Contracts Branch, Cancer Etiology Contracts Sections, EPS 620, 6120 EXECUTIVE BOULEVARD MSC 7224 BETHESDA MD 20892-7224

Web Link

NCI Research Contracts Branch Homepage (http://rcb.nci.nih.gov/)

Record

Loren Data Corp. 20010322/BSOL003.HTM (W-079 SN50G7L3)