SOLICITATION NOTICE
U -- Training Course Development for CVM
- Notice Date
- 8/28/2003
- Notice Type
- Solicitation Notice
- 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
- Reference-Number-V230003
- Response Due
- 9/15/2003
- Archive Date
- 9/30/2003
- Point of Contact
- Lauren Waller, Contract Specialist, Phone 301-827-7163, Fax 301-827-7151,
- E-Mail Address
-
lwaller@oc.fda.gov
- 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 a Request for Quote (RFQ) No. V230003. These soliciation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The Standard Industrial Classification (SIC) Code is 8299, and the North American Classification System (NAICS) Code is 611430. The Center for Veterinary Medicine is soliciting firms to fill the following requirements: (I) Training Course #1 - Proper Drug use and Residue Avoidance. (A) Description of Services/Statement of Work - Develop a training course on proper drug use and residue avoidance for food animal producers. Educational sessions of similar duration and timing also to be developed for veterinarians, animal dealers/haulers/transporters, auction yards, and slaughter plants. Contractor to develop course agenda, Power Point or similar presentations with realistic scenarios, visual aids (picture files and/or movie files), prepare a list of multiple choice test questions, prepare handout materials, and draft course announcements. Representatives from each FDA District Office will then attend an initial ?Train the Trainer Course? with the intent that they, in turn, host local sessions for regulated industry. With the development of standardized training materials we can ensure training consistency. (B) Objectives - The course objectives are to provide education to industry covering illegal drug residue avoidance of food products sold for human consumption. The course will cover both meat and milk residue avoidance practices. This training will provide an educational outlook in providing information regarding the meat and milk residue testing processes and residue avoidance practices for all types of food producers. The course will cover record keeping, drug treatment practices, animal identification, and treated animal separation requirements. The course will be conducted on one day due to food producers limited time schedules, potentially the course will only last approximately 2 hours. The course coverage will be on a strict time limit and power point slides are probably the most efficient tool to ensure time accountability. The producer segment will be limited to factors that producers have ability to control, their role in residue avoidance. In addition, there will be additional courses designed to cover the other segments of the food producing industries. For example, educational sessions (of similar duration and timing) for veterinarians, animal dealers/haulers/transporters, auction yards, and slaughter plants. (C) Topics to be addressed - Slaughter plant testing for beef, Milk plant testing for milk, USDA/Producer/FDA notification system-letters sent to producers, Animal Identification Systems, Drug Purchases/Storage/Labeling/Usage/Administration/Disposal, Veterinarians Involvement, Employee Training, Milk/Meat/Aquaculture (urine)Screening Tests, Record Keeping: Drug Treatments/Drug Inventory-computerization, Sales Certifications-Residue Free, Middlemen/Veal Drop Calves/Heifer Raising Facilities, Government Inspections/Results/Warning Letters/Injunctions, & BSE-Animal Feed Ban Regulations. (D) Course Announcement Avenues - Federal Register, Informational Letters to Trade Associations, Dairy Associations, Direct Mailings with residues, & FDA & The Veterinarian Newsletter (E) Course Materials/Handouts - FDA & The Veterinarian Booklets, BSE Pamphlets, Reduce the Threat of BSE, Milk & Dairy Beef QA Assurance Program Residue Prevention Protocol, CPGs, etc? (F) Reporting Requirements and Deliverable Items - The Contractor will deliver a series of short, concise courses designed to stress the importance of residue avoidance and provide the involved industries with a set of simple husbandry practices that, when implemented, will prevent drug residues in food-producing animals. Contractor will deliver course agendas, Power Point or similar presentations with visual aids, prepare a list of multiple choice test questions, prepare the handout materials referenced above in a well-organized format, and draft course announcements. The contractor will visit CVM prior to starting the project to discuss the objectives and deliverables. There will be quarterly meetings with CVM during the contract period to report on progress. The contractor will also submit quarterly reports and a final report (the fourth quarter report) to the project officer. The reports will contain all accomplishments since the previous report and the activities planned for the next quarter. (II) Training Course #2 - Develop Educational Program to Disseminate Information on Proper Drug Use, Compounding, and the Animal Medicinal Drug Use Clarification Act (AMDUCA). (A) Description of Services/Statement of Work - Develop educational program to disseminate information on proper drug use, compounding, and AMDUCA to compounding pharmacies and veterinarians. Contractor to develop course agenda, Power Point or similar presentations with realistic scenarios, visual aids (picture files and/or movie files), prepare a list of multiple choice test questions, prepare handout materials in an organized manner, and draft course announcements. Representatives from each FDA District Office and from the Center of Veterinary Medicine will then attend an initial ?Train the Trainer Course? with the intent that they, in turn, host local sessions for regulated industry. With the development of standardized training materials we hope to ensure training consistency. (B) Objectives - The main course objective is to provide education to veterinarians and compounding pharmacists regarding the FDA laws, regulations, and guidance documents that address the proper use of animal drugs, the compounding of drugs for use in animals, and the extra label use of drugs for use in animals. This training will emphasize the utilization of drug use and compounding practices that avoid the occurrence of drug residues in food-producing animals. The course will cover the basics of the FDA drug approval process; an understanding of extra label drug use regulation, 21 CFR Part 530; an understanding of the compounding compliance policy guidance document, 608.4000; the recordkeeping, and the rationale for and legal status of using drugs in an extra label fashion; and the rationale for and legal status of using compounded animal drugs. The course will be designed in a modular format to allow for the flexibility of one-hour presentations at general meetings to full day seminars on the topic and audiences of either veterinarians or pharmacists. When at all possible and appropriate, the PowerPoint-based presentation should incorporate visual aids and realistic examples and situations. Test questions may be given to the meeting participants and should be developed to match the modular design of the presentations. (C) Reporting Requirements and Deliverable Items - The Contractor will deliver a series of short, concise training modules designed to provide education to veterinarians and compounding pharmacists regarding the FDA laws, regulations, and guidance documents that address the proper use of animal drugs, the compounding of drugs for use in animals, and the extra label use of drugs for use in animals. Contractor will deliver course agendas, Power Point or similar presentations with visual aids, prepare a list of multiple choice test questions, prepare the handout materials in a well-organized format, and draft course announcements. The contractor will visit CVM prior to starting the project to discuss the objectives and deliverables and will work closely with the Project Officer throughout the contract period incorporating any suggested changes into the final product. At a minimum there will be quarterly meetings with CVM during the contract period to report on progress. The contractor will also submit quarterly reports and a final report (the fourth quarter report) to the project officer. The reports will contain all accomplishments since the previous report and the activities planned for the next quarter. (III) Duration of Project - This project is anticipated to be a 12-month Purchase Order. (IV) Evaluation Criteria for Proposals - (1) Qualifications of Personnel (35%) Offerors shall demonstrate that they have the personnel requisite to develop high-quality educational programs. An understanding of food animal husbandry practices is desirable as is knowledge of FDA?s Compliance Program addressing Illegal Drug Residues in Meat and Poultry. Offerors shall indicate which personnel would be participating in individual tasks and what percentage of their time would be devoted to this task. (2) Organizational Experience (25%) Course Development: Offeror shall demonstrate that they have the personnel requisite to develop a well-designed course. If a subcontractor (developer) is used, the qualifications of the subcontractor for this task must be sufficient to provide a high-quality product. (3) Technical Approach (25%) Offeror shall indicate how they would approach tasks stated in scope of work. The offeror should demonstrate their ability to interpret complicated regulatory information and present it in a format easily understood by varied educational levels. The Contractor shall describe facilities, computer capabilities, and ability to maintain frequent liaison with the Food and Drug Administration (CVM) on this project. Access to computer services shall be crucial for certain quick response tasks. (4) Quality Control Procedures (15%) The Contractor shall identify means of final draft quality to ensure that it is relatively free of typographical errors. The Government expects the contractor to carefully check data submitted and report accurately as to any potential method of compliance with this issue. All questions shall be submitted by Email to lwaller@oc.fda.gov or by fax to 301/827-7151 NO LATER THAN 2:00 p.m. (EST) ON SEPTEMBER 5, 2003. Responses shall contain a technical proposal and a price quotation. Responses are due no later than 3:00 p.m. (EST) ON September 15, 2003. Responses may be submitted electronically to lwaller@oc.fda.gov or mailed to the Contracting Office Address listed above, ATTN: Lauren Waller. The following FAR clauses shall apply to this solicitation: 52.212-1 Instructions to Offerors ? Commercial; 52.212-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfer. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. Evaluation/award will be based on the technically acceptable quote that offers the best value to the government. All quotes shall include price (s); a poc (name and telephone number); GSA contract number if applicable; business size; and payment terms. FAR provisions can be found on the following website: http://www.arnet.gov.
- Record
- SN00414870-W 20030830/030828213220 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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