Combined Synopsos Solicitation FDA-20-SOL-1222071.pdf

Combined Synopsis/Solicitation Number: FDA-20-SOL-1222071

Project Title: Interviewing Skills and Personal Safety Training Course

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-20-SOL-1222071

Posted Date: March 31, 2020

Original Response Date: April 27, 2020

Current Response Date: April 27, 2020

Classification Code: U099

Set-Aside: Small Business Set-Aside

NAICS Code: 611430

Contracting Office Address:

Office of Operations, Office of Finance Budget & Acquisitions Office of Acquisitions and Grants Services, Division of Acquisition Operations /SCB U.S. Food and Drug Administration 4041 Powder Mill Road #42075 Beltsville, MD 20705

PART 1

This is a combined synopsis/solicitation for Commercial Items prepared in accordance with the format in FAR Subpart 12.6, Simplified Procedures for Evaluation and Solicitation for Commercial Items, and 13.5, Simplified Procedures for Certain Commercial Items, as supplemented with additional information included in this notice. This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; quotes are being requested and a written solicitation will not be issued. This requirement is being solicited as a SMALL BUSINESS SET-ASIDE and the Government contemplates a Firm-Fixed Price Indefinite Delivery Indefinite Quantity (IDIQ) contract with cost reimbursable travel will result from this solicitation. The Solicitation Number is FDA-20-SOL-1222071. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-05 dated March 2020.

The associated North American Industrial Classification System (NAICS) code for this acquisition is 611430, Professional and Management Development Training Services.

Prospective quoters/offerors are responsible for downloading any amendments to this solicitation. It is the responsibility of the quoter /offeror to monitor the sam.beta.gov website for the release of any amendments.

The Government reserves the right to award a purchase order/contract without additional communication if the Contracting Officer determines that the initial offer(s) is/are the Best Value and additional communications are not necessary.

All interested prospective quoters/offerors shall provide quotations for the following:

PART 2

2.1 Overview

The FDA is establishing an Indefinite Delivery Indefinite Quantity (IDIQ) contract by which task orders will be issued to provide for training in personal safety when performing the basic Food, Drug, and Cosmetic Act (FD&C) and related regulations.

2.2. Contract Type

IDIQ with Firm Fixed-Price Task Orders is anticipated.

2.3 Pricing Schedule

2.2a As consideration of performance of the work stated in Part 3, Description/Statement of Work, the Government shall pay the contractor the firm fixed price of $ TBD per course.

2.2b Payment under this contract shall be contingent upon receipt and acceptance by the Government of reports and proper invoice as required in

Description of Supplies or Services

Item Unit Minimum Maximum Unit Price Year 1

Unit Price Year 2

Unit Price Year 3

Unit Price Year 4

Unit Price Year 5

Total Amount

Five-day Personal Training Course for up to 60 Participants as described by task orders

EA 1 course 50 courses

Travel associated with the course (cost reimbursable

EA 1 100

instructors (2 per course)

NTE

Amount per instructor

NTE

Amount per instructor

NTE

Amount per instructor

NTE

Amount per instructor

NTE

Amount per instructor

2.2c. Estimated and Allowable Costs for Cost-Reimbursable Travel The estimated cost for travel under this contract shall be subject to the provisions of FAR 52.232-20, Limitation of Cost, and FAR 52.216-7, Allowable Cost and Payment.

Total expenditures for domestic travel (Ground transportation, lodging, meals, and incidental expenses) incurred in direct performance of this contract shall be allowed Payment under this contract shall be contingent upon receipt and acceptance by the Government of reports and proper invoice as required in accordance with the Federal Travel Regulations (FTR).

2.2d. Task Order Limitations 2.2d(1) Minimum Order. The estimated minimum quantity to be ordered herein is one (1) personal safety course during the base year and four (4) one-year ordering periods of the contract.

2.2d(2) Maximum Order. The estimated cumulative quantity that can be ordered during the total period of performance of the contract is fifty (50) courses. The maximum is not guaranteed. Herein is one (1) personal safety course during the base year and four (4) one-year ordering periods of the contract.

PART 3– Description/Statement of Work

Statement of Work

Project Title: Interviewing Skills and Personal Safety Training Course

3.1 Background

The FDA has a continuing need to train its field and headquarters operational personnel in Personal

Safety when performing the basic enforcement aspects of the Food, Drug, and Cosmetic Act (FD&C) and related regulations. A clear and consistent understanding of personal safety during the enforcement of the FD&C Act and related regulations is essential.

The Office of Regulatory Affairs (ORA) has a need to assure an appropriate, uniform application of the administrative and compliance enforcement guidelines of the Agency can be conducted in a safe environment for its staff.

The ORA staff is the field component of FDA and as such, is engaged in investigative, scientific and compliance activities in support of the Agency’s consumer safety protection mission.

FDA employees are professionals who interact with the public daily. As a professional working to enforce the FD&C Act and related regulations; ORA staff must be mentally flexible to handle all the situations that come up in a typical day.

Objectives

The principle objective of this course is to provide FDA field and headquarters personnel with consistently presented ORA Personal Safety Course Training for enforcing the Agency laws and regulations.

Maintain the appropriate level of awareness necessary to conduct interviews and inspections safely.

Interviewing Skills and Personal Safety Training will allow the employee to remain centered and focused during any circumstance to redirect behavior, diffuse difficult situations, and generate voluntary compliance from people not on their best behavior. Through the proper preparation and application of a situational plan, the employee will be prepared to immediately deal with people who do not want to do what is asked of them.

Scope of Work

Independently and not as an agent for the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, except as provided in the schedule, and otherwise do all things necessary for or incident to the performance of the work as described below:

The Contractor shall provide necessary qualified personnel to provide appropriate instruction for ORA

Personal Safety Courses. The candidates should have significant presentation and training experience.

They should be well versed in proper adult learning techniques and be able to adapt presentation style to meet the needs of the audience. Prior law enforcement experience is a must. A biography outline shall be provided by the Contractor for each classroom instructor. If after the speaker performs at the course;

the Training Officer determines that the Instructor is not well qualified or for any reason deems he or she not a good fit, he/she may request the replacement of the Instructor. The Contractor will provide the

Training Officer a list of which instructors are assigned to each scheduled course at the beginning of each fiscal year (FY). The Contractor shall make available to the program all speakers approved by the assigned Training Officer. If for any reason a speaker is unavailable, the contractor shall be responsible for finding a suitable replacement in time for the course.

Courses will be held at ORA-U located at 11919 Rockville Pike, Rockville, Maryland or at other CONUS locations as determined by the Training Officer for approximately fifty (50) FDA students per course.

Each course shall be one (1) week (5 working days). Additional students may be assigned at the discretion of the Training Officer.

The Training Officer will identify any necessary changes/updates needed to course materials and provide the Contractor with a detailed errata sheet of changes needed. The Contractor will make the identified changes to the materials as needed by the next course offering.

Contractors will be involved in at least one (1) Course Advisory Group meeting per year to discuss/implement any major changes to the program and to discuss the delivery in the current/upcoming fiscal years. Upon discretion of the COR and/or Training Officer and according to need, courses may be held at locations other than ORA U. CAG meeting sessions shall be completed via conference call, webinar or in person. When there are significant changes for the program, there may be more than one CAG meeting in a year that the Contractor shall attend. The Government will be responsible for travel costs to and from the CAG meetings. The contractor will bill for actual hours participating in the meetings as compensation.

Contractors may be involved in site visits to specific FDA offices should the need arise. The Government will be responsible for travel costs to and from the visit sites and the contractor will bill for actual hours as compensation.

The class work day shall run from 8:00am to 5:00pm each training day. Anticipated schedule for 2020 follows:

Course Location Course Dates

Interviewing Skills and Personal Safety

Training Course Rockville, MD 6/15/2020 –

6/19/2020

Interviewing Skills and Personal Safety

Training Course Rockville, MD

7/20/2020 –

7/24/2020

Interviewing Skills and Personal Safety

Training Course Rockville, MD

8/10/2020 -

8/14/2020

Interviewing Skills and Personal Safety

Training Course Rockville, MD

8/31/2020 –

9/4/2020

Interviewing Skills and Personal Safety

Training Course Rockville, MD

11/2/2020 –

11/6/2020

Interviewing Skills and Personal Safety

Training Course Rockville, MD

2/8/2021 –

2/12/2021

Interviewing Skills and Personal Safety

Training Course Rockville, MD

4/26/2021 –

4/30/2021

The above list is tentative, and dates/locations are subject to change. The Government will provide a schedule for 2021 courses at a later date after contract award.

The Contractor shall present the course in lecture/workshop/class presentation/discussion format with

40% of the time per day devoted to lecture, 35% to workshop modules; 15% class discussion and 10% class presentation. FDA representatives will be used as monitors and will only participate in the program where their expertise is considered necessary to clarify current and precedent FDA policy and procedures.

Each course shall cover the fundamental aspects of Interviewing Skills and Personal Safety while enforcing the FD&C Act.

Many of the courses will be directed to students from field units who will need diversified rather than specific coverage of the FD&C Act. Some courses may be conducted for specific group disciplines, i.e., Import Operations, Office of Criminal Investigations, etc. Although additional time will not be added to the course to provide increased coverage of a specific topic area, the contractor shall appropriately adjust the agenda to accommodate the needs of the student audience.

The course shall be designed by the Contractor to address ORA’s training needs. The Contractor shall copy all reviewed/approved course materials and ship to course site, to arrive one (1) week prior to the course. The Contractor will provide copies of the “Gift of Fear” by Gavin de Becker for all students and use the ID Discovery video of the San Leandro incident during course instruction unless better source materials are identified by the Training Officer. If better source materials are found, the Contractor will supply those updated materials to students starting at the beginning of the next fiscal year.

The Contractor shall consider the following items when developing the course:

1. Course objectives and introduction

2. Course agenda

3. “Gift of Fear” by Gavin de Becker

4. Reference/Techniques – Job Aid for student use Any necessary PowerPoint presentations or video clips used to present or to reinforce materials

5. Application exercises for in class participation created by the Contractor and approved by the

Training Officer

6. ID Discovery Fatal Encounters “The Sausage King” Video

7. A course assessment developed by the Contractor and approved by the Training Officer to reinforce course objectives and clarify and misunderstanding/miscommunications of course materials

8. Course evaluation developed by the Contractor and approved by the Training Officer to track the effectiveness of this training and accompanying materials.

The Contractor shall update the course materials as directed by the Training Officer to reflect required Agency regulations and policies when such changes are necessitated by new Agency regulations and policies or changes affecting existing Agency regulations and policies.

The principles and tactics taught during the Interviewing Skills and Personal Safety Training will enable students to:

TASK

• Explain how the events that transpired in San Leandro affect investigator/analyst decision making.

• Explain the FDA Personal Safety Policy and its influence on inspections

• Explain the FDA Personal Safety Policy and its relevance to inspections

• Apply proper interpersonal communications skills in an interview/inspection setting

• Explain the basic communications models discussed in this class

• Explain why an assertive attitude works best in an interview/inspection situation

• Describe the various components of verbal communications and how they affect the delivery of the message

• Describe the various components of non-verbal communication and how they affect the delivery of the message

• Recognize barriers that can affect one’s ability to communicate

• Demonstrate the ability to employ proactive listening skills in an interview/inspection setting

• Recognize and diffuse the various levels of aggression

• Explain how to recognize the potential signs of aggression

• Identify basic behavioral and verbal tools that are useful for diffusing aggressive behavior

• Demonstrate the ability to plan and conduct an investigative interview

• Explain the process involved in planning for an interview

• Identify the basic flow of an interview

• Describe the various ways to elicit information during an interview

• Explain why empathy is an important interviewing tool

• Demonstrate how empathy can be used during an interview

• Explain why establishing rapport is important

• Demonstrate techniques to establish rapport with those you are interviewing

• Demonstrate how to identify leads during an interview

• Demonstrate how to pose related follow up questions to established leads

• Identify vocal and verbal cues of deception (i.e. text bridges; stalling techniques; avoiding contractions; distancing language; use of pronouns; use of euphemisms to avoid reality; the word never; making positive statements negative, etc.)

• Identify how to effectively document threats and information gathered during interviews

• Describe various neurolinguistic indicators of deception

• Discuss critical points in the interview process

• Maintain the appropriate level of awareness necessary to conduct interviews and inspections safely.

• Describe the various levels of mental awareness

• Explain various personal factors that can affect our ability to conduct interviews and inspections safely

• Explain various environmental factors that can affect our ability to conduct interviews and inspections safely

• Discuss various factors about the case itself that can affect our ability to conduct interviews and inspections safely

• Develop a personal safety inspection plan that will enhance personal safety and provide tools to proactively manage potentially dangerous situations

• Identify when a personal safety inspection plan is needed

• Develop a Personal Safety Inspection Plan appropriate for the situation

• Identify different questioning techniques.

• Demonstrate how to effectively employ open ended and probing questions during interviews.

• Identify anti-government extremist groups (Sovereign Citizens, militia extremists, etc.) and how this could impact your inspection.

• List common factors that increase the likelihood that someone will progress from conflict aggression.

• Use behavioral, verbal, and decision-making tools to diffuse conflict and aggression.

• Demonstrate the use of empathy as a tool to diffuse aggressive behavior.

• Identify the ways to document a personal safety issue objectively in writing.

• Describe various indicators of deception.

Deliverables and Reporting Requirements

The Contractor shall provide necessary qualified personnel to provide instructional services at a minimum of one (1) or a maximum of fifty (50) one-week (5 days) courses in ORA Personal Safety. A current biographical sketch must be provided by the Contractor for each instructor. Courses will be held at ORAU located at 11919 Rockville Pike, Rockville, Maryland for approximately 60 students per course. Additional students may be assigned at the discretion of the Training Officer. Upon discretion of the Training Officer and according to need, some courses may be held at locations other than ORAU. All sessions shall be completed by August 2025.

The following shall be submitted electronically, government compatible in Microsoft Office (i.e., Word, Excel, Power Point, etc.) by the Contractor to the Training Officer/COR and vice versa, no later than (6) six weeks prior to the first course for review:

o Course Objectives and Introduction o Course Agenda o Draft Course Materials

Government Furnished Property and Equipment a.) The Government will:

Provide necessary AV equipment such as flip charts, white board, LCD projector, VCR/DVD, and microphone.

Arrange for training facility to accommodate FDA personnel.

Arrange a block of hotel lodging rooms: for contractor, FDA, and state personnel at CONUS locations other than at ORA U, Rockville, MD.

Arrange for FDA subject matter experts to participate in the course and meetings as needed. They can be expected to fully explain current and precedent setting Agency policies and procedures.

b.) The Training Officer/Project Officer:

The Training Officer/Project Officer will discuss dates and locations of scheduled courses with the

Contractor and provide a final course schedule in a timely manner. The Contractor will be kept in the loop as to possible course postponements and/or change of course location.

Travel

The Project Officer will review and as necessary approve the following travel related arrangements for the contractor:

➢ Rental car use must be authorized by the Project Officer

➢ Actual expense for hotel

➢ The Contractor may use a personal vehicle and claim mileage at the established government rate if it does not exceed the cost of government airfare to the course site. If POV is used in lieu of airfare, the Contractor will be reimbursed as most cost advantageous to the government.

➢ Travel cost will be reimbursed in accordance with Federal Travel Regulations.

Contractor Support:

Note: All materials will not include copyright material and will be copied and distributed for the government. All materials created shall become property of the U.S Government. All materials should be provided in a format that is consistent with the current ORA/OTED standard software products and meet Federal 508 compliance needs. (provided below)

Materials will be designed by the Contractor to meet FDA needs. The Contractor shall update these materials as directed by the Training Officer. These changes may include but are not limited to: Agency regulations and policies and when such changes are necessitated by new Agency regulations and policies or changes affecting existing Agency regulations and policies. Each time materials are changed the

Contractor will provide the Training Officer a new master copy of the material as needed in electronic and hard copy format.

The Contractor shall provide the Training Officer with a roster of instructors and related bios prior to the beginning of the base year, and prior to the beginning of each ordering period.

The Contractor shall make his/her own transportation/reservations including hotel and rental car as authorized by the Training Officer/COR. Receipts and invoice must be provided to the Contracting Officer for payment. The Contractor must use the most cost-effective method of transportation.

508 Compliance

E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) 302 Functional Performance Criteria (Appendix C Application and Scoping Requirements) Additional scoping and technical requirements based on your acquisition:

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation (Appendix C Functional Performance Criteria and Technical Requirements)

601 General

602 Support Documentation

603 Support Services

• Procurement & Contracts 508 Compliance Review Resource http://inside.fda.gov:9003/it/InternetIntranet/Accessibility/ucm421770.htm#main

• Text of the Standards and Guidelines - United States Access Board https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#E205-content

Place of Performance:

Please reference the Statement of Work

Period of Performance:

a. Period of Performance:

The period of performance is from date of award for a four-year ordering period.

b. Time of Delivery for Individual Task Orders

The performance period/delivery dates for supplies/services ordered under this contract shall be specified with each task order issuance.

PART 4—PACKAGING, MARKING, SHIPPING

All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract/order number and contractor name.

PART 5 – INSPECTION AND ACCEPTANCE

For the purpose of this PART, the COR (TBD) is the authorized representative of the Contracting

Officer.

Inspection and acceptance will be performed at the location identified in PART VI. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt.

PART 6 – DELIVERIES and PLACE OF PERFORMANCE

6.1 Deliveries

Deliveries required by the contractor shall be made F.O.B. destination to the specified addresses/addresses listed below.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#601-general https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#602-support-documentation https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#603-support-services http://inside.fda.gov:9003/it/InternetIntranet/Accessibility/ucm421770.htm#main https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#E205-content https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#E205-content

POCs “Shall be provided at time of award.”

Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see PART VIII) between the hours of 8:30 a.m. and 4:30 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

6.2 Place of Performance

Work will be performed at: Courses will be held at ORAU located at 11919 Rockville Pike for approximately 60 students per course. Upon discretion of the Training Officer and according to need, some courses may be held at locations other than ORAU.

PART 7—CONTRACT ADMINISTRATION DATA

a. The following personnel will represent the Government for the purpose of this contract:

1. Contracting Officers Representative (COR)

To be determined upon contract award The COR is responsible for: (1) monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

Contract Specialist:

Sharon Masciana Sharon.Masciana@fda.hhs.gov 240-402-7631

Contracting Officer:

Anthony S. Wimbush Anthony.Wimbush@fda.hhs.gov 240-402-7628

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

mailto:Sharon.Masciana@fda.hhs.gov mailto:Anthony.Wimbush@fda.hhs.gov

PART 8—SPECIAL CONTRACT REQUIREMENTS

8.1 Government Holidays

Unless otherwise directed, contractors will adhere to standard working hours, working no more than 40 hours per week and observe all U.S. Government holidays. Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January New Year’s Day September Labor Day

January Martin Luther King Day October Columbus Day

February President’s Day November Veterans Day

May Memorial Day November Thanksgiving

July Independence Day December Christmas Day

8.2 Contractor Support

Note: All materials will not include copyright material and will be copied and distributed for the government. All materials created shall become property of the U.S. Government. All materials should be provided in a format that is consistent with the current ORA/OTED standard software products and meet Federal 508 C compliance needs.

Materials will be designed by the Contractor to meet FDA needs. The Contractor shall update these materials as directed by the Training Officer. These changes may include but are not limited to: Agency Regulations and policies and when such changes are necessitated by new Agency regulations and policies or changes affecting existing Agency regulations and policies.

Each time materials are changed the Contractor will provide the Training Officer a new master copy of the material as needed in electronic and hard copy format.

The Contractor will provide the Training Officer with a roster of instructors and related bios prior to the beginning of the base year, and prior to the beginning of each ordering period.

The Contractor shall make his/her own transportation /reservations including hotel and rental car as authorized by the Training Officer/COR. Receipts and invoices must be provided to the Contracting Officer for payment. The Contractor must use the most cost-effective method of transportation.

8.3 Government Furnished Property and Equipment

Provide necessary AV equipment such as flip charts, white board, LCD projector, VCR/DVD, and microphone;

Arrange for training facility to accommodate FDA personnel;

Arrange a block of hotel lodging rooms: for contractor, FDA, and state personnel at CONUS locations other than ORA U, Rockville, MD;

Arrange for FDA subject matter experts to participate in the course and meetings as needed. They can be expected to fully explain current and precedent setting Agency policies and procedures.

8.4a The Training Officer/Project Officer:

The Training/Project Officer will discuss dates and locations of scheduled courses to the Contractor and provide a final course schedule in a timely manner. The Contractor will be kept in the loop as to possible course postponement and/or change of course locations;

The Project Officer will review and as necessary approve the following travel arrangements for the contractor:

1. Rental car use must be authorized by the Project Officer;

2. Actual expense for hotel;

3. The Contractor may use a personal vehicle and claim mileage at the established government rate as long as it does not exceed the cost of government airfare to the course site. If POV is used in lieu of airfare, the Contractor will be reimbursed as most cost advantageous to the government.

4. Travel cost will be reimbursed in accordance with Federal Travel Regulations (FTR).

8.4b Post-Award Administration

Completion of all deliverables, quality and timeliness of delivery, as well as incident and type of defects, will be used to evaluate the Contractor’s progress and suitability.

PART 9 – INSTRUCTION AND EVALUATION

The following solicitation provisions apply to this acquisition:

• FAR 52.212-1 Instructions to Offerors-Commercial Items (MAR 2020)

• FAR 52.212-3 Offeror Representations and Certifications-Commercial Items (MAR 2020)

Offerors must complete annual representations and certifications online at https:\\SAM.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications-Commercial Items.

Paragraph (j) of the provision is not applicable.

• FAR 52.217-5 Evaluation of Options (JUL 1990)

The following contract clauses apply to this acquisition:

• FAR 52.212-4 Contract Terms and Conditions -Commercial Items (OCT 2018)

• FAR 52.212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders (MAR 2020) (See full text of Clause FAR 52.212-5 in Addenda 1.)

Quotation Preparation Instructions:

Quotations must be submitted no later than 10:00 P.M. ET on Friday, April 27, 2020.

Quotations must be submitted electronically via email to Sharon.Masciana@fda.hhs.gov.

The email subject line shall read: RFQ FDA-20-SOL-1222071: Interviewing Skills and Personal Safety Training.

Please allow for sufficient processing time for emails to go through the FDA Network Security The FDA will not be held responsible for any delays that may be incurred getting your quotation through FDA network security.

Late submissions will not be evaluated. FAX submissions are not authorized. Requests for information concerning this requirement must be submitted in writing and must be emailed to the above Contract Specialist email address.

Quoters may submit all questions regarding this RFQ to Sharon Masciana via email at Sharon.Masciana@fda.hhs.gov. The FDA must receive your questions no later than April 15, 2020 by 10:00 PM ET. The subject line must read: RFQ FDA-20-SOL-1222071: Interviewing Skills and Personal Safety Training Questions. FDA will not answer questions received after this date and time, and will not answer any questions submitted to individuals other than the named contact point (no phone calls please). It is anticipated that RFQ questions and FDA responses will be posted to beta.sam.gov web site on or about April 20, 2020. It is the vendor’s responsibility to check beta.sam.gov web site for the questions and responses inclusive of any other amendment issued for the RFQ.

Quotes must clearly demonstrate the Offeror’s understanding of the Statement of Work requirements, as well as convey the Contractor’s capability for transforming its understanding into successful performance under any resultant contract/order.

A complete quote must consist of: 1. a cover letter; 2. a technical quote; 3. a business/price quote;

4. past performance information; details are provided below.

Quotes which merely offer to conduct a program in accordance with the requirements of the Government’s scope of work will not be eligible for award. Quotes must convey an explanation of The proposed approach in conjunction with the tasks to be performed in achieving the project objectives.

A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. The technical approach shall be in as much detail as necessary to fully explain the proposed technical approach. The technical quote must include information on how the project is to be organized, staffed, and managed. Information shall be provided which will demonstrate the quoter’s understanding and management of important events of tasks. Quoters shall provide an explanation of how the management and coordination of consultant and or subcontractor efforts will be accomplished.

The technical quote shall include a list of names and proposed duties of the professional personnel, consultants, and key subcontractor employees proposed for the work.

Resumes of proposed employees shall be submitted and shall contain information on education, background, recent experience [within last three (3) to five (5) years], and specific scientific or technical accomplishments. The technical quote shall provide the general background, experience, and qualifications of the quoter’s organization. Quoters shall submit information on past work performance for related work, similar in type, size, and scope. Quoters shall submit and list the contract/subcontract number, name of the project officer and contracting officer/grants officer, as applicable. Technical quotes shall be prepared and submitted in the following format: 1. Table of Contents; 2. Background (associated relevant work completed and or published; 3. Plan of Work (describe plan of work); 4.

Objectives (statement of overall objectives and accomplishments to be achieved); 5. Experience and qualifications (organizational and personnel background, experience, qualifications); 6. Resource Information (direct materials, labor, equipment, travel, other resources); and, 7. Other Considerations (other considerations to support the quote).

Quoters are hereby advised that the Government will acquire the right to use, duplicate, or disclose in any manner and for any purpose whatsoever, and have or permit others to do so, all subject data required to be delivered under any contract /order resulting from this solicitation. Any reservations to these stated Government rights to data should be enunciated in the quote and will be resolved during any subsequent communications.

Any assumptions forming the basis of the submittal must be clearly identified in the cover letter submitted with the quoter’s submission in response to the RFQ.

All quotes will be handled by the Government in accordance with FAR Subpart 3.104.

Information requested by the Government herein must be furnished in writing and be fully and completely in compliance with RFQ instructions. The information requested and the manner of submission is essential to permit prompt evaluation of all quotes on a fair and uniform basis. Simple statements of compliance with the RFQ requirements without a detailed description of how compliance will be accomplished may not be considered sufficient evidence that the Contractor can meet the technical requirements.

Contractor employees responsible for preparing material that may be source selection information must Mark each page that the Contractor believes contains source selection information with the legend, “Source Selection Information.”

As noted above, all Quotes shall consist of a technical quote, a business quote and past performance information.

For planning purposes, if your organization intends to submit a quote in response to this solicitation, please inform the Contract Specialist of your intent by sending an email to Sharon Masciana, Contract Specialist at Sharon.Masciana@fda.hhs.gov by no later than 4:00 PM ET, April 21, 2020.

The signature of an official authorized to bind the Quoter/Offeror shall be identified in your quote. Your quote shall be submitted as follows:

The provision FAR 52.212-2 incorporated in this solicitation is completed as follows: The Government intends to award a single Indefinite Delivery Indefinite Quantity contract as a result of this RFQ to the responsible quoter whose offer/quote, conforming to the solicitation, represents the best value to the Government, price and other factors considered.

The Government will evaluate offers for award purposes by adding the total price for all ordering periods to the total price of the basic requirement. The Government may determine that an offer is unacceptable if the ordering periods prices are significantly unbalanced. Evaluation of ordering periods shall not obligate the Government to implement the ordering periods.

In order to be considered technically acceptable, the quote must meet or exceed all of the solicitation requirements. All price/cost related elements (i.e. labor hours and/or installation prices) must be included in the quote.

Evaluation Factor 1 – Technical Approach

The Contractor will be evaluated on how it demonstrates the technical approach to the conduct of the courses and related supporting materials is demonstrated by approaches such as format, methodology, feasibility, and appropriateness of the proposed methods together with any unique or imaginative approaches for the conduct of the courses. The technical approach demonstrates a clear and practical knowledge of the project’s subject matter and means of utilizing adult education principles.

Evaluation Fact 2 – Key Personnel

The Contractor will be evaluated on its composition of proposed key personnel to support the work.

Evaluation Factor 3 – Past Performance

The Contractor will be evaluated on past performance of similar work in type, size, and scope.

The Government will evaluate any assumptions and conditions, based upon the assessment of risk to the Government and potential of impact to the factors within the technical quote. The Government reserves the right to reject any or all assumptions or conditions that alter the Government’s requirements, schedule, start of performance, and quantities (number and location of personnel).

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time specified n the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

3) PRICE:

The quoter/offeror shall submit complete pricing. The quotation shall include:

(i) All services requested or NONE.

(ii) Quoter/Offerors must show any pricing related to labor hours, and materials associated with providing the requested services.

CLAUSES

52.216-1 Type of Contract. (Apr 1984)

The Government contemplates award of an Indefinite Quantity Indefinite Delivery contract to include Firm Fixed Price Task Orders resulting from this solicitation.

(End of provision)

52.216-18 Ordering. (Oct 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from date of award through sixty (60) months.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c)If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of clause)

52.216-19 Order Limitations. (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than one course, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor-

(1) Any order for a single item in excess of fifty (50) courses;

(2) Any order for a combination of items in excess of fifty (50) courses; or

(3)A series of orders from the same ordering office within (60) days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c)If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

https://www.acquisition.gov/content/52216-21-requirements#i1058745

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within ten (10) days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

52.216-22 Indefinite Quantity. (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after six (6) months of the expiration of the contract.

(End of clause)

52.252-2 Clauses Incorporated by Reference. (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/ https://www.acquisition.gov/hhsar https://www.acquisition.gov/

(End of clause)

FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

HHSAR Clauses

Reference Subpart 302.1—Definitions

352.203-70 Anti-Lobbying. (December 18, 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in subsections (a), (b), and (c) above shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

(End of clause)

352.237-75 Key Personnel. (December 18, 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause)

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (December 18, 2015)

(a) In addition to complying with the clause at

FAR 52.222-26, Equal Opportunity, the Contractor shall, in good faith, cooperate with the Department of Health and Human Services (Agency) in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614. For purposes of this clause, the following definitions apply:

(1) Complaint means a formal or informal complaint that has been lodged with Agency management, Agency EEO officials, the Equal Employment Opportunity Commission (EEOC), or a court of competent jurisdiction.

(2) Contractor employee means all current Contractor employees who work or worked under this contract. The term also includes current employees of subcontractors who work or worked under this contract. In the case of Contractor and subcontractor employees, who worked under this contract, but who are no longer employed by the Contractor or subcontractor, or who have been assigned to another entity within the Contractor’s or subcontractor’s organization, the Contractor shall provide the Agency with that employee’s last known mailing address, e-mail address, and telephone number, if that employee has been identified as a witness in an EEO complaint or investigation.

(3) Good faith cooperation cited in paragraph (a) includes, but is not limited to, making Contractor employees available for:

(i) Formal and informal interviews by EEO counselors or other Agency officials processing EEO complaints;

(ii) Formal or informal interviews by EEO investigators charged with investigating complaints of unlawful discrimination filed by Federal employees;

https://www.acquisition.gov/content/52222-26-equal-opportunity#P359_63934

(iii) Reviewing and signing appropriate affidavits or declarations summarizing statements provided by such Contractor employees during the course of EEO investigations;

(iv) Producing documents requested by EEO counselors, EEO investigators, Agency employees, or the EEOC in connection with a pending EEO complaint; and

(v) Preparing for and providing testimony in depositions or in hearings before the MSPB, EEOC and U.S.

District Court.

(b) The Contractor shall include the provisions of this clause in all subcontract solicitations and subcontracts awarded at any tier under this contract.

(c) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of clause)

Attachment 2 Contractor Personnel Security Clearance Standards and Residency Requirements (October

2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that…