Sol_Doc - Amend 0001 - RFP_Attachment_4 RFP QUESTIONS_RESPONSES.xlsx
XLSX spreadsheet 20 KB Posted
- Solicitation number
- 75F40124R00064
About this file
This document is a Request for Proposals (RFP) for a Food and Drug Administration (FDA) Indefinite Delivery-Indefinite Quantity (IDIQ) contract to provide multi-phase clinical studies and laboratory support services. The contract is a 100% small business set-aside with a performance period of 5 years and a contract ceiling of $50 million. The work is divided into two performance areas: (A) Clinical Operations Support and Trial Execution, and (B) Bioanalytical/Biomarker Analysis and Laboratory Support. The prime contractor must have in-house capabilities for performance area A, which will represent the majority of the work. The contractor will be responsible for conducting multiple Phase I clinical trials per year and providing a full range of services to support the trials, as well as laboratory services including bioanalytical, biomarker, and omics analysis. The current incumbent is Spaulding Clinical Research LLC under contract 75F40119D10032. Proposals are due by 9/2/24.
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KTR QUESTIONS AND RESPONSES
| QUESTION # | RFP SECTION | RFP Page(s) | Paragraph(s) | Reference | Question | Answer |
| 1 | RFP Body | - | General Question | What volume of the work is expected over the 5-year period of performance? How many independent Phase 1 studies are expected in each year of the five-year period? | The volume of work will vary depending on work reuired, but the FDA expects one (1) to two (2) Phase 1 studies per year over the potential five (5) year period of performance (POP). | |
| 2 | RFP Body | 5 | REQUIREMENT | “To qualify for award, organizations must have in-house capabilities in Performance Area A” | Can the Government confirm that “organizations” include the prime and subcontractors? | Organization = Prime contractor. Please see the Amendment 0001 updated SOW. To qualify for award, the Prime contractor submitting the proposal must have in-house capabilities (i.e. facilities owned and operated by the prime) for Performance Area A. |
| 3 | RFP Body | 5 | REQUIREMENT | “To qualify for award organizations must have in-house capabilities in Performance Area A” | Can the Government confirm that “organizations” may include a team formed by two or more businesses that form the Contractor Teaming Arrangements? | No, the prime must have adequate facilities in-house to perform Task A requirements as discussed in the solicitation. The solicitation Statement of Work (SOW) has been updated via Amendment 0001 with more specific languauge regarding facility requirements of the Prime. |
| 4 | RFP Body | 5 | REQUIREMENT | “To qualify for award organizations must have in-house capabilities in Performance Area A” | Can the Government confirm that “in-house” refers to the Offeror’s team that may include a prime contractor and sub-contractors? | No; The prime must have adequate facilities in-house to perform Task A requirements as discussed in the solicitation. The solicitation Statement of Work (SOW) has been updated via Amendment 0001 with more specific languauge regarding facility requirements of the Prime. |
| 5 | RFP Body | 10 | OBJECTIVES/SCOPE | “To qualify for award organizations must have in-house capabilities in Performance Area A, which will represent the majority of the work” | Can the Government give an approximate percent work distribution between Performance Area A versus Performance Area B? | The majority (>51%) of the work will be in performace area A, which drives work in performance area B. The Government estimates an 80/20 (Task A/Task B) split between performance areas, but this estimate could vary greatly. |
| 6 | RFP Body | 13 | 4.2 Task 2 – Trial Execution | “The FDA expects the contractor to have adequate facilities for completing task orders applicable under Performance Area A at its own institution.” | Can the Government confirm that “contractor” refers to the prime and subcontractor teams? | No; The prime must have adequate facilities in-house to perform Task A requirements as discussed in the solicitation. The solicitation Statement of Work (SOW) has been updated via Amendment 0001 with more specific languauge regarding facility requirements of the Prime. |
| 7 | RFP Body | 19 | 4.4 Insurance | “The contractor and all collaborating sites participating in the conduct of approved protocols shall provide sufficient malpractice insurance and indemnification for trial related injuries to volunteers” | Can the Government provide guidance related to minimum insurance requirements? | Please see the updated Amendment 0001 SOW: The contractor and all collaborating sites participating in the conduct of approved protocols shall provide malpractice insurance and indemnification for trial related injuries to volunteers. The FDA will not |
provide third party liability insurance.
| 8 | RFP Body | 26 | PLACE OF PERFORMANCE | “Performance Area A shall be carried out at the contractor’s facility.” | If the proposal is being written by prime and subcontractor; does this mean Performance Area A must be performed at prime contractor’s facilities only? | Yes, Performance Area A must be performed at the Prime contractor's facility only. The prime must have adequate facilities in-house to perform the totality of Task A requirements as discussed in the solicitation. The solicitation Statement of Work (SOW) has been updated via Amendment 0001 with more specific languauge regarding facility requirements of the prime. |
| 9 | RFP Body | 137 | L 3.3 Volume II-Factor IV – Past Performance | “A past performance questionnaire (PPQ) should be submitted (when possible) for each of the Past Performance references cited which does not have a recent CPARS report.” | a. Can the Government confirm that “recent” experience is within the last five years? | a. Yes, recent experience is considered to be within the past 5 years per solicitation Section L.3.3. |
| b. Can the Government confirm that if recent CPARS exist, then PPQs are not required? | b. Yes, if CPARS reports exist, a completed Past Performance Questionnaire (PPQ) is not required for a particular Past Performance reference. Please submit a copy of the CPARS report in lieu of the PPQ. | |||||
| 10 | RFP Body | 137 | L 3.3 Volume II-Factor IV – Past Performance/Pricing for Contractor Teaming Arrangements | "Primes may partner with other primes but shall not submit more than one offer as a prime" | Can a small business form a CTA with a large business? | Yes, a small business can team with a large business, however, the small business must perform all Task A requirements in-house, and must perform at least 51% of the contract requirements overall. |
| 11 | Not Provided | Not Provided | Not Provided | Not Provided | Are there any limitations on subcontracting to large businesses under the small business set aside for this RFP? In other RFPs, we have seen specific requirements such as less than 30% of project spending to large suppliers. | As long as the small business prime performs at least 51% of the work, a small business prime may subcontract to large businesses. Please note that the small business prime must have adequate facilities in-house to perform Task A requirements as discussed in the solicitation. The solicitation Statement of Work (SOW) has been updated via Amendment 0001 with more specific languauge regarding facility requirements of the prime. |
| 12 | Objectives/Scope | 10 | RFP | The Contractor shall ensure adequate contracting support is provided to the FDA. This Statement of Work (SOW) has been divided into two (2) Performance Areas: A) Overall Clinical Operations Support and Clinical Trial Execution in Healthy Subjects or Patients and B) Bioanalytical/Biomarker/’Omics’ Analysis and Laboratory Support. To qualify for award, organizations must have in-house capabilities in Performance Area A, which will represent the majority of the work. Organizations may either have in-house or sub- contracting capability for Performance Area B. | Our interpretation of the organization referenced in the RFP includes the teaming entity submitting the proposal (prime and subcontractors). Specifically referencing the language “organizations must have in-house capabilities in Performance Area A”. Please confirm the bidding organization can be composed of a small business and subcontractors. | Please see the answer to Question #10b. |
| 13 | Not Provided | N/A | General | General | We request that the government consider extending the due date of the response by 3 weeks from the time the Q&A’s are released. | The propposal due date will stay as currently stated in the SAM.gov posting of 9/2/24 1500 (ET). The typographical error in the SF1149 has been corrected via Amendment 0001, which inadvertantly indicated that the closing date and time was 8/22/24 1500 (ET). |
| 14 | Not Provided | N/A | General | General | Is there an incumbent currently performing these services, if so please provide the contract number and name of the incumbent. | Yes, Spaulding Clinical Research LLC is the incumbent under FDA contract number 75F40119D10032. |
| 15 | Not Provided | NA | SOL, Att. 2, Wage Determination | References WD 2015-4269 Rev 24 published on 12/26/2023 | Would the government please revise the WD applicable to this opportunity? It is now WD 2015-4269, Rev. 26 published 7/22/2024. | Yes, the solicitation is being updated regarding the wage determination to the most currently published wage determination via Amendment 0001. |
| 16 | Not Provided | Pg 142 | M.2 EVALUATION OF PROPOSALS Factor I | Not Provided | Can the prime subcontract out the clinical component (Phase I units) to a company or companies that has multiple Phase I units in areas of high diversity? Having multiple companies involved would provide capacity in the case of another pandemic, as was mentioned in the RFI. | No, the prime contractor must have adequate facilities in-house to perform Task A requirements as discussed in the solicitation. The solicitation Statement of Work (SOW) has been updated via Amendment 0001 with more specific languauge regarding facility requirements of the prime. |
| 17 | Not Provided | Pg 18 | 4.3.1 Facilities, Equipment and Other Resources 3 | Not Provided | When a company has multiple phase l units in different areas of the country can multiple pharmacies be used? | Yes, multiple sites/pharmacies can be used for the purposes of executing the clinical studies. |
| 18 | Not Provided | Pg 17 | 4.3 Clinical Trial Analysis, Close-Out, and Final Clinical Trial Reporting 1. e. | Not Provided | Will the contractor be responsible for delivering the final data files in CDISC format? | The format of final datasets would depend on the clinical study. A portion of the clinical studies may need final datasets following Clinical Data Interchange Standards Consortium (CDISC) formats. |
| 19 | Not Provided | Pg 22 | 5.2: Deliverables – Task 1 d | Conduct teleconferences and meetings | Does this include in-person Investigator Meetings as required? | Yes, in-person meetings may be needed, though majority of interactions would be virtual. If in-person meeting is needed, the FDA will travel to the site. |
| 20 | Not Provided | Pg 24 | 5.4 Deliverables -Task 4 | Provide Information and Technology System | Does FDA have a preferred CTMS or other system compatibility requirement more specific than those identified in Section 11.2? | The FDA does not have a prefered system. The system is the responsibility of the contractor. |
| 21 | Not Provided | Pg 10 | Section C: Deliverables and Scope | “organizations must have in-house capabilities in Performance Area A” | Does “in-house” mean under the Prime or is subcontractor with LOI and agreement acceptable? | The prime must have adequate facilities in-house to perform Task A requirements as discussed in the solicitation. The solicitation Statement of Work (SOW) has been updated via Amendment 0001 with more specific languauge regarding facility requirements of the Prime. |
| 22 | Not Provided | Pg 9 | Background | Phase I-type clinical trial operations | Can you confirm these programs will be limited to Phase I? | Yes, the programs will be limited to Phase I trials. |
| 23 | Not Provided | Pg 14 | 4.2.1 Protocol Implementation: Compliance and Oversite: f) | DSM | Will organization of a DSMB be in the scope of this project? | No, a Data and Safety Monitoring Board (DSMB) id not anticipated for any of the clinical studies. However, the contractor will need to have access to a local Institutional Review Board (IRB). |
| 24 | Not Provided | Pg 19 | Deliverables | Copies of all relevant SOPS | The program could have upwards of 30+ SOPs and manuals. Please confirm if copies of each is being requested or a TOC? | The contractor is responsible for developing and maintaining all Standard Operating Procedures (SOPs) for clinical studies and bioanalysis under Performance Area A and B. SOPs do not need to be submitted with the proposal and are not part of the evaluation. The contractor who receives the contract will be expected to provide copies of all SOPs relevant to the task orders under the contract for each task order. |
| 25 | Not Provided | Pg 26 | Staffing/Key Personnel | FDA Clearance | Please clarify this requirement | The contractor should provide information regarding the level of FDA clearance (credentials providing access to FDA facilities or equipment), if any, that key personnel currently have. Note that access to FDA facilities or equipment is not anticipated for this contract. |
| 26 | Not Provided | Pg 14 | Task 4.2- Regulatory Compliance | Throughout the process, essential regulatory documents as specified in ICH guideline should be generated and stored in files/folders and be available for monitors and at the end of the studies all essential regulatory documents at the clinical research unit should be placed in the master regulatory file for archiving. | Will the contractor be responsible for the entirety of the TMF? | Yes, the contractor will be responsible for the entirety of the Trial Master File (TMF). |
| 27 | Not Provided | Pg 14 | Task 4.2- Regulatory Compliance | Throughout the process, essential regulatory documents as specified in ICH guideline should be generated and stored in files/folders and be available for monitors and at the end of the studies all essential regulatory documents at the clinical research unit should be placed in the master regulatory file for archiving. | Will the contractor be responsible for clinical monitoring? Will a clinical monitoring plan be required by the contractor? | A clinical monitor from FDA will be assigned and will perform site inspections. The contractor is responsible for conducting the study in in accordance with ethical principles that have their origin in the Declaration of Helsinki, International Council for Harmonisation (ICH) harmonised tripartite guideline E6 (R2): Good |
Clinical Practice, and all applicable laws and regulations, including without limitation, data privacy laws and compliance with appropriate regulations, including human subject research requirements set forth by the Institutional Review Board (IRB).
| 28 | Not Provided | Pg 24 | 5.4.1 Provide Clinical/research Laboratory Facilities | Adequate facilities and equipment for conducting protocol-required tests and assays such as PK and specialty PD assays on blood, plasma, other body fluids and tissues found in both animal species and humans, as applicable and as needed. | Does the government expect any animal experiments to be conducted at the facility, or is this referring only to animal samples that would be provided by the FDA (e.g., the research on the animals itself is not included in this solicitation) | No, there will not be any animal studies. |
| 29 | Not Provided | Pg 3 | Ac | Standard operating procedures (SOPs) | Will the SOPs be provided by the government or need to be developed by the contractor | All SOPs will be provided by the contractor. |
| 30 | Not Provided | Pg 4 | Ac | Quality Control systems | Is a 21 CFR 11 compliant QMS system in place? | A QMS system is the responsibility of the contractor, and is required to be in place. |
| 31 | Not Provided | Pg 6 | Regulatory compliance | FDA submissions | As an IND also comprises CMC and nonclinical sections, who is responsible for the development of these Module 2,3 and 4 sections? Who is the IND holder? | An Investigational New Drug (IND) application is not anticipated to be needed for any of the planned clinical studies. Planned studies would only be for FDA approved products. |
| 32 | Not Provided | Pg 11 | Performance area B | Bioanalytical laboratories | Do the bioanalytical laboratory need to be in the USA or can a global facility be used? | A non-US located laboratory is allowed. Bioanalytical laboratories will have to be able to conduct bioanalysis according to the M10 Bioanalytical Method Validation and Study Sample Analysis guideline. |
| 33 | Not Provided | Pg 13 | C Sample Analysis | Reference standard | Where will the reference standard be sourced from? Purchased or from a CDMO? | Drugs for clinical studies and bioanalysis under Performance Area A and B would need to be purchased by the contractor. |
| 34 | Not Provided | Pg 18 | 10. Key personnel | Key personnel | Need Regulatory strategist | This labor category is not considered to be a Key Personnel labor category required for this contract. |
| 35 | Not Provided | Pg 24 | 5.4.1 Provide Clinical/research Laboratory Facilities | Adequate facilities and equipment for conducting protocol-required tests and assays such as PK and specialty PD assays on blood, plasma, other body fluids and tissues found in both animal species and humans, as applicable and as needed. | Does the government expect any animal experiments to be conducted at the facility, or is this referring only to animal samples that would be provided by the FDA (e.g., the research on the animals itself is not included in this solicitation) | No animal studies will need to be performed. Samples provided by FDA from animal studies may need to be analyzed under Performance Area B. |
| 36 | Not Provided | Page 136 of 145 | L.3.3 Volume II – Factor IV – Past Performance | At least one (1) of the cited past performances shall be an example for which the Offeror was the prime contractor. | This restricts new entities from submitting proposals. Does the Government maintain a list of PRIME contractors that is publicly available so that new entities can establish a network? Our company works exclusively within Industry and only recently started to investigate government opportunities. We have excellent independent clinical trial facilities within our network that would be ideal for this opportunity but none with prior PRIME experience. | The Government cannot penalize a new contractor for not having Past Performance, so this would not restrict new entities from submitting proposals. If a contractor does not have Past Performance, a Neutral rating would be assigned. For those Prime contractors who do have Past Performance references, the Government is requiring that at least one (1) of those references for the Prime contractor is provided in the proposal. Regarding a list of parties available for teaming arrangements, this list can be found on SAM.gov under the synopsis/soliciation post on the left-hand side navigation link titled, "Interested Vendors List." If you do not see the link under "Award Notices" you will need to contact the SAM.gov Helpdesk and ensure that you have the proper roles to view it. |
| 37 | Not Provided | Not Provided | Not Provided | Not Provided | Can the Multi-phase clinical study contract can be performed from any state or is it restricted to certain states/location? | Yes, performance may occur in any state. |
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