CLINICAL AND REGULATORY AFFAIRS SUPPORT CONTRACT

Release Date:  March 17, 1999  

RFP AVAILABLE:  NIH-NIAID-DMID-00-21

P.T.

National Institute of Allergy and Infectious Diseases

The Clinical and Regulatory Affairs Branch (CRAB), Division of Microbiology
Diseases (DMID), National Institute of Allergy and Infectious Diseases
(NIAID), has a requirement to provide regulatory support services for the
operations of the Clinical and Regulatory Affairs Branch.  The purpose of the
Request for Proposals (RFP) is to seek responsible offerors for  data and
document collection and compilation for regulatory filing (pre-IND, IND) with
the U.S. Food and Drug Administration (FDA); technical review and report
preparation; clinical site monitoring activities; final container packaging,
purchase, labeling, storage, distribution and tracking of investigational
products; storage of biological samples; implementing and maintaining computer
information systems; providing administrative coordination and general
logistic support for regulatory activities, and other services as required. 
To this end, this solicitation is to support activities of the CRAB, DMID,
NIAID, NIH, and the clinical research and development of vaccines and
therapeutics for a wide variety of diseases including those bacterial, viral
and parasitic origin.

It is anticipated that one cost-reimbursement, completion type contract will
be awarded for a period of seven years, beginning approximately March 1, 2000. 
RFP NIH-NIAID-DMID-00-21 will be available electronically on or about March
15, 1999, and may be accessed through the NIAID Contract Management Branch
(CMB) Home Page at the following URL:  http://www.niaid.nih.gov/contract, then
select the "RFPs" link and then select "RFP-NIH-NIAID-DMID-00-21."

Please note that the RFP for this acquisition has been revised to include only
the Statement of Work, deliverable and reporting requirements, special
requirements and mandatory qualifications, if any, the Technical Evaluation
Criteria, and the proposal preparation instructions.  All information required
for the submission of an offer will be contained in the electronic RFP
package.  Following proposal submission and the initial review process,
offerors comprising the competitive range will be requested to provide
additional documentation to the Contracting Officer.

Responses to this RFP will be due June 20, 1999.  Any responsible offeror may
submit a proposal which will be considered by the Government.

This advertisement does not commit the Government to award a contract.

INQUIRIES

Nancy Hershey
Telephone:  (301) 496-0193
FAX:  (301) 402-0972
Email:  nh11x@nih.gov

No collect calls will be accepted.

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