SOLICITATION NOTICE
A -- Development and Validation of analytical methods
- Notice Date
- 12/18/2008
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- REQ1051629
- Point of Contact
- Monifa N Coleman, Phone: 301-827-7164
- E-Mail Address
-
monifa.coleman@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) has a requirement for the development and validation of analytical methods. This requirement will be sole sourced to AOAC international in accordance with the Code of Federal Regulations (CFR) 2.19, Methods of analysis, 2005 CFR Title 21, Volume 1. AOAC has been working to provide customers and stakeholders with scientifically validated Official Methods of Analysis (OMA) among various other work products and services. AOAC adopts methods validated by Study Directors (SD) and (proposed) methods submitted through liaison with other organizations. To be adopted as an AOACŪ Official MethodSM, every protocol is expected to meet the following criteria: Accuracy, Reliability, Practicality, Availability, Validated by inter-laboratory studies, and accepted for publication in an appropriate peer-reviewed scientific periodical. This contract shall provide the Government with accurate, reliable, practical, validated and published AOAC official Methods for analytes in a wide range of matrices. This contract shall, also, assist with obtaining and disseminate scientifically reliable information about AOAC Official Methods that can be used to support Government activities, including those related to public health as well as regulatory activities. (I)Subject Matter Experts(s): The Contractor shall utilize one or more subject matter experts. (II)Engagement of Customers and Stakeholders: For applicable task orders, the Contractor may continue to utilize AOAC staff to engage the industry (indirect customers) to participate in ingredient-specific Working Groups and to form new Working Groups. The Contractor may continue to encourage Working Group members (stakeholders) to submit methods and validation data, attend meetings, donate materials for validation studies, serve on Expert Review Panels, serve as Study Coordinators and Study Directors, and to volunteer their laboratories. The Contractor shall ensure that such engagement efforts do not compromise output. (III)Contract Deliverable Definitions for task orders about dietary supplements: With respect to AOAC Official Methods, the contractor shall deliver AOAC collaborative study manuscripts; the timeframe of new deliverables will be determined within individual task orders. When specified, a reviewed collaborative study manuscript will be acceptable as a deliverable if: (1) the method was either explicitly specified by the Government or championed by an Expert Review Panel regardless of whether or not the method is approved (General Referee (GR) and Committee K) as a First Action Official Method of Analysis; or if (2) the method selected was not chosen by an Expert Review Panel but the collaborative study is approved (GR and Committee K) and scheduled for publication as a First Action AOAC Official Methods. If a non-proprietary method studied utilizes a test kit as a reagent, but the study was championed, sponsored, conducted, or otherwise performed by an individual or group not affiliated with the test kit manufacturer, the resulting study may be acceptable as a deliverable, but must undergo the same processes described in (1) or (2). Completed collaborative studies shall not be deliverables until scheduled for publication in the Journal of AOAC International. The NAICS code is: 541712. It is anticipated that one (1) cost reimbursement type contract is expected for one (1) base year period of performance and four (4) one year options. NO QUESTIONS WILL BE ENTERTAINED AT THIS TIME This is not a Request for Proposals. Sources interested in this requirement must provide a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met. Responses must be in writing and must be received within nine (7) calendar days from the date of this amendment. A determination by the Government not to compete the proposed contract based on responses from this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=c801eb72e9f01dd0637caa41ffeba33a&tab=core&_cview=1)
- Place of Performance
- Address: 5100 Paint Branch Parkway, College Park, Maryland, 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN01720902-W 20081220/081218214812-e5c8c9bb0a50abb023d0a0ea0122b63c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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