Sources Sought Notice_01262021.pdf

Sources Sought Notice 1237354

Office of Regulatory Affairs (ORA) – Office of Training Education and Development (OTED)

THIS IS NOT A REQUEST FOR PROPOSALS/QUOTES - THIS IS A SOURCES SOUGHT NOTICE/REQUEST FOR

INFORMATION, AND INFORMATION SUBMITTED WILL BE USED FOR MARKET RESEARCH PURPOSES

ONLY.

This Sources Sought/Request for Information (RFI) is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers. The purpose of this RFI is to identify small businesses (i.e., Small Businesses, SBA Certified 8(a) Small Businesses, Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB) that are capable of providing the full range of services described in this RFI and the draft statement of work (SOW). FDA will use this market research information to assess the market's capability to successfully meet FDA OTED's requirements for Biomanufacturing Principles and Process Training. FDA welcomes responses from all interested small businesses. FDA does not intend to make a decision or award a contract on the basis of responses nor otherwise reimburse interested sources for the preparation of any information submitted for FDA's use of such information. FDA reserves the right to contact vendors if additional information is required.

Objective:

The Food and Drug Administration (FDA)/ORA/OTED is interested in working with an institution that does not create/produce products that are or will be regulated by the FDA and/or marketed or introduced to the market and thus regulated by FDA. The objective of this project is for a Contractor to deliver the four-course training curriculum, developed under a different contract by a different source, to FDA investigators. The curriculum is designed to give investigators a greater understanding of biomanufacturing processes, and analytical testing methods.

The curriculum shall be delivered via distance learning technologies, classroom instruction coupled with practical experience in the vendor’s facilities. Multiple contracts may be awarded and students will complete the entire four (4) course series from an individual contractor.

The instructional areas to be covered in four courses include, but are not limited to:

• Quality Control;

• Analytical Testing;

• Upstream Bioprocessing;

• Downstream Bioprocessing; and

• Aseptic Processing

Scope:

The scope of work details the overall requirements for delivering the biomanufacturing principles and processes curriculum and developing the accompanying instructor and participant guides for that curriculum.

The Contractor shall deliver curriculum via distance learning, followed by classroom instruction, coupled with practical experience. Course delivery shall consist of asynchronous web-based, synchronous web-based, synchronous classroom and laboratory training and the development of comprehensive instructor and participant guides to go with the delivery of the synchronous classroom and laboratory training with respect to the manufacture of biological therapeutic drugs. ORA employees will have access to the web from their desktop. ORA employees will travel to the vendor’s facilities for the on-site portion of the training.

Due to the COVID-19 pandemic, the FDA and the Contractor may request that the portion of this course that is typically conducted in-person at the vendor’s facilities be conducted virtually. The Contractor should be able to accommodate virtual delivery of the courses Quality Control/Analytical Testing, Upstream Bioprocessing, Downstream Bioprocessing and Aseptic Processing via virtual learning platform if requested or necessary due to the risks of traveling during the COVID-19 pandemic.

It is the Government’s intention to award a contract with a performance period of one (1) year with three (3) one (1) year options.

General Instructions:

A complete response to the RFI must include the information requested below. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g., The response must go beyond the statement that, "XYZ company can provide training support.").

Provide a brief narrative explaining your company’s experience in providing a training facility equipped with the necessary support as described in the Statement of Work for this requirement. Include specific examples of the services provided to other agencies/companies. Please provide a capability statement.

1. What are your qualifications to design and deliver curriculum?

2. What is your experience doing course design, delivery, and management?

3. What is your experience designing biotechnology/biomanufacturing curricula? If possible, provide samples of past work.

4. Do you have experience delivering curriculum virtually? If so, how was virtual curriculum delivered?

Please provide documentation of the size of your business for the selected North American Industry Classification System (NAICS) code: 611710. If you are classified as a small business, Historically Underutilized Business Zone small business, Veteran-owned Small Business, Service-Disabled Veteran Owned Small Business, Woman-Owned Small Business and/or SBA 8(a) certified small business. Please provide a capability statement in addition to the other information for acquisition strategy determination. Additionally, please demonstrate your firm's capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting.

Attachments:

1. Draft SOW: See attached DRAFT statement of work (SOW), which is subject to change.

Responses to this notice must be submitted via email to Alice Mihill (Alice.Mihill@fda.hhs.gov).

Responses will not be accepted by any other means. Responses are due by 4:00 PM Eastern Time (ET), Thursday, February 4, 2021. Late responses may not be considered.

THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for quote/proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. The result of this market research will contribute to determining the method of procurement.

mailto:Alice.Mihill@fda.hhs.gov mailto:Alice.Mihill@fda.hhs.gov