Amendment 3.pdf

(x)

75F40124R00002 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

HFT-323

JEFFERSON AR 72079

3900 NCTR ROAD

OAGS - Field Operations Branch

FDA/OO/OFBA/OAGS/DAP

07/30/20240003

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/01/2024

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to provide answers to questions received. All questions have been answered with this amendment.

The amendment also includes the following attachments:

Amendment 3 Attachment 1 HHSAR Clauses and Provisions Full Text

Amendment 3 Attachment 2 BEST 3 Task Order 1 SOW

Amendment 3 Attachment 3 Solicitation 75F40124R00002 BEST 3.

Phase 1 response date has been extended until 1:00PM Central Time on August 5, 2024.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Document RFP Section Title RFP Page

RFP Language Question or Recommendation

1. Attachment 1

BEST3 IDIQ PWS

4.1. KEY

PERSONNEL

25 Key Personnel at the Task Order Level are…

The Base IDIQ document lists 4 key personnel (Dir. Of Ops, PI, Proj Mgr, Epi) however it states that they are at the Task Order level. In contrast, the TO1 SOW names 4 key personnel that are different (PI, Proj Mgr, Epi, Research Analyst). Please confirm the first list is correct as written, and actually intended for the IDIQ and not the TO.

Response: There are no key personnel in the IDIQ, only in the Task Order. The Task Order key personnel are correct.

2. Attachment 2

BEST 3 Task Order 1 SOW

Missing TOC Missing According to the Table of Contents, there are several sections missing from Attachment 2.

Specifically, Section 6 "Instructions/Format";

Section 7 "Technical Approach"; Section 8 "Basis for Task Order Award"; Section 10 "Attachment B". If they are NOT missing, then please clarify if/how the Offeror is to submit a written response to Task Order 1 and how to provide pricing.

Response: Those references in the task order table of contents should be deleted and there’s no Attachment B. Refer to Section E.2 for Instructions to Offerors; Technical Approach E.2.1.2 and E. 3 Task Order 1 Basis for Award on page number 51 of the solicitation. Pricing is in B.2.5, B.2.6 and E.2.1.4.

3. PWS 2.5

REPRESENTATIVE

DELIVERABLES &

MEETINGS

14 "Establish web-based resource library

Is the FDA anticipating the library being developed on the contractor’s platform, or in the FDA environment where deliverables are being shared?

Response: The web-based library containing materials relevant to the project can be developed on either the contractor’s platform or FDA environment, as long as the following are met: 1) final deliverables (i.e., protocols, reports, and other final work products) shall later be accessible to the public on the BEST website following clearance by the FDA, contractor, and subcontractors, and 2)

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RFP Language Question or Recommendation any working document(s) used for the production of these deliverables (including editable versions of figures, tables, etc.) shall be made available to the FDA. Please note that FDA users should be able to provide feedback/input to the contractors with whichever platform is being used during the development of final products.

4. RFP

75F40124R00002 B.4.5 Personnel Security Clearance Standards and Residency Requirements (October 2017

17 "Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be sent to the Contracting Officer and COR for review and approval.

Amendment 1 clarified a written proposal for the technical approach is not required. We assume this applies to both the IDIQ response and Task Order 1 response. Is the FDA anticipating bio-sketches of the key personnel?

If so, how shall they be submitted?

Response: The FDA expects resumes or curriculum vitae to accompany all proposed key personnel once the task order is awarded for FDA review and approval.

5. RFP

75F40124R00002 Proposal format 38 The cover page, table of contents, and cover letter are excluded from the page limitation in responses.

Can you clarify if a glossary is allowed and excluded from the page limitation?

Response: Yes, a glossary is allowed, but must remain within the 5 page limitation.

6. RFP

75F40124R00002 Proposal format 38 The text of the proposal shall be electronically formatted in Microsoft Word as follows: 8-1/2” by 11” paper, single-spaced (double-spaced preferred) 12-point font or greater. Page margins

Regarding text format for the written responses to Phase I - Factors 1, does 12 pt font apply towards tables and graphics as well? Is 10 pt acceptable for table and graphics?

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RFP Language Question or Recommendation shall be 1” top, bottom, left and right.

Response: Tables and graphics may use a 10-point font.

7. RFP

75F40124R00002 Proposal format 40 Prior Experience

Summary of Data:

Page Limitation: Five

(5) pages.

Will the FDA consider extending the page limitation for Phase I from 5 pages to 6 or 7 pages?

Response: No.

8. RFP

75F40124R00002

E.2.1.2 PHASE II –

TECHNICAL, PAST

PERFORMANCE

AND IDIQ/Task Order CONTRACT

PRICING

FACTORS, under "Audio/Video Recording"

40 b. No more than five (5) total Offeror participants can attend the oral presentation, including the key personnel (See the three Key Personnel positions below), who can respond to the government’s technical exchanges questions.

The RFP states that no more than 5 participants may attend the orals, including the keys "(See the three Key Personnel positions below)" however there are no keys listed below. In fact on page 13 of the RFP document, it states that key personnel will be "identified at the task order level". However there are 4 positions named as Base IDIQ Key Personnel named in the Attachment 1 document, and a slightly different set of 4 positions as TO1 Key Personnel. Please clarify which set of keys are indicated here for orals and further, who can/is required to attend the orals presentation.

Response: The Key Personnel are those individuals identified in the Task Order.

9. RFP

75F40124R00002 Oral Presentation Agenda:

41 The RFP is providing only "up to 20 minutes" for the Technical Factors presentation, while requesting information pertaining to all of Task 1 in both the IDIQ and Task Order 1. We believe that this is an insufficient amount of time to fully cover the requirements. Will the Government please consider increasing the amount of time for this section?

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RFP Language Question or Recommendation

Response: No, the Government will not increase the amount of time for this section.

10. RFP

75F40124R00002 E.2.1.3 Factor 3 – Recent and Relevant Past Performance Instructions

44 c) With respect to the relevancy of completed contracts, and specifically as it relates to completion of the “Relevance of the referenced contract to the current requirement” response required under Section 1 of the Attachment 5: PPEQ, offerors shall compare and contrast their completed contracts described in the “Description of Work” addressed in Section 1 of that same Questionnaire to provide the relevancy of the Animal Care and Technical Procedures to include type, scope, complexity and size of the work similar to this requirement.

RFP page 44: "Animal Care and Technical Procedures" appears to be a copy/paste error.

What is the correct text?

Response: No animal care. The text should read: “Relevance of the referenced contract to the current requirement data sources for the surveillance of biologic” response required under Section 1 of the Attachment 5: PPEQ.

11. RFP

75F40124R00002 Evaluation Factors 48-

The government will assess its level of confidence that the

RFP page 48-49 state confidence ratings (high, medium, low) for Factor 2 and 3 only. Do these ratings also apply to Factor 1?

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RFP Language Question or Recommendation

PHASE I –

ADVISORY DOWN

SELECT

Factor No. 1 Demonstrated Prior Experience

Offeror’s response to each of the two (2) elements (data sources and analytic capabilities as describe above) clearly and thoroughly demonstrated that the Offeror has prior experience to successfully perform the contract requirements.

PHASE II –

TECHNICAL, PAST

PERFORMANCE, AND

IDIQ/Task Order

CONTRACT PRICING

FACTORS

Factor No. 2 - Technical Approach The government will assess its level of confidence that the Offeror has the technical approach to each of the elements 1 through 4 to successfully perform the contract requirements.

Response: Yes, Phase I uses confidence ratings.

12. RFP

75F40124R00002 Task Order 1 Basis for Award

52 c) Describes capability and experience with

There appears to be no Management Section to respond to at all. Is that correct?

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RFP Language Question or Recommendation management and organizational approach to ensure productive and efficient operations between data sources and

FDA.

Response: This section has been updated with the Amendment.

13. RFP

75F40124R00002 B.2.5 Pricing Schedule-Labor Categories.

6 LABOR CATEGORIES

Labor categories below required to support the system over the duration of the contract. If proposed labor categories are different, offerors should map their labor category titles to those in the pricing table.

To avoid confusion, will FDA consider renaming the Research Analyst/Programmer labor categories from levels I, II (10 yrs), II (5 yrs), and III – to levels I, II, III, and IV, respectively?

Response: No.

14. RFP

75F40124R00002 B.4.2 Additional Labor Categories

15 B.4.2 Additional Labor Categories At any time and throughout the life of the contract, at the request of either the Contractor or the Government, the Contractor may propose additional labor categories, rates and descriptions in addition to the Government labor

Additional Labor Categories. May the Contractor propose additional labor categories in its proposal for both the IDIQ and Task Order 1?

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RFP Language Question or Recommendation categories identified in Section B to support the tasks as identified in the SOW and/or RFTOP.

Response: No. Not at the initial IDIQ award or the initial Task Order 1 award. LCATs will be added via a modification at a later time if needed.

15. Amendment 1 E.2.1.1 PART I –

Technical, Past Performance and Price Proposal Instructions

2 Government response:

There is no written response for factor 2 besides the optional presentation slides.

Since there is not a written technical proposal expected under Phase II - Factor 2, is the FDA expecting the Orals slide deck to be submitted along with Factors 3 and 4 by the 8/19/2024 deadline?

Response: No. The slide decks are for the Offerors talking points only. The Government will not evaluate the offerors oral presentation based on the slide decks.

16. Amendment 2 E.2.1.2 PHASE II –

TECHNICAL, PAST

PERFORMANCE

AND IDIQ/Task Order CONTRACT

PRICING

FACTORS

41 d. Offerors shall provide the Contracting Officer with the name, title, employer/company, and email address of the Offeror’s participants for the oral presentation as part of its Phase II Technical Factor Cover Letter submission.

In Amendment 1, FDA clarified that no written response (technical volume) is expected for Phase II -Factor 2, hence no cover letter is needed. Given this, where should the oral presenters’ names and affiliations be included in Phase II package?

Response: Refer to page number 39 of the solicitation “Proceeding to Phase II”.

17. Amendment 2 Task Order 1 Basis for Award 51 FACTOR 2: Technical

Approach The offeror will be evaluated on its technical approach and if they are capable of being

From Amendment 1 we assumed that a written technical proposal is not expected for the IDIQ or Task Order 1. However, from this language under Task Order 1 Basis for Award, it seems the government is still anticipating a written

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RFP Language Question or Recommendation successful in fulfilling and managing the work outlined in the SOW. The Government will evaluate the extent to which the Offeror’s proposal: a), b), c), d).

technical proposal for Task Order 1. Can you please clarify?

Response: The solicitation has been updated.

18. Solicitation. The FAR regulations are mentioned throughout the solicitation. Can you provide a list of every FAR required for the BEST 3? Do you have a listing of the FAR differences between the FDA-SOL-1224068 (2020 BEST 3 RFP) and

75F40124R00002 (2024 RFP)?

Response: The FAR provisions and Clauses are included in the solicitation. FAR 52.212-5 has an “x” marked on the applicable clauses within that clause. We do not have a listing of the FAR differences between FDA-SOL-1224068 (2020 BEST 3 RFP) and

75F40124R00002 (2024 RFP).

19. Amendment 2 B.2.5 9-10 Pages 9-10, B2.6, Labor Categories, has hours proposed as blank, where pages 6-9 have Ordering Periods 1-5 with prescribed hours— should the proposed hours be the summation of all 5 years, or would Order Period 1 be the same as Seed?

Response: The hours in B.2.5 are for evaluation purposes for the IDIQ. All offerors will use those hours that will provide a total evaluated price for ordering periods 1 through 5. The hours are an estimated example of the level of effort of all contractors for a particular ordering period. Section B.2.6 is the offerors price to perform the seed task order #1: data sources for surveillance of Biologics. An individual offeror’s level of effort will be different and will include the breakout and summation of hours. The task order B.2.6 pricing is the level of effort that the contractor believes is sufficient to do the work in the task order including any ODCs.

20. Solicitation 38 On page 38, the potential Oral Presentations dates are during 8/20/2024-8/23/2024. It is the

75F40124R00002 Amendment 3 9 of 30

RFP Language Question or Recommendation week of ICPE 2024, and most of our Key Personnel will be traveling to the ICPE 2024 conference during that week. Will there be flexibility in the FDA-selected day and time of the presentation?

Response: No.

21. BEST #3 aids the FDA in the surveillance of risk and adverse events of biologics. Is the FDA interested in Death as an adverse risk?

Would FDA be interested in data sources to link with external death data aggregators?

Response: The FDA/CBER team is interested in many adverse risks including death. That said, contractor(s) shall provide data sources that can link with our coordinating center; as such, individual-level (rather than aggregated) data are needed for this initiative.

22. IIS linkages can be with individual IIS jurisdiction or with an IIS data aggregator.

Would FDA allow the use of an IIS aggregator? If yes, will the IIS aggregator be subject to the subcontractor Small Business vendor percentage?

Response: As noted in the previous question, we are not interested in aggregated data sources. This solicitation is seeking data partners that can provide data sources from which individual-level data can be accessed for surveillance purposes. Therefore, the FDA would not permit the use of an IIS aggregator.

23. SOW Page

Page 5, 1st paragraph last sentence. ” The IIS linked data will be updated on a monthly (or every two weeks) basis as well.” Individual IIS allow linkages at different intervals including, but not limited to, once, once a month, every two, weekly, and daily. Does FDA want us to

75F40124R00002 Amendment 3 10 of 30

RFP Language Question or Recommendation include all IIS regardless of the update interval or only IISs that will update every month?

Response: Although the FDA/CBER BEST team prefers regular updates to the IIS linkage data, the frequency of updates would be dependent on what resources and capabilities are available from the given contractor/data partner. Ultimately, it is expected that all IIS data is included and updated regularly.

24. SOW 2.1.2.5 7 Page 7. 2.1.2.5 Provide a secure portal for communication and data transfer. Will the secure portal be the responsibility of the Coordinating Center or each Data Source Collaborator / Data partner?

Response: It is the responsibility for the data partner to be able to collaborate with the BEST team through a secure portal from which to provide results and other interim analytical files. Data transfers must not be done through email. While it may not necessarily be the responsibility of the data source collaborator/data partner, there must be a secure mechanism from which to share/transfer files. This can involve a mechanism between the coordinating center and data partner(s), or between the FDA/CBER BEST team and the data partner. Regardless, the mechanism shall adhere to all data security precautions required to ensure that there are secure data-encrypted transfers between entities that protects sensitive and proprietary information.

25. SOW 28-

Pages 28-29, The Program Manager, Project

Management, and Project Coordinator educational requirements are “Education:

Bachelor of Science or master’s degree”. Can the Program Manager, Project Management, and Project Coordinator have a Bachelor’s in a non-science area such as business, management, computers, or arts?

Attachment+2+BEST+3+Task+Order+1+SOW

(SOW)

Attachment+1+BEST3+IDIQ+PWS (IDIQ)

Response: Yes.

26. SOW Task order There are different Task Order Deliverables &

Meetings items in the tables among the SOW

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RFP Language Question or Recommendation

SOW

11-

IDIQ

13-

(pages 11-12) and IDIQ (pages 13-14). Which table is correct?

Response: The IDIQ deliverables and meetings are representative deliverables and meetings of what may be required in a task order.

The task order SOW are performance requirements that the task order awardee must complete.

27. Solicitation B.4.2 15 B.4.2 Additional Labor Categories, page 15, paragraph 1; Can FDA confirm that we can suggest alternate labor categories that would be appropriate for this contract?

Response: No. Not at the initial IDIQ award or the initial Task Order 1 award. LCATs will be added via a modification at a later time if needed.

28. Solicitation B.2.5 6 B.2.5 Pricing Schedule, page 6, paragraph 3;

The RESEARCH ANALYST/PROGRAMMER II labor category appears twice in the Labor Categories.

However, the education requirements for both labor categories are different. Can FDA confirm these should be included under the same level II.

Response: There are two distinct labor categories for the Research Analyst/Programmer II labor categories. One that requires more education than the other and needs to be clearly identified in your price proposal.

29. Solicitation E.2.1.1 40 E.2.1.1 Phase 1; Factor 1: Demonstrated Prior

Experience (Written), page 40, paragraph 5;

Will FDA allow for Prior Experience Summary of Data information (i.e., contract/task order/reference no., etc.) to be provided in an

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RFP Language Question or Recommendation appendix and not count towards the 5 page limit?

Response: No.

30. Solicitation B.2.5 6-7 B.2.5 Pricing Schedule, page 6-7; Can FDA confirm if the level of effort represented in the IDIQ RFP represents the expected level of effort for all activities, or is it a sample table?

Response: The level of effort is for price evaluation purposes for the IDIQ. It is a sample table of the level of effort for all activities among all contractors.

31. Solicitation

Amendment 2 34 Attachment: amendment 2 attachment 1

Solicitation 75F401R00002 BEST 3, Page 34.

Can the government confirm if they will allow Contractor Teaming Arrangements (CTAs) with data providers, or if they will only allow prime/subcontract relationships?

Response: The Government will allow contractor teaming arrangements with data providers. This teaming arrangement must be finalized by all parties at the time of your proposal submission.

32. Solicitation amendment 2 43 Attachment: amendment 2 attachment 1

Solicitation 75F401R00002 BEST 3, Page 43.

Can the government consider removing the written Phase II component for Factor 3 (Recent and Relevant Past Performance)?

While we have relevant past performance with the FDA CBER, many offerors also have relevant pharmacovigilance clients who are FDA Sponsors (life sciences companies) who usually do not name their contracting companies for confidentiality and competitive reasons. So, this means that the pharmacovigilance projects with life sciences

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RFP Language Question or Recommendation companies cannot be submitted directly by life sciences companies under the current requirements.

Response: No.

33. Attachment 1

BEST3 IDIQ PWS

5 labor category descriptions

27 Attachment 1 BEST3 IDIQ PWS, 5. Labor Category Descriptions, page 27, RFP Language: DIRECTOR OF OPERATIONS qualifications: The Director of Operations has at least a Ph.D. or MD and 10 years of experience. Would CBER accept a Master’s Degree with at least 10 years of experience in lieu of a PhD or MD?

Response: No.

34. Attachment 1

BEST3 IDIQ PWS

5 labor category descriptions

28 Attachment 1 BEST3 IDIQ PWS, 5. Labor Category Descriptions, page 28, RESEARCH ANALYST/PROGRAMMER III:

Ability to conduct project tasks with minimal supervision, general knowledge of research techniques, conduct programming projects with minimal supervision, write reports, and devise data input strategies. Computer programming knowledge and proficiency with different computer languages and different software.

Education: Master’s Degree in related field with 10 years of experience.

RESEARCH ANALYST/PROGRAMMER II:

Ability to conduct project tasks with minimal supervision, general knowledge of research techniques, conduct programming projects with minimal supervision, write reports, and devise

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RFP Language Question or Recommendation data input strategies. Computer programming knowledge and proficiency with different computer languages and different software.

Education: Bachelor of Science or Master’s Degree in related field with 10 years of experience.

RESEARCH ANALYST/PROGRAMMER II:

Ability to conduct project tasks with minimal supervision, general knowledge of research techniques, conduct programming projects with minimal supervision, write reports, and devise data input strategies. Computer programming knowledge and proficiency with different computer languages and different software.

Education: Bachelor of Science or Master’s Degree in related field with 5 years of experience.

RESEARCH ANALYST/PROGRAMMER I:

Ability to conduct project tasks with supervision, general knowledge of research techniques, conduct programming projects with supervision, write reports, and devise data input strategies. Computer programming knowledge and proficiency with different computer languages and different software. Education:

Bachelor of Science or Master’s Degree in related field with 5 years of experience.

Would the government consider combining Analyst/Programmer II (10 years) and III into a

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RFP Language Question or Recommendation combined Analyst/Programmer level III by requiring a Master’s Degree or equivalent in the related field with 10 years of experience?

Response: No.

35. SOW The only difference between Research Analyst

Programmer I and II (5 years) is level I requiring supervision and level II requiring minimal supervision, is this intentional?

Response: Yes, it is intentional, and it indicates a junior position.

36. The solicitation says that an ODC NTE will be provided at the Task Order level. Task Order 1 does not appear to include a NTE, is this intentional?

Response: The ODCs are up to each offeror to propose based on the technical solution at meeting the requirements of the task order SOW. It is anticipated that each offeror will have different ODCs. When a task order is issued a not to exceed amount will be provided based on the offerors task order pricing with any ODCs.

37. Will the government please clarify the types of studies that will fall into the Infrastructure and Methods Study request type?

Response: Infrastructure or methods development studies are defined as activities that expand the data infrastructure or develop new epidemiologic or biostatistics or informatics methods to be applied to the inferential studies (see IDIQ PWS Section 2.1.2). Studies in Methods are the development of a formal protocol is required ahead of a study initiation, and to integrate qualitative and quantitative techniques, and new technology, to derive study designs, analytical approaches, or techniques as complex regulator questions emerge (see Methodology for Categorization of Request in the Task Order SOW Section 2.5).

38. Will the government please provide the full text of the following clauses as the full text is not available at https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-

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RFP Language Question or Recommendation provisions-contract-clauses/index.html or https://www.acquisition.gov/hhsar.

352.239-71 Security Requirements for Information Technology Resources (Feb 2024) 352.239-74 Information System Hosting, Operation, Maintenance or Use (Feb 2024) 352.239-75 Security Controls Compliance Testing (Feb 2024) 352.239-79 Information and Communication Technology Accessibility (Feb 2024) 352.239-72 Information System Security Plan and Accreditation (Feb 2024) 352.239-78 Information and Communication Technology Accessibility Notice (Feb 2024)

Response: Full text is provided in Attachment 1 of the Amendment.

39. Solicitation E.2.(b) Section E.2(b) references submission of the proposal as Part 1: Technical Proposal, Part 2:

Past Performance Information, and Part 3:

Business Proposal. Later in the solicitation, in section E.2.1.1, the headings transition to Phases rather than Parts and then to Factors.

Will the government clarify whether the proposal sections should be referenced as Parts, Phases, or Factors?

Response: Each PART has a sub-criterion which is a FACTOR. The Government is separating the documents (Demonstrated Prior Experience – Phase 1 and Technical Approach, Recent and Relevant Past Performance and IDIQ Contract Pricing – Phase 2) into two PHASES.

40. Solicitation Requesting clarification for Part 1, Phase I, Factor 1. Is the solicitation allowing relevant recent examples of demonstrated prior

75F40124R00002 Amendment 3 17 of 30

RFP Language Question or Recommendation experience for both the Prime Contractor and subcontractors?

Response: Demonstrated prior experience is for the Prime Contractor.

41. The solicitation lists the participants for the

Technical Approach/ Oral Presentation. Will the government consider allowing an additional participant so that a member of the Offeror’s Contract management team may also attend the presentation without having to reduce the number of technical SMEs?

Response: No.

42. Is there a minimum requirement for the number of recent and most relevant contracts/orders to include in Factor 3?

Response: There is no minimum requirement for the number of contracts/orders.

43. Requesting clarification for Part 2, Phase II, Factor 3. Will the government consider revising the Recent and Relevant Past Performance Instructions to allow submissions from both the Prime Contractor and subcontractors?

Response: No.

44. The solicitation references pricing data

"proposed in section B.3.1". Should this reference be section B.2.5 of the RFP?

Response: Yes, it should be B.2.5.

45. Task order SOW 1.4 5 Reference - Task Order SOW Document, Section 1.4, Page 5, Bullet 6. Can the Government please specify whether the referenced distributed database network currently exists (either in an early or final

75F40124R00002 Amendment 3 18 of 30

RFP Language Question or Recommendation stage)? Further, please detail if there is any contractor support required beyond providing data sources.

Response: This solicitation is a recompete for an existing contract. FDA/CBER presently has a contract in place the contractors provide data in a distributed database network that supports the CBER BEST program. This referenced distributed database network does already exist through the support and maintenance of data provided by current contractors. For this recompete, contractors shall provide data sources for this distributed network (refer to Sections 1.3, 1.4, 2.1.1, 2.14, 2.1.3, 2.1.4 in the SOW for additional details), and contractors shall work with the FDA’s BEST Coordinating Center and conduct data analytics on these data shared in the distributed database network. Since this is a recompete, the distributed database network may change as new databases are added to the network and some databases will no longer be part of the network of databases. The contractor shall provide the necessary personnel such as epidemiologists, experts on their own databases, computer programmers, and project managers to maintain, update, and analyze the data. Contractors shall run data queries and conduct studies in a distributed data network environment using their own databases (please see Sections 1.4 bullets 3, 6, 7 and Section 2.1.2 for additional information).

46. Task order SOW 1.4 5 Reference - Task Order SOW Document, Section 1.4, Page 5, Bullet 10. Can the Government please elaborate in the extent of the Contractor's role in supporting maintenance and improvements to the governance structure?

Response: FDA/CBER has a coordinating data center that is managed and governed under another participating contractor entity.

For this solicitation, the contractor shall have the capability to leverage its own data sources in collaboration with this coordinating center, while also performing analytical activities that can improve the maintenance, data quality, and subsequent data analyses from this center. The contractor shall provide the necessary personnel to support and perform maintenance and improvements in coordination with this distributed database network and governance structure.

47. Solicitation 39 Reference - RFP Document, Factor No. 1 -

Demonstrated Prior Experience, Page 39, Paragraph 5. The section for Demonstrated Prior Experience requires that, "Offeror may provide up to four (4) relevant recent examples of demonstrated prior experience in their submission." May these four (4) recent

75F40124R00002 Amendment 3 19 of 30

RFP Language Question or Recommendation examples of demonstrated prior experience include a combination of contract experience from both the Offeror Prime Contractor and teammate Subcontractors performing a significant role in the performance of the proposed BEST Initiative #3 contract?

Response: No.

Document RFP Section Title RFP

Page

RFP Language Question or Recommendation

48. Attachment 1

BEST3 IDIQ PWS

4.1. KEY

PERSONNEL

25 Key Personnel at the Task Order Level are…

The Base IDIQ document lists 4 key personnel (Dir. Of Ops, PI, Proj Mgr, Epi) however it states that they are at the Task Order level. In contrast, the TO1 SOW names 4 key personnel that are different (PI, Proj Mgr, Epi, Research Analyst). Please confirm the first list is correct as written, and actually intended for the IDIQ and not the

TO.

Response: There are no key personnel in the IDIQ, only in the Task Order. The Task Order key personnel are correct.

49. Attachment 2

BEST 3 Task Order 1 SOW

Missing TOC Missing According to the Table of Contents, there are several sections missing from Attachment 2.

Specifically, Section 6 "Instructions/Format"; Section 7 "Technical Approach"; Section 8 "Basis for Task Order Award"; Section 10 "Attachment B". If they are NOT missing, then please clarify if/how the Offeror is to submit a written response to Task Order 1 and how to provide pricing.

75F40124R00002 Amendment 3 20 of 30

RFP Language Question or Recommendation

Response: Those references in the task order table of contents should be deleted and there’s no Attachment B. Refer to Section E.2 for Instructions to Offerors; Technical Approach E.2.1.2 and E. 3 Task Order 1 Basis for Award on page number 51 of the solicitation. Pricing is in B.2.5, B.2.6 and E.2.1.4.

50. PWS 2.5

REPRESENTATIVE

DELIVERABLES &

MEETINGS

14 "Establish web-based resource library

Is the FDA anticipating the library being developed on the contractor’s platform, or in the FDA environment where deliverables are being shared?

Response: The web-based library containing materials relevant to the project can be developed on either the contractor’s platform or FDA environment, as long as the following are met: 1) final deliverables (i.e., protocols, reports, and other final work products) shall later be accessible to the public on the BEST website following clearance by the FDA, contractor, and subcontractors, and 2) any working document(s) used for the production of these deliverables (including editable versions of figures, tables, etc.) shall be made available to the FDA. Please note that FDA users should be able to provide feedback/input to the contractors with whichever platform is being used during the development of final products.

51. RFP

75F40124R00002 B.4.5 Personnel Security Clearance Standards and Residency Requirements (October 2017

17 "Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be sent to the Contracting Officer and COR for review and approval.

Amendment 1 clarified a written proposal for the technical approach is not required. We assume this applies to both the IDIQ response and Task Order 1 response. Is the FDA anticipating bio-sketches of the key personnel? If so, how shall they be submitted?

Response: The FDA expects resumes or curriculum vitae to accompany all proposed key personnel once the task order is awarded for FDA review and approval.

52. RFP

75F40124R00002 Proposal format 38 The cover page, table of contents, and cover letter are excluded from the page limitation in responses.

Can you clarify if a glossary is allowed and excluded from the page limitation?

75F40124R00002 Amendment 3 21 of 30

RFP Language Question or Recommendation

Response: Yes, a glossary is allowed, but must remain within the 5 page limitation.

53. RFP

75F40124R00002 Proposal format 38 The text of the proposal shall be electronically formatted in Microsoft Word as follows: 8-1/2” by 11” paper, single-spaced (double-spaced preferred) 12-point font or greater.

Page margins shall be 1” top, bottom, left and right.

Regarding text format for the written responses to Phase I - Factors 1, does 12 pt font apply towards tables and graphics as well? Is 10 pt acceptable for table and graphics?

Response: Tables and graphics may use a 10-point font.

54. RFP

75F40124R00002 Proposal format 40 Prior Experience Summary of Data:

Page Limitation: Five (5) pages.

Will the FDA consider extending the page limitation for Phase I from 5 pages to 6 or 7 pages?

Response: No.

55. RFP

75F40124R00002

E.2.1.2 PHASE II –

TECHNICAL, PAST

PERFORMANCE

AND IDIQ/Task Order CONTRACT

PRICING

FACTORS, under "Audio/Video Recording"

40 b. No more than five (5) total Offeror participants can attend the oral presentation, including the key personnel (See the three Key Personnel positions below), who can respond to the government’s technical exchanges questions.

The RFP states that no more than 5 participants may attend the orals, including the keys "(See the three Key Personnel positions below)" however there are no keys listed below. In fact on page 13 of the RFP document, it states that key personnel will be "identified at the task order level". However there are 4 positions named as Base IDIQ Key Personnel named in the Attachment 1 document, and a slightly different set of 4 positions as TO1 Key Personnel. Please clarify which set of keys are indicated here for orals and further, who can/is required to attend the orals presentation.

75F40124R00002 Amendment 3 22 of 30

RFP Language Question or Recommendation

Response: The Key Personnel are those individuals identified in the Task Order.

56. RFP

75F40124R00002 Oral Presentation Agenda:

41 The RFP is providing only "up to 20 minutes" for the Technical Factors presentation, while requesting information pertaining to all of Task 1 in both the IDIQ and Task Order 1. We believe that this is an insufficient amount of time to fully cover the requirements. Will the Government please consider increasing the amount of time for this section?

Response: No, the Government will not increase the amount of time for this section.

57. RFP

75F40124R00002 E.2.1.3 Factor 3 – Recent and Relevant Past Performance Instructions

44 c) With respect to the relevancy of completed contracts, and specifically as it relates to completion of the “Relevance of the referenced contract to the current requirement” response required under Section 1 of the Attachment 5: PPEQ, offerors shall compare and contrast their completed contracts described in the “Description of Work” addressed in Section 1 of that same Questionnaire to provide the relevancy of the Animal Care and Technical Procedures to

RFP page 44: "Animal Care and Technical Procedures" appears to be a copy/paste error.

What is the correct text?

75F40124R00002 Amendment 3 23 of 30

RFP Language Question or Recommendation include type, scope, complexity and size of the work similar to this requirement.

Response: No animal care. The text should read: “Relevance of the referenced contract to the current requirement data sources for the surveillance of biologic” response required under Section 1 of the Attachment 5: PPEQ.

58. RFP

75F40124R00002 Evaluation Factors

PHASE I –

ADVISORY DOWN

SELECT

Factor No. 1 Demonstrated Prior Experience

48-49 The government will assess its level of confidence that the Offeror’s response to each of the two (2) elements (data sources and analytic capabilities as describe above) clearly and thoroughly demonstrated that the Offeror has prior experience to successfully perform the contract requirements.

PHASE II – TECHNICAL,

PAST PERFORMANCE,

AND IDIQ/Task Order

CONTRACT PRICING

FACTORS

Factor No. 2 - Technical Approach The government will assess its level of confidence that the Offeror has the technical approach

RFP page 48-49 state confidence ratings (high, medium, low) for Factor 2 and 3 only.

Do these ratings also apply to Factor 1?

75F40124R00002 Amendment 3 24 of 30

RFP Language Question or Recommendation to each of the elements 1 through 4 to successfully perform the contract requirements.

Response: Yes, Phase I uses confidence ratings.

59. RFP

75F40124R00002 Task Order 1 Basis for Award

52 c) Describes capability and experience with management and organizational approach to ensure productive and efficient operations between data sources and

FDA.

There appears to be no Management Section to respond to at all. Is that correct?

Response: This section has been updated with the Amendment.

60. RFP

75F40124R00002 B.2.5 Pricing Schedule-Labor Categories.

6 LABOR CATEGORIES

Labor categories below required to support the system over the duration of the contract. If proposed labor categories are different, offerors should map their labor category titles to those in the pricing table.

To avoid confusion, will FDA consider renaming the Research Analyst/Programmer labor categories from levels I, II (10 yrs), II (5 yrs), and III – to levels I, II, III, and IV, respectively?

Response: No.

61. RFP

75F40124R00002 B.4.2 Additional Labor Categories

15 B.4.2 Additional Labor Categories At any time and throughout the life of the contract, at the request of either the Contractor or the

Additional Labor Categories. May the Contractor propose additional labor categories in its proposal for both the IDIQ and Task Order 1?

75F40124R00002 Amendment 3 25 of 30

RFP Language Question or Recommendation

Government, the Contractor may propose additional labor categories, rates and descriptions in addition to the Government labor categories identified in Section B to support the tasks as identified in the SOW and/or RFTOP.

Response: No. Not at the initial IDIQ award or the initial Task Order 1 award. LCATs will be added via a modification at a later time if needed.

62. Amendment 1 E.2.1.1 PART I –

Technical, Past Performance and Price Proposal Instructions

2 Government response:

There is no written response for factor 2 besides the optional presentation slides.

Since there is not a written technical proposal expected under Phase II - Factor 2, is the FDA expecting the Orals slide deck to be submitted along with Factors 3 and 4 by the 8/19/2024 deadline?

Response: No. The slide decks are for the Offerors talking points only. The Government will not evaluate the offerors oral presentation based on the slide decks.

63. Amendment 2 E.2.1.2 PHASE II –

TECHNICAL, PAST

PERFORMANCE

AND IDIQ/Task Order CONTRACT

PRICING

FACTORS

41 d. Offerors shall provide the Contracting Officer with the name, title, employer/company, and email address of the Offeror’s participants for the oral presentation as part of its Phase II Technical Factor Cover Letter submission.

In Amendment 1, FDA clarified that no written response (technical volume) is expected for Phase II -Factor 2, hence no cover letter is needed. Given this, where should the oral presenters’ names and affiliations be included in Phase II package?

Response: Refer to page number 39 of the solicitation “Proceeding to Phase II”.

75F40124R00002 Amendment 3 26 of 30

RFP Language Question or Recommendation

64. Amendment 2 Task Order 1 Basis for Award

51 FACTOR 2: Technical Approach The offeror will be evaluated on its technical approach and if they are capable of being successful in fulfilling and managing the work outlined in the SOW. The Government will evaluate the extent to which the Offeror’s proposal: a), b), c), d).

From Amendment 1 we assumed that a written technical proposal is not expected for the IDIQ or Task Order 1. However, from this language under Task Order 1 Basis for Award, it seems the government is still anticipating a written technical proposal for Task Order 1. Can you please clarify?

Response: The solicitation has been updated.

65. Attachment 1:

IDIQ PWS –

Section 2.1.3.2.

7 Will the government confirm whether section 2.1.3.2 (IDIQ) and 2.1.3 (TO) for medical records include: retrieval and redaction of medical records to be transferred to the coordinating center, or should additional resources be accounted for the abstraction and adjudication of these records as well?

Response: Contractors shall have the capacity to validate/adjudicate cases in medical records (in addition to retrieval and redaction), which can either be through its own ability to have clinicians adjudicate records through case-review reports, and/or through deidentification of patient-identifiable information and transferring of records to the coordinating center from which an adjudication process can then be conducted to confirm whether medical records are true cases. Note: It is not necessary for data to be transferred to the coordinating center, as long as the validation (i.e., adjudication process) can be conducted. The coordinating center may provide a summary of the aggregated data to the FDA/CBER. Refer to Section 2.1.3.2 of the IDIQ which specifies that the contractor should be able to “obtain patients’ medical charts, and in some cases have clinicians adjudicate relevant exposures, outcomes, and covariates; in other cases, the data provider will obtain the medical charts, remove all personal identifiers, and transfer them to the coordinating center(s) so that the chart review process will be documented by the coordinating center and its experts.”

75F40124R00002 Amendment 3 27 of 30

RFP Language Question or Recommendation

66. Attachment 1:

IDIQ PWS -

Section 2.1.3.2

7 How many medical records and cohorts of patient-provider lists should be assumed per year for ODC estimates?

Response: Reminder, the IDIQ PWS are representative tasks and the Task Order 1 SOW is for the actual performance and will be included in the performance requirement when Task Order 1 is issued/awarded. ODCs shall be for the Task Order 1 SOW performance requirements. The total number of medical records can range from a few hundred or more charts depending on each given study question and desired outcomes. That said, we would not want to limit the number of medical records and cohort lists. In your proposal, we ask that your determined number of patients offer enough statistical power to sufficiently account for confounding and allow for sensitivity analyses that may be needed to account for biases from real-world data. Thus, the expected number of medical records is contingent on the resources and staff available from the contractor(s). Per Section 2.1.3 of the SOW, indicate what clinical expertise and knowledge is available to conduct case abstraction and adjudication, as well as what reasonable number of records you can provide based on your expected costs. Refer to page 7 of the SOW for more details, which states: “The contractor shall have the capability and capacity to obtain patients’ medical charts for certain queries and studies in a timely manner, to abstract the relevant data, and in some cases have clinicians adjudicate relevant exposures, outcomes, and covariates; in other cases, the data provider will obtain the medical charts, remove all personal identifiers, and transfer them to the coordinating center(s) so that the chart review process will be conducted by the coordinating center and its experts.

67. Attachment 2:

Task Order 1 SOW 11 Can the government confirm whether the requirement for a web portal and email communications is applicable to all contractors or just the coordinating centers?

Response: Contractors shall regularly communicate by phone and by email. Regarding the web portal, we anticipate that it will be necessary to share and collaborate through a shared platform where the BEST team can provide and review interim (working) documents and deliverables prior to finalization. During this collaboration, it may be necessary to share files that are data-encrypted and not through email. Thus, any data partner that is part of this initiative shall communicate and share results electronically.

68. Attachment 2:

Task Order 1 SOW

- Section 2.3.3

10 Will the government clarify whether section

2.3.3 is applicable to all offerors, or just to the coordinating centers?

Response: It is applicable to all Offerors.

69. Solicitation

75F40124R00002, 9-10, Task Order #1 pricing instructions require

Offerors to furnish a price breakdown by

75F40124R00002 Amendment 3 28 of 30

RFP Language Question or Recommendation

Section B.2.6 Task Order 1: Data Sources for Surveillance of Biologics and Section E.2.1.4 (c) Task Order #1 Pricing (Time and Materials Task Order)

SOW task area and labor category. Will the government please clarify whether Offerors should submit separate tables for each task, or may we add a column to the table provided at B.2.6 to indicate the applicable tasks for each LCAT?

Response: Columns may be added to the tables in B.2.6 and/or can also submit separate pricing information.

70. Solicitation

75F40124R00002 Section E, E.1 34 FAR 52.222-46 requires that Offerors submit a Total Compensation Plan as part of their proposals. The Total Compensation Plan is not listed in the Factor 4 - Business Proposal instructions. Will the government confirm whether the Total Compensation Plan should be included in Factor 4?

Response: It is included in Factor 4.

71.…