Revised QA responses.xlsx

XLSX spreadsheet 25 KB Posted Feb 9, 2024

Attached to: Post-Market Bioequivalence of Generic Drug Products
Solicitation number: Amendment75F40123R00023
Issued by: Department of Health and Human Services Food and Drug Administration

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Written by GovTribe AI · Feb 9, 2024

This document contains revised questions and answers regarding a solicitation for post-market bioequivalence studies of generic drug products. The solicitation is seeking proposals for conducting clinical pharmacokinetic studies to evaluate generic drug products. Key details include:

The incumbent contract is new without an existing incumbent. Pricing will be determined at the task order level. Studies will involve healthy adult volunteers and may include pediatric or special populations.
Offerors should include key personnel experience in their past performance. The sample task order pricing template requires pricing to include escalation factors. The project manager and contract manager are considered full-time resources but required hours are not specified.
Extensions to the response due date of 3 weeks were agreed to. The contractor is responsible for sample storage and retention for 6 months after bioanalytical report finalization. Protocol submission to IRB is expected within 150 calendar days of task order award with IRB approval anticipated within 180 days.

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Other files

File	Type	Posted
Attachment E - Labor Categories Minimum Qualifications.docx	DOCX document	Feb 21, 2024
Attachment B - FAR 52.212-5-Contract-Terms-and-Conditions (SEP 2023) (Updated).docx	DOCX document	Feb 21, 2024
Attachment G - Labor Categories Minimum Qualifications Sample Task Order.docx	DOCX document	Feb 21, 2024
Attachment H - Past Performance Questionnaire.doc	DOC document	Feb 21, 2024
Attachment D - HHS Class Deviation 2020-02 - Accelerated Payments.pdf	PDF	Feb 21, 2024
Attachment F - Sample Task Order Statement of Work.docx	DOCX document	Feb 21, 2024
Attachment A - Pricing for Sample Task Order.xlsx	XLSX spreadsheet	Feb 21, 2024
RFP.docx	DOCX document	Feb 21, 2024
Attachment C - FAR Deviation 18-01 (Whistleblower Protection-Commercial).pdf	PDF	Feb 21, 2024

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Sheet1

No.	Page	Section No./Name	Text	Question	Response from FDA
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 previously contracted research examples to address the concerns associated with guidance development or post-market surveillance of generic drug products.

New tasks or studies for the contract in this RFP will address similar or different scientific questions in relation to bioequivalence or pharmacokinetics of generic products, and one example is 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. This step may or may not be needed depending on a project. We understand that this in-vitro work may be outside of the contractor's expertese. If it becomes necessary as a part of the contract, FDA will work with the contractor to determine the test requirement and to provide the support. However, the contractor should provide required information on the quality of study drug products as needed in the contract (by itself or through the work with partner/s).
				Will the lab/lab equipment for the characterization study be identified and/or provided by the government?	FDA typically does not provide any laboratory equipment when the contractor conducts the required studies. However, depending on the need and/or circumstances, we would consider various options available, which could potentially include the acquisition of the equipment.
				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?	Section 3.4 REQUIREMENTS in RFP describes type of BE studies that may be needed under this contract. The majority of the studies are anticipated to involve healthy adult volunteers. Although less likely, the need to study pediatric subjects or other special populations requiring additional consent documents cannot be ruled out. The contractor will have a chance to discuss its concerns if any when RFTOP is issued.
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 retension time of six months from the time of bioanalytical report finalization could be assumed for the cost estimation purpose. Depending on a project, the retention time may differ, but it will be specified in RFTOP or a modification may be initiated if the requirement changes during the study.

				Will the Contractor receive input/concurrence from the Government on the selection of an appropriate bioanalytical method?	Yes. Please refer to Section 3.4 REQUIREMENTS in RFP.
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?	For the majority of studies we conducted so far, the study drug products were approved and marketed in the U.S. However, there could be a need to procure the drug products from overseas, and in those cases, the contractor will be notified and the timeline will be adjusted accordingly.

As the drug products will be used in the bioequivalence/pharmacokinetic studies, it is preferred to procure each study drug from one lot. Most studies are anticipated to involve healthy subjects, therefore, it is less likely that study products include co- and/or rescue medications as standard of care. However, depending on a project, another drug product could be a part of study drugs.

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?	At this time, there is no plan to investigate or compare devices, and no need for IDE is identified. However, depending on a project, it may become necessary, and if such a need arises, it will be included in RFTOP or the contractor will be notified to make necessary adjustments if there is a change from RFTOP issurance.
				Are the planned studies with a standalone device, a combination product or as a companion diagnostic?	At this time, the studies do not intend to investigate devices or use any companion diagnostics. There could be a study involving a combination product, and if so, it will be included in RFTOP.
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 study population and design. However, since the studies will be phase I type, pharmacokinetic study in healthy subjects, a single center approach would be more feasible and practical to produce reliable data with robust quality control and better study coordination.
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. It will be included in RFTOP if needed.
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, and adjustment to the timeline will be made accordingly as needed. 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?	Once the study design is finalized in collaboration withh FDA, the protocol will be primarily drafted by the contractor. FDA will be involved in development of the protocol and informed consent form.
				Will the Principal Investigator get appointed by the Government?	The contractor shall propose the principal investigator at the site. The contractor should ensure that the principal investigator is qualified by education, training, license, certificate as needed, and experience to take responsibilities for the proper conduct of the study. The qualifications of the principal investigator should also be reviewed and approved by FDA. 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?	Authoring of the scienific manuscripts by the contractor is not required. During the study, the the authorship will be discussed if the contractor is interested in authoring. Typically, FDA will author scientific manuscripts under this contract, and the contractor is welcomed to collaborate in manuscript preparation. 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.	Offerors can include key personnel’s experience that would be potentially crucial to assess their abilities to perform the required tasks. However, Volume III is meant for the past performance of the offerors as a whole. Lack of past performance will not result in negative evaluation.
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.

File details come from the government source that posted it. Updated Feb 9, 2024.