75D301-23-R-72697 Qs As_8.9.23.pdf

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CDC/CFA Epidemiology Studies Federal contract opportunity
Solicitation number
75D301-23-R-72697
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

About this file

This document contains questions and answers related to solicitation number 75D301-23-R-72697 from the Centers for Disease Control and Prevention for epidemiology studies services. The CDC seeks a contractor to provide rapid analyses of electronic medical record data from a network of at least three million patients to assess disease trends, characterize health threats, and complete up to five epidemiological studies per one-year contract period. Key requirements include accessing and utilizing large-scale EMR data sources through a common data model, establishing an analytic workgroup, developing study protocols for CDC approval within 21 days, and delivering interim and final analyses within defined timeframes unless otherwise agreed. The contractor will also abstract relevant medical records as needed on a study-by-study basis and respond to two to four ad hoc data requests per study. Security requirements and authorization to operate the federal system are not applicable provided no system is delivered under the contract. The period of performance is estimated to begin on September 29, 2023.

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CDC/CFA Epidemiology Studies

Solicitation No. 75D301-23-R-72697

Questions and Answers (Qs&As)

Q1. The Past Performance Questionnaire references the ”Safety and Healthcare Epidemiology Prevention Research Development (SHEPheRD) Program” under the Contractor Name section. Can CDC confirm this is an error since this RFP was not released under SHEPheRD? Attachment 1 – Past Performance Questionnaire pg. 1

A. Attachment 1 revised with the correct program name.

Q2. The RFP notes 8/01/2023 as the start date for the contract. Can CDC please clarify the anticipated start date since proposals are due 8/24/2023? Section B Section F.2 pg. 2 pg. 34 A. Estimated start date of the Period of Performance is September 29, 2023. See Amendment 2.

Q3. Will the public website be hosted and maintained by CDC or is the contractor expected to host and maintain a public website throughout the period of performance of the contract? Section 4 Task 2,#6c pg. 6 A. The public web-site will be hosted by CDC.

Q4. For budgeting purposes on Task 4, Medical Records, can CDC provide an estimate of the number of patient medical charts that would require abstraction and clinician adjudication either on each study or over the period of performance? Section 4 Task 4,#1 pg. 7

A. Per study, estimate 0-500, average 250

Q5. For budgeting purposes, can CDC estimate the number of ad hoc data calls to expect during each contract year? Section 4 Task 6,#2 pg. 8

A. Per study, estimate 2-4, average 3

Q6. Can CDC clarify what kind of "documentation of health record data" is required in the associated deliverable for Tasks 1-4? Section 7, Deliverables/ Reporting Schedule pg. 8 A. A description of the EHR data source, a data dictionary, A description of the population represented by health care providers represented by EHR.

Q7. Can CDC clarify what reference materials will be provided as based on the punctuation something may have been left off? Section 5 Reference Materials pg. 8 A. This is an error - deleted. See Amendment 2.

Q8. If an “authority to operate (ATO)” is required, as stated on p. 17, will CDC consider revising the due dates for deliverables since the ATO process can take many months during which time the contractor would not be able to share data files with CDC? Section 7, Deliverables/ Reporting Schedule, and Section 9, Additional Requirements/ Information Security and Privacy pg. 8 pg. 17

A. Based on the nature of this work CDC does not anticipate the need for an ATO. As described an IT system is not being built and or delivered. In the unlikely event that an ATO is needed CDC will make accommodations for any delays on CDC’s part in the ATO process.

Q9. For budgeting purposes, can CDC estimate the number of hours required for the annual “HHS/CDC

Contractor Information Security Awareness, Privacy, and Records Management training”? Section

9, Additional Requirements/ Training pg. 13

A. An estimate of 8 hours per contractor per year will accommodate these trainings will accommodate these training and all others.

Q10. Can CDC clarify whether or not contractor staff will need to complete “role-based training”? If they do, can CDC estimate the number of hours required for this training? Section 9, Additional

Requirements/ Training pg.13

A. The offeror will not be required to participate in RBT. These training are typically for staff managing

CDC owned data and those who developing CDC hosted systems.

Q11. Will the offeror be using CDC’s REDCAP product? If not, does Vanderbilt’s REDCAP environment meet CDC’s requirements? Section 9.A.2, SA&A pg. 17

A. Offeror will not be collecting new data or designing a study. The intent is that offeror will be using existing data from a data provider who has access to large amounts of EHR data as described in Section I and Section 8: “Vendor must have at a minimum, access to electronic medical records, including inpatient and outpatient data on a minimum of 3 million persons. Preference will go to proposals with shorter data lags, larger overall sample size, longer duration of coverage for covered persons, and better coverage of vulnerable populations. Preference will also be given to proposals that contain a higher proportion of health care encounters of covered persons and to those that can link individual records to state immunization Registries"

Q12. Should the offeror include the costs of an independent 3rd party security controls assessor or pen test in their budget or will the agency perform these activities? Section 9, Annual Assessment pg. 19

A. There is no intent to develop a system. This work will not be needed.

Q13. Can the required HHS Section 508 Product Assessment Template be included as an appendix to the

Business Proposal? Section 508 compliance pg. 30

A. Yes. The intent of this requirement is to assure offeror is aware of all 508 requirements for deliverables and that all deliverables will be 508 compliant.

Q14. Can CDC please confirm that the evaluation criteria for “Technical Approach & Understanding the

Requirement” are correct as stated in the RFP. We note that they are exactly the same as the evaluation criteria for RFP#75D301-23-R-72696, CDC/CFA Demographic Social Comorbidities Table, and several of the criteria appear to be more relevant to this CFA DSCT solicitation than to the CFA Epidemiology

Studies solicitation. Evaluation Criteria pg. 75

A. The RFP 75D301-23-R-72697 (CFA Epidemiology Studies) contained the correct evaluation criteria for “Technical Approach & Understanding the Requirement”.

B. FYI: The RFP 75D301-23-R-72696 (CFA DSCT) the evaluatio criteria for “Technical Approach &

Understanding the Requirement” has been revised under Amendment 1.

Q15. Under 4. Management Approach, item f is blank – can CDC confirm whether there is missing information and if there is, provide it? Evaluation Criteria pg. 77

A. No. This is a typo – renubmer the item. See Amendment 2.

Q16. The period of performance in the RFP starts on 8/1/23. Since the RFP response is due on 8/24/23, please provide the anticipated period of performance for each year of the contract. Section B pg.

2-3

A. Estimated start date of the Period of Performance is September 29, 2023

Q17. The CLIN Structure in Section B states the unit of measure for each CLIN is “1 Job”. Are Offerors to assume that “1 Job” is equal to one contract year completing Tasks 1-6 as described in Section C, Section

4 – Tasks to be Performed? OR Will CDC clarify how Tasks 1-6 as described in Section C convert to a

“Job” as referenced in Section B? pg. 2; 5-8

A. Yes, Offerors are to assume that “1 Job” is equal to one performance year. All tasks in Section C, Section 4 are to be completed each contract year.

Q18. The RFP states that vendors are to provide access to a network of large-scale distributed databases transformed into a common data model that include near real-time data with less than 1-month data lag. Is CDC requesting monthly data refreshes of data sources or more frequently? Typically, a monthly refresh would have a 1–3-month data lag depending on data source/processing to CDM and size of database. Task 1 pg. 5

A. CDC is not requesting these data. The timeliness of the data accessed by the offeror is required to inform the epi studies that are a deliverable in a timely manner, with data used for the studies being lagged no more than one month.

Q19. Please clarify what types of data are expected to be transferred through the secure portal. Task 2

pg. 6

A. Studies proposed, analytic plans, interim results, draft reports, discussions of these, and other communications concerning potential or actual studies will be communicated through the secure portal.

In the event that a special request is made as a result of an epi study to perform chart abstraction, the results of the abstraction would also be expected to be transmitted via a secure portal.

Q20. Please clarify whether CDC anticipates recurring studies/analyses, or if all expected studies will be bespoke and require new protocols, programming etc. Task 3 pg. 6

A. CDC may anticipate recurring studies/ analyses depending on CFA’s need. However, expected studies within performance period may be bespoke and require new protocols.

Q21. Infectious and noninfectious threats: Can CDC be more specific about the area of analyses that might be studied? Section 2, Task 2

A. Examples from CFA’s early work considered COVID-19 variant severity and natural history including roles of vaccines and treatments (PMID 35737591, 35675841, 37386005). Work under this contract will most likely comprise infectious or noninfectious diseases or conditions that are the subject of an activation of the CDC’s Emergency Response, or may become so. Recent examples include Zika virus, acute pediatric hepatitis, e-cigarette or vaping-associated lung injury, mpox, and poliomyelitis.

Q22. Maximum of 5 studies per period of performance: Can CDC elaborate on the types or complexity of anticipated studies? Task 3 pg. 6-7

A. See answer to Q21. These studies comprised (in two cases) several sophisticated multivariable analyses with sensitivity analyses per study, and (in one case) a descriptive study of natural history of

COVID-19 following Paxlovid treatment that involved manual review of charts.

Q23. Maximum of 5 studies per POP under Task 3 does not align with deliverables/reporting schedule on page 9 under Studies quantity/format indicates on request by CFA. If this is an error in the RFP, please clarify the requirements. Task 3 pg. 7

A. CFA may request up to 5 studies per performance period of 1 year. This is reflected on page 9, ‘Studies’ row.

Q24. Medical Records: Can CDC elaborate on expected or NTE number of medical records to aid in staffing plan due to FFP offering? Task 4 pg. 7

A. Per study, estimate 0-500, average 250

Q25. For Task 6.2, would CDC please provide either a proposed level of effort or anticipated number of instances per year for ad hoc data calls, so that we can accurately estimate pricing? Task 6 pg. 8

A. A. Per study, estimate 2-4, average 3 data calls

Q26. Task 6.1 requirements appear to duplicate Task 5; and Tasks 6.3 and 6.4 appear to duplicate Tasks

2.5 and 5. Was it CDC’s intention to duplicate these requirements? Task 6 pg. 8

A. These are not duplicate requirements, as they differ in their application to the larger task at hand. For example, Task 6.1 refers to communication and research aspects, while Task 5 activities are related to operational management.

Q27. Task 6 is titled, “Communications and Research” but does not contain any communications requirements. Did CDC intend to include communications requirements in Task 6? Pg. 8

A. Yes, CDC included communications requirement in Task 6 to encompass communication needed to respond to ad-hoc data calls, refine project findings and address CFA questions and concerns (#2).

Q28. Please clarify why FedRAMP Compliant ATO is necessary given CDC is requesting a distributed data network model. Privacy and Security Requirements pg. 22

A. In this case it is not. This is standard language for all CDC information contracts added by the security office. If a system were to become a deliverable this would then become applicable.

Q29. The technical proposal shall be limited to no more than 20 pages of text. Appendices shall be limited to no more than 10 pages of text. Cover pages, tables of contents, appendices, resumes, or the budget spreadsheets are not counted in the number of pages limitation". Would CDC please clarify if appendices are limited to 10 pages, or do not count in page limits? CDCA_L011 (b) pg. 71

A. The technical proposal shall be limited to no more than 20 pages of text. The appendices shall be limited to 10 pages for cover pages, tables of contents and other appendices. Page limits for resumes are unlimited. Budget spreadsheets are not counted in the number of pages. See Amendment 2.

Q30. Would CDC consider extending the proposal submission deadline to Wednesday, August 30th so that we can factor into our response CDC’s answers to questions submitted? Pg. 72

A. No. We are on a time crunch to meet fiscal year deadlines.

Q31. “(b) Offerors shall submit the past performance information as part of their business, technical or as a separate proposal. The offeror should 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.”

Pg. 74

A. This seems to be a duplicate question that has already been answered.

Q32. For the “last three contracts” requirement, can offerors simply provide three contracts that are either active or completed during the past three years that demonstrate our ability to fulfill the RFP requirements? Pg. 74

A. Must be relevant to the scope and size of the requirement

Q33. For the “All contracts currently in process” requirement, would CDC accept a list that includes only relevant active contracts? Pg. 74

A. We are only asking for three recent and relevant contracts

Q34. For the “all contracts currently in process” requirement, did CDC intend to require submission of all information items 1 through 11 for all of those active contracts? Or is that information required only for three recent relevant contracts from the past three years? Pg. 74

A. That is the information required only for the three recent relevant contracts from the past three years.

Q35. Will CDC please define “major subcontractor”? CDC0.L01 pg. 74

A. See Amendment 2.

Q36. Are contractors required to provide past performance as a third volume to their RFP response?

Pg. 74

A. Offerors shall submit the past performance information as part of their business, technical or as a separate proposal.

Q37. “f.” is missing text. Did CDC intend to include any text for this requirement? 4. Management

Approach pg. 77

A. renumbered. See amendment 2.

Q38. Text from requirement h. appears to be a continuation of requirement g. Did CDC intend to have h and g combined as a single requirement? 4. Management Approach pg. 77

A. This is a typo - renumered. See amendment 2

Q39. Is there a target level of effort for this opportunity? Note that data vendors often price access based on sample size, numbers of years accessed, and number of research topics. Section 4, Task

1 pg. 5

A. Per study, this depends on the complexity and required sophistication of the analytic approach.

Q40. Other than the OMB Race and Ethnicity standard referred to on page 76, are there any other specific data standards about social determinants of health, or other data, that CDC is interested in.

Task 1 pg. 6, 76

A. No other specific data standards are referenced. However, high levels of completeness for a variety of social determinants of health are preferred. Other social determinants of health of particular interest include: occupation, education, income. Use of data standards for other social determinants is encouraged.

Q41. Will the contractor be responsible for the logistics of these meetings? Are the members of the workgroup restricted to CDC and contractor employees? How often will the workgroup meet and will the meetings be virtual? Task 2: Analytic capabilities pg. 6

A. Yes, the contractor is responsible for meeting logistics and efficient operations (see Task 5, page 7).

Members of the workgroup are restricted to CDC-affiliated staff, CDC staff, and Offeror staff. Cadence of workgroup meetings will be determined based on CFA need and whether there is ongoing study. Virtual meetings are acceptable.

Q42. Does CDC have a target LOE/budget for this work? Can target hours, number of publications, and number of presentations be provided to support budgeting? Section 4, Task 2 pg. 6

A. Each study (5/POP) is anticipated to have approximately 1-2 presentations, one publication.

Q43. Who are the other contractors who may participate in design of Studies and analytic plans?

Task 5: Operations and management pg. 7-8

A.Other contractors who may participate are contracting staff who report to CFA.

Q44. Please clarify if CDC is anticipating 5 study requests per period of performance or 5 completed/final analyses submitted to COR per performance period. Also, we are assuming a “period of performance” in this case is a 12-month period and not the full period of performance of the contract (5 years). Is that correct? Task 3: Studies pg. 7

A.Yes, “period of performance” in this context is defined as 12-month period. CDC anticipates 5 study requests per period of performance. However, studies are intended to be rapidly completed (see page

9). First interim analysis will be expected within 21 days and final analyses will be expected within 42 days, unless otherwise agreed.

Q45. Can the CDC provide an estimated number of charts to review? Typically, the number and scope of review drives the budget for these activities. Section 4, Task 4 pg. 7

A. Per study, estimate 0-500, average 250 (see Q24)

Q46. Can the CDC provide estimates on the number of frequency of these data calls to support budgeting? Section 4, Task 6 pg. 8

A. See answer in Q5.

Q47. Should the contractor budget for a virtual or in-person kick-off meeting? Section 7 pg. 8

A. Virtual

Q49. The SOW also discusses the development of study protocols before analysis. Does the 21 days begin after the protocol is developed and approved by the COR? Or is the protocol developed and approved in the 21-day period between the initial request and delivery of first interim analyses? Also, does the deliverable schedule/due date change if medical abstraction is involved? Deliverables table, Task 2-5 pg. 9

A.The 21 days begin after the protocol is developed and approved by the COR. See page 7. The deliverable schedule and due date change may be different if medical abstraction is involved. See Task

4: “The timeline for obtaining and reviewing medical records will vary depending on the type of study and will be agreed upon by CFA and the contractor on a study-by-study basis.”

Q50. This study is supposed to primarily utilize EHR data. Should this requirement be specific to EHR data (at least 33 million in EHR data) Section 8 – Minimum Vendor Qualifications pg. 9 A. Amendment 1 changed to 3 million.

Q51. Can CDC clarify whether this is considered a High Value Asset and must therefore perform all work in an environment with an Authorization to Operate (ATO)? Section 9 Additional Requirements

pg. 17

A.An ATO is not required as long as a developed system does not become a deliverable.

Q52. Since CFA is seeking indirect access to data and a data analytics environment (DAE) managed, operated, and secured by the contracting team, it does not appear that the DAE meets the applicability criteria for the security requirements in this RFP. The DAE would not contain private government information and would not be a federal system. We have existing data security commitments, and an existing approach to meet those commitments and audit compliance. Does CFA intend the contractor to demonstrate that the DAE complies with the security requirements in this section and seek a FedRAMP compliant ATO? Does CFA intend these requirements to apply to any system other than the DAE?

Section 9 – additional requirement, information security and privacy pg. 9-29

A.No. Language included in PWS regarding ATO and or FedRAMP compliance is required to be included but only applies to systems being developed as an deliverable to CDC.

Q53. It does not appear that the security requirements in this RFP would apply to the data analytics environment (DAE) (see previous question). Therefore, it is unclear how the production of these deliverables should be accounted for in the budget and schedule. Does CFA intend the contractor to produce these deliverables for the DAE? For any other systems? Section 9 - Schedule of

Deliverables pg. 28-29

A. The security requirements are included as standard launguage in the event a data system being delivered becomes a deliverable. As stated in the question the DAE is not subject CDC security requirements.

Q54. The proposal is due August 24. Should the period of performance be October 1, 2023 through

September 30, 2028? F.2 Period of Performance pg. 34

A. The Period of Performance is estimated to begin September 29, 2023.

Q55. Pg. 71 of the RFP refers to budget spreadsheets not counting toward the page limitation of the technical proposal, however there is no mention of budget spreadsheets in the business proposal instructions (section L.4 on pg. 72). Are offerors required to submit their budget in spreadsheet format and if so can the government please provide instructions on what should be included in the spreadsheets?

A.See Amendment 2. Page 73 has been revised to include cost and pricing data.

Q56. The instructions (L.5) state the offerors shall include the information for the last 3 completed contracts and all current contracts. The evaluation criteria (M.7) mention relevant contracts. Can CDC confirm what offerors should submit to satisfy CDC’s request in Section L.5? The last 3 contracts completed or the last 3 relevant contracts completed? And all contracts currently in process or only relevant current contracts? To satisfy the requirement for 3 completed contracts, can offerors provide a project description for a current project that is ongoing and has been underway for over a year? Note that all contracts completed or in process could be in the hundreds for some vendors.

A. The last 3 relevant contracts current or completed.

Q57. …a description of the performance techniques and methodology they propose in performance of this task. The Offeror shall provide a Project Management Plan and a Contract Work Breakdown

Structure (CWBS) describing the process and approach they propose to use in successfully completing this project. The CWBS should correlate to the Offeror’s price/cost proposal. This sentence is in the technical approach section, but there’s also a separate management approach section – where should this information be provided?

A. In the Technical Approach

Also, given the 20-page constraint of the technical proposal, can the PMP and CWBS be moved to an appendix? Section M.3, 1. Technical Approach & Understanding the Requirement – 40 Points

Maximum pg. 75

A. No

Q58. “Page formatting can alter for illustrations and tables but must be easily readable.” Please confirm this means that it is acceptable for illustrations and tables to contain font sizes less than 12pt/other than

Times New Roman, as long as they are easily readable.

A. Yes

Q59. Are linkages to state immunization registries the only type of linkage of interest to CDC? 1.

Technical approach pg. 76

A.No, other data linkages may be of interest. Preference will be given to those that can link individual records to state immunization records (see page 9).

Q60. Is this linkage expected to link individual patients to an individual vaccination record?

A.If the Offeror has capability to link the DAE to state immunization registries, yes, the linkage is ideally expected to link individual patients to their vaccination records.

Q61. Was text accidentally deleted from sub-bullet “4.f”? 4. Management approach pg. 77

A. No. This is a typo – renumbered. See amendment 2

Q62. How many past performance questionnaires should be completed for this proposal? In the past, the CDC has required 3 completed questionnaires. Also, can a CPARS be submitted for a project in lieu of a questionnaire? Section M.7 Past Performance pg. 78

A. Three. No

Q63. Are the three projects requested in the Similar Experience section the same 3 projects used for the past performance questionnaire (sections L.5, p.74; M, M.7 - Past Performance, p. 78)?

Can offerors provide a project description for a current project that is ongoing and has been underway for over a year?

A. Yes and Yes

Q64. The past performance questionnaire language needs to be updated with the name of this opportunity.

A.Updated. See Amendment 2.

Q65. Does the CFA envision the offerer working with other data partners to co-conduct certain studies?

Section 2-Purpose/Objective pg. 5

A.No, CFA does not envision the Offeror working with other data partners outside of CDC.

Q66. Conversion of data sources to a common data model (CDM) and related data refresh increases data lag. We assume the CFA would like to have the data sources in both their native form for shorter time lag and have the option to convert native format to CDM only when cross-partner collaboration is needed. Please confirm. Section 3-Scoope of Work pg. 5

A. We want the CDM also updated with short data lag

Q67. Is the CFA anticipating the offeror to assemble a network of data partners, or work with CFA's existing network of data partners? Task 1: Data Analysis Environment & Data Sources pg. 5

A. CFA does not anticipate building a new network. Per section I of the PWS, “CFA seeks access to a large-scale data source from electronic medical records and health claims in the United States that will enable rapid analyses to assess such quantities as disease incidence and prevalence, severity, sequelae, countermeasure effectiveness, overall and in subgroups of particular interest for reasons of vulnerability or health equity”.

Additionally in section 8: “CFA seeks access to a large-scale data source from electronic medical records and health claims in the United States that will enable rapid analyses to assess such quantities as disease incidence and prevalence, severity, sequelae, countermeasure effectiveness, overall and in subgroups of particular interest for reasons of vulnerability or health equity”.

CFA anticipates the offeror will be part of an organization that has this access or will work with an organization that has access to this data.

Q68. Is the CFA anticipating the offeror functioning in a combined coordinating center and data partner role? Task 1: Data Analysis Environment & Data Sources pg. 5

A. The Offeror shall function as a data partner and shall take on operational responsibilities to ensure that studies are completed in timely manner.

Q69. We assume that the studies anticipated under Task 3: Studies are full-length epidemiologic studies involving complex design and causal inference between risk exposure and health outcomes. Under Task

2, Analytic Capabilities, is the CFA anticipating less complex descriptive, feasibility, and ad-hoc analysis

"to investigate trends and to detect, monitor, and especially to characterize emerging infectious and noninfectious threats"? How many such descriptive analyses does the CFA anticipate conducting annually? Does the CFA have any assumptions of the level of effort for each? Pg. 6

A. The level of effort for each study may vary, depending on the needs of CFA. The Offeror and CFA will pre-determine the timeline for each study, ensuring that requested work is feasible within timeframe.

However, each study is intended to be performed relatively rapidly. See page 9: first interim analyses expected to be available within 21 days and final analyses expected to be available with 42 days, unless otherwise agreed. See question 21. Here is an example of papers that CFA already produced here as examples for the level of effort:

https://pubmed.ncbi.nlm.nih.gov/?term=37386005,35737591,35675841

Q70. The level of effort related to the studies could vary significantly depending on whether the

Government requires medical chart reviews, family linkages, IIS data linkage, and whether we need to use the common data model version of one or more data sources. For budgeting purposes, can CFA provide additional detail and level of effort regarding the anticipated five studies? Task 3: Studies

pg. 7 https://pubmed.ncbi.nlm.nih.gov/?term=37386005,35737591,35675841

A. The level of effort for each study may vary, depending on the needs of CFA. The Offeror and CFA will pre-determine the timeline for each study, ensuring that requested work is feasible within timeframe.

However, each study is intended to be performed relatively rapidly.

Q71. Since the core data requirement of the RFP is EMR data and claims data is optional, is it correct to assume that the CFA anticipates all 5 studies use the EMR and the claims data would only be used if needed to address a study question not possible with the EMR? Task 3: Studies pg. 7

A.Yes, this is an accurate assumption.

Q72. Please clarify "within 21 days" of what milestone and whether it is calendar days or business days.

Section 7 - Deliverables/Reporting Schedule

A. The 21 days begin after the protocol is developed and approved by the COR. See page 7. Deliverable schedule is in calendar days.

Q73. Data from state immunization registries is not discussed in Section 4, but is mentioned in Item h in the evaluation criteria for the technical approach. Is the Government interested in accesing state immunization data as part of this work? The RFP amendment newly added the vaccine registry data under Section 8. Does CFA intend to link the vaccine registry data with EMR, or with claims, as the Level of Effort and compliance requirement will be different Section 8-Minimum Vendor Qualifications

pg. 9

A.. CFA intends to link vaccine registry data with EMR data.

Q74. Please confirm that FedRAMP security requirements only applies to those cloud based solutions and not applicable if the Offeror's proposed solution is a Contractor-Owned, Contractor-Operated

(COCO) internal on-premise solution. Section 9 - Additional Requirements pg. 15

A. FedRAMP security requirements do not apply to this work as long as a system does not become a deliverable.

Q75. Please confirm that federal ATO is not required since the Offeror is only using deidentified data to produce aggregated results, using a Contractor-Owned, Contractor-Operated (COCO) internal on-premise solutions. Security Assessment and Authorization (SA&A) pg. 17

A. Federal ATO is not required for this work s long as a system does not become a deliverable.

Q76. What is the anticipated start date for the period of performance?

A. September 29, 2023

Q77. Who are the Key Personnel required for this contract, including roles/responsibilities and minimum education/experience? In addition, please verify if resumes for Key Personnel are required. H.19

Point of Contact pg. 55

A. These are the offerors key personnel. Yes, resumes for proposed Key Personnel are required (limited to two (2) pages per resume).

Q78. Please confirm that Times New Roman/Arial Narrow 8 point font is acceptable for tables, figures, graphics, and exhibits. Pg. 71

A. 8 point font is acceptable for tables and figures only.

Q79. Please confirm that offerors can provide a separate, standalone Past Performance volume, inclusive of the requested information (e.g., Volume III - Past Performance), with no prescribed page limit. Pg. 74

Yes, but past performance should be submitted on no more than 4 pages.

Q80. Please confirm that the Government's intent is for Offerors to provide only three past performance citations, for either completed or on-going awards of similar scope/complexity, and not a comprehensive list of all current/active contract awards which would include contracts not relevant to this RFP. In order to provide the most relevant past performance, we respectfully recommend that the

Government modify this language to "The Offeror should include 3 relevant contracts performed during the last 5 years"

A. Offeror only needs to provide three projects completed wihtin the past three years ofsimilar scope, size, and complexity similar to the requirements described in the SOW.

Q81. Does the requirement for all proposed major subcontractors include "the last 3 contracts", "all contracts", or both? In order to provide the most relevant past performance, we respectfully recommend that the Government modify this language to "The Offeror should include 3 relevant contracts performed during the last 5 years"

Information for subcontractors is no longer needed. See Amendment 2.

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