Description
The USDA, Animal and Plant Health Inspection Service (APHIS), Biotechnology Regulatory Services (BRS), Riverdale, MD, has a requirement for specialized services for a contractor to review policy and regulatory documents (scientific and regulatory in nature). Period of performance is September 2004 to March 2005. This requirement consists of one (1) line item, but for the purpose of reviewing specific tasks, see and complete the sub line items listed below. Award will be firm fixed price. Small business set-aside under NAICS 541611, business size $5 million. QUOTATIONS ARE DUE September 23, 2004, by 10:00 a.m. local time. Submit written or faxed quotation to “Purchasing Section”, at (612) 370-2136 Attention Joanne Mann. Simplified procurement procedures will be used as well as commercial item acquisition regulations per FAR 12. This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotations are being requested and a written solicitation will not be issued. This solicitation document incorporates provisions and clauses which are in effect through Federal Acquisition Circular 01-25. Applicable FAR clauses are incorporated by reference: Instructions to Offerors -Commercial Items 52.212-1; Evaluation-Commercial Items 52.212-2; Offeror Representations and Certifications 52.212-3; Contract Terms and Conditions - Commercial Items 52.212-4; Prohibition of segregated facilities 52.222-21; Equal Opportunity 52.222-26; Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-35; Affirmative Action for Workers with Dsiabilities 52.222-36; Employment Reports on Special Disable Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-37; Installment Payments on Commercial Items 52.232-30; Payment by Electronic Funds Transfer - Central Contractor Registration 52.232-33. FAR Clause 9.505 Organizational and Consultant Conflicts of Interest will be included in the purchase order awarded All responsible sources may submit a quotation for consideration. NOTE: 52.212-3 NEEDS TO BE COMPLETED AND RETURNED WITH THE OFFERORS QUOTE. The following evaluation process is used in accordance with 52.212-2. Technical capability, past performance, and price, trade off process, best value to the Government. Non-price related factors are significantly more important than price In order to evaluate firms, provide: 1. Narrative of knowledge of biotechnology programs, procedures, and regulations including the review of petitions and permits and the development of environmental documents including environmental assessments. 2. Narrative of the history of biotechnology programs and systems, worldwide. 3. Description of experience with the legal system and recent experience and knowledge of the international scientific biotechnology community and be able to provide international perspectives. 4. Description of work experience on similar projects and providing similar services to other regulatory organizations including other governments (foreign or domestic). 5. Past performance information to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information). SPECIFICATIONS: BRS requires the services of a contractor to review policy and regulatory documents (which are scientific in nature) such as Environmental Impact Statements, for consistency and gaps, and from an international perspective (to facilitate acceptance by trading partners); to facilitate BRS sponsored scientific workshops and meetings; and to conduct other related scientific, legal, and international-related services such as preparing standardized text that can be used in regulatory document such as risk assessments. REQUIREMENTS AND DELIVERABLES: Task A - Participate in the review of scientific and regulatory documents (to include several portions of the Environmental Impact Statement and related analyses such as the complete analysis, the cost benefit analysis, the information collection analysis, as well as scientific and environmental portions of the actual statement) to assure consistency and gaps are addressed and to provide an international perspective. Documents - 4 Time Frame for Delivery: Within 15-30 days of assignment, depending on complexity. $ ____________ Task B- Facilitate scientific and regulatory meetings and workshops (such as scientific workshops to obtain recent scientific information relevant to the review and revision of the confinement conditions for field testing of plants engineered to produce pharmaceuticals and industrials. These meetings and workshops will advance issues identified in the recent report by the National Academy of Sciences on Biological Confinement of Genetically Engineered Organisms. Meetings/ workshops: 2; Dates of meetings/ workshops to be mutually agreed upon. $ ________ Task C - Related scientific/regulatory services, as assigned. One example includes preparing standardized language for regulatory biotechnology documents including risk assessments and environmental assessments. Another example is the analysis of scientific issues to advance the science underpinning risk assessments related to biotechnology. This will assist in the development of policies to address risk assessment and the acceptance of our decisions surrounding the risk assessments by international trading partners. Services: 4, yet to be determined. Time frame for Dellivery: Within 15 to 30 days of assignment, depending on complexity. $ ________