Notice Number: NOT-AI-06-040
Key Dates
Release Date: June 7, 2006
Receipt Date: September 18, 2006
Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
Description
The National Institute of Allergy and Infectious Diseases (NIAID), 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.
Recent threats of the use of infectious agents as biological weapons have generated increased concern for the safety of the general American populace. Bacillus anthracis (B. anthracis) is the etiologic agent of anthrax. The ability to generate high titer anthrax spores using basic microbiological techniques combined with the ability of these agents to be disseminated by aerosolization, has made anthrax a primary bioterrorist and military threat. With the deliberate exposure of citizens of the United States to B. anthracis spores in 2001, there is an urgent need to stockpile appropriate and effective medical countermeasures to protect all U.S. citizens from the morbidity and mortality associated with infection from these instruments of terror.
It is anticipated that one or more cost reimbursement, completion type contracts will be awarded for a three-year period of performance beginning on or about June 8, 2007, In addition, the contract will contain two Options. If executed, and will require the contractor to design and conduct a Phase 1 dose escalating clinical trial in healthy subjects ages 18 to 40 and up to two Phase 2 clinical trials in healthy subjects ages 18 to 55. It is estimated that the provision of FTEs will be approximately as follows: 13 FTE for Base Year 1 & 2; Reduced to 7.25 FTEs for Base Year 3; 2.1 FTEs for Year 3 -Option 1; 2.1 FTEs for each Option 2 -Years 4-7. The Option periods could increase the contract value and extend the contract by up to four years. This RFP NIH-NIAID-DMID-07-12 will be available electronically on or about June 19, 2006 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 September 18, 2006. NIAID intends to solicit this project utilizing full and open competitive procedures under NAICS 541710. 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. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.
Inquiries
Inquiries regarding this notice may be directed to:Ross Kelley
Contracting Officer
Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20892-7612
Phone 301-402-2234
Fax 301-480-4675
Email: [email protected]
Barbara Shadrick
Acting Branch Chief
Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20892-7612
Phone 301-496-7288
Fax 301-402-0972
Email: [email protected]
and Human Services (HHS)
