SPECIAL NOTICE
U -- Regulatory science, problem formulation/risk assessment, and agricultural biotechnology Training
- Notice Date
- 8/12/2022 10:59:32 AM
- Notice Type
- Special Notice
- NAICS
- 611710
— Educational Support Services
- Contracting Office
- MRPBS MINNEAPOLIS MN MINNEAPOLIS MN 55401 USA
- ZIP Code
- 55401
- Solicitation Number
- SS-1075789
- Response Due
- 8/22/2022 8:00:00 AM
- Point of Contact
- Kim Yen Tu, Phone: 16123363602
- E-Mail Address
-
kimyen.n.tu@usda.gov
(kimyen.n.tu@usda.gov)
- Description
- The Government hereby submits a notice of intent to award a sole source firm fixed price contract to�EDINBURGH INNOVATIONS LIMITED for customized training that combines regulatory science, problem formulation/risk assessment, and agricultural biotechnology learning modules for USDA APHIS BRS staff members.� Limited Source/Brand Name Justification FAR 13.106-1(b)(1) � Simplified Acquisitions 1. Identification of the agency and the contracting activity. Animal and Plant Health Inspection Service Biotechnology Regulatory Services (BRS) 4700 River Road Mail unit 89 Riverdale MD 20737 Contracting Activity USDA APHIS AAMD Contracting 250 Marquette Ave Suite 410 Minneapolis, MN 55401 2. Description of supply or service required to meet the agency�s needs. Customized training that combines regulatory science, problem formulation/risk assessment, and agricultural biotechnology learning modules with case studies involving plant biotechnology products and regulatory factors BRS staff members will consider when rendering regulatory decisions under 7 CFR part 340. 3. The rationale or circumstances for limiting competition. Although training is individually available in regulatory science, problem formulation and agricultural plant biotechnology, the only institute that combines all of these disciplines into customized training that reflects the statutory and regulatory criteria application in the BRS Regulatory Status Review process (7 CFR part 340) is from Edinburgh Innovations Ltd, which is a wholly owned subsidiary within the University of Edinburgh. University of Edinburgh is ranked 5th in the world for industry, innovation and infrastructure and is home to the Global Academy of Agriculture and Food Systems. Alan Raybould is a professor at the University of Edinburgh who focuses improving the efficiency and effectiveness of regulation of products of new technology in agriculture and offers customized training services through Edinburgh Innovations Ltd. Professor Raybould is a renowned expert in the application of risk principles in the context of agricultural biotechnology and has published leading articles in this area, including: Hypothesis-Led Ecological Risk Assessment of GM Crops to Support Decision-Making About Product Use; Problem Formulation for Off-Target Effects of Externally Applied Double-Stranded RNA-Based Products for Pest Control; Advancing ecological risk assessment on genetically engineered breeding stacks with combined insect-resistance traits; Problem formulation and phenotypic characterisation for the development of novel crops; Using problem formulation to clarify the meaning of weight of evidence and biological relevance in environmental risk assessments for genetically modified crops; and Policy-�Led Comparative Environmental Risk Assessment of Genetically Modified Crops: Testing for Increased Risk Rather Than Profiling Phenotypes Leads to Predictable and Transparent Decision-Making. The customized training would include � A pre-course survey to assess students� knowledge and experience to ensure training modules meet the students where they are in their learning development; � Development of custom learning and training materials based on the core principles of problem formulation, the statutory and regulatory criteria BRS is obligated to consider under 7 CFR part 340, BRS� internal processes for conducting Regulatory Statutes Reviews, and current literature and research on the topic. � Development test cases to facilitate and apply learning to scenarios students are likely to face when undertaking Regulatory Status Reviews. � Develop curriculum for three, full-day learning modules related to o Regulatory decision-making as hypothesis testing o Testing hypotheses to inform regulatory decision-making o Making decisions: dealing with uncertainty and the role of judgement 4. A description of the market research conducted and the results or a statement of the reason market research was not conducted. BRS scientists are engaged in domestic and international conferences and workgroups involving regulatory oversight of products of agricultural biotechnology. Through experiences, exposures, networks, and scientific publications, Edinburgh Innovations Ltd. at University of Edinburgh and Professor Raybould are routinely and consistently identified as the leading sources for leaning and training in the context of regulatory decision-making related to agricultural biotechnology. Although BRS has identified separate training courses for regulatory science, problem formulation/risk assessment, and agricultural biotechnology, BRS has not identified any other source (aside from Edinburgh Innovations Ltd.) that combines these disciplined into a customized training with case studies involving products and regulatory factors BRS staff members will face when making regulatory decisions under 7 CFR part 340. 5. Estimated price, including all options, if applicable. The estimate for the customized training is $29,000 which include travel and lodging.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/33690912de154d438052bb27029e4fd1/view)
- Record
- SN06424754-F 20220814/220812230118 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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