MODIFICATION
A -- DAIDS Virology Quality Assurance
- Notice Date
- 8/26/2004
- 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
- Reference-Number-SS-NIH-NIAID-DAIDS-05-16
- Response Due
- 9/2/2004
- Point of Contact
- Lisa Coleman, Contract Specialist, Phone 301-496-0612, Fax 301-480-5253,
- E-Mail Address
-
lcoleman@niaid.nih.gov
- Description
- The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), helps to ensure an end to the HIV/AIDS 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 purpose of this planned acquisition is to seek a contractor to continue an ongoing quality assessment program for virologic assays performed on samples from subjects enrolled in DAIDS-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, assessment of treatment, vaccine efficacy and other preventive measures. The VQA has been in operation since 1988 and has developed and standardized quality control procedures for approximately 25 virologic assays used in DAIDS-sponsored clinical trials. DAIDS is seeking capability statements from organizations capable of performing the following tasks: (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 Virology Quality Assessment technical and scientific data; (5) maintain computerized software systems that support the VQA Program; and (6) expand services to include additional Sites when necessary through exercise of Options. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITIES RECEIVED FROM THIS SOURCES SOUGHT THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE; 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SIZE ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. To ensure the validity and inter- and intra-laboratory comparability of virologic laboratory data obtained from DAIDS-supported clinical trials and HIV natural history studies, the contractor will continue a program for "Real-Time Assay Validation," where known quality control materials (QCMs) are tested by VQA-supported laboratories (Sites) in parallel with patient samples to ensure the validity of each assay “run.” The contractor will also conduct a "Proficiency Testing" (PT) program, where unknown QCMs are tested by the Sites to periodically monitor Site assay performance. The contractor will provide participating Sites with standardized reagents and controls for conducting research aimed at development and evaluation of virologic and statistical methodologies. 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. 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 work to be performed under this contract is currently being carried out by Rush Presbyterian – St. Luke’s Medical, under contract N01-AI-85354 and is expected to be completed on September 20, 2005. All capability statements will be evaluated against related ability and experience for providing this type and magnitude of support; available qualified personnel; corporate experience and existing facilities and resources. It is anticipated that this contract will be for a 7-year period of performance and require an estimated 9 to 19 FTEs with expertise consistent with the operations of a project of this size and complexity. All interested organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Please respond as directed by Government-Wide Numbered Notes 25 and 26. No collect calls will be accepted. No facsimile transmissions will be accepted. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (26-AUG-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 14-SEP-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIAID/Reference-Number-SS-NIH-NIAID-DAIDS-05-16/listing.html)
- Record
- SN00895705-F 20050916/050914213635 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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