REAGENT RESOURCES SUPPORT FOR AIDS VACCINE DEVELOPMENT - NIH-NIAID-DAIDS-03-
01

Release Date:  March 18, 2002
 
NOTICE: NOT-AI-02-011

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

Receipt Date: June 14, 2002

DESCRIPTION

The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National 
Institute of Allergy and Infectious Diseases (NIAID), National Institutes of 
Health (NIH), is recompeting their current contract with Quality Biological, 
Inc., Contract Number N01-AI-65278. This solicitation will be a 100% Small 
Business Set-Aside, NAICS Code 54171, 500 employees. 

DAIDS is committed to the development of HIV/AIDS vaccines and other 
prevention strategies (e.g., topical microbicides) for worldwide use in 
stemming the AIDS epidemic. While industry, government, and academia have all 
targeted considerable resources to this end over the past 15 years, 
identification of an efficacious vaccine against HIV/AIDS has yet to be 
accomplished. Therefore, the highest priority of the DAIDS continues to be 
the discovery and evaluation of HIV/AIDS vaccines. In this effort DAIDS 
supports basic, preclinical, and clinical research to identify vaccine 
strategies against HIV/AIDS. 

To facilitate this research, the DAIDS has long provided the research 
community with standardized, quality-controlled reagents through the NIH AIDS 
Research and Reference Reagent Program. However, large-scale preclinical and 
clinical vaccine and prevention research studies, such as those carried out 
by DAIDS-sponsored Simian Vaccine Evaluation Units (SVEUs) and the expanded 
international HIV Vaccine/Prevention Trial Networks (HVTN and HPTN), require 
larger quantities of such reagents not typically available through the NIH 
AIDS Research and Reference Reagent Program. Therefore, to advance the 
vaccine development process, DAIDS is seeking ways to generate and acquire 
reagents and technologies, as needed, for sponsored AIDS vaccine/prevention 
research and development projects. Many such reagents are not commercially 
available and require customized production and quality control. Reagents 
required for this research include but are not limited to viral gene products 
and associated peptides, adjuvants, cytokines, virus stocks, expression 
vectors (including recombinant plasmid DNAs and RNAs), monoclonal and 
polyclonal antibodies, topical microbicides, and sometimes unforeseen but 
timely produced reagents. These reagents will be generated for evaluating 
vaccine safety, immunogenicity, and efficacy. 

The current Contractor supports a facility to produce or otherwise acquire 
these types of reagents for AIDS vaccine research and has the capability to 
store, maintain, assure quality control and distribute large quantities of 
reagents. This contract is utilized by nearly all facets of the vaccine 
development program funded by DAIDS. Grantees, contractors, and other 
investigators regularly make requests through this DAIDS contract to obtain 
essential reagents for their vaccine development studies. In addition, novel 
procedures are often developed for optimizing the production of these 
reagents (e.g., greater yields and higher purity). Offerors will be expected 
to: 1) produce (either through purchase or other means), purify, and test 
reagents for the DAIDS Vaccine and Prevention Research Program; these 
reagents include an array of viral proteins and peptides, virus stocks, 
monoclonal and polyclonal antibodies, topical microbicides, vaccine adjuvants 
and cytokines, and any additional reagents deemed necessary for the DAIDS 
vaccine program, 2) have capabilities for genetic cloning and sequencing, 3) 
be capable of producing and testing unique and customized reagents at the 
request of the program, including preparing and/or producing soluble 
proteins, expression vectors, and gene products (including experimental AIDS 
vaccines) under current Good Laboratory Practice (cGLP) or Good Manufacturing 
Practice (cGMP) as appropriate for their intended use, and preparing and/or 
producing these in large-scale production lots, 4) be able to analyze all 
acquired or generated reagents for purity and integrity, and to provide for 
their quality control and assurance, and 5) provide appropriate facilities 
for receipt and inventory tracking, storage, maintenance and distribution of 
all reagents. 

The Contractor will be monitored by regular communications between the NIAID 
Project Officer and the contract Principal Investigator and through site 
visits by DAIDS staff. NIAID will receive written reports (quarterly updates 
and annual reports) as well as reports of data from individual studies in 
progress. It is anticipated that a single cost reimbursement, completion type 
contract will be awarded for a period of seven (7) years, beginning 
approximately February 14, 2003. The total effort is estimated to be 
approximately 76,285 total labor hours or 37 FTEs. 

RFP NIH-NIAID-DAIDS-03-01 will be available electronically on or about March 
14, 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 is 
also posted on FedBizOpps. Any responsible Offeror may submit a proposal that 
will be considered by the Government. 

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
Lois Eaton, Contract Specialist, Phone 301-496-0611, Fax 301-480-5253, Email 
le52u@nih.gov 
Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-
402-0972, Email bs92y@nih.gov

This announcement does not commit the Government to award a contract. No 
collect calls will be accepted.

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