B -- QUALITY ASSURANCE UNIT FOR THE HPV TYPE 16 VACCINE TRIAL IN COSTA RICA

Notice Date

June 6, 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-21003-50

Response Due

September 4, 2001

Point of Contact

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

E-Mail Address

Karen L. McFarlane (km63k@nih.gov)

Description

The Environmental Epidemiology Branch (EEB) of the Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) is planning a large randomized clinical trial in Costa Rica among 15,000 women designed to evaluate the efficacy of human papillomavirus type 16 vaccines. The present Request For Proposals (RFP) N02-CP-21003-50, through the Support Services For Studies of Emergent Cancer Master Agreement Pool, is for the Quality Assurance Unit (QAU) for this trial. The QAU will be responsible for five main areas of the trial: 1) developing and implementing a plan for monitoring of trial activities, 2) coordinating the reporting and review of serious adverse events requiring rapid reporting, 3) providing regulatory support and assistance in preparing submissions to the Food and Drug Administration (FDA), 4) maintaining up-to-date trial SOPs, manuals, and forms, and 5) supporting the NCI Project Officers and trial activities. This RFP will be available electronically. Those interested in obtaining a copy of this RFP should send their email address to Karen L. McFarlane at km63K@nih.gov and a copy of the RFP will be forwarded electronically. AN AWARD WILL ONLY BE MADE TO A MASTER AGREEMENT HOLDER IN THE SUPPORT SERVICES FOR STUDIES OF EMERGENT CANCER MASTER AGREEMENT POOL. The North American Industry Classification System (NAICS) code is 5417. Proposals will only be considered from offerors in the Support Services For Studies of Emergent Cancer Master Agreement Pool. Those not currently in the Support Services For Studies of Emergent Cancer Master Agreement Pool and who wish to be considered for inclusion should consult the Research Contracts Branch Website at http://rcb.nci.nih.gov/ under "Current Requests For Proposals" and refer to RFP/N01-CP-01005-50. The duration of the existing Master Agreement Pool is 10/31/2000 through 10/30/2005. The due date, for proposals to be included in the Master Agreement Pool, is November 15 of each year for those interested in being included in the projected annual review. It is anticipated that the present RFP, for the above Master Agreement Order, will be available at the end of July 2001. Questions should be directed, via facsmile or email, to Karen L. McFarlane, Contracting Officer, Epidemiology and Support Section, Research Contracts Branch, National Cancer Institute, Executive Plaza South, Room 620, Bethesda, MD 20892-7224. Phone (301) 435-3782; Fax: (301) 480-0241; email: km63k@nih.gov

Record

Loren Data Corp. 20010608/BSOL002.HTM (W-157 SN50O0O9)