MODIFICATION
A -- NIAID DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES:
- Notice Date
- 6/29/2007
- Notice Type
- Modification
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- RFP-NIH-NIAID-DMID-08-05
- Response Due
- 10/29/2007
- Archive Date
- 11/29/2007
- 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), Regulatory Support Affairs contract will provide regulatory expertise, technical, and administrative support for DMID's clinical research programs. </br> Research supported and conducted by the NIAID, NIH, DHHS, strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID, DMID supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which is funded through a variety of research grants and contracts. </br> Developing and testing new vaccines and therapies have historically been a major focus of the research supported by the DMID. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., avian influenza and West Nile Virus), as well as those supporting the evaluation of the safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). </br> In order to ensure that the development, testing and manufacture of products evaluated under DMID-supported clinical research are executed with a rigor that will support licensure by the Food and Drug Administration (FDA), DMID supports an infrastructure to provide regulatory assistance in the development and testing of these products. </br> Currently, DMID sponsors approximately 100 Investigational New Drug Applications (INDs) or Master Files (MFs) which span more than 200 clinical trials. This includes both multicenter trials and single center studies, and encompasses Phase 1, 2, and 3 clinical trials performed at both domestic and foreign sites. DMID files approximately 10-20 new INDs each year, and in this capacity, serves as the official IND sponsor and liaison with the FDA with respect to all regulatory requirements. Currently, the DMID IND portfolio is comprised of approximately 75% vaccine and other biologic INDs (monoclonal), 20% drug INDs, and 5% MFs. In addition, it is anticipated that Investigational Device Exemptions (IDEs) will be required during the contract period of performance. </br> It is anticipated that one cost reimbursement, completion type contract will be awarded for a seven-year period of performance beginning on or about April 1, 2008. </br> Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about May 22, 2007 and may be accessed through the NIAID Office of Acquisitions (OA) Home Page at http://www.niaid.nih.gov/contract and on FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.
- Place of Performance
- Address: 6700B Rockledge Drive, Room 3214, Bethesda, Maryland
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01331414-W 20070701/070629220455 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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