Question_and_Answers-Final-RFQ.doc

FDA-RFP-1142919

Amendment 1

Question/Clarifications and Answers Question 1:

SOW Section 2.2 & 7.8 Travel: Can the government clarify how many days the face-to-face meetings will take place for (i.e, one (1) day, two (2) days or a full week)? Additionally, does the government have a NTE travel number for the pricing table in 2.2?

Answer:

Generally, the face to face meetings will take place for one day. We ask that a reasonable travel number be used as all travel must be approved in writing by the COR prior to travel.

Question 2:

SOW Section 3.4.2, and 3.4.4 Will the government provide documentation on the current mathematical methods and algorithms used by CTP to implement the Tobacco Control Act?

Answer:

The contractor is responsible for obtaining all of the requisite information. If there is information available only to CTP, when available and feasible, this documentation will be provided.

Question 3:

Is there a current incumbent providing this work to CTP currently? If so, can the government identify whom the incumbent(s) are? And what is the current contract number(s) and total contract value?

Answer:

There is no incumbent providing this work.

Question 4:

Is there as specific font requirement that the government would like the offers to utilize (i.e 12 point or 10 point font, Times Roman New Roman or Ariel?)

Answer:

Time New Roman, 12 point font.

Question 5:

SOW Section 12.4.2 Technical approach indicates that the narrative approach should be no longer than 30 pages. Is this just for the technical approach, Factor I? Or does it included the Management, Factor II: Management Approach and Factor III: Relevant Past Performance?

Answer:

The thirty page limit is for the Technical Proposal—Factors I, II, and III.

Question 6:

SOW Section 3.4.4 Will the contractor be expected to aid the CTP in assessing health risks associated with exposure to various types of tobacco?

Answer:

No Question 7:

a. SOW 3.4.5 How often will the statistical analysis of enforcement activity data be performed? I.e., monthly, quarterly, yearly or some other period?

b. Will the results of the analysis be reported over the same periods as the analysis?

Answer:

a. The statistical analysis will be performed on an ad hoc basis. Tasks will be developed to address specific statistical analysis needs and these individual tasks will provide the scope and timeframes in which the analysis must be performed.

b. Yes, the results of the analysis will be reported based on the specific task requirements, however, the general expectation is that the reports will be provided upon completion of the analysis and not at the end of the contract period.

Question 8:

SOW (section) 3.4.5 Will enforcement activity data include personally identifiable information (PII)?

Answer: Yes, there may be minimal PII data provided with the datasets.

Question 9:

a. SOW (section) 3.4.5 Are there validation datasets that CTP specifically wants the models or data validated against?

b. If so, will CTP provide these to the contractor? If not, will it be up to the contractor to develop the datasets?

Answer:

a. All CTP-specific data will be provided to the contractor by CTP, including current data and any models or previously defined data validation criteria.

b. See above.

Question 10:

a. SOW Section 3.4.7 Does the data currently collected by the CTP include unstructured as well as structured data?

b. Does the CTP anticipate asking the contractor to evaluate data collection techniques for unstructured data?

Answer:

a. The data currently collected by CTP is structured, however, the collection process and reporting has changed over time, so there is potential for some of the data to be structured using a unique layout or obsolete reporting structure. Additionally, some of the data may be effected by unstructured actions that are external to, and outside of the control of, CTP, which, while not part of the main analysis, may need to be considered as having an effect on the dataset.

b. CTP will provide data to the contractor for evaluation that is in a structured format, however, the evaluation completed by the contractor may require comparison of the data to unstructured external actions.

Question 11:

SOW Section 3.4.7 Will the Government provide documentation on CTPs current data collection techniques and procedures?

Answer: Information regarding the applicable data collection techniques and procedures currently used by CTP will be included as part of any task created that relates to data collection evaluation.

Question 12:

Can the Government clarify the security requirement for this RFP? Does the contractors working on this need US Citizenship, background investigations, or special clearances?

Answer:

No. Contractors will need to be able to obtain a Public Trust level of clearance.

Question 13:

SOW Section 12.4.1 section 2 sub-paragraph a) states please briefly describe how you will evaluate the system dynamics modeling approaches outlined in this statement of work, such as discussion of metrics and methods that will be used to evaluate the approaches. Will the government please indicate the current system dynamics models they are using, otherwise a contractor will be non-compliant in their response based on this evaluation factor.

Answer:

FDA-CTP is currently interested in and investigating a broad range of system dynamics models. The evaluation approach should be broad enough to encompass a number of different system dynamics models.

Question 14:

Will the Government provide an estimate on how many task CTP anticipates awarding per year on this vehicle? Can the Government provide an estimate on the task size that they anticipate awarding under the IDIQ?

Answer:

At this time, the government is not anticipating more than 4 to 5 task orders on this contract.

Question 15:

SOW Section 12.5 Business Proposal – Does the Government require Certifications & Representations to be submitted with the proposal, or will the Government utilize the SAM database for this requirement?

Answer:

If your SAM record is up to date, we will utilize it. Otherwise, please submit with proposal.

Question 16:

Section 3.3 on the scope of work discusses the work to be done based on the “statistical and mathematical methods identified by the FDA - CTP”. In case there are multiple extensions and developments of these methods, will the offeror be expected to pursue all extensions or will the most viable extensions be chosen in discussion with the contracting officer representative (COR)?

Answer:

The most pertinent extensions will be chosen in discussion with the COR.

Question 17:

Will simulation studies be allowed in order to assess some of the methods identified by the CTP or will they only be based on existing data?

Answer:

Simulations may be used, when FDA staff and the contractor agree that it is appropriate.

Question 18:

The RFP requests that “all analysis be completed using SPSS, Stata, and ArcGIS software” (Section 7.7). Will there be any exceptions made if, during the course of the work, a need arises to use additional software with additional functionalities?

Answer:

Please disregard Section 7.7.

Question 19:

Are there any computing platform restrictions or will the offeror be allowed to choose a platform of preference including Windows, Linux, Unix, Macintosh, etc.?

Answer:

The contractor will need to utilize a platform that is supported by FDA, which includes Windows, while Linux and Unix platforms may also be available.

Question 20:

For the labor classes listed in section 2.2, would it be acceptable for the offeror to add additional labor classes to include such labor categories as programmers, research assistants, administrative assistants, and other labor categories that might be utilized with the proposal and resulting IDIQ award and task order opportunities?

Answer:

Yes additional labor categories may be added to the proposal.

Question 21:

Page 25 of the solicitation states that the narrative description of the technical approach to performing the work (Factor I: Technical Approach) should be no longer than 30 pages. Is there a page limit for the management plan and past performance sections (Factor II: Management Approach and Factor III: Relevant Past Performance)?

Answer:

The 30 page limit applies to the entire Technical Proposal—Factors I, II, and III.

Question 22:

Section 7.7 of the solicitation states that “all models, algorithms, and data provided to the Contractor during the course of performance are strictly confidential and shall not be disclosed.” In any publications resulting from this work, may the offeror refer to the models and algorithms in publications without any disclosure of their content? Additionally, can any models and algorithms developed by the offeror as part of work conducted under this contract (if such effort is required by the government) be published by the offeror?

Answer:

Any publications results from this contract must occur in collaboration with FDA staff and they must be submitted for FDA clearance prior to being sent out for publication. All confidential information must be treated in a manner that is consistent with FDA policy and procedures on confidential information.

Question 23:

Does the 30 page limit stated on page 25 of 29 apply to the entire Technical Proposal or the Technical Approach section of the Technical Proposal?

Answer:

The 30 page limit applies to the entire Technical Proposal—Factors I, II, and II.

Question 24:

Does FDA require resumes of proposed staff for each labor category? If so, please provide your requirements for the following:

a. Number of resumes

b. Number of pages per resume

c. Location of resumes in proposal

Answer:

There is no specification regarding the number of resumes and the number of pages in a resume. The resumes may be included in an appendix.

Question 25:

Please provide your definitions for the terms “bioinformatics methods for text analysis,” and “informatics methods.”

Answer:

Generally, this refers to methods for topic modeling and text analytics.

Question 26:

On page 5 of 29, the RFP states that “All deliverables shall be compliant with Section 508 of the Rehabilitation Act of 1973 …”. Please confirm this requirement. It appears that most deliverables for this contract would not be subject to Section 508.

Answer:

Deliverables, when applicable, shall be 508 compliant.

Question 27:

If an offer included innovative technology that required a service fee, can the service fee be recovered separately from the labor rates?

Answer:

Yes.

Question 28:

To provide better cost savings to the Government, may the successful contractors add labor categories after award? While we understand the need for consistent labor categories among the bidders for the proposal, some future support, such as 508 compliance, is not provided for in the categories currently listed in the RFP.

Answer:

Additional labor categories may be added to the proposal.

Question 29:

In section RFP Section 12.4, page 26 is the bidder free to submit resumes of proposed personnel?

Answer:

Yes, resumes may be submitted in an appendix.

Question 30:

In RFP Section 12.4.1, page 25, the RFP states, "the Offeror shall provide a narrative description, no longer than 30 pages, of the Offeror's approach.” Can the FDA verify that this page limit only applies to Factor I: Technical Approach? Can the FDA verify that no other page limits exist for the Technical volume?

Answer:

The 30 page limit applies to Factors I, II, and III.

Question 31:

Is there an incumbent on this project? If so, who is the incumbent?

Answer:

This is a new requirement, there is no incumbent.

Question 32:

The RFP (p.3) states that “[t]he contractor shall conduct a thorough experimental evaluation in which they compare a group of methods and algorithms identified by CTP”. Approaches employed in some methods and algorithms are open access, but others are proprietary. For proprietary approaches, will CTP provide the models/software to the research team charged with evaluating it?

Answer:

The contractor must obtain access to all identified models and algorithms.

Question 33:

a. The RFP (p.25) states that “[t]he offeror shall provide a narrative description, no longer than 30 pages [emphasis added], of the offeror's approach to performing the work described in the SOW for the Evaluation, Development, and Utilization of Statistical and Mathematical Methods. The narrative should describe the offeror's understanding of the project (both from a business and technical standpoint [emphasis added]), how the offeror intends to satisfy the technical requirements, any risks it foresees in carrying out its approach, along with mitigation strategies for those risks”. Does the thirty (30) page limit apply to both Volume I (Technical Proposal) and Volume II (Business Proposal)?

b. In other words can the combined Volumes I & II exceed 30 pages? If the 30 page limit applies only to the Technical Proposal, does it apply only to Factor I: Technical Approach or does it also subsume the Management and Relevant Past Performance sections?

Answer:

a. The 30 page limit only refers to the Technical proposal

b. It applies to the entire Technical proposal.

Question 34:

On page 16 of the RFP, 52.219-6, Notice of Total Small Business Aside has been checked. In addition, a Small Business Subcontracting Plan has been requested. This appears to possibly be contradictory from our understanding in that a Small Business Subcontracting Plan, noted in Section 8.5 of the RFP, would not be required if the project is a Small Business set aside.

Answer:

This was accidentally checked. This requirement is full and open with no small business restrictions.

Question 35:

a. Please clarify length of Technical Proposal: On pages 25 and 26 of the RFP, three evaluation factors are listed for Volume I – Technical Proposal (Technical Approach, Management Approach, and Relevant Past Performance). The length of the Technical Approach is specified as no longer than 30 pages – does that page limit apply to the entire Technical Proposal, or merely to the Technical Approach section of the Technical Proposal. If the latter, are there page limits to the Management Approach and Relevant Past Performance (and for an Introduction section for the Technical Proposal)?

b. May resumes or curriculum vitae for illustrative staff be included in an Appendix? If so, would resumes/CVs be evaluated as part of the scoring?

Answer:

a. Please see question 33

b. Yes, resumes can be included in an appendix.

Question 36:

Page 26 specifies that Teaming Agreements for all partners be included in the proposal. Are these to be included in an Appendix and thus not count against the page limitations?

Answer:

Teaming agreements included in an Appendix will not be counted against the page limitation.

Question 37:

There are five labor categories listed for which hourly rates are to be provided. However, there are various levels of experience within each labor category which could lead to varying hourly rates depending upon the individual determined best suited for a particular task. Can vendors identify levels within each labor category and provide hourly rates for each level rather than developing, one melded rate for each labor category that would need to apply regardless of the level of experience required for a particular task?

Answer:

Yes Question 38:

May additional labor categories be listed, such as Subject Matter Expert, Financial Analyst?

Answer:

Yes, additional labor categories can be listed in the proposal.

Question 39:

Must the three Past Performance examples discussed on page 26 all be from the prime offeror, or may Past Performances from sub-contracting partners be included?

Answer:

Past performance from sub-contracting may be included. However, the specific role, responsibilities and duties that were performed as a sub-contractor must be noted.

Question 40:

In Section 12, INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR RESPONDENTS, subsection 12.1 (page 23), representation and certification language is quoted from FAR 52.212-3. Should this language be included in the offer as a separate signed representation and certification or, if our SAM reps and certs are up to date, will this certification be considered made by implication merely via submission of the offer?

Answer:

Please see question 15.

Question 41:

Re Attachment 3, the Small Business Subcontracting Plan form, may a standard HHS SBSP form (Revised December 2011) be substituted?

Answer:

Yes.

Question 42:

In the Small Business Subcontracting Plan form, should the dollar amounts be left blank or indicated as “TBD”, given amounts will depend upon released Task Orders?

Answer:

For evaluation purposes an amount should be filled in.

Question 43:

Section 12.4.2 FACTOR II: MANAGEMENT APPROACH includes the following language on page 26: “If the offeror plans to form Contractor Teaming Arrangement(s) to provide an integrated solution to meet the Government’s requirements, the offeror shall submit signed copies of the Contractor Teaming Arrangement(s).”

The FAR defines two types of such arrangements:

9.601 Definition.

“Contractor team arrangement,” as used in this subpart, means 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 act as its subcontractors under a specified Government contract or acquisition program.

a. Should the above language in the RFP be interpreted to include both types of teaming arrangements?

b. That is, should copies of any and all teaming agreements be submitted, or should copies be submitted only for a partnership or joint venture under FAR 9.601(1)?

Answer:

a. Yes.

b. Signed agreements/ paperwork should be submitted to demonstrate a commitment of the arrangement.

Question 44:

Is there an incumbent on this effort? If yes, please identify them.

Answer:

Please see question 31.

Question 45:

As the Government plans to make two awards, what is the Government’s planned ceiling (annual and total) for the ID/IQ vehicle?

Answer:

This information is not relevant to an offeror’s ability to respond to this solicitation.

Question 46:

Is the Management Approach referred to in RFP section 12.4.2 intended to be included within the 30-page limit for the Technical approach (RFP 12.4.1)? If not, is there a page limit on the Management Approach section?

Answer:

Please see question 33.

Question 47:

Analytic Services, Inc. respectfully requests an extension of the proposal due date.

Answer:

Extension granted.

Question 48:

Is the Government willing to expand the definition of Relevant Past Performance to include contracts/orders that were awarded before the past 3 years but completed within that timeframe?

Answer:

No.

Question 49:

Does the one-page narrative referred to in RFP section 12.4.3.f count against page limits in any section? If yes, please specify.

Answer:

Yes, it counts against the overall 30 page limit for the Technical Proposal—Factors I, II, and III.

Question 50:

On what basis will the Government establish an offeror’s technical understanding and degree to which they are able to execute the mathematical, statistical and computational components of the task?

Answer:

The information provided in the Technical Proposal.

Question 51:

RFP section 13.1.3 states “The Offeror’s past performance information shall demonstrate the degree to which the offeror's success in performing comparable contracts/orders.” Some thoughts appear to be missing from this sentence.

Answer:

This should read: The Offeror’s past performance information shall demonstrate the degree to which the offeror has demonstrated success in performing comparable contracts/orders.

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