I. This is a combined synopsis/solicitation prepared in accordance with the subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Government intends to negotiate and solicit with only one source Society of Toxicology, 11190 Sunrise Valley Drive, Suite 300 Reston, Virginia 20191 to acquire toxicology training for the colloquia on Emerging Toxicological Science Challenges in Food and Ingredient Safety under the authority of FAR (13.106(b)(1)(i). Through market research and the current MOU with The Society of Toxicology, SOT is the only entity that can provide speakers of on Emerging Toxicology Sciences for CFSAN Community. They have some of the topnotch scientist in the Toxicology field speaking at our seminars. With this caliber of expertise our scientist updated on new research information. This is not a request for competitive proposals; however, any responsible offeror may submit a quote which will be given due consideration by the agency. II. This acquisition is issued as a Request for Quote (RFQ). III. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-01. IV. For purposes of this acquisition, the associated NAICS code is 611430. The small business size standard is 12.0 million. V. Line-Item Structure: The following is a list of line-item number(s) and items, quantities, and units of measure, (including option(s), if applicable) and should be reflected in the Offeror’s quote/proposal: Colloquia on Emerging Toxicological Science Challenges in Food and Ingredient Safety Line Item Description Quantity Price 1 Base Year: 2023-2024 Titles: The Big 8: Advances in Food Allergy Risk $ Assessment and Management Redesigning the Rodent Bioassay $ for the 21st Century Alternative Methods for Predictive Safety $ Testing: 3D Bioprinted Tissue Models Total $$$ 2 Option Year: 1 2024-2025 Titles to be determined $ Total $$$ 3 Option Year: 2 2025-2026 Titles to be determined $ Total $$$ VI. Specifications/Requirement: Purpose The purpose of this requirement is to acquire toxicology training as provided via the memorandum of understanding (MOU) number 225-22-018 between the Society of Toxicology (SOT) and the Food and Drug Administration (FDA). Background MOU number 225-22-018 is a five (5) year agreement that was established for the shared mutual interests among professional communities and government to support scientific training in interdisciplinary fields. This agreement allows the SOT and the FDA to work collaboratively to promote best practices regarding regulatory science and toxicology. Objectives In fiscal year 2024 procurement is needed to conduct training on colloquia on emerging toxicological science challenges in food and ingredient safety. More specifically, the SOT shall provide no more than four (4) one-half day workshops on toxicology, new toxicology methods and initiatives, and toxicological regulatory science in the interval. Scope The SOT shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things required for or incident to performance of the work. Task Requirements and Deliverables The SOT shall conduct the following training with regards to colloquia on emerging toxicological science challenges in food and ingredient safety. Training Course Due Date The Big 8: Advances in Food Allergy Risk Assessment and Management No less than one (1) month from the effective award date. Redesigning the Rodent Bioassay for the 21st Century No less than one (1) month from the effective award date. Alternative Methods for Predictive Safety Testing: 3D Bioprinted Tissue Models No less than one (1) month from the effective award date. Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 (29. U.S.C. 794d), as amended by the Workforce Investment Act 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this award must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards. This requirement is shall comply with the following standards. E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance (Appendix A, Application and Scoping Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) 302 Functional Performance (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed a https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except up approval of the Contract Officer or Representative. E207 Software (Appendix A, Application and Scoping Requirements) E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements) Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) All EIT must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at: https://www.section508.gov/ . Period of Performance The period of performance shall be One base year and two-year options. Delivery/Performance Requirements The Contractor shall provide pricing for both virtual and in person training. Note: The government intends to only exercise either virtual or in person training (not both simultaneously). The ceiling price will reflect the greater amount. Acceptance/Surveillance Presentation shall be sent prior to training. Travel No travel is anticipated. However, any required travel will be pre-approved by the Contracting Officer and/or the COR and will be reimbursed in accordance with the Federal Travel Regulations. Holidays and Government Closures SOT is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area: New Year’s Day Martin Luther King Day President’s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract). In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work. FDA Point of Contact Jason Aungst Project Officer Email:
[email protected] 4300 River Road College Park, MD 20740 M. Thomas Keels, COR Level II Email:
[email protected] 4300 River Road College Park, MD 20740 VII. The provision at 52.212-1, Instructions to Offerors – Commercial DEVIATION 2018-O0018, applies to this acquisition. The following addenda have been attached to this provision: In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong. VIII. Evaluation Criteria – N/A – Sole Source IX. Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer. X. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause: NONE. XII. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited are applicable: 52.204-10 REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT AWARDS (JUN 2020) 52.204-7 System for Award Management (Oct 2018) 52.209-6 PROTECTING THE GOVERNMENT’ INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT (OCT 2015) 52.217-7 OPTION FOR INCREASED QUANTITY-SEPARATELY PRICED LINE ITEM (MAR 1989) 52.217-8 Option to Extend Services. 52.217-9 Option to Extend the Term of the Contract. (MAR 2000) 52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013) 52.222-3 CONVICT LABOR (JUN 2003) 52.222-21 PROHIBITION OF SEGREGATED FACILITIES (APR 2015) 52.222-26 EQUAL OPPORTUNITY (SEP 2016) 52.222-36 AFFIRMATIVE ACTION FOR WORKERS WITH DISABILITIES (JUL 2014) 52.222-50 COMBATING TRAFFICKING IN PERSONS (JAN 2019) 52.223-18 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING (AUG 2011) 52.225-13 RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (JUN 2008) 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—CENTRAL CONTRACTOR REGISTRATION (OCT 2018) XII. The following additional contract requirement(s) or terms and conditions apply: 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018) 52.204-13 – System for Award Management Maintenance (Oct 2018) 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016) 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016) 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (Nov 2021) 52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT. (Nov 2021) 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES-REPRESENTATION. (Oct 2020) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS. (Mar 2023) 52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM. (Oct 2004) HHSAR clauses and provisions: 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (Dec 2015) 352-232-71 Electronic Submission of Payment Requests 352.239-73 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE (Dec 15) 352.239-74 Electronic and Information Technology Accessibility (Dec 15) INVOICE INSTRUCTIONS FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts. Registration emails are sent via email from
[email protected]. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to
[email protected] or phone (866) 973-3131. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days. If your company is already registered to use IPP, you will not be required to re-register. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures. d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable). e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category; Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount; Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant; Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed; Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor; Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable. f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) list of all invoices submitted to date under the subject award, including the following: (1) invoice number, amount, & date submitted (2) corresponding payment amount & date received (b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance. g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate. h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO. i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays. j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort. k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at
[email protected]. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue. (xiv) Quote is due electronically via email to
[email protected] for this acquisition no later than 28 November 2023, 11:59pm. Eastern Time. Late submissions may not be evaluated. The following language will be included in the resultant contract award: Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the period of performance of this contract shall not have macro enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.