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RFP 2016-N-17753
TITLE: PPHF 2016: Diabetes Prevention – Developing and Validating two Computer Simulation Models to Predict the Long-term Health and Economic Outcomes of Interventions for Preventing Diabetes and its Complications – Financed Solely by 2016 Prevention and Public Health Funds
Subject: Questions and Answers
| 1 |
| Would the CDC consider a proposal in which the new models to be developed would be embedded within an existing Diabetes model? |
| CDC prefer offerors to build new models, not modify existing models. CDC encourages offerors to use innovative ways to advance the diabetes modelling field. |
| 2 |
| To clarify, does CDC intend that all the software and programming code, equations, algorithms and the two computer models be solely owned by the CDC? |
| Yes |
| 3 |
| If the Offeror has proprietary models that may be applicable to this effort, can they be proposed? |
| CDC does not believe current existing model including the proprietary models can serve the CDC need. Therefore, modifying the current models is not a good approach. |
| 4 |
| Will the CDC be providing commercial, open access to the developed computer simulation models? |
| No decision has been made regarding the commercial, open access of the developed computer simulation models at this points. As this is a tax funded project, CDC will encourage public use of the model. But additional resources are needed to provide technical support if the models were accessed publically. Whether CDC has the resources needed for the technical support is not known. |
| 5 |
| Does the CDC have the intention of deriving any revenue from the commercial use of the developed computer simulation models? |
| No. The primary purpose of the project is for CDC use. CDC has no intention of deriving revenue from the commercial use of the developed computer simulation models. |
| 6 |
| The RFP specifies the distinct development of two models for type 1 and type 2 diabetes. |
Would an alternative approach be accepted in which the model structure is defined and implemented generically to reflect disease progression in both diabetes types and then the differences between T1D and T2D would be established through the type specific epidemiological data and risk equations?
CDC prefers to have two models as stated in the RFP unless the offeror can demonstrate one combined model is superior to the two separate models to meet all technical and foundational requirements as described in the RFP.
| 7 |
| Is 60 calendar days required for proposal validity? |
| We request that the offeror’s proposal remain valid for 90 days |
| 8 |
| How does CDC envision the Offeror obtain diabetes computer simulation models that are not published? Does CDC have these available to provide to the Offeror? |
| Some of the exiting models may not be published in referred literature. These modelling groups may have been participated in various modeling group meetings such as Mt Hood Challenge. Writing to the modelling group may be another way. CDC does not have access to those unpublished models, thus will not provide any additional information or software to the offerors. |
| 9 |
| Are the External Scientific Evaluation Committee (ESEC) meetings intended to take place in Atlanta, Georgia? |
| Yes. The contractor will be responsible for coordinating available dates and times for the meetings with the ESEC team, developing agendas, and preparing minutes from the meetings. |
| 10 |
| Please provide additional guidance regarding the OMB Clearance Package. As this is a significant undertaking, does CDC have any additional information as to whether or not the Clearance Package would be required? |
Should the Offeror assume the Clearance Package will be required?
This is dependent on the type of data and how the data is being obtained by the contractor. CDC does not have any additional information as to whether OMB clearance is required. The offeror should assume the clearance package will be required and plan accordingly for clearance if applicable.
| 11 |
| Sub paragraph (1) requires the Offeror to revise the work plan based on the recommendations of the ESEC and CDC COR and submit the final plan (task 5). |
Should this be Task 6?
Yes this should have been listed as Task 6 (see amendment 0001 to the RFP)
| 12 |
| Does the CDC have a requirement for which non US country is to be embedded in the model as a default non US country? The determination of the non US country may affect the pricing provided. |
| No. The main purpose of the requirement is to ensure the new developed models can have appropriate structures to be adopted in different country settings, especially developing country settings. |
| 13 |
| Aside from presenting confidence ranges in the |
outputs, what is meant with post simulation statistical testing?
Post simulation statistical testing meant the differences in some or all simulated outcomes can be tested for statistical significances.
| 14 |
| The RFP states, “The model shall consist of at least the following components: mathematical/ statistical equations/parameters, algorithms for combining these equations/parameters and executable computer software that implements the equations/parameters and algorithms.” |
Is the term algorithm used in the context of overall modeling approach to be employed? E.g. to specify whether patient-level or cohort-level modeling approaches are foreseen, stochastic vs. deterministic approaches etc.?
The term algorithm means the ways in which mathematical/ statistical equations/parameters of the model are linked together.
| 15 |
| The RFP states, “The Contractor shall identify and acquire all of the data that is needed for the model. Data quality will play a critical role in determining the validity and predictive ability of the mathematical equations. For the purpose of developing the mathematical equations, large, accurate, and longitudinal cohort data should be used.” |
Are longitudinal datasets from sources (e.g., ACCORD study, ARIC, CARDIA) provided from the CDC or is the acquisition of these datasets the responsibility of the contractor and should be factored in the technical approach and cost volume?
The acquisition of these datasets are the responsibility of the contractor and should be factored in the technical approach and cost volume.
| 16 |
| Does CDC have a specific recommendation regarding the number of other study groups that would be required in the construction of the risk equations needed for the model? |
| No, but using high quality and contemporary data from clinical trials, insurance claim or electric medical records is critical in the construction of the risk and cost equations needed for the model. The RFP described some of the critical sources. Collaboration with those who have the data are needed especially if the data is not public available. |
| 17 |
| Does the CDC intend to provide the computing |
environment for the diabetes model?
Yes.
| 18 |
| Should proposals include considerations to use publically available risk equations based on contemporary populations/treatment scenarios that are already developed? |
For example, the RFP states, “…the Pittsburgh Epidemiology of Diabetes Complications (EDC) study can be good sources for developing mathematical equations needed for the model. “ However, there is a risk equation in the public domain that predicts the risk of cardiovascular events based on the study findings which could be used alternatively and with considerable scope decline.
Yes, but only under the condition that the available risk equations meet the model need.
| 19 |
| The RFP states that risk equations should be also developed for individuals with type 1 diabetes, type 2 diabetes, prediabetes and individuals with normal glucose levels. Since the development of equations for 4 distinct populations significantly increases the project scope, could you confirm that our below understanding (highlighted) is correct? |
o Risk equations should be developed for all relevant micro- and macrovascular complications in diabetes. Longitudinal datasets from contemporary studies should be used to derive risk equations for the below populations:
Individuals with normal glucose levels Pre-diabetes (IGT) Type 1 Type 2 E.g. should four risk equations be developed for the risk of myocardial infarction based on multivariate analysis of four distinct datasets?
Yes. Risk equation, cost equations, utility equations and mortality equation should be developed for the populations mentioned.
| 20 |
| The RFP states, “…the Contractor shall justify the approach and data sources used to develop the mathematical equations.” |
Does this statement mean the contractor should already suggest likely studies/data sources in the proposal or shall those be subsequently identified in a literature search during the project?
Both. The contractor should suggest likely studies/data sources in their proposal and identify additional sources found through their literature search.
| 21 |
| Can the CDC clarify what is meant in terms of |
recalibration? If newly developed risk equations fail to predict external evidence in the validation exercises, does calibration refer to the integration of adjustment factors to enable a reproduction of external studies?
Recalibration referred the process of adjusting some of the model parameters based on the external validation results to improve the predictive power of the model.
| 22 |
| In a FFP environment, the Offeror is being asked to complete recalibration of the updated model after validation. How can the Offeror be assured that this will not be an extensive effort? |
| The offeror shall recalibrate the updated model after validation. Whether or not the recalibration is an extensive effort may depend the validation results. The government does not assure the recalibration is not an extensive effort. |
| 23 |
| Within the monthly and annual progress reports, CDC is asking for an actual versus planned level of effort broken down by individuals, including cumulative expenditures incurred. Is it CDC’s intent that this is provided to monitor the progress of the work effort against the staffing plan proposed and the labor hours proposed, even though the effort is FFP? |
| Yes |
| 24 |
| CDC has stated that no Government Furnished |
materials, facilities or property will be provided to the Contractor? Does CDC plan on making any materials from prior Diabetes Modeling available? What does CDC have that the Offeror can’t obtain publically?
This RFP is a new project. CDC will not provide any unpublished models or data. The offeror need to identify best data sources needed for the project and collaborate with those who have the data if data cannot be obtained publically.
| 25 |
| Deliverable #8 asks for the Work report documenting the results of data analyses on diabetes type 2 development equations. Is there a corresponding requirement to provide the same work report on the diabetes type 1 development equations? |
| No. Type 1 diabetes model starts at persons with type 1 diabetes, not those at high risk develop the disease like type 2 diabetes models. |
| 26 |
| FAR clause 52.215-12 is included. Is CDC requesting certified cost and pricing data from subcontractors? |
| Yes |
| 27 |
| CDC has included the FAR clause 52.244-6 |
Subcontracts for Commercial Items in this solicitation. Does CDC intend that the Offeror propose a commercial item (diabetes model) rather than develop a new model? If so, how would the Offeror or its subcontractor retain Intellectual Property Rights in a commercial item?
CDC intends to build a new models. The government intends to have Intellectual Property Rights. CDC does not intend to commercialize the two developed models from this project.
| 28 |
| CDC has requested detailed pricing information to include price analyses of subcontractor proposals. If a commercial item is proposed by a subcontractor, is price analysis required? |
| If a commercial item is proposed by a subcontractor, we expect that the price be justified in accordance with FAR 12.209 |
| 29 |
| CDC has requested a copy of current approved |
indirect cost rate agreement – what should be provided if the Offeror does not have an approved indirect cost rate agreement?
Evidence that the offeror has applied for an Indirect Cost rate Agreement and/or interim indirect rates.
| 30 |
| Subparagraph d) references the requirements of the Technical Proposal to include Information Security. Sub paragraph e) indicates the title page, executive summary, table of contents, Information Security, references, appendices and resumes of key personnel are excluded from the 30 page count limit. What is required for Information Security, as this is not listed |
in the Evaluation Criteria?
Information Security requires all data obtained for the project should be stored safely. Identities of those individuals contained in the data set cannot be identifiable. This a basic requirement for all offerors, so it is not listed in the evaluation criteria.
| 31 |
| Section F4 (pg. 31) is in conflict with Task 2 – that requires in person meetings in Atlanta, GA, each quarter. Which is correct? |
| There is no conflict, Section F4 is indicating place of performance, task 2 is referencing project update meetings. |
| 32 |
| How does CDC intend for the Contractor to invoice – monthly, or on the basis of milestones, or on the basis of the deliverable schedule, or in some other agreed upon invoicing schedule? |
| Monthly (see instructions G.2) |
| 33 |
| Homeland Security Directive – 12 HSPD 12 |
Requirements (Nov 2011) is cited requiring the position sensitivity level (s) of Level II. Does this preclude individuals who are not American Citizens from performing work under this effort? Is this applicable to the members of the External Scientific Evaluation Committee also?
See Section H.8 of the RFP. This is not applicable to the members of the ESEC team as they are making recommendations based on what the contractor is proposing for the models. The data/information that they are reviewing is information found from the literature reviews and information found from current models being used.
| 34 |
| Is the proposal to be submitted electronically or hand delivered? (The cover page/SF33 lists 6 copies due). If the CDC requires delivery of physical copies, can you provide more guidance on what is expected of vendors for this requirement? |
| No electronic copies of the Offeror’s proposal will be accepted. 6 hard copies each for the business and technical proposals to be accompanied by CDs must be hand delivered to the name and address provided in the RFP either by the offeror or via carrier (e.g., FedEx, USPS, etc.). This includes an original and 5 copies each of both the Business and technical proposals. |
| 35 |
| Travel – Is a copy of the corporate travel policy |
required for subcontractors?
Yes, travel should be submitted in accordance with the Federal Government Travel Regulations
| 36 |
| Section L.8 indicates the contents of the Technical Proposal should include Past Performance, Information Security, References and Appendices. In Section M.2 there is no mention of evaluation of Past Performance, Information Security, References and |
Appendices. What is required in terms of content for Past Performance, Information Security, References and Appendices and how will this information be evaluated?
See Section M.4
| 37 |
| Would the contracting office clarify the page count limit is 30 or 25 pages? There is conflicting information in RFP |
| 30 pages as indicated in L.7 (See Amendment 0001 to the RFP) |
| 38 |
| Will the contracting office consider changing the 30 page limit to only cover Criterion 1: Technical Approach; and providing separate page count limits for Criterions 2-4 (Mgmt. Plan; Staffing Plan; Similar Experience)? |
The page count, as it stands, will make it extremely difficult to provide complete information on our technical approach.
No, the contracting office will not consider changing the 30 page limit. Offerors can use attachments and appendices to supplement the 30 page limit.
| 39 |
| Will the contracting office allow for vendors to |
provide resumes for non-key staff as well as key staff? We would assume that the non-key resumes would be a part of the 120 appendices page limit.
Yes – resumes of non-key staff can be included as part of the 120 appendices page limit.
| 40 |
| In terms of providing a delivery schedule, will the contracting office allow for vendors to submit a separate MS Project file vs. embedding it in the technical volume? (and providing a summary table in the volume?) |
| The delivery schedule should be in accordance with the instructions in the RFP. |
| 41 |
| Staffing Plan – notes resumes from key personnel (limited to 10 pages). Does this mean the resumes of all key personnel are limited to 10 pages, or that each key personnel may not have a resume more than 10 pages? |
| Resumes from key personnel should not exceed 10 pages collectively (not each key staff have 10 pages) additional information can be included as part of the 120 page limit appendices. |
| 42 |
| There was no instruction to include a payment schedule. Does the government wish vendors to submit a payment schedule with their proposals, or will that be negotiated after award? |
| See Section G.2 of the RFP |
| 43 |
| May vendors simply state that Representations & Certifications are updated in the SAM.gov database? Or does the government wish us to submit a completed Section K? |
| We would prefer that the offeror submit a completed Section K. |
| 44 |
| There is a discrepancy with the page length. Section L.7 states 30 pages. Section L.8 states 25 pages. We would request the government set the page limit at 30 pages. |
| See Amendment 00001 to the RFP |
| 45 |
| In L.8 (d), the government asks for the proposal to be laid out in a particular order and format. However, there is no instruction regarding what the Government would like to see in the areas of “Information Security” or “References”. For “Information Security”, we assume the government would like an overview of our InfoSec procedures and processes. Can you please confirm? For References, how many would the government like us to include? |
| The Government expects the offeror to provide a Security Plan with the overview of procedures and processes that the offeror has in place for information securities. This can be included as part of the appendices. |
| 46 |
| L8 (e) specified the font size. Arial 11 is roughly equivalent to Times New Roman 12 in size. May vendors use Arial 11? |
| The Government prefers that the offerors use “Times New Roman 12” font size |
| 47 |
| The CDC specifically mentions landmark clinical trials that could offer timely, longitudinal data to inform the development and validation of the models (e.g., from DPP, ACCORD, and Look AHEAD). Has the CDC already coordinated with these study teams in some fashion to secure the use of the data for this project, or is the contractor solely responsible for securing the data? |
| Contractor is solely responsible for securing data (see question 15) |
| 48 |
| It is clear from the RFP that the simulation models should extent to non-US settings. Does the CDC envision that the models will be capable of predicting diabetes progression in low- and middle income countries, or does it envision applicability only to high income regions? |
| CDC envision that the models can be modified for conducting studies in non-US settings, either high-, low- or middle income countries. Developing risk, cost, and utility equations in no-US setting is not the focus of the project. But the model can be potentially be modified for non-us setting by modifying the non-US county included in the model. |
| 49 |
| Is the assumption correct that the “web-based environment” that will host the tools be provided by the CDC at no cost to the contractor? |
| Yes. But the offeror shall ensure the developed web-based model can be run in CDC IT environment at no cost to CDC. |
| 50 |
| Line item 23 in the deliverable schedule states “3 manuscripts submitted for journal review based on mathematical equations developed for the two models (2 for type 1 and at least 2 for type 2)”. Can you clarify the discrepancy here (3 versus 2+2)? |
| At least 1 manuscript for the type 1 model and at least 2 manuscripts for the type 2 model. The minimum is 3. |
| 51 |
| Will CDC provide an estimate of an expected level of effort in response to this RFP? |
| No, the CDC will not provide an estimate of an expected level of effort. Offerors are expected to provide their best proposal in accordance with the instructions in the RFP |
| 52 |
| Does the 30 page limit referenced in Section L.7. refer to the entire technical proposal or only to criterion 1 technical approach? Section L.8. Also mentions a page length of 25 pages. Will CDC clarify the page length requirements for each of the criterion of the technical proposal? |
| Yes, 30 pages is the entire technical proposal including all criterion (excluding attachments and appendices). Part of the goal of the limitations is to facilitate the efficient review of the proposals without engaging in a protracted effort. |
| 53 |
| Does CDC expect bidders to contact proposed members of the External Scientific Evaluation Committee (ESEC) be contacted for the proposal? Or does CDC prefer bidders identify potential experts without contacting them? |
| Members of External Scientific Evaluation Committee (ESEC) will be proposed by the offeror and approved by CDC after the award. There is no need to contact any potential experts. |
| 54 |
| Is it CDC’s expectation that members of the External Scientific Evaluation Committee (ESEC) will be provided honoraria for their participation? If so, should this be included in the budget? |
| The offeror is responsible for convening the members, coordinate available dates and times for the meetings and develop agendas. CDC will discuss with panel members when/and if applicable. |
| 55 |
| Would CDC consider extending the due date for proposals? An extension is required to complete subcontracting agreements with academic institutions. |
| No, the CDC will not consider extending the due date for proposals. This RFP has a posting time of 45 days from the date that RFP was initially posted through the proposal due date of July 7, 2016. It is our experience from past requirements of this nature that 45 days should be more than sufficient time for potential offerors to prepare and submit a proposal. |
| 56 |
| Will CDC clarify what is needed to complete the ATO process? Will a third party security assessment and artifacts be required? Should the budget include hiring a firm to conduct a third party assessment? |
| The artifacts for the Authority to Operate (ATO) will be prepared by the contractor in conjunction with CDC. CDC will provide templates and instructions to the contractor to ensure the artifacts are acceptable prior to issuing an Authority to Operate (ATO). The contractor will not need to hire a third party security assessor. The contractor should work with NCCDPHP’s ISSO to ensure the simulation models are compatible with CDC’s IT environment. |
| 57 |
| Will CDC clarify what activities are expected to require OMB clearance and approval? |
| See question 10 |
| 58 |
| Will CDC allow the prime contract holder to subcontract with organizations and individuals outside the U.S. to ensure the best individuals and data are used for the project? |
| Prime and subcontractors are to be within the U.S. (project monitoring, challenges with time zone differences, and logistical challenges preclude contracting with organizations outside of the U.S. for this effort. |
| 59 |
| Will CDC clarify whether the web-based analytical platform referenced in Task 9 is to be hosted on a CDC-hosted and maintained server? |
| Yes. The web-based analytical platform be hosted on a CDC-hosted and maintained server. The contractor would be responsible to make the analytical platform fully functional. |
| 60 |
| Is the effort to develop the two diabetes models considered by CDC to be the development or implementation of an electronic information systems/electronic data collection effort that will require a Certificate and Accreditation (C&A) prior to operation resulting in an Authority to Operate (ATO) from CDC? | |
| The artifacts for the Authority to Operate (ATO) will be prepared by the contractor in conjunction with CDC. CDC will provide templates and instructions to the contractor to ensure the artifacts are acceptable prior to issuing an Authority to Operate (ATO). The contractor will not need to hire a third party security assessor. The contractor should work with NCCDPHP’s ISSO to ensure the simulation models are compatible with CDC’s IT environment. | |
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