Vendor QA for Repacker Solicitation_Final.docx

Vendor Questions & Answers for Solicitation# 36C77026R0004 Repacker Services for National CMOP

1. Would you confirm if this is an entirely new effort or is there an incumbent currently providing these services? If so, would you please provide the incumbent contract details?

This will be a follow-on to contract# 36C77020D0001 awarded to Aphena Pharma Solutions.

2. Regarding labeling, can you please confirm whether the bottle label and cap label images/templates included in the solicitation attachments are the labels that must be affixed to each repackaged bottle (including application of the cap label), and that offerors should not apply their own proprietary labels in place of these VA-required labels?

The labels must meet the requirements as stated in the Performance Work Statement.

3. Are you able to share a sample or redacted task order from the previous CMOP repackaging RFP or confirm whether offerors should rely solely on the task order structure implied in the current solicitation and Performance Work Statement?

Please refer to Sections K, L, and M in the Performance Work Statement.

4. The price schedule references volume-based discounts for quantities up to 50,000 bottles. Can you please confirm whether these quantity ranges are intended solely as pricing breakpoints for application of discounted per-bottle rates and not as a limit on the quantity of bottles that may be ordered under a single task order?

The volume and lot discounts are calculated for every individual delivery order and are for pricing breakpoints.

5. Is the volume estimate below from the solicitation reflecting annual volume or volume over the contract length? Annual

6. Regarding the reporting duties shown below, the charges associated with managing the request are invoiced monthly and currently a task order is issued to cover this request. Will this be added to the pricing schedule for this solicitation? Yes. Please see the updated pricing schedule provided.

7. Does the VA/CMOP currently have an existing, qualified bottle/cap system or designated manufacturer that the Contractor is required to procure for the My HealtheVet (and other VA logo) convertible child-resistant closures or may the Contractor select and use any commercially available bottle/cap system that meets all performance, imprinting, and testing requirements in Sections J.2 and J.3, subject to Contracting Officer approval?

No, the VA/CMOP does not have a designated or required manufacturer for purchasing bottles, caps, and labels. Yes, they all must be commercially available and meet all requirements as stated in the Performance Work Statement.

8. Will existing CPSC child-resistance (16 CFR 1700) and USP moisture/light test reports from the packaging material manufacturer(s) be acceptable as evidence of compliance, provided the bottle/cap configuration used in production matches the tested configuration or must the Contractor perform new third-party testing on the final assembled bottle and cap configuration?

The Contractor shall supply testing data/certification showing that the cap bottle assembly/unit is in compliance with the Consumer Product Safety Commissions (CPSC) current protocol and standards for child resistant effectiveness as per Code of Federal Regulations (CFR) Title 16, Part 1700. (This paragraph does not apply to the bulk up sized bottles, i.e. liter size bottles).

9. Because the Contractor must procure and inventory custom-printed caps with multiple VA logo types and sizes, will the Government provide estimated annual usage volumes by cap size and logo type (e.g., My HealtheVet, other VA logos) to support appropriate inventory planning and to minimize waste and excess stock?

Yes, please see #5 above.

10. Please provide the estimated number of unique oral solid pharmaceutical SKUs (drug name + strength + dosage form) expected to be ordered annually under this contract, based on recent CMOP utilization data.

Please refer to Section P in the Performance Work Statement.

11. Please provide the estimated average and typical range (minimum and maximum) of order quantities per SKU per production batch.

Please refer to Section P in the Performance Work Statement.

12. If available, please also confirm the typical frequency at which repeat orders are placed for the same SKU (e.g., weekly, monthly, quarterly, or as needed).

Please refer to Section P in the Performance Work Statement.

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