Amendment_1.pdf

Amendment 1 Purpose:

1. Answer all questions received.

2. Change the Due Date for quotes to 11 PM Eastern Time on August 8, 2018

3. Remove Typo under NOTICE OF NAICS/SET-ASIDE: Set Aside for 100% Small Businesses – Requirement is Full and Open

4. Remove HHSAR Clause 352.224-70

5. Remove Attachment FDA 1350 Access to Non-Public Information

BACKGROUND

The FDA Office of Training Education and Development (OTED) has a Food Processing & Technology Course (FD 152) that is a part of the manufactured food curriculum for training Federal, State, local and tribal investigators/inspectors to conduct these regulatory inspections. Currently, the Food Processing and Technology Course is 4 ½ days in length and provides an overview of the basic principles in food processing, technology, awareness of associated equipment used to ensure the safety of manufactured foods. Coursework includes detailed studies of food microbiology, food characteristics and properties, food chemistry, thermal processing and heat transfer, fluid flow, emerging technologies, preservation technologies, fillers and packaging technology. Extensive “hands-on” experience with processing equipment is provided in a pilot laboratory setting. The skills and knowledge obtained by investigators through this course will result in an increased protection of the public health.

OTED is seeking a maximum of three (3) Contractor(s) that will provide a training facility equipped with, qualified instructors, A/V support i.e. projector, screen, microphone etc. OTED is also seeking a pilot processing laboratory facility equipped with facilitators and a variety of food equipment used in food manufacturing/processing/packaging i.e. retorts, heat exchange systems, thermal processors, evaporators, dryers and evaporators, freezing equipment, extruders, homogenizers, pumps, and packaging equipment.

It is the FDA’s intent to award a contract with a performance period consisting of a 12-Month Base Year and three(3) twelve (12) month option years.

NOTICE OF COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. This is a request for quotations (RFQ) for commercial items in accordance with (IAW) the procedures of FAR Part 12 – Acquisition of Commercial Items, and FAR Part 13.5 – Simplified Procedures for Certain Commercial Items.

NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2005-98, effective May 31, 2018.

FAR provisions and clauses referenced in this RFQ can be found on the following website: www.acquisition.gov

HHSAR provisions and clauses referenced in this RFQ can be found on the following website: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2012_6.html#wp1088488 http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

NOTICE OF NAICS/SET-ASIDE

This requirement is being competed under North American Industry Classification System (NAICS) Code 611710, “Educational Support Services” ($15.0 million size standard).

CONTRACT REQUIREMENTS

See (Attachment A) for the Statement of Work for a full description of the supplies/services to be acquired.

CONTRACT TYPE

The Government anticipates awarding a Firm Fixed Price type contract.

QUESTION SUBMITTAL INSTRUCTIONS

Offerors may submit questions/clarifications in reference to any areas of the RFQ. Questions/clarifications must be submitted via email to Food and Drug Administration/OAGS: Haritha Raja, Contract Specialist, at haritha.raja@fda.hhs.gov, and Anthony Wimbush, Contracting Officer, at anthony.wimbush@fda.hhs.gov. The subject line of the email must read: Contractor Questions, Training and Pilot Processing Laboratory Facility Services, RFQ No. FDA-18-SOL-1195225.

Questions/clarifications submitted by any other means will not be accepted. Questions/clarifications must identify the applicable section of the RFQ. Questions/clarifications will be answered in an amendment to the solicitation. Questions/clarifications will not be discussed over the phone.

All questions/clarifications must be submitted by 11:00 AM Eastern Time on 26 July 2018. Questions submitted after the due date may not be answered.

Offerors will receive a confirmation email within two (2) business days that their questions were received.

If an offeror does not receive a confirmation email within two (2) business days, it is their responsibility to follow up with the contract specialist to ensure their questions were received.

QUOTATION SUBMITTAL DUE DATE

Quotations are due no later than 11 PM Eastern Time on 8 August 2018. Quotations must be submitted via email to Food and Drug Administration/OAGS: Haritha Raja, Contract Specialist, at haritha.raja@fda.hhs.gov, and Anthony Wimbush, Contracting Officer, at anthony.wimbush@fda.hhs.gov.

The subject line of the email must read Training and Pilot Processing Laboratory Facility Services , RFQ No. FDA-18-SOL-1195225. If submitting multiple emails, the subject line must clearly identify the total number of emails and which sequence the submission is.

All emails/quotations must be received by the due date and time. The late submission instruction found in FAR provision 52.212-1(f) regarding electronic submissions, applies to this solicitation.

QUOTATION FORMAT AND SUBMITTAL REQUIREMENTS

Each quotation shall consist of four (4) separate volumes (attachments).

mailto:haritha.raja@fda.hhs.gov mailto:anthony.wimbush@fda.hhs.gov mailto:haritha.raja@fda.hhs.gov mailto:anthony.wimbush@fda.hhs.gov

Volumes:

• Volume 1 – Executive Summary (No Page Limitation)

• Volume 2 – Technical Quotation (Page Limitation – 40 pages)

• Volume 3 – Past Performance (Page Limitation – 20 pages)

• Volume 4 – Price (No Page Limitation)

Note: Attachments must be clearly labeled to indicate to which volume they correspond.

Volume 1 shall contain 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:

o Name of Offeror and Address o DUNS o Point of Contact – Name, telephone number and email address o Acknowledgement of Latest Amendment – Offerors who fail to acknowledge the most recent amendment, may be considered non-responsive.

o Statement that the quotation is valid for 30 days.

o Identification of any teaming arrangements, joint ventures, mentor-protégé relationships, subcontracting relationships, etc.

• Completed representations and certifications, not already completed in SAM.gov.

• Organizational Conflict of Interest (OCI) – The offeror shall identify any possible OCIs and plan to mitigate any OCI issues, if they exist. If there is no potential OCI, offerors must provide a written statement indicating this. If the OCI mitigation plan is deemed unacceptable, the offeror may not be deemed eligible for award.

Note: Information contained in Volume 1 should not include information required under the evaluation factors.

Volume 2 shall contain the information requested under Evaluation Factor 1 (Technical Approach).

See EVALUATION CRITERIA AND BASIS FOR AWARD for details.

Volume 3 shall contain the information requested under Evaluation Factor 2 (Relevant Experience). See EVALUATION CRITERIA AND BASIS FOR AWARD for details.

Volume 4 shall contain the information requested under Evaluation Factor 3 (Past Performance).

See EVALUATION CRITERIA AND BASIS FOR AWARD for details.

Volume 5 shall contain the information requested under Evaluation Factor 4 (Price). See EVALUATION CRITERIA AND BASIS FOR AWARD for details.

Each volume shall include a cover sheet which clearly identifies each volume by number, solicitation name (Training and Pilot Processing Laboratory Facility Services RFQ No. FDA-18-SOL-1195225), and date of submission. The pages of the Offeror’s quotation shall include page headers with the same information and page numbers. The Offeror shall submit each volume in its native format (e.g., Word, Excel) as well as PDF format.

The specific formatting instructions for each volume are as follows:

General Formatting Instructions:

Offerors shall use the following page setup parameters:

• Font Type - Calibri, Arial, Times New Roman or similar font style

• Font Size – Minimum of 11 pt.

• Margins – Top, Bottom, Left, Right – 1”

• Gutter – 0”

• From Edge – Header, Footer – 0.5”

• Page Size, Width – 8.5”

• Page Size, Height – 11”

• Pages must be numbered

Each paragraph shall be separated by at least one (1) blank line. Tables and illustrations may use a reduced font size not less than 10-point and may be landscape.

The following items are not included in the stated page limitations:

• Cover Page

• Table of Contents

• Glossary

• Resumes, no more than 3 pages in length

• CPARS Evaluations

• Past Performance Questionnaires

Federal Acquisition Regulations (FAR) Provisions

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 this/these address(es): www.acquisition.gov.

FAR PROVISION # TITLE DATE

FAR 52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS. (JAN 2017)

FAR 52.204-4 PRINTED OR COPIED DOUBLE SIDED ON RECYCLED PAPER (MAY 2011)

FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (JAN 2017)

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017)

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

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

FAR 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

CONTRACTORS (DEC 2013)

FAR 52.242-15 STOP - WORK ORDER (AUG 1989)

FAR 52.245-1 GOVERNMENT PROPERTY (APR 2012)

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

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

EVALUATION CRITERIA AND BASIS FOR AWARD

FAR 52.212-2 Evaluation—Commercial Items. (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

• Factor 1 - Technical Approach

Quoters shall submit a detailed work plan indicating the overall objectives and the specific accomplishments hoped to be achieved, as well as rationale for plan and relation to comparable work elsewhere. The quoter shall outline the plan of work providing a description of how the project is to be organized, staffed, and managed. This shall include information demonstrating understanding and management of important task and events and discussion of phases. The quoter shall describe in detail the methodologies that will be used, indicating level of experience, areas of anticipated difficulties, and any anticipated unusual events. The quoter shall provide a schedule of completion of the work and delivery of items specified on the SOW. Delivery schedules shall indicate any phases or segments of the program and shall be shown in terms of calender months.

The technical approachs should include the following Proposal Sections:

• Section A – Classroom Training Facility and Pilot Processing Laboratory Facility

• Section B – Food Processing & Technology Course (FD152) Instruction

• Section C – Air Travel and Lodging Accommodations

• Section D – Transportation between Lodging and Training Venue

• Section E – Quality Assurance

• Section F – Deliverables

• Section G – Cost Summary Proposal

Contractor(s) should have proposal submissions divided into the following sections above. Each section should contain an itemized list of items the Contractor(s) are able to provide under the contract and the costs associated with being able to provide those items in that Section. Overall costs should be reported in the Section G. Include in Section G, if annual adjustments to contract are planned. For example, if Contractor(s) plan to increase amount of instruction offered between base year and option years.

The contract awarded to the Contractor(s) will include Sections A, B, C, D, E, F and G.

• Factor 2 – Relevant Experience

Quoters shall describe its experience in successfully performing food processing and technology requirements and performing or supporting projects of similar size, scope and complexity. Quoters shall identify other organizations with which you have acted while participating in the efforts. Quoters shall include the degree of its involvement and other information describing its experience. They must also submit information describing the experience and qualifications of personnel who will be assigned to provide the work. The information shall show the composition of the task or work group and shall identify the key personnel including any consultants/subcontractors that will be assigned. The information shall identify the roles and responsibilities of each. Resumes reflecting education background, recent experience and accomplishments are required for key personnel.

• Factor 3 – Past Performance

Past performance will be evaluated as a risk assessment. The Quoter must be able to demonstrate past experience directly relevant to the types of work required in this solicitation. Such experience includes descriptions of projects performed in the past three (3) years that are similar to this requirement. Quoters must provide three (3) CPARS evaluations in support of its past performance. If CPARS evaluations are not available completed past performance questionnaires must be provided. Quoters with no previous past performance will be neutrally evaluated. Quoters with no past performance history will be judged neither positively not negatively for this evaluation factor. The risk assessment will be completed on all offerors.

• Factor 4 – Price

Quoters shall provide a breakdown of associated price/costs. Price analysis will be conducted to verify that the overall price is considered fair and reasonable.

Technical and past performance, when combined, are more important than price. Highest consideration will be given to the Quoter that can provide the most requests listed in Section A and Section B at the most reasonable cost to the federal government and whose proposed locations are the most cost effective and feasible for hosting the course.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

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

(End of provision)

FAR 52.212-3 Offeror Representations and Certifications—Commercial Items (NOV 2017)

This provision applies to this solicitation. Offerors shall provide the required data as (Attachment C) with their quotations.

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website, located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision.

https://www.sam.gov/portal

Federal Acquisition Regulations (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):

www.acquisition.gov

FAR CLAUSE # TITLE DATE

FAR 52.201-4 PRINTED OR COPIED DOUBLE SIDED ON RECYCLED PAPER (MAY 2011)

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017)

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (JAN 2017)

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

FAR 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

CONTRACTORS (DEC 2013)

FAR 52.242-15 STOP - WORK ORDER (AUG 1989)

FAR 52.245-1 GOVERNMENT PROPERTY (APR 2012)

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 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

FAR Clauses in Full Text:

FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

(a) Definitions. As used in this clause– “Internal confidentiality agreement or statement” means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

“Subcontract” means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

“Subcontractor” means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%202_1.html#wp1145507

(e) In accordance with 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) use of funds appropriated (or otherwise made available) is prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

(End of clause)

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items (JAN 2018)

The additional FAR clauses cited in this clause that have an “X” next to them are applicable to this solicitation.

(END OF CLAUSE)

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 prior to the contract expiration date; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least prior to the order expiration date. 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 fourty two (42) months.

(END OF CLAUSE)

Health & Human Services Acquisition Regulation (HHSAR) Clauses

HHSAR CLAUSE # TITLE DATE

HHSAR 352.208-70 PRINTING AND DUPLICATION (DEC 2015)

HHSAR 352.211-3 PAPERWORK REDUCTION ACT (DEC 2015)

HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY (DEC 2015)

HHSAR 352.231-70 SALARY RATE LIMITATION (DEC 2015)

HHSAR 352.203-70 ANTI-LOBBYING (DEC 2015)

HHSAR 352.208-70 PRINTING AND DUPLICATION (DEC 2015)

a) Unless otherwise specified in this contract, no printing by the Contractor or any subcontractor is authorized under this contract. All printing required must be performed by the Government Printing Office except as authorized by the Contracting Officer. The Contractor shall submit camera-ready copies to the Contracting Officer’s Representative (COR). The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing.

(b) If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10-3/4 by 14-1/4 inches. This page limit applies to each printing requirement and not for all printing requirements under the entire contract.

(c) Approval for all printing, as well as duplicating/copying in excess of the stated limits, shall be obtained from the COR who will consult with the designated publishing services office and provide direction to the contractor. The cost of any unauthorized printing or duplicating/copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

(END CLAUSE)

HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

OPPORTUNITY INVESTIGATIONS (DEC 2015)

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

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

(2) Contractor employee means all current Contractor employees who work or worked under this contract.

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

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

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

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

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

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

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

District Court.

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

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

(END OF CLAUSE)

HHSAR 352.224-71 CONFIDENTIAL INFORMATION (DEC 2015)

http://www.ecfr.gov/cgi-bin/text-idx?node=pt48.2.52#se48.2.52_1222_626

(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:

Any information contained within the following:

• Capitol HR System – EHRP/CAPHR

• USA Staffing System

• Electronic Official Personnel Folder (eOPF)

• Human Resources Enterprise Personnel System (HREPS)

All data from these systems, all physical personnel files and any HR system implemented during the course of this contract will need to be kept restricted within specific OHR groups.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: Exemption #2 under the Freedom Of Information Act: Information related solely to the internal personnel rules and practices of an agency.

(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.

(END OF CLAUSE)

HHSAR 352.237-75 KEY PERSONNEL (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

(END CLAUSE)

352.239-74 Electronic and Information Technology Accessibility (DEC 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.

(c) The Section 508 accessibility standards applicable to this contract are:

• E101.2 Equivalent Facilitation E203 Access to Functionality

• E204 Functional Performance Criteria

• E205 Electronic Content

• 302 Functional Performance Criteria

(d) 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.

(e) 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 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 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.

FOOD & DRUG ADMINISTRATION (FDA) REQUIREMENTS

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.

FDA PERSONNEL OBSERVICE THE FOLLOWING DAYS AS HOLIDAYS

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

Any other day designated by Federal statue 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.

Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the contract. In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor will direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies.

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

FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS (OCT 2017)

See (Attachment E).

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 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 or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract.

Offerors submitting quotations 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 CONTRACT – 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 9.501).

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 default, 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 quotations 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).

(End of clause)

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 F 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.

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.

PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this contract.

NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENT FUNCTIONS

Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Project Officer to the Contractor's Project Manager. 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.

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.