Amendment 00001-Questions and Answers Final.pdf

Questions and Answers

1. Question: In regards to the Tuberculosis Trials Consortium Services contract, if we have a domestic and international site, can we enroll only latent tuberculosis infection patients from the domestic site and active tuberculosis patients or must we also enroll a minimum of at least 3 active TB patients from the domestic site as well. Essentially, Is there a maximum allowable indirect cost rate of international sites?

Answer: The recruitment, screening, consent, enrollment and follow-up minimum enrollment capacities (C.4.1.a.iii, page 10 of the solicitation) differentiate between low to medium- and high-TB incidence, not between US-based and international. For the purposes of this answer, US-based, domestic sites are low to medium-TB incidence, and we are assuming that ‘international’ site means high-TB incidence.

If a vendor is proposing a collaboration between low to medium- and high-TB incidence sites it is expected that the low to medium TB-incidence site enrolls at least 50 LTBI participants and 3 TB participants, annually; AND the high TB-incidence site enrolls at least 75 TB participants annually. As there is important value attached to enrollment of even small numbers of active TB patients in the low to medium-TB incidence settings, such as the US, US-based sites are expected to have capacity to enroll at least 3 newly diagnosed active tuberculosis patients each year across all actively enrolling TB treatment protocols.

In short, yes, under a collaboration including both low to medium- and high-TB incidence sites, the low to medium TB-incidence site must also enroll a minimum of 3 newly diagnosed active tuberculosis patients each year across all actively enrolling TB treatment protocols.

2. Question: Does the description of “work similar in size and complexity” (Solicitation page 88) mean clinical trials of human subjects only, any human subjects research or any contract of any kind that is of similar financial magnitude?

Answer: Clinical trials of similar size and complexity is considered optimal. If such work has not been done, offerors may report other human subjects research that is clinical in nature and that is of similar size and complexity as this solicitation. As stated “any contract of any kind that is of similar financial magnitude” does not meet the definition of “work similar in size and complexity”.

3. Question: In the guidance for the technical proposal, section 3.A.ii, reference is made to “patients with latent TB infection, or who would be eligible for LTBI treatment under the current treatment guidance”. Does “eligibility…under current treatment guidance” refer to local guidance under routine care or eligibility according to guidance in a study protocol? For example, both age ranges and criteria for establishment of infection might be more restrictive in routine guidance than in a study protocol.

Local guidance would still permit enrollment in a study that uses broader criteria. Should projected enrollment be based on the criteria in the appended protocols (studies 35 & 37) or local “current treatment guidance”?

Answer: The experience of the TBTC is very much the opposite: eligibility under local guidance in the U.S. generally is far more lenient (5 to10-fold) than is eligibility under protocol criteria. To comprehensively address this Technical Evaluation Factor, summarize the number of persons who would be eligible for LTBI treatment under your current local guidance, and describe the guidance. A description of your local guidance will serve to highlight any key differences between this guidance and potential enrollment population for study purposes as described by enrollment criteria in the appended protocols. Additionally, you can summarize the number of persons who would be eligible for the appended protocols. Further, we are interested in the total number of persons in key special populations such as pregnant women, infants, children, adolescents and immunocompromised individuals. Lastly, a proposer with exceptionally strong capacity to enroll adults age 18-65 would not be disqualified by local restriction on enrollment of young children, the very elderly, or pregnant women, but capacity would need to be strong to counterbalance this disadvantage.

4. Questions: Page 47: “A description of the public health data to be collected or generated in the contract period of performance”

a. What type of public health data is this referring to?

Answer: Refer back to the clause at H13 where Public Health Data is defined, in relation to this contract, as “digitally recorded factual material commonly accepted in the scientific community as a basis for public health findings, conclusions and implementation.” As such, data generated and submitted in the course of TBTC trials are considered digital public health data. Sites participating in TBTC are required to develop a Regulatory Compliance & Quality Management Plan (RCQMP) applicable to each study protocol in accord with standards of the CDC TBTC Data & Coordinating Center (see attachment J.10 for a sample template). This site- and study-specific RCQMP will fulfil the requirements of Clause H.13. Additionally, staff within the Clinical Research Branch are responsible for study-specific data management plans which include content addressing the bulleted list on pages 47-48 of the solicitation.

b. Does this include data collected for the purpose of submitting this proposal?

Answer: No

c. Is the DMP plan part of the 30-page limit or is it to be submitted separately as an appendix?

Answer: It is not required for this solicitation to submit a complete RCQMP. This plan will be required after contract award. However, the elements related to data management required as part of the Technical Response are detailed on pages 11-12 and pages 14-15 and page 87, which must be addressed in your proposal.

5. Question: Page 83 element 1.B.i: What is meant by TB laboratory – should this include not only the lab where study sputum is tested for TB but also where bloodwork is done (CBC, CMP, HIV testing)?

Answer: Page 83 focuses specifically on the TB laboratory where smears, cultures and PCR testing for tuberculosis is performed. Page 84 addresses laboratories where bloodwork (including routine tests such as CBC, etc., as well as IGRA testing) is performed. Both types of capabilities are required;

applicants are free to organize their proposals so as best to characterize, describe and document their capacities, including whether the TB and bloodwork capacities will be performed at one or more facilities.

6. Question: Can NIH-format bio-sketches be used in place of CVs/Resumes?

Answer: Yes. If NIH-format is used, offerors should seek to assure that applicant qualifications are well-represented in this more efficient format.

7. Question: 1) Some sections of the solicitation specify that studies of treatment for LTBI will be limited to US sites (e.g., Section 2: “Emphasis will be given to studies of latent TB infection in the United States, and studies of active TB disease both domestically and internationally.”). Other sections suggest that international sites can and should plan to participate in LTBI treatment studies (e.g., Section 3: “Awarded contractor(s) shall conduct all phases of clinical trials in patients with TB disease or latent TB infection, including (as needed) screening, diagnosis, enrollment, treatment, observation, clinical testing, data collection, and follow-up after treatment.”). May offerors with non-US sites complete sections on approaches to—and capacity for—enrollment in LTBI treatment studies?

Answer: See response to Q.1 above. Currently it is CDC’s intention to conduct studies of active TB in high TB-incidence settings, and studies of LTBI in low- and medium-TB incidence settings. See Solicitation Amendment 00001.

8. Question: Section F.2. on Deliverable(s) Schedule refers (in most years) to expectation that IRB approval packages be delivered “within 30 days after award for current protocols...”. Should offerors be prepared to apply for IRB approval prior to the award decision if required to meet 30-day IRB approval deadline? If so, could you please specify to which protocols this would apply?

Answer: No, offerors should not be prepared to apply for IRB approval prior to award decision. To further clarify the Deliverables table (starting on page 19 of the solicitation), sites will be required to submit Registration Packages to their local IRBs within 75 days of contract award OR as specified in study start-up requirements. Once the protocol is approved locally, sites will be required to submit to TBTC notification of that approval within 30 days of receipt of approval OR as specified in study start-up requirements. The requirement is not that sites will receive local IRB approval within 30 days of contract award. See Solicitation Amendment 00001.

9. Question: If an application includes 1 or more subsites, does the technical proposal need to contain the same level of detail for subsites or can detailed descriptions of subsites be included in appendices? Are there parts of the solicitation that only apply to the primary offeror and are not required of subsites?

Answer: The offeror’s comprehensive response must satisfy the applicable performance standards of the solicitation. As such, adequate detail about subsites and how they will contribute to the offeror’s ability to perform the work in the solicitation is required. The offeror need not duplicate materials applicable to more than one clinical site, but can rather indicate this with statements such as “Facility B at subsite B satisfies the same standards as those described for Facility A at Primary site A.”

10. Question: Wanted to ask if only Principal Investigator/Program Director (PI/PD) was allowed of if multiple PI/PDs were allowed and if so if there was a limit.

Answer: Each proposal should indicate a Principal Investigator (PI) who is responsible for overall implementation of the contract and who is the key contact for technical aspects of the contract. This will generally be the investigator located at the institution which is the recipient of the primary award. In some instances, the proposal will also indicate Site Investigator(s) of Record (IOR, or co-PI, or site PI) at a site which is distant from the primary awarded site. Often the IOR at the distant site will be better positioned to direct and guide the work at the distant site. In such cases, the distant site is usually funded through a sub-contract with the primary awarded site. The subcontract should be so constructed as to assure that any obligations and responsibilities of the primary awarded site (such as compliance with Good Clinical Practice, other regulatory, and human subjects protections requirements) effectively pass through and have legal validity to the subcontracted site; this is often achieved by including the parent site’s contract with CDC as an attachment to the subcontract, and specifying in the subcontract that these requirements flow down to the subcontracted site. There are circumstances where a site may have one or more co-investigators on-site. However, primary responsibility will always reside with the site receiving the primary award, and there should be a clearly denominated single individual who assumes this responsibility.

11. Question: Our site, ____________________________ is located in Uganda, a high TB incidence country. For vendors in a high TB incidence country like Uganda, is it correct that we only consider conducting TB treatment protocols (treating newly-diagnosed active TB cases) and not consider TB prevention protocols? (referencing page 10, section C.4.1.a.iii.a.ii)

Answer: Yes; see responses to Q.#1 and Q.#7 above

12. Question: Does the requirement for a Data Management Plan referenced on page 79, Section L.8 apply to international sites where only research data is collected or is this relevant only to U.S.

public health data? All of our patient activities are conducted in Uganda.

Answer: See answer to Q.#4 above

13. Question: I looked at the TBTC services call 75D30120R67869 due on 5/18. Are you accepting applications from new sites within the US? (particularly for TB prevention trials).

Answer: Yes.

14. Questions: Can CDC please provide uniform cost assumptions, for pricing purposes? Added information on the specifics of the SOW/contemplated work, estimated LOE, etc. will be helpful in ensuring accuracy of pricing.

a. For example, regarding assumptions for #s of studies: the SOW for the Options contains wide ranges for estimated #s of new studies, such as 0-2, 0-4, etc. Can CDC provide a uniform # of studies for estimating purposes?

Answer: Offerors are advised to rely on the enrollment maxima in constructing their budgets.

b. Also, assumptions on the # of sites is needed to assist in accurate cost estimates. This is important because an offeror that includes several sites might be deemed too costly compared to an offeror who proposes only one. If more than one site is proposed, should offerors submit one proposal response per site?

Answer: The number of sites proposed is dependent upon how the offeror configures/devises their technical approach. Proposals will be evaluated utilizing best-value with trade-offs whereby the government is permitted to accept a higher technically rated proposal for a higher cost. Offerors are permitted to submit multiple proposals.

15. Question: Is double-spacing correct for the Technical Proposal? This decreases by half the amount of information that can be provided compared to a standard single-spaced proposal.

Answer: See Solicitation Amendment 00001

16. Question: Is it correct that the technical text is to be double-spaced as stated on page 81, section L.10 (b) - “…not exceed 30 pages (excluding the cover page and table of contents), double-spaced…”

Answer: See Solicitation Amendment 00001

17. Question: - Page 7, Purpose states that "Emphasis will be given to studies of latent TB infection in the United States". Page 10 states that "Vendors based in areas of low to medium TB incidence (≤ 100 cases per 100,000 population), shall enroll a minimum of 50 latent tuberculosis patients each year across all actively enrolling TB prevention protocols; and a minimum of 3 newly diagnosed active tuberculosis patients each year across all actively enrolling TB treatment protocols." I wonder if we (a domestic site) can have a subcontract with an international clinical site with low TB incidence (≤ 100 cases per 100,000 population) so that they can recruit study subjects for latent TB infection?

Answer: Yes

17. Question: The RFP requires that past performance surveys be sent to references, for completion/submission to CDC (Att. J.4.). Can CDC clarify, if these are needed for projects for which CPARs are available, OR only for projects with no CPARs? CPARS are typically used for past performance reference information (as the RFP notes on pg. 79), and their use by CDC would avoid extra burden on Government representatives. If desired, offerors could include copies of latest CPARs for reference projects, with our proposals, for added convenience for CDC. Please confirm.

Answer: Requirement remains unchanged. Offeror will decide to whom to submit past performance surveys.

18. Question: There are fewer than 30 days between release of the RFA (April 21) and the due date (May 18). Is there flexibility in the due date for this offer considering the ongoing COVID-19 pandemic restrictions and availability of the research teams to acquire needed information for this submission?

Answer: See Solicitation Amendment 00001.

19. Questions: Page 87: “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.”

a. Can performance agreements other than contracts (e.g., grants) be used for this past performance requirement?

Answer: Contracts and Grants

b. “When the POC has completed the Past Performance Information Survey Form, he/she will submit the questionnaire….” Is there a deadline for the POC to submit the surveys to

CDC?

Answer: See Solicitation Amendment 00001

c. What is the difference between teaming partner, joint venture, and subcontractor?

Answer: Per FAR 9.601 a Contractor team arrangement is an arrangement in which

(1) Two or more companies form a partnership or joint venture to act as a potential prime contractor;

or

(2) A potential prime contractor agrees with one or more other companies to have them as its subcontractors under a specified Government contract or acquisition program.

Teaming arrangements are subject to FAR 52.219-14, “Limitations on Subcontracting” while joint ventures are not. Joint Ventures must be approved by the Small Business Administration (SBA) whereby teaming arrangements do not.

Subcontractor is an individual or business contracted to perform part or all of a Prime Contractor’s contract.

Please refer to the SBA and/or the FAR for additional guidance.

d. Will the Past Performance surveys be considered part of the 30-page limit?

Answer: No

e. Is the CPARS representative someone from the CDC or from our organization?

Answer: Refer to www.cpars.gov

20. Question: Page 82:

a. “The written technical proposal shall include, at a minimum, the following sections:

(1) Cover Page (including solicitation number and name of Offeror)

(2) Table of Contents

(3) Concise Presentation of each of the Evaluation Criteria for the Overall Contract:

(a) Technical Approach

(b) Staffing/Management Plan

(c) Relevant Experience

(d) Quality Assurance

(4) Past Performance

(5) Sub-Contracting Plan”

Since the past performance surveys are being sent directly to CDC, what information should be included in the “Past Performance” section of the written technical proposal?

Answer: Please refer to Section L.10(d)(5) of the Solicitation.

b. “Requirement to submit a cross reference between the RFP and technical proposal to assist in the review.” What type of cross reference is needed here? What information is being sought?

Answer: We are seeking a clear description of location within the offeror’s proposal for each of the Technical Approach factors in Section L.10 of the solicitation. This can be achieved by listing each Technical Approach factor and the page number where it is addressed in the proposal.

21. Question: Pg. 82 The instructions detail a sub-contracting plan is required for the Technical Proposal, but no further information is provided about what to include in this section. Can you please let us know if this section is required and instructions for what to include?

Answer: This is required if a vendor intends to utilize subcontractors in performance of the Performance Work Statement. Please refer to the Federal Acquisition Regulations (FAR) Part 19.704 for additional detail.

22. Question: Should we use the headings/questions in our response or just the numbering of sections and questions?

Answer: Please prepare your response in accordance with sections L and M of the solicitation.

23. Question: For the re-application now, is it possible to apply as an “individual” or company on our own or do we need a US partner or bigger consortium to be part of?

Answer: A U.S. partner or consortium is not required; however, offerors must satisfy U.S. federal contracting requirements as described in the solicitation. As such, prepare your response in accordance with sections L and M of the solicitation.

24. Question: We would very much appreciate an additional 2 weeks of time?

Answer: See Solicitation Amendment 00001.

25. Questions: Could you please provide additional guidance on the request for references and past performance surveys?

a. First, do these apply exclusively to contracts and not to grants?

Answer: Contracts and Grants. See Solicitation Amendment 0001.

b. Second, if the offeror (or a sub-offeror) on the current solicitation was a subawardee on a prior grant/contract, are references and past-performance surveys still relevant?

Answer: Please prepare your response in accordance with Sections L & M of the solicitation.

3. If so, should they come from the funder or the prime recipient of the contract/award?

Answer: These surveys should come from the funder.

26. Question: Could you please provide more information on the contents of the appendix to the submission? Aside from resumes and CVs, no specific documents are requested. Would letters of support from collaborating institutions be considered part of the appendices

Answer: Appendices could include CVs or Biosketches, letters of support, possibly publications, certifications, policies, etc. Per the solicitation, “The technical proposal should “stand alone” with the appendices used only for clarifying or backup information.” As such information provided in the Appendices that does not serve to clarify or backup information in the offeror’s technical submission will not be considered in the evaluation process.

27. Question: We note that the solicitation was released approximately one month before the due date.

While the specifications in the solicitation are similar to those of the 2009 solicitation (and therefore some preparation was possible), 18 out of 48 Technical Proposal sub-sections are substantively new in 2020. In light of the current COVID-19 pandemic, many offerors and collaborators are likely struggling to accommodate completion of the proposal and their crisis response. Would the CDC consider a deadline extension, until at least June 8?

Answer: See Solicitation Amendment 00001.

28. Question: Given the length and complexity of the solicitation, the application will require considerable time and effort from many people who are currently deployed to help in the response to the COVID pandemic. Could there be an extension of the deadline so we don’t have to choose between putting together our best application and assisting in this public health crisis?

Answer: See Solicitation Amendment 00001.

29. Question: Will all the questions you receive and their answers be made available to the public?

Answer: These will be posted to BetaSam.gov

30. Question: Our question is: can this timeline of May 18 can be altered to accommodate teams now involved in the COVID-19 response? To give you a realistic timeline, we do not foresee any diminution of COVID related activities in Canada until July, 2020 at the earliest. We feel that we will not be able to make an adequate submission in time for the May 18 deadline, which would be a potential loss. We would greatly appreciate an exception to this deadline in light of the extraordinary public health events we face in our respective regions.

Answer: See Solicitation Amendment 00001.

31. 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

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

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

33. 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.

34. Question: Information about the Tendering Procedure and Guidelines Answer: Refer to sections L & M of the Solicitation.

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

36. Question: Any Extension of Bidding Deadline?

Answer: See Solicitation Amendment 00001.

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

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

38. Question: Regarding Notice ID is 75D30120R67869, "In quickly looking through the website and attachments I notices that most of the dates have already passed. If I’m not mistaken, this announcement itself does not constitute and RFP for applications --- is that correct? Has your office announced when that will be forthcoming and other --- possibly revised --- dates in the application process?

Answer: Please refer to the Solicitation document and all attachment documents most recently released in association with Notice ID 75D30120R67869.

39. Question:- I understand that we have to submit the proposal by May 18th, but it will be a complex document as we would like to partner with an international site. I wonder if you could consider extending the deadline?

Answer: See revised Solicitation Amendment 00001

40. Question: Essentially, Is there is a maximum allowable indirect cost rate of international sites?

Answer: Indirect rates are unique to each Offeror. This question is not clear.