Final RFQ FDA-SOL-1243158_08132021.pdf

Request for Quotation (RFQ) No. FDA-SOL-21-1243158

Center for Veterinary Medicine (CVM) Talent Development Learning Center (TDLC)

Technical Writing and Practical Grammar Content

1. DESCRIPTION/COMMERCIAL ITEM PROCUREMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a Request for Quotes (RFQ) for commercial items in accordance with the procedures of FAR Part 12 Acquisition of Commercial Items and Part 13 Simplified Acquisition Procedures.

The associated North American Industry Classification System (NAICS) Code is 611430 – Professional and Management Development Training.

This is a small business set-aside solicitation in accordance with FAR Subpart 19.5 Set-Asides for Small Business.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2021-06, effective July 12, 2021.

FAR provisions and clauses referenced in this solicitation can be found on the following website:

www.acquisition.gov

HHSAR provisions and clauses referenced in this solicitation can be found on the following website:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

3. PURCHASE ORDER REQUIREMENTS

See Section 6, Statement of Work, for a full description of the supplies/services to be acquired.

4. CONTRACT TYPE

The Government anticipates awarding one (1) Firm-Fixed-Price (FFP) type purchase order. The total purchase order period of performance consists of a base year and four (4) option years.

5. PRICING

Services shall be provided in accordance with the services described in the Statement of Work – Services to be performed during the anticipated periods of: August 31, 2021 through August 30, 2022 (Base Year); and if exercised from August 31, 2022 through August 30, 2023 (Option Year 1); August 31, 2023 through August 30, 2024 (Option Year 2); August 31, 2024 through August 30, 2025 (Option Year 3); and August 31, 2025 through August 30, 2026 (Option Year 4).

http://www.acquisition.gov/

Base Year: August 31, 2021 through August 30, 2022 (estimated)

Requirement Firm-Fixed Price Technical Writing and Practical Grammar Content $

Base Year: August 31, 2021 – August 30, 2022 (Estimated)

Webinar Course Title Quantity of Courses Per Year

Unit Price Total

Practical Grammar 3 $ $ Technical Writing 2 $ $ Technical Writing* (Optional) 1 $ $ Ceiling Price Base Year $

*Will exercise if needed.

Option Year 1: August 31, 2022 through August 30, 2023 (estimated)

Option Year 1: August 31, 2022 – August 30, 2023 (Estimated)

Per Year

Unit Price Total

Practical Grammar 3 $ $ Technical Writing 2 $ $ Technical Writing* (Optional) 1 $ $

Option Year 2: August 31, 2023 through August 30, 2024 (estimated)

Option Year 2: August 31, 2023 – August 30, 2024 (Estimated)

Per Year

Unit Price Total

Practical Grammar 3 $ $ Technical Writing 2 $ $ Technical Writing* (Optional) 1 $ $

Option Year 3: August 31, 2024 through August 30, 2025 (estimated)

Option Year 3: August 31, 2024 – August 30, 2025 (Estimated)

Per Year

Unit Price Total

Practical Grammar 3 $ $ Technical Writing 2 $ $ Technical Writing* (Optional) 1 $ $

Option Year 4: August 31, 2025 through August 30, 2026 (estimated)

Option Year 4: August 31, 2025 – August 30, 2026 (Estimated)

Per Year

Unit Price Total

Practical Grammar 3 $ $ Technical Writing 2 $ $ Technical Writing* (Optional) 1 $ $

6. STATEMENT OF WORK

Food and Drug Administration (FDA)

Background:

The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM), Talent Development Learning Center (TDLC) manages a competency based organizational development program to ensure CVM staff has the requisite competencies needed to successfully carry out the CVM mission. FDA/CVM/TDLC has a need for a training series that focuses on technical writing and practical grammar skills.

Objective:

The objective of this training is to ensure that all CVM staff are trained to provide professional and effective communication, which adheres to the plain language writing principles established by the FDA. The Technical Writing and Practical Grammar classes are crafted around these principles to ensure that staff are able to organize complex subject matter and edit for conciseness and clarity.

Scope:

The Contractor shall supply a total of six (6) trainings (one optional) related to technical writing and practical grammar. The training topics are as follows:

Technical Writing:

• Describe the step-by-step process of “The Writing System”.

• Explain how to organize complex subject matter.

• Identify how to edit for conciseness and clarity.

Practical Grammar:

• Identify and use parts of speech correctly.

• Write complete, clear sentences.

• Avoid common sentence faults.

• Use punctuation marks correctly.

• Recognize common punctuation errors.

Tasks, Deliverables, and Milestones

Base Year: August 31, 2021 – August 30, 2022 (Estimated)

Webinar Course Title Quantity of Courses Per Year Practical Grammar Three (3) Technical Writing Two (2) Technical Writing* (Optional) One (1)

*Will exercise if needed.

Option Year 1: August 31, 2022 – August 30, 2023 (Estimated)

Webinar Course Title Quantity of Courses Per Year Practical Grammar Three (3) Technical Writing Two (2) Technical Writing* (Optional) One (1)

Option Year 2: August 31, 2023 – August 30, 2024 (Estimated)

Webinar Course Title Quantity of Courses Per Year Practical Grammar Three (3)

Option Year 3: August 31, 2024 – August 30, 2025 (Estimated)

Practical Grammar Three (3)

Option Year 4: August 31, 2025 – August 30, 2026 (Estimated)

Practical Grammar Three (3)

Period of Performance:

Base Year August 31, 2021 – August 30, 2022 Option Year 1 August 31, 2022 – August 30, 2023 Option Year 2 August 31, 2023 – August 30, 2024 Option Year 3 August 31, 2024 – August 30, 2025 Option Year 4 August 31, 2025 – August 30, 2026

Place of Performance Virtual communications via Adobe Connect platform.

Contract Type Anticipated to be Firm-Fixed Price

Government-Furnished Property (GFP/Information (GFI) No equipment or information will be supplied to the Contractor.

Invoice Submission

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is TBD (TBD@fda.hhs.gov).

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses

52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite- Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than

NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the 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.

Federal Acquisition Regulation (FAR) Clauses

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 will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es):

FAR: www.acquisition.gov

HHSAR:

https://www.hhs.gov/grants/contracts/contract-policies- regulations/hhsar/index.html

(End of Clause)

FAR CLAUSE # TITLE DATE

FAR 52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL

CONFIDENTIALITY

(JAN 2017)

FAR 52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES

OR EQUIPMENT

(AUG 2020)

FAR 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES

REPRESENTATION

(OCT 2020)

http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

FAR 52.227-14 RIGHTS IN DATA – GENERAL (MAY 2014)

FAR 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

CONTRACTORS (DEC 2013)

FAR 52.245-1 GOVERNMENT PROPERTY (JAN 2017)

FAR 52.247-34 F.O.B DESTINATION (NOV 1991)

FAR 52.247-35 F.O.B DESTINATION, WITHIN CONSIGNEE’S PREMISES (APR 1984)

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders— Commercial Items (JUL 2021)

The additional FAR clauses cited in this clause that have a “check” or an “x” next to them are applicable to the acquisition. (Full text of this clause is in Attachment A – FAR 52.212-5 In Full Text Applicable to This Acquisition.)

(END OF CLAUSE)

Health & Human Services Acquisition Regulation (HHSAR) Clauses

HHSAR CLAUSE #

HHSAR 352.208-70

TITLE

PRINTING AND DUPLICATION

DATE

(DEC 2015)

HHSAR 352.211-3 PAPERWORK REDUCTION ACT (DEC 2015)

HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

HHSAR 352.224-70

INVESTIGATIONS

PRIVACY ACT

(DEC 2015)

(DEC 2015)

HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY (DEC 2015)

352.224-71 Confidential Information (December 18, 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: includes any Personally Identifiable Information for attendees.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are:

Any confidential information related to this contract; and personally identifiable that is covered through applicable laws and regulations shall not be published and shall be protected accordingly.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce

Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section- 508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

The Section 508 accessibility standards applicable to this contract are:

• 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) http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/Far/02.htm#P10_603

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative

• E207 Software (Appendix A, Application and Scoping Requirements)

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

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional.

(a) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(b) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

352.203-7 ANTI-LOBBYING (DEC 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 http://508.hhs.gov/ http://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html 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)

Federal Acquisition Regulation (FAR) Provisions

52.217-8 Option to Extend Services (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the contract expires.

FAR 52.217-9, OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor at any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract including the exercise of any options under this clause, shall not exceed 30 months.

(End of Clause)

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:

FAR: www.acquisition.gov HHSAR: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR PROVISION # TITLE DATE

FAR 52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN

INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS-

REPRESENTATION (JAN 2017)

FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS (JUL 2021)

FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (FEB 2021)

HEALTH & HUMAN SERVICES ACQUISITION REGULATION (HHSAR) PROVISIONS

HHSAR PROVISION # TITLE DATE

HHSAR 352.239-73 ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE

(DEC 2015)

Food & Drug Administration (FDA) Articles

CONTRACTOR ADVERTISING OF CONTRACT AWARD

The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205–1, in any manner which states or implies the Food and Drug Administration's approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services.

The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

http://www.acquisition.gov/

GOVERNMENT CLOSURES

Recognized Federal Holidays – The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year's Day Columbus Day Washington's Birthday Veterans' Day Memorial Day Thanksgiving Day Juneteenth National Christmas Day Independence Day Independence Day Martin Luther King’s Birthday Labor Day

Any other day designated by Federal Statute. Any other day designated by Executive Order.

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, except as set forth in the contract.

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather.

In the event the Federal Government is closed by order of the President of the United States or the U.S.

Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the COR will reschedule any meetings impacted by a closure at no additional cost to the Government.

REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447-8477), 8:00 am – 5:30 pm Eastern Time, Monday –Friday. Fax 1-800-223-8164, TTY 1-800-377-4950. All telephone calls will be handled confidentially. The e-mail address is hhstips@oig.hhs.gov and the mailing address is:

HHS TIPS Hotline TIPS HOTLINE P.O. Box 23489 Washington, D.C. 20026

IDENTIFICATION OF CONTRACTOR EMPLOYEES

During the period of this contract, the rights of ingress and egress to and from any Government office for Contractor representatives shall be made available as required. All Contractor employees whose duties under this contract require their presence at any Government facility shall be clearly identifiable by a mailto:hhstips@oig.hhs.gov distinctive badge furnished by the Government. All prescribed information shall immediately be delivered to the FDA Personnel Security Branch for cancellation or disposition upon the termination of the employment of any Contractor personnel. All on-site Contractor personnel shall abide by security regulations applicable to that site.

OFFEROR’S CERTIFICATION - ORGANIZATIONAL CONFLICTS OF INTEREST

As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual, potential, or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract.

Offerors submitting quotes to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future contract actions. The Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found to be acceptable by the Government, and enforced.

POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS ORDER – Offerors shall review the Statement of Work in detail to identify any particular aspects that may present organizational or individual COI, either actual or apparent.

DEFINITION OF CONFLICT OF INTEREST - Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.5).

ORGANIZATIONAL CONFLICT OF INTEREST

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for cause, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(h) As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract action.

(i) Offerors submitting proposals to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions. Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found acceptable by the Government and enforced

(j) POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS CONTRACT - Offerors shall review the Statement of Work included in each RFTOP in detail to identify any 47 particular aspects that may present organizational or individual COI, either actual or apparent.

(k) DEFINITION OF CONFLICT OF INTEREST - Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.501).

FDA 1350 ACCESS TO NON-PUBLIC INFORMATION

All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided as Attachment B –to this contract If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA Project Officer and the

Contracting Officer. Any new Contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand-deliver it to the Contracting Officer ten (10) days prior to said new employee's commencement of work on this contract.

The prime Contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted.

BRIEFINGS

An FDA representative (typically, the Contracting Officer’s Representative) will conduct an orientation briefing for the Contractor and subcontractor employees. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/IT requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

The Contractor shall brief all Contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of their responsibility to protect it.

The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized party. The Contractor shall conduct an updated briefing annually and shall submit a report to the FDA Project Officer within ten (10) days after the briefing which includes: an outline of the briefing; copies of any briefing materials; the date the briefing was conducted; and the names of the attendees.

If this is an information technology/telecommunications (IT/TC) contract, in addition to the above briefings, the FDA COR and the FDA Center/Office Information Systems Security Officer (ISSO) will brief the Contractor and subcontractor personnel on security measures required pertinent to any hardware/software being utilized. Furthermore, appropriate Contractor and subcontractor personnel shall attend training courses as directed by the FDA to fulfill requirements of the Computer Security Act of 1987. These courses are generally one (1) day in length, and attendance at one (1) course is sufficient.

This training will be provided at no cost to the Contractor.

GOVERNMENT-FURNISHED DATA AND MATERIALS

The Government shall retain all rights and privileges, including those of patent and copy, to all Government-furnished data and materials. The Contractor shall neither retain nor reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data. These rights are not exclusive and are beyond any other rights and remedies to which the Government is otherwise entitled elsewhere in this contract.

NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENT FUNCTIONS

Pursuant to FAR 37.1, no personal services shall be performed under this contract. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer-employee relationship will exist between the Government and the Contractor. The Contractor and the Contractor’s employees are not employees of the federal Government and are not eligible for entitlement and benefits given federal employees.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

Contract Management

CONTRACTING OFFICER/CONTRACT SPECIALIST

Alice Mihill Alice.Mihill@fda.hhs.gov

CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor effects any changes to this contract or orders at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO is the only Government Official authorized to change term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

mailto:Alice.Mihill@fda.hhs.gov

CONTRACTING OFFICER REPRESENTATIVE (COR)

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

To be identified at time of award.

The COR will be responsible for the following:

• Receiving the Monthly Report

• Tracking compliance with Limitations on Subcontracting clause

• Perform required annual performance evaluations in CPARS

• Reviewing changes to staffing matrix

b. The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the Contract.

c. The responsibilities and limitations of the COR are as follows:

(1) The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, and such other responsibilities as may be specified in the contract.

(2) The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the Contract price, terms or conditions. Any Contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in the effective and efficient performance of this contract.

A smooth and orderly transition between the Contractor and a predecessor or successor Contractor is necessary to ensure minimum disruption to vital Government business. The Contractor shall cooperate fully in the transition.

Quotation Instructions

The quote must be prepared and submitted in three parts: “Volume I – Executive Summary,” “Volume II -- Technical Quote,” and “Volume III – Business Quote.” All parts shall be separate attachments and complete so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

Volume I - Contains the Executive Summary, which includes the following information:

• Cover Letter – Must be signed by an individual that has the authority to bind the company. The cover letter must include the following, at a minimum:

• Name of Offeror and Address o DUNS o Point of Contact – Name, telephone number and email address o Statement that the quote is valid for 90 days

• Disclosure and Use of Lobbying Activities

Volume II –Technical Quote

The Technical Quote must include information on resources required, such as labor categories and hours, subcontractors, travel, etc., but no associated costs should be provided in Volume II -- Technical Quote.

The Technical Quote shall disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the Technical Quote instructions and the technical evaluation criteria listed below. The technical quote (Volume II) shall be limited to 15 pages. This limitation excludes resumes (if provided) and any commitment documentation. The technical quote shall include a table of contents.

The technical quote is the most important item in the evaluation of your capability to perform the desired services. Therefore, your quote must present sufficient information to reflect a thorough understanding of the work requirements and a detailed technical approach for achieving project objectives as set forth in the Statement of Work (SOW).

To permit a thorough and effective evaluation, the technical portion of your quote must be as concise, complete and clear as possible to enable the Government to make a sound determination of your ability to successfully complete the requirements set forth in the SOW . The inclusion of any important considerations not covered by this request is encouraged. Statements to the effect that the Offeror “understands and will comply” with the SOW (in whole or in part) or phrases such as “standard procedures will be used” or “well-known techniques will be utilized,” and other such generalities will not constitute compliance with the requirements. It is essential that you present in your quote, information in sufficient detail to permit the Government to make an evaluation of the technical quote without further information being required. The Government reserves the right to award based upon initial quotes received.

The Offeror shall clearly state any areas in which assumptions are based or clearly state areas that deviate from the requirements stated in the SOW .

Qualifications of the Contractor:

The Contractor that is awarded this contract must:

• demonstrate the ability to teach practical technical writing skills in the virtual environment, leveraging applications such as Zoom or Adobe Connect to highly skilled technical and business professionals

• demonstrate experience with the Federal Government’s Plain Language Writing Act, and its implications for staff producing written documents

• have a textbook or other resource available to reinforce key concepts

• can teach to a system of writing for technical professionals that achieves the desired results

Volume III –Business Quote

A. The Business Quote shall consist of a cover page, a table of contents, and the information requested in the Business Quote Instructions set forth below. There is no page limitation for the business quote.

Authorized Official and Submission of Quote: The quote must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this solicitation.

The Offeror shall submit a business quote fully supported by underlying cost information (i.e., price breakdown) adequate for the Government to determine the reasonableness of the unit pricing proposed, and to evaluate whether the proposed costs are consistent with the technical quote and the Offeror’s effort to perform the requirement. Any notes or assumptions.

Offerors must submit, as a minimum, a business quote fully supported by pricing data adequate to establish the reasonableness of all proposed costs.

Offerors must submit a payment schedule which should be based upon deliverables for this requirement.

B. Additional Documents to be submitted with Business Quote

a. Disclosure and Use of Lobbying Activities

Standard Form LLL, "Disclosure of Lobbying Activities," has been included as Attachment C for use in accordance with FAR 52.203-11- Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (SEP 2007) and is accessible at:

https://www.gsa.gov/portal/forms/download/116430. If the Offeror has activity to report, it shall complete SF-LLL “Disclosure of Lobbying Activities” and shall include one originally signed copy with the business quote.

Firm-Fixed-Price -- Pricing Information Instructions

Offerors must submit, as a minimum, a business quote fully supported by pricing data adequate to establish the reasonableness of all proposed costs.

For price analysis purposes, a breakout of unit pricing for the quote must be provided. The Offeror must provide sufficient documentation to show breakdown of costs so that a fair and reasonable determination can be made.

Specific formatting instructions for each volume are as follows:

General Formatting Instructions:

Offerors shall use the following page…