SOLICITATION NOTICE
A -- FDA Document Services
- Notice Date
- 8/4/2023 12:03:17 PM
- Notice Type
- Combined Synopsis/Solicitation
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25023Q0978
- Response Due
- 8/14/2023 9:00:00 AM
- Archive Date
- 11/12/2023
- Point of Contact
- Kevin Adkins, Contracting Officer, Phone: 317-988-1544, Fax: Dejanee Evans
- E-Mail Address
-
kevin.adkins@va.gov
(kevin.adkins@va.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Awardee
- null
- Description
- Attachment 1: Template for Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 03/15/2023 Revision: 01 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2023-04 (eff. 06/02/2023) This solicitation is set-aside for Small Business The associated North American Industrial Classification System (NAICS) code for this procurement is 541512, with a small business size standard of $34.0 Million The FSC/PSC is AA11 The Ann Arbor Medical Center, 2215 Fuller Road, Ann Arbor, Michigan is seeking to purchase document preparation and assistance services for FDA Pre-Market Approval of an Automated Control of Artificial Lung Systems to Meet Patient Metabolic Needs. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 Principal Consultant 200 HR 0002 Staff Consultant 456 HR Statement of Work: FDA Pre-Market Approval of an Automated Control of Artificial Lung System ID# 506-23-4-1373-0196 General Objectives and Requirements Title of Project Toward FDA Pre-Market Approval of an Automated Control of Artificial Lung Systems to Meet Patient Metabolic Needs Authority for the project Joseph Potkay, PhD Purpose of the project: This project will advance the artificial lung control system we are developing under our current VA RR&D Merit Award ( Automated control of artificial lung systems to meet patient metabolic needs , VA RR&D Merit I01RX003114) toward commercialization. It will ready our system for the FDA approval which is necessary for commercialization and use in humans by generating the necessary FDA documents. Background: The long-term goal of this technology-development project is to improve Veteran rehabilitation from lung disease by engineering the first prosthetic lung systems that automatically respond to the changing needs of the patient. Chronic Obstructive Pulmonary Disease (COPD), an etiology of End Stage Lung Disease (ESLD), affects 5% of the US population, but 16% of Veterans. The only definitive treatment for ESLD is lung transplantation, but the wait list is long, and many patients are not candidates due to age or comorbidities. Mechanical ventilation provides some relief but can damage the lungs and exacerbate the disease. Artificial lung systems can provide respiratory support without the drawback of ventilator-induced injury. Ambulatory artificial lungs have enabled rehabilitation through physical therapy in the ICU and wearable artificial lungs are currently under development. However, no current artificial lung system can respond to the changing respiratory needs of the patient. They thus risk removing too much CO2 during periods of rest or improved lung function (causing hypocapnia and blood alkalosis) or not enough CO2 during activity or poor lung function (causing dyspnea and discomfort). Thus, activity, comfort, and especially physical therapy and rehabilitation are severely limited using current systems. The goal of our Merit study is to develop an automated controller for all artificial lung systems that varies CO2 clearance to meet a patient s moment-to-moment respiratory needs. To date, the controller has been fully designed and specified and individual components and subsystems have been tested. We are nearing completion of the complete system and will begin extensive in vitro testing within the next 1-2 months, followed by animal studies in 2023. The current system represents an expansion in scope of our recent work that developed a portable system to automatically modulate pump-driven air flow through an artificial lung based on exhaust gas CO2 content and tested it in in vitro and acute in vivo studies. This previous system was only applicable for CO2 removal and was not FDA compliant. The current VA Merit study expands and refines this previous work to create a fully integrated smart controller applicable in nearly all artificial lung systems and validate it in benchtop and acute and chronic animal studies. With this Scope of Work, the contractor will generate the necessary documents to ready our Merit system for the FDA approval necessary for commercialization and use in humans. Scope and methodology: During this Scope of Work, the contractor will generate the necessary documents to ready our VA Merit Award system for the FDA approval necessary for commercialization and use in humans. Contractor shall specialize in medical device software and FDA regulatory requirements A detailed timeline and deliverables are provided below. Tasks and Associated Deliverables Description of tasks and associated deliverables Table 1: A timetable for the Statement of Work Specific Aims Year 1 M1 2 3 4 5 6 7 8 9 10 11 12 1. Develop System Requirements Specifications SyRS Meetings with Contractor and VA PI / team ×××× × × × 2. Develop System Interface Communications Descriptions SyAD Meetings with Contractor and VA PI / team ×××× × × × 3. Develop System Architectural Specifications ×××× × × × SyICD Meetings with Contractor and VA PI / team 4. Complete System Risk Management SyRM Meetings with Contractor and VA PI / team ×××× × × × Milestone Complete / Delivery of Requirements Documents Milestones: The System Requirements Specifications, System Architectural Specifications, System Interface Communications, and System Risk Management documents are required by the FDA and will be completed according to the following timeline. Complete System Requirements Specifications (SyRS - Month 3) Complete System Architectural Specifications (SyAD - Month 6) Complete System Interface Communications Descriptions (SyICD - Month 9) Complete System Risk Management (System Risk Analysis and Control) (SyRMP, SyRAR, SyRCM Month 12) Deliverables: Contractor shall use IBM s software DOORS for all engineering requirements management related activities, including generation of the above listed documents. Contractor shall export all files to Microsoft Word and provide them to the PI at their completion. Project Management and Logistics: Dr. Potkay will be responsible for overall project management and for assisting and collaborating with the contractor on preparation for an FDA submission. At the start of each phase of the project, weekly meetings between Dr. Potkay and the Contractor will used to provide the Contractor with the information needed to develop the necessary specifications and documents. As each phase advances, meetings will decrease as the contractor works to implement the plan and each document. The Contractor and Dr. Potkay will communicate via email/phone/videoconferencing as needed in between in person meetings. Reporting requirements: Contractor shall provide copies of all documents to the PI upon completion (see Milestones above). Contractor shall meet with and report to the PI regularly as described in Project Management and Logistics above. The purchase order period of performance is 120 Days from date of award. Place of Performance/Place of Delivery Address: Ann Arbor, MI. Postal Code: 48105 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions and clauses apply to this acquisition: FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (DEC 2022) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (JUN 2023) The following subparagraphs of FAR 52.212-5 are applicable: subparagraph (b)(4),(8), (9),(15), (28), (30), (31), (33), (35), (36), (48), (52), (59),(63). subparagraph (c)(1), (2), (7), (8) Wage Determination No.: 2015-4833 rev 23 applies. FAR Clauses 52.204-13 System for Award Management Maintenance (OCT 2018) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) VAAR Clauses 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (JAN 2023) (DEVIATION) 852.232-72 Electronic Submission of Payment Requests (NOV 2018) 852.235-70 Research Misconduct (DEC 2022) 852.235-71 Protection of Human Subjects (DEC 2022) 852.235-72 Animal Welfare (DEC 2022) 852.235-74 Acknowledgement of Support and Disclaimer (DEC 2022) 852.235-75 Scientific and Technical Reports (DEC 2022) (End of Addendum to 52.212-4) FAR Provisions 52.204-7 System for Award Management (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020) VAAR Provisions 852.209-70 Organizational Conflicts of Interest (OCT 2020) All quoters shall submit the following: Demonstrated Technical capability to complete the requested services of the SOW. Examples of past performance of similar services. All quotes shall be sent by email to kevin.adkins@va.gov Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following are the decision factors: Contractor shall specialize in medical device software and FDA regulatory requirements Ability to provide in person services in the locality. Demonstrated capability in generating the necessary documents (system requirements specification, system interface communications descriptions, system architectural design specifications, system risk analysis and management), advising on architectural/system improvements to increase safety and manage risk, and providing guidance on traceability and system testing to meet FDA requirements. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR. The following provision is incorporated into 52.212-1 as an addendum to this solicitation: FAR 52.212-1 Instructions to Offerors Commercial Products and Commercial Services (Nov 2021) (a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits a quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition Is set aside for small business and has a value above the simplified acquisition threshold; or Uses the HUBZone price evaluation preference regardless of dollar value, unless the quoter waives the price evaluation preference; or Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value. (b) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified. Quotes may be submitted on letterhead stationery, or as otherwise specified in the RFQ. As a minimum, quotes must show (1) The solicitation number; (2) The time specified in the solicitation for receipt of quotations; (3) The name, address, and telephone number of the quoter; A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary; (5) Terms of any express warranty; (6) Price and any discount terms; (7) ""Remit to"" address, if different than mailing address; (8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the quoter shall complete electronically); (9) Acknowledgment Request for Quotation amendments; (10) Past performance will not be considered in simplified acquisition procurements. (11) Quote should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations and certifications, information requested in (1) to (9) and accept the terms and conditions of the solicitation may be excluded from consideration. (c) Period for acceptance of Quotes. The quoter agrees to hold the prices in its quote firm for 30 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation. (d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotes. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender s request and expense, unless they are destroyed during testing. (e) Multiple Quotes. Quoters are encouraged to submit multiple quotes presenting alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each quote submitted will be evaluated separately. (f) Late submissions, revisions, and withdrawals of quotes. (1) Quoters are responsible for submitting quotes so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that quotes are due. (2) Any quotation received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is ""late"" and may not be considered unless it is received before purchase order issuance and the Contracting Officer (CO) determines that accepting the late quotation would not unduly delay the acquisition. (3) If an emergency or unanticipated event interrupts normal Government processes so that quotations cannot be received at the Government office designated for receipt of quotes by the exact time specified in the solicitation, and urgent Government requirements preclude a notice of an extension of the closing date, the time specified for receipt of quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. (g) Issuance of Purchase Order. The Government may issue a purchase order to one or more quoters as identified in the Request for Quote (RFQ). Therefore, the quoter s initial quote should contain the best terms from a price and technical standpoint. However, the Government may reject any or all quotes if such action is in the public s best interest. The Contracting Officer (CO) may issue a purchase order to other than the quoter with the lowest priced quotation. (h) Multiple awards. The Government may issue a purchase order for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations. Unless otherwise provided in the Schedule, quotations may not be submitted for quantities less than those specified. The Government reserves the right to issue a purchase order for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quotation. (1) Availability of requirements documents cited in the solicitation. (i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to- GSA Federal Supply Service Specifications Section Suite 8100 470 East L Enfant Plaza, SW Washington, DC 20407 Telephone (202) 619-8925, Facsimile (202) 619-8978. (ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee. (2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites: (i) ASSIST ( https://assist.dla.mil/online/start/). (ii) Quick Search ( http://quicksearch.dla.mil/). (3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by- (i) Using the ASSIST Shopping Wizard ( https://assist.dla.mil/wizard/index.cfm); (ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or (iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462. (4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance. (j) Unique entity identifier (UEI). Applies to all quotes that exceed the micro-purchase threshold, and quotes at or below the micro-purchase threshold if the solicitation requires the contractor to be registered in the System for Award Management (SAM).) The quoter must enter, in the block with its name and address on the cover page of its quote, the annotation ""Unique Entity Identifier"" followed by the unique entity identifier that identifies the quoters name and address. The quoter also must enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the UEI. The suffix is assigned at the discretion of the quoter to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the quoter does not have a UEI, it should contact the entity designated at www.sam.gov for UEI establishment directly to obtain one. The quoter should indicate that it is a quoter for a Government contract when contacting the entity designated at www.sam.gov for establishing the UEI. (k) [Reserved] (l) Requests for information. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ). However, quoters may request information on purchase order(s) resulting from this solicitation with the CO. ADDENDUM to 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Basis for Award. The Government will issue a purchase order to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical or Quality Past Performance Veterans Involvement Price Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. 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. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following: Technical or Quality: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.> Past Performance: The past performance evaluation will assess the relative risks associated with a quoter s likelihood of success in fulfilling the solicitation s requirements as indicated by the quoter s record of past performance. The past performance evaluation may be based on the contracting officer s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis.> Veterans Involvement: In accordance with Veterans Affairs Acquisition Regulation (VAAR) 852.215-70 (DEVIATION), Service-Disabled Veteran-Owned and Veteran-Owned Small Business (VOSB) Evaluation Factors, the Government will assign evaluation credit for a Quoter (i.e., prime contractor) which is a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a VOSB. To receive credit, an offeror must be registered and verified in Vendor Information Pages (VIP) database at time of quotation submission and at time of award ( https://www.vip.vetbiz.va.gov/) and must meet federal small business size standards for the North American Industry Classification System (NAICS) code assigned to this solicitation. Non-SDVOSB/VOSB quotations that use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation Factor. Quoters must state in their quotations the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be registered and verified in the VetBiz.gov VIP database ( https://www.vip.vetbiz.va.gov/) and must meet federal small business size standards for the NAICS code assigned to this solicitation at time of both quotation submission and at time of award.> Price: The Government will evaluate the price by adding the total of all line item prices. The Total Evaluated Price will be that sum. (End of Provision) 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. Submission of your response shall be received not later than 12PM EDT August 14,2023 at kevin.adkins@va.gov Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Kevin Adkins , kevin.adkins@va.gov
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/23be0132c5a647f9bc851f317305c3d3/view)
- Place of Performance
- Address: Ann Arbor 48105
- Zip Code: 48105
- Zip Code: 48105
- Record
- SN06777252-F 20230806/230804230051 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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