Pre-Solicitation Conference - Questions and Answers .pptx

Centralized Vaccine Distribution Pre-Solicitation Conference Questions and Answers December 13, 2022

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Questions and Answers

Centralized Vaccine Distribution Pre-Solicitation Conference

Question 1 Question:

Would the CDC provide a total provider list w/ licensure to the awarded vendor or would the vendor be responsible for identifying/vetting providers to ensure appropriate licensure is in place?

Answer:

CDC sends provider master data information to the distributor with provider orders. This does not include provider licensure information.

Centralized Vaccine Distribution Pre-Solicitation Conference

Question 2 Question:

Please consider extending the timeline from award to go live for transition activity.

Answer:

A period of up to six months will be available for transition post award.

Question 3 Question: (Background and Purpose) From the time of recommendation from ACIP, what is the onboarding period expected including Receipt, Inventory and Distribution?

Answer: The timing between ACIP recommendation (plus VFC resolution for vaccines used in children) and first receipt of product for distribution varies depending on whether the vaccine is new and when commercial supply is anticipated to be available. Another factor is how the timing fits within CDC's regular vaccine contracting cycles and whether or not CDC needs to create a new contract or modify an existing contract to purchase the vaccine. Based on these factors, timeline to implementation would generally average between 1 and 6 months from ACIP recommendation (plus VFC resolution for vaccines used in children).

Question 4 Question: (Historical Data) Would the CDC consider sharing a breakdown of non-flu vaccination utilization?

Answer: CDC utilizes survey data to monitor vaccination utilization in the US. Information and results from CDC's primary immunization survey, the National Immunization Survey, can be found online at:

https://www.cdc.gov/vaccines/imz-managers/nis/about.html

Question 5 Question: (Repackaged vaccines) Would you please clarify if the request is to break cartons down to vial level or at the case level down to child cartons?

Is the request to break cartons down to vial level or at the case level down to child cartons?

Answer: Routine distribution is done at the carton level. When vaccine is repackaged, cartons are broken down to individual vials.

Question 6 (Repackaging Vaccines) Question: Will the chosen vendor be responsible for managing the transportation of product from Central Depot/Airport to the six USAPI awardees?

Answer: The Distributor is responsible tor managing transportation of product from CDC's centralized vaccine distribution depots to the delivery address(es) for each of the six USAPI awardees. CDC will update Exhibit C in the PWS in the solicitation to reflect the current number of delivery addresses for each of the USAPI awardees.

Question: Do any specific packaging requirements exist?

Answer: Packaging must be qualified to maintain temperature during the transit to the destination where the vaccine will be received and stored.

Question 7 Question: (Frozen Vaccine Option) Can USG provide similar operating/stockpile inventory as stated above (2-8c) for the frozen products?

Answer: Currently, CDC does not stockpile frozen vaccines at its centralized distribution depots. This is subject to change as new frozen vaccines are licensed.

Question 8 (Frozen Vaccine Option) Question: Does the “Average Order Size” refer to the number of lines per order or total quantity of doses?

Answers: "Average Order Size" refers to doses.

Question: Is the “Annual Number of Orders” the average number of POs they generated in the last 5 years?

Answers: "Annual Number of Orders" is the average number of provider orders generated in the last 5 years.

Question: Will these orders be transmitted throughout the day or on a specified schedule, for ex. Monday - Sunday?

Answers: Orders are transmitted throughout the day.

Question 9 Question: (Returns ) Will the selected vendor be responsible for disposing nonviable vaccines returned from providers or vaccine vendors?

Answer: The distributor is responsible for processing vaccines returned from providers and those that expire or spoil on site and shipping these vaccines to the destruction location identified by the manufacturer. The manufacturer is then responsible for destruction/disposal.

Question 10 Question: (Section 1. Receive/store/report on inventory, 1.3) Please provide example instances of special procedures.

Answer: When awardees purchase vaccine from manufacturers or distributors OUTSIDE of the CDC contracts, there are no EDI communications and DSCSA information is received via paper or access to a portal system. In this case, the distributor is required to enter DSCSA information manually and transmit it to CDC electronically.

Question 11

1.12 Participate in routine reconciliation processes with CDC to ensure inventory information in the Contractor IT system remains synchronized with VTrckS, including conducting research to understand and resolve open orders, inventory discrepancies, failed inventory movements, growth/shrinkage, etc. in collaboration with CDC.

Question: Does this need to be an automated process or can it be a periodic reconciliation process?

Answer: Reconciliation is a manual rather than automated process, though there are some reports created by CDC from VTrckS data and distributor data feeds that support the identification of discrepancies. The reconciliation cadence is typically weekly.

Question 12

3.6. Implement a repackaging process to support shipment of less than a package size of certain vaccines specified by CDC when ordered in less than package quantities

Question: Would you please clarify if the request is to break cartons down to vial level or at the case level down to child cartons? Is the request to break cartons down to vial level or at the case level down to child cartons?

Answer: Routine distribution is done at the carton level. When vaccine is repackaged, cartons are broken down to individual vials.

Question 13

3.14. Develop a plan to mitigate vaccine loss during shipment

Question: Will the vendor be able to engage with CDC and/or the manufacturer to review product stability/efficacy if delays are experienced while in transit?

Answer: A temperature excursion is defined as exposure to temperatures outside of the manufacturer's specified cold chain parameters for the vaccine. If vaccine experiences a temperature excursion during shipment (as indicated by the temperature monitoring indicators/devices included in the shipper), the vaccine is deemed non-viable.

Question: Will the vendor be provided with advanced notice by CDC and/or manufacturer indicating the time/temperature that vaccines must adhere to while shipping?

Answer: The temperatures at which the vaccines must be maintained during shipping are available to the vendor via the manufacturer’s package insert and the FDA website.

Question 14

4.3 Ensure provider order shipments maintain cold chain parameters and include high and low temperature indicators to document temperature excursions

4.3.1 Frozen products may include diluent that cannot be frozen

Question: What are the expectations or requirements for shippers (Dry ice sufficient or is -15 to -25 PCM units with temp monitors required?

Answer: The expectation for the shippers is that they are qualified containers and packouts that have been tested to maintain the manufacturer's specified cold chain parameters for the vaccine during transport for a certain amount of time that is sufficient to successfully reach the provider site.

Question: Can dry ice be leveraged for all frozen vaccines, which involves shipping at up to -77c? Or must -15c to -25c (traditional frozen) be maintained for some or all frozen vaccines?

Answer: Of note, dry ice may not be consistent with the manufacturer's specified cold chain parameters for the shipment of certain frozen vaccines.

Question 15

6.4. Ensure vaccine cold chain process/parameters (including vaccine pack-out for shipments) are met and consistent with manufacturer guidance.

Question: For these scenarios, will CDC/and or manufacturer provide the vendor with specific cold chain processes/parameters that each vaccine must adhere to?

Answer: The temperatures at which the vaccines must be maintained during shipping are available to the vendor via the manufacturer’s package insert and the FDA website.

Question 16

9.3 Receive non-viable vaccines sent by providers/awardees and sort/store vaccine to prepare for vaccine returns to manufacturer that will be coordinated by CDC

Question: Will the CDC pay for related expenses for disposing of vaccines or will this be the responsibility of Vendor?

Answer: The distributor is responsible for processing vaccines returned from providers and those that expire or spoil on site and shipping these vaccines to the destruction location identified by the manufacturer. The manufacturer is then responsible for destruction/disposal.

Question 17 We submit the following suggested language revision: 11.1. The Contractor shall insure all inventory in its possession at commercial CDC replacement cost value against all situations that may result in loss of vaccine. Contractor is limited to $100 million annual aggregate loss under this contract. Certificates of insurance or evidence of sufficient self-insurance shall be made available to the CO and COR annually.

Question: Would the CDC assist Contractor in product liability indemnification from the manufacturer?

Answer: CDC does not have a distribution agreement with vaccine manufacturers; instead, we purchase vaccine from the manufacturers in use in the VFC and Section 317 programs. CDC’s vaccine purchase contracts do not require the manufacturer to provide indemnification for patient bodily injury resulting from the vaccines.

However, as part of the routine vaccine program in the US, the National Vaccine Injury Compensation Program is available and provides an alternative to traditional products liability and medical malpractice litigation for persons injured by the receipt of one or more of the standard childhood vaccines. More information about this program is available at: National Vaccine Injury Compensation Program | HRSA. Additionally, during a declared public health emergency, the Public Health Preparedness and Response (PREP) act provides immunity from liability for claims. More information about the PREP Act is available at: Public Readiness and Emergency Preparedness Act (hhs.gov).

Question 18

11.3. The Contractor shall be fully responsible for all CDC & awardee purchased vaccine inventories from the point that they take possession of the vaccine from the manufacture until receipt at the provider’s office.

Question: (11. Liability for routine vaccines, 11.3) How does possession liability impact for six USAPI awardees?

Answer: Liability for vaccine shipments to USAPIs is the same as liability for vaccine to shipments to other jurisdictions.

Question 19

11.3 This determination of vaccine viability will be determined by the vaccine manufacture , and CDC will make additional determination about the use of vaccine that has a shortened shelf life or inability to handle further excursions.

Question: Will advanced notice for vaccine viability be provided by all vaccine manufacturers or will this be on a case by case basis?

Answer: When vaccine stored on site at the centralized distribution depot experiences a temperature excursion, determination of vaccine viability will be determined by the manufacturer on a case by case basis.

Question 20

12. Information and Messaging Specifications Question: Does VTrckS consolidate provider orders or are orders transmitted individually from the provider locations?

Answer: Providers and awardees submit or upload orders into VTrckS and orders are submitted via EDI to the distributor. Individual orders are batched and sent out every 15 minutes.

Of note, most awardee ordering systems create multi-line orders, but some create individual single line orders for each item ordered. Such single line orders are typically consolidated for delivery by the Distributor , CDC does not consolidate the orders

Centralized Vaccine Distribution Pre-Solicitation Conference

Question 21

12. Information and Messaging Specifications

12.1 Map appropriate data fields into applicable EDI message formats to send data to/receive data from CDC’s EDI messaging system; complete internal contractor development/configuration, system testing; participate in end-to-end testing with CDC to cover all EDI transactions and various business scenarios to be used with VTrckS for timeliness, accuracy and completion.

Question: Will the specifications for all required EDI documents be provided ahead of time?

Answer: Yes

Question 22

12. Information and Messaging Specifications

12.3.6. 852 (goods movements, will include an ASN identifier for confirmation of DSCSA data on GR for orders placed on CDC contract)

Question: Is the 852 EDI transaction required?

Answer: Yes

Question 23 Scope of Work

13. Security Requirements, 13.1. 7 Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6) Question: Is a phased approach acceptable?

Answer: No. The agency-wide IPv6 policy requires that all new networked Federal information systems are IPv6-enabled prior to being made operational.

Question 24

13. Security Requirements, 13.10.) a.

10) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

Question: Please further define the way in which PII/PHI would be transmitted.

Answer: PII/PHI data must be encrypted in transmission by using Transport Layer Security (TLS) 1.2/1.3. TLS is often used to encrypt data in transit for transport security, and Secure/Multipurpose Internet Mail Extensions (S/MIME) is used often for email message encryption.

Question 25

13. Security Requirements, 13.8. H.) Records management and Retention The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

Question: What are the expectations on collaboration platforms?

Answer: The content within the PWS applies to all parties associated with the contract.

Question 26

15.17. International Donation Requirements

Total transit timeline for which cold chain must be supported when vaccine is packaged for international destination: 72-120 hours Question: Will the vendor be required to procure a specific shipping system/packout process that can support product temp for 72-120 hours?

Answer: The vendor will not be required to procure any specific unit and has the option to find an available qualified cold chain solution off the shelf.

Question 27

15.17.3.1. Option #1: Delivery to CONUS airport or airbase for further transit Vaccines packaged for international transit and delivered to CONUS airport or airbase for further transit to an international destination by a USG arrangement with a third party. These shipments will incorporate extended pack-outs and will utilize temperature monitoring indicators/devices as described in section 15.17.

Question: Will this extended pack-out be communicated to Vendor by CDC?

Answer: The vendor will not be required to procure any specific unit and has the option to find an available qualified cold chain solution off the shelf.

Question 28

15.17.3.1. Requirements for customs/export will not be the responsibility of the Contractor but will be handled by the USG. If a decision is made to include ancillary kits, appropriately matched ancillary kits will also be shipped to arrive at the airport/air base at the same time as vaccine.

Question: What specific customs/export requirements will exist?

Answer: Requirements for customs/export will not be the responsibility of the Contractor but will be handled by the USG.

Question 29

15.17.5. Liability: Option #1: Delivery to CONUS airport

The Contractor shall have liability for vaccine loss or damage to the US destination point, including temperature excursions.

Question: Will vaccines be repackaged by CDC or will Contractor be expected to package shipments to maintain temperature to align with end mile destination and duration?

Answer: The distributor is expected to package shipments to maintain temperature to align with end mile destination and duration.

Question 30

20. Reports and Data Feeds, 20.1.2. Tables I. - VII.

Multiple references to "excel or similar formats" in Tables I. - V.11 Question: File format is mentioned as “excel or similar formats”. Is a compressed file acceptable for efficiency of delivering and receiving the reports?

Answer: Email Reports should be sent in Excel.

Data feed files should be PIPE delimited, and not compressed and should be sent via an EDI AS2 channel.

Question 31 Question: Will all doses be ready for distribution at the same time (8/1/23), or will they be staggered?

Answer: A period of up to six months will be available for transition post award.

Question 32 Question: Does the CDC plan to make a single award or multiple awards?

Answer: A single award

Question 33 Question: On page 17 Section 7. Stockpiles, is the CDC able to provide an average number of doses over the last five years?

Answer: As noted in the background section, over the past five years, the stockpile reserves held at the centralized distributor have ranged between 1.3M and 2.5M doses per month.

Question 34 Question: What are the temperature requirements for the stockpile? Can the CDC provide a break-down on the temperature requirements for the stockpile?

Answer: Temperature requirements for the stockpile depend on the vaccines included in the stockpile. Vaccines in stockpile shall be stored at the same temperature as they are stored in operating inventory so they can be rotated.

Question 35 Section 14 Question: Do you have a designated window of time for the transition period?

Answer: A period of up to six months will be available for transition post award.

Question 36 Section B – Routine Program – Frozen Option Question: For three types of frozen distribution; Frozen, Store Ultra Cold Ship Ultra Cold, and Store Ultra Cold Ship Refrigerated should there should be three prices as the costs differ?

Answer: Yes, Section B will be updated prior to posting the solicitation.

Question 37 B.1 and C – Scope of Work 15.20 and 15.21 There is a discrepancy in the language between the Section C. Scope of Work Sections 15.20 and 15.21 and Section B.1.

Section B.1 asks for one price, however there are multiple Options listed in 15.20 and 15.21 utilizing Throughput and Volume tiers.

Question: Will Section B.1 be updated to include Option pricing tiers consistent with those listed in Section C.15.20:

Answer: Yes, Section B will be updated prior to posting the solicitation

Question 38 Section 15.20 – Pandemic Option.

Question: Will the government consider subdividing the high through-put tier into two tiers?

Answer: CDC will review the tier structure in 15.20 and make revisions if needed.

Centralized Vaccine Distribution Pre-Solicitation Conference

Question 39 Question:

Can the prime award a fixed fee contract to a sub contractor in CLIN 0003?

Answer:

Please refer to FAR 52.244-2 Alt I, as shown in section I in the draft solicitation.

Centralized Vaccine Distribution Pre-Solicitation Conference

Question 40 Question:

Will the government allow bidders to submit alternate solutions for the pandemic response?

Answer:

Alternate proposals will not be accepted. Offerors shall submit their best approach in a single proposal to address the requirements included in the solicitation.

Centralized Vaccine Distribution Pre-Solicitation Conference

Question 41 Question:

I’m just trying to figure out of the government has a target RFP release date to meet the 6/30/23 award date and also determine if the value is anticipated to be relatively similar to that of the incumbent $1.5B.

Answer:

The CDC plans to release the RFP prior to the end of the calendar year 2022. The contract value will be determined by the volume of vaccines distributed and which options are exercised.

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