SOURCES SOUGHT
A -- Clinical Pharmacology Quality Assurance and Quality Control
- Notice Date
- 2/27/2007
- Notice Type
- Sources Sought
- 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
- 00000
- Solicitation Number
- NIH-NIAID-DAIDS-08-14
- Response Due
- 3/13/2007
- Archive Date
- 4/1/2007
- Description
- This notice is for information and planning purposes only. 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 capability statements received from this sources sought notice, this acquisition may be solicited as a 100% small business set-aside or as full and open. All small business organizations (small business, small disadvantaged business, women-owned small business, HUB Zone small business, veteran-owned small business, and small disadvantaged veteran-owned small business) are encouraged to respond to this notice. The Government does not intend to award a contract based on responses under this announcement. Any proprietary information should be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. The NAICS code is 541710 with a size standard of 500 employees. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) is seeking to acquire a contractual resource, called the Clinical Pharmacology Quality Assurance and Quality Control (PQA/QC) Program, designed to assess and enhance the quality, reliability and comparability of pharmacological tests performed on samples from subjects enrolled in NIAID-supported and/or collaborative multi-site studies that measure antiretroviral and anti-opportunistic infection drugs and microbicides. The Contractor will (1) periodically execute Proficiency Testing (PT) to evaluate laboratory performance of clinical pharmacology assays; (2) develop and validate pharmacology methods, and implement the validated assays at Sites; (3) acquire, characterize, store, document and distribute analytical grade reference standards (AGRS)/reference drug powder, quality control (QC) materials and reagents; (4) train Site laboratory staff for PT and for the conduct of clinical pharmacology studies; (5) conduct on-site laboratory inspections and audits; (6) disseminate technical and scientific data; and (7) maintain computerized systems to track the PQA/QC activities. This program will serve nine US and one non-US laboratories. It is anticipated that one (1) completion type contract will be awarded for a period of seven (7) years. This is a new requirement. Place of performance is unknown at this time Potential sources must demonstrate and document the following in their capability statements: 1) immediate availability of adequate facilities, equipment and resources to conduct PQA/QC activities, 2) established procedures and systems to obtain analytical grade drug reference standards (AGRS)/reference drug powder for PT, and for assay development, validation and implementation, 3) experience in on-site laboratory inspection, audit and staff training, and 4) compliance with the Clinical Improvement Amendments of 1988 (CLIA) and other applicable Federal, state, and local laws and regulations. Interested Small Business organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Written capability statements should be received by the NIAID Contracting Officer by March 13, 2007 at 4:00 p.m. (EST time). These submissions must be submitted by E-mail or paper copy to Ms. Michelle Scala, Contracting Officer. She can be emailed at mscala@niaid.nih.gov. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the Subject line Reference: NIH-NIAID-DAIDS-08-14. A paper copy can sent via regular mail at the address provided below. All inquiries concerning this announcement shall be directed to Ms. Michelle Scala or Ms. Eileen Webster-Cissel (telephone number 301-496-0612). . No collect calls will be accepted. No facsimile transmissions will be accepted. Contracting Office Address Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions Attn: Michelle Scala 6700 B Rockledge, Room 3214 MSC 7612 Bethesda, MD, 20892-7612
- Record
- SN01239631-W 20070301/070227220502 (fbodaily.com)
- Source
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