75F40125R126822 Solicitation.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NO. 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect calls)

8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

CODE

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

RFQ IFB RFP

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

29. AWARD OF CONTRACT: REF. OFFER

DATED . . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

31b. NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NAICS:

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

8 (A)

EDWOSB

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

75F40125R126822

Suzanne Martella, Contracting Officer (870) 543-7540 75F401

FDA/NCTR

3900 NCTR Road Jefferson, AR 72079-9502

Same as Block 9

U. S. Food and Drug Administration Attn: Vendor Payments, DPS 10903 New Hampshire Ave.

WO32, 2nd Floor, Mail Hub 2145 Silver Spring, MD 20993-0002

See Section B, Paragraph B.2.2

Suzanne Martella

811210

$34.0 million

04/09/2025

05/09/2025

3:00 P.M. CDT

FDA/OO/OFBA/OAGS/DAP

Field Operations Branch Suzanne Martella 3900 NCTR Road, Building 50, Room 419 Jefferson, AR 72079-9502

STANDARD FORM 1449 (REV. 2/2012) BACK

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

40. PAID BY

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELPHONE NUMBER OF AUTHORZED GOVERNMENT REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER 34. VOUCHER NUMBER 35. AMOUNT VERIFIED

CORRECT FOR

PARTIAL FINAL

37. CHECK NUMBER

38. S/R ACCOUNT NO. 39. S/R VOUCHER NUMBER

36. PAYMENT

COMPLETE PARTIAL FINAL

FDA Solicitation: 75F40125R126822 Page 3 of 59

Section B - Continuation of Standard Form (SF) 1449 The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-03 effective January 17, 2025.

B.1 Invoice Submission

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

Addendum to SF1449 Block 18b.

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). (see 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;

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov

FDA Solicitation: 75F40125R126822 Page 4 of 59

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

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

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

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

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

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

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

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

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.

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents 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). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

B.1.2 Contract Type mailto:ERIC@fda.hhs.gov

FDA Solicitation: 75F40125R126822 Page 5 of 59

The Government intends to award a single firm fixed price (FFP) contract for a base period and four (4) option periods for on-site laboratory equipment maintenance, repair, and fabrication services.

B.2 SERVICES AND PRICES- Addendum to SF1449, Blocks 19/20

B.2.1 Description of Services

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires on-site laboratory equipment maintenance, repair, and fabrication services. The Contractor shall provide all labor, to include but not limited to supervision, administrative, and technical support, and all material, equipment, and supplies not otherwise identified as government-furnished, to perform the services as defined in Attachment 1- Performance Work Statement (PWS).

The successful contractor shall provide the required services in accordance with Section D, Attachment 1 – Jefferson Laboratories On-Site Laboratory Equipment Maintenance, Repair, and Fabrication Services Performance Work Statement (PWS) and appendices thereto.

B.2.2 Pricing Schedule Payment will be made monthly in arrears for services rendered and accepted by the Government, upon presentation of a proper invoice and in accordance with the following projected schedule:

Phase-In (if required) Item Description QTY Unit Unit Price Extended Amount

1 Phase-in Period (30 days):

From 6/22/2025 – 7/21/2026 1 MO $ $ __

Base and Option Year Pricing Item Description Qty Unit Unit Price Amount

Base Year: 7/22/2025 – 7/21/2026 On-Site Laboratory Equipment Maintenance, Repair, and Fabrication Services in accordance with the PWS

12 MO $ $ __

3 Option Year 1: 7/22/2026 – 7/21/2027 On-Site Laboratory Equipment Maintenance, Repair, and Fabrication Services in accordance with the PWS

12 MO $ $ __

4 Option Year 2: 7/22/2027 – 7/21/2028 On-Site Laboratory Equipment Maintenance, Repair, and Fabrication Services in accordance with the PWS

12 MO $ $ __

5 Option Year 3: 7/22/2028 – 7/21/2029 On-Site Laboratory Equipment Maintenance, Repair, 12 MO $ $ __

FDA Solicitation: 75F40125R126822 Page 6 of 59 and Fabrication Services in accordance with the PWS

6 Option Year 4: 7/22/2029 – 7/21/2030 On-Site Laboratory Equipment Maintenance, Repair, and Fabrication Services in accordance with the PWS

12 MO $ $ __

Total (Base Year and All Option Years): $_______________________

Note: in addition to filling in pricing above, also submit Attachment 2 – Pricing Schedule.

B.2.3 Contract Period of Performance (PoP) The periods of performance for this firm-fixed price (FFP) contract shall consist of a Phase-In period (if required), a base year and five (5) one-year option years, as shown below. (**Note: the PoP dates listed below are estimates only. The actual periods of performance will be established at time of award.)

Description Period of Performance Phase-In (if required) 6/22/2025 – 7/21/2025 Base Year 7/22/2025 – 7/21/2026 Option Year 1 7/22/2026 – 7/21/2027 Option Year 2 7/22/2027 – 7/21/2028 Option Year 3 7/22/2028 – 7/21/2029 Option Year 4 7/22/2029 – 7/21/2030

B.2.4 Contract Payments The Contractor shall provide the necessary personnel, equipment, supplies and support services (notwithstanding that supplied as per the PWS) to perform as described in Section B.2.1 of this document. In consideration for successful performance of these services, the Contractor shall be paid upon the presentation of a proper invoice in accordance with the applicable invoice clause. Payment will be made monthly, in arrears, for services rendered to and accepted by the Government.

Payment terms: Net 30 days after government acceptance of a proper invoice and acceptance of services. Advance payments will not be made.

B.2.5 Packing, Marking and Shipping

B.2.5.1 Preparation of Delivery All material to be delivered hereunder shall be afforded the degree of packing (preservation and packing) required to prevent deterioration and damages due to hazards of shipment, handling and storage. Best commercial practice will be accepted.

B.2.5.2 Prohibited Packaging Materials The use of asbestos, excelsior, newspaper, or shredded paper (all types including waxed paper, computer and similar hygroscopic or non-neutral material) is prohibited. In addition, loose fill polystyrene is prohibited for shipboard use.

B.2.6 Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Government’s COR specified at award. If the supplies or services are not acceptable, the COR shall document

FDA Solicitation: 75F40125R126822 Page 7 of 59 the nonconforming items/services and immediately notify the Contracting Officer.

B.2.7 Deliveries and/or Performance The Contracting Officer’s Representative (COR), a duly authorized representative of the CO, shall monitor the Contractor’s performance, evaluate the quality of services, and perform the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the COR specified herein.

B.2.7.1 Reporting Requirements and Deliverables Deliverables required by this contract are outlined in the PWS (Attachment 1 – Jefferson Laboratories On-Site Laboratory Equipment Maintenance, Repair, and Fabrication Services Performance Work Statement (PWS)) and appendices thereto.

B.2.7.2 Contractor Notice Regarding Late Delivery In the event the contractor, for any reason, anticipates or encounters difficulty in complying with the contract delivery schedule or performance dates, or in meeting any of the requirements of the contract, the contractor shall immediately provide written notification to the CO giving pertinent details. The data shall be informational in character and its receipt by the Government shall not be construed as a waiver by the contractor or any other rights or remedies provided to the Government by law or under this contract.

B.2.8 Place of Performance All work shall be performed on-site at NCTR, 3900 NCTR Road, Jefferson, Arkansas 72079. The Government’s primary operations at NCTR are conducted during the day from the core hours of 8:00 am to 4:30 pm, Monday through Friday, except Federal holidays listed in Section B.2.10 below.

B.2.9 Observance of Federal Holidays A. Government personnel observe the following Federal holidays:

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

B. Other Closures: During facility closures resulting from any Government directive (designated by Federal statute, Executive Order [EO], Presidential proclamation, local or national emergencies, administrative closings) contractor employees may not automatically be dismissed (even though Government employees may be).

B.3 CONTRACT ADMINISTRATION DATA

B.3.1 Government Personnel Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, administration of this contract shall require maximum coordination between the Government and the Contractor. The following individuals shall be the Government’s points of contact during performance of the contract:

B.3.1.1 Contracting Officer (CO)/ Contract Specialist (CS) 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to

FDA Solicitation: 75F40125R126822 Page 8 of 59 the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Contract Specialist (CS)/Contracting Officer for this contract is Suzanne (“Beth”) Martella, suzanne.martella@fda.hhs.gov.

All communications pertaining to the solicitation process, contractual, and administrative matters under the contract shall be addressed to the CS electronically only at the aforementioned email address.

B.3.1.2 Contracting Officer’s Representative (COR). The following COR will represent the Government for the purpose of this contract: (To be provided at contract award) Name:

Email:

Phone:

(a) Performance of the work under this contract shall be subject to the technical direction of the COR identified above, or a representative designated in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise services to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have the authority to issue any technical direction that:

(1) Constitutes a change of assignment of additional work outside the specification(s) or SOW;

(2) Constitutes a change as defined in the contract clause entitled "Changes;”

(3) In any manner causes an increase or decrease in the total contract price, or the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract;

(5) Interferes with the contractor’s right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the contractor’s employees.

(c) Technical directions may be oral or in writing. The COR shall confirm oral direction in writing within five workdays, with a copy to the CO.

(d) The Contractor shall proceed promptly with the performance resulting from the technical directions issued by the COR. If, in the opinion of the contractor, any direction of the COR, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the CO no later than the beginning of the next Government workday.

(e) Failure of the contractor and the CO to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the CO of any deficiencies observed. A letter of designation shall be issued to both the COR and the Contractor at the time of the contract award setting forth, in full, the responsibilities and limitations of the COR.

B.3.2 Contractor Key Personnel Pursuant to HHSAR Clause 352.237-75 Key Personnel, ONLY incorporated in this contract, the individuals cited below are key personnel. *Offeror: Please list proposed Key Personnel Titles below:

mailto:suzanne.martella@fda.hhs.gov

FDA Solicitation: 75F40125R126822 Page 9 of 59

Employee Title

(add more if needed; however, not all personnel will be “Key”)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the individuals specified above to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement’s skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The Government reserves the right to evaluate the technical skill and competence of any Contractor staff members, to require removal and replacement, upon written notice, of any individuals whose qualifications or performance are judged deficient at any time.

B.3.3 Conduct of Contractor Employees The Contractor’s employees shall adhere to standards of competency, conduct, appearance, and integrity that reflect credit to the employee, the Contractor, and the Government. The Contractor shall be responsible for such disciplinary action with respect to their employees as may be necessary.

The Contractor shall immediately report to the CO and COR in writing any planned termination of contract personnel and the cause of such termination. The Contractor shall not terminate any employee without prior notification to NCTR RCRM and shall take no action toward employee termination until NCTR RCRM and Security staff are present. NCTR RCRM and Security staff shall escort terminated contract employees at all times while on FDA property.

Contractor personnel shall comply with the NCTR’s traffic and safety rules and other regulations and instructions pertaining to conduct of persons on Government facilities. Contractor personnel shall, in no event, enter any area to which access is restricted, unless such an area has been specifically identified as an area in which services are to be rendered. The Contractor shall place their employees on notice that infraction of any of the above rules, regulations, or prohibitions may be grounds for removal from Government property.

B.3.4 Contractor Performance Assessment Reports In accordance with FAR Subpart 42.15, FDA will complete annual (interim) 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 two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an http://www.cpars.csd.disa.mil/cparsmain.htm

FDA Solicitation: 75F40125R126822 Page 10 of 59 automated CPARS email message which contains User IDs 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 14 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 the 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 https://www.cpars.gov/ system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/lc.htm . There is no fee for registration or use of the CPARS.

B.4 SPECIAL CONTRACT REQUIREMENTS

The contractor is expected to provide on-site Laboratory Equipment Maintenance, Repair, and Fabrication services in accordance with the terms and conditions stated herein, to furnish to and at FDA NCTR in Jefferson, Arkansas, the services and prices specified herein and in the referenced attachments, understanding the considerations outlined herein.

B.4.1 Travel Costs and Other Direct Costs Travel is not normally required under this contract; however, should travel be necessary, travel costs shall be limited to those authorized by FAR 31.205-46. Additionally, (1) no fee/profit will be allowed/paid; (2) all travel shall be authorized and requested in advance (minimum of 30 calendar days) to the COR, and (3) the Contractor will be responsible for making all required travel arrangements for its personnel. Travel claims/invoices shall include receipts required as attachments to the invoice to support travel claims:

1. Copy of common carrier ticket reflecting class of travel, dates of travel and amount of fare;

2. Lodging receipt;

3. Parking/tolls receipts;

4. Rental car receipt including receipts for gasoline;

5. Receipts for taxi (or Uber/Lyft or the like) travel.

B.4.2 Government Furnished Property Government Furnished Facilities and Property apply to this contract as set forth in the PWS under sections 2.5, Section 5, and Appendix 8. GFP will be handled in accordance with FAR 52.245-1.

B.4.3 Tobacco Free Facilities In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees and any subcontractor staff is made aware of, understand, and comply with this policy.

https://www.cpars.gov/ https://www.cpars.gov/lc.htm

FDA Solicitation: 75F40125R126822 Page 11 of 59

B.4.4 Personnel Security Clearance Standards and Residency Requirements (October 2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that results in a favorable determination.

Contractor employees who will work in DHHS-owned or leased space for less than thirty (30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all times while in DHHS-owned or leased space.

2. GENERAL - The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

• A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

• Confirmation all individual employee security information has been submitted properly; and

• “Contractor's Commitment to Protect Non-public Information Agreement” forms signed by each employee named in the roster.

Pursuant to HSPD-12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

If a Contractor’s employee changes job responsibilities under this contract, the Contractor must notify the COR, and the Government will make a determination whether an additional security clearance is required.

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change.

In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

3. BACKGROUND INVESTIGATIONS - With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor. Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

Note: Background investigations will be conducted by the Office of Personnel Management (OPM).

4. CONTRACT RISK DESIGNATION(S) - Contractor employees who will be in DHHS-owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive-12 (HSPD-12) in order to access to DHHS-owned or leased property without an escort.

(See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered visitors, as described above, and allowed onto DHHS-owned or leased property, but must be escorted at all times.

FDA Solicitation: 75F40125R126822 Page 12 of 59

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing system (e-QIP) system. The FDA Personnel Security Specialist will provide access to the e-QIP as well as guidance as to which forms will be required.

The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s): _2_

There are three (3) potential position risk designations, which are:

• Non-Sensitive Low Risk (Tier 1) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non-Sensitive Low Risk Positions.

• Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust Positions - Positions in which the incumbent’s actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. This information will be provided on the e-QIP form that will be electronically sent to the employee. The FDA Personnel Security Specialist will use this information to enter each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed. Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

5. PERSONAL IDENTITY VERIFICATION (PIV) CARDS - All PIV Cards (and any other type of Government-issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer. The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government-issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

6. PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, FDA Solicitation: 75F40125R126822 Page 13 of 59 a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document. Acceptable forms of identification are listed in Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

Required background investigations may include, but are not limited to:

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquiries covering the subject's background.

7. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS - Under the requirements for Homeland Security Presidential Directive-12 (HSPD-12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals. If any prospective foreign national contractor/subcontractor employee does not meet the residency requirements, he/she cannot qualify for a PIV Card under HSPD-12.

8. NON-PUBLIC DATA PROTECTION - The Contractor must protect the privacy of all information reported by or about Contractor employees and protect against unauthorized disclosure.

*Upon a favorable fingerprint return, the Contractor will be notified to return to the Badging and Credentialing Office for their building pass:

Food and Drug Administration Badging and Credentialing Office 8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time Office of Regulatory Compliance and Risk Management 3900 NCTR Road Bldg. 54, Room 128 Jefferson, AR 72079 Appointment required

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed. Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

a. Contractor employees who will work in the Washington D.C. metro area shall, at the direction of the FDA COR or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who will work on the National Center for Toxicological Research facility shall contact the following to arrange for fingerprinting:

Food and Drug Administration National Center for Toxicological Research Office of Regulatory Compliance and Risk Management

FDA Solicitation: 75F40125R126822 Page 14 of 59

3900 NCTR Road Bldg. 54, Room 128 Jefferson, AR 7207

Appendix A:

B.4.5 Required Insurance

a. Worker’s Compensation and Employer’s Liability. Contractors are required to comply with applicable Federal and State workers’ compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers’ compensation to be written by private carriers.

b. General liability. Bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence is required.

c. Automobile liability. The Contractor shall provide automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract. Policies covering automobiles operating in the United States, its possessions, and Puerto Rico shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

B.4.6 Access to Government Property, Service and/or Space When the Contractor’s team arrives at the Government facility, the team leader will make detailed arrangements with the COR for access to and availability of the property, services, and space. This contract schedule recognizes that Contractor liability, as required by law, is to exercise ordinary care with respect to that property.

B.4.7 Applicable Wage Rate Decision

The U.S. Department of Labor wage determination applicable to this contract is Wage Determination (WD) 2015-5121, Revision No. 25 dated 12/23/2024. A copy of the WD is included with Attachment 3 to this solicitation, but may also be obtained at: https://sam.gov/wage-determination/2015-5121/25

B.4.8 Safety Requirements

A. The Contractor shall appoint a Safety Manager, which may be a collateral duty with another position. The name of the Safety Manager and qualifications shall be submitted to the COR prior to commencement of work.

B. The Government reserves the right to conduct unannounced safety inspections at any time.

C. The Government reserves the right to investigate accidents involving Contractor personnel. The Contractor shall immediately report to the COR any bodily injury or death in performance of official duties, damage to Government property estimated to be in excess of $100, or loss of Government property resulting from the activities of the Contractor, its agents, or employees.

D. All Contractor personnel that may be required to enter restricted areas shall be identified to the COR during the transition period or upon employment, whichever is earlier.

https://sam.gov/wage-determination/2015-5121/25 https://sam.gov/wage-determination/2015-5121/25

FDA Solicitation: 75F40125R126822 Page 4 of 59

B.4.11 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 to the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447- 8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE P.O. Box 23489 Washington, D.C. 20026

B.4.12 Non-Personal Services

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

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; and,

• Be used in administration or supervision of procurement activities.

Work requirements shall flow only from the Contracting Officer or the COR to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All employee assignments, and daily work direction, shall be given by the applicable Contractor supervisor.

If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. 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 this contract and that if the other Contractor believes this communication to be a direction to change their contract, they shall 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 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 mailto:HHStips@oig.hhs.gov

FDA Solicitation: 75F40125R126822 Page 5 of 59 the other provisions of this 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.

B.4.13 Conflicts of Interest and Confidentiality

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

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

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

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

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

(d) Remedies. The Contracting Officer may terminate this award for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational…