Soliciation Questions and Answers - 2.24.2023.xlsx

XLSX spreadsheet 23 KB Posted Feb 24, 2023

Attached to: Centralized Vaccine Distribution
Solicitation number: 75D301-23-R-72522
Issued by: Department of Health and Human Services Centers for Disease Control and Prevention

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Written by GovTribe AI · Dec 27, 2023

This document contains a solicitation for a centralized vaccine distribution contract along with associated questions and answers. The Centers for Disease Control and Prevention requires a contractor to receive, store, pick, pack, ship, and distribute approximately 75 million routine vaccine doses annually to over 40,000 provider sites. The contractor must also distribute pandemic vaccines as part of the COVID-19 response and support international donations. Required capabilities include storage of routine, frozen, and ultra-cold vaccines as well as fulfillment of provider orders within specified timeframes. The period of performance is August 1, 2023 to July 31, 2024 with four option years. The agency intends to make a single award by June 30, 2023 using a best value tradeoff process evaluating technical, past performance, and price factors. The North American Industry Classification code is 493120 and there is no small business set aside. The incumbent is McKesson Specialty Distribution LLC under contract 75D30122C14691.

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Other files

File	Type	Posted
Exhibit G - QASP - 3.2.2023.docx	DOCX document	Mar 2, 2023
Solicitation - 2.28.doc	DOC document	Feb 28, 2023
Soliciation Questions and Answers 2.28.2023.xlsx	XLSX spreadsheet	Feb 28, 2023
Solicitation - 2.24.2023.doc	DOC document	Feb 24, 2023
Attachment 1 - Pricing Tables 2.24.2023.xlsx	XLSX spreadsheet	Feb 24, 2023
Questions and Answers 2.2.2023.docx	DOCX document	Feb 2, 2023
Attachment 1 - Pricing Tables 2.2.2023.xlsx	XLSX spreadsheet	Feb 2, 2023
Solicitation - 2.2.2023.doc	DOC document	Feb 2, 2023

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Sheet1

Questions and Answers that were received on time for solicitation 75D301-22-Q-75708.
Section /Content	Page	SOW Content	Potential Offeror Question	CDC Response
General	N/A	N/A	What are the reasons the solicitation does not follow FAR 15.204 Contract Format?	The format that the solicitation is current in will be the format used moving forward.
General	N/A	N/A	Please confirm this procurement (Solicitation No. 75D301-22-Q-75708) is being conducted under FAR Part 15.	Yes.
	N/A	N/A	Please clarify the solicitation due date. It is listed as Saturday 3/4 at 5PM ET in the amended RFP released 2/2. However, SAM states due date is: March 5th at 5AM and also 3/4 at 5PM.	The due date is 3/13/2023 at 9 AM EST.
General	N/A	N/A	Is the previous solicitation considered cancelled? Will the previous questions and answers be added to the solicitaion in an amendment?	The previous solicitation is replaced by this updated solicitation. The Questions and Answers from the previous solicitation are included in the SAM.GOV posting.
N/A	N/A	N/A	Within the SAM.gov posting the CDC states, "this is a best value acqusition using a tradeoff process." According to FAR 15.101-1 Tradeoff process the solicitation must identify all evaluation factors and significant subfactors that will affect the contract award and their relative importance shall be cleary stated in the solicitation. Will the solicitation be revised to clearly define the significant subfactors that will be used to conduct the trade off process?	Please see E.7.1 and E.7.2 for additional information regarding the trade-off process.
Clauses	N/A	N/A	Will FAR 52.245-1 Government-Furnished Property be added to the solicitation? Currently, it is only referenced in CDCA H040. It's our understanding that the vaccines will be provided by the CDC.	Vaccine are provided by the government but there is no transfer of ownership.
General	N/A	N/A	Does the CDC intend on adding FAR 52.243-1 Alt I Changes-Fixed Price to use for the non-commercial items?	Yes, if there are items that are determined in a future pandemic to be noncommerical.
General	N/A	N/A	The solicitation includes performance standards outlined in the	The PWS includes the performance matrix and a QASP will be provided early next week on SAM.GOV.
			performance matrix. Will there be a Quality Assurance Surveilance Plan (QASP) provided to potential offerors to identify what is going to be inspected and the inspection process?
Section B - Continuation of SF1449	3	If exercised, the below services under CLINs 0003, 1003, 2003, 3003, and 4003 shall meet the definition of commercial services in FAR 2.101.	Please explain why CLINs 0004, 0005, and 0006 (and their related option CLINs) are not considered “commercial.” If they are not commercial, how are they defined?	Those CLINs are commercial. They could be determined to be noncommercial at a later date given currently unknown parameters for a future pandemic. For those CLINs to be considered to be noncommercial, they must not meet the criteria for commercial services in FAR 2.101.
		In the event a future pandemic response includes requirements that do not meet the definition of commercial services in FAR 2.101, CLINs 0003, 1003, 2003, 3003, and 4003 will be determined to be non-commercial services and subject to negotiations.
B.1 Price Breakdown	13	All offerors will fill out and submit Attachment 1 – Price Breakdown with their proposal. This attachment will not count towards any page limits. This attachment is found posted on SAM.GOV. Note that the tables in Attachment 1 will be included in the final award.	Does the price per dose include the additional services required to perform the contract, i.e. customer service, EDI, etc.	Yes - with the exception of Pandemic Facilities all services are included within the price per dose.
D.1 Performance Work Statement – version	44		Please clarify the statement “CDC intends to seek approval to transition the distribution of varicella containing vaccines to centralized distribution over the course of its next distribution contract” is not in reference to this Solicitation No. 75D301-22-Q-75708 and offerors should not consider or include such a transition in their proposals.	The statement is in reference to Solicitation No. 75D301-22-Q-75708.

It is part of PWS section:

4.4.2 Varicella-containing vaccines can be packed out at controlled room temperature CRT (20⁰C to 25⁰C). While CDC does not currently distribute varicella-containing vaccines, based on the increased use of frozen vaccines during the COVID-19 pandemic, CDC intends to seek approval to transition the distribution varicella containing vaccines via centralized distribution over the course of this distribution contract.

We will update Section B to include this option (CLINs 0007, 1007, 2007,3007, 4007)

1.20.2023 based on Meeting with Program and OAS.
Frozen vaccines
Section B - Continuation of SF1449	3	1. CLINs 0005, 1005, 2005, 3005, and 4005 - References Section 5.	We are unable to locate Section 5 in the solicitation, please provide or advise of the section it pertains to.	This is referencing the PWS

5. Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at Ultra-Cold at option of CDC (Page 53) Section B - Continuation of SF1449 3 1. CLINs 0006, 1006, 2006, 3006, and 4006 - References Section 6. We are unable to locate Section 6 in the solicitation, please provide or advise of the section it pertains to. This is referencing the PWS

6. Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at (2ºC to 8ºC) at option of CDC (Page 54)

	31	(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Office of Financial Resources at 678-475-4510.	There are many attachments added within the solicitation document and references to Section J within. Can the CDC consider a Section J and/or provide the documents as attachments, with clear direction of which portion of the solicitation response to include?	See the revised solicitation.
PWS, 1. Receive/store/report on inventory; 1.2	49	1.2. Receipt of product and notifications to CDC and awardees occurs within timeframes specified in metrics; at a minimum, receiving should be supported during normal business days/hours	The timeframes and metrics were not included in the original or revised solicitation.	Timeframes are specified in PWS Section 21 starting on Page 89. For the pandemic option the Timeframes are specified in PWS Section 15.16 starting on page 72.

			Please define "timeframes specified in metrics" noted as "normal business days/hour" for receiving.	Vendors should propose their normal business days/hours for receiving
			Please provide the metrics that will be used to evaluate the Offeror.	All metrics will be used to evaluate the Offeror.
Program Scope	47	Operating inventory (non-Flu): Total monthly operating inventory (not including flu doses) over the past 5 years has ranged from as low as 8M to as high as 20M doses per month, depending on the time of year.	Please clarify the operating inventory broken down by frozen and ULT, as well as if that is additive to the 8M-20M non-flu range or included.	The program scope section defines the routine program which does not currently distribute frozen or ultra cold vaccine. Frozen and ultra cold vaccine volumn would be added to the current operating inventory described in this section.
13.2.D. Incident Response	66		Please provide a link to the HHS policies as it relates to this section for our review. According to Office of the Chief Information Officer the response times are in a "timely manner".	Please see below:

https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-preparing-and-responding-breach.html

PWS, 3. Pick/pack/ship (2 -8 C); 3.2	50	3.2. Fulfill provider orders within timeframes specified in metrics (including routine; flu; priority shipments) and in accordance with provider receiving hours	The timeframes and metrics were not included in the original or revised solicitation.	Timeframes are specified in PWS Section 21 starting on Page 89. For the pandemic option the Timeframes are specified in PWS Section 15.16 starting on page 72.
			Please define "timeframes specified in metrics" for each of the noted shipments that includes routine, flu and priority. If the Offeror will be evaluated on other shipment types, please include those as well as the timeframes and metrics.	Timeframes are specified in PWS Section 21 starting on Page 89. For the pandemic option the Timeframes are specified in PWS Section 15.16 starting on page 72.
			Please provide the "provider receiving hours".	Provider receiving hours are included as part of Provider Master data that is sent electronically to the distributor. Provider receiving hours are subject to change between orders and electronic updates will be provided.
PWS, 4. Process Frozen; 4.2	51	4.2. Fulfill provider orders within timeframes specified in metrics (including routine; priority shipments) and in accordance with provider receiving hours	The timeframes and metrics were not included in the original or revised solicitation.	Timeframes are specified in PWS Section 21 starting on Page 89. For the pandemic option the Timeframes are specified in PWS Section 15.16 starting on page 72.
			Please define "timeframes specified in metrics" for each of the noted shipments that includes routine, flu and priority. If the Offeror will be evaluated on other shipment types, please include those as well as the timeframes and metrics.	Timeframes are specified in PWS Section 21 starting on Page 89. For the pandemic option the Timeframes are specified in PWS Section 15.16 starting on page 72.
			Please provide the "provider receiving hours".	Provider receiving hours are included as part of Provider Master data that is sent electronically to the distributor. Provider receiving hours are subject to change between orders and electronic updates will be provided.
PWS, 5. Vaccine Ultra-Cold and Ship Ultra-Cold; 5.2	53	5.2. Fulfill provider orders within timeframes specified in metrics (including routine; priority shipments) and in accordance with provider receiving hours	The timeframes and metrics were not included in the original or revised solicitation.	Timeframes are specified in PWS Section 21 starting on Page 89. For the pandemic option the Timeframes are specified in PWS Section 15.16 starting on page 72.
			Please define "timeframes specified in metrics" for each of the noted shipments that includes routine, flu and priority. If the Offeror will be evaluated on other shipment types, please include those as well as the timeframes and metrics.	Timeframes are specified in PWS Section 21 starting on Page 89. For the pandemic option the Timeframes are specified in PWS Section 15.16 starting on page 72.
			Please provide the "provider receiving hours".	Provider receiving hours are included as part of Provider Master data that is sent electronically to the distributor. Provider receiving hours are subject to change between orders and electronic updates will be provided.
			In the pre-solicitation Q&A, the CDC stated it plans to make a single award. For the Centralized Vaccine Distribution solicitation published on Feb 2, 20223, does the CDC still intend to make a single award or multiple awards?	Single Award.
			Additionally, is the award date still expected to be on or around June 30, 2023?	Yes.
			In your previous response to questions you stated that this requirement could not be set aside for small businesses and that it was not a small business set-aside. This did not quite provide an answer to our question. If the contract requirement could not be separated, we respectfully ask, why not?	Due to the high level of complexity and complex logistics of this requirement it cannot be separated into individual requirements. However, the prime contractor is encouraged to have sub-contractors that are small businesses.
			We recognize that this is not a small business set-aside opportunity. Our request was not for this overall requirement to be set-aside, rather we are requesting that CDC consider disaggregating segments of the performance requirement. Will CDC disaggregate any portion of this requirement?	See the answer above.
			Will CDC encourage large business prime contractors to submit a individual subcontracting plan for this requirement rather than a commercial plan? A commercial plan would eliminate most subcontracting opportunities for local businesses and encourage subcontracting plans with requirements that do not allow subcontractors to have direct participation in the performance of the requirements.	The solicitation requests an individual subcontracting plan. However, if a company has a previously approved commercial plan, the CDC will consider it.
			We recognize that this is not a small business set-aside opportunity. We are not requesting that the requirement be changed into a small business set aside. What we are requesting is that the CDC consider disaggregating the requirement so that small businesses are able to participate in the performance of at least some the requirement.	See the answer above.
Reference Section			Potential Offeror Question	CDC Response
General			Would the Government verify that the formal title for this contract is “Vaccine Distribution Contract,” per RFP Section E.2, “Centralized Vaccine Distribution” per SAM.gov, or “Vaccines for Children,” as set forth in RFP D.1, the subsection entitled “Background and Purpose”?	"Centralized Vaccine Distribution" is the formal title.

D.1 contains additional background information about the largest program that is served by the Centralized Vaccine Distribution program.

	2/2/2023 Questions and Answers and RFP E.2	The answer to Question 26 states, “The “Performance Standards” tables in the PWS can be added as attachments in your proposal and are not subject to the page limit.” Would the Government add this directive to the proposal contents table in RFP E.2 and the directives of E.7.5?	See revised solicitation.
	Questions and Answers dated 2/2/2023 and RFP E.2	Question 27 asks whether certain sections of the PWS (11 “Liability for Routine Vaccines,” Section 13, “Security Requirements,” and 16 through 20), which seem to be asking offerors primarily to certify their compliance (rather than propose a solution), can merely assert their compliance—perhaps to entire sections with a blanket statement—without consuming excessive page count in Tabs B and C. The answer to Question 27 states, “Acknowledgement of compliance for these sections [PWS Sections] is needed in the proposal” although no directives are furnished for asserting this compliance. Would the Government consider allowing bidders to locate their responses to PWS 11, 13, and 16–20 in an uncounted attachment? Would the Government consider allowing offerors to certify blanket compliance to all the requirements set forth within these PWS, as appropriate, with the opportunity to specify and explain any exceptions or deviations, or provide further information in response to certain requirements as deemed warranted? (We also wish to point out that some requirements in these PWS sections will be considered in solutions set forth in response to other PWS sections covered in the three major technical sections within offeror proposals.)	The Government allows the bidders to locate their responses to PWS sections 11, 13, and 16-20 as an uncounted attachment. Responses to all other PWS sections must include the offeror's approach.
	Questions and Answers dated 2/2/2023 and RFP E.2	The answer to Question 28 allows Arial, Arial Narrow or Calibri fonts to be used in graphics. Would the Government add this directive to RFP Section E, the paragraph entitled “Proposal Format”?	See revised solicitation.
	Section E.7.2, the individual directives for the Proposal Sections	Would the Government update the page limitations for these sections to correspond to the new limitations set forth in the Proposal Contents table in RFP E.2?	These updates were made in the 2.2.2023 posted soliciation.
	Section E.2, the Proposal Contents table, page limit for Management and Transition Plan	There is a large amount of information that needs to be addressed in the Management and
Transition Plan that should be explained in some detail. Would the Government consider adding 10–15 pages to this section or allow offerors to locate their Transition Plan in a separate Attachment, with or without a page limitation?	See revised solicitation.
	Section E.8, paragraph (c) and Section E.7.2, the directives for the Management and Transition Plan	The referenced paragraph requires offerors to provide a “Staffing Plan” in the Business Proposal that had been “included in the technical proposal,” but no such plan was requirement in the Technical Proposal. If such a Plan is to be provided in the Technical Proposal (with the RFP changed accordingly), would the Government specify where it is to be located and the degree of detail to be provided? For example, does the Government want a staffing breakdown for the labor force at each Depot specified by job title/labor category? (We note that if the Plan is to cover all labor categories/job titles and their quantities for all offeror installations/offices, this will be a large table and will consume significant page space.)
	The staffing plan under E.8 is removed.
	Section E.8.2, Past Performance Information, paragraph (b)	The referenced paragraph directs offerors to “include the last 3 contracts completed during the past three years and all contracts currently in process for both the offeror and all proposed major subcontractors.” Accordingly, the requirement for “all contracts currently in process…” means that bidders must include hundreds, if not thousands of contractual relationships for review. We ask that the Government consider reducing the volume of agreements that should be identified. We normally see this capped at no more than five.	See revised solicitation.
	Section E.2	The solicitation states that proposals are due no later than March 4, 5:00pm eastern.
Notably, March 4th is a Saturday. The SAM notice indicates that proposals are due no later than March 5 at 5:00am, eastern. March 5th is a Sunday. Can the CDC clarify the deadline for proposal submission and consider placing it on Monday, March 6th at 5:00pm?	The due date is March 13, 2023 at 9:00 AM EST.
	The RFP directives of Section L, CDC0.L018 Past Performance Information:	Would the Government further clarify whether submitting Past Performance information for work undertaken by major subcontractors is mandatory versus allowable as subcontractors may not have three relevant contracts?	The offeror must provide the information as stated in the clause.
	Security Requirements	Security Requirements: Section 13 has numerous references to specific HHS or CDC policies and other references to unnamed HHS and CDC policies, templates, forms and other agency documents. It is unreasonable to ask a bidder to agree to comply with such documents that are not readily available to the public or even identified by name. Please provide copies of the applicable policies. We also ask that the CDC amend these requirements to provide clarity as to the identity of the actual policies contractors must comply with.	See the revised solicitation.
	13.1.3	Please identify what Personally Identifiable Information (PII) is handled by the contractor. To the extent the CDC’s definition of PII is different for other requirements in Section
13, please provide definitions for those sections	No PII collected.
	13.1.4	Please clarify which version of NIST Special Publication 800-53 is incorporated into the contract.	NIST 800-53 Rev. 4
	13.1.10	This requirement appears to relate to use of HHS’s personal identification cards. This requirement doesn’t seem to appropriately apply to a contractor that is operating solely at contractor facilities. Can the CDC confirm this provision applies to the contractor? Also, if it does apply, we need guidance on how to obtain these government ID cards	See the solicitation for additional information.
	13.1.11	Can the CDC provide guidance on what information is subject to the NDA and how is the CDC marking that information as subject to the NDA?	Any information relating to doses issued, shipment, etc. Contractor must maintain staff NDA (in house) and provide if necessary to CDC if requested.
	13.1.8	This provision applies to Government run websites. Can the Agency confirm this applies to the contractor’s work? It isn’t clear from the RFP what websites the contractor is creating	See the solicitation for additional information.
	13.2	Please provide copies of these trainings and referenced HHS policies	See the solicitation for additional information.
	13.7.3 & 13.7.5	These provisions are incredibly broad and very unusual for contracts that don’t involve classified information. It requires the contractor to purge from its system any information that was provided by the government or created by the contractor is purged by contract closeout. That obligation exists regardless of the sensitivity of the data. Moreover, it is contrary to normal documentation retention policies for government contractor records and for public companies. We ask the CDC to reconsider the reach of the clauses.	See the solicitation for additional information.
	13.5	The referenced regulations at Title 5, Part 700 do not support the CDC’s application of this requirement. High or moderate risk levels would normally be designated public trust positions. 5 C.F.R. § 731.106(b). “Such positions may involve policy making, major program responsibility, public safety and health, law enforcement duties, fiduciary responsibilities or other duties demanding a significant degree of public trust, and positions involving access to or operation of financial records, with a significant risk for causing damage or realizing personal gain.” Id. The Office of Personnel Management (OPM) designates a Sensitivity Level 1 as “Non-sensitive (NS)/Low Risk. No potential to bring about a material adverse effect on national security.
Potential to produce some limited harm to the public’s trust.” https://dw.opm.gov/datastandards/referenceData/1509/current?d-5590585-p=5. As written it reaches thousands, potentially hundreds of thousands, of workers. Requiring all personnel to meet the stringent standard of Level 5 will result in unnecessary administrative burden and significantly impair the mission. Many of our workers (i.e. delivery drivers, warehouse personnel) should be in the low risk, Level 1, category. Can the CDC revisit the applicability and reach of this provision?	See the solicitation for additional information.
	13.6, 13.7.4 & 13.7.6	Can the CDC revisit the applicability of these requirements? These requirements are incredibly broad and would require non-stop communication with the government about personnel changes.	See the solicitation for additional information.
	13.10	We don’t believe this provision applies to the contractor’s work. Can the CDC explain its applicability or remove it from the solicitation?	See the solicitation for additional information.
	13.3	Based on our understanding of the Personally Identifiable Information (PII) that is made available to the contractor, the Agency designation of the Confidentiality Impact Level of Moderate appears improper. We believe the designation should be no higher than Low. Will the CDC please reconsider the Impact Level designation for PII?	See the solicitation for additional information.

File details come from the government source that posted it. Updated Feb 24, 2023.