Notice Number: NOT-AI-05-051

Key Dates
Release Date: July 22, 2005
Receipt Date: November 1, 2005

The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), NIH has a requirement for the production of a Trivalent Recombinant Botulinum Vaccine for protection against serotypes A, B and E neurotoxins. This solicitation is being issued under full and open competitive procedures. If selected for this requirement, the Contractor will conduct advanced process development activities necessary to produce and formulate in accordance with current Good Manufacturing Practice (cGMP) one lot of trivalent vaccine that demonstrates protective efficacy against types A, B and E botulinum neurotoxins. The development process shall include the following: Developing and qualifying assays necessary to conduct FDA required nonclinical laboratory studies and stability testing; Preparing a clinical development plan; Submitting an Investigational New Drug (IND) application to the FDA; Conducting a Phase 1 clinical trial to assess the safety and immunogenicity of a trivalent (ABE) recombinant botulinum vaccine candidate in healthy populations under a Contractor-held IND; and Preparing and submitting reports for the Phase 1 clinical trial to NIAID. The Contract for this effort will also include an option for the development of animal efficacy models to support the requirements of 21 CFR 314.600 and 21 CFR 601.90-95, Subpart H, Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible, and for testing of the candidate vaccine in these animal models. [ The Request for Proposal (RFP) will contain two Mandatory Qualification Criteria that must be met at the time of receipt of the original proposal submission and they are as follows: Criterion 1 - Documented proof of access to starting materials and technologies suitable for the development and manufacture of the proposed candidate trivalent (ABE) botulinum neurotoxin vaccine: a) If the offeror has ownership rights to the source materials and technologies, the offeror must represent that they possess those rights in a letter signed by an official legally authorized to bind the organization contractually, and b) If the offeror has negotiated access to the source materials and technologies through or from another party(ies), the offeror must represent that they have secured access to those materials and technologies in a letter signed by the officials legally authorized to contractually bind both the offeror's organization and the other party(ies). Criterion 2 - Given the timeline requirements for this vaccine development effort, it is essential that efforts funded as a result of this RFP build on the most advanced vaccine candidate(s). Therefore, offerors must provide data demonstrating the ability of each monovalent vaccine component for serotypes A, B and E to provide 100% protection against a lethal challenge from at least 1,000 mouse IPLD 50 of a homologous serotype of botulinum neurotoxin in at least one standardized mouse protection bioassay.

It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 4-year period of performance beginning on or about September 1, 2006. This RFP NIH-NIAID-DMID-06-22 will be available electronically on or about August 1, 2005 and may be accessed at http://www.niaid.nih.gov/contract/rfps.htm or 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 1, 2005.

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.

Inquiries

For questions or further information, contact:

Ross Kelley
Contracting Officer
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD 20892-7612
Phone 301-402-2234
Fax 301-480-5253
Email: RKelley@niaid.nih.gov

Barbara Shadrick
Senior Contracting Officer
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
MSC 7612
Bethesda, MD 20892-7612
Phone: 301-496-7288
Fax: 301-402-0972
Email: BShadrick@niaid.nih.gov

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