SOLICITATION NOTICE
A -- Immunology Quality Assessment Program
- Notice Date
- 10/19/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- 20892-7612
- Solicitation Number
- RFP-NIH-NIAID-DAIDS-07-31
- Point of Contact
- Elizabeth Shanahan, Contracting Officer, Phone 301-594-6309, Fax 301-402-0972, - Eileen Webster-Cissel , Branch Chief, Phone 301-496-0349, Fax 301-480-4675,
- E-Mail Address
-
EShanahan@niaid.nih.gov, webstere@mail.nih.gov
- Description
- The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is seeking an organization to continue the Immunology Quality Assessment Program. Currently, the IQA Program serves approximately 85 U.S. and 60 non-U.S. laboratories. With the growing number of NIAID studies in the developing world, it is expected that the IQA Program will expand to evaluate the ability of approximately 125 U.S. and 100 non-U.S. flow cytometry laboratories to adequately enumerate CD4-positive T Cells and to provide laboratory assistance and training. This potential increase will be accommodated by the exercise of contract options. U.S. and non-US laboratories supported by the IQA Program shall hereinafter be referred to as Sites. Several NIAID programs and Study Groups have been served by this resource. Groups that will be supported by this resource include: the AIDS Clinical Trials Group (ACTG); the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT); the HIV Vaccine Trials Network (HVTN); the HIV Prevention Trials Network (HPTN); Microbicide Trials Network (MTN) (http://www3.niaid.nih.gov/news/newsreleases/2006/leadership.htm); the Women and Infants Transmission Study (WITS); the Women's Interagency HIV Study (WIHS); the Multicenter AIDS Cohort Study (MACS); the Comprehensive International Program of Research on AIDS (CIPRA); the Acute Infection and Early Disease Research Program (AIEDRP); and individual grantees (http://www3.niaid.nih.gov/about/organization/daids/). In addition, the contract shall serve as a resource to the Centers for Disease Control and Prevention (CDC) Global AIDS Program (GAP)-affiliated laboratories supporting the Presidents Emergency Plan for AIDS Relief (PEPFAR) activities http://www.cdc.gov/nchstp/od/gap/default.htm. The scope of activities to be carried out under this contract include: 1) design and execute proficiency testing programs to externally assess the ability of U.S. and non-U.S. DAIDS-support clinical trial sites (hereinafter referred to as Sites) to reliably: 1) perform immunological assays (e.g., T-cell subsets and other cytometry-based tests); 2) provide assistance and training to laboratories that are not performing according to established standards, especially to flow cytometry laboratories in non-U.S. resource limited countries; 3) conduct or support comparative evaluations of instruments, methods and reagents; 4) facilitate the development, standardization and assay characterization of new immunological assays, and of cheaper simpler methods to measure CD4, for implementation in multi-center investigations; and 5) evaluate the ability of Sites to adequately freeze viable peripheral blood mononuclear cells (PBMC) for future immunological tests. To accomplish these aims, the Contractor must: a) have access to a wide range of infected and non-infected donors to obtain human biological materials (e.g. plasma, PBMC, tissue); b) prescreen potential donors for existence of required characteristics (e.g. CD4 count, viral load level, HLA type, antigen response, vaccine titer); c) create panels of samples (coded when used for proficiency testing purposes), including replicates to assess within- and inter-laboratory variability; d) provide data management and statistical analysis capability; e) provide staff and facilities for on-site and off-site training; f) provide the facilities to store samples and reagents; and g) ship and track samples and reagents. In addition, the IQA laboratory shall be Clinical Laboratory Improvement Amendments (CLIA)-certified, conducting operations in accordance with Good Clinical Laboratory Practices (GCLP), and have local Institutional Review Board (IRB) approval for its activities. Three options, that may be exercised at the discretion of the Government, shall provide for expansion of the IQA Program to additional U.S. and non-U.S. Sites as follows: Option 1 CD4 Proficiency Testing Program: Addition of U.S. and Canadian Sites only to the CD4 Proficiency Testing Program. Option 2 United Kingdom National External Quality Assessment Service (UK NEQAS) Proficiency Testing Program: Addition of non-U.S. Sites participating in the UK NEQAS CD4 proficiency testing program. Option 3 Peripheral Blood Mononuclear Cells (PBMC) Cryopreservation Proficiency Testing Program: Addition of U.S. and non-U.S. Sites to the PBMC cryopreservation proficiency testing program. The incumbent contractor is the University of Medicine and Dentistry of New Jersey. It is anticipated that a cost-reimbursement, incrementally funded, completion form contract will be awarded for 7 years with options to potentially increase support to additional sites over the life of the contract. The Government considers the effort to be approximately 6 Full Time Equivalents (FTEs), per year. The RFP will be available on November 3. This RFP will be available electronically on the NIAID Office of Acquisitions home page: http://www.niaid.nih.gov/contract and the Federal Business Opportunities web site: http://www.fedbizopps.gov/. Any responsible offeror may submit a proposal that will be considered by the Government. This announcement 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. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (19-OCT-2006); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NIAID/RFP-NIH-NIAID-DAIDS-07-31/listing.html)
- Record
- SN01168354-F 20061021/061019231051 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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