Contractor Question- Answers CDER CLAT RFP No. FDA-20-SOL-1223486.pdf

Contractor Questions CDER CLAT RFP No. FDA-20-SOL-1223486

Due: 11:00 AM Eastern Time | July 10, 2020

Page Number

RFP Language Question

XI. Instructions to Offerors

33; 34;

35; 38;

33: An individual authorized to contractually bind the offeror shall sign the cover sheet of the technical proposal.

34: Each volume shall include a cover sheet…

35: COVER LETTER INSTRUCTIONS

Offerors shall include a cover letter that that contains, at a minimum, the following information:

Project Title Solicitation No.

Name of Offeror and Address Offeror DUNS number Offeror TIN number Point of Contact – Name, telephone number, and email address Business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.)

Statement that the proposal is valid for 6 months Identification of any teaming arrangements, joint ventures, mentor-protégé relationships, subcontracting relationships with proper Small Business Administration approvals Signature of Authorized Official – The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of the solicitation 38: An individual authorized to contractually bind the offeror shall sign the cover page of the Technical Volume.

Please confirm “Cover Letter” is required to be signed by an authorized official; and that the cover page is just the standard cover of the proposal that includes the title, solicitation number, due date, FAR language for disclosure of content, the submitted to address and the submitted by address. The solicitation is using cover sheet, cover letter, and cover page interchangeably, and it is unclear which is the requirement.

SEE AMENDED INSTRUCTIONS, however, Cover Letter is formal document, whereas cover sheet is not needing a signature.

35 The written Technical Proposal is limited to 35 pages and does not include the 2 page limit for Factor 1 Go/ No Go.

The table prior to this paragraph, excluding the 2 page factor 1, adds up to 33 pages. Please clarify?

Program Response: The solicitation will be amended to say, “The written Technical Proposal is limited to 35 pages and includes the 2 page limit for Factor 1 Go/ No Go.”

38 All critical information from appendices shall be summarized in the technical proposal.

What constitutes an appendix item: resumes, commitment documentation, Project Management Plan, Risk Management

Due: 11:00 AM Eastern Time | July 10, 2020

Plan, Transition In/Out Plan, Resumes, Letters of Commitment, please clarify?

Program Response: The solicitation will be amended to delete the below statement as follows:

“All critical information from appendices shall be summarized in the technical proposal.”

Instructions to Offerors | 3.0 Evaluation

39-45 Section 3.1: Sub-Factor 2

a. IDIQ Project Management

b. Task Order Project Management

Since Section 3.1: Subfactor 2 requires offerors to address IDIQ and task order Project Management approaches, will it be acceptable to the FDA to streamline responses in Factor 2 and Factor 3 by referring evaluators to Section 3.1: Subfactor 2 a. & b.?

Program Response: All offerors shall provide a response to these sections separately. These sections shall not be combined.

Instructions to Offerors | 3.0 Evaluation

39-45 Sub-Factor 2: IDIQ/ Task Order Project Management

a. IDIQ Project Management:

b. Task Order Project Management:

The evaluation criteria for Sub-Factor 2 a. and Sub-Factor 2 b.

are identical. The evaluation criteria for both seem to be more applicable to the Task Order. Are there different evaluation criteria for the IDIQ?

Program Response: The instructions for the IDIQ Project Management and the Task Order Project Management are different. Therefore, the evaluation criteria response for each should be different.

Instructions to Offerors | 3.0 Evaluation

39-45 Sub-Factor 2: IDIQ/ Task Order Project Management

a. IDIQ Project Management:

Key Personnel: Key personnel identified in terms of appropriateness and adequacy of experience, qualifications, and expertise to ensure successful completion of the requirement.

The IDIQ does not require the identification of key personnel.

Would the FDA please remove the evaluation criteria for key personnel within subfactor 2: a. IDIQ Project Management

Program Response: The solicitation will be amended to delete the IDIQ Project Management identification of Key Personnel.

“Key Personnel: Key personnel identified in terms of appropriateness and adequacy of experience, qualifications, and expertise to ensure successful completion of the requirement.

Due: 11:00 AM Eastern Time | July 10, 2020

Instructions to Offerors | 3.0 Evaluation | 3.1 Volume Technical | Factor 1: Go/No-Go

40 Describe at minimum one project using Commercial off-the-shelf (COTS) or publicly available Open Source with the same or similar requirements within the last three years. Include the agency/company name, project name, project value greater than $500K, project period of performance.

Could the FDA please confirm that the project specified must have been completed by the prime contractor, lead team member of a CTA, or the lead member of a JV?

Program Response: The government does not have a position on the completion of the project relating to any company relationship to the project.

Instructions to Offerors | 3.0 Evaluation | 3.1 Volume Technical | Factor 1: Go/No-Go

40 Factor 1: Go/ No Go of Salient Characteristics of Genomics Platform from IDIQ SOW (2 Pages) Instructions:

The Government will evaluate Factor 1 on a Go/No Go Basis. The offeror shall provide a narrative of the below conditions. Offeror shall provide a description of:

Requirement - The offeror shall demonstrate at least two years of experience in artificial intelligence technology on both image and text analysis, including image to image and text to text similarity algorithms, comparing both image art and text against a data source. The offer shall present the results of the similarity and comparison that is user readable as follows:

• Describe at minimum one project using Commercial off-the-shelf (COTS) or publicly available Open Source with the same or similar requirements within the last three years. Include the agency/company name, project name, project value greater than $500K, project period of performance.

Evaluation:

The Government will evaluate the offeror’s ability to meet all of the Go No/Go evaluation factors on a pass or fail basis. If the Offeror’s proposal does not meet all of the Go No/Go evaluation factors below, it will be deemed by the Government as failed and will not be considered for further evaluation.

The text displayed immediately after this section contains an additional requirement for the evaluation, which includes nearly identical text to the requirement listed earlier in the section.

Could the FDA please delete one of the requirements’ sections for this evaluation criteria?

Program Response: The solicitation will be amended to delete the identical text stated immediately after the initial Factor 1:

Go/No-Go section.

Instructions to Offerors | 3.1 Volume I- Technical

40 Factor 1: Go/ No Go of Salient Characteristics of Genomics Platform from IDIQ SOW (2 Pages)

The Government has asked the offeror to describe a minimum of one project to meet the Go/ No Go criteria. It is extremely rare that a government contract would involve a single project

Due: 11:00 AM Eastern Time | July 10, 2020

Requirement - The offeror shall demonstrate at least two years of experience in artificial intelligence technology on both image and text analysis, including image to image and text to text similarity algorithms, comparing both image art and text against a data source. The offer shall present the results of the similarity and comparison that is user readable as follows:

• Describe at minimum one project using Commercial off-the-shelf (COTS) or publicly available Open Source with the same or similar requirements within the last three years. Include the agency/company name, project name, project value greater than $500K, project period of performance.

having a period of performance for more than 1 year. Would the Government consider reducing the requirement from two years to one year to allow offerors to effectively include projects which meet the technical requirements?

Program Response: The government’s requirement for the number of years shall remain “at least two years of experience in artificial intelligence technology on both image and text analysis.” The number of years of experience and the minimum one project are separate requirements.

An amendment will be issued to delete the term, “Genomics” and it does not apply to this solicitation.

XI. Instructions to Offerors | 3.0 Evaluation | 3.1 Volume Technical | Factor 2: IDIQ (Attachment I)

41 Page 41 states the following: The technical proposal shall present sufficient information to reflect a thorough understanding of the work requirements and a detailed technical approach for achieving project objectives as set forth in the IDIQ SOW and Task Order SOW.

Given the page constraints and the fact this evaluation factor is for the IDIQ and Factor 3 is for the Task Order, can the Government please remove any response to the Task Order SOW from this section, reserving this Factor 2 section for the IDIQ and a response to its referenced Attachment I?

Program Response: The solicitation will be amended to delete the words, “and Task Order SOW”

Instructions to Offerors | 3.0 Evaluation | 3.1 Volume Technical | Factor 2 & Factor 3

40-42 Factor 2: IDIQ (Attachment I) Evaluation:

The Government will evaluate the extent to which the Offeror demonstrates a thorough understanding and knowledge of regulatory labeling review activities and the technical requirements in the IDIQ and Task Order Task Areas, and demonstrates the technical capability, identified associated risks with proactive mitigation strategies and overall offers a sound, logical, and effective approach.

The Government will evaluate whether the experience of all technical requirements and the extent to which the Offeror has proposed a management and staffing matrix that demonstrates the experience and capabilities to support the requirements of the Statement of Work (Key Personnel meet minimum requirements).

The Government will evaluate the extent to which the Offeror proposes a Quality Assurance (QA)/Quality Control

The evaluation criteria for Factor 2 and Factor 3 both include evaluation of the offeror’s technical approach to the task order.

When developing our response to Section 3.1 Factor 2., will it be acceptable for offerors to refer evaluators to section 3.1:

Factor 3 so the entire technical approach to the task order is contained in one section? Could the IDIQ evaluation criteria be changed to reflect this?

the words, “and Task Order”

Due: 11:00 AM Eastern Time | July 10, 2020

(QC) process, Risk and Mitigation Plan, Project Management Plan, and Transition-In/Transition-Out Plan that satisfy the requirements of the statement of work.

Factor 3: Task Order (Attachment II) Evaluation:

The Government will evaluate the extent to which the Offeror’s technical solution is feasible for the development and implementation of the automation of FDA labeling review activities that demonstrates technically sound methods, techniques and procedures including associated risks and mitigation strategies, either through a COTS or Open-Source software with the application of artificial intelligence, image processing, optical character recognition (OCR), machine learning, natural language processing, advanced pattern matching techniques, and other technologies for labeling review activities.

or any other novel or emerging technologies.

The Government will evaluate the methods and processes proposed for user experience/user interface design excellence; the use of best practices; customer engagement; file access, organization and system navigation; and reporting functionality.

XI. Instructions to Offerors | 3.0 Evaluation | 3.1 Volume Technical | Factor 2: IDIQ (Attachment I)

41 Page 41 states the following: The Government will evaluate the extent to which the Offeror proposes a Quality Assurance (QA)/Quality Control (QC) process, Risk and Mitigation Plan, Project Management Plan, and Transition- In/Transition- Out Plan that satisfy the requirements of the statement of work.

Given the page constraint of 9 pages, may the offeror provide the Risk Management Plan, Project Management Plan, and Transition-In/Out Plan as part of the appendices, in draft form, with delivery at the time of the kick-off meeting for the contract?

Program Response: The solicitation will be amended to provide instructions to the Factor 2: IDIQ relating to Quality Assurance (QA)/Quality Control (QC) process, Risk and Mitigation Plan, Project Management Plan, and Transition-In/Transition- Out Plan.

“Offeror shall provide a summary of their processes in the following areas: Quality Assurance (QA)/Quality Control (QC) process, Risk and Mitigation, Project Management, and Transition-In/Transition- Out, that satisfy the requirements of the statement of work.

Due: 11:00 AM Eastern Time | July 10, 2020

XI. Instructions to Offerors | 3.0 Evaluation

41 Factor 2:

Evaluation:

The Government will evaluate the extent to which the Offeror demonstrates a thorough understanding and knowledge of regulatory labeling review activities and the technical requirements in the IDIQ and Task Order Task Areas, and demonstrates the technical capability, identified associated risks with proactive mitigation strategies and overall offers a sound, logical, and effective approach.

The Government will evaluate whether the experience of all technical requirements and the extent to which the Offeror has proposed a management and staffing matrix that demonstrates the experience and capabilities to support the requirements of the Statement of Work (Key Personnel meet minimum requirements).

The Government will evaluate the extent to which the Offeror proposes a Quality Assurance (QA)/Quality Control (QC) process, Risk and Mitigation Plan, Project Management

The evaluation criteria for Factor 2 appears to be limited to addressing IDIQ elements. The evaluation criteria refers to Key personnel and staffing matrices associated with the Task Order evaluation. Would the FDA consider removing references to key personnel and staffing matrices for Factor 2?

this area. This criteria is only applicable to the Task Order.

XI. Instructions to Offerors | 3.0 Evaluation | Factor 4 Past Performance

44 Subfactor 1: 1 IDIQ/ Task Order Staffing Matrix states the following: Sub-Factor 1 IDIQ/ Task Order Staffing Matrix, Instructions…Evaluation…

This section defines the requirements for past performance but then also includes language (following the past performance requirements) that appear to be relevant to the IDIQ and Task Order factors (independent of each other). Subfactor 2 IDIQ/Task order Project Management (under Factor 4 Past Performance) appears to be a subfactor to Factor 2 IDIQ and Factor 3 Task Order (independent of each other) and not a subfactor to Factor 4. Please clarify?

Program Response: The solicitation will be amended to correct the numbering and separation of the IDIQ and Task Order requirements throughout this area.

Section 3.1: Sub-factor 1 is deleted and replaced with Section 3.1: Factor 5; and the word “IDIQ” is deleted.

Section 3.1: Sub-factor 2 is deleted and replaced with Section 3.1: Factor 6

Due: 11:00 AM Eastern Time | July 10, 2020

XI. Instructions to Offerors | 3.0 Evaluation

44 Equal Importance:

• Factor 2: IDIQ,

• Factor 3: Task Order, Sub-Factor 1: IDIQ/TO Project Management Sub-Factor 2: IDIQ/TO Staffing Matrix

Descending Order of Importance:

• Factor 4: Past Performance (Risk Assessment)

Subfactor 1 and Subfactor 2 on page 44 are listed under Factor

4. Could FDA please confirm that they should be listed as subfactors to Factor 3? If so, should the IDIQ subfactor (a.) be aligned to Factor 2?

Program Response: Same as Above Response

Task Order SOW 30 IX.II FDA Information Technology Security – Contracts Involving Cloud Services

It appears that this section may have been inadvertently inserted or truncated. Could FDA please remove this reference or provide the full section?

See Amended Task Order SOW.

Pricing Template Labor Rates Tab

The labor categories identified on the Labor Rates tab are titled slightly differently and are missing some LCATs identified in the IDIQ SOW, pages 44-48. Could FDA update the pricing sheet to include all LCATs or remove them from the SOW?

See Amended Pricing Template.

Pricing Template Task Order Tab

Column A - Task Area In Column A, Could the Government Specify that the data element to be entered is a carry down of the Task Area identified in the ehader for each section, i.e. “Task 1 Prototype for CLAT” should be listed in Cell A11?

Program Response: The government recommends using the same value consistent with each separate header task area.

See amended Pricing Template.

General Question Proposals are due no later than 11:00 AM Eastern time on 23rd of July 2020.

Given the extent of the questions and potential changes to the FDA-20-SOL-1223486+Instructions, we respectfully request an extension for three weeks from the date questions are answered.

Program Response: Defer response to the CS. However, please note, per a previous question requesting an extension, we agree and propose an extension of 5 calendar days from July 23 to July 28, 2020.

Due: 11:00 AM Eastern Time | July 10, 2020

Company -2 Questions

1. Do you have any recommendations on identifying potential teaming companies? I have a couple in mind, but was curious if there are any you feel could be ideal for this project.

Program Response: The government is not a position to recommend teaming companies.

2. How may I find out what tools the FDA currently utilizes to handle image analysis, optical character recognition, and other computer vision problems? An ideal solution for this project could build upon services already in-use by the FDA.

Program Response: FDA does not currently utilize a particular tool as this is a new requirement. You may provide a tool/solution that meets the requirements in the solicitation.

3. Will it be possible to request an extension to the proposal deadline of July 23rd?

Program Response: Yes, the government will allow an extension of the proposal. The new due date is July 28, 2020 at 11:00 am

EST.

Company-3 Questions

Factor 1: Go/ No Go

Requirement - The offeror shall demonstrate at least two years of experience in artificial intelligence technology on both image and text analysis, including image to image and text to text similarity algorithms, comparing both image art and text against a data source. The offer shall present the results of the similarity and comparison that is user readable as follows:

• Describe at minimum one project using Commercial off-the-shelf (COTS) or publicly available Open Source with the same or similar requirements within the last three years. Include the agency/company name, project name, project value greater than $500K, project period of performance.

Due: 11:00 AM Eastern Time | July 10, 2020

Question 1: Will government kindly consider one project with value greater than $500K having experience either on image to image OR text to text similarity algorithms as Go/No Go factor?

Program Response: The offeror shall demonstrate experience “in artificial intelligence technology on both image and text analysis, including image to image and text to text similarity algorithms”. The government’s requirement shall remain as is.

Question 2: Since we are overwhelmed with couple of proposal submissions, we are requesting government to kindly extend 7 (seven) more days for submission due date of this project.

Program Response: We agree with an extension but 5 business days to July 28, 2020.