Training Services for Office of Regulatory Affairs (ORA) Center of Excellence

The purpose of this amendment is to extend the dealine for repsonses to April 17, 2020 at 3:00pm (Eastern). This is not a solicitation announcement. This is a Request for Information only. The purpose of this Request is to gain knowledge of all types of qualified organizations and business sources as well their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) 611310, - Colleges, Universities and Professional Schools and/or 611710 - Educational Support Services. Responses to this Request for Information will be used by the Government to make appropriate determinations about potential sources and availability of required training. Project Title: Training Services for Office of Regulatory Affairs (ORA) Center of Excellence Background: ORA seeks to establish an Inspectorate Training Center of Excellence (Training Center) charged with developing, acquiring and delivering advanced technical training to meet the science, engineering and technology training needs of FDA investigators and compliance staff. The Training Center will be governed by a steering committee or governing body comprised of ORA program leadership together with representation by FDA Centers. The Training Center's goal will be to enhance ORA investigators and compliance officers technical expertise and ensure their continued readiness to conduct oversight of regulated product manufacturing with a focus on advanced manufacturing and innovative products and methods. This new training will complement existing ORA Office of Training, Education and Development (OTED) training by focusing on more complex scientific and technical curricula. The initial focus of the Training Center will be on medical products, but its ultimate scope will include all regulated commodities (including human and animal food) and scientific laboratory activities. Project Description: The objective of this contract is to procure services that will facilitate and support the establishment of a Training Center and the development of a comprehensive cross-operational strategy to identify advanced technology training needs, and mechanisms and means for acquisition and delivery of such advanced technical training including the leveraging, through Public Private Partnerships or other arrangements, of external training courses and resources. The FY2020-2021 goal is to establish an advanced technical training framework and best practices, and to procure such advanced technical training for ORA's Office of Medical Products and Tobacco Operations (OMPTO) investigators and compliance officers, consistent with the needs of the ORA workforce. In FY2021 and beyond, the goal will be to expand the scope of the Training Center to non-medical product program areas in ORA. The scope of this contract is to acquire the full range of technical training for advancing or new technologies and management services necessary to provide and enhance training for the ORA Inspectorate Training Center. The scope of work encompasses the following task areas: - Program/Project Management - Transition - Develop, update and/or expand plan for Training Center - Establish Training Center and implement plan - Monitor and assess Summary of Requirements: The Contractor shall provide the complete range of training services (classroom (face to face or virtual) and online modules), workshops, and hands-on opportunities for the (OMPTO) investigators and compliance officers. The Contractor shall: Work with ORA SMEs to identify appropriate courses regarding suitability. Propose a list of available courses and workshops identifying advanced technical topic areas and opportunities to use specialized facilities and/or equipment that are suited to the investigators and compliance officers training needs. (Deliverable 1) Provide recommended approaches to providing training services. As required, develop, adopt and/or adapt curricula and advanced technical training programs, with relevant partners, for delivery to ORA operational staff in each program area. Issue a listing of existing advanced technical training opportunities in each specialty area; including course descriptions, location, name of provider, participant eligibility requirements, required time commitment and cost. (Deliverable 2) Identify and propose new advanced technical training opportunities on a continuing basis. Deliver the training as described. Obtain and exchange feedback on course content from ORA participants (Deliverable 3) Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size - Times New Roman 11 or larger). A copy of the company capability statement will also be accepted (but not in place of providing responses to the questions). After review of the responses received, a combined synopsis/solicitation may be published in the Federal Business Opportunities. Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions: Provide a brief corporate profile of your company to include the following: a. Organization's official name and dba name, if applicable; b. Length of time the Organization has been in business; c. Types of services provided by your Organization; d. Types of clients by industry (i.e. Federal, Commercial, Local Government, etc.); e. Is the Organization, U.S. based or International; f. Is the Organization a subsidiary of another Organization; g. DUNS number and CAGE number; h. Organizations website address; i. Main point of contact name, phone number, and email address; j. SBA size designation information and small business concern type (if applicable); k. Number of employees in the organization; l. Organization's most recent annual receipts amount as defined by the SBA. (Limit 1 page) What is your Organization's experience relevant to the requirements described in the attached draft SOW. Provide a narrative (Limit 3 pages) describing three (3) contracts/Task Orders that were awarded in the last three (3) years that are most like/similar the work as described in Attachment 1- Draft SOW to include the following: a. Contract Number / Task Order Number b. Govt Agency /Company c. POC for the Contract Number d. Period of Performance e. Contract Type (FFP, T&M or Labor Hour) and award dollar value Is the scope of the draft SOW clearly defined? Do you understand what FDA requires? If not, what information needs to be added, changed, and/or reworded in order to clarify the Government's requirements? Please provide the sections and page numbers. (Limit 2 pages) Please complete the Questionnaire provided in Attachment 2. List your GSA schedule contracts that are applicable to the SOW and include the current periods of performance as well as any and all future option periods. What, assuming all schedule option periods are exercised, is the final day of your company's GSA Schedule 70? Provide the GSA Schedule recertification date, if applicable. (Limit 1 page) State whether your Organization creates and/or produce products that are or will be regulated by the FDA and/or marketed or introduced to the market and thus regulated by FDA This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this notice can be mailed to: U.S. Food and Drug Administration Attn: Pierre Smith Office of Acquisitions and Grant Services 4041 Powder Mill Road Beltsville, MD 20705 Electronic mail responses will also be accepted at: Pierre.Smith@fda.hhs.gov. Telephone responses will not be accepted. Responses must be received in writing, by no later than 3:00PM (Eastern) on Friday, April 17, 2020. No solicitation is currently available. Responses to this Request for Information notification will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Reference No. 1223072