Q_and_A_-_CTP_OCE_IDIQ.doc

QUESTIONS & ANSWERS

For everyone’s convenience, duplicate questions will be only answered once. Similar questions with the same answer will be grouped together and answered once. Questions with typographical or grammatical errors have been revised for clarity. All questions have been formatted for consistency.

Question: Is there an incumbent Contractor? If so, who?

Is there an incumbent Contractor currently performing these services? If so, can they provide the name of the incumbent and the contract number?

Would the Government please identify if the tasks identified in Sections 5.3 – 5.7 are currently being supported by Government personnel, Contractors, or if they are new requirements? If they are supported by Contractors may you please identify the incumbent(s) and their contract number?

Is there an incumbent or incumbents for this program in its totality or parts of?

Please provide the name of the incumbent(s) Contractor(s).

What SOW tasks are currently supported by incumbent Contractor(s)?

There is a reference to an existing incumbent listed in Section 5.1 of the RFP. Will the Government please identify the incumbent for this work?

Is the FDA – either directly or via a third party - currently performing the work described in 5.7 Surveillance of Sale to Minor... etc.?

If a third party organization is being used to meet the requirements of Task Area 5.7, please provide organization name and comment as to whether FDA wishes to continue with that organization?

Answer: Areas of this contract have historically been performed by various different contractors, however this requirement is considered new as there have been various changes and additions to the requirement.

Question: Where will performance take place?

Notwithstanding task 5.7 which will be performed in Virginia, will future task orders be performed at Contractor or Government site?

Will any of the tasks be performed at Government site?

Which tasks will be performed at Government site?

Will any of the tasks be performed at Contractor site?

Which tasks will be performed at Contractor site?

How many workstations will be provided at Government site for this IDIQ?

Answer: All services tasked through this IDIQ will be performed at the Contractor’s facilities. Certain tasks will require delivery of documents to FDA’s White Oak campus in Silver Spring, Maryland, twice daily. Couriered documents must be delivered to the Contractor’s physical location so that they are processed the same day.

Question: Does “Kr. Site” refer to Contractor site? [ref: Pricing worksheet] Would you please clarify what "Kr Site" is referring to on the Excel Pricing Worksheet? Also, should the pricing be based on the work at the Contractor's site or the Government site?

Answer: Yes, “Kr Site” means Contractor Site; all pricing should reflect rates for work performed at the Contractor site.

Question: Shall offerors provide only Contractor site rates in proposals?

To complete the pricing worksheet, can the Government confirm whether proposed labor rates are to be based upon Government site rates or Contractor site rates so that a fair comparison can be made between all offerors?

Answer: Yes, rates shall be provided for work to be performed at the Contractor Site only.

Question: Given that the IDIQ includes compliance buys over the internet as well as processing of enforcement actions for violations discovered during these compliance buys, is it safe to assume FDA does not consider the performance of compliance buys and processing of enforcement actions to be a conflict?

Answer: The scope of work for this IDIQ does not present a conflict of interest in and of itself. Whether or not work currently performed by an offeror would present an organizational conflict of interest will depend on the specific circumstances for each offeror. Offerors should submit information on the potential for organizational conflict of interests describing the specific relationships that may present the conflicts. The offerors should then describe whether they believe the circumstances create an organizational conflict of interest and why. The offeror may also present a mitigation plan if a conflict is present that the offeror believes could be mitigated.

Question: Would a Contractor currently performing one of the tasks identified in the scope of work under a separate contract with FDA CTP be precluded from performing as a subcontractor for this IDIQ due to conflict of interest?

Does FDA perceive a conflict of interest between this IDIQ and the current TRIPS contract to review state FDA-funded tobacco surveillance systems? In other words, is the TRIP Contractor eligible to bid this IDIQ?

Answer: Whether or not work currently performed by an offeror would present an organizational conflict of interest will depend on the specific circumstances for each offeror. Offerors should submit information on the potential for organizational conflict of interests describing the specific relationships that may present the conflicts. The offerors should then describe whether they believe the circumstances create an organizational conflict of interest and why. The offeror may also present a mitigation plan if a conflict is present that the offeror believes could be mitigated. A Contractor currently performing work similar to any task in this requirement under a separate contract with FDA CTP is not precluded from performing as a subcontractor for this IDIQ solely on this basis.

Question: Would FDA CTP approve a firewall/mitigation plan to allow for a Contractor currently performing one of the tasks under a separate contract to perform services as a subcontractor under this IDIQ?

Answer: Whether or not work currently performed by an offeror would present an organizational conflict of interest will depend on the specific circumstances for each offeror. Offerors should submit information on the potential for organizational conflict of interests describing the specific relationships that may present the conflicts. The offerors should then describe whether they believe the circumstances create an organizational conflict of interest and why. The offeror may also present a firewall or mitigation plan if a conflict is present that the offeror believes could be mitigated.

Question: Will FDA provide guidance on what it would consider an acceptable mitigation plan for a proposed subcontractor currently performing task 5.7 under a separate contract?

Will FDA provide guidance on what it would consider an acceptable mitigation plan for a proposed subcontractor currently performing tobacco retail inspections under a separate contract?

Answer: No guidance will be provided on what is considered an acceptable mitigation plan.

Question: Does the incumbent Contractor have a contractual transition out responsibility that mandates knowledge transfer? [ref: Section 5.1] Answer: No, the incumbent Contractors do not have a contractual transition out responsibility that mandates knowledge transfer. However, the Government will provide information to facilitate transition in of the task orders.

Question: This clause seems unusual for a service contract unrelated to acquisition support. Will the contractor be providing acquisition support under this IDIQ? [ref. DO NOT COMPETE]

Will the government remove this clause from the RFP?

The RFP states the contractor shall: “2) Not furnish either as a prime contractor or subcontractor the requirements or services described in paragraph a.1) above.” However, the location of paragraph a.1) is unclear. Will the government please provide clarification as to the services the contractor shall not provide as prime contractor or subcontractor?

Will the government please correct the reference to paragraph a.1)?

Will the government please provide paragraph a.1)?

Answer: This clause includes a typographical error which will be amended on the solicitation. The reference to paragraph “a.1)” should reference paragraph “1).” There is no acquisition support required under this contract. The clause will not be removed.

Question: The Government did not specifically mention Earned Value Management (EVM) – is an EVM approach acceptable to the Government?

Answer: No, EVM is not an acceptable approach for this effort.

Question: Will the Government accept a secure cloud solution for housing the database that will support the data collection, analysis and reporting solution?

Answer: On a task by task basis, the FDA will provide access to Government databases and systems into which the Contractor will be inputting data. The Contractor will be required to provide other deliverables in a specific electronic format. Any storage of data at the Contractor’s facilities must be secure and comply with the contract clauses.

Question: What Government Furnished Equipment (GFE) will be made available to the Prime awardee and how many units will be provided?

Answer: GFE will vary by task and will be listed in individual task orders. GFE will be provided directly to the prime Contractor to manage.

Question: Does the past performance submitted as part of the proposal have to reside with the 8(a) Prime, or may past performance be submitted based upon the Team/Subcontractors' experience?

Answer: Past performance of the offeror only will be evaluated. Past performance of subcontractors will not be evaluated. If the offeror is a Joint Venture or legal entity comprised of multiple Contractors, past performance reflecting any of these parties will be considered.

Question: Will the Government consider subcontractor’s relevant experience as part of the Offeror’s Relevant Experience?

Answer: At a minimum, proposals shall include relevant experience of the offering firm. Experience demonstrated by proposed subcontractors may be considered if determined relevant at the Government’s discretion.

Question: The RFP states that the “associated NAICS code for this procurement is 541611” and that “its associated Small Business Size Standard is 500 employees.” The latest modification of the NAICS size standards by OMB, NAICS 2012, indicates that the 541611 code has a size standard of $15 million.

RFP document states “The associated North American Industrial Classification System (NAICS) code for this procurement is 541611. Its associated Small Business Size Standard is 500 employees”. NAICS code 541611 Small Business Size Standard is $15M in revenue rather than 500 employees. Please clarify Small Business Size Standard for this procurement Answer: The size standard shall be updated to reflect the current standard of $15 Million.

Question: Section 6 states “In compliance with federal and local laws, the Contractor shall be required to perform Task 5.7 - Surveillance of Sale to Minors by Regulated Tobacco Product Manufacturers, Distributors, Importers, and Retailers - within the Commonwealth of Virginia.” Can the Government please specify what element of this task is unique to Virginia?

Answer: Due to the legal requirements of this task, purchases must take place within the state of Virginia.

Question: Must the actual purchase be made in Virginia? [ref. Task 5.7] Is the minor required to be located in Virginia at the time of an online purchase?

Answer: Yes Question: Must the minors be residents of Virginia? [ref. Task 5.7] Answer: No Question: Must the minors be employed in Virginia? [ref. Task 5.7] Answer: No Question: Must the tobacco retail establishment be located in Virginia? [ref. Task 5.7] Answer: No, the tobacco retail establishments do not have to be located in Virginia. Additional details and/or instructions about the establishments will be provided in the individual task.

Question: The individual over the IDIQ is listed as the Project Director in this section but the Key Personnel in Section 11 is called the Program Manager. Would the Government please clarify that Project Director is intended to be Program Manager?

Can the Government confirm that the Program Manager listed as Key in Section 11 maps to the Project Director position in Attachment B.

Answer: The Key Personnel identified will be revised to “Project Director” for consistency.

Question: Would the Government please clarify whether the Service Contract Act applies? Several of the labor categories appear to map to SCA positions but the information for the SCA has not been provided as part of this RFP. Should Section 20 also have “x” by 52-222.41, 52-222.42, 52-222.43, and 52-222.55?

Answer: The Service Contract Act and above referenced clauses are not applicable to this effort.

Question: Will the Government allow a cover letter to be excluded from the page count?

Answer: No.

Question: Will the Government allow a 2-page Executive Summary to introduce the offeror and allow it to be excluded from the page count?

Answer: No.

Question: Section 23 states offerors must include “A listing of at least three past performance references to whom the Offeror sent the past performance questionnaires, Attachment D. Performance references shall be current within three years of the RFQ closing date.” Section 24, III. Relevant Experience states offerors must “Describe projects that are ongoing or have been completed within the last five (5) years. Section 24, IV. Past Performance states “This Offeror shall send the Past Performance Questionnaire (Attachment D) appended to this RFP to the 3 references cited in Relevant Experience. Will the Government allow offerors to submit both Relevant Experience projects and Past Performance references that have been completed within the last five (5) years?

Regarding RFP Section 24 “ of Award and Evaluation Criteria on Page 38 under the section entitled “Past Performance Volume”, the first bullet states that “performance references shall be current within three years of the RFQ closing date. However, on Page 40 under the section entitled “Relevant Experience”, the RFP references a narrative that describes projects that are ongoing or have been completed within the last five (5) years. And in the Past Performance subsection, the Government states the PPQs shall be sent to references cited in the Relevant Experience subsection. Please clarify whether Past Performance references that the PPQ are sent to can be five (5) years old or only three (3)?

Answer: The RFP will be amended to reflect a window of 5 years for both Past Performance References and Experience for consistency.

Question: This volume contains two sections – references and past performance questionnaires. Does the Government want copies of the questionnaires submitted with this volume since we will not be allowed to submit the completed questionnaires?

Answer: Per the proposal instructions, the offeror is required to have each reference completed the questionnaire and sent a copy to the Contract Specialist no later than the proposal due date. Questionnaires should not be attached to the offeror’s proposal.

Question: For this volume we are required to include “A listing of at least three past performance references to whom the offeror sent past performance questionnaires, Attachment D.” Please clarify whether we are required to submit only the three references for the Relevant Experience narratives, or are we allowed to submit additional questionnaires?

Answer: You are asked to submit a listing of at least three however you may submit additional questionnaires.

Question: Where in our proposal does the Government want us to place the sentence that we are required to include? The sentence reads: “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

Answer: Please place this sentence where it can be easily found and identified. Suggestions include on the bottom of the first or last page.

Question: This paragraph requires that we include copies of subcontracts but we do not actually execute subcontracts until award, therefore, will contingent subcontracts be acceptable Will the Government accept a fully executed Teaming Agreement in lieu of an executed Subcontract agreement for any proposed subcontractors? Subcontract agreements will not be finalized until after contract award.

Answer: Yes. Proposed subcontractors do not need to have fully executed contracts at this time.

Question: The position “Lead Regulatory Data Analyst” appears in attachment B, Labor Categories, however it is not appear on the Pricing Table. Please clarify.

Answer: This position will be removed from the Labor Category attachment.

Question: Please confirm which positions are SCA labor categories.

Answer: None.

Question: The pricing sheet does not include a place to provide an offeror’s G&A which would be proposed on all ODC’s (e.g. vans in support of Task 5.7, or if travel is required IAW Section 10). Also, page 38 of 63 requires that “each task order will include labor categories and number of hours and amount of materials.” Please clarify if FDA wants the offeror to provide the G&A rate that would be applied to ODC’s.

Answer: The pricing worksheet has been amended to include G&A.

Question: The Proposed Price List provides estimated annual hours per labor category and requires the offeror to provide a fully burdened rate for each labor category in each performance period. However, the Proposed Price List does not provide any cells to show totals. Are offerors supposed to provide totals by multiplying the estimated annual hours for each labor category by the fully burdened rate for each labor category? If so, will the Government please provide a revised Excel workbook?

Answer: No, offerors are not required to provide totals. The Government will perform the calculations and evaluate the price proposed.

Question: What did the Government use as a staff year in the pricing worksheet (i.e., 1880, 1920, 2080)?

Answer: The staffing worksheet does not utilize staff year, it utilizes hours as its units.

Question: Can the Government confirm which solicitation number is correct since the SF1449 and the cover page (page 3 of 63) of the solicitation do not match?

Answer: Solicitation numbers FDA-16-1144645 and 16-223-SOL-00002 may be used interchangeably. FDA-16-1144645 is the internal FDA solicitation number and 16-223-SOL-00002 is the system assigned solicitation number.

Question: What validity period does the Government want our proposal to be good for?

Answer: Proposals shall be valid for a period of 6 months.

Question: Please provide the number of FTEs currently supporting this contract. Both Contractors and/or Government employees.

Answer: Transition-In details maybe provided in individual tasks, if transition is required.

Question: What is the required timeframe for transition-in?

Answer: Transition-in will be described in individual tasks and time frames will vary.

Question: Is there an existing Government provided document management systems and/or electronic database(s) that the Contractor should use for tracking documents and data entry activities? If such systems exist, please provide technical specifications for all systems/databases Answer: Some tasks will require the Contractor to submit deliverables in common electronic formats such as Excel, Word and Adobe PDF. On a task by task basis, the FDA will provide access to Government databases and systems into which the Contractor will be reviewing and inputting data and technical specifications for all systems/databases.

Question: Is the Contractor expected to provide the necessary document management system and databases to enter, store, and manage documents and data for this contract?

Answer: Task orders issued under 5.3 and 5.4, FDA will provide access to Government databases and systems. The Contractor will not be required to provide a document management system or database.

Question: Please provide estimated number of document submissions – monthly/annually.

What is the daily or annual volume associated with this task? [ref. 5.3] Answer: This information will be provided in individual task orders and will vary.

Question: Requirements for Task 5.2 Program Management and Project Management (5. TASKS, page 7) and Management Approach (EVALUATION CRITERIA, page 39) are very similar, if not duplicates. In order to avoid duplicating responses for the above proposal sub-sections, would the Government consider consolidating all Program/Project Management requirements under Factor 2 –Management Approach for the proposal response?

Please consider consolidating Task 5.2 Program Management and Project Manager (page 7) into Factor 2 – Management Approach (page 39) since requirement for both subsections are similar. This will avoid duplicating responses for the proposal.

Answer: The Government’s Evaluation Criteria and Program and Project Management task are not duplicates. The evaluation criteria are used to evaluate the offerors proposal, while the task provides the scope under which individual task orders will be completed.

Question: Is all inspection data to be indexed? If so, what is the related volume of data?

Answer: The Contractor is not required to index the inspection data or manage the Government database. The Government database is searchable. The volume of data will be provided in the individual task orders and will vary.

Question: Please confirm if the Government has a preferred ECM tool that it wishes the offeror to specify in its response?

Answer: The Contractor should determine the best approach to fulfilling the technical requirements including the use of any ECM tools.

Question: Data collection frequency: Will it be single point in time data collection (say once per year each year for five years) or ongoing data collection (i.e., monthly data collection over the five year period)?

Answer: This will be specified in individual task orders and will be likely ongoing during the period of performance.

Question: Is the preference for the offeror to recruit and train minors once a year and these same minors will collect the data for whatever intervals are required for that year OR should we plan to recruit and train a different group of minors to participate in each data collection cycle? Or, some hybrid of the two approaches?

Answer: The specifics in an individual task order will determine the best approach for timing and process for recruitment.

Question: What’s the minimum number of minors that should participate in this research?

Answer: The Contractor is not required to propose a specific number of minors for the overall IDIQ requirement. The number of minors to be utilized will be proposed at the individual task orders.

Question: Participants: Should the minors represent the entire State of Virginia or can they come from a sample of municipalities across the State?

Answer: There are no constraints on minors recruited other than the Contractor is required to recruit minors to conduct online purchases of regulated tobacco products that are within the required age range of 16 or 17 years old.

Question: Incentives: Can we pay the minors (and their families) an honorarium for participating in this research? If so, is there a cap on the amount we can pay them and if so how much?

Answer: The minors are listed as a labor category and on the pricing worksheet. Please include pricing information for minors as requested. In the case of a fixed price task, the Contractors are free to compensate minors (and families) as appropriate.

Question: Will OMB approval be required to engage minors as required by SOW section 5.7?

Answer: Given the scope of work, we are not aware of any OMB approval required under this contract. You may clarify this question if necessary.

Question: Are resumes required for all labor categories, or just the Contract Program Manager?

Answer: The offerors shall provide the resumes of qualified Key Personnel. The Project Director is the only key personnel position listed, and as such it is the only individual that we require a resume for.

Question: If this solicitation includes the TIMS contract, please name the incumbent for the TIMS contract.

Answer: This solicitation does not include the TIMS contract.

Question: Who are the credit/debit cards registered to when a minor attempts to purchase tobacco products online (i.e., is the personal information fictitious?) [ref. page 57] What facility or address would be given to the retailer for delivering the online purchased tobacco products? [ref. page 57] Answer: This page does not reference credit/debit cards or delivery of online purchased tobacco products. If necessary, additional information will be provided with the individual task order.

Question: Where are the online purchases being made (minor’s home, Contractor’s office, or other?)

Answer: All services tasked through this IDIQ will be performed at the Contractor’s facilities.

Question: Who is required to accompany the minor when making online purchases (parent(s), guardian, etc.)?

Answer: There are no requirements for the minor to be accompanied when making an online purchase. However, the Contractor has oversight responsibility for minors and is required to facilitate, complete, and document purchases including payment and shipment.