Notice Number: NOT-AI-06-032

Key Dates
Release Date: April 12, 2006
Receipt Date: August 15, 2006

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

Description

It is anticipated that up to one cost-reimbursement completion type contract will be awarded for a period of five years, beginning approximately June 15, 2007.  RFP NIH-NIAID-DMID-07-12 will be available electronically on or about April 14, 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 August 15, 2006. 

The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) supports research to understand, and ultimately prevent and/or treat, infectious and immune-mediated diseases that continue to threaten millions of lives each year.  The Government has a requirement to design and conduct a multi-site Phase II/III clinical trial for Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). NIAID intends to solicit this project utilizing full and open competitive procedures under NAICS 541710.   The objective of a contract will be to advance the field of clinical management for uncomplicated skin and soft tissue infection caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) and to determine the optimal outpatient treatment strategy.  If selected the contractor would be expected to provide the scientific, technical, and managerial infrastructure, facilities, and other resources required to design and conduct a multi-site Phase II/III clinical trial.  In addition, the contractor must have the ability to determine the efficacy of off-patent oral antimicrobials and/or wound care for the treatment of outpatients with uncomplicated community-acquired skin and soft tissue infection in areas in the U.S, where the prevalence of CA-MRSA is high.

An uncomplicated skin and soft tissue infection is defined as the presence of wound infection, abscesses, folliculitis, cellulitis or erysipelas.  Community-acquired methicillin-resistant Staphylococcus aureus infections are defined as the isolation of methicillin-resistant Staphylococcus aureus from the relevant disease process from subjects who have not been hospitalized within the previous fourteen (14) days.  In order to preserve the efficacy of vancomycin and linezolid, evaluation of these two antimicrobials would not be supported under this effort. In addition, clinical trials of invasive diseases (e.g., bacteremia, endocarditis, osteomylitis or pneumonia) or clinical trials with hospitalized patients would not be supported under this contract.  Clinical trials under this effort would require a minimum of two (2) and a maximum of five (5) clinical trial sites. Each clinical trial site, included would also be required to have access to one hundred and twenty (120) subjects with skin and soft tissue infection every three (3) months to ensure enrollment of a minimum of forty (40) subjects every three (3) months.  It is estimated that a total effort of approximately 9.65 FTEs per year will be needed to accomplish this project.  

It is anticipated that a single cost reimbursement, completion type contract will be awarded for a five-year period of performance beginning on or about June 15, 2007. 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 August 15, 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. 

Inquiries

Inquiries regarding this notice may be directed to:

Ross Kelley
Contracting Officer
Microbiology and Infectious Diseases Research Contracts Branch-B, OA, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail: Use Zip Code 20817-7612)
Phone: 301-402-2234
Fax: 301-480-4675
Email: rkelley@niaid.nih.gov

Barbara Shadrick
Acting Branch Chief
Microbiology and Infectious Diseases Research Contracts Branch-B, OA, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail: Use Zip Code 20817-7612)
Phone: 301-496-7288
Fax: 301-402-0972
Email: bs92y@nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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