Questions.docx
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- Post-Market Bioequivalence (BE) Studies
- Solicitation number
- FDAFO121683-Amendment
About this file
The file is a Questions and Answers document for a federal contract opportunity for Post-Market Bioequivalence (BE) Studies issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services. The solicitation (FDAFO121683) is a new Indefinite Delivery/Indefinite Quantity (IDIQ) contract that was originally an 8(a) set-aside but was removed from that designation on 04/30/2025 due to no capable 8(a) proposals meeting technical requirements. The opportunity involves conducting bioequivalence studies for generic oral products, specifically focusing on coadministration with acid-reducing agents in healthy volunteers.
Key details include the solicitation being full and open/unrestricted, a reissuance of a previous RFP (No. 75F40124R00023) with minimal changes, and requiring offerors to submit all required elements including past performance references. Attachments include a Sample Task Order Statement of Work (Attachment F) and a Pricing Worksheet (Attachment 1). Offerors are expected to provide a narrative description of their approach to the sample task order requirements, with the technical evaluation involving review of the proposed approach, past performance, and pricing documentation.
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Other files
| File | Type | Posted |
|---|---|---|
| Attachment 1-Price Worksheet.docx | DOCX document | |
| Attachment F - Sample Task Order Statement of Work.docx | DOCX document | |
| Attachment E - Labor Categories Minimum Qualifications.docx | DOCX document | |
| Attachment H - Past Performance Questionnaire.doc | DOC document | |
| Attachment G - Labor Categories Minimum Qualifications Sample Task Order.docx | DOCX document |
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QUESTIONS 121683
Q1: On page 57 of RFP, it states “For evaluation purposes, a Sample Task Order Statement of Work (Attachment F) and a Sample Task Order Pricing Sheet (Attachment A) are attached to this Solicitation.”
A: Attachment A is Attachment 1-Pricing Worksheet. All other documents uploaded
Q2: Page 58 also says: “The offeror shall also provide a narrative description of their approach to the sample task order requirements, “Bioequivalence of generic oral products coadministration with acid-reducing agent (ARA) in Healthy Volunteers” (See Attachment F – Sample Task Order Statement of Work).”
A: Referenced documents uploaded
Q3: Can you confirm if there is an incumbent contractor, or if this is a new program?
A: This is a new IDIQ
Q4. 8.6. Volume IV – Past Performance, Proposal Content Instructions-Please confirm that, since this is a reissuance of RFP No. 75F40124R00023 with only minimal changes, offerors who submitted responses on February 29, 2024, and intend to use the same past performance references, are not required to resubmit their Past Performance Questionnaires.
A: Offerors should submit all required elements, including past performance references
Q5: General - The GovWin posting lists the new RFP as full and open/unrestricted, whereas the original RFP No. 75F40124R00023 identified the requirement as an 8(a) set-aside. We would like to confirm that this opportunity continues to be 8(a) set aside. If not, we request clarification on the factors or considerations that led to the change in market approach and the removal of the 8(a) designation.
A: This solicitation was removed from 8(a) set aside on 04/30/2025 because there were no capable 8(a) proposals received that satisfied the technical requirements.
File details come from the government source that posted it. Updated .