Solicitation 75F40124Q00508 9-17-2024.pdf

Solicitation No: 75F40124Q00508

Center for Veterinary Medicine Assistance with Diagnostic sample collection and

Subject Matter Expertise for Vet- LIRN Proficiency Exercises and Consumer Complaint Follow-up

Issue Date: September 17, 2024

Background

The United States Food and Drug Administration (FDA) has a mission to protect public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. In addition, FDA is responsible for facilitating innovations that make medicines more effective, safer, and more affordable.

To accomplish these goals, FDA has stimulated advancement of regulatory science, which is defined as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA regulated products.” FDA’s vision is to facilitate the integration of new science into the process of evaluating the safety and efficacy of proposed and marketed products and to close the gap between scientific innovation and this process of drug review. To achieve this vision, we perform mission-critical research to develop and evaluate tools, standards, and approaches to assess the safety, efficacy, quality, and performance of drugs.

NOTICE OF SYNOPSIS/SOLICITATION

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2024-05, effective August 29, 2024. This is a solicitation for the acquisition of services prepared in accordance with the format in Federal Acquisition Regulation (FAR) 15.204-1. In accordance with FAR Part 5.201.

This is a competitive solicitation authorized under FAR Part 12 “Acquisition of Commercial Products and Commercial Services” and 13 “Simplified Acquisition Procedures”.

NOTICE OF NAICS

The associated Product Service Code (PSC) is Q301 – Laboratory Testing Services. The associated North American Industry Classification System (NAICS) code is 541940 (Veterinary Services). This requirement is being solicited as full and open competition. Offerors must have an active registration in SAM.gov (https://sam.gov/), with completed representations and certifications, by the close date of the solicitation. Submissions by offerors not registered in SAM.gov will not be considered.

PART 1

B. SERVICES PRICE/COSTS

See Attachment 1 – Price Schedule

C. DESCRIPTION/STATEMENT OF WORK

See Attachment 2 - Statement of Work

D. PACKAGING AND MARKING

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

1. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and

2. Deliverables under this contract shall be prepared and packaged for shipment using standard shipping practices to ensure safe and timely delivery.

3. All postage and fees related to distribution of deliverables including forms, reports, etc., shall be paid by the Contractor.

E. INSPECTION AND ACCEPTANCE

All work hereunder shall be subject to review by the Government. Acceptance of the final deliverables shall be made in writing by the Contracting Officer’s Representative (COR).

F. PERIOD OF PERFORMANCE

Delivery in accordance with the Statement of Work.

Period of Performance is as follows:

Contract Year Period of Performance

Base Year Date of Award through twelve months.

Option Year 1 End of Base Period through twelve months Option Year 2 End of Option Period 1 through twelve months

Option Year 3 End of Option Period 2 through twelve months Option Year 4 End of Option Period 3 through twelve months

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.

G. CONTRACT ADMINISTRATION DATA

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the project; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The following person is the Contracting Officer for this contract:

Nicholas Bisher Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705 Email: Nicholas.Bisher@fda.hhs.gov

The Contracting Officer Representative:

To be determined at award

CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) has responsibility for ensuring the performance of all necessary actions for effective contracting, ensuring compliance with the terms of the contract, and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract and resulting orders, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO. No statement, whether oral or written, by anyone other than the CO, shall be interpreted as modifying the terms and conditions of this contract. It is the Contractor's responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for any work not authorized by the CO, including work outside the scope of the contract.

CONTRACTING OFFICER REPRESENTATIVE

The Contracting Officer may designate other Government personnel, known as the COR, to act as his or her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the order. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the order.

H. SPECIAL CONTRACT REQUIREMENTS

CLASSIFIED INFORMATION

Classified material will not be issued or supported by this contract. General security requirements will be established, maintained, and monitored per the applicable FDA security standards.

DATA RIGHTS

mailto:Nicholas.Bisher@fda.hhs.gov

The FDA shall have unlimited rights to, and ownership of all deliverables provided under this contract, including consumer and industry materials, reports, recommendations, briefings, work plans and all other deliverables as applicable and defined by the order or ad-hoc service request.

Including any optional order deliverables exercised by the contracting officer. Also, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227- 14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.

INVOICING INSTRUCTIONS AND REQUIREMENTS

Health and Human Services Acquisition Regulation (HHSAR) 352.232-71 - Electronic Submission of Payment Requests (FEB 2022)

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

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

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

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

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

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(1) invoice number, amount, & date submitted (2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

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

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

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

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

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll- free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov.

Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

CONTRACTOR ADVERTISING OF CONTRACT AWARD (SEP 2012)

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 U.S. 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.

NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENTAL

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 to benefits given Federal employees.

Contractor personnel under this contract shall not:

• Be placed in a position where there is an appearance that they are employed by a Federal Officer, or are under the supervision, direction, or evaluation of a Federal Officer.

• Be placed in a position of command, supervision, administration, or control over personnel or personnel of other Government contractors or become a part of the Government organization.

• Be used in administration or supervision of procurement activities.

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 ensure 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.

TRAVEL

No travel will be required for this contract.

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 mailto:hhstips@oig.hhs.gov

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 prior to being assigned to the awarded contract.

ADDITIONAL SECURITY AND CONFIDENTIALITY REQUIREMENTS

The Contractor shall realize the regulatory nature of FDA and accepts responsibility for diligence in protecting the security and confidentiality of any information acquired with the FDA networking infrastructure, staff projects, meetings, seminary or other sensitive information.

During the course of the contract, if questions arise as to what information can be shared with potential solution providers, others performing maintenance on systems, third party or other staff, the contractor will seek guidance and approval for the COR.

CONTRACTOR PERFORMANCE EVALUATION(S)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of the individual who will be responsible for serving as the Contractor’s CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User ID and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 60 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

http://www.ppirs.gov/

I. CONTRACT PROVISIONS/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): [https://www.acquisition.gov/far/]

Health and Human Services Acquisition Regulation (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

FAR Provisions Title and Date

52.203-11 CERTIFICATION AND DISCLOSURE REGARDING SEP 2007

PAYMENTS TO INFLUENCE CERTAIN FEDERAL

TRANSACTIONS

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT JAN 2017

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS - REPRESENTATION

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

REPORTING

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR AUG 2020

52.204-24 REPRESENTATION REGARDING CERTAIN NOV 2021

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OCT 2020

OR SERVICES-REPRESENTATION

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED NOV 2015

DOMESTIC CORPORATIONS-REPRESENTATION

52-212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL MAR 2023

PRODUCTS AND SERVICES

52.212-3 Offeror Representations and Certifications—Commercial Items (DEC 2022)

This provision applies to this acquisition. Offerors are to provide required data as (Attachment B) with their proposals.

(End of provision)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

NUMBER TITLE DATE

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE CERTAIN JUN 2020

FEDERAL TRANSACTIONS

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR JAN 2021

PERSONNEL

http://www.acquisition.gov/far/ https://www.hhs.gov/grants/contracts/contract-policies-%20regulations/hhsar/index.html

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2019

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

MAINTENANCE

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS DEC 2014

AND CERTIFICATIONS

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL DEC 2022

ITEMS

52.223-5 POLLUTION PREVENTION AND RIGHT-TO-KNOW MAY 2011

INFORMATION

52.223-6 DRUG-FREE WORKPLACE MAY 2001

52.224-1 PRIVACY ACT NOTIFICATION APR 1984

52.224-2 PRIVACY ACT APR 1984

52.227-14 RIGHTS IN DATA – GENERAL MAY 2014

52.232-1 PAYMENTS APR 1984

52.232-23 ASSIGNMENT OF CLAIMS MAY 2014

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS JUN 2013

52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL MAR 2023

BUSINESS CONTRACTORS

52.233-1 DISPUTES MAY 2014

52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM OCT 2004

52.237-3 CONTINUITY OF SERVICES JAN 1991

52.242-15 STOP-WORK ORDER AUG 1989

ALTERNATE I (APR 1984)

52.242-17 GOVERNMENT DELAY OF WORK APR 1984

52.243-1 CHANGES-FIXED-PRICE AUG 1987

52.243-1 CHANGES-FIXED-PRICE, ALT I APR 1984

52.245-1 GOVERNMENT PROPERTY SEP 2021

52.245-9 USE AND CHARGES APR 2012

52.246-4 INSPECTION OF SERVICES—FIXED-PRICE AUG 1996

52.246-25 LIMITATION OF LIABILITY-SERVICES FEB 1997

52.249-1 TERMINATION FOR CONVENIENCE OF THE APR 1984

GOVERNMENT (FIXED-PRICE) (SHORT FORM)

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items (June 2023) The additional FAR clauses cited in this clause that have an “X” next to them are applicable to this solicitation. Full text of this clause is provided in (Attachment A).

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.

(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.

52.204-21 Basic Safeguarding of Covered Contractor Information Systems. Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

(a) Definitions. As used in this clause—

Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C.

3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products or commercial services, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of clause)

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 Order. 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 six (6) months. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the Order expires.

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; provided that the Government gives the Contractor a preliminary written notice of its intent 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 five (5) years and six (6) months.

(End of clause)

HHSAR CLAUSES INCORPORATED BY REFERENCE

352.203-70 Anti-Lobbying (Dec 2015) 352.208-70 Printing and Duplication (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.224-70 Privacy Act (Dec 2015) 352.224-71 Confidential Information (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015)

SECTION J - LIST OF ATTACHMENTS

Attachment 1: Price Schedule (Excel) Attachment 2: Statement of Work (PDF) Attachment 3: FAR 52.212-5 (PDF) Attachment 4: Standard Form 1449 Attachment 5: RFQ Question Template

PART IV

K. REPRESENTATIONS, CERTIFICATIONS

Offeror must be a Vet-LIRN member laboratory and accredited by AAVLD.

L. INSTRUCTIONS TO OFFERORS

QUESTIONS SUBMITTAL INSTRUCTIONS

The quote must be prepared and submitted in four parts: “Volume I – Executive Summary,” “Volume II -Technical Proposal,” Volume III - Past Performance,” and “Volume IV – Price Proposal.” 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. The FDA is not responsible for any costs incurred in preparing the documents described in this email.

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:

o Name of Offeror and Address o Unique Entity ID (UEI) o Point of Contact – Name, telephone number and email address o Statement that the quote is valid for 90 days

Offeror(s) may submit questions for clarification in reference to any areas of the solicitation using Attachment 5 (RFQ Question Template). Questions must be submitted via email to Food and Drug Administration/OAGS: Nicholas Bisher, Contracting Officer, Nicholas.Bisher@fda.hhs.gov. The subject line of the email must read: Contractor Questions –FDA 75F40124Q00508.

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

All questions must be submitted by 4:00 PM Eastern time (ET) on September 23, 2024.

Questions submitted after the due date and time may not be answered.

QUOTE SUBMITTAL DUE DATE

Your quote is due no later than 4:00 PM Eastern time (ET) on October 3, 2024, and shall contain the signed DD 1449 and also acknowledgement of any amendments to the solicitation. Quotes must be submitted via email to Food and Drug Administration/OAGS:

Nicholas Bisher, Contracting Officer, at Nicholas.Bisher@fda.hhs.gov.

The subject line of the email must read: FDA-75F40124Q00508 Diagnostic sample collection and Subject Matter Expertise for Vet- LIRN Proficiency Exercises and Consumer Complaint Follow Up. If submitting multiple emails, the subject line must clearly identify the total number of emails and which sequence the submission is for. All emails providing proposal submission 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. Please submit in advance for timely submission of your quote.

PROPOSAL FORMAT AND SUBMITTAL REQUIREMENTS

Offeror(s) shall submit three (3) volumes as further detailed below:

• Volume 1: Executive Summary (No page limitation)

• Volume 2: Technical Proposal (Page Limitation – 50 Pages)

• Volume 3: Past Performance (Page limitation – 10 pages)

• Volume 4: Price Proposal (Attachment 1, Excel Spreadsheet)

Each proposal Volume must include a cover sheet which clearly identifies each by volume number, solicitation number (75F40124Q00508) and the date of submission. The pages of the Offeror’s proposal must include page headers with the same information and page numbers. The Offeror must submit each volume in its native format (e.g., Microsoft Word, Excel) and PDF format. The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

M. EVALUATION CRITERIA

BASIS FOR AWARD AND EVALUATION FACTORS

(a) Basis for Award – This will be a best value selection conducted using the FAR 15.101-1 Tradeoff process. The Government intends to award one (1) firm fixed-price contract resulting from this solicitation; however, the Government reserves the right not to award a contract at all.

The award resulting from this solicitation will be made to the responsible offeror whose offer, conforming to this solicitation, is determined to be the best value to the Government, technical, price and other factors considered.

The following factors shall be used to evaluate quotes: Technical Capability, Past Performance, and Price. When combined, technical capability and past performance are more important than price in determining the best value to the Government. If the Government determines non-price factors to be essentially equal, price becomes more important as the discriminating factor. Price will be evaluated separately from technical and will be evaluated for fairness and reasonableness.

A quote which merely paraphrases the requirements stated in the Statement of Work (SOW) will be ineligible for award. In addition, a proposal that addresses only a part of the requirements will be considered nonresponsive to the solicitation and unacceptable for award.

FDA reserves the right to make an award decision without conducting post-quotation communications.

Responsibility - To be eligible for an award, the Offeror must be determined responsible in accordance with the standards in FAR Part 9.104.

FAR 52.212-2 Evaluation—Commercial Items (NOV 2021)

Factor 1 - Technical Capability

The Government will evaluate technical capability based on the degree to which the quotation meets the Statement of Work and below requirements. Proposals shall describe the approach for accomplishment of the work. Include direct cost and resources information, such as the type and number of proposed labor categories and number of hours, list of materials, subcontracts, etc., so that understanding of the project may be evaluated. Proposals shall demonstrate the ability to provide diagnostic samples including, but not limited to necropsy, tissue or diagnostic samples from large animals – horses, cattle, and pet - dogs, cats. Samples include liver, or other organs, serum, plasma, blood, urine, feces. Proposals shall also demonstrate the ability to conduct preliminary testing using Inductively Coupled Plasma (ICP) for metals or Gas chromatography– mass spectrometry (GC-MS) for other analytes.

Note: The Contractor for this requirement must be a Vet-LIRN laboratory and have AAVLD accreditation.

Factor 2 - Past Performance

The Government will assess its level of confidence that the Offeror will successfully perform all requirements based on the information submitted for Factor 2 Past Performance. The Offeror’s past performance information shall demonstrate the Offerors success in performing comparable contracts/orders. Past performance shall be based on the provided list of two contracts/orders, similar in scope, duration, and price to the work described in the SOW.

Recent and relevant past performance evaluation will take into account the currency, relevancy, type, scope, complexity, duration, and price of past projects. Identify all ongoing and completed work (within the last 3 years from date of this solicitation). Identify experience with Vet-LIRN Proficiency Exercise program and conducting proficiency exercises. For each of these past performance references, provide a contract/order number, detailed description of the work, the period of performance, the dollar value of the work, your role and responsibilities as either a prime or subcontractor, the client name and address and client point of contact name, phone number, and email address. Demonstrate capability to provide the types of samples outlined in this solicitation. Provide this same information for any proposed subcontractor who will be performing a critical aspect of the required work or will otherwise be performing more than 25% of the total proposed price. Limit Past Performance to 10 pages.

Factor 3 – Price: The Government will evaluate the Offeror’s total price submitted in its Volume 4 – Price Proposal (Attachment 1, Excel Spreadsheet). A price analysis will be performed to determine whether the quoted price is fair and reasonable.

The business quote/price evaluation shall represent the Offerors response to the requirements of the solicitation. The price evaluation consists of the combination of all proposed pricing over the contract’s performance period. The Offerors pricing schedules shall represent firm fixed-pricing.

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.

Communications

(a) Communications prior to Contract Award

The Offeror shall direct all communications to the attention of the Contracting Officer, Nicholas Bisher Nicholas.Bisher@fda.hhs.gov. Communications with other officials may compromise this acquisition and result in cancellation of the requirement.

(b) Release of Information Contract selection and award information will be disclosed to Offerors in accordance with regulations applicable to negotiated acquisition.

(c) Preparation Costs This RFQ does not commit the Government to pay any cost for the preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed acquisition.