Notice Number: NOT-AI-06-037

Key Dates
Release Date: May 18, 2006
Receipt Date: December 15, 2006

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

The Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), has a requirement to evaluate vaccine and therapeutic candidates in Phase 1 through Phase 4 clinical trials, as well as to conduct other types of evaluations and analyses, for viral (other than HIV), bacterial, parasitic and fungal pathogens, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). The scope of investigational vaccine and therapeutic candidates includes live, attenuated, killed, vectored DNA and combination vaccines, adjuvants, novel therapeutic agents such as immunomodulatory agents, and approaches to vaccine or therapeutic delivery, dose finding, schedule, routes and modes of delivery. The Contractor shall incorporate novel vaccine and therapeutic technologies as they are developed into clinical trials. Clinical research will be carried out in the general population, including pediatric, adult and elderly subjects, as well as additional populations, when necessary, such as women of reproductive age, pregnant women, immunocompromised populations, non-U.S. populations, and populations with underlying medical conditions. Contractors shall be experienced clinical research sites with access to general and additional study populations and the capacity to provide research facilities, services and personnel to carry out the full range of clinical research activities. These activities require outpatient and inpatient clinical research facilities, clinical and research laboratory facilities, research pharmacy facilities, and other general, non-clinical facilities. Scientific and technical staff shall have expertise, training and experience in the conduct and oversight of clinical trials and clinical studies in infectious diseases in accordance with Good Clinical Practices and applicable Federal regulations governing research involving human subjects.

It is anticipated that up to eight (8) cost reimbursement, completion type contracts will be awarded for a period of seven (7) years, beginning approximately November 1, 2007. RFP NIH-NIAID-DMID-08-03 will be available electronically on or about June 2, 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 December 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:

Teresa A. Baughman
Contracting Officer
Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20892-7612 (Express mail: Use Zip Code 20817-7612)
Phone 301-451-3690
Fax 301-480-4675
Email: tb14j@nih.gov