NIH GUIDE, Volume 22, Number 41, November 12, 1993


P.T. 34


  Chemotherapeutic Agents 

  Chemical Synthesis 

  Infectious Diseases/Agents 

National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID),

National Institutes of Health (NIH), supports a number of programs

designed to identify and develop promising therapeutic agents active

against a wide spectrum of infectious agents, including HIV,

tuberculosis, and viral and non-viral opportunistic infections

associated with the Acquired Immune Deficiency Syndrome (AIDS).  Many

of these research endeavors require pharmaceutical research and

development resources such as chemical resynthesis, pharmaceutical

analysis, and preparation of pharmaceutical dosage forms to provide

therapeutic agents of sufficient quantity and quality to permit a

proper evaluation of their efficacy and safety.  The purpose of this

solicitation is to provide a contract for resynthesis and acquisition

of chemicals for testing as anti-infective agents.  These chemicals

will be used to prepare dosage forms for clinical evaluation and for

use in animal models of infectious diseases, toxicological studies,

as required to support the Government's ongoing evaluation of these

agents.  The Division of AIDS (DAIDS), NIAID previously awarded a

contract to provide a chemical resynthesis capability on a scale of

1-1000g to support the drug discovery effort for infectious diseases.

The current contract will expire in October 1994.  The anticipated

contract will be a set-aside for small business concerns.  The

Government's requirements specify the following two mandatory

qualification criteria that must be met:  (1) Neither the Offeror nor

a proposed subcontractor may be a pharmaceutical company, defined as

an organization that sells drugs or other therapeutic agents to the

general public for profit and (2) The Offeror must be able to

manufacture pharmaceutical materials in compliance with current Good

Manufacturing Practice regulations (21 CFR 210-211) at time of Best

and Final Offers.  Documentation of this capability is required.

This is an announcement for an anticipated Request for Proposals

(RFP).  RFP NIH-NIAID-DAIDS-95-05 was issued on  November 1, 1993 and

proposals will be due the close-of-business February 15, 1994.  It is

anticipated that one (1) level-of-effort type cost-reimbursement

contract will be awarded for a five year period to carry out

requested scale up and/or modify the synthetic procedure to yield

increasingly larger batches as required for the further evaluation on

new agents.

A short-form version of the RFP will be available, for informational

purposes, which includes the background information, full Statement

of Work and Evaluation Criteria, and the Reporting Requirements.

There is sufficient information in this document to enable

prospective offerors to determine if they have the

experience/capability to meet the Government's requirements.  A full-

text version is also available, which includes all the necessary

information, business forms, etc., to submit a proposal.  There are a

limited number of full-text versions available.  Therefore, request

the short-form RFP first, then the full-text version only if you

intend to submit a proposal.  Telephone inquiries will not be

honored.  Specify if you are requesting the short-form or full-text

version of the RFP (if no distinction is made, the short-form version

will be sent).  FAX responses are acceptable, but it is preferred

that requests be submitted in writing with two self-addressed mailing

labels attached to ensure proper delivery.  All proposals from

responsible sources will be considered by the NIAID.  This

advertisement does not commit the Government to award a contract.


Requests for the RFP are to be directed in writing to:

Ms. Merilee Rahe-Stoline

Contract Management Branch

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3C07

6003 Executive Boulevard

Bethesda, MD  20892

FAX:  (301) 402-0972


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