FDA RESPONSES TO VENDOR QUESTIONS-FDA-RFP-1223623.pdf

FDA-RFP-1223623 – FDA RESPONSES TO VENDOR QUESTIONS

FDA-RFP-1223623 – FDA Responses to Vendor Questions

1.

Solicitation Section/Subsection Number: B.3 Page 2

Question: The SOW outlines Task 7: Follow on Environmental Scan and Analysis (Task 7, SOW 2.1.7) and Task 8: Advancement of the Center of Excellence (Task 8, SOW 2.1.7);

however, labor categories and hours are not provided for these tasks. Would the Government add 1) a Survey and Research Analyst labor category and allocate 3,960 hours for Task 7, and

2) a Strategic Planning Analyst labor category and allocate 3,960 hours for Task 8?

Furthermore, would the Government add an additional 990 hours to the Sr. Project Manager labor category to provide oversight for these additional Tasks?

Government Response

(For Government use only)

As stated in solicitation Section B.3, the solicitation only provides the “anticipated” Level of effort. This section of the solicitation further specifies that “Offerors shall propose equal or similar Labor Categories and estimated annual hours per labor category shown below are for budgeting purposes only.” Accordingly, Offerors may propose their own Level of Effort that demonstrates compliance with all areas of the solicitation.

2.

Training Instructors are needed to deliver the training content – would the Government add Training Instructor as a labor category and allocate 990 hours?

Government Response

(For Government use only)

Please refer to the Government’s response to Question number 1 above.

3.

Solicitation Section/Subsection Number:

SOW 2.1.1 Task 1: Project Management Support, Planning, and Outreach, SOW 2.3.1 Project Management Support, Planning and Outreach

Question: In SOW 2.1.1 Task 1, the Government outlines the need to work with the Drug Manufacturing and Quality Expert to identify and secure substantial subject matter expert support for each specialized training course, yet only anticipates 483 hours of Compounding Expert support. Would the Government add another 1,000 hours for subject matter experts support to provide sufficient support for the training development?

Government Response

Please refer to the Government’s response to Question number 1 above.

4.

Solicitation Section/Subsection Number: L.3, Page 71

Question: Please clarify that the intent of this evaluation criterion is to evaluate that the contractor can develop training that participants who deliver pharmacy services may receive continuing education credits for successfully completing. Otherwise we respectfully recommend deletion of this evaluation criterion as the scope detailed in Attachment 1, Statement of Work does not include the performance of pharmacy services, e.g.

manufacturing.

Government Response

(For Government use only)

The intent of the Government’s evaluation criteria is as stated in the solicitation Sections L and M. There is no specific reference to continuing education (CE) credits within the evaluation factors, therefore this question lacks clarity. But for the sake of providing clarification to Offerors, please note that Statement of Work requires the Contractor to provide CE credit for all training developed under this contract as specified in SOW sections 2.1.2.1, 2.1.2.2, 2.1.3, and 2.1.4.

Solicitation Section/Subsection Number: L.3, Volume II (Factor 4) Price Proposal, Page 73 and Page 84

5.

Question: Since the Government has written this RFP, as a “combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6”, would the Government please remove all references that require Offerors’ to provide fully burdened rates, direct labor, fringe benefits, applicable indirect costs, and profit for each labor category, as these commercial rates have already been deemed fair and reasonable?

Government Response

Offerors shall provide all price/cost information required by the solicitation.

6.

Solicitation Section/Subsection Number: M.6 Factor 2 – Relevant Past Performance, Page 79

Question: Since the Government recognizes highly-complex projects with multiple and diverse workstreams similar to those outlined in the statement of work require contracts that are at least 12 months in duration, please confirm past performances can be contracts that are on-going.

Government Response

Factor 2 requires examples of successfully completed contracts after January 01, 2015.

7.

H.5 Procurements Requiring Information Security and/or Physical Access Security

A.3 Information Security Categorization

Question: Section H.5 states that based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract does involve PII. However, SOW Section 7, subsection A.3. indicates that that the solicitation/contract does not involve PII. Based on our review of the RFP scope, and awareness of the scope for the existing Compounding support contract, delivery of the SOW requirements does not involve PII. As a result, we respectfully recommend that Section H.5 be updated accordingly to reflect that the contract does not involve PII.

Government Response

(For Government use only)

Section H.5 of the solicitation will be revised in a forthcoming amendment to specify that no Personally Identifiable Information (PII) is involved in this effort.

8.

L.3 Volume I Technical Factor 1 – Technical Approach/Understanding the Requirement

M6 Technical Evaluation Criteria, Factor 1- Technical Approach/Understanding the Requirement

Question: SOW 2.1.8 Task 8 requires the development of a three-year strategic plan and charter; however, Factor 1, Section 4 evaluates contractor on the proposal for a Center of Excellence model, which is being delivered under the current contract. Is the government open to revising the evaluation criteria to “developing a charter and three-year strategic plan for the Center of Excellence”?

Government Response

Solicitation Sections L & M (Factor 1) will be revised in a forthcoming amendment.

SOW 2.1.2.1 Virtual Lab-Related Training

SOW 2.1.2.2. Training on Investigations and CAPA

9.

Question: Please confirm that the existing virtual/in-person courses (Environmental Monitoring, Sterile Drug Compounding, Cleanroom, and Investigations & CAPA) meet the projected training time frame requirement (stated in the SOW as 4.5 days) since the existing courses are currently 4 day courses (In Person: ~8 hrs/day, Virtual: ~4 hrs/day) and not 4.5 day courses.

Government Response

(For Government use only)

Sections 2.1.2.1 and 2.1.2.2 of solicitation Attachment 1 (Statement of Work) will be revised in a forthcoming amendment to specify four (4) day courses.

10.

B.3 Labor Categories

B.3 Contract Line Items

Question: The Government has provided Labor Categories and Hours but has not included a separate CLIN for Travel/ODC costs. Would the Government please clarify how Travel or other ODC costs should be incorporated into the Section B schedule?

Government Response

(For Government use only)

Solicitation Section B.3, including the pricing table within Section B.3, will be revised in a forthcoming amendment to provide an area for Offerors to list and insert Other Direct Costs, Travel costs and any other cost elements proposed for the purposes of price/cost analysis.

However, please note that there will be only one (1) Time and Materials Contract Line Item for each 12 month period in any resulting contract, and as stated in the solicitation, “The Contractor shall provide services in accordance with the Statement of Work (Attachment 1), in compliance with all other sections of this solicitation on a Time and Materials (T&M) basis inclusive of all labor, materials, overhead, profit, fee, general and administrative costs, travel, etc.”.

SOW Section 2.2 (Table 1)

Section E – Inspection and Acceptance, Deliverable Chart

11.

Question: Where there are discrepancies between other sections and the Deliverables and Schedule Table in SOW Section 2.2 (Table 1), please confirm that the Deliverables and Schedule Table in SOW Section 2.2 (Table 1) is the governing scope.

Government Response

(For Government use only)

Section 2.2.1 (Table 1 – Deliverables and Schedule) of solicitation Attachment 1 (Statement of Work) and the Deliverables Chart within Section E of the solicitation will be revised in a forthcoming amendment to address any discrepancies.

12.

Solicitation Section/Subsection Number: Part I, Section A, Page 1

Question: Given the incumbent work was issued and awarded under NAICS code 541990 – All Other Professional, Scientific, and Technical Services and the scope of work detailed in Attachment 1 does not include the services (primarily manufacturing prescriptions) described under NAICS code 325412, will the Government please consider changing the NAICS code assigned to this procurement?

Government Response

(For Government use only)

The solicitation NAICS code will be revised in a forthcoming amendment to “541990 – All Other Professional, Scientific, and Technical Services.”

13.

Question: Sections 5.1 and 5.2.1 list 2 Senior Project Managers as key personnel, but the evaluation factors outline only one Senior Project Manager. Can the Government please confirm that resumes of two Senior Project Managers will be evaluated?

Government Response

Solicitation Sections L & M (Factor 3) will be revised in a forthcoming amendment.

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