RFP ANNOUNCEMENT: IN VITRO AND ANIMAL MODELS FOR EMERGING DISEASES AND 
BIODEFENSE - NIH-NIAID-RFP-DMID-03-39

Release Date:  October 1, 2002

NOTICE: NOT-AI-02-056

National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)

Receipt Date:  January 30, 2003

DESCRIPTION

The National Institute of Allergy and Infectious Diseases intends this 
contract to provide targeted screening to identify potential therapeutic and 
preventive modalities, as well as resources to characterize additional 
antimicrobial activities of already licensed antimicrobial agents, small 
animal and non-human primate models to test the safety and efficacy of 
therapeutic and preventive modalities that target emerging infectious agents 
including, Bioterrorism Category A-C agents as outlined in the CDC website 
http://www.bt.cdc.gov/Agent/Agentlist.asp.  A list of priority organisms is 
also available on the NIAID website 
http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm.

The objective of this contract is to provide a range of developmental 
resources to bring new therapies and preventive measures from the laboratory 
to initial clinical testing in humans.  The contract consists of six parts, 
listed below, which each contribute to the overall development effort.  These 
contracts will provide a ready capacity in a number of needed areas and will 
be utilized as products become available for testing.  Test articles that are 
found to have activity in Part A may progress through development using 
contractors from other parts.  For Parts C, D, E and F, various vaccine 
concepts may be tested based on the following categories:   (a) synthetic 
peptides, (b) recombinant subunits, (c) vector based vaccines, (d) virus-like 
particles/replicons, or (e) nucleic acid based vaccines. The contract will 
have six (6) parts.

Part A: In Vitro Screens for Antimicrobial Activity.  Part A will provide the 
capacity to screen test articles for antimicrobial activity against emerging 
infectious agents including, Bioterrorism Category A-C agents.  Materials for 
testing will be obtained by NIAID and provided to the contractor for testing.  
This contract is not intended to cover antiviral screening against viral 
hemorrhagic fevers or poxviruses, which is covered by a separate contract.  

Part B: Clinical Isolate Panels for Selected Bacterial Pathogens.  Part B 
will provide the capacity to perform antimicrobial activity determination 
against clinical panels of bacterial pathogens to arrive at tentative 
susceptibility breakpoints. This activity is to be performed using bacterial 
pathogens classified as emerging infectious agents, including Bioterrorism 
Category A-C agents.  Antimicrobial agents to be tested under this contract 
will be selected on the basis of their activity against select genera and 
species of bacterial pathogens using reference strains. 

Part C: Small Animal Models for Selected Pathogens, including GLP Studies.  
Part C will support the development, validation and use of various small 
animal models to screen new therapeutic, diagnostic and preventive agents or 
test the efficacy of therapeutics, immunotherapies, diagnostics, and vaccines 
with activity against emerging infectious agents including, Bioterrorism 
Category A-C agents.  

Part D:  Non-human Primate Models for Selected Pathogens, including GLP 
Studies.  Part D will support the development, validation and use of various 
non-human primate models to screen new therapeutic, diagnostic and preventive 
agents or test the efficacy of therapeutics, immunotherapies, diagnostics, 
and vaccines with activity against emerging infectious agents including, 
Bioterrorism Category A-C agents.  

Part E:  Safety and Immunogenicity Testing for Vaccines.  Part E will support 
the testing of vaccine preparations as required prior to initial clinical 
evaluation (under GLP).  This includes testing candidate products for safety 
and immunogenicity (both cellular and humoral) in small animals and, if 
appropriate, in non-human primates.

Part F: Safety/Toxicology and Pharmacology Testing for Therapeutics.  Part F 
will support the testing of candidate products for safety, including 
reproductive toxicology and other appropriate tests, in small and large 
animal, and if necessary, in non-human primates.  This activity includes all 
such tests as are required to support clinical use in humans; testing must be 
sufficient to meet requirements for IND filing (GLP).

It is anticipated that multiple awards will be made for each part of this 
Indefinite Delivery Indefinite Quantity (IDIQ) solicitation.  The ordering 
period of this IDIQ will be in effect for seven (7) years.  An IDIQ contract 
provides for an indefinite quantity, within stated limits, of supplies or 
services to be furnished during a fixed period, with deliveries or 
performance to be scheduled by the Government placing orders with the 
contractor.  Task orders will be issued to the pre-qualified pool of 
contractors for parts A, B, C, D, E or F based on the specific requirements 
of the task order. The RFP contains at least one actual task for each of 
these six parts. In response to this RFP, potential Offerors may submit 
proposals for one or more of the six Parts described above.  For Parts A and 
B, Offerors should propose as many organisms or groups of organisms as 
possible.  Within Parts C, and D Offerors may submit proposals for one or 
more of the models using the same organisms/disease or models for more than 
one organism/disease. Offerors for Parts E and F should propose a 
comprehensive services to cover all aspects of the Statement of Work.  
Proposals will undergo peer review based on the evaluation criteria and 
awards will be made to the most qualified proposals.  Each Offeror awarded a 
contract under a given Part or Category, will receive a guaranteed minimum 
dollar award over the term of the Contract.  The following scale will 
determine the guaranteed minimum dollar awards for each part:

Part A $  75,000
Part B $  75,000
Part C $100,000
Part D $150,000
Part E $100,000
Part F $100,000

NIAID anticipates award of one IDIQ contract beginning approximately 
September 30, 2003. 

RFP NIH-NIAID-DMID-03-39 will be available electronically on or about 
September 30, 2002, and may be accessed through the NIAID Contract Management 
Branch (CMB) Home page at http://www.niaid.nih.gov/cgi-shl/cmb/rfps.cfm and 
will be posted on FedBizOpps at http://www.fedbizopps.gov/.  Please note 
that the RFP for this acquisition will only includes the work statement, 
deliverable and reporting requirements, special requirements, 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 asked to provide 
additional documentation to the Contracting Officer. Responses to this RFP 
will be due approximately January 30, 2003.  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.  No collect 
calls will be accepted.  No facsimile transmissions will be accepted.

Contracting Office Address:

National Institutes of Health
National Institutes of Allergy and Infectious Diseases
Contract Management Branch 
6700-B Rockledge Drive
Room 2230, MSC 7612 
Bethesda, MD, 20892-7612

Point of Contact:

Paul McFarlane, Contracting Officer, Phone 301-496-0349, Fax 301-402-0972, 
Email pm24@nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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