Questions and Answers 2.2.2023.docx

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Memorandum

The following questions were received on time by the January 6, 2023 deadline under 75D301-23-R-72522. The answers from the CDC are in blue text below.

1. The over 100-page Solicitation No. 75D301-23-R-72522 (“Solicitation”) was posted on SAM.gov on Friday, December 16, 2022 at 4:26 pm EST. Proposals are currently due by 5:00 pm EST on Monday, January 23, 2023. Subtracting weekends and federal holidays, potential offerors have 23 business days to prepare offers. However, many employees have previously scheduled vacations around the Christmas and New Year holidays. Thus, the actual amount of time available to offerors to prepare a proposal is likely less than 23 business days.

The term of the current vaccines storage and distribution contract runs through July 31, 2023, and includes one 6-month option period, which would extend the term of the contract through January 31, 2024. The awarded value of the current contract (12 month base plus 6 month option) is $1,554,330,184.46. The Solicitation contemplates a potential five year contract – 12 month base year plus four one-year options. Using the current contract’s awarded value, a contract awarded under the Solicitation would be valued in excess of $5 billion.

Based on the above and given the critical services (vaccines inventory/storage and distribution including providing such services during a pandemic) being procured, we respectfully request a one calendar month extension of the current proposal due date to and including February 28, 2023. The additional time will allow offerors sufficient time to prepare competitive proposals including responding to the cost reimbursement CLINs in the Solicitation. A one calendar month extension of the due date for proposals will maximize competition and not prejudice the Government because it has contracted for the services being procured through January 31, 2024.

Answer: See the revised solicitation for the revised due date.

1. Section B, CLINs x002 and x003: CLINs x002 and x003 are CPFF CLINs, but the pricing schedule requests “unit price” and “extended price” for these items, rather than estimated cost and fixed fee. Please clarify how the Government intends offerors to populate these cells.

Answer: See the revised solicitation.

1. Section B: The stated Quantity and Unit for every CLIN is “1 Job.” Please clarify whether the “1 Job” is all work for each CLIN’s Period of Performance, or if the Government intends some other Quantity and Unit. Given that the quantity is specified as “1,” does the Government intend “Unit Price” and “Extended Price” to be identical for each CLIN?

Answer: Propose the maximum based on the pricing proposed in B. The “1 Job” designation is for all of the work housed in that CLIN for that specific period of performance. Yes, the Government does intend the “Unit Price” and “Extended Price” to be identical for each CLIN.

1. The CDC has not provided sufficient information for bidders to determine a reasonable scope for their proposed technical solutions and by extension to provide estimated costs and a fixed fee. To ensure intelligent bidding, and a common apples-to-apples basis for evaluating proposed prices/costs and level of effort, the solicitation must provide a reasonable estimate of quantities. See FAR 16.503(a)(1). While the CDC has provided two levels of weekly throughput and total cumulative volume tiers for all vaccines distributed over a period of performance, there is no information or estimates of how much of each of the four vaccine product categories (i.e., refrigerated; frozen; ultra-cold distributed ultra-cold and ultra-cold shipped refrigerated) are to be used in developing a technical solution, cost structure or a fixed fee. For the CPFF CLINs, in particular, offerors will be unable to bid, much less on a common basis, without knowing this information. For the CPFF CLINs, what is the Government’s estimate of the total number of each of the four product categories (i.e., refrigerated; frozen; ultra-cold distributed ultra-cold and ultra-cold shipped refrigerated).

Answer: We have added more to B.1 to include each of the different volume tiers for CLIN 0003, CLIN 1003, CLIN 2003, CLIN 3003, CLIN 4003. We have added additional and more recent information to the Program Scope section as well as Exhibits B, C, and E. We have also added a new Exhibit F. This is addressed in the revised solicitation.

1. Can the CDC please include the Variation in Estimated Quantity clause in the contract so that the Fixed Fee will be adjusted?

Answer: See the revised solicitation.

1. Section B, Page 6: The solicitation states: “The final quantities for the table above will be added before award.” What “quantities” does the Government mean (the table has cells only for costs, fee, and total CPFF)? When does the Government intend to add such quantities? Also, this table is the only place in the RFP where the lump sum, Fixed Fee is addressed. If the bidders are not to populate this table, where does the CDC expect bidders to propose their Fixed Fees?

Answer: See the revised solicitation.

1. Section B, Page 7: The solicitation states: “Payment is based on actual doses distributed at the unit price within each CLIN.” Please confirm that this statement applies only to the Fixed Price CLINs.

Answer: See the revised solicitation.

1. Section B.1, Page 9: The solicitation requests cost estimates for pandemic transition activities. The first two rows request an estimate to Ramp Down a facility, but the requested cost estimate is on a per dose basis. The last two rows request cost estimates for transferring viable and non-viable inventory, but the requested cost estimate is not on a per dose/kit basis. It appears to us that the CDC has reversed the cost estimates that should be provided on a “per vaccine/ancillary kit basis.” Can the CDC clarify its request? If the per unit pricing for this work is not being altered, can the CDC please provide guidance on how many doses and kits will be in a DC?

Answer: This table was removed. See the revised solicitation. In addition, as noted in PWS Section 15.19, these activities are at no additional or separate cost to the CDC.

1. Section B.1: The price breakdown tables repeatedly ask for “cost” information under FP CLINs and “price” information under CPFF CLINs. Please confirm that the Government is seeking only pricing for the FP CLINs and only cost information (without fee) for the CPFF CLINs.

Answer: See the revised solicitation.

1. The RFP incorporates FAR 52.216-8, which states fee shall be paid as specified in the contract schedule. The solicitation’s schedule, however, does not specify when fee will be paid. On page 62, the solicitation states “[o]rdinarily the fixed fee . . . may be billed in the ratio of incurred costs to total estimated cost as set forth in the contract, with the final 15 percent to be billed on the final invoice or voucher.” Please confirm that fee may be invoiced and will be paid in the ratio of incurred costs to total estimated cost. Similarly, please confirm that the costs will be invoiced and paid as they are incurred.

Answer: See the revised solicitation.

1. PWS 11.6 (Liability for Vaccine Shipments to Provider Sites): The PWS provides several examples of when the contractor is liable for replacing certain orders with temperature excursions or other issues. Please confirm that, under the CPFF CLINs, any such replacement and reshipment costs will be treated as allowable costs to be reimbursed by the Government, and that the liability provisions for replacement and shipment “at no cost to the Government” applies only to the FFP CLINs. Coverage of this cost by the contractor is an extraordinary financial risk, especially in a pandemic. It is hard enough to project the amount of temperature excursions, but impossible for bidders to determine the price of the replacement vaccines. We note that the rumored commercial cost of Pfizer’s Covid-19 vaccine is $300/dose. This means the minimum cost to the contractor of a temperature excursion would be $30,000 and larger shipments could easily approach $500,000 or more. In the context of cost reimbursement work where the contractor’s profit is very limited, this financial risk may make the contract untenable.

Answer: See the revised solicitation.

1. The CDC is procuring commercial items through this contract. FAR 12.207(a) prohibits the agency from using cost-reimbursement type contracts. Will the CDC please change the pandemic CLINs to Time and Materials and Firm, Fixed Price?

Answer: See the revised solicitation.

1. CDCA_L011 General Instructions - The CDC Vaccines for Children program has grown more complex and the RFP requests more information than the 2016 RFP. Yet, the CDC has reduced the limit to just 95 pages for the technical proposal. That is not nearly enough pages to provide an adequate technical response. Can the CDC expand the page limit, remove the page limits by section (i.e., A, B, C, etc.) within the technical proposal and exempt all attachments and exhibits from counting toward the page limit?

Answer: We expanded the page limits for Tab A, B, and C with in the technical proposal. See the revised solicitation.

1. Section B.1 Pricing: For CLINs x001, the CDC requests pricing for refrigerated vaccines based on four Tiers. Can the CDC confirm that the determination of which Tier is applicable excludes distribution of frozen vaccines?

Answer: No - See the revised solicitation.

1. B.1 Pricing: For CLINs x001, the CDC requests pricing for refrigerated vaccines based on four Tiers. However, for the three types of frozen vaccines within CLINs x001, the CDC provides no quantity limits. Can the CDC provide some volume data so that bidders know what they are signing up to perform?

Answer: The updated Section B.1 includes tiers for Frozen and Ultra Cold vaccines.

1. Pg 96. Proposal Instructions: The Government specified .doc and .xls as acceptable formats for electronic files. Current industry standards are .docx and .xlsx extensions with the older versions specified carrying compatibility and security challenges. Please confirm that .docx and .xlsx formats are also acceptable.

Answer: This change is acceptable, and we have updated the solicitation to reflect this change.

1. Solicitation Clauses: Will the government consider incorporating economic price adjustment clauses for the FFP CLINs?

Answer: See the revised solicitation.

1. B.1 Pricing / C.15.20 & 15.21 Pandemic Throughput and Volumes, Page 39: The table in C.15.20 outlines eight different scenarios based on volume tier and throughput (Moderate vs. High). Section C.15.21 talks about how the price for pandemic distribution could change based on where in the 15.20 table the final distribution volume lands. However, Section B.1 only requests pricing for a single price per dose for Moderate throughput and a single price per dose for High throughput. So the requested pricing is not consistent with Table 15.20 or the process outlined in 15.21. Please clarify whether bidders are to propose different prices for the various pandemic volumes. Also, if 15.20 and 15.21 do impact an offerors pricing, can the CDC provide more guidance on how 15.21 will be applied with products subject to four different temperature ranges?

Answer: Updated the Table in 15.20 as well as included additional scenarios in Section B.1 to align with the Table in 15.20.

1. Section 15.22: The CDC requests bidders to indicate the number of depots necessary to support the various volumes and throughputs set forth in Table 15.20. Table 15.20 does not specify the products being distributed. Can the CDC confirm that its their intent for bidders to specify the number of depots necessary for each of the four different product categories?

Answer: We have updated the table in 15.20 to reflect the different product categories. Yes - CDC’s intent for the bidder to specify the number of depots necessary to support all of the scenarios in table 15.20 and we have added additional language to 15.22 to clarify.

1. C.15.22 & Section M, Factor 3 – Price/Cost: In Section 15.22 the CDC specifies that the Facility Startup CLINs may not include any expenses other than “actual facility start-up costs.” The directions for evaluation factor 3 also expressly prohibit the distribution pricing from including recovery of facility start-up costs, training, IT, materials, travel, overhead, etc. Consequently, the CDC has made “training, IT, materials, travel, overhead, etc.” costs unallowable costs as they are not to be included in either the distribution or facility CLINs. We ask that the CDC reconsider its treatment of these costs. Further, to the extent some costs will be deemed unallowable by virtue of the contract, can the CDC provide greater specificity than the use of “etc.” in describing those costs?

Answer: The costs will be covered under FFP in the applicable CLINs.

1. Section G, CDCA_G01101 Contractor Billing Instructions for Cost-Type Contracts (Mar 2022), Page 60: Will the Contractor be required to submit invoices for the FFP CLINs (x001) in the same format, or will there be an equivalent provision / instruction for FFP CLINs?

Answer: See the revised solicitation.

1. Section L, General Instructions, Business Proposal, Page 97: The instructions state: “The business proposal shall consist of all pertinent pricing information and other information requested below in section E.8 Business Proposal Instructions. All shall be based on the price per dose, which includes distribution costs, stockpile and storage costs, and depot transfer costs. Include a price breakdown that includes the sub-pricing elements that make up the price per dose and supporting documentation.” Section E.8 does not appear in the RFP. Can the CDC provide an updated reference? Also, can the CDC provide examples what would be considered a “sub-pricing element” that should be separately listed in the price breakdown.

Answer: See the revised solicitation. The revised language will read: “The business proposal shall consist of all pertinent pricing information and other information requested below in the Business Proposal Instructions.”

1. Section L, Business Proposal Instructions, Page 98: Does the entire proposal need to follow the FAR Table 15-2 instructions / format, or just the cover sheet?

Answer: See the revised solicitation.

1. Section L, Business Proposal Instructions, Page 98: Please confirm if cost data is required for all CLINs on the contract, including the commercial FFP CLINs x001 Answer: Cost and pricing data is not required for commercial items. See the revised solicitation.

1. Section L, Business Proposal Instructions, Page 98: The instructions mention that contractors should provide a completed Section G – Indirect Rate Tables. Can you confirm that these are the provisional billing rates per CDC42.0003 (page 63)?

Answer: See the revised solicitation.

1. RFP Section M: The subsection entitled “Performance Standards” requests the completion and inclusion of the two matrixes contained in PWS 15.16 and 21, but there is no indication In Sections L or M where these completed tables are to be furnished in offeror proposals. Would the Government consider having these included as proposal attachments with no page limitations, as the matrixes consume several pages and offerors would merely be furnishing completed copies of them Answer: The “Performance Standards” tables in the PWS can be added as attachments in your proposal and are not subject to the page limit.

1. PWS Sections 11 “Liability for Routine Vaccines,” Section 13, “Security Requirements,” and 16 through 20 primarily mandate acknowledgement and contractual compliance (although some contain pieces of information that may need to be considered in some way in technical and management solution content). Would the Government provide further guidance concerning how offerors should address these sections in their proposals—e.g., just confirm it will comply—and where (as non page-counted Attachments)? This question arises given the length of these sections and the page limitations of the Technical Proposal sections.

Answer: Acknowledgement of compliance for these sections is needed in the proposal.

1. CDCA-L011 General Instructions: To improve the clarity and readability of graphics, especially for those graphics that are larger and more complex and contain extensive notation, would the Government consider allowing use of a sans serif font such as Arial, Arial Narrow or Calibri?

Answer: Those fonts are allowed.

1. Pandemic International Pricing: In the Pandemic International Donations CLIN 004, 1004, 2004, 3004 & 4004, what do Options 4.1 and 4.2 relate to?

Answer: The table in B.1. has been corrected and it now matches with the PWS section 15.17.3.

1. Which portions of the contract would CDC consider unbundling as a Small Business and/or a VA/SBA verified Service Disabled Veteran Owned Small Business Set Aside?

Answer: This contract requirement cannot be separated. This is not a small business set-aside opportunity, although the prime contractor is encouraged to have sub-contractors that are small businesses.

1. We are respectfully requesting that the CDC consider more equitable opportunities for small businesses to perform as Prime Contractors. Which portions of the contract would CDC consider unbundling as a Small Business and/or Service-Disabled Veteran Owned Small Business Set-Aside (VA/SBA Verified)?

(1) Break out, or set-aside the coverage service areas into separate, smaller geographic areas (Attachment J.1 Awardees)

(2) Break out, or set-aside the USAPI’s for a separate distribution contract (Exhibit C)

(3) Break out, or set-aside the processing of non-viable vaccines for return to the manufacturer or to an appropriate destruction/disposition company (Section 9, 9.1-9.7)

(4) Break out, or set-aside the Stockpile portion of the contract (Section 7, Stockpiles 7.1-7.3)

(5) Break out, or set-aside the requirement for processing and handling of International Donations (Section 15.17)

(6) The frozen vaccine shipments are made directly by the manufacturer under the existing contract, although it includes an option for frozen vaccine distribution. Will the CDC consider unbundling this portion of distribution as a function to be performed by a Small Business, and/or an SDVOSB, as a set-aside?

Answer: This contract requirement cannot be separated. This is not a small business set-aside opportunity, although the prime contractor is encouraged to have sub-contractors that are small businesses.

1. Reference: Page 13, Program Scope Inventory/Non-flu, Flu, Stockpile.

31. Dose per pallet. Pallet size (dimensions and weight) Answer: Dose per pallet and pallet size varies by vaccine.

31. Can pallets be stacked. If so, how high?

Answer: This is dependent on the recommendations of the vaccine manufacture

31. Are pallets required to be stored on racks?

Answer: No

31. Is floor storage acceptable?

Answer: Yes

1. Reference: Page 14, section 2.1/continuity of operations

32. Will CDC assist in obtaining the necessary licenses to help the contractor comply with state/federal regs necessary to distribute to CDC’s 62 Awardees from all depots?

Answer: Obtaining the necessary licenses is the responsibility of the distributor.

1. Reference: Page 15, section 1.6/Inspection, Breakdown, Product Rotation

33. What inspection, breakdown, and batch/lot procedures are required?

Answer: Examples of required procedures include:

· Ensuring the Packing List complies with DSCSA

· Ensuring the Packing List matches what was received

· Ensuring there is no visible damage.

· Ensuring product dating matches CDC requirements

· Ensuring there were no temperature excursions during shipment to the depot

1. Reference: Page 16, section 3.5/2 to 8 Requirements

a. Does the statement “meet manufacturer guidance” equate to cGMP/GDP standards?

Answer: Vaccine guidance as provided in the manufacturers’ product package insert

1. Reference: Page 17, section 3.14/Labeling

35. Who provides labeling?

Answer: The Distributor provides the labeling for shipping

1. Reference: Page 17, section 4.12/FDA Registrations

36. Does the contractor need to carry all 62 awardees states/territories?

Answer: Yes – for all depots

1. Reference: Page 17, section 4.16/Plan to mitigate loss

a. Is this referring to proper SOPs?

Answer: The contractor should describe their approach to mitigating vaccine loss during shipment in the proposal.

1. Reference: Page 19, section 7/Stockpiles

38. What are the stockpile quantities? Pallet count?

Answer: Stockpile inventory: Over the past five years, the stockpile reserves held at the centralized distributor have ranged between 1.3M and 2.5M doses per month.

Dose per pallet varies by vaccine

1. Reference: Page 30, section 14.2/Start-up plan

39. Is this a formal business plan to execute the contract?

Answer: The Start-up plan is proposed by the contractor.

1. Reference: Page 51, Exhibit A-Awardees

40. Is the contractor required to delivery directly to approximately 41,000 providers?

Answer: Yes

1. Reference: Page 58, section F.1/Performance Period

41. Does the start commence exactly on Aug 1, 2023? Can the performance ramp up over a period of 3-6 months?

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

1. Reference: General Transportation Questions

42. Are shipments transported LTL (less than load) or full container?

Answer: Shipments are required to be delivered directly to all participating providers, how transportation is carried out is the responsibility of the Contractor.

42. What are the transportation lanes for full load shipments?

Answer: Shipments are required to be delivered directly to all participating providers, how transportation is carried out is the responsibility of the Contractor.

42. Dimensions/weight and geographic service area(s)?

Answer: Shipments are required to be delivered directly to all participating providers, how transportation is carried out is the responsibility of the Contractor.

Geographic service areas are detailed in Exhibit A

42. Frequency & volume of shipments? On-demand?

Answer: Shipments are to respond to orders received from the participating providers according to the timelines specified in the Metrics (Section 21 and 15)

42. Consistent shipments?

Answer: Shipments are to respond to orders received from the participating providers according to the timelines specified in the Metrics (Section 21 and 15)

42. What level of reporting is required?

(deviation reporting-how specific: pallet by pallet? Truck/container as a whole?)

Answer: Details about reporting can be found in Section 20

42. *how do we account for cost increases?

Answer: Price increases are accounting for in the contractor’s business proposal.

1. Reference: Distribution Questions

43. Does this contract just require the storing and logistics of vaccines?

Answer: A summary of the requirements can be found in the PWS.

43. Are we required to officially take custody or ownership of products?

Answer: Contractor has custody of the product, but the Government maintains the ownership.

43. Are we re-selling products?

Answer: No

1. Reference: CDCA_L011 GENERAL INSTRUCTIONS (NEGOTIATED) (JAN 2000), Date Response Due: 1/23/2023 at 5:00 PM EST, Pg. 96, "Date Issued: 12/16/2022

44. CDCA_L011 GENERAL INSTRUCTIONS (NEGOTIATED) (JAN 2000), Date Response Due: 1/23/2023 at 5:00 PM EST Answer: The solicitation response date was revised. See the revised solicitation.

1. Reference: PWS 1.1, Pg. 14, In the PWS 1.1 it says, maintain at least 2 depots for vaccine storage and distribution. There’s no mention of number of Pandemic Facilities, this could be performed out of the vaccine storage and distribution facilities but not clear. In 2.1., it says, for continuity of operations purposes, a minimum of two depots located in 2 different geographically distinct locations must be used.

45. How many facilities are being utilized in the existing contract?

Answer: 2 for Routine and originally for the Pandemic Option it was 4 however now it is 2 for Pandemic.

1. Reference: Pg. 13 – 14, All data tables that includes Orders, Frozen vaccines, Returns, and Customer Service

46. Please provide all the data in the past 5 years since to account for 2+ years of that timeframe with suspected fluctuations due to the COVID-19 pandemic.

Answer: Information in the Program Scope section includes data from 2017-2021 for Orders, Frozen vaccine, Returns and Customer Service. In addition, Exhibits B and E have been updated with additional data that goes through 2022. We have also added Exhibit F.

1. Reference: Section H - CDCA_H009, Pg. 64, The key personnel cited below are considered essential to the work performed under the contract. Pursuant to the terms of HHSAR Clause 352.237-75, Key Personnel, the Contractor shall not replace or divert any of these individuals without the written consent of the Contracting Officer.

47. In the current contract, how many key personnel positions are on the roster?

Answer: Key personnel are proposed by each offeror.

1. Reference: 11. Liability for routine vaccines, Pg. 19, 11.1 - 11.6

48. Would you consider that the replacement cost of damaged inventory be “CDC replacement cost” as opposed to “commercial CDC replacement cost.”

Answer: In the event that the loss of vaccine is greater than 500 doses for one particular product, per month, it would then be up to the discretion of the Government as to whether this would be a cost reimbursement or a dose for dose replacement. Doses for dose replacement will occur at the Contractor’s own expense and at commercial prices.

1. Reference: 11. Liability for routine vaccines, Pg. 19, 11.1 - 11.6

49. Would you consider an annual cap on our liability for inventory loss to be $100M annual aggregate?

Answer: There is not an annual cap on the distributor’s liability for inventory loss.

1. Reference: 20. Reports and Data Feeds, 20.1.2 Tables I. - V11, Pg. 40 – 46, Tables I. - V11

50. What is the size limit (MB’s) on the receiving mailbox?

Answer: Where files are too large for email they may need to be compressed

1. Reference: 20. Reports and Data Feeds, 20.1.2 Tables I. - V11, Pg. 40 – 46, Tables I. - V11

51. Does “excel or similar format” include .CSV?

Answer: Email Reports should be sent in Excel.

1. Reference: 20. Reports and Data Feeds, 20.1.2 Tables I. - V11, Pg. 40 – 46, Tables I. - V11

52. Is EDI AS2 an acceptable alternative to email delivery for reports that are too large to send via email?

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.

1. Reference: 20. Reports and Data Feeds, 20.1.2 Tables I. - V11, Pg. 40 – 46, Tables I. - V11

53. For the requirements of SLA reports to be received by 8:00 AM that will contain data as of Midnight EST, will this expectation be standard across all time zones?

Answer: Yes.

1. Reference: Section 12. Information and Messaging Specifications, Pg. 21 – 22, 12.1 - 12.8

54. Are we sending “all data – products, orders, shipments” or only certain NDC to CDC elements in the feeds/reports?

Answer: All NDCs must be included in the feeds/reports sent to CDC.

1. Reference: Section 12. Information and Messaging Specifications, Pg. 21 – 22, 12.1 - 12.8

55. Please clarify what data elements are required in the 860, for example, will the data be used in a sales order?

Answer: The 860 does use some of the data elements from the original sales order.

55. What is the timing expectation of the transaction in relation to when the original order was sent?

Answer: 860 can be sent at any time after the original order was sent.

1. Reference: Section 12. Information and Messaging Specifications, Pg. 21 – 22, 12.1 - 12.8

56. Please describe how the CDC will receive material numbers, etc. for order without an 832 or catalog type file.

Answer: Material numbers are not sent via EDI. NDCs are used as material numbers in all EDI exchanges.

1. Reference: 12. Information and Messaging Specifications, 12.1, Pg. 21 – 22, 12.1 Map appropriate data fields into applicable EDI message formats to send data to/receive data from CDC's EDi messaging system.

57. Will the specifications for all required EDI documents be provided ahead of time? Please provide the EDI specifications and a copy of the EDI implementation guide.

Answer: Yes, Implementation guides for implementing the EDI messages will be provided.

1. Reference: 12. Information and Messaging Specifications, 12.3.2, Pg. 21, 12.3.2. 850 (sales orders; return sales orders; purchase order; return purchase order)

58. Please explain the difference between a sales order and purchase order for the 850.

Answer: The Sales order is used to notify the distributor of the details related to the items that are to be shipped to the provider (Product, Quantities, Ship to address etc).

The Purchase order is used to notify the distributor of the products that will be arriving at the distributor from the manufacturer. The original PO is sent to the manufacturer and a copy of the PO is sent to the distributor as reference.

1. Reference: Background and Purpose, Pg. 11, Following licensure, new vaccines are regularly added to the federal contracts based on ACIP recommendations. In addition to VFC and Section 317 funds, state, and local funds are used to purchase vaccines for children, adolescents, and adults not served by the federal programs.

59. Is the awarded vendor expected to verify each provider site for appropriate licensure and maintenance necessary to distribute pharmaceuticals or does eligibility flow down from the CDCs provider verification process?

Answer: Provider eligibility to order and receive vaccine is determined by CDC and Awardees

1. Reference: RFP Section B.1 Price Breakdown, Pandemic Transition Activities, Pg. 7, B.1 Price Breakdown – table

60. This is the only Price Breakdown section that only includes “Cost Estimate” without “(Price per dose).” Was this intentional?

If so, please explain why “(Price per dose)” was not included.

Answer: This piece of the table was removed. See the revised solicitation.

1. CDCA_G01101 CONTRACTOR BILLING INSTRUCTIONS FOR COST-TYPE CONTRACTS (MAR 2022), Pg. 60, The Contractor shall submit a detailed breakout of costs and supporting backup information and shall place the following signed Contractor Certification on each invoice/voucher submitted under this contract:

I certify that this voucher reflects (fill in Contractor’s name) request for reimbursement of allowable and allocable costs incurred in specific performance of work authorized under Contract (fill in contract number)/Task (fill-in task order number, if applicable), and that these costs are true and accurate to the best of my knowledge and belief.

61. Please confirm this clause only applies if the Government exercises the cost plus, Pandemic option (e.g., CLINs 0002 and 0003) in the contract. In other words, for all firm fixed price CLINs, the awardee is only required to comply with FAR 32.905 Payment documentation and process.

Please confirm that, to the extent this clause applies, it only applies to the cost plus CLINs portion of a contractor’s invoices and not CLINs invoiced on a fixed price basis (e.g., CLIN 0002).

Answer: Please see the revised solicitation.

1. Reference: CDCA_G020 APPLICABLE SERVICE CONTRACT LABOR STANDARDS WAGES (JUL 2017), Pg. 63, The referenced Wage Determination, No. dated specifies hourly rates of wages and fringe benefits that shall be paid to covered employees performing work required under this contract. These rates have been determined by the Secretary of Labor in accordance with the provisions of the Service Contract Labor Standards statute. (See FAR 52.222-41, incorporated by reference in Section I.)

62. Given that the contractor will be required to distribute vaccines to approximately 41,000 providers located in all 50 States, will CDC obtain a National Wage Determination from the Department of Labor covering the distribution services to be provided?

Answer: Yes, wage determinations will be included in the final awarded contract.

1. Reference: CDC42.0003 BILLING RATES (MAY 2015), Pg. 63, Sections (a) - (e)

63. Please confirm this clause is only applicable if the Government exercises the cost plus, Pandemic option (e.g., CLINs 0002 and 0003) in the contract.

Answer: Please see the revised solicitation.

1. Reference: CDCA_H009 KEY PERSONNEL (JAN 2021), Pg. 64, The key personnel cited below are considered essential to the work performed under the contract. Pursuant to the terms of HHSAR Clause 352.237-75, Key Personnel, the Contractor shall not replace or divert any of these individuals without the written consent of the Contracting Officer.

64. Can the proposed Key Personnel be employees of an offeror’s subcontractor?

Answer: The Government is contracting with the Prime contractor, not the sub-contractor.

1. Reference: CDC0_L015 BUSINESS PROPOSAL INSTRUCTIONS, COST REIMBURSEMENT (MAY 2020), (d) Accounting System, Pg. 98, In the event you do not have a Government approved accounting system and/or have never had a Government cost reimbursement contract, the following is required (include major subcontracts) to be submitted with your proposal: Description of your present accounting system and any changes contemplated as a result of your proposal;

Make-up or basis for the indirect cost rate(s) you propose in response to this RFP;

Current financial statement (balance sheet and/or profit and loss statement for the last two years).

65. Please confirm that an offeror’s Annual Reports filed with the SEC for the last two years satisfies the “Current financial statement (balance sheet and/or profit and loss statement for the last two years)” requirement.

Answer: See the revised solicitation.

1. Reference: CDC0_L015 BUSINESS PROPOSAL INSTRUCTIONS, COST REIMBURSEMENT (MAY 2020), (c) Cost Data Information, (4) Subcontracted Items, Pg. 98, (4) Subcontracted Items: Conduct price analyses of all subcontractor proposals. Conduct cost analyses for all cost reimbursement type subcontracts. Include these analyses as part of your own cost submissions for subcontracts (see FAR Subpart 44.2 for information required to support a request for subcontract consent);

66. Please clarify if only subcontractor price and / or cost analyses are required for submission in conjunction with an offeror’s proposal or are all of the consent criteria contained at FAR Subpart 44.2 required for submission as well.

Answer: See the revised solicitation.

1. Reference: CDC0_L015 BUSINESS PROPOSAL INSTRUCTIONS, COST REIMBURSEMENT (MAY 2020), (f) Other Administrative Data, Pg. 99, Your proposal must stipulate that it is predicated upon all the terms and conditions of this RFP. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt by the Government;

67. A Certificate of Current Cost or Pricing Data (see FAR 15.406-2) shall be submitted prior to award if requested by the Contracting Officer. As CLIN 0001 is to be awarded on a commercial item basis and therefore exempt from Truthful Cost or Pricing Data requirements, please clarify what portions of this contract may be subject to submission of certified cost or pricing data.

Answer: See the revised solicitation.

1. Reference: Section K - Representations, Certifications and Other Statements of Offerors, Pg. 83, Provision 52.230-1

68. The CAS clause at 52.230-1 is included in this section. As CLIN 0001 is to be awarded on a commercial item basis and therefore exempt from all CAS requirements, please clarify what portions of this contract may be subject to coverage under the Cost Accounting Standards.

Answer: See the revised solicitation.

1. Reference: Returns, General

69. How will returns be managed?

Will it be based on the size of the items ordered/shipped, or will there only be returns at the pack or dose level size?

Answer: Returns from providers can be any size, individual doses or full packs.

Returns to vendor represent consolidated shipments returned by providers and damaged/expired vaccine stored at the depots.

1. Reference: Transition Timeline, (Discussed on the Q&A vendor call)

70. Please clarify the transiton timeline referenced in the pre-solicitation call. A six (6) month transition period was referenced. Our intial understanding was an award in June 2023 with an effective date of August 2023.

Does the transition start at time of award, or time of contract start, i.e., June or August?

Answer: Transition start time is expected to start August 1, 2023

70. Can we anticipate all product to be moved at once at the end of the transition period, or in a phased approach throughout?

Answer: Phased approach.

1. Reference: 5. Store Vaccine Ultra-Cold and Ship Ultra-Cold, Pg. 17, 5.1 - 5.16

71. Is ultra cold only a component of the pandemic optional CLINs, or are there requirements to consider during routine distribution CLIN?

Answer: Ultra cold distribution is an option in the routine program and is also incorporated in the pandemic option

1. Reference: 5. Store Vaccine Ultra-Cold and Ship Ultra-Cold, Pg. 17, 5.1 - 5.16

72. Please provide an estimate for monthly order volume for ULT.

Answer: Information was added to the Program Scope about transition of COVID-19 vaccines into the routine program and we have also added new Exhibit F.

1. Reference: Program Scope, Pg. 12 – 13, Historical data in this section is provided for information only and may not be predictive of future distribution, based on legislative or programmatic changes that may occur.

73. What does a dosage translate to?

Answer: The CDC does not understand this question. See the revised solicitation and if this question still remains, please ask again during the revised Q&A period with more detail.

73. What is the physical size of each dosage?

Answer: The physical size of each dosage varies based on the presentation, vial, sprayer or prefilled syringe.

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