OTED Solicitation_Amend0001_4-1-2022.pdf

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 items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT 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.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

DSAAG

The purpose of this amendment is to: 1) Update the Statement of Work (SOW); 2) Update the instructions for Factor 3; and 3) Include a Past Performance Questionnaire as Attachment 2.

DHHS/FDA/OAGS/DSAAG

ATTN: Pamela Lee 4041 Powder Mill Road Beltsville MD 20705

75F40122Q00014

1 1

04/01/2022

03/18/2022

75F40122Q00014

PART 2 – LINE ITEMS AND PRICES

The Government intends to issue a Purchase Order resulting from this solicitation.

Offerors are requested to provide a fixed price quote in accordance with the Statement of Work.

The Contractor is to provide skilled instructional design services necessary to facilitate and deliver meaningful training virtually and to adjust OTED’s current training plan and model to successfully achieve and maintain the transition of ILT to vILT and create new vILT courses.

CLIN Description Qty Price CLIN 0001 Base Year - Virtual Production

Training Services 1 Year

CLIN 0002 Option Year 1 -Virtual Production Training Services

1 Year javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','')

PART 3 - Statement of Work for OTED-Virtual Producing Training Course

Office of Training, Education and Development (OTED)

Background:

The Office of Training, Education and Development (OTED) within the Office of Regulatory Affairs (ORA), U.S. Food and Drug Administration is responsible for developing the strategic training, education, and development plan for regulatory staff. The pandemic caused by the coronavirus, SARS-CoV-2, has impacted the implementation of the training plan. Under the pandemic, OTED is transitioning and adapting its current training model for ORA personnel and state and local regulatory partners that is primarily based on instructor-led training (ILT) to training delivered by virtual instructor-led training (vILT) and web-based platforms. Currently, OTED is primarily using Adobe Connect and Zoom.gov to implement vILT additional platforms may be introduced to achieve desired instructional goals.

For the purposes of this Statement of Work, instructor-led training (ILT) includes any and all training delivered in a physical space (e.g.: classroom-based, face-to-face, in-residence, etc.). Virtual instructor-led training (vILT), commonly referred to as a synchronous-distributed training courses, includes any and all training designed, developed, and delivered using web-conference and other media to provide a virtual classroom experience.

Addressing the Coronavirus’ impact requires additional and different training methods for the Office to continue to meet the high demand for its training. OTED intends to establish and re-establish curricula by applying these methods to:

• Redesign and develop a defined portion of its catalog of ILT;

• Design and develop vILT web-courses and blended training; and

• Design/redesign and develop/redevelop web-courses and deliver as vILT, web-courses, and blended solutions

Objective:

The primary objective is for the Contractor to provide skilled instructional design services necessary to create and facilitate (Train the Trainer) TTT for OTED’s instructors to be able to effectively design, develop and facilitate VILT sessions.

OTED’s personnel should be enabled to facilitate and deliver meaningful training virtually and to be able to adjust OTED’s current training plan and model to successfully achieve and maintain the transition of ILT to vILT and create new vILT courses.

Scope:

The Contractor shall provide personnel, materials, services, facilities, except as provided in the statement, and otherwise do all things necessary for, or incident to, the javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','') performance of the work as described to accomplish the tasks and deliverables to provide training, job aides, and hands on experiences to develop and demonstrate skillsets in the area of virtual facilitation and virtual course production.

A successful virtual training goes beyond an informational webinar and requires a facilitator to understand the learners’ needs and create a welcoming and inclusive virtual space. The Contractor shall provide training on how to select learning methods and facilitate activities in a virtual environment that will keep learners engaged throughout the event and prepare them to apply what they have learned on the job. This modality requires instructors to plan differently than a traditional face to face course. This course shall identify the differences in delivering courses virtually and how/what to plan in advance of the program; training techniques to employ and how to meet objectives virtually; to ensure success and make the overall process easier.

Training provided shall include learning methods and engagement strategies for use in the virtual classroom with techniques for building rapport and connection in the virtual environment. Students will also need to know how to work with other subject matter experts (SMEs) to get the best presentation materials to fit the objectives in a virtual course vs a face-to-face course and strategies to deal with difficult situations with students, presenters, or technology when they arise in the virtual classroom. This shall include how to establish material review timeliness; creation of program run sheets; and how to coach and provide feedback to these same SMEs to help them present and engage in a meaningful way with students in the virtual world.

Instruction shall also include information on how to plan and hold a successful program rehearsal, multiple facilitation techniques to create a professional and engaging learning experience. effective facilitation techniques to assess and ensure a supportive learning environment. Instruction shall provide techniques to engage learners, communicate effectively, manage group dynamics and behaviors during a learning event, and assess and use the appropriate mix of learning modalities to support specific contexts, learners, and learning objectives in a virtual learning setting. All training techniques and learning materials provided should provide specific instructions to fit all learning platforms used by OTED when appropriate. Materials should not focus on a single platform as that may change over time.

Course facilitators should be aware of aspects of facilitation including effective VILT exercises, how to facilitate them, how to convert in person exercises to effective virtual ones, how to get students and speakers to participate, tips and tricks, etc.

Tasks:

The Contractor shall furnish the necessary personnel to perform the work described below. The following tasks shall be performed:

• Provide an instructor-led off the shelf virtual interactive training course(s), for up to 95 students, that meets the needs stated in the scope of work including hands-on practice of skills learned during the course and instructions compatible virtual javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','') platforms used by FDA/ORA/OTED, currently Adobe, Zoom but subject to change during contract performance. Contractor will be able to limit class size or breakouts as needed (e.g., to practice skills).

• Expected total seat time for training course is 5 days.

• Provide each student with written feedback identifying strengths and weaknesses for future practice with recommended tools and resources that are readily available to students at low or no additional cost at the end of the training session

• Deliver training course(s) virtually

• Schedule course(s) offerings such that all employees have the opportunity to attend a live session

• Record and provide 1 full session for future internal use by FDA/ORA/OTED delivered in format compatible with OTED LMS, currently MP3 but subject to change during contract performance

• Create and deliver job aides for future registered students’ reference to support skill sets

• Create and disseminate course material including but not limited to: student and instructor manuals; job aides; student feedback forms (evaluation); and student resource list, and course evaluation student feedback template

Deliverables:

The Contractor shall provide the deliverables described below

Deliverable Delivery Date

Provide instructor led virtual training course(s) including: course materials, job aides, student manuals, student feedback forms and student resource list

As proposed by contractor, as soon as possible after contract award and no later than one month after contract award

Schedule several course offerings As proposed by contractor

Issue course materials to registered students in advance of training course

At least 1 week prior to course offering

Record and provide 1 offering in OTED LMS compatible format As proposed by contractor and agreed upon by OTED

Create course evaluation for student feedback to measure courses effectiveness. Issue evaluation to registered students. Collate and provide OTED with data report and raw data for reference.

At the end of each course offering

Deliver course offerings As proposed by contractor and agreed upon by OTED javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','')

Government- Furnished Property and Information

No Government-furnished property will be provided.

Travel None. Training shall be delivered virtually.

508 Compliance

Best Practices for 508 compliant training material:

Source documents and Images Before the vendor SCORM’s the content, the vendor must provide FDA with a copy of a PDF, Word, or PowerPoint source file (we will not accept any HTML created sources files or content created in HTML as the source file). If the vendor put images in the content, they must purchase the images and not use free sources. This will prevent malware being introduced to the files.

The course uses appropriate Alternate text for Images and objects.

Images have proper alt tags, or set to no alt tag for non-descriptive images.

All background images are set to use empty alt tags when published to HTML.

All hyperlinked text utilizes descriptive text.

Avoid generic phrases like “Click here” and instead, use phrases that let users know about the content of the linked page prior to selecting it like “More information about…”

Utilize recommended fonts i.e., Times New Roman, Verdana, Arial, Tahoma, Helvetica, or Calibri

Font size no smaller than 12pt for text and 16pt for headers or titles Headers are provided for tables and pages.

Menu Navigation, Reading order, and Tab order have been configured and test with a screen reader.

No conflicting audio.

For slides that have multiple audio files, ensure that only one audio file is or can play at a time.

Slides should have controls to Play, Stop, and Pause. Any video player should also have accessible navigation controls.

Synchronized closed captions and transcripts have been included with all multimedia.

Internal 508 compliance and accessibility checker has reported no 508 errors.

The course has been navigated using a screen reader like JAWS and a keyboard only.

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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)

Place of Performance Performance will be via an FDA-compatible virtual platform, currently either Adobe or Zoom.gov but subject to change during contract performance.

Period of Performance:

Base Period: One (1) year from date of contract award

Option Period 1: One (1) from end of base year

PART 4 - GENERAL EVALUATION INFORMATION EVALUATION AND AWARD

The Government intends to make award based on Lowest Priced, Technically Acceptable (LPTA).

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number;

4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service;

6) Offerors shall meet specifications as noted in the synopsis. The total number of pages for the technical quote shall not exceed ten (10) pages. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.

The solicitation does not commit nor obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

The Government will assess the offeror’s ability to successfully perform the major tasks outlined in the SOW based on the evaluation of the following:

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Factor 1: Technical

We will evaluate the Contractors’ ability to provide, via the instructor-led virtual interactive course:

1) Training on how to select learning methods and facilitate activities in a virtual environment that will:

• Keep learners engaged throughout the event, and

• Prepare them to apply what they have learned on the job.

This modality requires instructors to plan differently than a traditional face to face course.

2) Training that identifies:

• The differences in delivering courses virtually and how/what to plan in advance of the program,

• Successful training techniques to employ, and

• How to meet objectives virtually

3) Training that includes learning methods and engagement strategies for use in the virtual classroom with techniques for building rapport and connection in the virtual environment.

4) Training on how to work with other subject matter experts (SMEs) to get the best presentation materials to fit the objectives in a virtual course vs a face-to-face course

5) Training on strategies to deal with difficult situations with students, presenters, or technology when they arise in the virtual classroom, including:

• How to establish material review timeliness,

• Creation of program run sheets, and

• How to coach and provide feedback to these same SMEs to help them present and engage in a meaningful way with students in the virtual world.

6) Training on how to plan and hold a successful program rehearsal including multiple, effective facilitation techniques to:

• Create a professional and engaging learning experience and assess and ensure a supportive learning environment

• Engage learners, communicate effectively, manage group dynamics and behaviors during a learning event, and javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','')

• Assess and use the appropriate mix of learning modalities to support specific contexts, learners, and learning objectives in a virtual learning setting.

7) Additionally, all training techniques and learning materials provided should provide specific instructions to fit all learning platforms used by OTED when appropriate;

materials should not focus on a single platform as that may change over time.

8) The provided training and accompany material are 508 compliant as described in the statement of work.

Table 1. Technical Acceptable/Unacceptable Ratings

Rating Description

Acceptable Proposal clearly meets the minimum requirements of the solicitation.

Unacceptable Proposal does not clearly meet the minimum requirements of the solicitation.

Factor 2 – Past Performance. The Government will evaluate the Offeror’s Past Performance on the probability of meeting the solicitation’s requirements as indicated by that offeror’s record of past performance. Past Performance is assessed at the factor level after evaluating aspects of the offeror’s recent past performance and focusing on performance that is relevant to the services being procured under this solicitation.

• Past performance information may be obtained from any other sources available to the Government, to include, but not limited to, the Contract Performance Assessment Reporting System (CPARS)/Past Performance Information Retrieval System (PPIRS), Federal Awardee Performance and Integrity Information System (FAPIIS), Electronic Subcontract Reporting System (eSRS), or other databases; interviews with Program Managers and Contracting Officers. Past performance areas of evaluation include: - Quality of Service - Customer Satisfaction.

• Recency Assessment. An assessment of the past performance information will be made to determine if it is recent. To be recent, the effort must be ongoing or must have been performed during the past 3 years from the date of issuance of javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','') this solicitation. Past performance information that fails this condition will not be evaluated.

• Relevancy. To be relevant, the effort must be similar in nature of work, size, and complexity. The Government will conduct an in-depth evaluation of all recent performance information obtained to determine if it is the same or similar in nature of work, size, and complexity to the services/products being procured under this solicitation. Recent past performance is defined as not more than 3 years from the RFP release date; relevant in terms of similar nature of work, size and complexity.

• Past Performance Rating. In conducting a past performance evaluation, each Offeror shall be assigned one of the ratings identified in Table 2 below.

Table 2 - Past Performance Evaluation Ratings

Rating Description

Acceptable Based on the offeror’s performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort, or the offeror’s performance record is unknown.

Unacceptable Based on the offeror’s performance record, the Government has no reasonable expectation that the offeror will be able to successfully perform the required effort.

• Offerors without a record of relevant past performance or for whom information on past performance is not available or so sparse that there is no meaningful past performance rating can be reasonably assigned; the offeror may not be evaluated favorably or unfavorably on past performance. Therefore, the offeror shall be determined to have unknown past performance. In the context of acceptability/unacceptability, “unknown” shall be considered “acceptable.”

Factor 3 – Price. The Price factor will not be scored or rated. The Government will consider the narrative, and the Total Evaluated Price from the offeror’s pricing spreadsheet. The Government will evaluate the Offeror’s proposed prices to determine if it is fair and reasonable, balanced and complete using price analysis techniques. The Government will determine whether prices are fair, reasonable, balanced and complete.

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• The Offeror’s narrative and Pricing Workbook submission will be used by the Government to analyze and evaluate each Offeror’s price proposal for the entire period of performance.

• Offerors responding to this solicitation are advised that, prior to award, the Government may request Offerors to submit substantiating information/data to support price reasonableness.

• Definitions:

o Reasonableness - A price is reasonable if, in its nature and amount, it does not exceed that which would be incurred by a prudent person in the conduct of competitive business.

o Completeness/Accuracy - The offeror’s proposal is in compliance with the Price Volume instructions in the solicitation.

o Unbalanced Pricing- Pricing that exist when, despite an acceptable total evaluated price, the price of one or more contract line items is significantly over or understand as indicated by the application of cost or price analysis techniques.

PART 5 – PROPOSAL INSTRUCTIONS

SOLICITATION TECHNICAL INQUIRIES AND QUESTIONS:

All questions regarding the solicitation, of a contractual nature or technical nature, must be submitted in writing via email to Pamela Lee (Pamela.Lee@fda.hhs.gov), no later than on 03/28/2022, @ 10:00 A.M. (Eastern Standard Time), [Company Name]

– RFQ 75F40122Q00014. Submission of questions and any resulting answers from the Government will not require the Contracting Officer to extend the solicitation closing date. The Questions with the Government’s responses will be posted at one time via email to all prospective Offerors.

All quotes are due by e-mail to Pamela Lee, Pamela.Lee@fda.hhs.gov on or before April 15, 2022 at 10:00 am (Eastern Standard Time).

Proposals must be submitted in two (2) separate Volumes: Volume I - Technical, and Volume II - Business

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','') is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

Cost of Proposal Preparation

This solicitation does not commit the Government to pay any cost for the preparation and submission of a proposal. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed acquisition.

PART 6 – CONTRACT CLAUSES

6.1 INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Technical Point of Contact will perform inspection and acceptance of the materials delivered.

Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

6.2 CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government to this contract:

Technical Representative:

To be determined upon contract award

The Technical Representative is responsible for: (1) monitoring the Contractor’s technical progress, including the 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.

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Contracting Officer (CO): Contract Specialist (CS):

Madeline Bryant Pamela T. Lee 4041 Powder Mill Rd 4041 Powder Mill Rd Beltsville, MD 20705 Beltsville, MD 20705 Madeline.Bryant@fda.hhs.gov Pamela.Lee@fda.hhs.gov

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: (1) 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 any costs incurred during the performance of this contract; or, (5) otherwise change any terms and conditions of this contract.

6.3 HHS 352.232-71 Electronic Submission of Payment Requests

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

6.4 FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl04$DocumentNumberLink','') mailto:Madeline.Bryant@fda.hhs.gov http://www.ipp.gov/vendors/index.htm

52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3

- 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

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• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

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k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

6.5 Federal Acquisition Regulation (FAR) Clauses Incorporated by Reference

6.5.1 FAR 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 shall make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html.

52.202-1 Definitions (Jun 2020) 52.212-4 Contract Terms and Conditions-Commercial Items (Nov 2021) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Nov 2021) 52.233-4Applicable Law for Breach of Contract Claim (Oct 2004) 52.233-5

6.6 Federal Acquisition Regulation (FAR) Clauses in Full Text

6.6.1 FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items. (Jan 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

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(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment . (Nov 2021) (Section 889(a)(1)(A) of Pub. L.

115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public

Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the

Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct

2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-

Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment . (Nov 2021) ( 31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Sep

2021) ( 15 U.S.C. 657a).

__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small

Business Concerns (Sep 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer ) ( 15 U.S.C. 657a).

__ (13) [Reserved] __ (14)

(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (15)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

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__ (ii) Alternate I (Mar 2020) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct

2018) ( 15 U.S.C. 637(d)(2) and (3)).

__ (17)

(i) 52.219-9, Small Business Subcontracting Plan (Nov 2021) ( 15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2021) of 52.219-9.

__ (18)

(i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (Sep

2021) ( 15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep

2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small

Business Set-Aside (Sep 2021) ( 15 U.S.C. 657f).

__ (22)

(i) 52.219-28, Post Award Small Business Program Rerepresentation (Sep 2021) ( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Sep 2021) ( 15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Sep 2021) ( 15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C.

637(a)(17)).

__ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

__ (28) 52.222-19, Child Labor-Cooperation with Authorities and

Remedies (Jan 2022) (E.O.13126).

__ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__ (30)

(i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

__ (31)

(i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (ii) Alternate I (Jul 2014) of 52.222-35.

__ (32)

(i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

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__ (ii) Alternate I (Jul 2014) of 52.222-36.

__ (33) 52.222-37, Employment Reports on Veterans (Jun 2020)

( 38 U.S.C. 4212).

__ (34) 52.222-40, Notification of Employee Rights Under the National

Labor Relations Act (Dec 2010) (E.O. 13496).

__ (35)

(i) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

__ (36) 52.222-54, Employment Eligibility Verification (Nov 2021) .

(Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (37)

(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–

Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 ( 42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (40)

(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun

2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (41)

(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-

Consuming Products (May 2020) ( 42 U.S.C. 8259b).

__ (43)

(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

__ (44) 52.223-18, Encouraging Contractor Policies to Ban Text

Messaging While Driving (Jun 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47)

(i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

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