SOLICITATION NOTICE
A -- NIAID Division of Microbiology and Infectious Diseases: Clinical Agent and Specimen Repository
- Notice Date
- 8/15/2007
- Notice Type
- Solicitation Notice
- 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-08-26
- Response Due
- 12/21/2007
- Archive Date
- 12/31/2007
- 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) has a requirement for clinical agent and clinical specimen repository support. 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 Division of Microbiology and Infectious Diseases 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. 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). 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 the establishment and operation of a Clinical Agent and Specimen Repository (CASR) that adheres to current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID sponsored clinical trials and research programs in the U.S. and abroad. Regulatory support services are currently being recompeted through a separate contract solicitation. Clinical agents include investigational study products (drugs, vaccines, and therapeutics), commercial products, placebos, syringes, and other protocol-mandated supplies to be used in DMID-sponsored clinical trials. For the purposes of this contract, other protocol-mandated supplies include electronic adherence measuring devices and associated devices for downloading data, thermometers, oral syringes, adaptors for transferring liquids from bottles to syringes, syringes for injection, and pregnancy test kits. Clinical specimens include sera or other protocol-mandated specimens obtained from DMID-funded clinical research sites, to be distributed to DMID-approved testing laboratories for analysis. It is anticipated that one cost reimbursement, completion type contract will be awarded for a 7-year base period of performance beginning on or about August 2008, with the following options: Option 1: Increase clinical specimen capacity of the CASR in order to accommodate the following: -80oC (approximately 1600 cu. ft.) and -20oC (approximately 1600 cu. ft.). Option 2: Increase the length of time for the storage of clinical specimens in the CASR to exceed the short-term storage requirement of two (2) years as specified in the base requirement, to provide for storage until the end of the contract period of performance. Option 3: The Government may extend the contract for up to an additional two (2) years. It is estimated that the provision of FTEs will be approximately as follows: for Option 1: 0.6 FTE; for Option 2: 0.4 FTE; and for Option 3: given that this is an expansion of the base, 11.05 FTEs would be required. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about August 27, 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.
- Record
- SN01373220-W 20070817/070815220505 (fbodaily.com)
- Source
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