SPECIAL NOTICE: ANTIBODY PREPARATIONS FOR SEVERE ACUTE RESPIRATORY SYNDROME
(SARS) 266-03-SARSANTB
RELEASE DATE: April 25, 2003
NOTICE: NOT-AI-03-027
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
RECEIPT DATE: May 16, 2003
DESCRIPTION
The National Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), DHHS is seeking capability statements from
organizations with the expertise to develop antibody preparations for Severe
Acute Respiratory Syndrome (SARS). The purpose this effort is to identify
commercial entities capable of entering into the development and production
of polyclonal or monoclonal antibody preparations that might benefit patients
exposed to or suffering from infection by the coronavirus that causes Severe
Acute Respiratory Syndrome or SARS. The respondent should consider the
following elements:
1. The U. S. government is mindful of the epidemiologic exigencies created
by the emergence of this new virus and wishes to accelerate the development
of appropriate interventions where possible.
2. The research and development needed to obtain antibody therapies that
will satisfy regulatory requirements of the FDA.
3. The possible need to provide substantial supplies of this material.
4. The ability to conduct preclinical and clinical testing of the product.
5. Documented history of successful development of a monoclonal or
polyclonal antibody preparation is essential.
6. The U.S. government may also provide access to samples of the SARS virus.
The research and development will require BSL-3 level facilities if work is
proposed with the SARS virus in the laboratory.
NIAID is interested in receiving letters of interest and capability
statements from interested organizations. Interested organizations should
submit their capability statements that contain descriptions of their
potential development plans, their research and development capabilities and
interests, and their potential or available manufacturing capabilities for
these antibody preparations in substantial quantities. Any perceived
barriers to the conduct of this research should also be indicated. The
capability statements, along with any supporting documentations should not
exceed 15 pages. It is also requested that interested organizations indicate
their overall cost estimate for their proposed effort. The NIAID is not
requesting a detailed cost proposal but rather an overall estimate of the
effort per major line item. Capability statements and letters of interest
will be kept confidential and will help in determining the need for an RFP to
support research and development activities and in assembling a potential
source list for distribution of any resultant RFP. This is not a Request for
Proposals and does not commit the Government to award a contract now or in
the future. Submission of any information based on this request for
information is purely voluntary. Please specify, if applicable, the small
business size status of your company (See Federal Acquisition Regulations,
Part 19). No solicitation is available at this time. No collect calls will
be accepted. Submit your responses to Sharon Kraft, Contract Specialist, at
the address listed in this special notice.
266-03-SARSANTB will be available electronically on or about April 22, 2003
and may be accessed through the Internet on the Contract Management Branch
Homepage, located at http://www.niaid.nih.gov/contract and will be posted on
FedBizOpps at http://www.eps.gov/servlet/Documents/R/634409.
Responses to this Special Notice will be due on Friday, May 16, 2003.
Contracting Office Address:
National Institutes of Health
National Institutes of Allergy and Infectious Diseases
Contract Management Branch
6700-B Rockledge Drive
Room 2230, MSC 7612
Bethesda, MD, 20892-7612
Point of Contact:
Sharon Kraft, Contract Specialist, Phone 301-402-5825, Fax 301-402-0972,
Email [email protected]
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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