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04/11/24: The purpose of Amendment 0001 is to update the Solicitation and Statement of Need with red font changes, and attach the RFQ Q&A. No other changes were made. ---------------------------------... 04/11/24: The purpose of Amendment 0001 is to update the Solicitation and Statement of Need with red font changes, and attach the RFQ Q&A. No other changes were made. ---------------------------------------------- Combined Synopsis/Solicitation Solicitation Number: 75N99224Q00002 Purchase Description: HEROES Data Variables This is a Combined Synopsis/Solicitation Notice for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation/notice; responses/quotes are being requested, further written solicitation will not be issued. This solicitation will be posted to the sam.gov as a Full and Open Competition. The ARPA-H is issuing this combined synopsis/solicitation, 75N99224Q00002, as a Request for Quote using FAR Part 12 Acquisition of Commercial Item, FAR Part 13 Simplified Acquisition Procedures, and Subpart 13.5 Simplified Procedures for Certain Commercial Products and Commercial Services. This is not a small business set-aside; the North American Industrial Classification System (NAICS) code for this procurement is 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), and size standard of 1,000 employees. The Government intends to award a Firm Fixed-Price Commercial Award. The solicitation document and incorporated provisions and clauses are in effect through Federal Acquisition Circular 2024-03 effective February 23, 2024, and Health and Human Services Acquisition Regulation Supplement (HHSAR) via 48 C.F.R. Ch. 3 effective October 1, 2023, respectively. All federal and state laws and regulations are in effect during the term of the contract. DESCRIPTION OF ITEMS/SERVICE: All CLINs F.O.B. Destination. To effectively support the HEROES program's data toolkit, ARPA-H outlines minimal requirements that encompass a comprehensive data variable framework and meticulous data management strategies. For Severe Obstetric Complications (SOC), the requirements align with definitions by CMS, including a broad spectrum of conditions ranging from acute myocardial infarction to ventilation. Additionally, the HEROES program specifies data variables for admissions related to mental health conditions and leaves room for the inclusion of further variables over the term agreement. These datasets should be linked to a de-identified unique patient ID and extend to capture claims or health system encounters 60 days postpartum, diverging from current specifications. The contractor shall provide all items IAW Attachment 3 – Statement of Need. CLIN STRUCTURE: The contractor shall complete Attachment 2 and include shipping cost in the cost line-item cost. CLIN 1001: Severe Obstetric Complications Data Variables Product/Service Code: B529 Product/Service Description: SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA Period of Performance: 08/30/2024 to 08/29/2025 Quantity: 12 Unit of Issue: Month Unit Price: $_____________ Extended Price (Quantity X Unit Price): $________________ CLIN 1002: Atherosclerotic Cardiovascular Disease and Associated 10-Year Risk Scores Data Variable Product/Service Code: B529 Product/Service Description: SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA Period of Performance: 08/30/2024 to 08/29/2025 Quantity: 12 Unit of Issue: Month Unit Price: $_____________ Extended Price (Quantity X Unit Price): $________________ CLIN 1003: Additional Data Variables specific to HEROES program Product/Service Code: B529 Product/Service Description: SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA Period of Performance: 08/30/2024 to 08/29/2025 Quantity: 12 Unit of Issue: Month Unit Price: $_____________ Extended Price (Quantity X Unit Price): $________________ CLIN 2001: Severe Obstetric Complications Data Variables Product/Service Code: B529 Product/Service Description: SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA Period of Performance: 08/30/2025 to 08/29/2026 Quantity: 12 Unit of Issue: Month Unit Price: $_____________ Extended Price (Quantity X Unit Price): $________________ CLIN 2002: Atherosclerotic Cardiovascular Disease and Associated 10-Year Risk Scores Data Variable Product/Service Code: B529 Product/Service Description: SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA Period of Performance: 08/30/2025 to 08/29/2026 Quantity: 12 Unit of Issue: Month Unit Price: $_____________ Extended Price (Quantity X Unit Price): $________________ CLIN 2003: Additional Data Variables specific to HEROES program Product/Service Code: B529 Product/Service Description: SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA Period of Performance: 08/30/2025 to 08/29/2026 Quantity: 12 Unit of Issue: Month Unit Price: $_____________ Extended Price (Quantity X Unit Price): $________________ PLACE OF DELIVERY: Bethesda, MD 20892 DELIVERY DATE(S): Monthly after effective date of the contract. LIST OF ATTACHMENTS: Attachment 1 – Solicitation SF33 Attachment 2 – Continuation Sheet (CLINs) Attachment 3 – Statement of Need Attachment 4 – Applicable Provisions and Clauses Attachment 5 – HEROES Toolkit Data Format Requirements Attachment 6 - RFQ Q&A_Responses_Final QUESTIONS: Questions shall be received no later than Tuesday 09 April 2024 at 4:00 pm (Eastern Daylight Time). Forward responses by e-mail to elaine.wong@arpa-h.gov and mike.smith@arpa-h.gov. Inquiries received after the deadline will not be responded to. QUOTES: Follow ALL directions and requirements within the solicitation. Incomplete submittals may be considered nonresponsive for failure to provide a complete submittal. Quotes in response to this RFQ will be valid for 120 days (unless a different period is proposed by the Vendor). Responses/quotes MUST be received no later than Friday 19 April 2024 at 12:00 am (Eastern Daylight Time). Forward responses by e-mail to acquisitions@arpa.gov. Any quote, modification, or revision of a quote received after the exact time specified in this solicitation shall be determined as late and will not be considered. If a late quote is received before award is made, only the Contracting Officer could make the determination that accepting the late quote would not unduly delay the acquisition, and it was the only quote received. **Only the three lowest quotes deemed technically acceptable will be considered for evaluation for award.** OTHER INFORMATION: Per FAR Subpart 4.1102, offerors are required to be registered in System for Award Management (SAM) at time of submission of quote and the potential awardee must be determined responsible pursuant to FAR 9.104 to be eligible for award. Failure to be actively registered in SAM at the time of submission and be deemed responsible will result in the offer being ineligible for award. Conflict of Interest: If the offeror currently provides support or anticipates providing support to other vendors which may create or represent an actual or potential Organizational Conflict of Interest (OCI), the offeror shall immediately disclose the actual or potential OCI to ARPA-H in accordance with FAR Subpart 9.5. Disclosure may be made via memo on offeror company letterhead and included after the cover letter in the quote for each area impacted. The offeror agrees to disclose information concerning the actual or potential conflict with any quote relating to any work in the contract for the duration of the contract term. All actual or potential OCI situations shall be handled by the Contracting Officer (CO) in accordance with FAR Subpart 9.5. To avoid any potential conflicts of interest, by providing a quote the offeror agrees that it may not restrict the conception, design, or configuration of its analyses, recommendations or findings in connection with this RFQ and any subsequent contract in a manner that will favor any endeavors that are its separate marketing efforts or those of its affiliates, subordinates, or other commercial ventures. Notice to Offeror. The Government reserves the right to cancel this Request for Quote (RFQ), either before or after suspense date. In the event the Government cancels this RFQ, the Government has no obligation to reimburse an offeror for any costs. The contractor shall not request, nor will the Government make, payment for any preliminary measurement, quotes, bids, site visit, time or quotation cost incurred. Interchanges. The Government intends to award a purchase order without interchanges with respective vendors/quoters. The Government, however, reserves the right to conduct interchanges if deemed in its best interest. Under appropriate circumstances, interchanges can be an effective method to improve the Government's evaluation of Offerors' quoted approaches and may reduce acquisition cycle time. Interchanges may be written, email, phone call, etc., or any method which would accurately capture the contemporaneous sharing of information between the Government and the Offerors. Interchanges may also be oral conversations between the Government and the Offerors. Site Visit: A site visit will not be held for this requirement. INSTRUCTIONS TO OFFERORS: Offerors shall comply with FAR 52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (Sep 2023) FAR 52.212-1 is hereby tailored as follows: 1. Any inconsistency between FAR Provision 52.212-1 and the Addendum to FAR 52.212-1 shall be solved by giving precedence to the Addendum to FAR 52.212-1. 2. After receipt of quotes the Government may, with or without notice, negotiate with and, if desired, seek quote revisions from as many or as few quoters as it, in its discretion, deems appropriate. 3. The term “offeror” or “offer” as used in FAR 52.212-1 shall be understood to mean “quoter” and “quote,” respectively. Further, the term “award” shall be understood to describe the Government’s issuance of an order or contract. 4. The Government will consider all quotes that are timely received and will not consider late quotes. Failure of a quote to address any items required in the submission package may make a quote unacceptable and ineligible for award. 5. Paragraph (b) of FAR Provision 52.212-1, Submission of Offers, is amended as follows: 5.1 In addition to the quote submission requirements stated in FAR provision 52.212-1, quoters shall provide the following, as part of the quote submission package, no later than the required time and date for quote submission: 5.1.1 SF33 complete and signed (Attachment 1) 5.1.1.1 Fill in the following blocks: 1, 12, 13, 14 if applicable, 15A/B/C if application, 16, 17, 18 5.1.2 Cover page to include the offeror’s: 5.1.2.1 Company Name and Company Doing Business As (if applicable) 5.1.2.2 Physical Address 5.1.2.3 Cage code and Unique Entity ID 5.1.2.4 Point of Contact 5.1.2.5 Phone number 5.1.2.6 Email address 5.1.2.7 Business Type 5.1.2.7.1 Socio-economic category, if any, as it relates to the NAICS under Purchase description 5.1.2.8 Initial delivery date after award 5.1.2.9 Statement of Understanding of the Performance Work Statement 5.1.3 Firm Fixed Pricing to align with Continuation Sheet CLINs (complete Attachment 2 or equivalent with below information): 5.1.3.1 Price Per Unit 5.1.3.2 Price Per CLIN 5.1.3.3 Total Price 5.1.3.4 Discount Terms (if applicable) 5.1.3.5 Quote Number (if applicable) 5.1.4 Technical Capability 5.1.4.1 Quote must identify the data variable(s) covered under each line item. 5.1.4.2 Quote must include data variable description that reflects the characteristics identified in the statement of need to show that the quality will satisfy the Government’s need. 5.1.4.3 Limit 20 pages for this section. Any quote attachments/exhibits/addendums, etc. count towards the page limitations. (End of Provision) EVALUATION: ADDENDUM TO FAR 52-212-2 EVALUATION—COMMERCIAL ITEMS (Nov 2021) Paragraph (a) is hereby replaced with the following: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Quotes that do not include all requested information in FAR 52.212-1 in 5.1.1 will be considered nonresponsive. Award will be made to the responsible offeror with the lowest price technically acceptable (LPTA) offer. The following factor(s) shall be used to evaluate offers: 1. Technical Capability: Items meet the Government requirement/specifications in the statement of need. Quotes that simply rephrase or restate the Government requirements without convincing rationale to address how the quoter intends to meet the requirement will be deemed unacceptable. If all requested information is not provided or does not meet the requirements identified, the Government will determine the quote to be nonresponsive and no longer considered for award. Information that is contained in pages exceeding the page limit will not be considered. 2. Price: 2.1 The lowest priced quote will be evaluated for technical acceptability first. The Government will evaluate quotes for acceptability but will not rank the quotes by non-price factors. If the Government receives fewer than three (3) quotes, all quotes will be evaluated for Technical Acceptability. If the Government receives more than three (3) quotes, the Government will only select the three (3) lowest priced quotes to evaluate for Technical Acceptability. The Government reserves the right to evaluate additional quotes for technical acceptability if it is in the Government’s best interest to do so. The FAR 52.217-8 extension period shall be evaluated at an amount of 5/12th of the last yearly total evaluated price (i.e., equal to five months of performance). 2.2 Price will be evaluated using the total evaluated price (TEP) on the bottom-line price for the entire effort. A price is reasonable if, in its nature and amount, it does not exceed that which would be incurred by a prudent person in the conduct of competitive business. The Government may use various price analysis techniques and procedures to ensure a fair and reasonable price. Some of those techniques are, but not limited to, comparison of quoted prices received in response to the solicitation and/or comparison of quoted prices with the Independent Government Estimate. Prices must be determined fair and reasonable. 2.3 No additional information from the quoter will be required if the price is based on adequate price competition. In the event adequate price competition does not exist, the Contracting Officer will obtain information from the quoter to the extent required to determine the reasonableness of the offered prices. (End of Provision)