16-223-SOL-00036_Revision_1_-_NCTR_Animal_Care_RFP.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

1163255

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

16-223-SOL-00036

6. SOLICITATION ISSUE DATE

10/18/2016

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

Suzanne Martella

b. TELEPHONE NUMBER (No collect calls)

(870) 543-7540

8. OFFER DUE DATE / LOCAL

TIME

November 18, 2016

12:00 P.M. CST

9. ISSUED BY CODE HFT-323 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: 100 % FOR:

FDA/OO/OFBA/OAGS/DAP

SMALL BUSINESS WOMEN-OWNED SMALL BUSINESS

Field Operations Branch Suzanne Martella

HUBZONE SMALL

BUSINESS

(WOSB) ELLIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM NAICS:

541711 3900 NCTR Road, Building 50, Room 430 Jefferson AR 72079-9502

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

EDWOSB

8 (A) SIZE STANDARD:

1,000

11. DELIVERY FOR FOB DESTINAT-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS 13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

FDA/NCTR

3900 NCTR Road Jefferson AR 72079-9502

SAME AS BLOCK 9

17a. CONTRACTOR/

OFFERER

TELEPHONE NO.

CODE FACILITY

CODE

18a. PAYMENT WILL BE MADE BY

Food and Drug Administration Vendor Payments, OFS FDA 3900 NCTR Road Building 50, 6th Floor, Suite 616 Jefferson AR 72079-9502

CODE HFT-324

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 SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

On-site Animal Care, Technical Procedures, Formulation and Veterinary Care Services, NCTR as outlined herein and in the provided Attachments.

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

25. ACCOUNTING AND APPROPRIATION DATA

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

27a.SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED

27b.CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN __1__

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 HEREIN.

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

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

30c. DATE SIGNED

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

Jerry W. Martin

31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 1449 (REV. 02/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

16-223-SOL-00036 Revision 1 Page 2 of 34

TABLE OF CONTENTS

SECTION B - CONTINUATION OF STANDARD FORM (SF) 1449

B.1 3-WAY INVOICE SUBMISSION INSTRUCTIONS – Addendum to SF1449 Block 18b B.2 SERVICES AND PRICES/COSTS – Addendum to SF 1449, blocks 19/20

B.2.1 Description of Services B.2.2 Pricing Schedule B.2.3 Pricing Breakdown B.2.4 Contract Payments – Labor Hour Contract B.2.5 Travel B.2.6 Packing, Marking and Shipping B.2.7 Inspection and Acceptance B.2.8 Deliveries or Performance B.2.9 Contract Period of Performance

B.3 CONTRACT ADMINISTRATION DATA

B.3.1 Government Personnel B.3.2 Contractor Personnel B.3.3 Contractor Performance Evaluations

B.4 SPECIAL CONTRACT REQUIREMENTS

B.4.1 Government Furnished Property B.4.2 Tobacco Free Facilities B.4.3 Occupational Health & Safety B.4.4 FDA 1335 Personnel Security Clearance Requirements B.4.5 Required Insurance B.4.6 Reporting Matters Involving Fraud, Waste, and Abuse B.4.7 Collective Bargaining Agreement (CBA) / Applicable Wage Rate Decision B.4.8 Non Personal Services B.4.9 Organizational Conflicts of Interest B.4.10 Data Disclosure Procedures B.4.11 Phase-In/Phase-Out B.4.12 Continuity of Services

SECTION C – CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS (DEVIATION 2015-02) (FEB 2015)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS – COMMERCIAL ITEMS (MAR 2016)

SECTION D – LIST OF CONTRACT DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION E – SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.2 52.203-98 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS—REPRESENTATION (DEVIATION 2015-02)

E.3 ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO OFFERORS–COMMERCIAL ITEMS (OCT 2015) . 18

E.3.1 Proposal Instructions E.3.2 Proposal Mailing Instructions E.3.3 Proposal Disqualification

E.4 52.212-2 EVALUATION–COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFERORS REPRESENTATIONS AND CERTIFICATIONS–COMMERCIAL ITEMS (JUL

2016)

16-223-SOL-00036 Revision 1 Page 3 of 34

SECTION B - CONTINUATION OF STANDARD FORM (SF) 1449

B.1 3-WAY INVOICE SUBMISSION INSTRUCTIONS – Addendum to SF1449 Block 18b A. The Contractor shall submit one (1) original copy of each invoice to the address specified below:

FDA/OC/OA/OFO/OFS

Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th Floor, Suite 616 Jefferson, AR 72079

870.543.7446 or 870.543.7042

An electronic invoice can be mailed to the following address: nctrinvoices@fda.hhs.gov

One (1) copy should be sent to the following, clearly marked "courtesy copy only": suzanne.martella@fda.hhs.gov pamela.mack@fda.hhs.gov , robin.stingley@fda.hhs.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25

(Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, 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;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA payment office at the telephone number or e-mail address provided above.

mailto:nctrinvoices@fda.hhs.gov mailto:suzanne.martella@fda.hhs.gov mailto:pamela.mack@fda.hhs.gov%20, mailto:pamela.mack@fda.hhs.gov%20, https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html

16-223-SOL-00036 Revision 1 Page 4 of 34

B.2 SERVICES AND PRICES/COSTS – Addendum to SF 1449, 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 Animal Care, Technical Procedures, Formulation, and Veterinary Care Services. The Contractor shall provide support services to NCTR’s animal research program, which includes but is not limited to the provision of quality care to all research animals, sanitation of all animal care and diet preparation/formulation facilities, provision of protocol-specified technical procedures, provision of veterinary care to the nonhuman primate colony, and provision of formulation services (receipt, storage, formulation, packaging, and distribution of animal diets and test articles).

Ancillary tasks necessary to accomplish these services are included (e.g., quality control, occupational safety and health, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive training program). The need for these services is paramount as the preponderance of NCTR’s research mission can only be accomplished through animal research. In addition, major funding sources for the Center’s research program, such as the National Toxicology Program, mandate animal-based research projects.

Such projects are highly regulated and demand exemplary execution in accordance with (IAW) Attachment 1- Performance Work Statement (PWS).

B.2.2 Pricing Schedule Phase-In

CLIN Description Total Price 0001 PHASE-IN PERIOD (30 days)

From 06 Feb 2017 – 5 Mar 2017

Base Period and Option Pricing

CLIN Description Annual Price

0002 SERVICES BASE PERIOD

On-Site Animal Care, Technical Procedures, Formulation, and Veterinary Care Services IAW the PWS.

0003 TRAVEL BASE PERIOD

Funds allocated for travel and training in support of services at NCTR IAW the PWS. Cost Reimbursement.

1001 SERVICES OPTION PERIOD 1

1002 TRAVEL OPTION PERIOD 1

2001 SERVICES OPTION PERIOD 2

2002 TRAVEL OPTION PERIOD 2

3001 SERVICES OPTION PERIOD 3

3002 TRAVEL OPTION PERIOD 3

4001 SERVICES OPTION PERIOD 4

4002 TRAVEL OPTION PERIOD 4

TOTAL (CLINs 0001-4002)

NOTE 1: The maximum dollar values for Contract Line Items 0001 through 4002 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.

16-223-SOL-00036 Revision 1 Page 5 of 34

NOTE 2: For the purpose of a balanced evaluation, Offerors are to insert the price of $25,000 in each of the Travel CLINs (0003, 1002, 2002, 3002 and 4002) in the Pricing Table above.

B.2.3 Pricing Breakdown See Attachment 6 – Pricing Worksheet, to provide breakdown of the above pricing.

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 anticipated under this requirement. If at a future date the Government does require one or more Contractor employees to travel (training, conferences, national/local AALAS, etc.), the travel line item will be funded and the Contractor will be responsible for making all required travel arrangements for Contractor’s personnel.

Upon completion of travel, in accordance with FAR 31.205-46, Travel Costs, 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.

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 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 Deliveries or Performance 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 are as follows:

CLIN No. Period Period of Performance 0001 Phase-In Period 06 Feb 2017 – 5 Mar 2017 0002-0003 Base Period 06 Mar 2017 – 5 Mar 2018 1001-1002 Option Period 1 06 Mar 2018 – 5 Mar 2019 2001-2002 Option Period 2 06 Mar 2019 – 5 Mar 2020 3001-3002 Option Period 3 06 Mar 2020 – 5 Mar 2021 4001-4002 Option Period 4 06 Mar 2021 – 5 Mar 2022

16-223-SOL-00036 Revision 1 Page 6 of 34

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). 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 Jerry W. Martin.

B.3.1.2 Contract Specialist (CS). All communications pertaining to contractual and/or administrative matters under the contract shall be addressed to the CS at the following address:

Attn: Suzanne Martella

FDA/OO/OFBA/OAGS/DAP/FOB

National Center for Toxicological Research 3900 NCTR Road, Building 50, Room 430 Jefferson, AR 72079 Phone: (870) 543-7540 or electronically at suzanne.martella@fda.hhs.gov

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) / 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.

(c) Technical directions may be oral or in writing. The COR shall confirm oral direction in writing within five work days, 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 work day.

(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 mailto:suzanne.martella@fda.hhs.gov

16-223-SOL-00036 Revision 1 Page 7 of 34 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 the individuals cited below in the PWS are key personnel applicable to this contract. 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 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) 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 Evaluations In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract.

Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of 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 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 30 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 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

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

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.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 the FDA NCTR, 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 per 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 http://www.cpars.csd.disa.mil/cparsmain.htm https://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm

16-223-SOL-00036 Revision 1 Page 8 of 34

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 Health & Safety 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 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 work place 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 FDA 1335 Personnel Security Clearance Requirements The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that all DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or leased space for less than thirty (30) calendar days are exempted from the background investigation requirement but shall still undergo a background check initiated by the

16-223-SOL-00036 Revision 1 Page 9 of 34

NCTR RCRM Security Specialist. These contractor employees must be escorted at all times while in DHHS-owned or leased space.

The Contractor shall comply with the Personnel Security Clearance Requirements set forth in Attachment 2.

B.4.5 Required Insurance FAR 52.228-5, Insurance-Work on a Government Installation is supplemented to require the following minimum amount of 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 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.4.7 Collective Bargaining Agreement (CBA) / Applicable Wage Rate Decision For workers under the Collective Bargaining Agreement (CBA), CBA-2010-4067 (2014-2016) applies to this contract and is included at Attachment 3. The Contractor shall provide the Contracting Officer with copies of any collective bargaining agreement(s), and any amendments thereto, which arise during the course of this contract and that apply to Contractor employees working under this contract.

For employees not covered under the above-listed CBA, the U.S. Department of Labor Wage Determination applicable to this contract is Wage Determination (WD) 2005-2035, Revision No. 1 dated 9/1/2016. It is incorporated and located at Attachment 4.

B.4.8 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 mailto:HHStips@oig.hhs.gov

16-223-SOL-00036 Revision 1 Page 10 of 34 other Government Contractors, or become a part of the Government organization; and,

• Be used in administration or supervision of procurement activities.

B.4.9 Organizational Conflicts of Interest

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

c. The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

d. All contractor personnel involved in this requirement shall abide by the FDA’s Commitment to Protect Non- Public Information Employee Agreement included at Attachment 5.

B.4.10 Data Disclosure Procedures Dissemination, Publication and Distribution of Information Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor’s right to use data or information obtained from a non-restrictive source. Any questions concerning “privileged information” shall be referred to the Contracting Officer.

Any questions about use or release of the data or information or handling of material under this contract shall be referred to the COR who must render a written determination to the Contracting Officer (CO). The COR’s determination will reflect the results of internal coordination with appropriate program and legal officials. After receipt of the COR’s written determination, the CO will make a final decision authorizing the release of information.

B.4.11 Phase-In/Phase-Out This contract requires a Phase-in and a Phase-out (transition) period of thirty (30) days.

B.4.11.1 Contractor Phase-In. During the thirty (30) day phase-in, incoming Contractor personnel shall review ongoing work, review plans and schedules, prepare plans and schedules for upcoming work and perform all tasks necessary to take over and complete all work in progress at the beginning of the new contract performance period.

Upon award, the Contractor shall begin phase-in execution in accordance with the approved Transition Plan.

B.4.11.2 Incumbent Phase-Out. The phase-in of incoming Contractor personnel may occur in conjunction with a phase-out of incumbent employees. The Contractor shall not assume that incumbent employees will be able to guide, direct, or specifically orientate each incoming Contractor employee. The in-coming Contractor shall cooperate with the incumbent during the phase-in period.

B.4.12 Continuity of Services The Contractor is expected to meet full performance requirements from the stated date of the contract. The Contractor shall provide sufficient experienced personnel during the phase-in period to ensure that the services specified by this contract are maintained at the required level of proficiency. FAR Clause 52.237-3 “Continuity of Services” applies to the phase-out period of this contract.

16-223-SOL-00036 Revision 1 Page 11 of 34

SECTION C – CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

FAR Clauses: http://www.acquisition.gov/far/index.html HHSAR Clauses: http://farsite.hill.af.mil/vfhhsara.htm

(End of Clause)

FAR NUMBER TITLE DATE

52.203-3 Gratuities Apr 1984 52.203-12 Limitation on Payments to Influence Certain Federal Transactions Oct 2010 52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform

Employees of Whistleblower Rights Apr 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper May 2011 52.204-9 Personal Identity Verification of Contractor Personnel Jan 2011 52.212-4 Contract Terms and Conditions - Commercial Items Alternate I (May 2014) May 2015 52.217-8 Option to Extend Services

For the purposes of this clause the blank(s) is/are completed as follows:

“…within one (1) calendar day of contract expiration.”

Nov 1999

52.217-9 Option to Extend the Term of the Contract For the purposes of this clause the blank(s) is/are completed as follows:

“(a)…within one (1) calendar day of contract expiration…at least 30 calendar days…”

“(c)…shall not exceed five (5) years, excluding any extension under FAR clause 52.217-8.”

Mar 2000

52.223-3 Hazardous Material Identification and Material Safety Data Alternate I (Jul 1995) Jan 1997 52.223-5 Pollution Prevention and Right-to-Know Information May 2011 52.223-10 Waste Reduction Program May 2011 52.227-1 Authorization and Consent Dec 2007 52.227-14 Rights in Data - General May 2014 52.228-5 Insurance - Work on a Government Installation Jan 1997 52.229-3 Federal, State, and Local Taxes Feb 2013 52.232-7 Payments under Time-and-Materials and Labor-Hour Contracts Aug 2012 52.232-18 Availability of Funds Apr 1984 52.232-23 Assignment of Claims May 2014 52.232-39 Unenforceability of Unauthorized Obligations Jun 2013 52.232-40 Providing Accelerated Payments to Small Business Subcontractors Dec 2013 52.237-2 Protection of Government Buildings, Equipment, and Vegetation Apr 1984 52.237-3 Continuity of Services Jan 1991 52.242-13 Bankruptcy Jul 1995 52.242-15 Stop Work Order Aug 1989 52.245-1 Government Property Apr 2012 52.245-9 Use and Charges Apr 2012 52.247-34 F.O.B. Destination Nov 1991

HHSAR NUMBER TITLE DATE

352.203-70 Anti-Lobbying Dec 2015 352.208-70 Printing and Duplication Dec 2015 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations Dec 2015 352.223-70 Safety and Health Dec 2015 352.231-70 Salary Rate Limitation Dec 2015 352.233-71 Litigation and Claims Dec 2015 352.237-75 Key Personnel Dec 2015 352.239-74 Electronic and Information Technology Accessibility Dec 2015 352.270-5b Care of Live Vertebrate Animals Dec 2015 http://www.acquisition.gov/far/index.html http://farsite.hill.af.mil/vfhhsara.htm

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C.2 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS (DEVIATION 2015-02) (FEB 2015)

(a) The Contractor shall not require employees or contractors seeking to report fraud, waste, or abuse to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The contractor shall notify employees that the prohibitions and restrictions of any internal confidentiality agreements covered by this clause are no longer in effect.

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

(d)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), use of funds appropriated (or otherwise made available) under that or any other Act may be prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(2) The Government may seek any available remedies in the event the contractor fails to comply with the provisions of this clause.

(End of Clause)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS – COMMERCIAL ITEMS (MAR 2016)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 and 108-78 (19

U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995)

(41 U.S.C. 4704 and 10 U.S.C. 2402).

X (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009

(June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L.

109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

X (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub.

L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

X (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41

U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014)

(if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

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__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved] X (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

X (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (iv) Alternate III (Oct 2015) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

X (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15

U.S.C. 657 f).

X (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-

Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns

Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2016) (E.O. 13126).

X (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

X (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

X (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

X (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496).

X (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

X (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners

(JUN 2016) (E.O. 13693).

__ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

__ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

X (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O.

13513).

__ (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

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