119774-DRAFT-Q&A.pdf

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Economic Studies of FDA Regulations
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FDA-19-RFP-119774
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Questions and Answers from draft RFP.

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Attachment-2-Subcontracting_Plan.doc DOC document
FDA-19-RFP-119774.pdf PDF
Attachment_1-Pricing_Schedule.xlsx XLSX spreadsheet

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FDA-19-DRAFT-119774: Q&A

Question 1: Will there be an opportunity to propose different labor categories and expertise?

Answer: We do not see any reason for additional labor categories.

Question 2: How will this program interact with the CERSI research projects?

Answer: We do not expect this program to interact with the CERSI research projects.

Question 3: Will this program interact with NIIMBL?

Answer: We do not expect this program to interact with NIIMBL.

Question 4: Will travel be allowed to gather current and relevant information in the US and OCONUS? Focus groups and gap analyses may allow for collection of key data; conference attendance

Answer: Travel would be allowed, in both the US and abroad, if necessary to gather current and relevant information.

Question 5: (Section 2.2) For proposal purposes only and to establish a level playing field for FDA to compare competing proposals, will FDA be providing labor category hours, per ordering period, in the Pricing Schedule, and require that all bidders price those exact hours?

Answer: Yes

Question 6: In the pricing schedule will FDA be including a line item for the Other Direct Cost plug amount of $50,000 per contract period, and a line item for bidders G&A/Material Handling charge?

Answer: Yes

Question 7: For each labor category description FDA states that the Government has a “preference” for a certain educational and years of experience. Are these descriptions by position to be used by Bidders only as a guide and for informational purposes reflecting the types of personnel expected to perform the work, and not as required minimum educational and experience qualifications that each proposed staff person must satisfy?

Answer: Correct, however offerors who can meet or exceed these preferences will be evaluated more favorably than those who cannot do so.

Question 8: Will each RFTOP issued by FDA also identify the type of task order contemplated (e.g.

FFP, T&M, LH)?

Answer: Yes. Future requests for task order proposals will specify the task order type.

Question 9: This section references the Past Performance Information Retrieval System (PPIRS). It is our understanding that effective January 15, 2019 PPIRS was merged into CPARS. Will FDA delete the reference to PPIRS?

Answer: Correct. This reference will be updated in the final solicitation.

Question 10: Under “Basic Format” the RFP requires that Offerors submit two volumes (technical and price), but on page 27 a reference is made to a Volume #3 Subcontracting Plan. Please clarify if three volumes are required to be submitted, or whether the Subcontracting Plan will be included as part of the price volume #2.

Answer: The subcontracting plan shall be submitted as a separate volume (Vol. 3). A template for the subcontracting plan with the FDA’s goals will be provided along with the final RFP.

Question 11: Under “Basic Format” will Offerors alternatively be allowed to submit any parts of their technical or price volumes in PDF format?

Answer: PDF format (in which the reader can search for text) is also acceptable for submission and will be included in the final draft.

Question 12: As prescribed in FAR 22.1207, it appears that FAR 52.222-17 “Non-displacement of Qualified Workers (MAY 2014)” may not be applicable to this RFP. FAR 22.1207 instructs Contracting Officers to insert FAR 52.222-17 only in Solicitations for service contracts, as defined at FAR 22.001, that succeed contracts for performance of the same or similar work at the same location. This Solicitation appears that it will not result in award of a service contract since the principal purpose of the work will not be performed by service employees, but by bona-fide executive, professional, and administrative personnel. Additionally, except for any incumbent, the work would not be performed by any successful offeror at the exact same location. Would FDA consider unchecking the applicability of the referenced FAR clause 52.222-17?

Answer: This requirement will be removed from the final RFP.

Question 13: Does FDA anticipate issuing any task orders under the new contract during the current fiscal year (FY 2019)?

Answer: Yes.

Question 14: On page 2, Section 2.5, it states that the maximum aggregate dollar value over the 5-year IDIQ ordering period shall not exceed the established ceiling of $4 million.

Would FDA consider setting a higher ceiling to allow more flexibility over the life of the contract?

Answer: The final RFP will include a higher ceiling. We emphasize that this is simply a contract ceiling, which does not equate to actual funding.

Question 15: Pages 5 through 7 lists the anticipated labor categories for the contract.

Would FDA consider adding additional labor categories to provide more flexibility and tailoring of staffing plans for each individual task order to provide the Government with best value?

For example, we recommend adding the following labor categories (with corresponding adjustments in requirements for years of experience across labor categories): Senior Advisor, Midlevel Statistician, Junior Statistician, Midlevel Economist, Midlevel Programmer, Midlevel Analyst, Midlevel Editor, Data Collection Support, Interviewer, Junior Survey Scientist, Midlevel Survey Scientist, Senior Survey Scientist.

Answer: We decided not to add any additional labor categories.

Question 16: For the Project Director labor category on page 5, does FDA anticipate that this person would serve as the manager of the IDIQ contract?

Answer: Yes

Question 17: For the Program Manager labor category on page 5, does FDA anticipate that staff in this labor category would lead individual task orders?

Answer: Yes, but the Project Director could also lead a task order.

Question 18: On page 25, Basic Format, item (1), it states that the offeror’s proposal shall consist of Volume 1: technical capability and Volume 2: price. On page 27, it states that Volume #3 will comprise a subcontracting plan. Should page 25 state that there are 3 volumes?

Answer: Please refer to question 10.

Question 20: Is it the Government’s intention to solicit competing proposals from the two contract awardees for each task order?

Answer: Yes.

Question 21: Can the Government confirm that the maximum proposal length is 250 pages (excluding cover sheet and table of contents)?

Answer: In the final RFP, we will set the maximum length of the Technical Proposal at 300 pages.

Question 22: Are senior-level Personnel expected to have expertise in specifically FDA-regulated industries?

Answer: Senior-level personnel are not required to have expertise in specifically FDA-regulated industries. However, those that have this expertise should include it in the relevant sections of their proposals.

Question 23: Can the Government cite a publicly available example of each type of analysis/evaluation specified in the SOW 3.4.A.(1)-(7)?

Answer: We do not have a public repository for these types of analyses.

Question 24: What is the typical period of performance for each type of analysis/evaluation specified in the SOW 3.4.A.(1)-(7)?

Answer: We do not differentiate between the types of analyses specified in the SOW 3.4.A.(1)-(7), but we expect the periods of performance to range from about eight months to thirty months.

Question 25: Can the Government provide an estimated level of effort (number of labor hours by labor category) for each type of analysis/evaluation specified in the SOW 3.4.A.(1)-(7)?

Answer: No, we do not have an estimated level of effort for each type of analysis/evaluation specified in the SOW 3.4.A.(1)-(7). However, we project the labor hours per task order to range from as low as 500 hours to as high as 3,000 hours.

Question 26: Are small businesses required to submit a subcontracting plan?

Answer: No, however small businesses responding to this notice are cautioned to clearly indicate their small business status on their coversheet.

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