QA response.xlsx
XLSX spreadsheet 25 KB Posted
- Solicitation number
- 75F40124R00023
About this file
This document contains questions and answers regarding a solicitation for post-market bioequivalence studies of generic drug products. The solicitation is issued by the Department of Health and Human Services Food and Drug Administration, with questions due by December 22, 2023 and proposals due by January 12, 2024. The studies would be conducted in healthy adult subjects and are intended to compare pharmacokinetic performance of approved generic and reference drug products. Pricing would be determined at the task order level, with the sample task order pricing template indicating a three-year period of performance but not distinguishing pricing escalations year-over-year. Key details include responsibilities for drug procurement, clinical data management systems, adverse event reporting, and publication of results.
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Sheet1
| No. | Page | Section No./Name | Text | Question | Tentative response from ORS |
| 1 | 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. | OAGS Repsonse - Agreed, extend 3 weeks | ||
| 2 | General | Please advise who the incumbent is on the current contract. | This is a new requirement | ||
| 3 | General | Please advise what the total value is on the incumbent contract. | This is a new requirement | ||
| 4 | General | Please advise if the two studies included in this RFP are related. | It is noted that the two studies presented in RFP (page 8-9) are the previous contracting research examples to address the concerns associated with guidance development or post-market surveillance of generic drug products. These projects were conducted and completed by performing their own scope of work. |
Tasks or studies for the current project will be ordered to address different scientific questions in relation to bioequivalence of oral generic products as described in Attachment F - Statement of Work.
| 5 | 10 | RFP 3.4 | In discussion with FDA, perform quality characterization on drug products including but not limited to dissolution and assay of drug substance and related substances in accordance with the United States Pharmacopeia standards if needed. | Please confirm the Contractor is responsible for the characterization of the drug product and what is the expected final deliverable from this task? | The characterization step of the drug product may need to ensure quality assurance of drugs products, reference and generic products, used in the human bioequivalence/pharmacokinetic studies. The contractor should provide sufficient information on the quality of study drug products. |
| Will the lab/lab equipment for the characterization study be identified and/or provided by the government? | FDA does not provide any laboratory equipment when the contractor conducts the required studies. | ||||
| Will Government audit of the lab be required prior to initiation of the characterization study? | FDA's actions such as site inspections or visits may or may not occur prior to initiation of the contracting study. It would be determined depending on the required task and (or) FDA's discretion. | ||||
| 6 | 10 | RFP 3.4 | Submit protocol, informed consent form and any related documents needed for in vivo BE/PK studies to a local Institutional/Independent Review Board (IRB) for review and obtain approval before conducting any clinical studies. | Will any of the studies include pediatrics or special populations requiring additional consent documents and study considerations? | Based on the objective and plan for the project, it is recommended to conduct the studies in healthy adult subjects. Thus, pediatric subjects or special populations are less likely to be included in the studies. Please refer to Attachment F - Statement of Work. |
| 7 | 10 | RFP 3.4 | Develop an appropriate bioanalytical method, submit a validation report, and perform sample analysis including Incurred Sample Reanalysis. Depending on a study, multiple analytes including, but not limited to a metabolite may be needed. FDA’s | Is the contactor responsible for bio sample maintenance, storage and retains? What is the expected retention time? | The contractor is responsible for maintaining and storing samples during the study, which will be described in a contract with FDA for the project. |
The retention time will be determined in discussion with FDA to conform to applicable Good Clinical Practice (GCP) regulations and and Code of Federal Regulations (CFR).
| Will the Contractor receive input/concurrence from the Government on the selection of an appropriate bioanalytical method? | Yes. Please refer to Section 3.4 REQUIREMENT in RFP and Section 4.2 in Attachment F - Statement of Work. | ||||
| 8 | 10 | RFP 3.4 | Procure study drugs as needed. Most BE/PK studies require the procurement of multiple bottles of the same lot. | Are most products domestically produced or will we need to plan for importation? Are there specific batch requirements? Will any products have co-med, rescue meds included as standard of care? Other considerations? | Provided that the study is designed to achieve the current purpose of the project, the study drug products are approved and marketed reference or generic drugs in the U.S. |
As the drug products will be used in the planned bioequivalence/pharmacokinetic in vivo studies, it is preferred to procure each study drug from one same batch.
Co-medication or rescue medicines during the studies can be used as a standard of care procedure or per site's standard operating procedures, at the discretion of an investigator as a health care professional.
It is noted that, based on the objective and plan for the project, the studies would be conducted in healthy adult subjects.
Please refer to Attachment F - Statement of Work.
| 9 | 10 | RFP 3.4 | Conduct clinical studies and monitor and record adverse events through the study in accordance with all applicable regulations/guidance/policies including, but not limited to 45 CFR 46, 21 CFR, and Good Clinical Practice. | Is there a preferred pharmacovigilance system/database? | The contractor may use any reliable and validated system/database for safety monitoring for the studies if it meets all applicable regulations/guidance/policies including GCP regulations and Code of Federal Regulations. Please refer to the Agency's Guidance: Safety Reporting Requirements for INDs and Bioavailability/Bioequivalence Studies. |
| 10 | 10 | RFP 3.4 | Establish and maintain all essential documents. It may include a regulatory submission including, but not limited to Investigational New Drug and Investigational Device Exemption. Ensure all records that are generated during the project are maintained and retained in accordance with all applicable regulations, policies, and guidelines. | Is there a plan to investigate or compare devices, why IDE? | Based on the primary objective of the project, the studies do not intend to investigate or compare devices including IDE. However, some medical devices may be used for assessments (e.g., pharmacodynamic assessment) during the studies. |
| Are the planned studies with a standalone device, a combination product or as a companion diagnostic? | Based on the objective of the project, the studies do not intend to investigate devices or use any companion diagnostics. Please refer to Attachment F - Statement of Work | ||||
| 11 | 11 | RFP 3.4 | Be responsible for subject recruitment, supplies, equipment, and computational software. May need to recruit a patient population. | Depending on the population, may need to utilize multiple center approach to meet recruitment goals? | A multicenter study approach may be utilized to meet recruitment goals depending on the planned study population and design. However, since the current objective of the project is to compare pharmacokinetic performance of drug products in healthy subjects, a single center study would be more feasible and practical to produce reliable data with robust quality control and better study coordination. Please refer to Attachment F - Statement of Work |
| 12 | 11 | RFP 3.4 | Remote site access, direct data entry/capture and/or remote monitoring platform/capability are preferred. | Are there a preferred systems specifications for clinical data base, eTMF, Clinical Trial Management, randomization, etc.? | The contractor may use any reliable and validated system/ database for the studies if it meets all applicable regulations/guidance/policies including GCP regulations and the FDA's Title 21 CFR Part 11. Please refer to the Agency's Guidance: Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations. |
| 13 | 11 | RFP 3.4 | 10) In discussion with FDA, act as an IND and/or IDE holder and assume responsibilities as needed. | Will the Contractor be the Sponsor or the Sponsor’s representative? | An IND/IDE holder will be the contractor if the application is required. |
| 14 | 13 | RFP 3.4 | Submission of IRB 150 calendar days, expected approval 180 calendar days after task order award. | What is the process if there is a delay in approval of IRB submission due to unforeseen circumstances or questions/edits? Will a delay caveat be added to the deliverables table? | The contractor should ensure if the routine review process of IRB (e.g., IRB's SOP or timeline) meets the requirements in relation to IRB submission and approval in RFP. If an unforeseen situation occurs and leads to a delay in IRB's decision which affects the conduct of the study, the contractor should notify FDA. The contractor should also discuss alternative plan and timeline with FDA ahead of time or soon after its occurrence. |
| 15 | 13 | RFP 3.4 | Contractor to submit Protocol and Implementation Plan with the timeline for Government review. | Is the protocol to be authored by the Contractor or the Principal Investigator? | The protocol will be primarily drafted by the contractor. FDA as Sponsor will be involved in development of the study design and protocol. |
| Will the Principal Investigator get appointed by the Government? | The contractor appoints the principal investigator. The contractor should ensure if principal investigator is qualified by education, training, and experience to take responsibilities for the proper conduct of the trial. The qualifications of the principal investigator should also be reviewed and endorsed by IRB (during the review of the protocol) and FDA as the sponsor. Please refer to Section 5.1 Key Personnel in RFP and Attachment G: Labor Categories & Minimum Qualifications for Sample Task Order. | ||||
| 16 | 16 | RFP 3.4 | Scientific manuscripts/publications resulting from work conducted by the Contractor and Government site investigators will be prepared and published according to guidelines agreed upon at study initiation by the investigator team for that study. | Will the authoring (medical writing) of any scientific manuscripts be required to be performed by the Contractor? | Yes. FDA will also participate in and advise on preparation and publication of any manuscript according to guidelines and (or) contracts agreed upon at study initiation by the investigator for that study. Please refer to Section 3.6 of RFP (Page 16). |
| 17 | 72 | RFP 20.3 | General | Please advise if offerors can use Key Personnel experience as a past performance reference. | Offers can include key personnel’s experience that would be potentially crucial to assess their abilities to perform the required tasks. |
| 18 | Attach. A - Pricing for Sample TO | The government only provides a pricing template for the Sample TO. Does the government intend to request IDIQ rates after award? | All pricing will be at the task order level. | ||
| 19 | Attach. A - Pricing for Sample TO | The Sample Task Order (STO) requires a period of performance of 3 years but no distinction for pricing year over year to adjust for escalations or increases in supply or other costs. We understand the Sample TO is just a sample and the government does not intend to award a TO with the contract, but can the government confirm Offerors should assume a static pricing for this evaluation purpose? | You should provide pricing w/ Escalation. | ||
| 20 | Attach. A - Pricing for Sample TO | In order to make a fair assessment of the pricing, would the government please confirm the Project Manager and Contract Manager are full time resources and indicate that the number of hours required for each (e.g., 1880, 1920, etc.)? | These would be bussiness decisions by the vendor. |
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