SOURCES SOUGHT
U -- Biomanufacturing Principles and Processes Training and Curriculum - FDA-SS-1176554
- Notice Date
- 12/2/2016
- Notice Type
- Sources Sought
- NAICS
- 611430
— Professional and Management Development Training
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1176554
- Archive Date
- 1/4/2017
- Point of Contact
- Lisa K. Yaw, Phone: 240-402-4018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Sources Sought for Bio-manufacturing Principles and Processes Training and Curriculum SMALL BUSINESS SOURCES SOUGHT NOTICE: Biomanufacturing Principles and Processes Training and Curriculum NOTE: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses, service-disabled, veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, which is 611430, Professional and Management Development Training. The associated small business standard is $11.0 M dollars. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information it submits. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Background FDA trains field and headquarter investigators and analysts to conduct inspections of biopharmaceutical and pharmaceutical manufacturing processes and practices for compliance with good manufacturing practices (GMP) regulations through DHRD. FDA is looking for a contractor who has the capability to provide investigators additional biological therapeutic drug training with the objective of exposing course participants to: • Products • Product development • Facility and equipment design • Technology transfer • Manufacturing processes • Analytical testing methods During the contract, the offeror will be required to design, develop, and deliver four courses. Students will be given 12 months to complete all four courses. The courses are intended for FDA ORA field and operational personnel, and will include web-based, classroom, and hands-on training. Each course will allow for a maximum enrollment of 15 students, to take place over a five-week period, and require 32 contact hours. A total of eight contact hours will be provided via online instruction over the first four weeks of the course. The remaining 24 hours of instructional time will take place over three days onsite at the offeror’s facility in the fifth and final week of the course. For each course, Continuing Education Units (CEUs) will be awarded in accordance with criteria established by the International Association for Continuing Education and Training (IACET). Scope The offeror will develop and electronically deliver a Project Management Plan (PMP) that details processes, schedules, and milestones for this contract’s deliverables for review by DHRD. The PMP will give a detailed description of how work will be accomplished to meet the requirements in the SOW and explain the offeror’s management and technical processes, procedures, methodologies and tools for accomplishing the tasks identified in this SOW. As a part of the PMP, the offeror will determine how the proposed approach will be structured to minimize and control risk. The PMP will detail the schedule for developing and implementing the curriculum in a “phased-in” approach. The offeror will produce an event-based plan that measures program maturity by capturing the initiation/conclusion of the tasks, key events, significant accomplishments, and accomplishment criteria as well as the processes necessary to implement the program. The design of training materials will involve the development of templates for the online training materials. The offeror will submit template designs and prototype content to DHRD for approval prior to developing training program content. For the synchronous web-based component of the curriculum, the Design Guide will describe the following: • Webinar objectives • Interface design for the webinar • Webinar course outline • Instructional strategies for presenting the material • List of visual aids • Webinar schedule • Instructions for accessing the webinar For the classroom component of the curriculum, the Design Guide will describe the following: • Course objectives • Prototype of the participant guide • Prototype of the instructor guide • Classroom course outline • List of materials to be used For the hands-on component of the curriculum, the Design Guide will describe the following: • Objectives • The facilities that will be used for each course • Outline of the instructional activities • Hands-on activities • Schedule of events CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested, qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement. The capability statement will be sent electronically to Lisa Yaw at Lisa.Yaw@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement will be no more than five pages, excluding a cover page and table of contents, and will include examples of successfully completing relevant similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses will also include company information to determine eligibility, including their contact information, Dun and Bradstreet (DUNS) number and size and business type (e.g. 8(a), HUBZone, etc.,) based on the applicable NAICS code for the proposed acquisition, Biomanufacturing Principles and Process Training and Curriculum. The associated small business standard is $11.0 M dollars. Entities have until 2 pm ET, Tuesday, December 20, 2016 to respond to the FDA.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1176554/listing.html)
- Place of Performance
- Address: Web-based and/or vendor's facility, United States
- Record
- SN04341385-W 20161204/161202233849-34d072b794274ee79f0127fd226e27a1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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