Release Date:  March 21, 2002


National Institute of Allergy and Infectious Diseases (NIAID)

Response Date:  April 15, 2002

Purpose of Announcement

The purpose of this announcement is two-fold: first, to inform potentially 
interested individuals, institutions and organizations of a draft project 
requirement of the National Institute of Allergy and Infectious Diseases 
(NIAID), National Institutes of Health (NIH), designed to establish a 
contract for the Development Resources Master Contract, and second, to 
solicit comments from interested parties with respect to the scope, design 
and requirements of this draft solicitation.

Please note that proposals are not being solicited at this time. With this 
announcement, the NIAID is soliciting comments and recommendations on draft 
Statement of Work in order to: (1) determine interest in this solicitation; 
(2) assure that requirements included in the documentation will meet the 
intent of the solicitation; and very importantly, (3) identify or clarify 
what may appear to be problems, conflicts, or obstacles for an institution or 
organization that might otherwise wish to become a potential offeror.

It is anticipated that one cost-reimbursement contract will be awarded for a 
period of five (5) years. As provided for by FAR.5.205 entitled "Special 
Situations," a draft project requirement is being broadcast.    


The development of vaccines to prevent the spread of HIV infection or counter 
bioterroism threats (BT) is among the NIAID's highest priorities.  Likewise, 
there is a critical need to promote the development of novel microbicides for 
prevention of sexual transmission of HIV, particularly in the absence of an 
effective, or even partially effective, vaccine.  While advances in 
immunology and molecular biology continue to offer an expanding array of 
approaches to the development of new candidate vaccines, the limited capacity 
to move promising concepts through the development process presents a barrier 
to the achievement of this goal.  Limited industry involvement in developing 
both vaccines and microbicides requires the need for a nontraditional, 
proactive and developmentally oriented response by NIAID to meet this public 
health challenge.  When promising candidates emerge from investigator-
initiated research studies, there is a need to provide rapid support to 
quickly and efficiently move the candidates toward clinical lot production.  
The type of products needed to provide efficacy against HIV/AIDS or BT are 
currently not known, thus production facilities with the ability, flexibility 
and experience staff must be identified and readied for quick mobilization as 
promising new concepts are identified.  Clinical testing of a product 
requires that the product first be approved for such testing by the Food and 
Drug Administration, and such approval is only achieved after considerable 
preclinical safety and immunogenicity testing.  Since it is envisioned that 
many promising candidates will lack industry backing, there is a need to 
provide support for enabling studies leading to IND submission and approval.  
Providing sufficient support to move concepts with little or no industry 
support from the development stage through to production and FDA approval 
will greatly expand the pipeline of products reaching human clinical trial 


The objective of this initiative is to expand the number of vaccine and 
microbicide products for HIV/AIDS, BT and other emerging diseases of national 
importance that can be evaluated in human clinical trial testing.  This 
initiative will provide overall project management and the capabilities to 
support all phases of preclinical development, including process and product 
development, clinical lot production, formulation, preclinical enabling 
studies and associated tasks leading to the filing of investigational new 
drug (IND) applications.  The Contractor will be required to assist in 
identifying products that are ready for development and production by 
assembling information on experimental vaccines and microbicides.  This will 
be accomplished by collecting, maintaining, analyzing and disseminating 
information arising from all preclinical development efforts, including data 
generated by SIV Vaccine Evaluation Units, the Integrated 
Preclinical/Clinical Program for HIV Topical Microbicides (IPCP/HTM), and 
other prevention grants and contracts.  The Contractor will be required to 
identify potential subcontractors with the capability and interest in 
producing clinical product lots and to issue and administer subcontracts for 
the production of products as assigned by the Project Officer.  The 
Contractor will also be required to perform all preclinical testing of the 
products necessary for Investigation New Drug (IND) application, either in-
house or via subcontracts, and to compile and submit this data in the form of 
a formal IND submission to the FDA.  The Contractor will be expected to 
provide information management and IND preparation and filing support as part 
of their in-house activities.


Specifically, the Contractor shall:

Provide overall project management to establish and meet development time 
lines, monitor progress, provide frequent verbal/written communication and 
updates to NIAID, ensure coordination among subcontractors, suppliers, NIAID 
and NIAID supported grantees or contractors, as well as ensure the most 
efficient and expeditious entry of a product into clinical trial. 

Develop candidate vaccines as assigned by the Project Officer, including 
process development and production of GLP/GMP pilot lots suitable for phase 
I/II human trials, and perform the necessary characterization tests required 
for release for clinical use.  Various types of vaccine concepts will be 
developed including but not limited to (a) synthetic peptides, (b) 
recombinant proteins, (c) plasmid DNA, (d) vector (bacterial or viral) based 
vaccines, (e) whole killed/virus-like particles, and (f) attenuated viruses.

Develop candidate non-vaccine prevention modalities as assigned by the 
Project Officer, including identification, characterization, process 
development and production, and formulation appropriate for human clinical 
trials.  Various types of prevention modalities will be developed, including 
but not limited to microbe direct inactivators, (b) inhibitors of attachment,
fusion, or entry, enhancers of natural mucosal defense mechanisms.

Carry out pre-clinical testing of vaccine and microbicide preparations as 
required prior to initial human clinical trial evaluation.  This shall 
include testing candidate products for safety and in the case of vaccines, 
immunogenicity (both cellular and humoral) in small animals and, if 
appropriate non-human primates.

For each product produced and tested above and in collaboration with the 
vaccine or microbicide supplier, develop a Master File, Investigator's 
Brochure, and compile an Investigational New Drug Application (IND) including 
a vaccine or microbicide trial protocol (provided by the Project Officer) 
appropriate for submission to the FDA for an IND. 

Conduct market surveys and /or review scientific and industry publications on 
new or related vaccine and microbicide product development, create and 
utilize a database or databases identifying and comparing potential products, 
as well as preparation of reports of product characteristics that can be used 
to support selection and prioritization of candidates for further 

Assist in identifying promising vaccine and microbicide candidates for 
development through compilation of data from animal studies.  This will 
entail the development and utilization of a computer-based data management 
system to collect data generated in NIAID-supported animal studies, as 
directed by the Project Officer.


We encourage you to respond electronically to Brenda Brooks, NIAID 
Contracting Officer, on this matter, using the Response Guidelines provided 
below, to indicate issues or elements you are particularly in favor of, or 
which you find problematic to the response capacity of your institution or 
organization. Electronic responses should be submitted by Monday, April 15, 
Please note that the Government does not intend to award a contract on the 
basis of this solicitation or to otherwise pay for the information solicited. 
Although "proposal" and "offeror" are used in this Announcement, your 
response will be treated as information only. It shall not be used as a 

Whether you review this draft project requirement as a potential future 
offeror or as a fact-finding exercise, the NIAID is interested in your 
feedback. The NIAID is actively soliciting input from academic and industry 
sources to improve and refine this draft requirement and is seeking to gauge 
the degree of interest in this effort. PROPOSALS ARE NOT BEING SOLICITED AT 
THIS TIME. Candid questions and concerns elicited by this notice are 
encouraged. Please note that the Government will not provide individual 
responses to questions/inquiries. However, the extent to which a dialogue may 
be established with any individual or business entity concerning a given 
issue raised by this notice shall, for purposes of fairness and compliance 
with Agency regulations, be determined by the NIAID Contracting Officer after 
consultation with the cognizant NIAID Technical Program Office.

Examples of feedback may include, but are not limited to:

1.  Level of interest in pursuing a prime contract with the NIAID, or a 
subcontract, consultant or other collaborative relationship with a potential 
prime Contractor, for this requirement. If there is no interest at this time, 
please explain why.

2.  Comments, questions and/or concerns regarding the scope and/or design of 
the Master Contract for Preclinical Development.

Responses should be clear and succinct. We do not desire the submission of 
any technical or cost proposals. Any critique of the draft project 
requirement should adequately describe concerns and offer recommendations 
and/or solutions, which might be used by the NIAID in refining the 
requirement. Critical technical concerns should be supported with questions 
posed in such a way as to point toward possible alternatives that may be 
pursued by the NIAID in refining some aspect(s) of the requirement.

Responses should be submitted electronically by Monday, April 15, 2002.  All 
responses should include the name, position/title, telephone/extension, 
facsimile number(s), and electronic mail address(es) of the contact 
individual. The response should also identify the institution, organization, 
company, etc., and the complete street address (including, where applicable, 
location identifiers, e.g., office stop and room number) including zip code.

All response information should reference NIH-NIAID-DAIDS-03-18 and be 
directed in writing via electronic mail to:

Brenda Brooks, Contracting Officer
Phone:  (301) 435-2765
Facsimile:  (301) 402-0972 or (301) 480-5253

Additionally, please provide a copy to:

Jacqueline C. Holden, Senior Contracting Officer
Phone:  (301) 496-7119
Facsimile:  (301) 402-0972 or (301) 480-5253

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