RFP Announcement: Development of Animal Models and Assays for Plague Vaccine - NIH-NIAID-DMID-07-06

Notice Number: NOT-AI-06-045

Key Dates
Release Date: September 11, 2006
Receipt Date: November 16, 2006

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious diseases.  The NIAID, Division of Microbiology and Infectious Diseases (DMID), supports a comprehensive extramural research program focused on the prevention and control of diseases caused by virtually all infectious agents (with the exception of the Human Immunodeficiency Virus).  This includes basic research, such as studies of microbial biology and physiology; applied research, including the development of vaccines, therapeutics and medical diagnostics; as well as clinical studies to evaluate experimental drugs and vaccines.

The NIAID has a requirement for the development, optimization, qualification, and validation via Good Laboratory Practices (GLP) (21 CFR Part 58) and Good Manufacturing Practices (GMP) (21 CFR Part 211) of product-neutral immunological assays, potency assays, and animal efficacy models for the evaluation and assessment of plague vaccine candidates based on F1 and V antigens.  These immunoassays and animal models will be developed under GLP and GMP and in a manner that will support licensure of a plague vaccine under the FDA “Animal Rule,” (21 CFR Part 601.90-95).  NIAID will require that a minimum of two species of reproducible animal efficacy models shall be developed and characterized for both the pneumonic and bubonic forms of plague, one of which shall be a small animal model and the other a NHP model.  Innate and adaptive immune responses shall be analyzed and from these, correlates of protection shall be identified.  The development and subsequent validation of immunoassays associated with the correlates of protection includes the identification and provision for adequate amounts of standardized reagents for subsequent studies.  NIAID will require that potency assays be developed, characterized, and validated.  Once validated, these immunoassays, potency assays, and animal models will provide important tools for researchers and manufacturers, and therefore, reagents, methods, and procedures must be transferable.  This effort will become a crucial part of a joint Government Agency effort to develop and license a plague vaccine for both military and civilian needs.

It is anticipated that one or more contracts will be awarded for a period of 3 years, beginning approximately September 10, 2007.  In addition, the contract will contain multiple options for the establishment of Central Reference Laboratories and a fourth year of performance for completion of these optional requirements if exercised.  RFP NIH-NIAID-DMID-07-06 will be available electronically on or about September 12, 2006 and may be accessed at http://www.fedbizopps.gov/.  Only electronic copies of the solicitation will be available.  All information required for the submission of an offer will be contained in the solicitation.  Responses to this RFP will be due approximately November 16, 2006. 

Any responsible Offeror may submit a proposal that will be considered by the Government, however, this notice does not commit the Government to the award of a contract.  No collect calls will be accepted.

Inquiry

Inquiries regarding this notice may be directed to:

David T. Lisle
Contracting Officer
Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-451-2617
Fax 301-402-0972
Email:  Dlisle@niaid.nih.gov

Ross Kelley
Contracting Officer
Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Rm. 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail: Use Zip Code 20817-7612)
Phone:  301-402-2234
Fax:  301-480-5253
E-mail:  RKelly@niaid.nih.gov


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