Attachment D.7 - Questions and Answers.pdf

Solicitation 75D301-20-Q-71779 - Attachment D.7 – Questions and Answers

TBTC Monitoring Questions and Answers:

Office of Acquisition Services (OAS)

1. Question: I am hoping to find out if there is an incumbent contractor currently performing these services, if similar services have been performed in the past, or if this is a new requirement. If there is an incumbent, could you please provide the contract or task order number?

Answer: Incumbent contractor is Nues, LLC

2. Question: List of Items, Schedule of Requirements, Scope of Work, Terms of Reference, Bill of Materials required.

Answer: All solicitation documents have been or will be posted on BetaSam.gov

3. Question: Soft Copy of the Tender Document through email.

Answer: You are to pull all documents from BetaSam.gov

4. Question: Names of countries that will be eligible to participate in this tender.

Answer: Refer to the Solicitation and Solicitation Amendment 00001 for all detail.

5. Question: Information about the Tendering Procedure and Guidelines Answer: Refer to sections 12 & 13 of the Solicitation.

6. Question: Estimated Budget for this Purchase Answer: This information cannot be released.

7. Question: Any Extension of Bidding Deadline?

Answer: See Solicitation Amendment 00001.

8. Question: Any Addendum or Pre Bid meeting Minutes?

Answer: Any amendments to the solicitation, should they occur, will be posted to BetaSam.gov

9. Question: Per solicitation section 12, pg. 19, To avoid conflicting with the statement in item 3.(b) on page 19 of the solicitation that, "The technical proposal shall not contain reference to cost", can the Subcontracting Plan be added as an Attachment/Amendment?

Answer: Subcontracting Plan is moved to (6) under number 5 titled “Business Proposal Instructions (Apr 2000) of solicitation section 12 titled “Instructions, Conditions, AND Notices to Offerors”). See Solicitation Amendment 00001.

10. Question: Per solicitation section 12, pg. 19, Can the government confirm that the Excel file requested in item 3.(e) on page 19 of the solicitation is only required for the budget spreadsheet?

Answer: All costs captured in the Business PDF should be captured in the Excel document.

11. Question: Per solicitation section 12, 4(D)(5).B., pg. 24, Can the consent letter(s) (Attachment

D.5) from major subcontractors/teaming partners or joint ventures be included as an Appendix under TAB B?

Answer: Yes. See Solicitation Amendment 00001.

12. Question: We are looking to apply for the latest TBTC Montoring Services contract opportunity

(TBTCMonitoring42747), and while we’re aware that the annual project value it $9M we are seeking the value of the monitoring piece specifically for our budgeting purposes.

Answer: This is a competitive requirement and offerors must develop their own budgets for proposing purposes.

13. Per 4. TECHNICAL PROPOSAL INSTRUCTIONS; page 22 - (c) … The technical proposal shall be single spaced, single-sided, and on standard 8½ X 11-inch pages with 12 font characters.

Question: May Offerors utilize a smaller font (i.e. 10 font characters) for tables and graphics?

Answer: No

14. Per section B CONTINUATION CONTINUATION OF SF1449, page 3 - Section B Pricing Tables for Items 0001, 1001, 2001, etc.

Regarding completing Section B as part of the Business Proposal, the format of Section B in Items 0001, 1001, 2001, etc. calls for Time and Material (“T & M”) pricing of labor costs. The Section B tables for these Items list a quantify of “1 Job” with a “Unit Price” and a “Not To Exceed” value.

Question: Please clarify with regard to the “Unit Price” if the Government is requesting T&M rates for individual labor categories or if you want a single “Unit Price” that encompasses all services that will be performed in each yearly Item?

Answer: CLINS are revised and refer to revised section B.2 titled “Suggested Labor Categfories per Year. See Solicitation Amendment 00001 Question: It is unclear how to use the format with 1 Job as the quantity in a T&M format?

Answer: Please refer to revised Section B.2 titled “Suggested Labor Categories per Year”.

Question: Is the total price listed in Section B.2 of the RFP with the suggested labor categories intended to be the value that is used as the “Unit Price” for each year’s Job?

Answer: See revised section B.2 titled “Suggested Labor Categfories per Year” for additional details. See Solicitation Amendment 00001.

15. Per (2) Detailed Pricing Information on page 26 and the Section B Item tables relating to Items

0002, 1002, 2002, etc - Various references to “plug” travel and ODC costs Question: In (2) Detailed Pricing Information on page 26 of the RFP, the instructions indicate that offerors should propose “Travel, Other Direct Costs, or other ODCs that apply.” There is a note in the tables of Section B related to travel and ODCs (Items 0002, 1002, 2002, etc.) and in

(4) on page 26 that that indicate offerors should use a $10,000 plug value for these costs. These instructions regarding using a plug value appear to contradict the instructions to propose travel and ODCs “that apply”. Please clarify whether offerors should use the plug value or disregard the plug value and propose specific travel and ODC costs? Or if you intended something else?

Answer: See Revised CLINs and (2) “The completed Section B and Detailed Pricing Information” of Section 5 titled “Business Proposal Instructions (Apr 2000) under Section 12 of the solicitation titled “ Instructions, Conditions, And Notices to Offerors”. Solicitation Amendment

00001.

16. Per Section 10, Travel of the Solicitation Base Year: pg. 17 – Base Year:

International Travel: 4 international trips for a cumulative total of 16 days TDY will be required for performance in the base year. This is a maximum.

Domestic Travel: 3 trips to Atlanta, GA for a cumulative total of 10 days TDY will be required for performance in the base year.

Domestic Travel: 12 domestic US trips for a cumulative total of 48 days TDY will be required for performance in the base year. This is a maximum.

Question - Based on the language in the RFP related to the maximum number of days, can you clarify the number of site visits the monitor is to conduct considering that the expectation is for:

On-site initiation visits for all participating sites prior to first enrollment; On-site periodic monitoring visits; this could be up to 32 visits if all sites are initiated in the Base year?

Answer: See section 10 titled “Travel” and Section 6 titled “Period of Performance”.

17. Per CDC100_0004 Data Management Plan (Instructions) (Nov 2018), page 29 of the solicitation -

“CDC requires awardees of contracts that involve the collection or generation of public health data with federal funds to develop, submit, and comply with the requirement of a Data Management Plan (DMP) for each collection or generation of public health data undertaken.

Consistent with the terms of and activities expected under the statement of work, the offeror shall develop and submit a DMP as part of its proposal in response to this solicitation, and if awarded a contract, update the DMP throughout the life cycle of the public health data collected or generated during the performance period. …..”

Question: Can you clarify expectations for offerors to provide a DMP as part of their proposal submission as well as the role of the Data Analyst? Should offerors assume database development and data management support as part of their proposal response? Normally, the contractor responsible for these activities is responsible for DMP development.

Answer: Data Management Plan is no longer required. Refer to revised section B.2 titled

“Suggested Labor Categfories per Year” and PWS for understanding of Data Analyst role. See

Solicitation Amendment 00001.

18. Per (d)(5).A. Past Performance Information, page 23-24 of the solicitation - Past Performance

Information Question: The government requests that for relevant contracts offeror should provide the name and address of customer/client or government agency; contract number; contract type; total contract value; description of duties; performed (not just a title); period of performance;

contracting officer’s address, telephone, fax, and email address; program manager’s name, address, telephone, fax, and email address; and international location where work was performed. Please confirm the following:

1. Bidders are to provide this information for every relevant contract currently being performed (that is, not for any other current contracts).

Answer: The solicitation states offerors are to provide a list of all contracts currently in process for work similar in size and complexity to this acquisition and that for each contract provide the following information:

a) Name and Address of customer/client or Government Agency,

b) Contract Number,

c) Contract Type (Fixed Price, Cost Reimbursement, etc.),

d) Total Contract Value,

e) Description of Duties Performed (not just a title),

f) Period of Performance,

g) Contracting Officer’s, address, telephone, fax, and email address, and

h) Program Manager’s name, address, telephone, fax, and email address.

i) International location where work was performed

2. Bidders are also to provide this information for the last three relevant contracts completed in the last five years.

Answer: The solicitation states “Provide a list of the last three (3) contracts completed during the past five years”. It says nothing about “the last three relevant contracts…”.

3. Bidders may include contracts which did not include international work.

Answer: Yes, unless the solicitation explicitly states otherwise.

19. Per (d)(5).A. Past Performance Information, page 23-24 of the solicitation - Past Performance Information Question: Please consider waiving the need for submission of a Past Performance Survey for contracts where a CPARS evaluation is available. We have found in the past that COs have been reluctant to complete a questionnaire if a CPARS is on file.

Answer: See revised section (d)(5)(B) of number 4 titled “TECHNICAL PROPOSAL

INSTRUCTIONS” of solicitation section 12 titled “Instructions, Conditions, AND Notices to

Offerors”). See Solicitation Amendment 00001.

20. Per (d)(5).A. Past Performance Information, page 23-24 of the solicitation - “The Offeror shall provide a list of the last three (3) contracts completed during the past five years and all contracts currently in process for work similar in size and complexity to this acquisition.”

Question: With respect specifically to the requirement to provide “all contracts currently in process”…would the Government accept a summary of all of the Offeror’s relevant experience to this solicitation in the last 5 years (as opposed to the full details required of past performance), as this list can be quite long for large organizations likely far exceeding page limitations of the proposal), and the details (e.g. items a-i) are often confidential, particularly for commercial contracts?

Answer: Requirement remains unchanged. Please See Solicitation Amendment 00001.

21. Question: The NAICS code is listed as 541690 on SF 1449 (box 10), whereas the code on the companion TB clinical study RFP was 541714. Should this one also be 541714, consistent with the TB clinical study RFP? (In our experience, monitoring RFPs/contracts have typically been 541714 or 541715). Please confirm.

Answer: Solicitation NAICS is 541690.

22. Question: Please clarify whether the Data Management Plan will count against the page limitation.

Answer: Data Management Plan is no longer required. See Solicitation Amendment 00001.

23. Question: Per Section (d)(5).A. of the solicitation on pg. 23 - In our experience, many contracting officers are reluctant to complete the past performance surveys when an active CPARS evaluation is available. May offerors submit the most recent CPARS for each past performance reference in lieu of the past performance surveys?

Answer: See answer to #19 and Solicitation Amendment 00001

24. Question: Per Section 5.6. of the solicitation on pg. 29 - Will the CDC please verify whether the Data Management Plan requested as part of the business volume applies to this scope of work?

Based on the definition of tasks 1-5, this contract does not require offerors to generate or collect data. If it does apply, please provide a sample template, as the University of California link provided is password-protected.

Answer: See answer to #22 and Solicitation Amendment 00001

25. Question: Per page 22: Staffing/Management Plan: The statements: “State the estimated time to be spent on the project and his/her proposed duties” and “State the estimated time each will spend on the project….” If will be impossible to state, the estimated time per PM/Sr. CRA and CRAs since we have not been provided a full list of the sites and scheduling visit. Can CDC address this statement?

Answer: Refer to solicitation section B.2 titled “Suggested Labor Categories per Year”. Offerors shall also refer to section 6 titled “Period of Performance” for estimated number of studies to be initiated over the course of the contract’s period of performance. Offeror’s proposed response to (d)(2) of number 4 titled “TECHNICAL PROPOSAL INSTRUCTIONS” of solicitation section 12 titled “Instructions, Conditions, AND Notices to Offerors”) shall be based on their proposed

Technical Approach. See Solicitation Amendment 00001.

26. Question: Per page 26: “The offeror should propose Other Direct Costs, including Travel or other ODCs that apply. Note offerors are to use a travel plug number of $10,000.00 for each year (Base and each option) in developing their Business Proposals.” Can CDC explain this statement ? Is the Contractor expected to calculate the travel cost per year or just insert the $10,000 per year ? If CDC expect the contractor to calculate travel cost, can you provide the list of sites (locations) both international and north America since travel cost varies depending on the location of the sites and time of travel. If CDC expects a default insertion of $10,000 will this be a cap on the travel budget during contract performance, as the $10,000 estimate is low based on the frequency of travel as mentioned in Section 10 – Travel.

Answer: See answer to #15 and Solicitation Amendment 00001.

27. Question: Per page 25: “The completed Section B” Does CDC expect the contractor to complete SF1449 and submit with proposal as this is T&M contract without complete information on the extent of monitoring visits.

Answer: Yes, refer to (2) “The completed Section B and Detailed Pricing Information” of Section

5 titled “Business Proposal Instructions (Apr 2000) under Section 12 of the solicitation titled “

Instructions, Conditions, And Notices to Offerors”. Refer to sections 6 titled “Period of

Performance” and 10 titled “Travel” guide decision.

28. Question: Per page 25: If the contractor is already registered in SAM, should we still complete the Reps and Certs?

Answer: Yes

29. Question: Per page 10: “Task 5 Investigational Product Management”. Does CDC already have an IP vendor available with an Master Service Agreement in place? Where are the Central IP depot located?

Answer: No and there is no centrail IP

Program:

30. Question: Will alternate methods to onsite monitoring be considered depending on the situation with COVID-19?

Answer: Yes, see Section 3 of the PWS titled “Scope of Work” (revised) and (d)(1) of number 4 titled “TECHNICAL PROPOSAL INSTRUCTIONS” of solicitation section 12 titled “Instructions, Conditions, AND Notices to Offerors”) as well as various other sections that contemplate remote monitoring. See Solicitation Amendment 00001.

31. Question: Is there any additional detail that can be provided on possible site locations e.g., specific countries of interest?

Answer: See Solicitation Section 9 titled “PLACE OF PERFORMANCE”. Sites may be in United

States/Canada or in countries of high TB prevalence and incidence.

32. Question: The Pre-solicitation mentions a Monitoring Services task will be to “Identify and establish contractual agreements with clinical research vendors to support study needs.” What specific types of clinical research vendors are anticipated?

Answer: See Task 4.5 titled “Investigational Product Management” of PWS Section 4 titled

“Tasks to be Performed” This relates to investigational product management.

33. Question: Is this a recompete project for the current studies underway or is the plan to have additional support for the current studies underway and the planned studies?

Answer: Monitoring services shall be in support of current study protocol, Study 37 and, is attached as an addendum (attachment titled “Attachment D.6 – Study 37) to this solicitation;

and future studies to to be developed. See Solicitation Amendment 00001.

34. Question: Does the government intend to extend the new studies to be conducted at centers outside the continental US?

Answer: Yes.

35. Question: Per solicitation section 9, pg. 16, Is there any additional detail that can be provided on possible site locations, e.g., specific countries of interest?

Answer: See answer to #31.

36. Question: Could additional information on the TBTC2 web application be provided such as system compatibility requirements?

Answer: TBTC2 is a web-based system requiring use of current version of Internet Explorer.

37. Question: Regarding Task 5 – Investigational Product Management, for shipping purposes, will all products originate in the US?

Answer: No.

38. Per Section 3 – Scope of Work page 6. - The scope of this network of monitoring activities….. The following will be required:

• On-site initiation visits for all participating sites prior to first enrollment;

• On-site periodic monitoring visits;

• On-site close out visits” Question: Based on the current and anticipated COVID-19 environment, should Offerors assume on-site visits for all visits or a mixture of on-site and remote visits?

Answer: See answer to #30. The number of each type of visit must be determined by the offeror as part of their proposed Technical Approach. Refer to Section 10 titled “Travel” for the number of expected trips to guide decision.

Question: If a mixture, can you confirm the number and type of visits for each study?

Answer: See answer to #30. The number of each type of visit must be determined by the offeror as part of their proposed Technical Approach. Refer to Section 10 titled “Travel” for the number of expected trips to guide decision.

39. Per section 3 – Scope of Work page 7 - Input into study monitoring plan incorporating principles of risk-based monitoring;

Question: Can you please confirm if there is a standard % of source document verification that should be used for risk-based monitoring for each study or should Offerors use their standard assumptions?

Answer: There is no standard percent of source document verification that will be provided.

Offerors should use their standard assumptions.

40. Per Section 6 of the solicitation “Period of Performance”, pages 11-12 – Base Year: The government estimates that 0-3 new studies may be initiated during this phase.

Option Year One (First Option Period): The government estimates that 0-2 new studies may be initiated during this phase.

Option Year 3 (Second Option Period): The government estimates that 0-2 new studies may be

Option Year 4 (Third Option Period): The government estimates that 0-4 new studies may be

Option Year 5 (Fourth Option Period): The government estimates that 0-2 new studies may be

The TBTC Study A provided in section ii. of section (d)(1) Technical Approach on page 23 of the RFP states, “The study is being conducted at up to 12 clinical research sites in the United States and one site each in Canada, South Africa, Uganda and the United Kingdom.”

Question: Can you clarify if Offerors should assume the same number of sites/countries for all potential studies identified in the Base and each Option Period? If not, please clarify the number of site(s)/country(ies) Offerors should assume for each study for budget purposes.

Answer: Offerors should use the maximum number of estimated studies for each year of the period of performance as identified in section 6 titled “PERIOD OF PERFORMANCE” when developing business and technical proposals. See Solicitation Amendment 00001

41. Per (4) Suggested Labor Categories and Estimated Level of Effort Tables, page 26-27 of the solicitation – Medical Monitor A. Oversee clinical study site management/monitoring activities in compliance with ICH-GCP, sponsor SOPs, local laws & regulations, protocol, site monitoring plan and associated documents.

B. Ensure study patient safety, study protocol development, investigator support, pharmacovigilance and safety data review for sponsors C. Review final report data and safety review prior to submission to regulatory agencies D. Advise on local and international regulations and requirements needed for clinical studies.

E. Disseminate medical information from sponsor medical team to all study participants and support staff.

Question: Please clarify the Medical Monitor role. Will the CDC assign a Medical Monitor for each study or should the offeror include full Medical Monitoring for each study? The description of responsibilities seems to infer full Medical Monitoring, but this in not included in the Scope.

Answer: Refer to the PWS and solicitation section B.2 titled “Suggested Labor Categories per

Year”. CDC will not provide Medical Monitor and proposed labor mix is a determination made by the offeror based on their proposed technical approach.

42. Per (4) Suggested Labor Categories and Estimated Level of Effort Tables, page 26-27 of the solicitation – Data Analyst A. Design, implement, and maintain complex data systems and databases B. Use statistical tools to interpret data C. Create appropriate documentation D. Prepare reports, supporting documents, diagrams, data, and database specifications to effectively communicate and support program functions, and system modification needs

Question: Please clarify the Data Analyst role. Will the CDC be responsible for database build/data management or should the offerors include full Database build and Data

Management services for each study. The description of responsibilities seems to infer full data base/data management, but this in not included in the Scope.

Answer: Refer to PWS and solicitation section B.2 titled “Suggested Labor Categories per Year”.

CDC is responsible for database build. See Solicitation Amendment 00001.

43. Per (4) Suggested Labor Categories and Estimated Level of Effort Tables, page 26-27 of the solicitation - Labor Categories/Qualifications – Senior CRA – “C. Involved in the development of protocols and Case Report Forms (CRFs) as assigned.”

Question: Please clarify expectations by Offerors for protocol development. 1) Will Offerors be responsible for full protocol development or just review and input?

Answer: Section B.2 titled “Suggested Labor Categories per Year” has been revised to reflect Review and input. See Solicitation Amendment 00001.

44. Per Section 3 – Scope of Work, page 6-7 of solicitation - To support the on-site monitoring, the

DCC team will provide: “• Central monitoring of study data and activities;”

Question: Please clarify what is meant by “Central monitoring of study data and activities that the DCC team will provide?

Answer: DCC team conducts quality assurance and evaluation of protocol compliance. These activities will continue with central monitoring.

Question: Does this mean that the DCC team will provide Offerors with data analytics for monitoring?

Answer: DCC team will provide quality assurance.

Question: Or should Offerors assume they are responsible for the data analytics for centralized/remote monitoring?

Answer: See Tasks 4.3 titled “Reporting to Sponsor” of PWS Section 4 titled “Tasks to be Performed”, specifically Task 3.3 thereunder.

45. Question: Can a firm be awarded this TB monitoring contract, if it also is an awardee of the TB clinical study contract (resulting from RFP 75D301-20-Q-71779)?

Answer: No, this would be a Conflict of Interest.

46. Question: Per Task 2 on pg. 8 - In regards to Task 2.15 to "Utilize an existing clinical trial management system that includes real-time data entry and central monitoring tools." Is TBTC2 the CDC's clinical trial management system (CTMS) Or do offerors need to include our CTMS?

Answer: See revised Task 4.2.15 under Section 4 titled “Task to be Performed”. See Solicitation Amendment 00001.

47. Question: Per Section 4.b. of the solicitation on pg. 20-21 - Please confirm whether the following appendices are exempt from the 30-page limit for the Technical Proposal:

• Technical proposal-RFP cross-reference table: p.20, 4(c) Answer: Requirement for cross-reference table has been removed. See Solicitation Amendment 00001.

• Project management plan: p21, 4(d)(1)i.d. Answer: Not exempt

• Site monitoring plan(s) for sample scenario: p21, 4(d)(1)ii. Answer: Not exempt

48. Question: Are all the Labor Categories listed on Page 4 and Pages 26-28 the key persons? Or the key persons limited to the Project Manager/Senior CRA and other CRAs as mentioned the Staffing/Management Plan Section of in Page 22.

Answer: See revised (d)(2)(i) of number 4 titled “TECHNICAL PROPOSAL INSTRUCTIONS” of solicitation section 12 titled “Instructions, Conditions, AND Notices to Offerors”). See Solicitation

Amendment 00001.