SOLICITATION NOTICE
U -- Feed Manufacturing Training Course
- Notice Date
- 8/24/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1004133
- Response Due
- 9/13/2005
- Archive Date
- 9/28/2005
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items or services prepared in accordance with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. 1004133. These solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The North American Classification System (NAICS) Code is 541690. The proposed acquisition is a total small business set aside. The Food and Drug Administration?s (FDA) Center for Veterinary Medicine (CVM) is seeking to obtain a Feed Manufacturing Training Course that addresses the topic and process of feed manufacturing and the quality assurance that goes into the development of agricultural feed. CVM has a highly educated and skilled workforce, consisting mostly of scientists, veterinarians, reviewers and consumer safety officers, who hold advanced academic, scientific and medical degrees. The audience for the course contemplated by this contract will primarily include employees from the Office of the Director (OD), Office of Management (OM), Office of New Animal Drug Evaluation (ONADE), Office of Research (OR) and Office of Surveillance and Compliance (OS&C). The work required by this effort will fall within the Scientific and Technical Competency category and the targeted competencies include a) Drug Development Process which involves understanding the steps involved in developing a drug for marketability and knows the standard steps in the development process (e.g. pilot studies, stability concerns, manufacturing pK/pD, dose determination/ characterization, etc.) and b) Drug Review Process which involves an understanding of the steps involved in the drug review process. Specifically, understands that there is an investigational process under the Investigational New Animal Drug (INAD) submission and what is involved, understands the New Animal Drug Application (NADA) review process, and the respective consults that are required for different submissions. Description of Work: The Food and Drug Administration?s (FDA) Center for Veterinary Medicine (CVM) is seeking to obtain a Feed Manufacturing Training Course that addresses the topic and process of feed manufacturing and the quality assurance that goes into the development of agricultural feed. The contractor shall coordinate with CVM?s Office of Research to develop and deliver a laboratory practicum associated with this course. The contractor shall provide a course outline per the deliverables with specific topics and subtopics identified and briefly described. This outline and topics shall ensure that course objectives will be met. The contractor shall also identify the recommended course length and schedule that they consider appropriate to ensure course objectives are met. The contractor shall also identify the recommended course length and schedule that they consider appropriate to ensure course objectives are met. The recommended course length and format will be subject to CVM?s approval. The contractor shall also identify any Government provided resources/support needed for the delivery of the course contemplated by this contract. Such identification of resources shall be identified before contract award in the contractor?s proposal. The contractor shall ensure that the following course objectives are met through the students? ability to: a) understand the basic principles of feed manufacturing, facility design and production capabilities; b) discuss product and ingredient inventory control; c) explain the role of quality control and the use of quality assurance principles in feed manufacturing; and d) list factors that contribute to variation of nutrients and feed additives. The contractor shall also ensure that the training development and delivered will provide students with the following learned skills: an ability to more effectively conduct and/or support reviews for medicated and non-medicated animal feed products; and an ability to more effectively conduct and/or support the inspection process for medicated and non-medicated animal feed products. The contractor shall also develop three to four questions for each topic area to be used for the purpose of pre and post assessments of the course material. These questions shall be submitted to CVM Staff College personnel in advance of the actual course delivery for approval by CVM. The contractor should assume a class size of approximately twenty five students. Deliverables: 1) Course outline including topics and subtopics and dates of and length of training for each topic area to be due within thirty days after contract award for CVM?s approval. 2) Laboratory Practicum Outline/Agenda to be due at least fifteen (15) days prior to the scheduled training. 3) Course reference materials ? Contractor shall be responsible for course reference materials for a minimum of twenty five (25) students to be due. Original set shall be provided to CVM at least 30 days prior to course delivery for CVM?s approval. Upon approval, the contractor shall provide copies at least five days prior to the scheduled training. 4) Course Notes and Assignments, if any are due at least 15 days prior to the scheduled training. 5) PowerPoint presentations (if to be used during course delivery) due at least five days prior to the scheduled training. 6) Pre-Post assessment questions to be due at least five days prior to the scheduled training. The Period of Performance for this contract shall be from the date of award through June 30, 2006. Work shall begin soon after the closing date of this solicitation. Evaluation Criteria: There is a preference for this acquisition to be awarded on a best value basis as technical considerations are more important than cost. The most important evaluation criterion is the extent to which the proposed personnel have the expertise and practical experience necessary to develop and deliver the required training. Specific technical evaluation criterion, listed here in descending order of importance, includes: a) the extent to which proposed personnel have an understanding of and practical expertise related to companion and production animal feed manufacturing, facility design, and production capabilities; b) the extent to which the proposed personnel have an understanding of and practical expertise in the concepts of quality assurance and quality control and good manufacturing practices applies to the manufacture of animal feed; c) the extent to which the proposed personnel have an understanding of factors influencing particle size, feed batching and mixing and feed handling equipment and systems; and, d) the extent to which the proposed personnel have an understanding of and practical experience applying the Food and Drug Cosmetic Act to the approval of veterinary drugs and animal feeds. The following FAR Clauses shall apply to this solicitation: 52.212-1, 52.212-2, 52.212-4, 52.212-5 Instructions to Offerors-Commercial; 52.214-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. All questions should be submitted in writing via e-mail to TONEILL@OC.FDA.GOV . FAR provisions can be found at the following website: http://www/arnet.gov.
- Place of Performance
- Address: Food and Drug Administration, Center for Veterinary Medicine (CVM), 7529 Standish Place, MPN5, Room 3524, Rockville, MD
- Zip Code: 208552773
- Country: USA
- Zip Code: 208552773
- Record
- SN00878105-W 20050826/050824212152 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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