12639521R0012_Amd_0001.pdf

(x)

12639521R0012 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

APHIS-MN-126395

MINNEAPOLIS MN 55401

SUITE410

250 MARQUETTE AVE

USDA APHIS

03/29/20210001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

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

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

03/10/2021

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

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

ORDER NO. IN ITEM 10A.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

ROBERT J. ZEGLIN

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

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

Tax ID Number: Not Available

DUNS Number: Not Available

Read the entire solicitation prior to submitting questions. All questions must be submitted in writing via email to the Contracting Officer Bob Zeglin at Robert.J.Zeglin@usda.gov

Questions by telephone or mail will not be accepted. ***AMENDMENT HAS BEEN ISSUED UNDER

P00001, ALL CHANGES ARE IDENTIFIED IN RED IN THIS DOCUMENT. PLEASE ACKNOWLEDGE THE

AMENDMENT IN THE EMAIL WHEN SUBMITTING YOUR PROPOSAL

Period of Performance: 05/01/2021 to 04/30/2026

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

Operational and Science Training Services National Bio and Agro‐Defense Facility (NBAF)

*All changes from the original solicitation in Amendment 1 are identified in red.

Schedule Estimated quantities. Curricula Development would be negotiated at the order level.

CLIN Description Unit CY1 CY2 CY3 CY4 0001AA Training Management Months 12 12 12 12 0001AB Digital Training Catalogue Subscription Months 12 12 12 12 0001AC Travel for Meetings Each 5 4 4 4 0002 Gap and Risk Assessment Each 1 0 0 0 0003 Digital Training Catalogue Development Each 1 0 0 0 0004AA On-Site Training (per week) Each 5 16 5 5 0004AB On-Site Training (per day) Each 100 170 20 20 0005AA Virtual Training (per week) Each 1 1 1 1 0005AB Virtual Training (per hour) Each 20 20 1 1 0006AA Mobile Lab Training (per week) Each 3 2 1 1 0006AB Mobile Lab Training (per day) Each 5 5 1 1 0006AC Mobile Lab Use Months 11 6 0 0 0007 Curricula Assessment & Recommendation Each 1 0 0 0 0008 Curricula Development Each 20 20 10 5

* Estimates are for the first four years; actuals may extend in to year 5 and may shift between years, a fifth year with hypothetical quantities is included in the tech exhibit price proposal section B so that pricing for orders in all possible years may be provided and evaluated. The quantities above are the actual total estimates.

This Contract is anticipated to be a single award Indefinite Delivery Indefinite Quantity contract with a maximum ceiling of $7,000,000.00. A minimum one-time order requirement of $250,000.00 is anticipated. Individual order minimums will be set at $1,000.00 and the maximum individual order amount will be set at $3,000.000.00 (changed in Amendment 1)

1.0 General Information

This is a commercial services Indefinite Delivery Indefinite Quantity (IDIQ) contract for Operational and Science Training Services for the National Bio and Agro‐Defense Facility (NBAF) located in Manhattan, KS. The total minimum (one time) order for this contract is $100,000 $250,000.00 (changed in Amendment 1) and the total maximum possible order total under this contract is $7,000,000. The individual order minimum is $1000.00 The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

1.1 Description of Services: The contractor shall provide all personnel, supervision, and other items and non‐personal services necessary to perform training services as defined in this

Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background: The National Bio and Agro‐Defense Facility (NBAF) located in Manhattan, KS, will be a state‐of‐the‐art biocontainment laboratory for the study of diseases that threaten America’s animal agricultural industry and public health. Current operations at the Plum Island Animal Disease Center (PIADC) will continue until the mission is fully transitioned to NBAF (anticipated full transition date is CY 2024). The NBAF capabilities include research, vaccine development, diagnosis of high‐consequence animal diseases, and training of veterinarians. The maximum biocontainment (BSL‐4) laboratories of NBAF will be capable of housing cattle and other large livestock to study high‐consequence zoonotic diseases.

This contract is a new requirement for the training of NBAF government personnel, including maintenance staff; engineering staff; laboratory technical staff; animal caretaker staff; training staff; field epidemiologist staff; and others as needed for unique technical knowledge and skills in the performance of work duties in a BSL-4 laboratory.

1.3 Objectives: Timely and comprehensive training of Government personnel to support the agricultural defense mission at NBAF with no interruption of the critical science mission and operational capabilities.

1.4 Scope: The scope of this contract involves Operational and Science Training Services which include facility and personnel familiarization; development of training topics, learning objectives, assessment tools, mentorship program details, technology platforms, target trainee lists, on-site and virtual training and mobile laboratory training, user friendly mobile platform, data and user rights, proposed trainer teams, progress reporting, and other general elements of training programs.

1.5 Period of Performance: The period of performance is anticipated to be for a 5-year duration with specific periods of performance specified at the order level. The overall contract period is anticipated for 15 April 2021 – 14 April 2026. Quantity estimates are for the first four years.

1.6 Place of Performance: Services shall be performed at one of the following locations as specified at the order level:

1. The National Bio and Agro‐Defense Facility (NBAF) located in Manhattan, KS.

2. the contractor’s facility.

3. in a contractor provided mobile laboratory; or

4. in a Government contracted off-site laboratory.

1.7 Type of Contract: This is an Indefinite Delivery, Indefinite Quantity (IDIQ) Contract. The contract work shall include providing labor, supervision, incidental materials and supplies, equipment, quality control, environmental protection, meeting safety requirements, transportation, and for performing all work required as specified at the order level. Individual orders may reference work described in detail in the base award. Compensation for all work shown, specified, or essential to completion of the project shall be included in the total price.

Except as otherwise specified in this contract, all costs associated with incidental work shall be included in the Pricing Schedule item with which that incidental work is most closely associated.

The payment provided for in the contract includes compensation for all risk, loss, damage, and expense arising out of the contract work or its prosecution, subject to terms and conditions of the contract.

1.8 Other Information

1.8.1 Quality Control: The contractor shall develop and maintain an effective quality control program (QCP) to ensure services are performed in accordance with contract requirements. The contractor shall perform quality assurance on all aspects of contract performance, including any subcontractor that the contractor has arranged to perform work under this contract. The contractor shall develop and implement procedures to identify, prevent, and ensure non‐recurrence of defective services. The contractor shall be responsible for maintaining satisfactory standards of employee competence, conduct, appearance, integrity, and for taking such disciplinary action with respect to employees as may be necessary. All work under this contract shall be performed in a skillful and workmanlike manner. A comprehensive written QCP shall be submitted to the cognizant Contracting Officer (CO) and Contracting Officer’s Representative (COR) within 14 calendar days of contract award and within 7 calendar days when changes are made thereafter. Quality assurance records and information shall be provided to the Government upon request. The QCP shall include, as a minimum, the following items:

a. Names, qualifications, duties, responsibilities, and authorities of each person assigned a contractor quality control function, including an organizational chart showing lines of authority

b. Procedures for scheduling, reviewing, and managing submittals, including those of subcontractors.

c. Control and verification tests

d. Procedures for tracking deficiencies from identification through corrective action. Establish verification procedures that identified deficiencies have been corrected.

e. Reporting procedures, including proposed reporting formats and tracking spreadsheets (training. SOP development, etc.)

f. Procedures for controlling PIV cards, key cards, access badges, lock combinations, Access Codes.

Development of the quality control plan shall be priced into the Gap and Risk Assessment.

1.8.2 Quality Assurance: The government will perform ongoing surveillance of the contractor’s performance and their QCP and quality control actions to ensure contract standards are met.

1.8.3 Recognized Holidays: The contractor is not required to perform services on federal holidays.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day

Washington’s Birthday Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

1.8.4 Hours of Operation: The contractor is responsible for scheduling and executing the work based on the schedule of NBAF staff and availability of training locations and equipment. Efforts will be made to ensure availability during business hours but given unique facility considerations may require evening or weekend scheduling. For these purposes regular business hours are Monday through Friday from 8:00 a.m. to 4:00 p.m.

Central Standard Time unless otherwise specified.

1.8.5 Security Requirements:

1.8.5.1 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each workday, government facilities, equipment, and materials shall be secured.

1.8.5.2 Key Control, Personal Identity Verification (PIV) Cards and Access Badges: The Contractor shall establish and implement methods of making sure all PIV cards/key cards/access badges issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. (See clause 52.204‐9, Personal Identity Verification of Contractor Personnel.) No keys issued to the Contractor by the Government shall be duplicated.

1.8.5.3 Federal Information Security Management Act (FISMA)

Requirements

The following FISMA requirements are applicable to this contract 36 CFR 1194.21 ‐ Software Applications and Operation Systems;

36 CFR 1194.22‐ Web‐based Intranet and Internet information and Applications;

36 CFR 1194.31 ‐ Functional Performance Criteria;

36 CFR 1194.41 ‐ Information Documentation and Support;

36 CFR I I 94.2(b) ‐ COTS/GOTS products; and 36 CFR 1194.3 (b) ‐ Incidental to Contract.

1.8.5.4 Confidentiality/Records

Contractor personnel may be working with systems and documents containing sensitive confidential information that must remain confidential. Contractor personnel shall not divulge, publish, or reveal (orally, in writing, by conduct, or by any other means), such information or knowledge, except as necessary in the performance of official duties related to this contract. Contractor personnel must adhere to data privacy (Privacy Act of 1974), information security requirements, and must handle information in accordance with relevant laws, regulations, and USDA directives. The following standard items relate to records generated in executing the contract. The list below identifies the minimum requirements:

• Citations to pertained laws, codes and regulations such as 44 U.S.C.

chapters 21, 29, 31 and 33; FOIA (5 U.S.C. 552); Privacy Act of 1974 (95 U.S.C. 552a); 36 CFR Part 1222 and 1228.

• Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

• Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

• Contractor shall not retain, use, sell, or disseminate copies of any deliverables that contains information covered by the Privacy Act of 1974 or that which is generally protected by FOIA.

• The Government Agency owns the rights to all data/records produced as part of this contract.

• The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.), and all supporting documentation created as part of this contract.

Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

• Contractor agrees to comply with Federal and Agency records management policies, including those associated with safeguarding of records covered by the Privacy Act of 1974.

These policies include the preservation of all records created or received regardless of format (paper, electronic, etc.), mode of transmission (e-mail, fax, IM, text messaging, etc.) or state of completion (draft, final, etc.).

• No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by Concealment, Removal, or Mutilation Generally. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records disposition schedules.

• Contractor is required to obtain the CO’s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

1.8.5.8 Controlled Unclassified Information (CUI)

Operational and Scientific Training material may be designated as Controlled Unclassified Information. The contractor shall comply with the following National CUI Policies that can be accessed at the following website:

https://www.dm.usda.gov/ohsec/pdsd/controlled_unclassified.htm

• Executive Order (EO) 13556, Controlled Unclassified Information

• 32 CFR Part 2002, Controlled Unclassified Information

• CUI Registry

1.8.5.9 Security Review

The Government may elect to conduct periodic reviews to ensure that the security requirements contained in this contract are being implemented and enforced. The Contractor shall afford USDA, including the organization of the USDA Office of the Chief Information Officer, the Office of the Inspector General, authorized Contracting Officer's Representative (COR), and other government oversight organizations, access to the Contractor's facilities, installations, operations, documentation, databases and personnel used in the performance of this contract. The Contractor will contact the USDA Chief Information Security Officer to coordinate and participate in the review and inspection activity of government oversight organizations external to the USDA.

Access shall be provided to the extent necessary for the government to carry out a program of inspection, investigation, and audit to safeguard against threats and hazards to the integrity, availability and confidentiality of USDA data or the function of computer systems operated on behalf of USDA, and to preserve evidence of computer crime.

1.8.5.10 General Security Requirements

The use of Non-U.S. citizens, including Lawful Permanent Residents (LPRs), is not permitted in the performance of this contract for any position that involves access to or development of any USDA IT system.

USDA will consider only U.S. Citizens and LPRs for employment on this contract. USDA will not approve LPRs for employment on this contract in any position that requires the LPR to access or assist in the development, operation, management, or maintenance of USDA IT systems. By signing this contract, the contractor agrees to this restriction. In those instances where other non-IT requirements contained in the contract can be met by using LPRs, those requirements shall be clearly described. Under provisions of U.S. Law, Title 18, U.S. Code section 499 and 701, the Contractor will return any expired USDA issued identification cards and building passes, Government owned property or those of terminated employees to the COR. If an identification card or building pass is not available to be returned, a report must be submitted to the COR, referencing the pass or card number, name of individual to whom issued, the last known location and disposition of the pass or card.

https://www.dm.usda.gov/ohsec/pdsd/controlled_unclassified.htm

1.8.5.11 Contractor Pre-Screening

Contractors requiring recurring access to Government facilities or access to sensitive but unclassified information and/or logical access to Information Technology (IT) resources shall verify minimal fitness requirements for all persons/candidates designated for employment under any USDA contract by pre-screening the person/candidate prior to submitting their name for consideration to work on the contract. Pre-screening the candidate ensures that minimum fitness requirements are considered and mitigates the burden of USDA having to conduct background investigations on objectionable candidates. The Contractor shall submit only those candidates that have not had a felony conviction within the past 36 months, illegal drug use within the past 12 months, or misconduct such as criminal activity on the job relating to fraud or theft within the past 12 months from the date of submission of their name as a candidate to perform work under this contract. Contractors are required to flow this requirement down to subcontractors. Prescreening involves contractors and subcontractors reviewing- Felony convictions within the past 36 months. An acceptable means of obtaining information on felony convictions is from public records, free of charge, or from the National Crime Information Center (NCIC). Illegal drug use within the past 12 months. An acceptable means of obtaining information related to drug use is through employee self-certification, by public records check; or if the contractor or subcontractor already has drug testing in place. There is no requirement for contractors and/or subcontractors to initiate a drug testing program if they do not have one already in place. Misconduct such as criminal activity on the job relating to fraud or theft within the past 12 months. An acceptable means of obtaining information related to misconduct is through employee self-certification, by public records check, or other reference checks conducted in the normal course of business. Pre-screening shall be conducted within 15 business days after contract award. This requirement shall be placed in all subcontracts if the subcontractor requires routine physical access, access to sensitive but unclassified information, and/or logical access to IT resources. Failure to comply with the pre-screening requirement will result in the Contracting Officer taking the appropriate remedy.

1.8.5.12 Removal of Contractor's Employees: The Contracting Officer may require the Contractor to immediately remove from the work site any employee who endangers persons or property, or whose physical or mental condition would impair the employee's ability to satisfactorily perform the required work. Notification to the Contractor will be verbal and in writing if time and circumstances permit. Otherwise, notification shall be verbal or by telephone, and shall be in writing as soon as possible. No such removal, however, shall reduce the Contractor’s obligation to perform all work required under this contract, and immediate replacement shall be made as required. This requirement shall not be the basis of any claim for compensation or damages against the Government.

1.8.6 Training Requirements: The contractor is responsible for ensuring personnel possess and maintain NBAF specific required training, as specified, during the execution of this contract. The contractor shall submit an Employee Training Roster that lists training and date completed per employee performing at NBAF within 14 calendar days of award and within 7 calendar days when changes are made thereafter. Contractor personnel who can provide evidence of completed training requirements under a previous USDA contract are not required to retake training.

1.8.6.1 Cybersecurity: This training shall be completed prior to gaining access to USDA networks. The contractor and any sub-contractor shall complete both cybersecurity computer-based training courses if access to both USDA and networks is required. This training takes one (1) hour to complete the initial training for each course (USDA) and one (1) hour to complete the annual refresher training. The refresher virtual interactive training requires a passing score of 80%. The contractor shall provide evidence of training before the employee is given access to work on any government network system. At this time contractor access to USDA networks is not anticipated.

1.8.7 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend the post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5.

The post award conference will be scheduled by the Contracting Officer within 10 days of award and shall be conducted telephonically.

1.8.8 Contracting Officer Representative (COR): A COR will be designated by the contracting officer to perform specific technical and administrative functions. The contractor will receive a copy of the written designation. It will specify the extent of the COR’s authority to act on behalf of the contracting officer. The COR is not authorized to make any commitments of changes that will affect price, quality, quantity, delivery, or any other term or condition of the contract.

1.8.9 Key Personnel: The personnel specified below are considered Key Personnel and shall not be removed or replaced without prior Contracting Officer approval. See Clause 452.237-74, Key Personnel and Technical Exhibit 2, Key Personnel Qualifications:

o Contract Manager o Scientist, Global Health Surveillance. Diagnostics, and Emerging Diseases o Biorepository Specialist, Agricultural and Crop Protection Research

1.8.10 Credentials: Contractor must currently possess the following current credentials, at a minimum: ISO 9001, ISO/IEV 17025. CLIA (CAP-accredited Reference Laboratory), GLP, cGMP, QSR (Quality System Regulation), and FDA Compliant.

1.8.11 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.8.12 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to, or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the

OCI.

1.8.13 Non-Disclosure Agreement: All Contractor employees, consultants and subcontractors shall sign a Non-Disclosure Agreement (DHS Form 11000-6) on behalf of the contractor. The contractor shall ensure that all contract personnel, including all subcontractors and consultants, performing on this contract shall sign and date a DHS Form 11000-6, Non-Disclosure agreement and adhere to the terms of the non-disclosure agreement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff that have not executed an individual non-disclosure agreement or failure to adhere to the non-disclosure agreement shall constitute default on the part of the contractor. Before commencing work, the contractor and any sub-contractors shall review the NDA training slides provided by USDA and sign the DHS Non-Disclosure Agreement. This form must be completed and sent to the COR prior to contractors gaining access to contract information and site access. A new NDA is not required for personnel that performed work on USDA contract 12639519D0034. All NDAs acquired under contract 12639519D0034 shall be resubmitted to the COR prior to commencement of work. The contractor shall be required to provide the status of NDAs upon request.

2.0 DEFINITIONS AND ACRONYMS

2.1. Definitions

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government.

Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, USDAs direction does not constitute a change, and has no funding implications. This individual does NOT have authority to change terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

2.1.6. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.7. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.8. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.9. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.10. SOP. As denoted in 5.3, for the purpose of this contract SOP refers to standardized documents, policies, work instructions, workflows, and Standard Operating Procedures.

2.1.11. WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.2.12. WORKING GROUP. Designated government personnel may include unit leads and technical experts.

2.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. Acronyms

ACOR Alternate Contracting Officer's Representative AGAR Agriculture Acquisition Regulation APHIS Animal Plant and Health Inspection Services ARS Agricultural Research Service ARU Animal Resource Unit BDM Biologics Development Module BRM Bio-risk Management BRT Biorepository Transfer BSL Biological Safety Level CFR Code of Federal Regulations CLIN Contract Line Item Number CO Contracting Officer CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf DOD Department of Defense GFE Government Furnished Equipment FADDL Foreign Animal Disease Diagnostic Laboratory FADRU Foreign Animal Disease Research Unit FAR Federal Acquisition Regulation FSAP Federal Select Agent Program IT Information Technology MEL Master Equipment List NAFMDVB North American Foot-and-Mouth Disease Vaccine Bank NBAF National Bio and Agro-Defense Facility OCI Organizational Conflict of Interest ODC Other Direct Costs PIADC Plum Island Animal Disease Center PIV Personal Identity Verification POC Point of Contact PPE Personal Protective Equipment PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RA Risk Assessment RTOP Request for Task Order Proposal SME Subject Matter Expert SOP Standard Operating Procedure TE Technical Exhibit TO Task Order

3.0 GOVERNMENT FURNISHED SERVICES, PROPERTY AND EQUIPMENT

3.1 Services: The Government shall not provide any services for this contract, except as otherwise specified.

3.2 Facilities: The Government will provide access to physical space for contractor training services to be performed on site at NBAF or at Kansas State University’s Biological Research Institute, located within 1 mile of the NBAF facility. These venues may include conference rooms, laboratory areas, maintenance areas, etc., and will include projector, white board, and tables, except in the case of contractor provided Mobile Laboratory Services.

3.3 Utilities: When the contractor works from authorized alternative locations, utilities are not government provided in those locations.

3.4 Equipment: The government will provide Personal Protective Equipment (PPE) and other safety-related materials and consumables to designated contractor personnel as needed for training in a controlled-access and/or containment suite. For remote-/distance learning events, NBAF/USDA will provide trainees with appropriate hardware and software to allow full participation in the training event. This shall include, at a minimum, a laptop with camera, speakers & microphone, and appropriate videoconferencing software.

3.5 Materials: The Government will provide access badges to authorized contractor personnel.

4.0 CONTRACTOR FURNISHED SERVICES, PROPERTY, AND EQUIPMENT

4.1 General: The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work under this contract with exception of items listed under Part 3, Government Furnished Services, Property, and Equipment.

4.2 Mobile Laboratory: The Contractor shall furnish a mobile laboratory as specified in 5.5.3 that is fully furnished with all laboratory equipment necessary for training ordered, with the exception of PPE for students. This mobile laboratory must be available for deployment within 7 business days of contract award and shall remain available throughout the period of performance of the contract.

5.0 SPECIFIC TASKS

5.1 Basic Services. The contractor shall provide virtual, on-site, and mobile Operational and Science Support Training services for NBAF government personnel assigned to NBAF in Manhattan, KS. Training provided shall be for a minimum of 100 NBAF government trainees, who include maintenance staff; engineering staff; laboratory technical staff; laboratory scientists;

animal caretaker staff; training staff; field epidemiologist staff; and others that will require a tailored curriculum to meet their job requirements. Science Support Training shall be provided in the following areas: Biological Safety and Security (BS&S); Laboratory Quality Management (LQM); Building automation systems and engineering features; Standard operating procedures (SOPs) and facility plans (e.g., Biosafety Plan, Chemical Hygiene Plan, Emergency Response Plan); Hazards management (chemical, waste, biological, radiological), emergency response and failure scenarios; Major equipment operation and maintenance; Facility Maintenance; and Animal Care.

5.1.1 Data Rights. The Government shall own all rights to use and reproduce training provided and/or developed by the contractor, including contractor provided training that has been previously developed by the contractor if it is training provided under this contract. These rights include the delivery of raw files applicable to training delivery.

5.1.2 System Integration. Contractor provided training may be utilized in the Government’s current training platform, Master Control. Contractor provided training shall be capable to easily integrate into Master Control.

5.2 Training Management

The contractor shall perform the following training management functions for the short-term and long-term operations to be conducted at NBAF. All contractor provided services under this section are firm-fixed prices, except for Travel for Planning Meetings, 5.2.5 which are firm-fixed price per contractor travel for Planning Meetings as specified below.

5.2.1 Contract Manager. The contractor shall provide a Contract Manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the Contracting Officer prior to commencing work. The Contract Manager or alternate shall be responsive to the COR or CO within 24 hours of request. For the purpose of this contract, it is intended that this position shall be an administrative position whose responsibility is to ensure compliance with contract specifications.

5.2.2 Planning Meetings. The contractor shall meet with current NBAF staff on-site or virtually within fifteen (15) business days of award for two consecutive work weeks to gain data, including roles and experience levels of government trainees and the physical resources of the facility, to establish, as well as provide monthly updates to training management areas. The contractors shall also meet with NBAF staff quarterly for two consecutive work weeks each contract year as ordered. The first year consists of five (5) planning meetings (initial and quarterly). Determination of meeting location, either on-site or virtually, for each of these meetings will be made by the Government within 15 days in advance of each planning meeting.

5.2.3 Monthly Training Schedule. The contractor shall prepare and submit a monthly training schedule to the COR for approval a minimum of 30 days prior to the first day of planned activities and shall deliver a written record of trainee attendance and performance within 30 days following the last day of planned activities. Monthly training schedule shall detail the trainees by unit, trainer(s), timing, and topics for delivery. The contractor shall coordinate with the COR to populate trainee rosters and refine the schedule delivery to minimize impact to NBAF operations and staff.

5.2.4 Reserved:

5.2.5 Travel for Planning Meetings: Training Management services require the contractor to travel to NBAF, Manhattan, KS, during the performance of this contract to attend Training Meetings outlined in 5.2.2, when these meetings have not been identified as virtual. All travel shall be scheduled at least 15 days in advance unless otherwise mutually agreed upon by both parties. Travel shall be scheduled at times mutually agreed upon.

Standard trips for a total of up to seventeen (17) trips for the contract duration, include initial award and quarterly trips to NBAF, Manhattan, KS for two (2) Contract Personnel for twelve (12) days.

Travel shall be paid on a firm-fixed-price basis for actual trips taken. The firm-fixed-price shall include transportation, lodging, meals, and incidental expenses. Travel pricing shall be in compliance with the Federal travel Regulation (FTR). The Government will provide conference rooms and/or an off-site laboratory when necessary. Other Ad hoc travel requirements may be authorized at the order level. Travel in addition to pre-priced travel will require fair and reasonable evaluation at the task order level by the Contracting Officer.

5.2.6 Digital Training Catalogue. The contractor shall collect, catalogue, and archive all written and electronic training resources currently used for training of PIADC/NBAF employees within 90 days of contract award. The contractor shall develop and implement course descriptions for contractor provided training topics included in 5.3, with the exception of SOP and scientific procedure driven topics, which include training agenda, course resources (including real-time mentorship via Workplace and/or Microsoft Teams), instructional goals, kinesthetic learning activities, methods for assessment of trainee success, etc. NBAF Government personnel will conduct updates after initial Training Catalogue is built by the contractor. The contractor developed database shall be housed in a system that is secure and sharable between PIADC/NBAF.

5.3 Gap and Risk Assessment and Report. The contractor shall conduct an on-site risk-assessment during the two-week meeting outlined in 5.2.2 and prepare a report of risks and recommendations for training activities. NBAF government personnel designated by the COR will provide the contractor access to previous risk assessment records and audits as well as be available for discussion of training related questions. All contractor provided services under this section are firm-fixed prices per assessment.

5.3.1. Gap Assessment.

The contractor shall develop and deliver a Gap Assessment within six (6) months of award that shall include, at a minimum:

A Catalog of all existing applicable PIADC/FADDL SOPs, policies, facility documents, program documents, training program materials and resources, and other physical information that is anticipated to be transferred to NBAF (the PIADC Catalog).

A list of recommendations for changes or development of the items in the Catalog in order to harmonize with the new NBAF facility features and conditions.

To the extent possible and practical, the Contractor will rely on existing resources rather than develop new materials.

5.3.2 Risk Assessment.

The contractor shall conduct and prepare a Biosafety and biosecurity risk assessment in coordination with PIADC/FADDL personnel based upon available facility documents and shall include the handling of all threat agents that are anticipated to be included in the NBAF operational mission. The contractor developed risk assessment shall be delivered within four (4) months of award and shall include the following, at a minimum:

• Hazard identification and characterization

• Assignment of risk level/prioritization of risks

• Evaluation and revision of risk mitigation strategies

• Recommendations

5.4. Training. The contractor shall deliver training either on-site at NBAF or at a Government provided off-site laboratory near NBAF, virtually or in contractor provided mobile laboratory.

The type of training delivery shall be as shown on the Monthly Schedule of training. Training resources may include course agenda and syllabus, video recordings, AR/VR activities, written documents, reference materials, exercises and activities, presentations, pre-recorded webinars, study guides, group learning exercises, examinations, and others. All contractor provided services under this section are firm-fixed prices per type and duration of training provided (On- Site, Virtual, Mobile Laboratory Training and Mobile Lab Use, per hour, per day, per week and/or per month).

5.4.1 On-Site Training

The contractor shall provide training events on-site as indicated at the order level, at an NBAF provided venue. The contractor shall deliver written record of trainee attendance and performance, along with any recommendations for further training or alternate training based on performance within thirty days after completion of each training event.

On-site training shall either be conducted in a duration of one (1) workday or one (1) work week (Monday through Friday). On-site training that is specified as one hour in duration on Technical Exhibit A will be ordered in no less than quantities of five (5) for one (1) workday for the contractor’s pricing and planning purposes. Pricing for these on-site training sessions is inclusive of travel, lodging, and all incidentals incurred by the contractor.

5.4.2 Virtual Training

The contractor shall provide training events utilizing a combination of live virtual training methods, virtual reality, and pre-recording virtual training for all of the courses provided in the electronic database. The contractor shall develop and launch secure on-line resources that enable a variety of trainee/trainer interactions including training delivery, group videoconferencing, one-on-one mentor interactions, and SME Q&A sessions. Resources may include Workplace®, Microsoft™ Teams, SharePoint, and/or other resources approved by the CO or designee.

5.4.3 Mobile Laboratory Training

The contractor shall provide mobile laboratory training. The Government will provide a list of dates, topics, and personnel within thirty (30) days of necessary training. Mobile laboratory training shall either be conducted in a duration of one (1) workday or one (1) work week (Monday through Friday). Mobile laboratory training that is specified as one hour in duration on Technical Exhibit A will be ordered in no less than quantities of five

(5) for one (1) workday for the contractor’s pricing and planning purposes. Pricing for these Mobile laboratory training sessions is inclusive of transportation costs, travel, lodging, and all incidentals incurred by the contractor. Utilities and parking for the Mobile Lab are specified in 3.0.

5.4.4 Mobile Lab Use

The contractor shall provide mobile laboratory for Government led training and use. The Government will provide a list dates for Mobile Lab Use within thirty (30) days of necessary training. Mobile laboratory use shall be conducted in a duration of one (1) month, thirty (30) day, increments. Mobile laboratory use is inclusive of transportation costs and all mobile lab incidentals incurred by the contractor. Utilities and parking of the Mobile Lab will be prepared for and paid for by the Government.

5.5 Curricula Assessment, Revision and Development

The contractor shall collaborate with PIADC/NBAF staff that have been involved with staff training to revise or develop and finalize curriculum for trainees based upon the COR and designated Government offices review of the approved Gap and Risk Assessment. Contractor provided Curricula Assessment and Recommendation Reports shall be each firm-fixed price per each service. Contractor provided Curricula Development (including Related Technical Document Development) are firm fixed price based upon individual Task Orders.

5.5.1 Curricula Assessment and Recommendation Report

The contractor shall assess the body of existing training resources for completeness and effectiveness in meeting the needs of the curricula. The contractor shall submit a list of recommendations for modification of existing training materials, or development of new resources, to the COR or designee for approval, within six (6) months of contract start date. To the extent possible and appropriate, contractor shall tailor provided training materials and resources to reduce the costs associated with development of materials. The recommendation report developed shall be submitted to the COR for approval of the draft, who shall submit the draft to the CO for approval. The report shall include training topics, learning objectives, assessment tools, mentorship program details, technology platforms, target trainee lists, proposed trainer teams, progress reporting, and other general elements of the training program. Curricula Revision that is approved by the CO may be ordered under curricula development. Curricula development will be negotiated at the task order level. The contractor will be issued a Request for Tas Order Proposal (RTOP). Vendor shall submit a proposal for the work detailed in the LTOP on a firm fixed price basis. This proposal shall include a detailed breakdown of the individual elements of the proposal to include labor mix, number of hours and fully burdened labor rates.

5.5.2. Curricula and Related Technical Document Development

The contractor shall identify and develop the framework of operational and technical training approved and ordered by the CO from 5.6.1. The curricula development shall be based upon function and responsibility of staff that interface with animal handling, laboratory activity, operations and maintenance, environmental health and safety, and security. The developed curricula shall employ blended learning approaches suited for professional adult learners that will build a knowledge base that can be expanded during stand-up and beyond. The approach to curricula development shall utilize existing training methods including didactic and hands-on learning but will enhance learning through virtual training and virtual reality methods. The contractor developed and launched secure on-line resources shall enable a variety of trainee/trainer interactions including training delivery, group videoconferencing, one-on-one mentor interactions, and SME Q&A sessions. To the extent possible and appropriate, contractor shall tailor provided training materials and resources to reduce the costs associated with development of materials. Requests for Task Order Proposal will be initiated by the CO for various Curricula Development per subject and/or method of training. Task Order Proposal procedures are outlined in section 5.6.

The curricula developed by the contractor is that related to preparing for the startup and operation of BSL-4 and BSL-4Ag laboratories, including written program development, research protocol development, training, emergency planning, BSL-4 facilities operations/alarms, waste handling and personal protective equipment procedures in compliance with Federal Select Agent and Toxins…