FDA Solicitation 75F40123R00001.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

HFT-323

3900 NCTR ROAD

ATTN: Tim Walbert OAGS - Field Operations Branch

FDA/OO/OFBA/OAGS/DAP

CODE 16. ADMINISTERED BYCODE

X

X

X

541714

SIZE STANDARD:

100.00 % FOR:SET ASIDE:UNRESTRICTED ORHFT-323

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

03/23/2023 1400 CT

02/22/2023

870-543-7267TIMOTHY WALBERT

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40123R00001

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 59 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

JEFFERSON AR 72079

TELEPHONE NO.

17a. CONTRACTOR/

Jefferson AR 72079-9501 3900 NCTR Road National Ctr for Toxicological Research U.S. Food & Drug Administration Pamela Mack, DVM (870) 543-7659

15. DELIVER TO

JEFFERSON AR 72079

3900 NCTR ROAD

ATTN: Tim Walbert OAGS - Field Operations Branch

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

1,000

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

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

FDA/OO/OFBA/OAGS/DAP

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), requires on-site Animal Care and Technical Procedures in accordance with the attached Performance Work Statement (PWS) and appendices.

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

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

REGINA R. WILLIAMS

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

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

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

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

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

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

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

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

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

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

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

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

59 2 of

75F40123R00001 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) 2023-01 effective December 30, 2022.

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 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 Products and Commercial Services 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.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

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

75F40123R00001 Page 4 of 59

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

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

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

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

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

*Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and *Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

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

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

*Invoice number, amount, & date submitted *Corresponding payment amount & date received *Total amount of all payments received to date under the subject contract or order, 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

75F40123R00001 Page 5 of 59 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 The Government intends to award a single Labor-Hour contract for a base period and five (5) option periods of animal care and technical procedures 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 support services for the Center’s animal research program, to include at a minimum the provision of superlative care to all research animals, sanitation of all animal care and diet preparation/formulation facilities, and the provision of protocol-specified technical procedures support; the requirement also includes those ancillary tasks necessary to the accomplishment of these services, i.e., quality control, occupational safety and health measures, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive training and cross-training program. These services are of paramount importance to the Center as the essential elements of the FDA's research mission can be accomplished only through animal research.

Animal-based research projects are highly-regulated and demand nonpareil execution in accordance with approved scientific protocols and the Performance Work Statement (PWS) Attachment 1 - Performance Work Statement (PWS) and Appendices 1-4.

B.2.2 Pricing Schedule Phase-In Period

CLIN Description Total Price

0001 PHASE-IN PERIOD (30 days) July 25, 2023 – August 24, 2023

Base Period and Option Pricing

CLIN Description Annual Price

0002 SERVICES: BASE PERIOD

On-site animal care and technical procedures in accordance with the PWS;

75F40123R00001 Page 6 of 59

0003 TRAINING/TRAVEL: BASE PERIOD

Funds allocated for travel and training in support of services in accordance with the PWS (cost reimbursement item); funding not to exceed $10,000.00;

$10,000.00

1001 SERVICES: OPTION PERIOD 1

1002 SEPARATELY-PRICED OPTION ITEM (FAR 52.217-7)

TRAINING/TRAVEL: OPTION PERIOD 1

Funds allocated for travel and training in support of services in accordance with the PWS (cost reimbursement item); funding not to exceed $20,000.00;

$20,000.00

2001 SERVICES: OPTION PERIOD 2

2002 SEPARATELY-PRICED OPTION ITEM (FAR 52.217-7)

TRAINING/TRAVEL: OPTION PERIOD 2

Funds allocated for travel and training in support of services in accordance with the PWS (cost reimbursement item); funding estimated not to exceed $20,000.00;

3001 SERVICES: OPTION PERIOD 3

3002 SEPARATELY-PRICED OPTION ITEM (FAR 52.217-7)

TRAINING/TRAVEL: OPTION PERIOD 3

Funds allocated for travel and training in support of services in

4001 SERVICES: OPTION PERIOD 4

4002 SEPARATELY-PRICED OPTION ITEM (FAR 52.217-7)

TRAINING/TRAVEL: OPTION PERIOD 4

Funds allocated for travel and training in support of services in

5001 SERVICES: OPTION PERIOD 5

5002 SEPARATELY-PRICED OPTION ITEM (FAR 52.217-7)

TRAINING/TRAVEL: OPTION PERIOD 5

Funds allocated for travel and training in support of services in estimated not to exceed $10,000.00;

$10,000.00

75F40123R00001 Page 7 of 59

6001 SEPARATELY-PRICED OPTION ITEM (FAR 52.217-7)

Dosed diet formulation services in accordance with the PWS Section 7.0 (page 32). Estimated funding not to exceed $1,500,000 for the duration of the contract.

$1,500,000.00

7001 OPTION TO EXTEND SERVICES (FAR 52.217-8)

The Government may require continued performance of any services within the limits and at the rates specified in the contract.

(up to six months).

TOTAL (CLIN’s 0001-7001)

NOTE: The maximum dollar values for Contract Line Items 0001 through 5002 are annual ceiling amounts for each year of the contract. The contract shall not exceed the total ceiling amount for the Base year and all Option periods without a bilateral within-scope mod to the contract increasing the ceiling.

CLIN’s 0003, 1002, 2002, 3002, 4002, 5002 – Training/Travel (Separately-Priced Option Item(s) (FAR 52.217-7) In accordance with Section 6.0 of the PWS, Government Funded Training will be used to specifically fund training offsite or by bringing in a trainer for new procedures, new species, and/or for areas having issues where additional hands-on skills outside the current expertise is required. Training on personnel safety, personnel or contract management, personnel productivity/communication, and conference/training attendance to maintain certifications or obtain new certifications (e.g., DVM, RQAP-GLP, CMAR, ILAM) are outside the scope of this line item. Training on items excluded from this section should be included in overhead. Any training and associated travel required under Section

6.0 of the PWS which exceeds the annual amount of $20,000 is the sole financial responsibility of the contractor.

B.2.3 Pricing Detail – Labor Categories The labor categories shown below are required to support contractor performance for the duration of the contract. Offeror shall complete Attachment 2 – Pricing Worksheet Labor Categories for each period of performance listed above (see reference version below). If proposed labor categories are different, offerors shall map their labor category titles to those shown in the table below. NOTE:

The table below is for reference only.

Position Title (Add or delete positions as needed) (Indicate "A" if Service Contract

Act Applies or "E" if Exempt) *See Note below

SCA,

Exempt, CBA

FTE

Base Hourly Rate

Hourly Rate with

Fringe Overhead

+ G&A

+ Profit

Final Loaded

Rate

# of Direct Labor Hours

Total Labor

Project Director (Veterinarian) Exempt $ - $ - $ - $ - $0.00

HR Administrator SCA $ - $ - $ - $ - $0.00

Animal Care Manager Exempt $ - $ - $ - $ - $0.00

75F40123R00001 Page 8 of 59

Supervisor Exempt $ - $ - $ - $ - $0.00

Technical Specialist SCA $ - $ - $ - $ - $0.00

Quality Assurance Manager Exempt $ - $ - $ - $ - $0.00

Animal Care Technician (NHP) CBA $ - $ - $ - $ - $0.00

Animal Care Technician (rodent) CBA $ - $ - $ - $ - $0.00

Quality Control & Safety Specialist Exempt $ - $ - $ - $ - $0.00 Asst Animal Care Technician

(NHP) CBA $ - $ - $ - $ - $0.00

Asst Animal Care Technician (rodent) CBA $ - $ - $ - $ - $0.00

Cage Processing Foreman SCA $ - $ - $ - $ - $0.00

Equipment Specialist SCA 0 $ - $ - $ - $ - $0.00

Behaviorist Exempt 0 $ - $ - $ - $ - $0.00

Training Manager Exempt 0 $ - $ - $ - $ - $0.00

Optional Services - Diet Formulation

Diet Prep Manager Exempt 0 $ - $ - $ - $ - $0.00

Diet Prep Technician CBA 0 $ - $ - $ - $ - $0.00

B.2.4 Contract Payments – Labor-Hour Contract Upon presentation of a proper invoice, payment will be made monthly, in arrears, for services rendered to and accepted by the Government.

B.2.5 Travel

a. There is no routine travel required by the Government which is anticipated under this requirement, other than the training and/or training-associated travel required by the Contractor under the PWS.

If, at a future date the Government does require one or more Contractor employees to travel (e.g.:

training, conferences, etc.), the travel line item will be funded as the need arises, and the Contractor will be responsible for making all required travel arrangements for Contractor’s personnel. Upon completion of travel, and in accordance with FAR 31.205-46, Travel Costs and all Federal Travel Regulations as prescribed by the General Services Administration, Contractor will be reimbursed only for actual travel costs incurred. No additional profit, G&A or fee of any kind will be allowed on the direct travel reimbursement.

b. Travel claims/invoices shall be submitted separately from monthly service invoices. Listed below is a description of 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 travel.

B.2.6 Packing, Marking and Shipping

B.2.6.1 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.

75F40123R00001 Page 9 of 59

B.2.6.2 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.2.7 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 the nonconforming items/services and immediately notify the Contracting Officer.

B.2.8 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.2.8.1 Reporting Requirements and Deliverables Deliverables required by this contract are outlined in the PWS.

B.2.8.2 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 date 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.2.9 Contract Period of Performance The anticipated performance period for the base year and option periods (to include Separately-Priced Line Items under FAR 52.217-7) are as follows:

CLIN No.

Description

Period of Performance

0001 Phase-In Period June 25, 2023 – July 24, 2023 0002-0003 Base Period July 25, 2023 – January 24, 2024 1001-1002 Option Period 1 January 25, 2024 – January 24, 2025 2001-2002 Option Period 2 January 25, 2025 – January 24, 2026 3001-3002 Option Period 3 January 25, 2026 – January 24, 2027 4001-4002 5001-5002

Option Period 4 Option Period 5 Dosed Diet Formulation

January 25, 2027 – January 24, 2028 January 25, 2028 – July 24, 2028 July 25, 2023 – July 24, 2028

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

75F40123R00001 Page 10 of 59 contact during performance of the contract:

B.3.1.1 Contracting Officer (CO) 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 the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Contracting Officer for this contract is Regina Williams, regina.williams@fda.hhs.gov.

B.3.1.2 Contract Specialist (CS) All communications pertaining to the solicitation process, contractual, and administrative matters under the contract shall be addressed to the CS electronically only at the following address:

timothy.walbert@fda.hhs.gov Tim Walbert

FDA/OO/OFBA/OAGS/DAP/FOB

National Center for Toxicological Research 3900 NCTR Road, Building 50, Room 426 Jefferson, AR 72079 Phone: (870) 543-7267

B.3.1.3 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 Address:

Phone:

Mailing Address:

(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 PWS;

(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.

mailto:regina.williams@fda.hhs.gov mailto:timothy.walbert@fda.hhs.gov

75F40123R00001 Page 11 of 59

(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 Personnel Contractor Key Personnel. Pursuant to HHSAR Clause 352.237-75 Key Personnel, ONLY those positions described and listed in the PWS are key personnel applicable to this contract and are as follows: Project Director, Program Manager, Supervisors (3), Behaviorist, and Internal Quality Assurance (IQA) Manager (see PWS Paragraph 4.1.4 et seq.) The contractor shall provide a complete list of all key personnel. Reference PWS paragraph 4.15 entitled Personnel outlining proposed contractor positions.

Key Personnel list (Project Director, Program Manager, Supervisors (3), Behaviorist, and Internal Quality Assurance (IQA) Manager will be included upon contract award.

Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions, along with their qualifications and experience) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer. The contract may be modified from time to time during the course of the contract to either add or delete personnel, as appropriate.

B.3.3 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 http://www.cpars.csd.disa.mil/cparsmain.htm

75F40123R00001 Page 12 of 59

CPARS, the Contractor will receive an 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 Animal Care 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 Government Furnished Property Government Furnished Facilities and Property apply to this contract as set forth in the PWS. GFP will be handled in accordance with FAR 52.245-1.

B.4.2 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.

B.4.3 Occupational Safety and Health Terms and Conditions

SECTION I – GENERAL OCCUPATIONAL SAFETY AND HEALTH TERMS AND

CONDITIONS

1. The contractor is responsible for ensuring contractor personnel comply with applicable OSHA requirements, report unsafe conditions or activities to the Contracting Officer’s Representative (COR), and avoid actions and conditions that may result in an accident.

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

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2. The contractor shall submit to the COR a site-specific safety and accident prevention plan and OSHA 300A reports from the past three calendar years.

3. The contractor shall report all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after discovery of the incident, illness or injury, or near-miss.

4. The contractor shall provide an investigation report at no cost to the Government for all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after the conclusion of the investigation of the incident, illness or injury, or near-miss.

5. The contractor shall report all activities or conditions that pose imminent danger or harm to persons, animals, or Government property immediately upon discovery to FDA Security or directly to local emergency services, as appropriate. In addition, the contractor shall report the incident to the COR immediately thereafter.

6. The contractor shall be responsible for any and all costs, expenses, and other obligations paid or incurred, due to the contractor’s noncompliance with federal, state, and/or local laws or ordinances.

7. As applicable, the contractor shall provide personal protective equipment (e.g., hard hats, safety glasses, work gloves) for anticipated hazards and ensure that contractor personnel wear the prescribed safety and health equipment within the work area, as prescribed by 29 CFR part 1910, Subpart I. The contractor shall provide instructions to personnel on the proper wear, maintenance, and limitations of the personal protective equipment prior to commencement of any work under the acquisition.

8. Prior to bringing any hazardous material to an FDA facility, the contractor shall provide the COR copies of any Safety Data Sheets (SDS) to obtain advance, written authorization.

8.1. Unless otherwise specified in the acquisition, the contractor is responsible for removing any hazardous material, or any material with an SDS, that the contractor brought with them for use at an FDA facility before or during performance of the acquisition.

SECTION II – HAZARDOUS AREA OCCUPATIONAL SAFETY AND HEALTH TERMS

AND CONDITIONS

1. Contractor personnel shall successfully complete, and maintain respective records of, all safety training requirements prescribed by OSHA regulations, federal, state, and local laws and regulations, the FDA, and the FDA occupational safety and health program – prior to starting work. The FDA-specific training requirements, if any, will be provided to the contractor by the Contracting Officer’s Representative (COR). FDA-specific training may be administered by the Contractor and/or FDA occupational safety and health personnel, as coordinated by the COR.

2. The Contractor is responsible for providing contract personnel with personal protective equipment (unless provided by FDA).

2.1 The U.S. Government may furnish additional personal protective equipment needed to minimize hazard exposures. Such personal protective equipment is considered Government-furnished property under FAR Clause 52.245-1, Government Property (Sep 2021), which is hereby incorporated by reference in accordance with FAR Clause 52.252-2, Clauses Incorporated by Reference (Feb 1998).

3. Prior to working on equipment or in areas posted with any caution, warning, danger or similar signage, contractor personnel shall consult with the COR.

SECTION III – BLOODBORNE PATHOGEN EXPOSURE TERMS AND CONDITIONS

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Contractor personnel shall adhere to the FDA Bloodborne Pathogens Exposure Control Plan which will be provided to the contractor by the Contracting Officer’s Representative.

SECTION IV – OCCUPATIONAL HEALTH CLEARANCE

1. Contractor personnel shall be medically cleared (with or without restrictions) by a physician at

NCTR OHU with respect to their current health status and the hazards to which they may be exposed, as applicable.

1.1 In general, the medical clearance process includes access to a robust occupational health program that may include, but not limited to, vaccinations or access to prophylactic therapies or medications.

1.2 Medical clearance is to be obtained every 12 months (or as directed by the Contracting Officer’s Representative (COR)).

2. Contractor personnel will be allowed to commence work only after medical clearance has been provided to and accepted by the COR, in addition to any additional requirements.

SECTION V – RESPIRATORY PROTECTION PROGRAM

Prior to commencing any work under the contract, workers shall participate in, a Respiratory Protection Program.

SECTION VI – ANIMAL EXPOSURE PROGRAM

The contractor is responsible for maintaining full compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (https://olaw.nih.gov/policies-laws/phs-policy.htm).The contractor is responsible for maintaining a working environment per applicable Animal Exposure Program (AEP) guidelines and complying with the FDA and applicable AEP occupational safety and quality assurance policies, procedures, programs, and guides.

1. The contractor is responsible for ensuring that contractor personnel participate in, and comply with, an AEP that is consistent with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

1.1. Contractor personnel shall be medically cleared (with or without restrictions) by a physician with respect to allergy prevention, pregnancy, and other risk factors related to animal exposure.

1.1.1. In general, the medical clearance process includes access to an occupational health program that may include, but not limited to, protective vaccinations or access to prophylactic therapies or medications.

1.1.2. Medical clearance is to be obtained every 12 months (or as directed by the Contracting Officer’s Representative (COR)).

2. Contract personnel will be allowed to commence work only after medical clearance has been provided to and accepted by the COR.

3. If contractor personnel do not participate in an AEP or do not comply with the provisions of the applicable AEP, then they are not permitted to (a) enter vivaria, animal holding areas, or animal procedure rooms; or (b) conduct the related tasks involving animals outlined in the Statement of Work. The contractor is responsible for any contract personnel changes necessary to carry out the tasks of the acquisition within the period of performance.

Review and approval of the Contractor’s proposed Occupational Safety and Health Plan by the Contracting Officer and/or his/her designated representative is not intended as, and shall not be construed as, any assumption of responsibility or liability by the government for the safety or health of the Contractor’s employees. Review by the Government includes, but is not limited to, imposition https://olaw.nih.gov/policies-laws/phs-policy.htm https://olaw.nih.gov/policies-laws/phs-policy.htm

75F40123R00001 Page 15 of 59 of minimal safety standards; requirements for personal protective equipment in various settings;

review of standard operating procedures; OSH training; and/or such additional safety measures as the Contracting Officer may determine to be reasonably necessary.

The government reserves the right to conduct unannounced safety inspections at any time and 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 its employees.

Some experimental animal studies may be conducted using chemicals that are known or suspected to be hazardous to humans. Strict biological, chemical, or radiological containment for safe work practices and proper waste disposal procedures shall be employed to minimize exposures to personnel and the work environment. Any new OSH SOPs for activities with hazardous chemicals shall be developed by the Contractor based on researchers’ approved protocols. If available, Material Safety Data Sheets (MSDS) from chemical manufacturers shall be used to determine the hazards and appropriate work practices. SOPs shall be in compliance with OSHA regulations including the Hazard Communication Standard (29 CFR 1910.1200), the OSHA Occupational Exposure to Hazardous Chemicals in the Laboratory (29 CFR 1920.1450), the Occupational Health and Safety in the Care and Use of Research Animals (National Research Council, 1997), Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH, 2007), and the Food and Drug Administration Safety Staff Manual Guides, safety manuals, and policies and procedures. The Contractor's SOPs pertaining to safety shall be reviewed by the NCTR Safety Staff and the COR prior to placing into service.

Subsequent to award the Contractor shall conduct an initial safety investigation of the workplace to determine what safety equipment, personal protective equipment, and/or other safety-related measures may be required to ensure safe performance of contract responsibilities. In addition, the Contractor shall report to the Contracting Officer within 48 hours any safety deficiencies or issues concerning the facilities that need correcting to make the workplace safe. Further, the Contractor shall re-assess such needs quarterly throughout the duration of this contract and include issues found in the Quarterly Occupational Safety and Health Report.

The Contractor shall be proactive and take steps to correct any anticipated unsafe conditions before they result in an accident. The Contractor shall continually review employee safety needs throughout the duration and performance of this contract and take the necessary action(s) to correct potentially hazardous situations.

It is the sole responsibility of the Contractor to determine and provide the type of occupational safety and health training the Contractor considers necessary for contract employees to perform their assigned tasks with maximum safety protection and in compliance with current Federal, State, and Local regulations. The Contractor shall assure by documentation that each employee assigned to a hazardous procedure or task has sufficient training and possesses the requisite knowledge and skills necessary to perform the procedure or task safely. The Contractor shall be required at all times to maintain training records for its employees demonstrating that they possess the requisite certifications.

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

75F40123R00001 Page 16 of 59 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 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.

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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.

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.

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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.