B -- CLINICAL SITE MONITORING FOR ANTHRAX VACCINE HUMAN TRIALS

Notice Date

December 19, 2000

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146

ZIP Code

30341-4146

Solicitation Number

2000-N-00177

Response Due

February 6, 2001

Point of Contact

Lorenzo Falgiano, Contract Specialist, Phone (770) 488-2629, Fax (770) 488-2670, Email ljf5@cdc.gov -- Michael Detmer, Supervisory Contract Specialist, Phone (770) 488-2634, Fax (770) 488-2670, Email MDetmer@cdc.gov

E-Mail Address

Lorenzo Falgiano (ljf5@cdc.gov)

Description

The Centers for Disease Control and Prevention (CDC) contemplates the award of a single contract to perform clinical site monitoring of existing multi-center vaccine trial sites. These sites were awarded contracts by CDC, in September 2000, to study and determine the immunogenicity and reactogenicity of the anthrax vaccine (AVA, manufactured by Bioport Corporation, Lansing Michigan). Five sites in the United States, including one site yet to be determined, will conduct a human clinical trial of the anthrax vaccine to obtain data to support changes in the route of administration and reduction in the number of doses in the currently recommended vaccination series. The successful contractor will be responsible for the following activities: (1) data and document collection; (2) compilation for regulatory filing for the Investigational New Drug (IND) application with the Food and Drug Administration (FDA); (3) clinical site monitoring activities; (4) providing administrative coordination and general logistical support for regulatory activities; and (5) any other services deemed by the government necessary to successfully complete work within the scope of this requirement. The CDC has scientific and regulatory responsibility for the clinical trials. The successful contractor, receiving the award of this contract, will be required to maintain close interaction and cooperation among the existing human sites already under contract with CDC throughout the performance period of this requirement. The period of performance will be sixty (60) months and the contract will be incrementally funded based on the government's availability of funds for each fiscal year. The schedule issue date is approximately January 4, 2001, No telephone requests will be accepted; only written requests for this solicitation will be honored. Requests should site RFP Number 2000-N-00177, All responsible sources that meet the above requirements may submit a proposal which shall be considered by the Agency.****

Web Link

Visit this URL for the latest information about this (http://www2.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=P&P=2000-N-00177&L=2965)

Record

Loren Data Corp. 20001221/BSOL002.HTM (D-354 SN5092D8)