1. Introduction: A. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. B. This solicitation is not restricted to any particular business size limitation it is open for competition among all business sizes. C. This solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular 2024-07 and VAAR Update 2008-37. The full text of the provisions and clauses can be obtained from the following websites: https://www.acquisition.gov/browse/index/far and http://www.va.gov/oal/library/vaar/. 2. Responding to this solicitation. Offeror must submit its quote via email to James.Whisner@va.gov. Offeror must provide the following information with its quote: A. Offeror s legal entity name, address, SAM Unique Entity Identifier (UEI) number; B. Information that demonstrates your company has a documented track record in evaluating the toxicology of PFAS compounds, including experience in developing toxicity-based benchmarks, risk assessment, and the creation and refinement of physiologically-based toxicokinetic models; C. Sample report of previous work product illustrating a risk assessment or similar activity where your company performed advanced modelling similar to what would be required in this contact. Appropriate reports would be EPA IRIS assessments, ATSDR assessments detailed in Toxicological Profiles, and similar assessments conducted for other authoritative bodies or regulatory agencies. D. Curriculum vitae for the key personnel (Senior Toxicologist(s) and Toxicologist(s)) who will be performing the services that demonstrate they meet the requirements stated in Paragraph 6.1 of the work statement, as well as their letter of commitment confirming their availability and commitment for the duration of this project; E. The completed Price Schedule - you must enter your quoted unit prices, amounts & grand total in the accompanying Price Schedule (see solicitation attachments). 3. Date & time quotes are due: November 13, 2024 at 11:00 AM Eastern. 4. Evaluation-Commercial Items. The Government intends to perform a comparative evaluation of offers in accordance with FAR 13.106-2(b)(3) to determine which offer provides the best benefit to the Government. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Alternate quotations may be submitted. Each response must meet the minimum requirements of the solicitation. The Government will award a contract to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The evaluation will consider the following: technical capability (e.g., past experience, key personnel), past performance, Veterans involvement (in accordance with VAAR 852.215-70), and price. 5. Description of Work: A. Contractor will conduct an extensive review of various data streams, including toxicological, epidemiological, and environmental information. This review will be integral to developing robust serum concentration models for PFAS compounds, delineating their relationship to potential adverse health effects in the veteran population. Contractor's responsibilities encompass expert peer review of hazard assessments, identification and refinement of serum/blood points of departure (PODs) for each toxic endpoint where sufficient evidence of an adverse effect exists, and the employment of advanced PBPK modeling to predict serum/blood concentrations at these PODs. In scenarios where data is insufficient for PBPK modeling, the contractor is expected to use contemporary, scientifically-defensible extrapolation methods to estimate serum/blood concentrations, aligning these findings with available human evidence from hazard assessments. (See the accompanying Work Statement attachment for details.) B. Contract Line-Item Numbers, quantities, unit of measure: (see the accompanying Price Schedule attachment for details). 6. The provision at FAR 52.201-1, Acquisition 360: Voluntary Survey. (SEPT 2023). 7. The provision at 52.212-1, Instructions to Offerors Commercial Services (SEP 2023), applies to this acquisition, including the following addenda: A. 52.204-7, System for Award Management (OCT 2018); B. 52.204-16, Commercial and Government Entity Code Reporting (AUG 2020); C. 52.204-20, Predecessor of Offeror (AUG 2020); D. 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021); E. 52.204-29, Federal Acquisition Supply Chain Security Act Orders-Representation and Disclosures (DEC 2023); F. 52.209-7, Information Regarding Responsibility Matters (OCT 2018); G. 52.233-2, Service of Protest (SEPT 2006); H. 852.233-70, Protest Content/Alternative Dispute Resolution (OCT 2018); I. 852.233-71, Alternate Protest Procedure (OCT 2018). 8. Offeror Representations and Certifications. Offeror must include a completed copy of the provision at 52.212-3. The offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the offeror has not completed the annual representations and certifications electronically, the offeror shall complete only paragraphs (c) through (u) of this provision. 9. The clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Services (NOV 2023), applies to this acquisition, including the following addenda: A. 52.204-13, System for Award Management Maintenance (OCT 2018); B. 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020); C. 852.201-70, Contracting Officer s Representative (DEC 2022); D. 852.203-70, Commercial Advertising (MAY 2018); E. 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (JAN 2023) (DEVIATION); F. 852.215-71, Evaluation Factor Commitments (OCT 2019); G. 852.232-72, Electronic Submission of Payment Requests (NOV 2018); H. 852.237-75, Key Personnel (OCT 2019); I. 852.242-71, Administrative Contracting Officer (OCT 2020). 10. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Products and Commercial Services (FEB 2024), applies to this acquisition, including the additional FAR clauses cited in the clause: A. 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020); B. 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023); C. 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020); D. 52.204-14, Service Contract Reporting Requirements (OCT 2016); E. 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023); F. 52.204 30, Federal Acquisition Supply Chain Security Act Orders Prohibition. (Dec 2023); G. 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021); H. 52.219-8, Utilization of Small Business Concerns (FEB 2024); I. 52.219-28, Post Award Small Business Program Rerepresentation (FEB 2024); J. 52.222-3, Convict Labor (JUNE 2003); K. 52.222-21, Prohibition of Segregated Facilities (APR 2015); L. 52.222-26, Equal Opportunity (SEPT 2016); M. 52.222-35, Equal Opportunity for Veterans (JUN 2020); N. 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020); O. 52.222-37, Employment Reports on Veterans (JUN 2020); P. 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010); Q. 52.222-50, Combating Trafficking in Persons (NOV 2021); R. 52.222-54, Employment Eligibility Verification (MAY 2022); S. 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021); T. 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024); U. 52.232-33, Payment by Electronic Funds Transfer System for Award Management (OCT 2018); 11. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" (Quoters shall list exception(s) and rationale for the exception(s), if any.)
Background
The Department of Veterans Affairs Office of Patient Care Services’ Health Outcomes Military Exposures (HOME), in partnership with U.S. Defense Centers for Public Health – Aberdeen Toxicology Directorate (DCPH-A/TOX), requires services for a critical project focusing on the hazard assessments of per- and polyfluoroalkyl substances (PFAS).
This initiative arises from the recognition of PFAS's wide range of toxicity concerns, especially for Veterans exposed to these substances in military contexts. The project aims to develop predictive models for adverse health effects associated with PFAS exposure, addressing health concerns related to PFAS exposure among Veterans as part of the PACT Act. This effort is critical in advancing the care and monitoring of Veterans' health in relation to environmental and occupational exposures during military service.
Work Details
The contractor will conduct an extensive review of various data streams, including toxicological, epidemiological, and environmental information. Responsibilities include:
1) Expert peer review of hazard assessments conducted by DCPH-A/TOX;
2) Development of additional hazard assessments as indicated by available data;
3) Identification and refinement of serum/blood points of departure (PODs) for each toxic endpoint where sufficient evidence exists;
4) Employment of advanced physiologically-based pharmacokinetic (PBPK) modeling to predict serum/blood concentrations at these PODs;
5) Use contemporary extrapolation methods when data is insufficient for PBPK modeling;
6) Consideration of relevant models for mixtures due to the occurrence of PFAS as mixtures in environmental contexts. The contractor must have a documented track record in evaluating PFAS toxicology, including experience in developing toxicity-based benchmarks and risk assessment.
Period of Performance
12 months
Place of Performance
Work will be performed at the Contractor’s home office or remotely at the Contractor’s discretion.