MODIFICATION
A -- DAIDS Virology Quality Assurance
- Notice Date
- 10/14/2004
- Notice Type
- Modification
- 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 Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFP-NIH-NIAID-DAIDS-05-16
- Response Due
- 1/5/2005
- Archive Date
- 1/20/2005
- Point of Contact
- Lisa Coleman, Contract Specialist, Phone 301-496-0612, Fax 301-480-5253, - Lisa Coleman, Contract Specialist, Phone 301-496-0612, Fax 301-480-5253,
- E-Mail Address
-
lcoleman@niaid.nih.gov, lcoleman@niaid.nih.gov
- Description
- The mission of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health, is to help ensure an end to the HIV/AID epidemic by increasing basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus, or HIV, supporting the development of therapies for HIV infection and its complications, and supporting the development of vaccines and other prevention strategies. The Division of AIDS intends to recompete a requirement currently being performed by Rush-Presbyterian St. Luke?s Medical Center under Contract No. N01-A1-85354, scheduled to expire on September 20, 2005. This solicitation is being issued under full and open competitive procedures. The primary focus of this solicitation is to continue an ongoing quality assessment program for virologic assays performed on samples from subjects enrolled in DIAIDS-sponsored multi-site clinical studies. The Virology Quality Assurance (VQA) Program is critical to the scientific integrity of on-going and future studies concerning HIV diagnosis, disease progression, and assessment of treatments, vaccine efficacy and other preventive measures. Currently, the VQA program serves approximately 55 domestic and 25 international Sites. The base contract is expected to cover these 80 Sites. Although the structure of the clinical trial networks is subject to change during the Contract period, the changes are not expected to result in changes to the number of participating Sites in the base Contract. However, the Government anticipates a need to expand the number of Sites during the course of the Contract, and such an increase in the Contractor?s activities may be activated, at the discretion of the Government, as one or more Options in each of the Contract years. The VQA Program will serve current and future DAIDS-sponsored clinical trial networks and collaborating study groups (User Groups). Currently supported User Groups include: the Adult AIDS Clinical Trials Group (AACTG), the Pediatric AIDS Clinical Trials Group (PACTG), the HIV Vaccine Trials Network (HVTN), the Women and Infants Transmission Study (WITS), the Women's Interagency HIV Study (WIHS), the Multicenter AIDS Cohort Study (MACS), the Community Program for Clinical Research on AIDS (CPCRA), the HIV Prevention Trials Network (HPTN), the Comprehensive International Program of Research on AIDS (CIPRA), the Acute Infection and Early Disease Research Program (AIEDRP), as well as other domestic and international individual grantees. Collaborations are anticipated with CDC Global AIDS Program (GAP)-affiliated laboratories supporting the President?s Emergency Plan for AIDS Relief (PEPFAR) activities. Most, but not all, Sites are currently linked through an electronic network which is used to transmit virology data from the Sites to a remote Central Database. Sites are also using a customized laboratory data management system (LDMS) that tracks specimens, provides assay templates, calculates derived quantities, produces reports, and generates data files for export from the Site. The successful offeror will be required to provide some VQA-related information through the DAIDS-ES. While some of this may be accomplished through a link from DAIDS-ES to the VQA web site, some data may need to be shared by the VQA, with DAIDS ES, in which case data sharing agreements, standards, etc. will be required. Specifically the contractor shall be required to perform the following: 1) implement standards of performance for existing and newly developed virologic assays and assess the ability of Sites to successfully perform the assays; 2) conduct studies on the adaptation, standardization and application of new and existing virologic and biostatistic methodologies; 3) acquire, characterize, store, document and disburse quality control materials and reagents to include biohazardous materials and infectious agents; 4) disseminate VQA technical and scientific data; 5) maintain computerized software systems that support the VQA Program; 6) expand services to include additional Sites when necessary through exercise of Options; and 7) implement a transition plan at the end of the contract. It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 7-year period of performance beginning on or about August 15, 2005 to August 14, 2012. This RFP will be available electronically on/about October 29, 2004, and may be accessed through the NIAID Contract Management Program (CMP) Home Page at http://www.niaid.nih.gov/contract on FedBizOpps. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to award or a contract. See Numbered Note 26. No collect calls will be accepted. No facsimile transmissions will be accepted. Primary Point of Contact: Lola Kellum, Contract Specialist; phone 301-451-7236, fax 301-402-0972 or email kelluml@niaid.nih.gov
- Record
- SN00694081-W 20041016/041014211646 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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