Consolidated_Questions_With_Response_7-27-2022.docx

VSD SOLICITATION 75D301 22R 72305

CONSOLIDATED QUESTIONS WITH GOVERNMENT RESPONSE

The Government understands that this is a complex project, and that this multiple-layered solicitation can be confusing. Accordingly, a brief outline of the document requirements and sequencing is attached to the end of this document.

1. Will CDC consider providing a two-week extension to the proposal deadline?

GOVERNMENT RESPONSE: NO. This acquisition is on a tight timeline.

2. (A24, Page 9, Section F.ii) If the ancillary files will be used for multiple studies will the lead sites be responsible for providing additional detailed requirements for “OB/GYN status”, “infant development”, and “contraceptive” variables?

GOVERNMENT RESPONSE: Yes

3. (A19, Page 19, Section A. Training) Are these new trainings in addition to the annual 308(d) and DUA that we already complete? Either way, will we need to provide documentation for each individual who completes the training or will we keep records on file locally and provide a proxy letter the way we do currently?

GOVERNMENT RESPONSE: If these trainings are required (CDC staff will need to confirm), then a proxy letter will likely suffice.

4. Is an NIH Biosketch sufficient for the requirement of Key Personnel resumes detailing relevant experience? Sample Task Order, B.2 p.13 GOVERNMENT RESPONSE: Yes

5. Please confirm Key Personnel are individuals at offerors organization that can hold principal investigator/co-investigator status and does not include data managers, program managers, or administrative personnel. Sample Task Order, B.2 p.13 GOVERNMENT RESPONSE: Key personnel may include PIs, data managers, and project managers. This is dependent on the role and critical need required of those personnel.

6. The IDIQ document states a page limit of 30 for the Technical Volume (bottom of p. 51). Is this for Parts 1 + 2, or just for Part 1? (We do see that the sample T.O. document states a page limit of 25 for the technical part of that application (p. 11 of that document) but would like to know if that’s to fit inside the 30-page limit, leaving only ~5 pages for Part 1.) IDIQ RFP, L.5. Technical Proposal Instructions; Sample Task Order, Instructions to Contractors IDIQ, p. 51; sample T.O., p. 11 GOVERNMENT RESPONSE: The Sample Task Order Proposal limit of 25 pages is separate from and not included in the 30 page IDIQ limit.

7. How many contracts should be included for the past performance section? Right now, it states: "The offeror should include the last (Government fill-in – number of contracts) contracts completed during the past three years and all contracts currently in process for both the offeror and all proposed major subcontractors." IDIQ RFP, L.7 CDC0.L018 Past Performance Information (May 2020) p. 53 GOVERNMENT RESPONSE: Three contracts should be included if the Offeror has a past performance history.

8. Where should evaluations of past performance be sent? (Are evaluators to send evaluations directly to CDC, or back to us to include as a part of the proposal submission?) IDIQ RFP, L.7 CDC0.L018 Past Performance Information (May 2020) pp. 53-54 GOVERNMENT RESPONSE: The Past Performance Volume should be submitted with the proposal.

9. Is there a form/template to use for the past performance evaluations? IDIQ RFP, L.7 CDC0.L018 Past Performance Information (May 2020) pp. 53-54 GOVERNMENT RESPONSE: No.

10. Do references count towards page limits? IDIQ RFP

GOVERNMENT RESPONSE: No

11. Are Co-Principal Investigators/Co-Directors allowable on the IDIQ contract? IDIQ RFP GOVERNMENT RESPONSE: Yes. However, no direct contact work is conducted on the IDIQ. All work will be conducted on task orders issued under the IDIQ.

12. Can we receive additional details about allowable labor categories? (Can additional labor categories be proposed for the Business Proposal and the Sample Task Orders, other than those categories included here?) IDIQ RFP, B7 p. 2 GOVERNMENT RESPONSE: Labor categories are determined by the Offeror based on their best business practices.in response to the requirements in the Task Order solicitation.

13. On future task orders released under VSD, are prime sites allowed to engage with subcontractors not named in the IDIQ Technical proposal? IDIQ RFP GOVERNMENT RESPONSE: Yes.

14. Does CDC consider VSD data to be Controlled Unclassified Information? IDIQ RFP, Section C.6 – IT Security. p. 16 GOVERNMENT RESPONSE: No, as far as we’re aware, VSD is not considered CUI.

15. Should proposed hourly rates for each labor category be loaded or fully loaded rates? IDIQ RFP, Section L.6 p. 53 GOVERNMENT RESPONSE: Rates shall be broken down to include Fringe benefits, indirect rates and any other expense covered in the Offeror’s negotiated indirect cost rate agreement.

16. This indicates that Audited Financial Statements should be submitted “when applicable or upon request”. Are they required for this submission, or only upon request? IDIQ RFP, Section L.6 (b). p. 53 GOVERNMENT RESPONSE: Only upon request.

17. States here that “Business Proposals shall be submitted in editable MS Word, with Pricing Spreadsheets formatted in editable MS Excel”. However, on page 14, section 8.4 (d), it states “Cost and pricing data is not required with initial proposals. If it is determined at a later date…”. Could CDC please clarify whether cost and pricing data is required for the Infrastructure Task Order? Sample Task Order, Section 8, Instructions to Contractors p. 11 GOVERNMENT RESPONSE: There are no direct cost associated with the IDIQ contract. The costs associated with the Sample Task Order Proposal solicitation will be used to evaluate the Offerors cost structure for the IDIQ.

18. Also Section 8, if cost and pricing is required - should cost and pricing data be fully loaded or loaded rates, or a detailed breakdown, as this Task Order is cost reimbursement?. Sample Task Order, Section 8 p. 11 GOVERNMENT RESPONSE: Certified Cost and pricing data are not required. This is totally different from contract pricing information.

19. We see that the staffing and management plan for the IDIQ should be overarching and assume this means it is not expected to be highly specific (IDIQ, p. 52). For the IDIQ Business Proposal, which is to contain only IDIQ responses and not responses applicable to the Sample Task Order (IDIQ, p. 52), we see that “The staffing plan included in the technical proposal shall be included in the business proposal, along with the proposed hourly rate for each proposed labor category” (IDIQ, p. 53). Although the IDIQ staffing plan is not expected to be specific, should the staffing plan in the IDIQ business proposal be identical (plus the hourly rates) to the staffing plan in the Sample infrastructure task order business proposal? IDIQ RFP, Mandatory Criteria for Award pp. 52, 53 GOVERNMENT RESPONSE: No. It is not necessary to repeat project specific information in the IDIQ proposal.

20. Is there anything else that needs to be included in Part 1 of the Technical Proposal aside from the responses to the mandatory criteria and a high-level overview of the staffing/management plan? (The L.5 Technical Proposal Instructions state that "The technical proposal consists of two parts: Part 1. Response to Mandatory Criteria Part 2. Technical approach to VSD Infrastructure sample task order, including staffing/management plan, and previous experience." Then on page 52, it says "In part 1 of the technical proposal, the Offeror shall provide a narrative and any other descriptive information or evidence of how their organization meets each of the mandatory criteria listed above. If the offeror meets these criteria, the Government will then evaluate the full technical proposal. ") IDIQ RFP, L.5. Technical Proposal Instructions pp. 51-52 GOVERNMENT RESPONSE: No

21. Are there templates that we should use and can be shared for the staffing plan required in the IDIQ Technical Proposal and/or the Sample Task Order? IDIQ, RFP, L.6 Business proposal instructions p. 53 GOVERNMENT RESPONSE: No

22. Are we supposed to list the salaries/fringe for each person on the IDIQ business proposal, or just the "proposed hourly rate for each proposed labor category" (page 53, business proposal)? (On page 50 of the IDIQ it states, "As part of their proposals, offerors will submit a total compensation plan setting forth salaries and fringe benefits proposed for the professional employees who will work under the contract.") IDIQ, L.1 FAR 52.222-46 p. 50 GOVERNMENT RESPONSE: Costs must be broken down into labor rate, fringe benefits, indirect rates and any other expense covered in the Offeror’s negotiated indirect cost rate agreement.

23. Is there a template we should use and can be shared for presenting the time and effort (labor hours) of proposed staff on this project and other projects (#3, B.2 staffing and management) Sample Task Order, B.2 Staffing and Management p. 13

GOVERNMENT RESPONSE: NO

24. There are 2 attachments to this email. One is the IDIQ solicitation. The second is a solicitation for a sample task order under the IDIQ for the VSD Infrastructure. Responses to the Sample Task Order solicitation will be used, in part, to evaluate the IDIQ Proposal. Offerors must provide a complete and separate response to both solicitations to be awarded the IDIQ contract.” Can you provide clarity on how to submit 2 complete and separate responses if indeed the Sample Task order relates to the Infrastructure portion but you say that the “Sample Task Order solicitation will be used, in part, to evaluate the IDIQ Proposal”?

GOVERNMENT RESPONSE: Yes. In response to multiple questions a brief outline of the expected submission is at the end of this Q&A.

25. If we follow the Sample Task Order format for the Infrastructure TO response, what does the separate IDIQ response look like?

GOVERNMENT RESPONSE: In response to multiple questions a brief outline of the expected submission is at the end of this Q&A.

26. Where does our budget for Infrastructure activities go? I don’t see a spot for it in the Sample Task Order attachment.

GOVERNMENT RESPONSE: The budget for the Infrastructure Sample Task Order is a technical Volume of RFTP 2022 VSD 01.

27. Is there a detailed budget required for the IDIQ?

GOVERNMENT RESPONSE: There are no direct cost associated with the IDIQ contract.

28. How many “past performance” contracts are required/requested?

GOVERNMENT RESPONSE: 3.

29. Would you like us to provide resumes for key personnel added through this application (not already submitted in prior VSD TOs)?

GOVERNMENT RESPONSE: Yes

30. Section C.6 IT security – is the VSD data infrastructure at our site regarded as “hosting or creating an information system on behalf of CDC”?

GOVERNMENT RESPONSE: No it is not.

31. Section L.7 CDC0.L018 Past Performance Information – looks like it is missing the number of completed contracts we need to include (currently has (Government fill-in – number of contracts)) GOVERNMENT RESPONSE: Three should be included.

32. Travel (Both sample TO RFTP and IDIQ RFTP) Travel procedures seem to differ in the IDIQ versus the sample infrastructure task order. Should we respond to each in differing ways in each document’s accompanying business proposal or follow “b” below for both?

a). In IDIQ, page 12, #5 under “travel” (and page 11, section 7 “travel”) states: “When authorized in the contract as a direct cost, travel costs that are directly related to specific contract performance may be billed as a direct cost” b). In the sample infrastructure task order, page 4, section iv: “All travel will be authorized and funded in advance by the Government via a modification to the task order. The contractor shall notify CDC in advance of any travel plans and will adhere to all federal travel policies.”

GOVERNMENT RESPONSE: Local Travel incurred incidental to performance of a project may be included as a direct expense. This is ancillary, local, nonroutine travel required to complete project activities.:

33. IDIQ pass but not awarded task order (IDIQ RFTP) Under what circumstances is a site not awarded a task order yet passed the IDIQ? Is there opportunity to engage with VSD in the future as funds become available if not awarded task order?

GOVERNMENT RESPONSE: Not all Offerors will be awarded an IDIQ contract. If awarded a tan IDIQ contract, awardees are eligible for task order award. It is likely, but not guaranteed, that all IDIQ holders will be awarded a task order shortly after award of the IDIQ. All IDIQ holders will be allowed to submit proposals for all future task orders.

34. Quality Assurance Performance Work Statement (sample TO RFTP) On page 24, attachment 3: Are offerors to address each component of the quality assurance PWS (e.g., standards-criteria for acceptance)?

GOVERNMENT RESPONSE: No specific response is required. This attachment is provided to inform the Contractor of the measures the Government will use to evaluate performance in payment, CPARS, and to help identify performance issues.

35. Past Performance (IDIQ RFTP)

a) Are the CPARS evaluations requested for past performance? On page 54, number 11 of the IDIQ Request for proposal instructions, it notes “Copies of the most recent Past Performance Evaluation issued to the offeror under each contract listed”.

b) Is it permissible to use past and current VSD contracts or is the government anticipating other past performance from other federal funding agencies, such as NIH grants? If so, is a letter from the project officer of the NIH grant indicating performance on the NIH grant acceptable?

GOVERNMENT RESPONSE: CPARS reports and other contract performance not on CPARS may be used to verify past performance on projects of similar size, relevancy, and scope to the IDIQ. Grant experience probably is not relevant to contract performance.

36. Sequential response to each requirement of each RFTOP

a) Does the government expect to see a sequential response to each requirement listed in the RFTOP as presented in the instructions section, or can offerors combine similar requirements found elsewhere in the RFTP together under one subheading and provide the government with a matrix for each requirement and its subsequent location in the response document?

b) for the IDIQ response document, can the offerors summarize their ability to accomplish the sample grant task order requirements at the end of the proposal document?

GOVERNMENT RESPONSE: Responses should be written in a manner that allows for an easy to understand and unambiguous evaluation. Responses shall not reference information in another volume. For example, a technical response cannot reference information in a business or Past Performance Volume. Combining responses is done at the risk of the Offeror.

37. Security requirements for IDIQ RFTOP (pages 15-31)

a) Page 15, Section H: Does the contractor expect/require response to each subsection of section H or are these informative data/specifications should the offeror be awarded the IDIQ?

b) Page 16, Section C.6: IT Security: Does the contractor expect/require response to each subsection of section C.6 standards or are these informative data/specifications should the offeror be awarded the IDIQ GOVERNMENT RESPONSE: Contractors do not need to respond to these sections. They are informational only.

38. General staffing management plan for IDIQ RFTOP (page 52) For the IDIQ technical proposal, we are to address the following components to, at an institutional level, demonstrate our ability to manage a large project within our research institute: “staffing and management plan for the IDIQ should address the Offerors overarching methodology for providing qualified staff for projects anticipated under the IDIQ, overall management of large scale projects, recruiting, retention of personnel, planning for contingencies, and other similar policies for maintaining a high quality staffing and management posture” Are we then to copy and paste this information into the IDIQ business proposal or summarize what is in the technical proposal?

GOVERNMENT RESPONSE: These items should be addressed in the Technical Volume only.

40. Scoring criteria: Past performance versus Previous experience (page 55 of IDIQ RFTOP) The term “previous experience” is used for the scoring criteria on page 55 of the IDIQ RFTOP (20 points). Is the term “previous experience” synonymous with “Past performance”, a required separate document described on pages 55-56 or is it a separate section/requirement?

GOVERNMENT RESPONSE: Similar Experience is not synonymous with Past Performance. Similar Experience is what you have done. Past Performance is an outside assessment of how well you did it.

41. Questions re: the Sample VSD Infrastructure TO, 8.2 Staffing and management:

GOVERNMENT RESPONSE: Resume of 2 or 3 key personnel are sufficient. Time and/or effort refers to estimated hours or percentage of annual effort, depending on the method used by your organization to track the effort expended. This is for this project only. Delete reference to “and other projects.”

41.Question re: IDIQ TO, Section L “Instructions, Conditions, And Notices To Offerors,” L.5 Technical Proposal Instructions, c:

The instructions say that the technical volume is limited to 30 pages. Does this mean that together the response to Part 1. Response to Mandatory Criteria, and Part 2. Technical approval to VSD sample task order are limited to 30 pages total? Do references count in the page limit?

GOVERNMENT RESPONSE: No. Technical Volume of IDIQ submission is 30 pages. The Sample Task Order technical proposal is an additional 25 pages.

42. Question re: IDIQ TO, Section L “Instructions, Conditions, And Notices To Offerors,” L.6 Business Proposal The instructions ask us to submit a completed copy of Section B (Supplies or Services and Prices/Costs). Can you clarify what offerors should be completing within Section B. We were wondering if we are to provide a unit price in the table, however, the business proposal instructions also state that “cost and pricing data is not required with initial proposals.”

GOVERNMENT RESPONSE: “Cost and Pricing Data” is legal term. Detailed estimated cost/pricing of the project is required.

43. Question re: IDIQ TO, Section L “Instructions, Conditions, And Notices To Offerors,” L.7 Past Performance Information.

Do you want past performance information for contracts involving only the VSD team members or any contracts held by our institution over the past 3 years? Can you confirm you need only contracts and not grants?

GOVERNMENT RESPONSE: Past performance on 3 Contracts is requested. Th may be with any Government or nongovernment entity. It is important that the contracts represent work that is relevant to, and of similar scope to the work contemplated in this IDIQ.

44. On Page 2 of document A.19, Section B.1 mentions an “as needed” mechanism to procure task orders. Does the CDC expect to issue multiple RFPs under this IDIQ, or will only one award be made? TO how many different IDIQ holders were awards made under the prior IDIQ? And of the current VSD participating organizations, are they all separate awardees under the IDIQ?

GOVERNMENT RESPONSE: The Government will issue multiple task orders to multiple IDIQ holders over the course of the IDIQ ordering period. Each IDIQ Contact is separate. The current IDIQ was awarded to 8 sites.

45. On Page 3 of document A19, section C.1, the RFP mentions a distributed data model. Will all work require a DDM, or will other solutions be considered using privacy-preserving linkage technology to directly analyze de-identified data?

GOVERNMENT RESPONSE: All work will require a DDM, and no other solutions will be considered for routine distributed data model transmissions for site-to-CDC data transmissions and to analyze de-identified data.

46. On Page 3 of document A19, section C.1, the RFP refers to “vaccine safety evaluation and monitoring through a large, diverse, population-based system.” Are there specific population gaps in the approach used to date that the government is interested in addressing going forward?

GOVERNMENT RESPONSE: Pregnant persons and people who are immunocompromised

47. On Page 3 of document A.24, section 5.3 (Scope of Work), the sample RFTOP mentions that the data are formatted in SAS. Is the CDC willing to consider other data formats?

GOVERNMENT RESPONSE: SAS is the current format that is best suited for use with the Distributed Data model; the model utilizes SAS programs, SAS datasets, and SAS transport files.

48. On Page 11 of document A.24, section 8, the instructions say “Proposals shall not include information regarding past performance…”; however, on Page 13, Section 8.3, the there is a request for one example of past performance. Shall we fulfill the requirements of 8.3?

GOVERNMENT RESPONSE: There is a requirement for 1 project citing similar experience, not past performance. Performance evaluations of that project is not required.

49. On Page 12 of document A.24, section 8.1, the approach refers to health plans. Will CDC consider other sources, such as large provider systems or other real-world data sources?

GOVERNMENT RESPONSE: Yes, as long as there is an electronic vaccine registry and there is routine access to medical records.

50. A24.C.ii. Requires the DDM functions to transmit emails to the government. Is the expectation that the data will be emailed? Or is the government open to other file transfer options like SFTP or box.com sites?

GOVERNMENT RESPONSE: The email function does not transfer data to the government, but the SAS programs that are submitted using the DDM contain emails that can be sent so CDC analysts can receive emails while the program is running and help troubleshoot any known issues. Data are only sent through the secure process of the DDM, which utilizes SFTP processes.

51. Is CDC planning to integrate the data from this work with existing data sources, and if so, can CDC provide information on what those sources are?

GOVERNMENT RESPONSE: To the best of our knowledge, no.

52. Is CDC interested only in electronic health record data, or would CDC also consider data from large, national claims databases?

GOVERNMENT RESPONSE: CDC would possibly consider this option depending upon the completeness of the data, the size, and if there is an electronic vaccine registry as well that captures vaccines on the entire cohort of interest.

53. Should we prepare 2 separate technical proposals, 1 for IDIQ and 1 for the sample RFTP, or should these be combined? If combined, please clarify the page limit; the IDIQ instructions state the word limit is 30 pages, and the RFTP instructions state that the word limit is 25 pages. [IDIQ section L.5, Technical Proposal Instructions, page 51 RFTP section 8, Instructions to Contractors, page 11]

GOVERNMENT RESPONSE: These are separate volumes.

54. Should we prepare 2 separate business proposals, 1 for IDIQ and 1 for the sample RFTP, or should these be combined? [IDIQ section L.6, Business Proposal Instructions, pages 52- 53 AND RFTP section 8.4, Business Proposal Instructions, pages 14-15]

GOVERNMENT RESPONSE: These are separate volumes.

55. Should the past performance proposal be submitted separately or combined with the technical proposal? The IDIQ instructions ask for this to be submitted separately, and the RFTP instructions ask for this to be included as a third part of the technical proposal called “Experience and Expertise”. [IDIQ section L.7, Past Performance Information, pages 53-54 AND RFTP section 8.3 Experience and Expertise, pages 13-14]

GOVERNMENT RESPONSE: Past Performance is a separate Volume of the IDIQ proposal.

56. Is there a specific format required for the IDIQ budget? [IDIQ section L.6, Business Proposal Instructions, pages 52-53]

GOVERNMENT RESPONSE: No

57. How many contracts should be listed in the Past Performance proposal as part of the IDIQ response? The instructions do not provide a number, rather it reads “Government fill-in – number of contracts”. [IDIQ section L.7, Past Performance Information, pages 53- 54]

GOVERNMENT RESPONSE: 3

58. Please clarify if staffing/management plan and previous experience sections are needed for the IDIQ technical response, or if these sections should only be provided as part of the RFTP technical response; the IDIQ evaluation criteria reference an “IDIQ Staffing/Management Plan” and “IDIQ Previous Experience” but the instructions also state that the “evaluation criteria are identical to the…sample task order”. [IDIQ section M.3, Technical Proposal Evaluation Criteria, page 55]

GOVERNMENT RESPONSE: Please see the attached Submission Outline. A staffing/management plan is not required for the IDIQ technical response, but examples of previous experience are required.

59. Our current infrastructure contract ends 9/27/2022. Please confirm that the Year 1 infrastructure option period for the new contract will not begin until 9/29/2022. [RFTP, section 3, Period of Performance, page 1]

GOVERNMENT RESPONSE: Correct.

60. Does CDC have a proposed data source for the Ob/Gyn status ancillary file referenced in the technical requirements section (i.e., ICD-10 vs. DXID vs. other structured data fields in the EHR)? [RFTP section 5.4 Technical Requirements, subsection F.ii., page 9]

GOVERNMENT RESPONSE: The data source is typically a combination of EHR fields that are not routinely available from the current inpatient and outpatient files.

61. Should the required statements be included with the business proposal, technical proposal, or both? [RFTP section 8, Instructions to Contractors, page 11] § Specific statement in question: “Your proposal must indicate that it is predicated on the terms and conditions of your VSD contract and is valid for a period of 90 days; and a brief statement indicating current or future commitments during the proposed performance period and any impact the commitments might have on performance of the task order.”

GOVERNMENT RESPONSE: Required Statements are a component of the Business Proposal.

62. Is there a specific format or page limit for resumes for key personnel? Would NIH biosketches be acceptable? [RFTP section 8.2, Staffing & Management Instructions, page 13]

GOVERNMENT RESPONSE: No limit. Yes, an NIH biosketch is acceptable

63. Is there a specific format required for the RFTP budget? [RFTP section 8.4, Business Proposal Instructions, pages 14-15]

GOVERNMENT RESPONSE: No

64. Can the deadline be extended?

GOVERNMENT RESPONSE: No

65. Is there a budget range or cap?

GOVERNMENT RESPONSE: No. Budgets will vary by site due to numerous factors. Price proposals will be carefully reviewed for appropriateness.

66.. (A19, Page 53, Section L.4 (b)) Please confirm the number of past/current contracts to include as part of past performance:

Offerors shall submit the past performance information as a separate proposal. The offeror should include the last (Government fill-in – number of contracts) contracts completed during the past three years and all contracts currently in process for both the offeror and all proposed major subcontractors. (A19, Page 53, Section L.4 (b))

GOVERNMENT RESPONSE: 3

67. (A19, Page 52, Section L.5 (d)) Should the solicitation name and number requested for inclusion on the cover/contact page be from the A19 RFA document (Solicitation no.: 75D301- 22-R-72305, Vaccine Safety Datalink Multiple Award IDIQ) or the A24 Sample RFTOP document (SAMPLE RFTOP Number: 2022 VSD 01, Request for Sample Task Order Proposal

GOVERNMENT RESPONSE. The IDIQ Proposal header should include reference to RFP 75D301 22 R 72305. The Sample Task Order header should include reference to RFTP 2022 VSD 01.

68. (A24, Page 9, Section F.ii) Please clarify whether the pregnancy, lactation, and maternal/infant outcomes ancillary files listed below are a one-time request for study #1355 Safety of COVID-19 during pregnancy (Quincer). If they need to be updated on an ad hoc basis depending on study needs, how frequently does CDC expect the files to be updated during the 5-year period?

Milk choice / breastfeeding status from maternal or infant clinical data Infant growth (length, weight, and head circumference in first year of life) Infant development (developmental screening data, when available) Teratogenic medication file Contraceptive medication file Ad-hoc updates to FAMID file, as requested Ob/Gyn status (e.g., menopausal, peri-menopausal, postpartum, etc.) from clinical data

GOVERNMENT RESPONSE: Correct, this is a current one-time data request for an existing study, #1355. There would not be an expectation for new sites who are not participating in the current study to complete these files. We apologize for the confusion.

69. (A24, Page 11, Section 8) Please clarify whether the statement below means that the past performance mentioned in the A19 RFP document (referenced in Q3 above) should not be included as part of the technical proposal:

Required Statements: Your proposal must indicate that it is predicated on the terms and conditions of your VSD contract and is valid for a period of 90 days; and a brief statement indicating current or future commitments during the proposed performance period and any impact the commitments might have on performance of the task order. Proposals shall not include information regarding past performance, letters of reference, or corporate capability. The proposal shall reference only the proposed work and budget for the referenced SAMPLE RFTP. Proposals containing information that is not specific to the proposed task will not be evaluated.

GOVERNMENT RESPONSE” Correct. The Past Performance Volume is separate from the Technical Proposal Volume.

70. (A24, Page 13, Section 8.3) Please clarify whether the project noted in the statement below should be included in the technical proposal. Is this separate from the past performance section mentioned in the A19 RFP document and referenced in Q3 above? The Contractor shall provide a description of one (1) project awarded or completed within the past three years that clearly demonstrates the Offeror’s experience in performing projects of similar scope, size and complexity to the requirements described in the solicitation.

GOVERNMENT RESPONSE: Experience listed in the sample task order is 1 project. This is totally separate from the PAST Performance Volume of the IDIQ proposal.

71. Please clarify conflicting instructions regarding page counts between the A19 RFP and A24 sample RFTOP documents. (A19, Page 51, Section L.5 (c)) The Technical Volume is limited to 30 pages (A24, Page 11, Section 8) Technical proposal shall not exceed 25 single spaced pages. Please clarify whether the 5 pages are intended to cover “Part 1. Response to mandatory criteria” and 25 pages are intended to cover “Part 2. Technical approach to VSD infrastructure sample task order, including staffing/management plan, and previous experience.”

GOVERNMENT RESPONSE: Technical Volume for IDIQ is 30 Pages. The Technical Volume for the Sample Task Order is an additional 25 pages.

72. Please clarify whether “Past Performance Information” is separate from the Technical Proposal and if it has no page limit.

GOVERNMENT RESPONSE: Correct.

73. A19. Request for Proposal IDIQ p. 51, L.5 Technical Proposal Instructions (c) Font size is specified as 12 points (down to 8 point for tables), is there a required font type or margin specifications for our response?

GOVERNMENT RESPONSE: Please use the font listed in the IDIQ for all responses.

74. A19. Request for Proposal IDIQ p.53, L.7 Past Performance Information “(b) Offerors shall submit the past performance information as a separate proposal. The offeror should include the last (Government fill-in – number of contracts) contracts completed during the past three years and all contracts currently in process for both the offeror and all proposed major subcontractors.” Please clarify the number of past performance contracts that should be provided.

GOVERNMENT RESPONSE: 3

75. A19. Request for Proposal IDIQ AND A.24 Sample Request for Task Order p. 51-52 L.5 Technical Proposal Instructions (c) and (d) AND p. 11 8. Instructions to Contractors In section L.5, (c) the page limit is specified as 30 pages, however in section (d) it references two part 1 (IDIQ response) and 2 (Infrastructure response). Additionally, in the Sample Task Order (Infrastructure) it indicates a 25 page limit. Is the total page limit for part 1 – 30 pages and part 2 – 25 pages, for 55 pages total? Please clarify.

GOVERNMENT RESPONSE: The Technical Volume, part 1&2, has a 30-page limit. The Sample Task Order Proposal has an additional 25-page limit.

76. Also - could you clarify the expected technical and business proposals requested?

IDIQ solicitation:

Sample Task order solicitation

GOVERNMENT RESPONSE: Correct.

77. A.24 Sample Request for Task Order p. 11, 8. Instructions to Contractors: ” Business Proposals shall be submitted in editable MS Word, with Pricing spreadsheets formatted in editable MS Excel.” p. 14, Business Proposal Instructions: “(d) Cost and Pricing Data Cost and pricing data is not required with initial proposals. If it is determined at a later date that cost and pricing data is required, the offeror must submit supporting cost and pricing data adequate to establish the reasonableness of the proposed amounts.” Similarly, one section seems to indicate cost/price proposal with the Sample Task Order (p.11) however the instructions for the business proposal indicates no cost/price proposal (p.13) please clarify where the cost/price proposal should be submitted.

GOVERNMENT RESPONSE: Certified Cost and Pricing data is different from contract pricing/cost estimates. The cost proposal for the infrastructure task order is a volume under the Sample Task Order.

78. A.24 Sample Request for Task Order p.13, 8.2 Staffing and Management “3. Time and effort (labor hours) of proposed staff on this project and other projects” Does “other projects” here refer to other funded VSD task order work, or all other federal projects? Please clarify.

GOVERNMENT RESPONSE: Delete “and other projects”

79. A.24 Sample Request for Task Order p. 11 8. Instructions to Contractors Please clarify if any font type, size, or margin specifications are required for the Sample Task order response.

GOVERNMENT RESPONSE: None are listed. Use parameters for the IDIQ as a guide.

End of questions Sample Submission Outline begins on the next page

IDIQ Submission RFP 75D301 22R 72305 (3 Volumes)

1. Technical Volume

a. Cover Letter (L5(d))

b. Response to Mandatory Criteria for consideration (L5(d)

c. Overview of Capabilities and ability to meet the requirements in the Statement Of Work (C.5.1, C.5.2, and C.5.3). Not RFTP Specific. Include a discussion of your organizations capability to comply with each of the Section 508 requirements (Section H, Page 15)

d. A statement that indicates that the Technical Volume for RFTP 2022 VSD 01 is included in the Sample Task Order Proposal.

e. Resumes of Key Personnel

2. Business Volume

a. Insurance Requirement (H5, P 32)

b. Applicable Representations from Section K, pages 44 – 49

c. Responses from Section L6, pages 52 – 53. Page 1 Items 15 and 16. Include page 2, but no pricing information is required. L6(b) and L6(d) are not required at this time.

d. A statement that indicates that the Business Volume for RFTP 2022 VSD 01 is included in the Sample Task Order Proposal.

3. Past Performance Volume

a. Past performance on 3 previous contracts that indicate relevant and recent performance of similar projects. Can include Government and non-government entities.

b. Grant information might not be of value.

Task Order Submission RFTP 2022 VSD 01 VSD Infrastructure (2 Volumes)

1. Technical Volume

2. Technical Approach and Methodology. As depicted in 8.1, Page 12

a. Staffing and Management. As depicted in 8.2, page 12-13

b. Experience and Expertise. One project as depicted in 8.3 pages 13-14.

3. Business Proposal. No stated format. Delete Reference to Contact Form Recommend

a. Cover Page Signed by authorized official.

b. Task Order Pricing

i. Labor category, Name if identified, estimated hour or percent of effort, fringe, indirect rate and amount, other direct costs(travel, subcontracts etc.). and total estimated cost.

ii. Broken out by contract year, plus a Task Order Summary with total cost.

c. Representations, Certifications, Terms and Conditions of the IDIQ contract apply, and need not be submitted with Task Order Proposal.