A24 Q_A Consolidated List 75N99225R00005 FINAL.xlsx
XLSX spreadsheet 31 KB Posted
- Solicitation number
- 75N992-25-SN-104
About this file
This document is a consolidated Questions and Answers (Q&A) file for the ARPA-H ADvanced Analysis for Precision Therapy (ADAPT) Contract Research Organization (CRO) Support Services solicitation (75N99225R00005). The solicitation seeks a single-award contract for a CRO to support a complex clinical trial program involving biological testing, data management, regulatory support, and statistical analysis across multiple cancer research sites. Key details include a proposal deadline of April 21, 2025 at 10:00 AM ET, with a planned contract focused on biological testing of patient samples, clinical data management, regulatory submission support, and statistical analysis across approximately 1,700 patients.
The contract involves specific technical requirements including performing multiple genomic and molecular assays such as ctDNA sequencing, whole exome sequencing, and whole transcriptome sequencing, with detailed performance metrics outlined in the attachments. The government will pay using a mix of firm-fixed price and time-and-materials pricing, with a fixed travel budget of $12,950 annually. Optional tasks include clinical site identification and recruitment support. The contract will support an evolutionary trial design with multiple Task Area (TA) performers, and the CRO will be responsible for collecting, deidentifying, and formatting clinical and biological data across multiple trial sites, with an emphasis on near-real-time data transfer and 21 CFR Part 11 compliance.
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Other files
| File | Type | Posted |
|---|---|---|
| A23 Attachment 2 Assay Testing Worksheet.xlsx | XLSX spreadsheet | |
| A23 Attachment 2a Assay Testing Requirements.xlsx | XLSX spreadsheet | |
| A23 75N99225R00005 AMD 0003.pdf | ||
| A23 75N99225R00005 Conformed 041525.pdf | ||
| A23 Attachment 1 Price Template.xlsx | XLSX spreadsheet | |
| A23 75N99225R00005 Conformed 040725.pdf | ||
| A23 75N99225R00005 AMD 0002.pdf | ||
| A23 Attachment ARPA-H-MAI-24-01-03 AMD 02.pdf | ||
| A23 75N99225R00005 Conformed AMD 0001 032825.pdf | ||
| A23 75N99225R00005 AMD 0001.pdf | ||
| A23 75N99225R00002 Final.pdf | ||
| A23 Attachment 1 Price Template.xlsx | XLSX spreadsheet | |
| A23 Attachment 3 HHS Subcontracting Plan Template.docx | DOCX document | |
| A23 Attachment 2a Assay Testing Requirements.xlsx | XLSX spreadsheet | |
| A23 Attachment 2 Assay Testing Worksheet.xlsx | XLSX spreadsheet |
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Sheet1
| Q&A Consolidated 75N99225R00005 | |||||
| Question # | Document | Section | Question | Government Response | |
| 1 | Performance Work Statement | C | Can the Government please provide potential bidders with the referenced Amendment 02 (ARPA-HMNAI-24-01-03, Amendment 02 document) to allow more insight into the requirements? | The Government has added the referenced document to the attachments in SAM.gov. | |
| 2 | SF1449, Section L - Instructions to Offerors | Sol, L | Given that the nature of this work is new, and the level of technical expertise being requested is extremely detailed - will the Government allow a 2-week extension to the deadline to ensure responses are as comprehensive as possible? | The Government granted a 1-week extension on April 7, 2025. The Government is granting an additional extension on April 15, 2025 via Amendment 0003. Proposals will be due at 10:00 AM ET on April 21, 2025. | |
| 3 | SF 1449, Section L - Instructions to Offerors | Factor A | Is the requirement meant to limit past performance to that of the Prime Contractor or is it to limit past performance to only Prime Contractor’s Prime Contracts? | Past Performance has been removed from the solicitation. | |
| 4 | SF 1449, Section L - Instructions to Offerors | Factor A | If the intent is to limit past performance to just Prime Contractor’s Prime Contracts, would the Government accept direct contracts issued by an Federally Funded Research and Development Center as a Prime contract? | Past Performance has been removed from the solicitation. | |
| 5 | SF 1449, Section M - Instructions to Offerors | Factor A | If the Prime contractor is part of a consortium that rotates the Prime role, and has served in the prime role, would their continuing execution of the relevant past performance meet the standard for accepting past performance associated with the continual operation under the related agreement? | Past Performance has been removed from the solicitation. | |
| 6 | SF1449, Section M - Evaluation factors for award | General | Does the government intend to award a contract to a single winner to provide CRO services for all items listed in the SOW? | Concur. In accordance with Amendment 0003, dated April 15, 2025, Section M was revised to clarify the Government intends to award a single-award contract to the responsible contractor that can provide the required services in the PWS. | |
| 7 | SF1449, Section M - Evaluation factors for award | General | Does the government intend to award contracts to multiple winners based on their areas of core competencies? | Non-concur. See answer to Question #6. | |
| 8 | SF1449, Section M - Evaluation factors for award | Factor A | Will the government consider revising the Factor A: Past Performance instructions to allow offerors to submit commercial projects for pharmaceutical companies for which they were the prime contractor or federal government projects for which they were a subcontractor? | Past Performance has been removed from the solicitation. | |
| 9 | SF1449 | General | In document “A23+75N99225R00005+Conformed+AMD+0001+032825”, under Schedule of Supplies/Services - Technical & Administrative Labor - PWS 5.5.1 through 5.5.6 - CLINs 1001, 2001, 3001, 4001, 5001 for “Technical and Administrative Labor” are Firm Fixed Price (FFP). Given the nature of the variability within PWS tasks 5.5.1 – 5.5.6, it will be difficult for Offerors to provide appropriate fixed lot pricing. Will these CLINs be changed to Time and Materials (T&M) to allow more favorable pricing to the Government? | Non-concur for CLINs 1001, 2001, 3001, 4001 and 5001. The Government intends to pay a monthly invoice for the administrative labor on a firm-fixed price basis. Laboratory Testing Services and Travel will be paid on a Time and Material Basis as identified in the Schedule of Supplies/Services. Please refer to the solicitation conformed to Amendment 0003 for revisions to Section L, Instructions to Offerors for Proposal Submission, Volume III: Factor C: Price. | |
| 10 | Price Template | General | In document “A23+Attachment+1+Price+Template” - If there are non-travel ODCs identified in support of PWS 5.5.1 – 5.5.6, where should they be priced? The pricing template allows labor only pricing under CLIN series *001 | Pricing per line item should be reflective of the vendor's price to fully perform the services outlined in the PWS. There is no separate line item for Other Direct Costs (ODC) or Indirect Costs. Section L, Instructions to Offerors for Proposal Submission, Volume III: Factor C: Price has been updated to provide further pricing instructions. | |
| 11 | Performance Work Statement | C | In document “A23+75N99225R00002+Final” under 5.5.2 Task Area 2. Biological Testing of Patient Samples, can the Government indicate if there a specific gene list requested for WES? | There is no specific gene list requested for WES. Industry-standard approaches that comply with the metrics outlined in Attachment 2a, Assay Testing Requirements worksheet are allowable. | |
| 12 | General | General | May offerors propose whole genome sequencing (WGS) as the primary modality for biological testing of patient samples in the ADAPT program, as outlined in Section 5.2.2 of the RFP? | It is the responsibility of the offeror to provide a solution based on the information contained in the solicitation. Please note that proposed solutions should comply with the metrics outlined in Attachment 2a, Assay Testing Requirements worksheet. WGS is an allowable application as long as the minimum requirements of the solicitation are met. | |
| 13 | SF1449, Section L - Instructions to Offerors | Sol, L | Please provide guidance on which volume, and to what level of detail, the Optional Tasks should be addressed | Please review Section L - Instructions to Offerors for Proposal Submission, starting on page 80, for instructions to provide a response to this solicitation. | |
| 14 | SF1449, Section L - Instructions to Offerors | Sol, L | Please confirm Optional tasks should be included in one of the volumes and exclusive from the current page limits | Please review Section L - Instructions to Offerors for Proposal Submission, starting on page 80, for instructions to provide a response to this solicitation. | |
| 15 | Price Template | General | Our proposed lab for 5.5.2 Task Area 2 (Biological Testing of Patient Samples) will require Other Direct Costs (ODCs) for sample shipping, specimen collection supplies, etc., but the Price Template does not allow for the addition of ODCs/pass-through costs. Please confirm if offerors can add ODCs/pass-through costs to the Price Template or whether a revised Price Template can be issued with additional rows. | Pricing per line item should be reflective of the vendor's price to fully perform the services outlined in the PWS. There is no separate line item for Other Direct Costs (ODCs) or Indirect Costs. Section L Volume III Factor C has been updated to provide further pricing instructions. | |
| 16 | Price Template | General | Please check the Total Travel Cost in Row 7, Column 8 of the “Summary” tab in the Pricing Template. The Base Year plus Options 1-4 years ($12,950*5) totals to $64,750, not $51,800. | The Government has revised the template and provided a new version as part of Amendment 0003. | |
| 17 | SF1449, Section L - Instructions to Offerors | Sol, L | Given the size, scope, and complexity of this opportunity and the ADAPT program, would ARPA-H consider a two (2) week extension of the proposal deadline to Friday, April 25th? | The Government granted a 1-week extension on April 7, 2025. The Government is granting an additional extension on April 15, 2025 via Amendment 0003. Proposals will be due at 10:00 AM ET on April 21, 2025. | |
| 18 | Performance Work Statement | General | What is the preferred cloud platform - AWS or Azure? | The Government has no preferred cloud platform. | |
| 19 | General | General | How will the TA2 contractor communicate protocol changes due to tumor evolution to the CRO in real time, and who will manage the adaptation rules centrally (ARPA-H, TA2, or CRO)? | The ADAPT TA2 performer will be responsible for initiating and implementing protocol changes and managing adaptation rules and patient trial arm assignments. This is not an assigned responsbility of the CRO. | |
| 20 | Performance Work Statement | C | For biological assays partially reimbursed by insurance, what are ARPA-H expectations for duplicate payment risk and reporting? | ARPA-H expects the selected vendor to submit only those costs not reimbursed by patient insurance for remuneration under the CRO support contract. Monthly insurance reimbursement reports should, at minimum, identify the number of tests and cost per test that were reimbursed by patient insurance that month. | |
| 21 | Performance Work Statement | C | Could you clarify which deliverable reports need to follow a specified government format? | Please refer to PWS Section 7.0. | |
| 22 | General | General | Please confirm the timeline for awards and award mechanism (e.g., ARPA-H Customer Experience Hub) for the TA1, TA2, and TA3 performers that will be collaborating with the CRO Support Services contractor. | The Government cannot provide a timeline of award for the performer agreements. The Government cannot provide final award mechanisms at this time. | |
| 23 | Performance Work Statement | C | Will TA2 or CRO be responsible for eTMF management/maintenance and regulatory submission to FDA. | The TA2 performer will be responsible for eTMF management, and the CRO will be responsible for providing the regulatory support services described in Task Area 4 of the PWS. | |
| 24 | Performance Work Statement | C | In support of 5.5.8 Task Area 8 Provision of Clinical and Molecular Data, could the Government provide details on the established datasets that are expected to be made available to TA1 performers for early model development? Specifically, what are the expected number and types of datasets, data volume, whether clinical data are in SDTM or another standardized format, the level of standardization for molecular data, and their sources or hosting locations (e.g., dbGaP, at individual clinical or laboratory sites). | The optional task for Provision of Clinical and Molecular Data refers to datasets which the offeror currently can provide immediately for use by the ADAPT program TA1 performers. The Government requires data from patients with lung, breast, or colon cancer. Preferred data types include clinical data types described in 5.5.3.1 and molecular data types including but not limited to those created by the assays described in 5.5.2.10. | |
| 25 | SF 1449 | General | In the absence of a protocol synopsis or draft protocol and with no indication of TA1, TA2, and TA3 contractors, the proposed Firm Fixed Price (FFP) budget type presents considerable risk for CRO Support Services offerors. We suggest that ARPA-H consider a T&M, Cost Plus Incentive Fee (CPIF), or Cost Plus Award Fee (CPAF) contract type. In our experience the T&M, CPIF, or CPAF contract types pair well with the QASP approach to managing this type of clinical study across multiple stakeholders and milestone dependencies. | Pricing per line item should be reflective of the vendor's price to fully perform the services outlined in the PWS. There is no separate line item for Other Direct Costs (ODC) or Indirect Costs. Section L, Instructions to Offerors for Proposal Submission, Volume III: Factor C: Price has been updated to provide further pricing instructions. | |
| 26 | General | General | Are there any restrictions in using Ex US subcontractors | PWS 6.5 has been updated to reflect language in regard to foreign subcontractors. | |
| 27 | General | General | Does the government want the supplier to use their own systems and does not provide access to government systems. | Access to government systems will not be provided to the contractor. | |
| 28 | Performance Work Statement | C | Does ARPA-H place any limitations on subcontracting for labs | Offerors may subcontract to perform tasks described in the PWS. Please note that performance of the assays described in PWS 5.5.2 (paragraph 10) by a single vendor is preferred. | |
| 29 | General | General | Does ARPA-H have any preferences for data management systems? | The government has no preference. | |
| 30 | General | General | Systems and softwares: which analysis tools also the government prefer? SAS or R etc | The government has no preference. | |
| 31 | Performance Work Statement | C | Please confirm the Solicitation is for only the following: A Study Operations and Review. B. Biological Testing of Patient Samples, C. Centralized Clinical and Research Data Management, D. Regulatory Submission Support and FDA Interface Coordination. E.Statistical Analysis and Reporting | Please review Performance Work Statement 5.5, beginning on page 14, for a list of the specific task areas that will need to be performed under this solicitation. Please ensure you are referring to the most recently updated version of the solicitation. | |
| 32 | SF1449, Section L - Instructions to Offerors | Sol, L | What is the appropriate volume for placing the HHS Section 508 Product Assessment Templates? Since these templates often exceed 10 pages, can you confirm that they are excluded from any page limitations? | HHS Section 508 Product Assessment Template is not a proposal submission requirement. Please review Section L - Instructions to Offerors for Proposal Submission, starting on page 80, for instructions to provide a response to this solicitation. | |
| 33 | SF1449, Section L - Instructions to Offerors | Volume: Administrative | What is the appropriate volume for placing the approved FWA from OHRP? | Please include approved FWAs or plans to obtain approved FWA within 30 days of award as part of the administrative volume. | |
| 34 | SF1449 | General | The RFP states that Line Item 1001 - Technical and Administrative Labor - is Firm Fixed Price (FFP). However, we believe it should be Time and Materials (T&M), based on the type and scope of the PWS. The Pricing Template (RFP Attachment 1) contains labor hours and rates in T&M format for those costs, and the Payments Clause for Labor (RFP Section I.(i)1(i.)A, pg. 40) states the following: "The amounts shall be computed by multiplying the appropriate hourly rates prescribed in the contract by the number of direct labor hours performed." That is not FFP, but rather T&M, to which we respectfully request the Line Item 1001 type be revised. | Non-concur for CLINs 1001, 2001, 3001, 4001 and 5001. The Government intends to pay a monthly invoice for the administrative labor on a firm-fixed price basis. Laboratory Testing Services and Travel will be paid on a Time and Material Basis as identified in the Schedule of Supplies/Services. Please refer to Amendment 0003 for revisions to Section L, Instructions to Offerors for Proposal Submission, Volume III: Factor C: Price and to Attachment 1. | |
| 35 | SF1449, Section L - Instructions to Offerors | Sol, L | The Payments Clause states the following for Indirect Costs (Material Handling, Subcontract Administration, etc.): "The | ||
| Government will reimburse the Contractor for indirect costs on a pro-rata basis over the period of contract performance at the following fixed price: None." However, we respectfully submit that applicable indirect costs - including those noted above - are permitted for T&M per FAR 16.601 "in accordance with the contractor's usual accounting procedures consistent with part 31". Please clarify. | Please review L, Instructions to Offerors for Proposal Submission, Volume III: Factor C: Price for updated instructions on how to propose pricing. | ||||
| 36 | SF1449, Section L - Instructions to Offerors | Sol, L | The RFP Payments Clause section on Labor (Paragraph B) references in several instances, "labor qualifications specified in the contract." Please clarify what labor qualifications are being referenced - in which Clause will these be specified, or can they be provided as an amendment to the RFP for offerors' reference? | The Government clarifies that in a Federal Acquisition Regulation (FAR) contract, labor qualifications are usually specified in the prescribed solicitation provisions, contract clauses, and the performance work statement. Contractors are encouraged to thoroughly review the entire solicitation to fully understand the terms and conditions, ensuring they comply with all requirements for doing business with the Government. | |
| 37 | SF1449, Section M - Evaluation factors for award | Sol, M | RFP Amendment added paragraph (d), which states that "ARPA-H support Contractors may access source selection and contract-related information. Support contractors have appropriate NDAs in place to support ARPA-H Activities." We presume that these support contractors are those assisting ARPA-H administratively, not those covered in RFP Section C.6.11 - Associate Contractor Agreement. Please confirm. | Concur. The definitions in PWS Section 6.11, paragraph (1) define the roles specific to the ADAPT program. ARPA-H internal support contractors are prohibited from participating in research and development opportunities as performers. | |
| 38 | Price Template | General | The Price template provides a few uniform cost assumptions (UCAs), e.g. travel dollars and estimated numbers of tests per period. Are there additional UCAs that the Government can provide, which will be helpful to ensure that cost estimates are as accurate as possible? | Pricing per line item should be reflective of the vendor's price to fully perform the services outlined in the PWS. There is no separate line item for Other Direct Costs (ODC) or Indirect Costs. Section L Volume III Factor C has been updated to provide further pricing instructions. | |
| 39 | General | General | The Module Announcement (ARPA-H-MAI-24-01-03, amendment 2), page 12, states "The ADAPT Program Manager team will select a Contract Research Organization (CRO) that is well suited to manage the regulatory affairs, data management, auditing, clinical trial planning, protocol management, site initiation, recruitment support, clinical monitoring, biomarker testing/integration, sample collection and distribution, among other centralized clinical trial components.". Also, section 5.5.4 of the RFP mentions the potential for IDE applications. However, the CRO RFP does not seem to include auditing, site initiation, and clinical monitoring services. Based on the evolutionary trial Appendix A description, FDA is highly likely to require that the study be conducted under an IND or IDE. Therefore, site monitoring, medical monitoring, and SAE assessment would be needed to comply with IND/IDE regulations. Should we include those services and their cost in our response? | The proposed pricing shall be for the Contract Research Organization services and associated terms and conditions included in 75N99225R00005 and its amendments. The R&D solicitation (ARPA-H-MAI-24-01-03, Amendment 2) was provided for informational purposes only. | |
| 40 | Performance Work Statement | C | Page 18, item 4 states that the contractor will "assemble individual subjects' electronic health records". Since electronic health records are usually created and maintained by the treatment sites, could you please provide more details on what the contractor is required to do? | The contractor will collect, collate, deidentify and format clinical and biological assay data into a single database across the multiple trial sites. This language has been added to PWS 5.5.3 paragraph 4 | |
| 41 | Performance Work Statement | C | Page 18, item 4 states that the contractor will "codify key treatment and outcomes data". Does this mean to map them to a controlled vocabulary or "list of values", to convert numerical outcomes into standardized units, or something else? | Codification of key treatment and outcomes data shall include, but is not limited to, mapping to vocabularies/nomenclatures/identifiers or developing and using data standards across the program as well as developing interoperability across the program data and tools. This language has been added to PWS 5.5.3 paragraph 5 in Amendment 0003. | |
| 42 | Performance Work Statement | C | Page 18, item 5 asks for summarization into reports or databases. Are these reports to summarize operational data (i.e., amount of data received, edited, backed-up, etc., in a given timeframe) or clinical data? | These reports are to summarize operational data and provide operational status updates. | |
| 43 | Performance Work Statement | C | Section 5.5.4, page 19, does not mention support for filing or maintaining an IND. Based on the evolutionary trial Appendix A description, FDA is highly likely to require that the study be conducted under an IND. Should we include cost for filing and maintaining one or more INDs or should we assume that none will be needed? | The contractor will not be responsible for Investigational New Drug (IND) filing costs. | |
| 44 | Performance Work Statement | C | The Module Announcement (ARPA-H-MAI-24-01-03, amendment 2), page 12, mentions recruitment support as one of the services that might be provided by a CRO. Section 5.5.5 of the RFP asks for communication links with ARPA-H clinical study sites to share files. Should those communication tools include public-facing information to support recruitment (i.e., study websites)? | The proposed pricing shall be for the Contract Research Organization services and associated terms and conditions included in 75N99225R00005 and its amendments. The R&D solicitation (ARPA-H-MAI-24-01-03, Amendment 2) was provided for informational purposes only. In accordance with 75N99225R00005 PWS Section 5.5.7 is Optional. Recruitment support required of the contractor will be limited to that described in optional task area 7 of the PWS. Support for PWS 5.5.5 item #2 refers to communications between ARPA-H and the contractor, not with the public. | |
| 45 | Performance Work Statement | C | Should we include recruitment costs such as mass media or social media campaigns and development of participant-facing documents? | Recruitment costs required by the contractor to perform optional task area 7 (PWS 5.5.7), item #3 should be included in cost proposals. | |
| 46 | Price Template | General | Should we include costs for central IRB review? | IRB review costs should not be included in cost proposals. | |
| 47 | Performance Work Statement | C | Regarding the optional 5.5.7 task, should the additional sites be limited to the US? | Concur. Clinical sites identified as part of the optional task 5.5.7 should be limited to the U.S. | |
| 48 | Performance Work Statement | C | Will the CRO database or the ADAPT TA3 Performer Data Lake be the official, 21CFR11-compliant database from which FDA reports (clinical study report tables/figures/listings, IND/IDE annual reports tables/figures/listings, individual case safety reports, etc.) will be generated? | The contractor should ensure that their database/systems are 21 CFR Part 11 Compliant. | |
| 49 | Performance Work Statement | C | Section 5.5.3, item 4, asks for evaluation and coding of key information before transfer to the ADAPT TA3 Data Lake. Does ARPA H require or expect the use of automated data extraction and processing pipelines? | While automated data extraction and processing is not a requirement, offerors may incorporate it into their solution to achieve the tasks outlined in the PWS. Timing and ease of transfers in near-real time is required for rapid biomarker development and applications. | |
| 50 | Price Template | General | Regarding the approval of travel and the expected travel costs for the RFP. Please confirm whether we are expected to provide a proposed travel cost without knowing the location of the sites and the potential length of time of each travel visit. | The Government clarifies that Travel has a fixed ceiling per year of performance ($12,950.00). Contractors shall not change the value on Attachment 1. | |
| 51 | Performance Work Statement | C | Site identification is noted for the base year and each option year. Is it expected that one clinical site will be utilized for the entire project or that a new clinical site will be identified after the base year for each option year? | Per solicitation PWS 5.5.2 Task Area 2. Biological Testing of Patient Samples, paragraph 2, the trial will include an anticipated minimum of 33 trial sites identified by the TA2 performers. Solicitation PWS [Optional] 5.5.7 Task Area 7 Clinical Site Identification is included so the contractor may identify additional clinical trial sites to address high patient enrollment on an as-needed basis. | |
| 52 | Performance Work Statement | C | For the data collection systems, will the contractor need to provide access to the agency, or is it expected that the contractor will provide the agency with reports on specific timelines? | The contractor will be required to provide the agency with reports. | |
| 53 | General | General | What is the precise definition of 'assay platform'? Does it refer to the kit, software, instrument, or a combination of these elements? (i.e. p94 “strongly preferred that an IVD testing platform is used.”) | Assay platform refers to the sum total of all components the offeror uses to conduct and report results from a biological assay. This language has been added to PWS 5.5.2 paragraph 10. It is understood that Research Use Only (RUO) assays are not typically considered an IVD. | |
| 54 | Price Template | General | For Attachment 1, Price - Sequencing Test Schedule, is it necessary to include names of personnel, or are titles sufficient to protect employee privacy? | Titles are sufficient for this attachment. Individuals that do not wish to be named on the proposal shall be replaced with "TBD" | |
| 55 | Assay Worksheet | General | For the sequencing coverage requirements (e.g., 100X for WES), please clarify if these refer to 'mean coverage' or 'median coverage'? | The Government clarifies that sequencing coverage requirements in Attachment 2 refer to mean coverage. This attachment has been updated. | |
| 56 | Performance Work Statement | C | Regarding the requirement to provide historical assay performance metrics, including specificity, sensitivity, variability, batch effect, and quality, is it acceptable to utilize vendor specifications for assays where in-house historical data is not available, such | ||
| as cfMeDIP-Seq? Also, please confirm which other assays, if any, require the submission of this data. | The requirement that the Contractor provide data detailing historical assay performance metrics including but not limited to specificity, sensitivity, variability, batch effect, and quality refers to those assays described in 5.5.2 Task Area 2. Biological Testing of Patient Samples, item #10. This may be substituted by vendor specifications for newly developed assays. |
| 57 | Assay Worksheet | General | For the ctDNA methylome sequencing targeted assay, which requires ≥500X coverage across a minimum of 500 genes, is there a specific set of genes that must be included? | There is not a specific set of genes for inclusion. Per Attachment 2, Assay Testing Requirements, higher numbers of genes are preferred. | |
| 58 | Performance Work Statement | C | The PWS states, 'Assays shall include but are not limited to...' Does this statement allow for the inclusion of other Omics assays beyond those specifically listed, provided they align with the project's objectives? | Performance Work Statement Section 5.5.2 paragraph 10 states, "...Assays shall include but are not limited to:..." Offerors may propose a solution based on the information contained in the solicitation. Please note that proposed solutions should comply with the minimum metrics outlined in Attachment 2, Assay Testing Requirements worksheet. The Government reserves the right to request additional assays be incorporated into the tasking throughout the performance of the contract. | |
| 59 | Performance Work Statement | C | In the context of the PWS, PWS 5.5.2 and other sections mention data deliverables such as FASTQ and BAM files, as well as patient-facing clinical reports. Please clarify the specific reporting requirements for each assay type (e.g., whether clinical reports are | ||
| required for all assays or only specific ones). | Contractors should adhere to industry standard approaches for patient-facing reports. All patient-facing reports produced by testing laboratories are required to be transferred to ADAPT TA2 clinical investigators within 4 weeks (required), but within 2 weeks is preferred. RUO assays without clinical reports do not need to submit a clinical report. | ||||
| 60 | Performance Work Statement | C | For the tissue biopsies, can you confirm whether the specimens will be Formalin-Fixed Paraffin-Embedded (FFPE) or fresh frozen? | The Contractor should be prepared for multiple sample collection and handling protocols per the example given in PWS 5.5.2 paragraph 2. | |
| 61 | Performance Work Statement | C | Please confirm the adequacy of an average of five blood draws per patient for performing both ctDNA and ctDNA methylome sequencing. | For the purposes of estimating the total number of biological tests to be performed, it is expected that patients will have, on average, five blood draws each over the course of their participation in the trial, upon which both ctDNA and ctDNA methylome sequencing will be performed. Each individual patient may have more or less than the average. | |
| 62 | Price Template | General | For Attachment 1, Price - Sequencing Test Schedule Tab, should the proposal only list the 'price per test' or the 'total price' (number of tests multiplied by cost per test) in Columns D-H? Cell A9 appears to suggest price per test only, but please confirm. | Attachment 1 Price Template automatically calculates total price. Please only provide "price per test." | |
| 63 | SF1449, Section L - Instructions to Offerors | Sol, L | What is the possibility of an extension to the proposal submission deadline? | The Government granted a 1-week extension on April 7, 2025. The Government is granting an additional extension on April 15, 2025 via Amendment 0003. Proposals will be due at 10:00 AM ET on April 21, 2025. | |
| 64 | General | General | Could you elaborate on any potential change orders and the process those would follow? | The Government does not anticipate any change orders at this time, however, if a change order is needed, it will be applied via bilateral modification of the contract in accordance with FAR 52.212-4(c) Changes. | |
| 65 | SF1449, Section L - Instructions to Offerors | Sol, L | Could you provide further guidance on the expected content and level of detail required for responding to Scenario 2 within the narrative volume of the proposal? | The narrative question (ii) has been revised to provide more clarity. Please see changes made to Section L. | |
| 66 | SF1449, Section L - Instructions to Offerors | Sol, L | In relation to Section K, can you confirm whether providing PDF attachments of all certifications is mandatory, or if having these up to date in our registration in SAM.gov is sufficient? | The solicitation incorporated by reference provision FAR 52.212-1 Instructions to Offerors – Commercial Products or Commercial Services (SEP 2023). In accordance with paragraph (b)(8), offerors must show 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 offeror shall complete electronically). | |
| 67 | Performance Work Statement | C | Section 5.5.5.2 States “Maintain compatibility with standard software used by ARPAH. | ||
| Can you elaborate on the software requirements? | Contractors should maintain up-to-date software to facilitate communication with ARPA-H via electronic mail, and to submit electronic reports, documents, or other deliverables that conform to the file types as noted in the deliverables schedule. | ||||
| 68 | Performance Work Statement | C | What is the expected timeframe for collection of patient laboratory data? | In accordance with the solicitation PWS Section 5.5.2, paragraph 10, the Contractor is expected to be prepared to begin performance of biological assays within 30 days of contract award. An expected total of approximately 1,700 patients may be enrolled over the performance of the contract. | |
| 69 | SF1449, Section L - Instructions to Offerors | Sol, L | What are the two “scenario response” questions? We only see one listed as a question under Instructions to Authors Volume III (i). Are there other questions that need to be addressed and if so, where are these questions? | Please review solicitation Section L, Volume II Factor B (i) and (ii) starting on page 88. | |
| 70 | General | General | Has the TA 2.2 program started to enroll patients? If no, when is the first patient anticipated to enroll? | While the ADAPT trials have not yet commenced, the contractor is expected to be prepared to begin performance of biological assays within 30 days of contract award. | |
| 71 | SF1449, Section L - Instructions to Offerors | Sol, L | Where do we attach our responses to the services requested in sections 5.5.1-5.5.7? | Please review Section L, starting on page 80, for instructions to provide a response to this solicitation. | |
| 72 | Performance Work Statement | C | If all 1700 patients will have ctDNA, ctDNA methylome performed at baseline, why are only 680 subjects having whole exome sequencing and whole transcriptome sequencing performed at baseline? | During their enrollment in the trial, patients will have an average of two tissue biopsies taken, upon which both whole exome sequencing and whole transcriptome sequencing will be performed. (2 biopsies x 2 tests per biopsy (WES and WTS) x 1700 patients = 6800). | |
| 73 | Performance Work Statement | C | When will the remaining 1020 subjects have whole exome sequencing and whole transcriptome sequencing performed? | Whole exome sequencing and whole transcriptome sequencing will be performed on all available tissue biopsies for all patients. During their enrollment in the trial, patients will have an average of two tissue biopsies taken, upon which both whole exome sequencing and whole transcriptome sequencing will be performed. (2 biopsies x 2 tests per biopsy (WES and WTS) x 1700 patients = 6800). | |
| 74 | Performance Work Statement | C | Are in-person meetings required or only suggested? Wouldn’t meeting via Zoom be more time efficient and cost effective? | As stated in PWS 5.5.5, item #1, the contractor shall attend bi-annual ADAPT program meetings in person and prepare and present briefings to ADAPT program performers at these meetings as directed by the ADAPT PM. These meetings may be performed in a virtual format should circumstances necessitate. This language has been added to PWS 5.5.5 paragraph 1. | |
| 75 | Performance Work Statement | C | If in-person meetings are required, how many per year - 2 or 4? | As stated in PWS 5.5.5, item #1, the contractor shall attend bi-annual ADAPT program meetings in person and prepare and present briefings to ADAPT program performers at these meetings as directed by the ADAPT PM. These meetings may be performed in a virtual format should circumstances necessitate. This language has been added to PWS 5.5.5 paragraph 1. | |
| 76 | Price Template | General | In order to budget for travel, where will the meetings be held? | Travel is a fixed amount on this solicitation and should not be changed. |
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