SOLICITATION NOTICE
U -- Food and Drug Law Training
- Notice Date
- 2/2/2007
- Notice Type
- Solicitation Notice
- NAICS
- 611710
— Educational Support 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-07-00150
- Response Due
- 2/17/2007
- Archive Date
- 3/4/2007
- Small Business Set-Aside
- Total Small Business
- Description
- Request for Quotation (RFQ) - Responses to this RFQ are due no later than February 17, 2007 at 5:00 pm EST. Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information contained in this notice. This announcement constitutes the only solicitation: proposals are being requested and a written solicitation will not be issued. This acquisition is a 100% small business set-aside. The associated North America Industry Classification System (NAICS) Code is 611710 with a small business size standard is $6.50 Million. A. Background Information The Food and Drug Administration (FDA) has a continuing need to train its field and headquarters operation al personnel in the basic legal aspects of the Food, Drug and Cosmetic (FD&C) Act and related regulations. A clear and consistent understanding of the laws, regulations, and legal precedents is essential to assure appropriate, uniform application of the administrative and compliance guidelines of the Agency. The Office of Regulatory Affairs (ORA) staff is the field component of FDA and is engaged in investigative, scientific and compliance activities in support of the Agency's consumer safety protection mission. Field personnel are the first line in gathering and reviewing evidence, maintaining its integrity, and recognizing its significance with respect to the laws enforced by FDA. For a number of years, the ORA staff has coordinated the formalized basic food and drug law training of field and headquarters personnel and, as the coordinating unit, will assure continuity of effort in both training and performance. Training in food and drug law is a major segment of a developmental program for newly hired investigators, inspectors, and analysts in the field. Continuation of this quality training is essential in order for FDA to maintain a cadre of field and headquarters personnel sufficiently acquainted with FDA laws and regulations to enforce Agency policies and statues in a uniform manner. FDA has a need to offer more advanced training for FDA staff of varying during and complexity. For example, expertise needs to be presented in the import area, advanced applications of the FD&C Act and expertise pertaining to commodity assets that the FDA regulates, such as veterinary medicine, drugs, device, foods, and regulatory actions pertaining to the law such as seizures and injunctive actions, etc. B. Objective The principle objective is to provide FDA field and headquarters personnel with consistently presented basic and advanced training in the laws and regulations enforced by the Agency. C. Scope of Work The contractor shall supply necessary qualified personnel to provide instructional services at a minimum of three (3) or an estimated maximum of ten (10) courses ranging in duration of one week (five workdays), four (4) days and /or from 8-16 hours depending on the course. Content covered includes food and drug law, basic and advanced, import regulations, injunction and seizure and aspects of the law pertaining to a particular commodity area, for example device, drug, foods , biologies or veterinary medicine. These courses will be held at government selected sites for approximately 40 FDA students per course. Up to 60 students may be assigned to the course at the discretion of the FDA Project Officer. All sessions should be completed by September 2012. Food Drug Law I and II Courses: The class workday will run from 8:00 A.M. to 5:00 P.M. Monday - Thursday and 8:00 A.M to 3:00 P.M. on Friday. Review classes held in the evening will be proctored by FDA employees. The contractor will provide a course review Friday morning from approximately 8:00 A.M. to 10:00 A.M., followed by a two hour test, one hour lunch and time allotted for test review. Scheduling evening sessions will be subject to completion of material during normal class day, and/or review of specific topics. Courses not following the 5 day schedule will be contracted for specified number of hours and times depending on course and content. The contractor will be notified at least 2 months before the course is announced to determine availability. Contractor will be provided with course objectives and number of days/hours when confirming availability. The contractor shall present courses in lecture/discussion format with approximately 85% of the time per day devoted to lecture and 15% to workshop modules and class discussion. FDA instructors/resource persons will be used as monitors and proctors and only participate in the program where their expertise is considered necessary by FDA to fully explain current and precedent Agency policy and procedures. Each course shall cover the fundamental aspects of the Food, Drug and Cosmetic (FD&C) Act and its implementing regulations, significant guidance documents, major judicial guidelines and opinions in this field, legal consequences of administrative actions and decisions, study of the government's burden of proof in court cases, and case development. Content for some courses shall be more specific and geared to the audience needs. Example content includes Untitled and Warning letters, Seizure, Injunction, Post Filing Activity/Coordinate Trial Preparations, Consent Decree/Order, Import Regulation; Veterinary Laws and Regulations. There shall also be summary analyses of other acts enforced by the FDA including, but not limited to: * Public Health Security and Bioterrorism Preparedness and Response Act * Dietary Supplement Health and Education Act * Safe Medical Devices Act * Generic Drug Enforcement Act * Prescription Drug Marketing Act * Nutritional Labeling Education Act * Radiological Control for Health and Safety Act * Title 18, Section 1001 Section 2 and Section 372 The majority of courses will be directed to students from field units who will need diversified rather than specific coverage of the FD&C Act. Some courses, however, will be conducted for specific group disciplines, i.e., students working primarily in foods, medical devices, biological health, drug, biologic, or veterinary medicine. The Contractor will be expected to appropriately adjust the agenda to accommodate the needs of the student audience. Times for presentation will also vary depending on the audience and material to be covered. The Food Drug Law I and II courses will be designed by the contractor with the use of an updated course outline provided by the Government that addresses our training needs through the use of the current textbook/workbook and current course materials, i.e., pre-course reading materials, quizzes and final testing mechanisms. The course should be developed to include: (a) A set of pre-course reading materials that will be distributed by the government tot he students prior to the course. The pre-course materials should be reviewed once every six (6) months and updated and /or re-designed as appropriate. The materials should provide the students with a basic understanding of the legal concepts within which FDA's enforcement policies and activities are framed. (b) A complete course outline which shows the learning objectives established for each time module, and the identification of workshops and precedent cases to be discussed during lecture/seminar sessions. (c) Lectures, workshops, or seminar discussion to illustrate application of the principles of the law explained during lecture presentation and plenary sessions to assure, as much as possible, a better understanding of the course content and goals through active involvement of all participants. (d) A textbook/workbook (which may incorporate any or all information in the current textbook/workbook) to provide an additional record of learning/reference material for the participants which includes: (i) Actual and hypothetical cases and case situations discussed or used as workshop exercises during the coach. (ii) Copies of multimedia aids to be used as reference material by participants. (iii) A testing mechanism on last day of the course designed to measure how effectively the learning objectives established for the course have been accomplished through the administration of written questions Note: The workbook will not contain copyright material and will be copied and distributed by the government. (e) A review of the final test to reinforce learning objectives and clarify misunderstandings. The Project Officer will determine the method of review. (f) Course content will be targeted to a specific audience, e.g. imports, veterinary medicine, medical devices, and drugs. Advanced applications of the Food Drug Law will be presented to the contractor at least two (2) months in advance in order for the contractor to prepare lectures and exercises based on defined objectives. The Project Officer will send the contractor the course agenda listing times and days of presentation. The number of hours may vary depending on course content. (g) Contractor shall be reimbursed for actual time spent preparing for and presenting the course. (h) Literature citations - FDA Law Syllabus, reprinted in FY 88. The contractor will update the Food Draw Law I and II courses semi-annually to reflect changes required by judicial rulings, agency policy changes, or other substantial development in terms of the effectiveness of the learning experience of the students as identified by evaluations and critiques. FDA employees are called upon to defend regulatory actions taken against a firm in a court of law. To prepare the employees for the types of questions that may be asked of an investigator, compliance officer or laboratory analyst, the contractor will be called upon to present a mock cross examination. The cross-examination will be filmed by FDA so that employees may have access when needed to prepare for cross examination in a trial. FDA employees will be used as trial participants. The cross-examination may be part of a course and filmed during the course or may be filmed independently to provide maximum film production. The Contractor shall make his/her own transportation/reservations including hotel and rental car as authorized by the Project Officer. Receipts and invoice must be provided to the Contracting Officer for payment. Contractor should not previously or presently be involved in lawsuits against the federal government. D. COMPENSATION Compensation for Base Year (September 1, 2007 thorough August 31, 2008): As consideration for the services described in the Statement of Work, the Government will pay the contractor the firm fixed price of $_________ per course. The estimated number of courses per year is ten (10). Payment will be made after acceptance of services and upon presentation of proper invoice. E. EVALUATION CRITERIA In determining which offer represents the best value (i.e., labor hours, special features, administrative costs) to meet the Government's needs, the Government shall evaluate responses using the following evaluation criteria that are listed in descending order of priority: The technical quotation will receive paramount consideration in the selection of the offerors for this acquisition. In any event, the government reserves the right to make an award based on a best value determination, cost and other factors considered. Offerors merely proposing to provide a service in accordance with the statement of work will not be eligible for award. The proposal must include a comprehensive plan for meeting the needs of the Government, addressing each of the requirements of the statement of work and explaining the proposed technical approach to be used. Failure to provide the information required to evaluate the proposal may result in the rejection of the proposal without further consideration. 1. Understanding the Requirements and Technical Approach 45 Points 2. Qualifications and Availability of Proposed Personnel 20 Points 3. Past Performance 35 Points Total Possible Points: 100 points 1. Understanding the Requirements and Technical Approach (Points: 45) The quotation must demonstrate a thorough understanding of the requirements of the Statement of Work and describe an approach which will demonstrate the achievement of acceptable performance as describe in the Statement of Work. The quotation shall present a comprehensive statement of the problem, scope, and purpose of the project to demonstrate an understanding of the requirements from a management and technical standpoint. Quotation will be evaluated on the following: *Understanding of the purpose and scope and work to be accomplished *Methodology to accomplish the objectives of the given task. *Quality control and quality assurance methods *Identification and use of appropriate technologies (Microsoft Outlook, Word, and Excel) to accomplish the objective *Management structure for the contract *Staffing patterns, including overlap among the programs and handling shifts. *Adequacy of strategies for coordination, interaction, and communication with the Government Project Manager to ensure that the work is accomplished in a timely and efficient manner, particularly as these strategies relate to keeping the Government Project Manager informed and up-to-date about customer service, technical or administrative operational issues 2. Qualifications and Availability of Personnel (Points: 20) Quoters must demonstrated evidence of the qualifications, experience, and availability of professional and technical personnel comprising the necessary project staff. Qualification statements for the following personnel: *Project Manager *Trainer Personnel proposed to be assigned and available for work under the project shall be evaluated on their demonstrated, documented, and relevant expertise, education, availability, and experience. Supporting documentation about the experience, training, and education (e.g., resumes) of proposed personnel must be provided. 3. Past Performance (Points: 35) The government is seeking to determine whether the quoter has consistently demonstrated a commitment to customer satisfaction and timely delivery of high quality services. a) Quoters shall submit a list and description of the last 1 or 2 contracts completed during the past three years and 1 or 2 contracts currently in process. Quoters shall be evaluated on (1) record of conforming to specifications; (2) adherence to contract schedules, including the administrative aspects of performance; (3) reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and (4) business-like concern for the interests of the customer. b) Offerors shall furnish documentation of corporate experience in the technical proposal that addresses the technical aspects specified in Technical Evaluation Corporate experience will be evaluated based upon the quoters's prior experience with similar activities. RESPONSE GUIDANCE The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999), 52.217-9 Option to Extend the Term of the Contract (Mar 2000). The period of performance for this contract is from 09/01/2007 to 08/31/2011 with one base year period and four (4) one-year options. Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. Please submit a detailed capability statement outlining the necessary knowledge, skills and abilities in meeting the Food and Drug Administration requirements. Supplemental materials, such as brochures, white papers, specification sheets, lab and field test results, cost and schedule information, etc. are welcome. If you choose to submit proprietary information, mark it accordingly. CONTACT INFORMATION Responses should forward the requested information via e-mail only to the point of contact listed below. No telephone calls or faxes will be accepted. The following are the Government Point of Contacts (POCs) for this RFQ: Kevin Doss Patricia Pemberton 5630 Fisher Lane 5630 Fisher Lane Room 2081 Room 5631 Rockville, Maryland 20857 Rockville, Maryland 20857 kevin.doss@fda.hhs.gov patricia.pemberton@fds.hhs.gov
- Place of Performance
- Address: Rockville, MD
- Zip Code: 20857
- Country: UNITED STATES
- Zip Code: 20857
- Record
- SN01224611-W 20070204/070202220409 (fbodaily.com)
- Source
-
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