Questions and Answers_5.25.22.pdf

RFP # 75D30122R72168

“Sexually Transmitted Infections Impact Research Consortium (STIIRC)”

Questions and Answers

I. Technical Questions:

Question 1: Task Order 0001 (Attachment J5) PWS Section C.5 page 75: Will all work for the STIIRC for Tasks 1-9 described in the Performance Work Statement for the Data Coordinating Center be included in Task Order 0001 or will there be subsequent task orders over the course of the IDIQ to cover work within Tasks 1-9.

Answer 1: Yes, all work described in Task Order Scope of Work will be included in Task Order 0001.

However, future task orders will cover additional requirements that fall under one or more of the four task areas of the basic IDIQ contract.

Question 2: Is international work related to STI elimination considered appropriate for this application?

Answer 2: No. This STIIRC IDIQ is for domestic (US) work only.

Question 3: From the description, it appears that the research to be conducted will be driven by the funders. Is that accurate? If so, is the expectation that the proposal should focus on what types of research the institution is ready to participate in at the start of the contract?

Answer 3: No. The research to be conducted will be driven by the Government and will be outlined in task orders originating with CDC. CDC does expect to obtain expert input to guide the content in task orders. The proposals must emphasize the offeror’s capacity, experience and expertise with respect to managing the type of research outlined in the task areas.

Question 4: Are the contractors expected to be able to implement research through both areas: 1) clinical trials, and 2) population-focused implementation science? Under subfactor 1, it appears a response regarding technical experience in both is needed for the application, but it is unclear if it will be held against the applicant if expertise is only available in one area.

Answer 4: Offerors must demonstrate their expertise to the best of their ability in all areas addressed by the solicitation. CDC has an interest in assuring both clinical trial and population-focused implementation science are adequately represented in the consortium.

Question 5: With respect to the staffing plan, is there any additional guidance on the number of tasks applicants should be prepared to implement or will that be determined based upon the staffing plans submitted?

Answer 5: The exact number of subsequent task orders cannot be determined at this time, although the Government intends to issue up to 15 task orders for this IIDIQ contract.

Question 6: Does the application allow for inclusion of a professional protocol management sub-contractor?

Answer 6: Yes, the request for proposal (RFP) allows for inclusion of a professional protocol management sub-contractor.

Question 7: I’d love to schedule a time to meet and discuss the new requests for proposals. In particular, I’m hoping to learn more about what you’re interested in supporting, the overall structure of what could be considered responsive, and, for development of novel diagnostic platforms, what the range of support might look like—i.e., from basic science, engineering actual devices, clinical trials devices—do you want the whole range, or would working on just subsets of that pathway be considered acceptable.

Answer 7: The Government will not be meeting with any potential offeror regarding this RFP. The task areas outlined in the RFP provide the guidance CDC can offer at this point. Specific research requirements will be outlined in future task orders

Question 8: It seems that only organizations serving an annual minimum volume are considered eligible to apply (e.g., 1,000 cases of syphilis; 8,000 cases of gonorrhea; and/or 1,000 cases of HIV). Is this indeed a defining aspect of eligibility?

Answer 8: To permit estimates of impact, some minimum morbidity is required. The morbidity criteria are at least two of the following three: 1,000 cases of infectious syphilis (includes congenital syphilis), 2,000 cases of gonorrhea, and 1,000 cases of HIV and/or People Living with HIV (PLWH). CDC emphasizes the requirements can be demonstrated from all cases occurring within the area in which the offeror proposes to operate (e.g., one or more cities or counties). Morbidity is not limited to cases seen in a given clinic or health system. CDC also reminds offerors that morbidity requirements may also be met through prime contractor/sub-contractor arrangements.

Question 9: Can some of the work (science) be performed at the CDC?

Answer 9: It is unlikely that any significant portion of work will be performed at CDC.

Question 10: Can an FQHC apply?

Answer 10: Any company registered in SAM.gov to receive contract awards from the Government under NAICS code 541990 "All Other Professional, Scientific, and Technical Services" may submit a proposal as a prime contractor. A company must be registered under “All Awards” in SAM.gov.

Question 11: did you discuss the staffing plan? Is the staffing plan only for TO1 or also for the basic

IDIQ?

Answer 11: The staffing plan is the criterion for the Task Order 0001 technical proposal. See section L.7 Technical Proposal Preparation Instructions of the RFP.

Question 12: Will you use a single IRB, or should we plan to use our local IRBs?

Answer 12: CDC plans to use a single IRB.

Question 13: Will CDC consider offerors who leverage external data sources to aid STIIRC efforts?

Answer 13: Offerors may use data sources external to their organizations as long as the offeror meets the criteria for any given task order. CDC emphasizes it will be the responsibility of the offeror to assure access to such information.

Question 14: Is the annual volume (..of at least two of the following STI:

1,000 cases of infectious syphilis, congenital syphilis diagnoses or syphilis diagnoses during pregnancy;

8,000 cases of gonorrhea; and/or 1,000 cases of HIV) definitive? My primary work involves rural areas, and even though my current NIH clinical trial crosses 16 counties and 6000 mi2, we simply don't have this volume.

Answer 14: To permit estimates of impact, some minimum morbidity is required. The morbidity criteria are at least two of the following three: 1,000 cases of infectious syphilis (includes congenital syphilis), 2,000 cases of gonorrhea, and 1,000 cases of HIV and/or People Living with HIV (PLWH). CDC emphasizes the requirements can be demonstrated from all cases occurring within the area in which the offeror proposes to operate (e.g., one or more cities or counties). Morbidity is not limited to cases seen in a given clinic or health system. CDC also reminds offerors that morbidity requirements may also be met through prime contractor/sub-contractor arrangements.

Question 15: Are you looking for a data managing center for ALL contractors?

Answer 15: Task Order 0001 seeks a Data Coordinating Center for all contractors who receive a Basic Contract Award.

Question 16: do you prefer that partner organizations be in the same geographic area?

Answer 16: CDC does not require that all organizations named in a proposal be in the same geographic area.

Question 17: Can the proposal have multiple PI/PDs (for example, 2 co-PIs) as long as there is a single contact PI?

Answer 17: CDC will consider proposals naming multiple principal investigators as long as the requirements of the contract are met.

Question 18: Will we be required to travel to CDC, and if so, how many people and how often so that it can be included in the budget proposal?

Answer 18: If there is a need for travel cost that will be determined at the task order level and must always be in accordance with the Joint Travel Regulation. There is no travel cost for Task Order 0001

Question 19: Are you asking us for our ideas of interventions that we think should be tested in this proposal. Or is this a situation where you will have specific interventions that you want us to implement and test? Do we have input in other words?

Answer 19: Offerors must follow the requirements listed in the Technical Evaluation Factors. It is not necessary to propose research for the basic contract. CDC anticipates gathering input and expertise on research priorities during the period of performance on a regular basis, including through regular communication with consortium members.

Question 20: Are we supposed to propose studies or just present the infrastructure information?

Answer 20: Offerors must follow the requirements listed in the Technical Evaluation Factors. It is not necessary to propose research for the basic contract. CDC anticipates gathering input and expertise on research priorities during the period of performance on a regular basis, including through regular communication with consortium members.

Question 21: Is it possible to apply as just a supplier to assist in clinical trials for reducing STIs, including Service delivery research. Our company is known for its blood spot cards testing for STIs and has worked with both the CDC and NIH in this arena. We specialize in research to development of assays, test and implement interventions to increase access to, and efficient use of, STI services, including home testing, specimen collection and other “out of clinic” models, express visit models, telehealth models, and collaborative networks at different levels of clinical and prevention capacity.

Answer 21: Offerors must demonstrate their expertise to the best of their ability in all areas addressed by the solicitation. Offerors proposing to meet only a subset of requirements will not be considered for award and may wish to consider sub-contractual arrangements.

Question 22: Can you explain in more detail the rationale for why everyone who wants to be part of this must apply for the data coordinating center component as well as the basic contract? The competencies for implementing trials are different from the competencies required to manage data. A group could be excellent at one and poor at the other; requiring both naturally cuts out sites that are highly capable of only one. Not to mention that it is inefficient.

Answer 22: The Government will not explain this rationale. Offerors must demonstrate their expertise to the best of their ability and address all terms and conditions listed in the RFP.

Question 23: The morbidity requirements are very challenging. For many people interested in this work, those case numbers can be achieved only with extensive partnership with other institutions and possibly across states. It is not possible for smaller organizations to establish meaningful partners on this timeline. By using case numbers instead of rates, you are also systematically excluding rural areas.

Answer 23: To permit estimates of impact, some minimum morbidity is required. The morbidity criteria are at least two of the following three: 1,000 cases of infectious syphilis (includes congenital syphilis), 2,000 cases of gonorrhea, and 1,000 cases of HIV and/or People Living with HIV (PLWH). CDC emphasizes the requirements can be demonstrated from all cases occurring within the area in which the offeror proposes to operate (e.g., one or more cities or counties). Morbidity is not limited to cases seen in a given clinic or health system. There are subcontracting opportunities available for this requirement for smaller organizations.

Question 24: Several people tried to ask this in the webinar, but there was almost no discussion of the scientific significance or impact of this program. At times, it seemed to be a review of the minutiae of contract making (with repeated admonitions for how one would be penalized for failing to adhere in every way) but almost nothing about the interest of CDC in growing a network, the importance of including underrepresented voices or partners, the need for geographic or demographic representation, the value of including large and small institutions, etc. I would love to hear more about why this solicitation is being released and what CDC sees as the strategic plan for it. This would help people determine whether their location/competencies will help CDC achieve those plans and thus whether to spend the considerable time it will take to respond.

Answer 24: The purpose of the contract is outlined in the solicitation. Interested offerors must respond to the technical evaluation criteria as those are the criteria on which proposals will be considered for awards.

Question 25: Can The Government please clarify if any or all data around social equity will be provided to the contractor(s) for this IDIQ, or if the contractor should plan to identify and procure external data sources such as population data, Social Determinants of Health Data, and other related health equity data as part of the performance within this contracts scope? • Please also Identify where in the solicitation this plan for data procurement should be addressed by the contractor within their response?

Answer 25: The contractor should plan to identify and procure data sources insofar as such sources are required for any task order. Such procurements should be identified in the Technical Proposal for the basic contract level (Volume I). CDC will allow contractors to use government datasets to the extent permitted by rule or regulation.

Question 26: Can the CDC please outline the source of any data that will be provided to the contractor in regards to Health Equity and if this information will require any 3rd party validation or supplementation with external data sources?

Answer 26: The contractor should plan to identify and procure data sources insofar as such sources are required for any task order. CDC will allow contractors to use government datasets to the extent permitted by rule or regulation.

Question 27: Are the references specific to the sites, or do you want references for the data coordinating center, as well?

Answer 27: The offeror must provide three references in the proposal for the basic contract as listed in Section L8. Past/Present Performance Volume Preparation Information of the RFP.

Question 28: If you want references for both the sites and the DCC, is it just 3 references split between sites and the DCC?

Answer 28: The offeror must provide three references in the proposal for the basic contract as listed in Section L8. Past/Present Performance Volume Preparation Information of the RFP.

Question 29: For the business plan, are we supposed to be requesting funds for the sites that is for core functioning, separate from the Task Orders?

Answer 29: The business proposals must contain cost/pricing for task order 0001.

Question 30: Can sites request funding as part of the basic contract, or only funding for task orders?

Answer 30: The Business Proposal shall be submitted for the Task Order 0001 only.

Question 31: Is the DCC coordinating across all of the sites that are eventually funded, or just for the sites that are in our specific application?

Answer 31: The DCC shall be expected to support all contractors that are awarded a basic contract.

Question 32: (asked on the call but not answered): We use a fiscal intermediary [Offeror’s Name] to administer our grants (SF Dept of Public Health). Can we have as PI someone from SFDPH, or does it have to be someone from [Offeror’s Name]?

Answer 32: The principal investigator may come from the offeror’s organization under these circumstances.

Question 33: You are only awarding one DCC, as we understand it. Are you requiring all applications to include an application to be a DCC as well as a base site?

Answer 33: Offerors must provide a proposal for both the basic contract and Task Order 0001 to be considered for an award.

Question 34: Will there be one contractor selected for task order 001 (DCC) and if so, is it possible that some contractors will be selected for the basic contract but not for task order 001?

Answer 34: Yes. CDC anticipates making one award for Task Order 0001.

Question 35: Is there a preferred format for the resume? Can we submit an NIH biosketch, or are you looking for something else?

Answer 35: NIH biosketches are acceptable formats for resumes as long as they contain the information pertinent to evaluating the expertise and capabilities of the individual described on the biosketch.

Question 36: Will you be sponsoring a single IRB for all sites to use, or should each site plan on using a local IRB?

Answer 36: CDC intends to use a single IRB.

Question 37: If we generally conduct grant-related rather than contract-related work, do you have a suggestion for how we submit “references,” as our funders may not be at liberty to complete a reference for us?

Answer 37: Please refer to Section L.8 (b) of the RFP it explains the situation when the references are not available and suggests other items that the government would consider.

Question 38: Do you want us to submit a data management plan? If so, does that get included in the business plan?

Answer 38: Yes. The Data Management Plan shall be submitted within the Business Proposal. See the revised RFP.

Question 39: Are Multiple PIs allowed?

Answer 39: CDC will consider proposals naming multiple principal investigators as long as the requirements of the contract are met.

Question 40: Is the decision to fund a site based on the overall score of the site and the DCC combined, or are they scored and considered separately?

Answer 40: Please refer to Section M1 of the RFP. See page 62 of 91. The government will conduct a separate technical evaluation for basic contract and the Task Order 0001. Proposals for the basic contract and the Task Order 0001 will be rated separately.

Question 41: C.4 TECHNICAL REQUIREMENTS, page 6, paragraph 4. Is it expected that the contractor will provide sites to conduct the research?

Answer 41: Yes, the contractor will be expected to provide sites to conduct research outlined in future task orders.

Question 42: C.4 TECHNICAL REQUIREMENTS, page 6, paragraph 4. Will the contractor be expected to provide protocols for consideration?

Answer 42: The contractor will be expected to provide protocols for research outlined in future task orders. This work will be supported by the DCC (Task Order 0001) and discussed with CDC.

Question 43: Page 76, Task Order 0001 For the purposes of budgeting for Task 5, how many questionnaires/data collection instruments/data management strategies should be assumed? What length of each should be assumed?

Answer 43: The Government expects one data management strategy per task order (up to 15 task orders overall), and one to four separate questionnaires or other data instruments per task order, depending on the specific requirements of the task order. See the revised RFP.

Question 44: Page 76, Task Order 0001 For the purposes of budgeting for Task 6, will CDC require weekly dashboards for each study? If yes, how many should be assumed? For additional statistical analyses, how many should be assumed for the budget?

Answer 44: The Government expects one document outlining an overall recommended statistical approach and alternatives per task order (up to 15 overall). Data monitoring approaches may include dashboards, but other approaches will be considered depending on the nature of the research. See the revised RFP.

Question 45: Page 77, Task Order 0001, Deliverables For the purposes of budgeting for Task 7, how many manuscripts should be assumed that will require the Data Coordinating Center to provide Methods and Results sections? How many drafts of each manuscript should be assumed for budgeting?

How many planning meetings should be assumed for each manuscript?

Answer 45: The Government expects the Contractor will contribute as specified to at least one major outcome paper per task order (up to 15 overall), and one to four other papers per task order, depending on the specific requirements of the task order. CDC anticipates planning meetings for manuscript production will typically be virtual. See the revised RFP.

Question 46: If we are selected as a contractor for the Basic Contract, are we able to then choose future research studies (task orders) of interest to submit a proposal for as they are issued or is the expectation that we participate in any and/or all future task orders?

Answer 46: Contractors awarded the Basic contract must apply for a minimum of three task orders (including Task Order 0001).

Question 47: Section C.2 Purpose, Page 5: The RFP states “The objective of this procurement is to establish a consortium of research centers…” In Attachment J5, C.5 Technical Requirements, Page 76, CDC includes references to research sites. Is the consortium of research centers that will be established as part of this opportunity the same as the research sites referenced in Attachment J5? If the research centers and research sites are different, can CDC provide more detail to distinguish them including whether the research sites have already been selected, the number of sites selected and their intended role as part of the consortium?

Answer 47: The term “research centers” refers to the anticipated contractors that will receive a basic contract. Research sites might or might not differ and have not been selected by the government.

Question 48: Will we need to support IND’s?

Answer48: The Government does not intend to conduct trials for investigational new drugs except possibly for INDs that are already approved by FDA and being investigated for an indication different than originally approved.

Question 49: How will we (as the data coordinating center - DCC) staff for individual task orders while still maintaining a consistent staff?

Answer 49: Please refer to the RFP Section L9. (b) 4. Your proposal must indicate whether you have the necessary financial capacity, working capital, and other resources to perform the contract without assistance from any outside source. (If not, indicate the amount required and the anticipated source).

Question 50: How does the government envision resource sharing?

Answer 50: To the extent permissible, the government will encourage collaborative action among the contractors that receive a basic contract award.

Question 51: What characteristics do we anticipate of the individual projects?

Answer 51: The government cannot determine characteristics of individual projects at this point.

Characteristics and technical requirements pertinent to the conduct of individual projects will be identified in future task orders.

Question 52: Who will be part of the DCC? Will there be multiple DCCs or will one overall DCC be selected for all projects?

Answer 52: CDC anticipates identifying a single DCC contractor

Question 53: Does the consortium have any liberty to choose the trials they will pursue?

Answer 53: Contractors participating in STIIRC must apply for at least three task orders (including Task Order 0001).

Question 54: Are there anticipated sources of data beyond EDC and laboratory? Examples: wearables, EHR, mobile apps.

Answer 54: Yes. The government anticipates data sources beyond electronic data capture and laboratory data; for example, collection of qualitative data or geographically-defined quantitative data.

Data requirements will vary by task order requirements.

Question 55: Are there other anticipated types of data such as images, proteomics, genetics?

Answer 55: The government cannot definitively identify precise types of data at this point. Data requirements will vary by task order requirements.

Question 56: If studying home-base specimen collection, who will be responsible for shipping supplies?

Answer 56: The contractor shall be responsible for shipping supplies.

Question 57: Will a central eConsenting system be used and if so, what will the role of the DCC be in managing this system?

Answer 57: Consent systems needed for research studies may vary by task order requirements, and the DCC may provide guidance and support in management of consent systems for research conducted through future task orders.

Question 58: What characteristics do we anticipate of the individual projects? (# participants, length of trial/project, international sites involved vs. domestic, adults vs. children, number of projects to be coordinated, etc.)

Answer 58: The government cannot determine these characteristics at this time. This information will be determined at the task order level. The work will be conducted in domestic (US) settings.

Question 59: Can a site be a subcontractor with more than one prime?

Answer 59: Yes, a site may be a subcontractor with more than one prime contractor (i.e., an offeror selected for a base award in STIIRC).

Question 60: Section C.5 Technical Requirements, Page 76, Task 3: Due to the firm fixed price nature of the contract, for budgeting purposes, can the government provide the number or range of study protocols to be designed for this task order per year?

Answer 60: The government cannot determine the exact number of study protocols to be designed in any given year. The Government expects one comprehensive overall study protocol per task order (up to 15 overall). See the revised RFP.

Question 61: Section C.5 Technical Requirements, Page 76, Task 4: Due to the firm fixed price nature of the contract, for budgeting purposes, can the government provide the number or range of statistical design plans to be summarized for this task order per year?

Answer 61: The government cannot provide the exact number of statistical design plans to be designed in any given year. The Government expects one document outlining a comprehensive overall recommended statistical approach and alternatives per task order (up to 15 overall). See the revised

RFP.

Question 62: Section C.5 Technical Requirements, Page 76, Task 5: Due to the firm fixed price nature of the contract, for budgeting purposes, can the government provide the number or range of questionnaires and data management strategies to be designed for this task order per year?

Answer 62: The government cannot provide the exact number of questionnaires or data management strategies to be designed in any given year. The Government expects one data management strategy per task order (up to 15 overall), and one to four separate questionnaires or other data instruments per task order, depending on the specific requirements of the task order. See the revised RFP.

Question 63: Section C.5 Technical Requirements, Page 76, Task 6: Due to the firm fixed price nature of the contract, for budgeting purposes, can the government provide the number or range of research studies where statistical analyses and written summaries will be required for this task order per year?

Answer 63: The government cannot provide the exact number of research studies to be designed in any given year. The government anticipates one to three research studies will be initiated through task orders in FY2023 and up to 15 studies via task orders overall. See the revised RFP.

Question 64: Section C.5 Technical Requirements, Page 76, Task 7: Due to the firm fixed price nature of the contract, for budgeting purposes, can the government provide the number or range of manuscripts will be prepared for this task order per year?

Answer 64: The Government expects the Contractor will contribute as specified to at least one major outcome paper per task order (up to 15 overall), and one to four other papers per task order, depending on the specific requirements of the task order. CDC anticipates planning meetings for manuscript production will typically be virtual. See the revised RFP.

Question 65: Section C.5 Technical Requirements, Page 76, Task 5 and Task 8: The government describes coordination activities across multiple STIIRC research sites. Due to the firm fixed price nature of the contract, for budgeting purposes, how many research sites does the government anticipate selecting? Please describe the role of the research sites in relation to the awards made as part of the Basic Contract. Please describe the anticipated relationship of the research sites to the DCC.

Answer 65: The Government expects one data management strategy per task order (up to 15 overall), and one to four separate questionnaires or other data instruments per task order, depending on the specific requirements of the task order. See the revised RFP.

Question 66: Section C.5 Technical Requirements, Page 76, Task 9: Due to the firm fixed price nature of the contract, for budgeting purposes, can the government provide the number or range of datasets and codebooks to be created for this task order per year?

Answer 66: The Government expects at least one complete and comprehensive dataset and one complete and comprehensive codebook per task order (up to 15 overall). The range of datasets (e.g., individual quantitative data, qualitative assessments, area-level variables) will depend on the specific requirements of future task orders and will be specified in those task orders. See the revised RFP.

Question 67: Section C.5, Reporting Schedule, Page 77: According to the deliverable schedule, Tasks 3 through 9 are dependent on the start and completion of research studies. To inform the intended level of effort required to support the DCC and timing of all associated DCC activities, when does CDC anticipate starting the first research study? How many research studies does CDC anticipate conducting annually?

Answer 67: The government expects to release one or more task orders for research studies in FY2023.

Question 68: We are a US-based small business, developing a rapid, portable and affordable point-of-care PCR-based diagnostic device for Sexually Transmitted Diseases and other infectious diseases.

Specifically, we are developing[ ].

We believe that our product and research fits well within the mission of the STI Impact Research Consortium, and are committed to developing and implementing accurate and effective diagnostic tests for sexually transmitted infections.

Our question is related to the scope of work as outlined in section C3 and C4 on pages 5 and 6 of the amended RFP https://sam.gov/api/prod/opps/v3/opportunities/resources/files/10c050018c714498ab33416efc75d51c /download?&token= We believe that our research falls within the task area #4: “Diagnostics research. Research into new STD diagnostic approaches to develop, test and implement diagnostic tools that increase the proportion of infected persons tested and diagnosed; clinical trials of new diagnostic tools and methods;

implementation research to increase use of efficacious and effective diagnostic tools.”

We wanted concurrence on the following before we move forward with submission of a proposal:

1. Does the development and third-party field-evaluation of our [ ] fall with the scope of the RFP?

Answer: The Government has deleted a portion of this question from public posting to protect the offeror. The Government cannot provide an answer from the information provided.

Proposals for the basic contract must be responsive to all the requirements listed in the RFP which will be addressed according to the technical evaluation criteria.

2. Does the pilot-production of our devices for clinical studies fall within the scope of the RFP?

Answer: The government cannot provide an answer from the information provided.

3. Does conducting FDA 510(k) enabling clinical studies that we estimate will begin in Q4 of 2023 fall within scope of the RFP? It is to be noted, that the clinical studies are not expected to fall within the BASE period of the contract as stipulated.

Answer: The government cannot commit an answer from the information provided.

Question 69: Are multiple PIs allowed for the STIIRCs (ie: can there be 2 or more equal project directors;

or is only one project director allowed) (Solicitation page 7) Answer 69: CDC will consider proposals naming multiple principal investigators as long as the requirements of the contract are met.

Question 70: Will the IDIQ identify a single DCC to advise and support investigators conducting research for task orders issued to STIIRC contractors?

Answer 70: CDC anticipates awarding a single DCC contract

Question 71: Will the DCC submit a response to each task order that is released to fund the activities and effort needed to support the aims of a given task order?

Answer 71: All contractors who receive a basic contract are expected to submit proposals for future task orders. Each task order will be funded separately. The contractor awarded the task order for the DCC will need to be prepared to provide methodological and statistical support to all contractors receiving a basic award. The contractor awarded the task order for the DCC will submit a response identifying the expertise and effort needed to support task order proposals from any contractor after those awards are made.

Question 72: Is the Performance Work Statement detailed in the IDIQ the only targeted funding to be provided to the contractor serving as the DCC throughout the entire project period?

Answer 72: The contractor awarded the DCC task order may apply for future task orders during the project period.

II. Contractual Questions:

Question 1: Is it possible that this RFA will be available in subsequent years to apply for? I am very interested in this to support service delivery research, but our preliminary project planning is not likely to be far enough along to complete an application by the end of June. I’d like to keep this in mind in following years if there’s a possibility it may be available.

Answer 1: There are no provisions in the current solicitation to allow onboarding of new contractors during the period of performance of the IDIQ contract. However, the offerors shall monitor sam.gov regularly for any updates/ changes posted in reference to this procurement in the future.

Question 2: Is it acceptable for multiple institutions/agencies to submit a joint application?

Answer 2: It is important to understand that as the result of this solicitation the government will issue a contract, not a grant. The government solicits offeror’s proposals and not applications (grant term). The offeror shall provide a proposal as a prime contractor and may engage in subcontracting opportunities with other offerors/agencies to respond to this RFP.

Question 3: It is stated that multiple types of institutions will be funded for this consortium, but it is unclear if multiple institutions can apply together to strengthen the application. Can you please clarify?

Answer 3: Yes. Multiple institutions can apply together by using prime contractor and subcontractor(s) partnerships. One offeror can submit a proposal as a prime contractor and one or more institutions may partner with the prime contractor as a subcontractor.

Question 4: Task Order 0001 (Attachment J5)/ Section B (Supplies or Services and Prices/Costs). The broad scope of the coordinating center in Task Order 0001 is more amenable to a Time and Materials price model rather than Firm-fixed price, as there is not a fixed amount of work described. Will Time and Materials price structure be considered for Task Order 0001?

Answer 4: The government considered Time and Materials price structure; however, it was determined that the Firm-Fixed Price Task Order type was in the best interest of the government. More details were added to the SOW. See the revised RFP.

Question 5: L.9 BUSINESS PROPOSAL INSTRUCTIONS/ Task Order 0001 (Attachment J5)/ Section B (Supplies or Services and Prices/Costs): Please specify total expected labor hours for Task Order 0001.

Answer 5: The Government will not provide the number of hours for Task Order 0001. The offeror shall propose based on the requirements described in the Statement of Work (SOW) of the Task Order 0001.

Question 6: Attachment J6: Can offerors provide recent CPARS evaluation in lieu of Past Performance Questionnaires (PPQs) (Attachment J6).

Answer 6: No, the Past/Present Performance Questionnaire shall be submitted with the proposal.

Question 7: Attachment J4: Please confirm whether requested fully burdened labor rates are requested for future Time and Materials task orders.

Answer 7: The Government confirms that the fully burdened labor rates are requested for future Time and Materials task orders and shall be used for all Firm Fixed Price and Times and Materials task orders.

Question 8: Could you kindly clarify whether Volume II, the technical proposal for Task Order 0001, is a required or optional part of the CDC STIIRC application?

Answer 8: The Government confirms that Volume II, the technical proposal for Task Order 0001, is required as a part of the proposal submission.

Question 9: a question about the recent funding announcement and the associated Task Order 0001.

We wanted to clarify whether all applicants must submit an application for both the basic contract and for Task Order 0001. The announcement mentions that one or more awardees will be getting the basic contract, but that only one Task Order 0001 will be selected.

Answer 9: The Government confirms that all offerors must submit the proposal for both the basic contract and Task Order 0001 to be considered for the award.

Question 10: Is this limited to applicants that are small businesses limited in size to $17M?

Answer 10: No, the requirement is not set aside (limited) to small business concerns.

Question 11: If we use a map from CDC as a figure to explain information in Volume 1, the basic contract description, do we have make sure all font is above 8 point font?

Answer 11: The text must be legible to be considered, but CDC will accept maps or similar graphics with embedded text or footnotes accompanying the graphic.

Question 12: Do the cover pages count in the page limit for volume 1 and volume 2? Are references included?

Answer 12: Cover pages are included in the page count when it relates to the page limits for the technical proposal for both the basic and the Task Order Proposals. However, the Government will allow the references to be included in proposal and these references will be excluded from the total proposal page limit. See page 54 of 91 in the revised RFP.

Question 13: any specific format for resume'? NIH biosketch okay?

Answer 13: NIH biosketches are acceptable formats for resumes as long as they contain the information pertinent to evaluating the expertise and capabilities of the individual described on the biosketch and do not exceed the total of 3 pages limit per each resume. See page 56 of 91 in the Revised RFP.

Question 14: Do citations count against the page limit?

Answer 14: The Government will allow the citations/references to be included in the proposal and these citations/ references will be excluded from the total proposal page limit. See the revised RFP page XXXX Citations/references will not count against the page limit.

Question 15: Where would we put letters of [reference] Answer 15: The Government clarified the references requirement in the revised RFP as follows. Also see the revised RFP:

a) The government allowed to include citations/ literature references with both Basic and Task Order technical proposal submissions. The citations/ literature references are excluded from the page count limitation. See section L.6 of the revised RFP;

b) The documentation/references mentioned within the Subfactor #2 of the Task Order 0001 technical evaluation criteria shall be submitted within the technical proposal for Task Order 00001 (Volume II) and are NOT excluded from the overall page count limitation (15 pages).

See section L.7 of the revised RFP;

c) The government clarified that the record of requesting 3 references via Past /Present Performance Reference Questionnaires within Volume III – has been excluded from the page count of the Volume III submission. See section L.8 of the revised RFP.

Question 16: For Task Order 0001, what do you anticipate as being part of the breakdown of the budget? Is the expectation that it just be personnel costs - or- is there something additional that may be included?

Answer 16: The Government will not provide the estimated cost breakdown. The offeror shall propose based on the requirements described in the Statement of Work (SOW) of the Task Order 0001.

Question 17: Is the DMP in Vol1 or in the Business plan (Vol 4) or in TO1 (Vol 2)/ here does the data management plan (DMP) go?

Answer 17: The DMP shall be included with the Business Proposal and is not subject to any page limitation.

Please see the revised RFP. Page 57 and 58 of 91.

Question 18: Is there a max award for the basic contract?

Answer 18: There is no max number of awards for the basic contract. The Government will award one or more basic contract awards.

Question 19: Should 3 page resumes be attached to Vol 1 and to Vol2 or only to Vol 2?

Answer 19: Resumes are a part of the Staffing Plan criteria, for Task Order 0001 only. Therefore, resumes shall be attached to Volume II only, Volume II - Technical Proposal for Task Order 0001

Question 20: Are resumes only allowed for "key personnel"?

Answer 20: The offeror shall provide resumes of proposed key personnel for Volume II - Technical Proposal for Task Order 0001 only. However, the offeror may provide resumes for other investigators providing pertinent additional expertise.

Question 21: Can the funds be used to cover the cost of testing and treatment of STIs?

can you please review the eligibility for this? I had a hard time finding it in the RFA?

Answer 21: This will be determined at the task order level depending on the technical requirements for future task orders.

Question 22: Can applications be just for the basic component and not the data management center?

Answer 22: The offeror must submit a proposal for the basic contract and for task order 0001m the Data Coordinating Center. Please note the basic contract proposal is evaluated before the task order proposal, and an offeror may be awarded a base contract without being awarded a contract for Task Order 0001, however, if there is no proposal submitted for the task order contract then the offeror will not be eligible for a basic contract award.

Question 23: Do our NAICs codes have to be already reflected in our SAM.gov profile?

Answer 23: Yes. The offeror shall have the applicable NAICS code for this requirement listed on their SAM.gov profile to be eligible for award.

Question 24: Can national research institute can apply for surveillance purpose?

Answer 24: Any offeror eligible for the award can submit a proposal for consideration.

Question 25: Does the CDC have an idea of how many contracts they plan on approving?

Answer 25: CDC expects to award one or more basic IDIQ contracts but cannot give an exact number at this point.

Question 26: Is academic research center can apply for non interventional physiopathological research regarding HBV?

Answer 26: Research and technical requirements will be specified in future task orders.

Question 27: can non/not-for profits be acceptable as small business partners?

Answer 27: Typically, non/not-for profit organizations are considered to be large business concerns;

however, there are no restrictions on subcontracting for this effort.

Question 28: Do submitted resumes need to be limited to key personnel or can we include resumes for other investigators who provide additional expertise that is relevant to the future work of the consortium?

Answer 28: The offeror may provide resumes for other investigators providing pertinent additional expertise.

Question 29: Who will perform the review and evaluation of technical proposals - people internal or external to CDC, and if internal to CDC, will the review be done only by CDC DSTDP?

Answer 29: This information will not be released.

Question 30: Will full indirect cost be allowed or is there a limit on that?

Answer 30: There are no contractual limits, however, all costs will be evaluated to determine price reasonableness.

Question 31: Also, resumes can be really long, suggest we use biosketch if that is acceptable?

Answer 31: Biosketches are acceptable formats for resumes as long as they contain the information pertinent to evaluating the expertise and capabilities of the individual described on the biosketch and do not exceed the total of 3 pages limit per each resume. See page 56 of 91 in the Revised RFP.

Question 32: Please clarify whether references and citations from the literature can be excluded from the page count.

Answer 32: The Government will allow the citations/literature references to be included in the proposal and these citations/ references will be excluded from the total proposal page limit. See the revised RFP page 54 of 91. Citations/references will not count against the page limit.

Question 33: Do volume 1 and volume 2 need separate list of references/citations from the literature?

Answer 33: Citations/references will not count against the page limit. The offeror may decide whether to include them in each of those volume separately or together.

Question 34: Will you accept applications that include the basic component, but not task order 0001?

Answer 34: No. The offeror must submit a proposal for the basic and for the Data Coordinating Center (Task Order 00001). Please note the basic contract proposal is evaluated before the task order proposal, and an offeror may be awarded a base contract without being awarded a contract for Task Order 0001, however, if there is no proposal submitted for the task order then the offeror will not be considered for award of a basic contract.

Question 35: Can you please clarify if subcontractors to a Prime contractor must also be registered in SAM. Typically, they must be registered.

Answer 35: Yes, both prime and subcontractors must be registered in SAM.gov. Per FAR Part 4.1102, Offerors and quoters are required to be registered in SAM at the time an offer or quotation is submitted in order to comply with the annual representations and certifications requirements.

Question 36: Does our contract with the federal government have to be active? We are in the process of reactivating/ updating services. We are in SAM.

Answer 36: The offeror must be active in SAM in order to be eligible for award. Per FAR Part 4.1102, Offerors and quoters are required to be registered in SAM at the time an offer or quotation is submitted in order to comply with the annual representations and certifications requirements.

Question 37: The timeline for this (~3 weeks from webinar to deadline) makes it nearly impossible for many institutions to apply. While the documents were released with a slightly longer timeline, as you observed today, they were very confusing for most people to parse. At my institution, to get the contracts/grants management office to begin to facilitate just the various system registrations and the subcontracts, I would have had to loop them in 3 weeks ago (we are obligated to start this process 6 weeks in advance of any deadline). This timeline means you are likely to get proposals mainly from the huge or corporate partners, not from “little guys” who are really interested in the science and would love to be part of CDC’s STD work.

Answer 37: Due to the nature of the requirement and the timeline of the requirement, the Government will only extend the due date of the proposal by one week to June 22, 2022. See the revised RFP.

Question 38: [Purpose of registration should say “All Awards” in order for a company to be to be able to apply for contracts.] Do you know how we can get that status?

Answer 38: Please contact sam.gov customer service.

Question 39: I just received step by step instructions to change our status to all awards. They told me that because of matching issues, everyone has to do an incident report so it may take 4 weeks.

Apparently when they got rid of the DUNS number they did not put in the new CAGE number matches.

Once that is corrected the process is quick. Can we still send our proposal in and just note that the registration status is in process if it is not done by then?

Answer 39: Per FAR Part 4.1102, Offerors and quoters are required to be registered in SAM at the time an offer or quotation is submitted in order to comply with the annual representations and certifications requirements.

Question 40: “Please confirm that the required Data Management Plan is exempt from the 15-page Volume 2 page limit or that it should be included in the Business Proposal appendix section.”

Answer 40: The Government confirms that the Data Management Plan is exempt from the page limit and shall be included in the Business Proposal. See the revised RFP.

Question 41: Section B - Supplies Or Services And Prices/Costs page 3, paragraph B.9 Can the CDC provide an estimate for the level of effort of work to be performed off-site at the Contractor location(s) compared to worked to be performed on site at the CDC location in Atlanta, GA?

Answer 41: The Government will not provide an estimate for the level of effort of any work. The offeror shall propose based on the requirements described in the Statement of Work (SOW) of the Task Order 0001. However, it is unlikely that any significant portion of work outlined in task orders will be performed at CDC.

Question 42: Attachment J3, page 70, Attachment J3 – please confirm that offerors are not required to include rates for the labor categories that are presented in consideration of the basic IDIQ contract?

Answer 42: That is incorrect. The rates for the basic IDIQ contract are required and shall be submitted within the Business Proposal volume, Attachment J4 (Volume IV). The attachment J3, Labor Categories, Descriptions/Duties and Qualifications/Education, shall be included with the technical proposal Volume I and will be used for all firm-fixed-price (FFP) AND time-and-materials (T&M) task orders issued under this contract and will help the Government in evaluation of the Basic IDIQ technical proposal as it will reflect to offeror’s understanding of the requirement. These labor rates will also be used for future task orders.

Question 43: Attachment J3, page 70, Attachment J3 – is there a budget associated with the CDC award for the basic IDIQ contract? IDIQs will often include a base Task Order which includes time to support the overarching administrative requirements of the IDIQ.

Answer 43: There is no budget associated with the basic IDIQ contract.