Questions and Answers - HT9426-26-Q-E022.docx
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- Solicitation number
- PANDHA-26-P-0000035401
- Issued by
-
Defense Health Agency
About this file
This is a Questions and Answers document for the Structured Product Labeling (SPL) solicitation HT9426-26-Q-E022, issued by the Defense Health Agency's Office of Regulated Activities within the Medical Research and Development Command. The requirement is for end-to-end SPL development services supporting FDA submissions for the DHA's 2 licensed New Drug Application products with up to 5 levels of primary and secondary labeling. This represents a new requirement with no incumbent contractor.
The contract is structured as a firm-fixed price acquisition with offerors required to independently develop their technical approach and staffing plan based on the provided Statement of Work. Normal operations require approximately 3 new SPL submissions annually and 2 updates to existing SPL labels per year, with an estimated surge capacity of 2 parallel submissions. A "Job" constitutes complete end-to-end SPL development including assessment, XML creation, validation, FDA submission via ESG gateway, and post-submission activities. The Government will conduct review and approval of contractor-generated SPLs prior to FDA submission with a standard 5 business-day review cycle. Contractors must provide their own SPL XML authoring tools, records management systems, and configuration management processes, as the Government does not supply these resources. Offerors must submit a completed Organizational Conflict of Interest form and Pricing Attachment 4 with their response, while the NDA form is only required post-award.
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Q&A – HT9425-Q-E022
1: Is there an incumbent providing these services?
No incumbent is currently providing these services for ORA. This solicitation represents a new requirement.
2: Can the government provide a LOE?
The Government is unable to provide a level of effort for the requirement. This is a firm-fixed price acquisition. Offerors are required to independently develop and propose their own technical approach, staffing plan, and associated costs based on the provided SOW and evaluation criteria listed in the solicitation.
3: Do we need to complete and submit the OCI form with the response?
Yes, please return the completed OCI form with your solicitation response.
4: Does the NDA need to be completed at the time of award.
The NDA form only needs to be completed after a contract is awarded.
5: Do we need to complete the pricing table as well in addition to pricing attachment 4.
Completion of attachment 4 pricing sheet will suffice.
6: In the Pricing Template, under BASE PERIOD – Structured Product Labeling (SPL) Generation (PWS Sections 2 & 3), the quantity is listed as 2 and the unit of issue is ‘Job.’ Could the Government please clarify what constitutes a ‘Job’ in this context?
Specifically, does one “Job” represent a complete, end‑to‑end SPL development effort (analysis, drafting, XML creation, validation, QC, and packaging), or another defined unit of work?
The “Job” is specific to the technical preparation and regulatory compliance of the SPL Submission. This is an end-to-end SPL development. This initiates with an assessment of the provided label, creation of content in current SPL XML format, validation, submission of files to the FDA via a valid ESG gateway/portal, and post-submission activities based on FDA feedback.
7a. Could the Government provide the estimated average number of new SPL submission requests generated during normal operations (per day or per month)?
Average SPL submission in normal operations is 3 SPL requests per year.
7b. Could the Government provide an estimate of the average number of existing SPL labels requiring updates during normal operations (per day or per month)?
Average number of existing SPL labels requiring updates is 2 per year.
7c. On average, how many final SPL packages are submitted to FDA per day or per month during normal operations?
Average number of SPL packages submitted is 3 per year
8. Review and Approval Process: Is there a government review and approval process that contractor‑generated SPLs must undergo prior to final submission to FDA?
Yes
If so:
1. Do Government personnel review and approve each SPL before submission? Yes
1. What is the typical review cycle time? 5 business days
9. SPL XML Authoring Tools: Does the Government provide any software tools for creating or editing SPL XML files?
No
10. Records Management / Collaboration Tools: Will contractor personnel have access to a Government‑provided records management or collaboration platform, such as SharePoint or an enterprise workflow management tool?
No
11. Does the Government provide a configuration management tool or repository for SPL artifacts, or should the contractor plan to use its own internal configuration management processes?
The contractor should plan to use its own internal configuration management processes
12. During historical surge periods, what was the maximum number of SPL submission requests generated within a surge window? Understanding historical surge volume will help vendors develop accurate surge pricing and staffing models.
Estimated surge window is 2 parallel SPL submissions
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