Attachment I - Responses to Questions.pdf

Solicitation instructions

Statement of Work Attachment A - Relevant Experience Form Attachment B - Past Performance Questionnaire Attachment C - Pricing Worksheet Attachment E - Labor Category Descriptions Other

# RFP Reference Section & Page #s Question Agency Response

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

Factor 1: Demonstrated Prior Experience.

Summary of Data, p.101 Element #4, p.104

For each contract cited, the offeror is to provide specific contractual information. The Government has provided two lists/locations of this required information.

Q: May the offeror combine these two lists into a single summary at the beginning of the response document?

An amendment will be issued for clarity purposes, in Section 12.0 PHASE I – ADVISORY DOWN SELECT, Factor 1: DEMONSTRATED PRIOR EXPERIENCE (WRITTEN), Summary of Data.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

Section 9, Oral Presentation, page 97 - Power Point Presentation Slides

Offerors may use Microsoft PowerPoint presentation slides (PDF), as talking points only, to clearly articulate their viewpoints, to provide their oral presentation based on all the Phase II Technical Factors. The Government will not evaluate the slides.

Q: Could the Government confirm that bidders should not submit their slides to the Government?

The government confirms that, per Section 2.0 MULTI-PHASE EVALUATION, the slides are optional; And per Section 9.0 ORAL PRESENTATION, Per PowerPoint Presentation Slides: Offerors "may" use Microsoft PowerPoint presentation slides (PDF), as talking points only, to clearly articulate their viewpoints, to provide their oral presentation based on all the Phase II Technical Factors. The government will not evaluate the slides.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

Section 10, Proposal Format, page 99, Font Size

All fonts shall be Times New Roman twelve (12) font size, except for diagrams and drawings where impractical. Fonts in graphics and charts shall be no smaller than eight (8) font size and each page within each attachment shall be numbered consecutively.

Q: Would the Government consider tables to be charts and allow bidders use a font no lower than eight for tables (as well as charts and graphics)?

The government does not consider tables to be charts. All texts in a table shall be Times New Roman twelve (12) font size.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

Section 9, Oral Presentation, page 97 - Power Point Presentation Slides

Offerors may use Microsoft PowerPoint presentation slides (PDF), as talking points only, to clearly articulate their viewpoints, to provide their oral presentation based on all the Phase II Technical Factors.

Q: May bidders use the PowerPoint widescreen (16:9) slide size for ease of viewing and readability?

The government does not have a requirement for PowerPoint slides size. Slide submission is at the discretion of the offeror.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

Section 9, Oral Presentation, page 97 - Power Point Presentation Slides

Offerors may use Microsoft PowerPoint presentation slides (PDF), as talking points only, to clearly articulate their viewpoints, to provide their oral presentation based on all the Phase II Technical Factors.

Q: During the orals presentation, will the Government allow presenters to display their presentations in the native PowerPoint application, rather than in an Adobe PDF format?

In this respect, slide submission is at the discretion of the offeror.

Please see amended RFP language deleting "PDF".

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

Element No. 7: Staffing Plan (WRITTEN PROPOSAL ONLY), page 108, Evidence of Joint Venture Agreement or Teaming Arrangement

All Offerors proposing a joint venture agreement or teaming arrangement shall submit their agreement (excluded from the page count) signed and approved by the Small Business Administration (SBA) demonstrating that they meet all of the requirements under the SBA’s joint venture program or teaming arrangement.

Q: As the SBA does not sign JV Operating Agreements, should the offeror provide the SBA's signed approval of the Mentor- Protege Program application and Mentor-Protege Agreement, as well as the JV Operating Agreement executed by both JV parties?

Yes. Please see the Amended RFP language pertaining to this section.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

13.2 FACTOR NO. 3 - PAST

PERFORMANCE (WRITTEN), page 108

The Offeror shall provide three (3) contracts and/or projects that demonstrate the Offeror’s past performance with the same or similar DMP PWS task areas performed within the last five (5) years.

Q: Could the Government confirm this should be a separate written document for submission and provide the page limit for Factor No. 3?

The page limitation for the response to Factor 3 is three (3) pages. It can be included within the Phase II written response/written proposal or be a stand alone document.

Attachment I - RFP Question Submittal Form; Solicitation No. 75F40123R00015

Prospective Offerors must use this form to submit all questions in relation to Solicitation No. 75F40123R00015.

The RFP Reference column should identify the RFP Section Title/Attachment associated with the question being asked.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

RFP Section 13. Phase II - Technical, Past Performance and IDIQ Contract Pricing Factors

Section 10, Proposal Format, page 99, Font Size

Section 13.1, Element No. 7: Staffing Plan (WRITTEN PROPOSAL ONLY), item number 5

All fonts shall be Times New Roman twelve (12) font size, except for diagrams and drawings where impractical. Fonts in graphics and charts shall be no smaller than eight (8) font size and each page within each attachment shall be numbered consecutively.

… Individual resumes must not be greater than three (3) pages in length.

Q: Taking the page limitation for resumes into consideration, would the Government allow resumes to use a smaller, but still legible, font in resumes?

The Key Personnel Resumes and Letters of Commitment are excluded from the page count.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

6.0 Amendments, page 96

If amendments to the solicitation are issued, all Offerors must acknowledge the amendments by signing the accompanying Standard Form 30 and returning the signed Standard Form 30 for all Amendments issued with the Offeror's proposal submission.

Q: Would the Government please confirm the offeror should provide a separate Factor 4 narrative document to place the signed Standard Form 30 for any/all amendments?

Q: If this is not acceptable, how should bidders provide these requested documents?

The offeror may include the signed Standard Form 30 within their written response(s) to Phase II or as a stand-alone document. It does not count against any page limit.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

6.0 Amendments, page 96

If amendments to the solicitation are issued, all Offerors must acknowledge the amendments by signing the accompanying Standard Form 30 and returning the signed Standard Form 30 for all Amendments issued with the Offeror's proposal submission.

Q: Would the Government please confirm the offeror should provide a separate Factor 4 narrative document to place the signed Standard Form 1449?

Q: If this is not acceptable, how should bidders provide the signed SF1449?

The offeror may include the signed Standard Form 1449 within their written response(s) to Phase II or as a stand-alone document. It does not count against any page limit.

11 RFP 8.0 Contract Clauses FAR 52.212-3 - Offeror Representations and Certifications - Commercial Items (Oct 2022), page 76

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certifications electronically in the System for Award Management (SAM) accessed through https://www.sam.gov.

Q: Where would the Government like the offeror to include paragraph (b) and acknowledgement of completion in SAM?

The offeror may include the completed FAR 52.212-3, as applicable, within their written response(s) to Phase II or as a stand-alone document. It does not count against any page limit.

RFP Attachment A, Pricing Tab

Pricing Tab Q: Would the Government please update the formula in cells H25, K25, N25, and Q25 to include rows 20 through 22?

Attachment A - IDIQ Pricing Worksheet has been updated to include rows 20-22 in the formulas for H25, K25, N25 and Q25. The revised Pricing Worksheet is attached to this Amended Solicitation.

RFP Attachment A, Pricing Tab

Pricing Tab

The Pricing Tab in Attachment A lists General Clerk I and General Clerk II as the two NE labor categories. On page 71 under FAR 52.222-42 - Statement of Equivalent Rates for Federal Hires (May 2014), it states, "In compliance with the Service Contract Labor Standards statute and the regulations of the Secretary of Labor (29 CFR part 4), this clause identifies the classes of service employees expected to be employed under the contract and states the wages and fringe benefits payable to each if they were employed by the contracting agency subject to the provisions of 5 U.S.C. 5341 or 5332." In the table below this, the Employees Classes are 01112 - General Clerk II and 01113 - General Clerk III.

Q: If the Employee Classes in the table on page 71 are correct, would the Government please update the Labor Categories in Attachment A?

Attachment A - IDIQ Pricing Worksheet has been updated to correct General Clerk I to General Clerk II, and General Clerk II to General Clerk III. The revised Pricing Worksheet is attached to this Amended Solicitation.

RFP Attachment A, Pricing Tab

Instructions

Instructions: Offers are to complete only the yellow highlighted portions of the spreadsheet. No other cells shall be altered in any way, or offers may be deemed non-responsive.

Q: How will the Government identify the offeror's name on Attachment A?

Q: Would the Government consider updating Attachment A to add cells at the top for the offeror to fill in with its name and any other necessary identifying information?

Attachment A - IDIQ Pricing Worksheet has been updated to add a box for the contractor to input its name in row 1, highlighted in yellow.

RFP Section 10.

Instructions to Offerors and Evaluation/Award Criteria

Section 9, Oral Presentation, page 97 - Power Point Presentation Slides

Offerors may use Microsoft PowerPoint presentation slides (PDF), as talking points only, to clearly articulate their viewpoints, to provide their oral presentation based on all the Phase II Technical Factors.

Q: If offerors choose to use PowerPoint during the oral presentation, can graphics be used in the presentation?

The government does not have a requirement for graphic use in PowerPoint slides. Slide submission is at the discretion of the offeror.

16 RFP 8.0 Contract Clauses FAR 52.229-11 Tax on Certain Foreign Procurements - Notice and Representation (Jun 2020), page 93

Since FAR 52.229-11 has not been incorporated into entity registration on sam.gov - Representation and Certifications, should offerors fill in and submit the clause with their proposal?

If yes, in which submission document should the offeror place the filled-out FAR clause?

Yes. The offeror may include the completed FAR 52.229-11, as applicable, within their written response(s) to Phase II or as a stand-alone document. It does not count against any page limit.

3. Description of Requirements/Performan ce Work Statement

(PWS)

5.0 Pricing and Ordering

of Services

3.0 Overview of Acquisition; Page 9

5.3.1 Ordering Procedures; Page 31

In section 3.0 of the PWS, under the Overview of the Acquisition section and the response to What is it , it states:

"The acquisition is for the data management services in support of the FDA Adverse Event Reporting System (FAERS) Data Management Program (DMP), in support of the FDA/CDER/RSS office use only." Under Section 5.3.1, it states "Any Contracting Officer of the FDA is authorized and may place orders under this IDIQ contract."

Please confirm that this IDIQ is only for use by FDA/CDER/RSS as stated in section 3.0 of the PWS?

Yes, the government confirms that this IDIQ is only for use by FDA/CDER/RSS as stated in section 3.0 of the PWS

3. Description of Requirements/Performan ce Work Statement

(PWS)

6.6.1 Program Management

Activities; Page 17

Item 4 under Section 6.6.1 of the PWS states "Provide monthly performance reports to include, at a minimum, the performance activities identified in the below deliverables table area as follows:" but no table follows.

Please clarify if there is supposed to be a table providing a list of all deliverables in one place.

An amendment will be issued for clarity purposes.

3. Description of Requirements/Performan ce Work Statement

(PWS)

11.0 Transition-In Activities; Page 24

12.0 Transition-Out Activities; Page 25

Section 11.0 states that the incoming contractor will have 30-calendar days to complete transition-in services. Section 12.0 states that the outgoing contractor will have 90-days to transition-out and that "At the COR designated turnover date, approximately 60-days after award, the successor contractor shall assume full responsibility of the contract." These dates don't reconcile with one another. For example, if I am the outgoing contractor, I will only have 30-days with the incoming contractor to turn over activities. Additionally, if the outgoing contractor is to assume full responsibility for the contract after 60-days, how does that mesh with the transition-in activities needing to be completed 30-days after award.

Please clarify whether the incoming contractor will have 90-days to complete transition-in. If they are allowed 90-days, the incumbent contract should not assume full responsibility until the last day of the outgoing contractors contract. The outgoing contractor will need to retain their employees through the last day on the contract to ensure successful performance.

Per Section 11.0 Transition-In Activities, the government clarifies that the incoming contractor shall have within thirty (30) calendar days to complete these services. Per Section 12.0 Transition-Out Activities, applies to the successor contractor to perform these services 90 days prior to the expiration date of the final task order.

5. Pricing and Ordering of Services

5.1 Overview of Pricing Schedule;

Pages 27-30

There are no instructions provided on how each of the hourly rates will be incorporated into each of the tables/ordering periods for the pricing schedule. Will the hourly rates be taken from our Attachment A submission or will Offeror's be allowed to negotiate these rates post-award?

The fully burdened labor rates proposed in the offeror's Attachment A submission will be incorporated into any award into the Pricing schedule (see p.27) for the applicable ordering periods.

5. Pricing and Ordering of Services; 8.3 FAR Clauses in Full Text;

Attachment B: Labor Category Descriptions;

and Attachment A: IDIQ Pricing Worksheet

5.1 Overview of Pricing Schedule

(page 27-30); FAR 52.222-42 – Statement of Equivalent Rates for Federal Hires (May 2014) (page 71);

Att. B (pages 1-2); and Att. A Pricing Tab

The solicitation and Attachment B both include General Clerk (GC) II and III in the list of labor categories, while Attachment A includes GC I and II. Can FDA please confirm that GC II and III are correct, and that offerors may update the spreadsheet to reflect this?

Attachment A - IDIQ Pricing Worksheet has been updated to correct General Clerk I to General Clerk II, and General Clerk II to General Clerk III. The revised Pricing Worksheet is attached to this Amended Solicitation.

10. Instructions to Offerors and Evaluation/Award Criteria

1.0 Introduction; Page 94

The introductory paragraph states that the evaluation process will be conducted under the auspices of the Department of Homeland Security (DHS) Procurement Innovation Lab (PIL).

Will DHS participate in evaluating proposals or just the oversight of how the procurement is evaluated?

Proposals will be evaluated by FDA, not DHS.

10. Instructions to Offerors and Evaluation/Award Criteria

8.0 Written Submissions; Page 97

This section, Written Submissions, states that the written submissions are to include: resumes, letters of commitment, and attachments.

For compliance purposes, is FDA expecting attachments other than the resumes or letters of commitment? If so, what other attachments are required?

The offeror is responsible for reviewing the complete solicitation and submitting any/all responsive documents or attachments, as applicable. The Government is not going to provide an exhaustive list of attachments. The attachments referenced in Section 8.0 Written Submissions refers to all attachments that are required to be submitted throughout the RFP solicitation.

RFP Section 10.0 - Instructions to Offerors and Evaluation/Award Criteria

8.0 Written Submissions; Page 97

Section 8.0 of the RFP instructions state that "All written submissions…shall be provided electronically via email…in only one (1) email…" Section 10.0 states the a "Total email cannot exceed 10 megabyte (MB)."

Please confirm that if our submission for any given phase is over 10 MB that Offerors are permitted to submit their proposals through multiple, consecutively numbered emails (i.e., 1 of 2).

Please see Amended RFP, Section 8.0.

10. Instructions to Offerors and Evaluation/Award Criteria

9.0 Oral Presentation; Page 98

Please confirm that all contractors participating in the Oral Presentation be given the same Scenario-based Pain Point Questions.

The government confirms that all contractors participating in the Oral Presentation will be given the same Scenario-based Pain Point Questions.

RFP Section 10.0 - Instructions to Offerors and Evaluation/Award Criteria

10.0 Proposal Format; Page 99

The RFP instructions limit the use of font size to "no smaller than eight (8)" for graphics and charts. The RFP instructions also require text in both the header and footer.

Would the FDA allow the use of a font no smaller than eight (8) in headers and footer?

No. Per Section 10.0 PROPOSAL FORMAT, all fonts shall be Times New Roman twelve (12) font size.

10. Instructions to Offerors and Evaluation/Award Criteria

12.0 Phase I - Advisory Down Select;

For prior experience examples, "one of which is to be from the Prime Contractor," if the Prime Contractor is a Joint Venture (JV), can the experience be from either of the members of the

JV?

Yes, the experience can be from either of the members of the JV.

Per p.100, "The Offeror may use prior experiences in which they serve as a prime, subcontractor, and other team organizations. The Offeror must identify the Offeror’s role in all the prior experience submitted."

10. Instructions to Offerors and Evaluation/Award Criteria

12.0 Phase I - Advisory Down Select;

When providing summary data for the prior experience and the contractor served as a subcontractor, does FDA want the Name of the Customer Agency/Organization to be that of the Prime Contractors information or the federal agency the prime contractor was awarded a contract by?

Additionally, would the Point of Contact Information be for the Prime Contractor or that of the federal agency that we supported as a subcontractor?

The name of the Customer Agendy/Organization is not the prime contractor if serving as a subcontractor, but rather the customer agency/Organization. The point of contact will be the customer agency/organization and not the prime contractor.

10. Instructions to Offerors and Evaluation/Award Criteria

13.1 Factor No. 2 - Technical

Approach; Page 105

Please confirm that the PowerPoint Slides are not to be provided to the government ahead as part of the written submission but rather will be used by the contractor to guide them through the oral presentation only.

The government confirms that the Power Point Slides are not to be provided to the government ahead as part of the written submission. If the offeror choses to present Power Point Slides, they can be used by the contractor during the oral presentation only. The government will not evaluate the slides.

10.0 - Instructions to Offerors and Evaluation/Award Criteria

13.1 Factor No. 2 - Technical Approach

(Element No.7)); Page 107-108

Page 107 of the RFP states that "At least three (3) key personnel must be employees of the Prime Offeror."

Please confirm that if submitting as a Joint Venture or Teaming Arrangement, that the key personnel must be employees of the 8(a) company who manages the relationship.

Is the requirement for 3 key personnel to be employees of the prime Offeror for evaluation purposes only or is this a requirement that will be incorporated into the PWS?

Is this requirement only at the IDIQ-level or across all task orders?

Please see revisions in Amended RFP Element 7. An employee of a Joint Venture or Teaming arrangment is considered to be an employee of the "prime." The three key personnel will be incorporated into any award. Task Orders may establish different Key Personnel. The base Solicitation, p. 107, for further information on substitution of key personnel. Task Orders may specify different key personnel.

10.0 - Instructions to Offerors and Evaluation/Award Criteria

13.1 Factor No. 2 - Technical Approach

(Element No.7)); Page 107-108

Page 107 of the RFP states (second paragraph after Bullet 5) that "At least three (3) key personnel must be employees of the Prime Offeror."

In the paragraph above this on page 107, Offerors are instructed to identify in the resumes if proposed Key Personnel are existing/contingent employees of the Prime Offeror, or a Contractor Teaming Arrangement, or Prime's Major Subcontractor. Additionally, page 108 addresses requirements for when a Subcontractor is included in a Prime Contractor's Key Personnel Submission.

Given that there are only three (3) Key Personnel identified in the RFP, can FDA please clarify if Subcontractor staff may be named as Key Personnel or if all three (3) Key Personnel must be provided by the Prime Offeror?

Please see Amended RFP Factor 2, Element seven, which revised this requirement.

Attachment A: IDIQ Pricing Worksheet

Pricing Tab

Can FDA please confirm that the estimated labor hours prepopulated in the Pricing tab are for evaluation purposes only to compare rates between offerors, and do not reflect any assumed level of effort under the IDIQ or subsequent task orders?

The labor hours contained in Attachment A are being utilized for evaluation purposes only. The hours are based upon historical data/usage, but the hours are not a guarantee of future requirements.

Attachment A: IDIQ Pricing Worksheet

Pricing Tab

The pricing table only includes one escalation rate for all labor categories (i.e., H10, K10). How should Offerors account for different escalation rates among the SCA and exempt personnel?

The government does not prescribe how offerors apply escalation.

The offeror may submit its notes for Attachment A under the "Notes and Assumptions" tab. The escalation rate in the pricing sheet is manual entry and utilized for ease of review. Escalation is to be include in the fully burdened labor rate for each.

Attachment A

RFQ Section 8.0 Contract Clauses

Pricing Sheet/Cells B14 and B15

8.3.(c)(1)/Page 67 of 112

FDA has the General Clerk I and General Clerk II positions listed as Non-Exempt positions in Attachment A, the Pricing Table.

The contract terms and conditions section (page 67 of 112) has the Service Contract Labor Standards (52.222-41) checked indicating that it is applicable to this contract.

Please confirm that these two positions are SCA positions for pricing purposes.

General Clerk II and III are non-exempt positions (see updated Attachment A) and SCA is applicable.

Attachment A

10. Instructions to Offerors and Evaluation/Award Criteria

Pricing Sheet, Columns D, G, J, M, and P

13.1 Factor No. 2 - Technical Approach

(Element No. 7: Staffing Plan); Page

Estimated labor hours for each labor category on the pricing table are provided. In addition, cell A-B 8-10 state that "Offers [sic] are to complete only the yellow highlighted portions of the spreadsheet. No other cells shall be altered in any way, or offers may be deemed non-responsive."

Section 13.1 in the RFQ, Element No. 7: item 1 states: "The offeror shall provide the following: 1. A table identifying the proposed labor mix and level of effort (number of hours) for each PWS task area..."

Please confirm that the FDA wants the Offeror to propose based on the number of Full Time Equivalents provided in Attachment A and shall not deviate from that number.

The FDA requests that offerors propose based upon the estimates labor hours contained in Attachment A and not deviate from those estimated hours.

Attachment A

10. Instructions to Offerors and Evaluation/Award Criteria

Pricing Sheet, Columns D, G, J, M, and P

13.1 Factor No., Element No. 7:

Staffing Plan/106 of 112

Section 13.1 in the RFQ, Element No. 7: item 1 states: "The offeror shall provide the following: 1. A table identifying the proposed labor mix and level of effort (number of hours) for each PWS task area..."

It appears that the FDA is requiring a staffing plan for a specific requirement (Task Order); however, no Task Order has been issued to respond to. The PWS associated with the IDIQ is provided on pages 4 – 27 or perhaps this is the PWS for the first Task Order. If that is the case, does the IDIQ have an associated

PWS?

Please clarify what specific requirement Offerors should develop their staffing plan from.

Also, if a staffing plan is being proposed, how will pricing for the work requirement be developed given that there is no information provided about any government furnished equipment being provided, the work location, or a place on the pricing sheet for other direct costs (ODCs).

Pages 4 - 27 are the IDIQ level PWS. Specific performance metrics and requirements will be provided at the task order level. The staffing plan should be developed for the IDIQ level. second part:

IDIQ Price proposals responsive to Factor 4 are to be developed in accordance with Factor 4 - IDIQ CONTRACT PRICING, RFP p.109 and Attachment A. Other Direct Costs (ODCs) shall be proposed at the task order level, as applicable, in accordance with the RFP p.31 "5.3 Ordering". Additionally, potential government furnished property will be determined at the Task Order level. As applicable, please refer to IDIQ PWS Section 6.2 for place of performance.

37 Attachment A Project Manager III

Attachment A and Section 5.1 of the RFP include the labor category "Project Manager III," yet the rest of the RFP and Attachment B - Labor Category Descriptions list "Project Manager." Please clarify.

Please see amended RFP, which has been revised for consistency.

38 Attachment B Program Manager

Project Manager

The minimum education requirements for both the Program and Project Manager state, "Bachelor's (BA/BS)/Associate's degree preferred in the Health Science or Information Management field." This is unclear as to whether a degree, either Bachelor's or Associate's, is preferred or if a degree is required and the field of study is preferred. Please clarify.

For both the Program and Project Manager positions, either a Bachelor's or Associate's Degree is the minimum requirement. A Bachelor's or Associate's Degree is preferred in the Health Science or Information Management field. Please see revised Attachment B to this Amended Solicitation.

39 Attachment B Technology Consultant

The requirement for a technology consultant seems to contradict Section 2.0, the second to the last paragraph, where it states "The DMP contract is supported by a separate support contract to maintain the FAERS software system which is managed by the FDA CDER's Office of Business Informatics (OBI). This separate contract is responsible for the enhancement and maintenance of the FAERS software system along with the integration of third-party tools. The DMP contract is not responsible for the operations and maintenance of the FAERS software system."

What systems will this position be responsible for given that OBI is providing software system support?

Please see revised Attachment B, attached to this Amended RFP.

40 Attachment B SME IV

The minimum education requirements for the SME IV labor category state that a "Bachelor's Degree…in a medically licensed profession." This statement is unclear as to whether the proposed personnel must have an active license to practice medicine in their field or not. Please clarify.

To clarify, an amendment will be issued to delete "in a medically licensed profession" and change to "in a medical profession". Please see revised Attachment B, attached to this Amended RFP.

41 Section 3.0 Schedule 95 Can the government confirm that the Phase II written proposal consists of the Staffing Plan (Element No. 7), Past Performance (Factor No. 3), and IDIQ Contract Pricing (Factor No. 4)?

Correct.

42 Section 3.0 Schedule 95

Can the government clarify whether the three components of the Phase II written proposal (Staffing Plan, Past Performance, and IDIQ Contract Pricing) should be submitted in one file or as separate files?

The Offeror may provide the Phase II written proposal as single file or separate files, except that FACTOR 4 - IDIQ Contract Pricing requests a submission on the IDIQ Pricing Worksheet provided as Attachment A.

Section 9.0 Oral Presentation

In order to allow offerors to better prepare, and to ensure comprehensive discussion and engagement between offerors and the government, will the government provide a sampling of scenario-based pain point questions that could be asked by the government during the oral presentation?

The government does not have a sampling of scenario-based pain point questions. Per page 99, Oral Presentation Agenda Item table, time allotted, during the first 15 minutes, the prospective offerors will be provided the scenario-based pain point questions. In addition, for review purposes, the offeror will be given up to 15 minutes and there will be a break of up to 45 Minutes.

Section 9.0 Oral Presentation

Can the government clarify how many scenario-based questions each offeror will be required to address?

Per page 99, Oral Presentation Agenda Item table, time allotted, during the first 15 minutes, the offerors will be provided the scenario-based pain point questions. In addition, for review purposes, the offeror will be given up to 15 minutes and there will be a break of up to 45 Minutes.

Section 10.0 Proposal Format

Can the government confirm that offerors are not required to use Times New Roman (12) font-size in the PowerPoint presentation (just in the Phase 1 and 2 written proposals) and are flexible to use fonts and sizes that will look visually appealing?

The government confirms that offerors are not required to use Times New Roman (12) font-size in the Power Point presentation.

Per page 96, Section 2.0 MULTI-PHASE EVALUATION, Oral Presentation/Slides are optional; and page 98, Section 9.0 ORAL PRESENTATION, "Offerors may use Microsoft PowerPoint presentation slides".

Per page 100, 10.0 PROPOSAL FORMAT, "All submitted documents shall comply with the instructions as follows:

Font/Size: 1. All fonts shall be Times New Roman twelve (12) font size".

46 Section 13.1 Factor No. 2 107

The government states, "At least three key personnel must be employees of the Prime Offeror," and then later states on page 108 that there are three key personnel positions. Can the offeror propose additional key personnel beyond these three positions?

The government only requires three key personnel positions and will only evaluate three key personnel.

47 Section 13.2 Factor No. 3 108

While the government has provided Attachment J, Past Performance Questionnaire, the government states on page 108, "The government will submit the Attachment J - Past Performance Questionnaire to each of the Offeror's references for a response." Can the government confirm that Attachment J was only provided for information purposes and that offerors should take no action on past performance questionnaires?

Per Section 13.2 FACTOR NO. 3 - PAST PERFORMANCE (WRITTEN), The government will submit the Attachment J - Past Performance Questionnaire to each of the Offeror’s references for a response.

The government confirms that Attachment J is for information purposes only. The government confirms that Attachment J is for information purposes only.

12.0 PHASE I – ADVISORY

DOWN SELECT

Factor 1:

DEMONSTRATED PRIOR

EXPERIENCE (WRITTEN)

The solicitation says "Page Limitation: Five (5) pages". Please clarify if it is a total of 5 pages for all three prior experience or 5 pages per prior experience

For clarity purposes, per Section 12.0 PHASE I – ADVISORY DOWN SELECT, Factor 1: DEMONSTRATED PRIOR EXPERIENCE (WRITTEN), the Page Limitation for this entire section shall not exceed five (5) pages.

Attachments A Attachment B

Page 1Page 8 Can we assume that the Project Manager labor category in Attachment A corresponds to the description for Project Manager III in Attachment B?

In Attachment B, "Project Manager" has been revised to "Project Manager III".

Attachments A Attachment B

Page 1Pages 1, and 2

In Attachment A the Geral Clerk labor categories are listed as levels I, and II. In Attachment B they are listed as levels II, and III. Can we assume levels II and III are being priced and may we update Attachment A to reflect that change?

Attachment A - IDIQ Pricing Worksheet has been updated to correct General Clerk I to General Clerk II, and General Clerk II to General Clerk III. The revised Pricing Worksheet is attached to this Amended Solicitation.

Solicitation File Instructions to Offerors

Section 10 Subsection 2.0 Page 95 and Subsection 13.1 Page 105

Iin the table in section 2.0 the method of response for Phase II is listed as an oral presentation/slides and an Optional written response. However on Page 105 for element 7 the staffing plan writeup is not indicated as optional. Can you please clarify that the submission for Phase II must consists of a 25 page slide presentation, a 5 page written staffing plan, a written response for past performance including the , and the pricing worksheet -none of which are optional.

Offerors may use Microsoft PowerPoint presentation slides (PDF), as talking points only, to clearly articulate their viewpoints, to provide their oral presentation based on all the Phase II Technical Factors, page limitation twenty-five (25) talking point slides. They are optional. The government will not evaluate the slides. The Staffing Plan (page imitation five pages, Past Performance (page limitation three pages), and IDIQ Contract Pricing are not optional.

Solicitation File Instruction to Offerors

Section 10, Subsection 2.0, Page 95 and Subsection 9.0, Page 97

The table describing the multi-phase evaluation process in Subsection 2.0 says that the PowerPoint slide presentation is optional; however Subsection 9.0 states it must be in PDF format which implies it will be submitted to the government, as this is the format of all other emailed submissions. Can the government please clarify if the PowerPoint slides must be submitted to the government for review at any point, and, if so, if they should be submitted along with the Phase II written submission or on the day of the Oral Presentation?

The government confirms that, per Section 2.0 MULTI-PHASE EVALUATION, the slides are optional; And per Section 9.0 ORAL PRESENTATION, Per PowerPoint Presentation Slides: Offerors may use Microsoft PowerPoint presentation slides (PDF), as talking points only, to clearly articulate their viewpoints, to provide their oral presentation based on all the Phase II Technical Factors. The government will not evaluate the slides.

Solicitation File Instruction to Offerors

Section 10, Subsection 9.0, Page 97

The only formatting guideline given for the Oral Presentation PowerPoint slides is that they be in PDF format. Please clarify any other format restrictions for oral presentation slides including font, font size, numbering, and slide header/footers.

The government does not have a requirement for PowerPoint slides size, numbering, and slide header/footer. Slide submission is at the discretion of the offeror.

Solicitation File Instruction to Offerors

Section 10, Subsection 9.0, Page 97

Under heading "Offer Participants," the RFP states that "No more than five (5) total Offeror participants can attend the oral presentation, including the key personnel." Does this mean that the three identified Key Personnel (Project Manager, SME (Medical) IV, and Pharmacist) must be three of the five oral presentation attendees? Or does this imply that there can be five attendees in addition to the three identified key personnel?

Please see Amended RFP Section 9.0 ORAL PRESENTATION, Offeror Participants, b. No more than five (5) total Offeror participants can attend the oral presentation.

Solicitation File Instruction to Offerors

Section 10, Subsection 9.0.e, Page 97 and Subsection 10.0 Page 99

A Phase II Technical Response Cover Letter is mentioned that is excluded from page count. Is a Cover Letter also approved for the Phase I submission that is excluded from page count?

Per Section 10.0 PROPOSAL FORMAT, Page Limitations, item no. 3.

The cover page, table of contents, and cover letter are excluded from the page limitation in responses. This includes response to Phase I Advisory Down Select and Phase II Technical and IDIQ Contract Pricing submissions.

Solicitation File Instruction to Offerors

Section 10, Subsection 10.0, Page 99

Under heading "Font/Size," font size specifications are given for both body text and for graphics/charts but not for tables. Please specify font size restrictions for tables within written submissions.

The government does not consider tables to be charts. All texts in a table shall be Times New Roman twelve (12) font size.

Solicitation File Instruction to Offerors

Section 10, Subsection 12, Page 100 and 104

For experiences referenced in the Phase I submission, on page 100 it states "Offerors may provide up to three (3) relevant recent examples of demonstrated prior experience in their submission." Within the table that expands on the elements of the Phase I submission, directions for Element 4 ask for experience examples (page 104) state "from at least three (3) contracts or projects." Please clarify the conflict of language ("up to" versus "at least") and whether or not the experience examples for element 4 are distinct from the 3 examples referenced on page 100.

This section has been revised for clarity.

Solicitation File Instructions to Offerors

Section 10 Subsection 13.1 Page 105, and element no 7 Staffing Plan Page

Section 13.1 Page 105 of the solicitation states that the PPT presentation is limited to 25 pages. The Staffing Plan is listed on page 106 as having 5 pages. Is the 5 page written response in addtion to the 25 pages - for a total of 30 pages combined?

Per Section 13.0 PHASE II – TECHNICAL, PAST PERFORMANCE AND

IDIQ CONTRACT PRICINGFACTORS, 13.1 FACTOR NO. 2 - TECHNICAL

APPROACH (ORAL PRESENTATION ONLY), the PowerPoint Slide (If an offeror chooses to provide), page limitation of Twenty-Five (25) Talking Point Slides is separate and shall not be combined with Element No. 7: Staffing Plan, page limitation which is Five (5) Pages.

The government will not evaluate the slides.

Solicitation File Instructions to Offerors

Section 10 Subsection 13.1 Page 105, and element no 7 Staffing Plan Page

Should we include slides in the PPT presentation with regards to Element 7 - staffing plan?

If an offeror chooses to provide Power Point Slides, the offeror shall not include slides relating to Element 7 - Staffing Plan. Per Section Per Section 13.0 PHASE II – TECHNICAL, PAST PERFORMANCE AND

IDIQ CONTRACT PRICING FACTORS, 13.1 FACTOR NO. 2 - TECHNICAL

APPROACH is for ORAL PRESENTATION ONLY, and Element No. 7:

Staffing Plan is a WRITTEN PROPOSAL ONLY.

Solicitation File Instruction to Offerors

Section 10, Subsection 13.1, Page 106 item 4.c, page 107 and 8 - item 5.

Page 106 item 4.c, page 107 item 5, and page 108 item 5 indicate key personnel may be from the Prime c or subcontractor.

Further down on Page 107 in item 5 the language conflicts with the the above 3 references which states that at least three (3) key personnel must be employees of the Prime Offeror.

Can the Government please clarify that the 3 key personnel may be proposed from either the Prime or subcontractors?

At least two key personnel must be from the prime contractor.

Please see Amended RFP Factor 2, Element seven, which revised this requirement.

Solicitation File Contract Administration Data and Instructions to Offerors

Section 6.2 Page 33 and Section 10 Subsection 13.1 Element 7 Page 108

On Page 33, under place of performance, the only onsite responsibilities are defined as Scanning and Courier servies.

However, on Page 108 in the instructions for the Remote Work Plan, the solicitation states: "The Offeror shall clearly and thoroughly describe in specific detail its’ remote work plan for all other services (other than scanning, courier services, and program management services) to be performed remotely by the contractor’s employees, within the CONUS (Continental United States of America)." Does this mean that all Program Management services must also be performed onsite?

Section 13.0 PHASE II – TECHNICAL, PAST PERFORMANCE AND IDIQ

CONTRACT PRICING FACTORS, 13.1 FACTOR NO. 2 - TECHNICAL

APPROACH, Element No. 7: Staffing Plan, item no. 7, Program Management Services will be deleted.

An amendment will be issued for clarity purposes to change Section 6.2.

Solicitation File Instructions to Offerors

Section 10 Subsection 13.2 Past Performance Pages 108-109

What is the page limit for each past performance writeup and what areas of Attachment J would you like responders to fill out?

The page limitation for the response to Factor 3 is three (3) pages.

Per Section 13.2 FACTOR NO. 3 - PAST PERFORMANCE (WRITTEN), The government will submit the Attachment J - Past Performance Questionnaire to each of the Offeror’s references for a response.

The government confirms that Attachment J is for information purposes only. Offerors shall not submit the Attachment J - Past Performance Questionnaire.

Solicitation File Instruction to Offerors

Section 10, Subsection 13.2 Page 109 and Attachment J

In regards to the Past Performance Questionaires, the solicitation states that "The government will submit the Attachment J -Past Performance Questionnaire to each of the Offeror’s references for a response." However, the due date for the Questionaire response is the same as the due date for the Phase II Past Performance written submission (02/06/2023 at 3pm EST). Does the offeror need to notify the government in advance of its past performance references in order to satisfy the deadline shown on the attachment?

Please see the attached revised Attachment J - Past Performance Questionnaire, attached to this Amended RFP.

64 Background, pg 4 Can you provide additional details on what is mean't by validate against entries inthe FDA Dictionary? Please provide a few examples.

Validation refers to matching the verbatim product name and the manufacturer name in the safety report against the Product Dictionary and the Manufacturer dictionary respectively.

Examples:

1. Matching verbatim Drug X in the safety report against Drug X in the Product Dictionary.

2. Matching verbatim Drug A in the safety report against Drug B in the Product Dictionary.

65 Background, pg 5

Our solution provides a analytics, reports, and business intelligence. What technologies suport LSMV data repository?

Does the the government planning to keep the LSMV data repository and data analytics or will the LSMV be replaced with the new solution

The LSMV underlying database is ORACLE.

The government plans to keep the LSMV data repository and data analytics.

66 Schedule 3.0, p. 95 Would the Government extend the due date of Phase 1 Proposals?

Please see revised schedule in Amendmended RFP.

Phase I - Advisory Down Select, Factor 1:

Deomonstrated Prior Experience

12.0, p. 100 Would the Government allow individual member company experience to count as a prime prior experience for the Joint Venture (JV) if the JV is the prime?

Yes. The Offeror may use prior experiences in which they serve as a prime, subcontractor, and other team arangements. The Offeror must identify the Offeror’s role in all the prior experience submitted. If the Offeror plays no role in any submitted prior experience, the Offeror must state that fact.

68 3.0 Schedule 3.0, p. 95 Would the Government provide an opportunity for Offerors to ask questions during Phase 2?

Per Section 9.0 ORAL PRESENTATION, Rules of Engagement item no.

4. The Offeror may not generally ask questions during the oral presentation. Any questions asked must be directed to the Contracting Officer/Contract Specialist and should only deal with logistics and conduct of the oral presentation.

69 Written Submissions 8.0, p. 98 Would the Government allow multiple email submissions to accommodate proposals exceeding 10MB?

Please see Amended RFP, Section 8.0.

Attachment C – PWS Appendices Section & Page #s: LSMV Case Processing Metrics

Is MedDRA coding a required step for all mandatory safety reports received electronically via ESG or is this step only for the ‘fall outs’ (i.e., for reports that do not automatically code)?

The government requires MedDRA coding only of mandatory safety reports received electronically that "fall out".

Attachment C – PWS Appendices Section & Page #s: LSMV Case Processing Metrics

What is the percentage of ‘fall outs’ mandatory safety reports at the Product and Manufacturing coding step?

The total combined percentage of mandatory safety reports received electronically that "fall out" at the Product/Manufacturing and MedDRA coding process steps is between 2% - 3%.

Attachment C – PWS Appendices Section & Page #s: LSMV Case Processing Metrics

What is the percentage of ‘fall outs’ mandatory safety reports at the MedDRA coding step?

The total combined percentage of mandatory safety reports received electronically that "fall out" at the Product/Manufacturing and MedDRA coding process steps is between 2% - 3%.

Attachment C – PWS Appendices Section & Page #s: LSMV Case Processing Metrics

For mandatory safety reports, are the adverse events reconciled between the narrative data and the structured event data that is reported?

The government does not normally reconcile adverse events between the narrative data and the structured event data that is reported.

However, the adverse events are reconciled as required under Section 6.7 Task Area 7: Data Quality Assurance and Training, 6.7.1 Data Entry and MedDRA Coding Quality Assurance.

Factor 1:

DEMONSTRATED PRIOR

EXPERIENCE (WRITTEN)

Section 12.0 PHASE I – ADVISORY DOWN SELECT, pgs. 101, 104

On pg. 104 it says for Element 4, “The Offeror shall clearly and thoroughly describe in specific detail their relevant experience, focusing on the PWS task areas 3 and 6 only, for the same or similar PWS task requirements from at least three (3) contracts or projects that the Offeror has performed within the last five

(5) years.” However, the overarching instructions on pg. 101 say "Offerors may provide up to three (3) relevant recent examples of demonstrated prior experience in their submission.” These instructions appear contradictory. Will the Government please clarify if we have to provide a minimum of three contract examples, or a maximum of three contract examples?

This section has been revised for clarity.

SOLICITATION

INFORMATION

Section 1, pg.4 Will the Government please clarify if this a new requirement or if is this a recompete? If this is a recompete, who is the incumbent contractor?

The government clarifies that this is a recompete acquisition. The incumbent contractor is BA-ZAI JV, LLC, 8(a) joint venture.

DESCRIPTION OF

REQUIREMENTS /

PERFORMANCE WORK

STATEMENT (PWS)

Section 11.0 Transition-In Activities,

pg. 24

Will the Government please clarify if existing staff on the current program (non-key personnel) will transition to the new contract?

The transitioning of non-key personnel to the new contract is based on Section 13.0 PHASE II – TECHNICAL, PAST PERFORMANCE AND

IDIQ CONTRACT PRICING FACTORS, 13.1 FACTOR NO. 2 - TECHNICAL

APPROACH, Element No. 6: Transition In/Continuity of Services, the Offeror shall clearly and thoroughly demonstrate in specific detail its’ ability and plan to meet the clause requirements in FAR 52.237- 3—Continuity of Services. https://www.acquisition.gov/far/52.237- 3 , focusing on all of the sections a, b, c, and d.

10. INSTRUCTIONS TO

OFFERORS AND

EVALUATION/AWARD

CRITERIA

3.0 SCHEDULE, Page 95

Is it possible to extend the deadline since there are only six business days between the questions deadline and the Phase I deadline, which leaves little time to assess Agency Responses.

Please see revised schedule in Amendmended RFP.