NIH GUIDE, Volume 26, Number 25, August 1, 1997




P.T. 34




  Disease Prevention+ 


National Institute of Allergy and Infectious Diseases


The development of vaccines and other biomedical interventions to

prevent the spread of HIV infection is a national goal of the highest

priority.  To help accomplish this goal, the Division of AIDS of the

National Institute of Allergy and Infectious Diseases plans to select

an organization(s) with experience in both: 1) vaccine development;

and 2) research management skills.  This group will manage a Master

Contract for Targeted HIV Vaccine Development and Related Biomedical

Prevention Research.  The contract will provide the NIAID with two

functions:  1) process development and cGMP production of pilot lots

of candidate HIV vaccines; and, 2) a rapid response mechanism for

funding high priority, targeted developmental research.  The NIAID,

in consultation with its advisory groups, will establish the

priorities for all research and development.


1 - Pilot Lot Production


The most important technical capacity of the contractor(s) is their

expertise in vaccine development, especially biologicals.  A Process

Development Team will support vaccine candidates or concepts,

identified by the NIAID, from the earliest stages of

identification/discovery through the IND issuance process.


2 - Other targeted research


The NIAID will also establish priorities for the other targeted

research by directing the Contractor to provide specific systems and

reagents (e.g. unique animal models, specialized assays, construction

and characterization of challenge stocks, cell lines expressing

particular co-receptor) for preclinical and clinical  vaccine

evaluation.  To accomplish "Other Targeted Research," the Master

Contractor will establish a peer review process, fund research

through subcontracts to selected groups, receive data, and monitor

technical and administrative progress of all work  (e.g., to create

novel reagents or utilize animal models for concept testing).


Both vaccine development and other vaccine evaluation activities will

require the Master Contractor to interact extensively with NIAID

staff, provide and update timelines, manage data, and coordinate all

activities, including those of subcontractors performing the targeted

developmental research, in accordance with the projected schedules.


Recognizing that the expertise to accomplish all work statement

requirements may not exist within one organization, the Master

Contractor may consist of one organization or a combination of

organizations [e.g., prime contractor and subcontractor(s) who

propose together].  The Master Contractor must have equal commitment

to the development of specific vaccines and to the scientific

management of vaccine evaluation projects.


As provided for by the FAR we are issuing a presolicitation notice

(DRAFT WORK STATEMENT) for this project which will be made available

for review through the NIAID Internet Home Page.  We are soliciting

comments on our initial Draft Work Statement in hopes of making

improvements, and avoiding obstacles, prior to issuing a

solicitation.  We are not soliciting proposals at this time.


The DRAFT WORK STATEMENT will be available electronically on or about

July  9, 1997, and may be accessed through either the NIAID Contract

Management (CMB) Home Page or the NIH Gopher by using the electronic

addresses and instructions: 1) NIAID/CMB Home Page  (via the World

Wide Web): Access by using and

select the "RFP" link. 2) To access the NIH Gopher: Point your gopher

client to GOPHER.NIH.GOV.PORT70 (you should now be in the NIH

Gopher).  Select "Grants and Research Information," then select "R&D

Request for Proposals (RFP)."  Please note that the draft work

statement can be found under NIH-NIAID-DAIDS-98-15.  THE DRAFT WORK

STATEMENT IS FOR COMMENT ONLY;  proposals are not being solicited at

this time.




Kristiane Cooper

Contract Specialist

National Institute of Allergy and Infectious Diseases

6003 Executive Boulevard, Room 3C07

Bethesda, MD  20892-7610

Telephone:  (301) 496-7288

FAX:  (301) 402-0972

Email:  kc116y@NIH.GOV



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