Vaccine_Distribution_Questions_04042016.pdf

General Questions

1. We would like to inquire about the transportation for this operation. Is transportation in the scope of this RFP?

Would you entertain vendors providing transportation capabilities and pricing as part of our RFP submissions?

If yes, would you be open to providing transportation data so that transportation could be quoted as accurately as possible? We are basing our question on delivery being a part of the solicitation.

The purpose of this solicitation is to award a contract with one entity that will serve as the prime contractor, that will perform all of the requirements within the solicitation. The Contractor may decide to subcontract (as defined in the Federal Acquisition Regulations) with other vendors to carry out specific aspects of the requirements, such as transportation.

2. How much of the storage needs to be refrigerated and frozen “under option”?

Refrigerated: Total refrigerated inventory ranges from 7 million to 15 million doses, depending on time of year, averaging approximately 10.4 million doses annually. This number includes seasonal influenza vaccine (July- June), but does not include stockpile doses. During influenza season last year, average monthly influenza vaccine inventory was approximately 3.1 million doses. [Program Scope of solicitation, Page 31]

In addition, current stockpile reserves held at the centralized distributor are approximately 2.5 million doses.

This may increase by as many as 1 million doses. [Program Scope of solicitation, Page 33]

Frozen: There is not a current contract for distributing frozen product, this is currently handled by the vaccine manufacturer. However, there are approximately 52,000 shipments annually of frozen vaccine, consisting of roughly of a total of 8.2 million doses [Program Scope of Solicitation, Page 32].

3. Is climate controlled storage acceptable for any of the product listed under the VFC program (ancillary supplies, etc.)

The only products in the VFC program are vaccines and all require compliance with cold chain as indicated in the manufacturer package inserts.

4. Of the required storage space; what is the square footage (or pallet) requirement under each storage range?

Based on the vaccine volumes provided above, the Contractor will need to determine the necessary square footage.

5. How does storage demand change based on various options within contract years with respect to square footage (or pallet)?

The Contractor must determine the necessary storage space requirements based on the vaccine volumes provided in Section B.

6. Furthermore, what are the specific temperature range requirements required for each storage type?

Information about temperature range for storing refrigerated and frozen vaccines is available in vaccine-specific manufacturer package inserts available on the FDA website.

7. Will the contractor be required to validate all refrigerated/freezer chambers at designated temperature requirements prior to facility acceptance?

Yes.

8. Provide guidance/clarification on the vendor requirements regarding unrestricted vs. set-aside participation.

The initial notice dated March 15, 2016, listed the solicitation as unrestricted. Subsequent updates, specifically Mod/Amendment dated March 23, 2016, notate a set aside within document, however this is not mentioned within update notes.

This solicitation is being conducted as an unrestricted, full and open competition. Any indication of a set-aside was included in error, and will be corrected on amendment.

9. Provide guidance/clarification on the repackaging requirements prior to shipment for refrigerated vaccines. It is stated that 5% of outbound vaccine product require repackaging in preparation for outbound distribution from contractor.

Repackagable vaccines are vaccines that can be ordered by providers and shipped out by the Distribution Contractor in amounts less than the manufacturer’s package size. Currently, approximately 5% of the vaccines in inventory are available for repackaging if requested. In 2015, the total doses ordered of these repackagable vaccines was approximately 300,000.

Questions Specific to Sections of the Solicitation

1. Section B. Line Items – Given the potential high value of shipments associated with Depot to Depot transfers

(>$50million), does the contractor have liability for product loss during Depot to Depot transfers of vaccines (due to physical damage, temperature excursion, etc)?

2. Section C.14 – With respect to C.11 HSPD-12, our interpretation is the contractor’s facilities would not be considered to be HHS-controlled facilities. Please confirm.

Upon further review and consideration, HSPD-12 will not be applicable to this Solicitation. The clause will be removed on amendment.

3. Section C.14 – Understanding that the contractor’s facilities are not considered to be HHS-controlled facilities and it does not appear the contractor would have access to an HHS controlled information system, the Directive can only apply if/when the contractor must have “access to sensitive HHS data or information.” Could the CDC please identify the data or information within this category so that bidders can scope their compliance obligations?”

Upon further review and consideration, HSPD-12 will not be applicable to this Solicitation. The clause will be removed on amendment.

4. Section D.1 – There appears to be an inconsistency in the RFP related to the quantity of doses of frozen vaccine that are distributed as part of the VFC Program. The quantity listed in Section B Line Items 0006-4006 is 800,000 doses per year while the quantity listed in Section D Program Scope (page 32) states the quantity is roughly 8.2 million doses. Can the CDC clarify the estimated quantity?

Section B should show 8M doses, and will be corrected on amendment.

5. Section D.1.2 – What level of DSCSA compliance is the current contractor providing (ASN electronic or manual, serialization, etc.)?

At this time, data are being manually processed to comply with DSCSA receiving requirements. Plans are currently underway to begin a transition to ASN electronic compliance with DSCSA receiving requirements.

6. Section D.1.10 – Can the government confirm that the influenza vaccine order timeline is 2 business days?

We have updated the Matrix, Section D.19, in the RFP to provide additional information about the timing of routine, priority and influenza vaccine orders.

7. Section D.2.1 – Does the Government require a single tenant/single client standalone facility? Furthermore, clarify the requirement of contingency/secondary facility requirements with respect to region or tertiary requirements.

The Government does not have specific requirements about single tenant/single client standalone facilities. The Government requires that the facility and vaccine storage units are protected from theft, unauthorized access.

The contingency/secondary facility requirement is designed to ensure continuity of operations.

8. Section D.2.3 – Provide clarification on specific insurance liability requirements toward all product maintained by contractor (with respect to products within contractor facilities and within transit to jurisdiction sites). Does “replacement value” represent CDC Cost/Dose for products listed on VFC Price List?

For losses less than 500 doses, Contractor liability shall be reviewed monthly and recovered to the Government quarterly by payment made to the US Treasury, using CDC Contract Prices. However, for losses of vaccine greater than 500 doses, the Government shall determine whether this would be a cost reimbursement or a dose for dose replacement. Dose for dose replacement will occur at the Contractor’s own expense and at commercial prices.

9. Section D.3 – What are the requirements or restrictions within the contractor’s management of transportation providers for distribution of product?

The Government does not have any requirements or restrictions within the contractor’s management of transportation for distribution of product. The distribution of vaccine product must meet the requirements in the Performance Work Statement.

10. Section D.3.2 –Will contractor be required to procure and validate the required outer packaging necessitated with cold chain shipping (shipping supply, temperature monitoring devices, etc.); specific to each product type?

11. Section D.8.6 – Provide clarification on requirements on return transportation of product from various jurisdictions, through no fault of contractor. Will the contractor be required to bear expenses of return transportation and material costs (outside of scenarios listed within 8.7 & 8.8)?

The Contractor bears the expense of all return transportations costs for vaccines returned to their depots, inclusive of Sections D.8.7 and D.8.8.

12. Section D.10.1 & D.10.2 – Provide clarification to the projected number of inbound call activities from providers on any reporting basis (monthly, annually).

In 2015, between 400 and 650 calls or emails per month were received by the centralized distributor’s customer service staff, with approximately 6,000 annually. The number of calls or email varies based on the types of issues and questions that come up each month.

13. Section D.10.1 & D.10.2 – Furthermore, are specific headcount numbers mandated to support customer service functions?

No specific headcount numbers are mandated; however, the Contractor must have sufficient customer service staff to be able to successfully meet the Monthly Customer Service Metrics.

14. Section D.10.1 & D.10.2 – Would standard service hours be considered 8:00 AM CST – 5:00 PM CST, Monday-Friday?

No – at a minimum, standard service hours cover routine business hours (8:00am – 5:00 pm) within all time zones in the continental US as defined in the PWS.

15. Section D.12.1 – Within the 62 jurisdictions supporting the VFC Program, are the approximately 150,000 unique ship-to locations relatively static, or dynamic (meaning will all locations be provided to contractor during an implementation period or be provided throughout course of agreement, as shipment is required)?

For Routine vaccine shipments the locations will be relatively static (47,000 providers, see Scope of Work page 34). However, during a Pandemic the number of shipment locations and the locations themselves can be very different than those for routine distribution and will depend upon the specific details of the pandemic.

16. Section D.18 – What is the standard expiration dating on vaccine product housed by the contractor (1 year, 2 years, etc.)?

This varies based on vaccine manufacturer supply and provider usage of the product.

17. Section E.7.1 – Please clarify the font size to be used in the RFP Proposal. There appear to be conflicting text size requirements referenced on Page 54, Technical Section which instructs to use text “no smaller than an 10-pitch type” and on Page 61 for each evaluation criteria that references “font size 11”.

Font refers to a "typeface" the characters in a fixed font occupy the exact same amount of space. The Pitch, on the other hand, refers to the number of characters printed per inch (measured horizontally). In other words, pitch defines the amount of space between each character. All text used should be no smaller than 10-pitch and font size 11.

18. Section E.7.1 – The CDC requires the offerer to comply with the requirements specified in the PWS. Can the CDC clarify which sections of the Performance Work Statement apply to or are included in the evaluation of the Technical Approach and Understanding of the Requirements for Storage & Distribution?

Technical approach/understanding of the requirements for Storage and Distribution includes all requirements other than the “Distributor Information and Messaging Specifications,” which has its own evaluation criteria.

19. Section E.9 – “Requirements for Certified Cost or Pricing Data and Data other than Certified Cost or Pricing Data” appears to be included in the solicitation by accident. Pursuant to FAR 15.408(l), the clause should be inserted “in solicitations if it is reasonably certain that certified cost or pricing data or data other than certified cost or pricing data will be required.” Certified cost or pricing data is not required because the government is procuring a commercial item and with adequate price competition. FAR 15.403-1(b)(1) and (3). Cost or pricing data is not required because adequate price competition exists. FAR 15.402(a)(2). Can 52.215-20 be removed from the solicitation?

Will remove this clause in an amendment.