FDA_SOL_75F40122R00051 Bldg 2 - Chiller Plant_P00004.pdf

FDA Solicitation No.: 75F40122R00051

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Table of Contents

PART I- THE SCHEDULE 4

SECTION B- SUPPLIES OR SERVICES AND PRICES/COSTS 4

SECTION C- DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 8

SECTION D- PACKAGING AND MARKING 8

SECTION E- INSPECTION AND ACCEPTANCE 8

SECTION F- DELIVERIES OR PERFORMANCE 9

SECTION G- CONTRACT ADMINISTRATION DATA 11

SECTION H- SPECIAL CONTRACT REQUIREMENT 15

PART II- CONTRACT CLAUSES 37

SECTION I- CONTRACT CLAUSES 37

PART III- LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS 42

SECTION J- LIST OF ATTACHMENTS 42

PART IV- REPRESENTATION AND INSTRUCTIONS 43

SECTION K- REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS OR RESPONDENTS 43

SECTION L- INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

OR RESPONDENTS 48

SECTION M- EVALUATION FACTORS FOR AWARD 56

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PART I- THE SCHEDULE

SECTION B- SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 Purpose

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires Bldg. 2 - Chiller Plant Construction and Associated Projects.

B-2 Compensation – Fixed Price Schedule

Contract Line Item

No.

Description Quantity Unit Price

Base Bid – During phase one of construction, following work shall be carried out

• Coordinate delivery schedule with vendor, unload and store government purchased four chillers (of 1500 ton each), one chiller (of 250 ton), two cooling towers (of 7664 GPM), one cooling tower (of 640 GPM), four generators (of 1500KW), one generator (of 2000 KW) and one generator (of 1000 kW).

• Removal of foundation of two big tanks and pipe stand on south side of two big tanks.

• Construction of new Bldg. 2.

• Installation of two chillers (of 1500 ton each), one chiller (of 250 ton), one cooling tower (of 7664 GPM) and one cooling tower (of 640 GPM) in Bldg. 2.

• Installation of four generators (of 1500 KW each) in Bldg. 2.

• Demolition and installation of campus chilled water lines except lines over roof of Bldg. 5B and 5C.

• Installation of two new chilled water pumps in mezzanine of Bldg. 14.

• Removal of 5,000 cubic feet underground concrete and back filling.

1 Job $_______

During phase two following work shall be performed

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No.

Description Quantity Unit Price

Option 1 –

• Installation of two chillers (of 1500 ton each) and one cooling tower (of 7664 GPM) in Bldg. 2.

• Demolition and installation of campus chilled water lines except lines over roof of Bldg. 5B and 5C.

• Installation of new generator (of 1000 KW at new location near Bldg. 26) as replacement of existing generator serving Bldg. 26 located on south side of Bldg. 14.

• Installation of one new generator (of 2000 KW) as replacement of three existing generator on south side of Bldg. 53A.

0003 Option 2 –

• Replace MCC breaker in Bldg. 53A. 1 Job $_______

Option 3 –

• Demolition of Bldg. 13 including foundation.

1 Job $_______

Option 4 –

• Rerouting of steam, steam condensate and compressed air lines (to serve Bldg. 26) through mezzanine of Bldg. 14.

• Demolition of existing overhead steam, steam condensate, compressed air lines over Bldg. 6, their structural support and foundation.

• Demolition of Bldg. 6 including foundation.

1 Job $_______

Option 5 –

• Construction of canopies on west side of

Bldg. 14.

• Demolition of three chillers in Bldg. 5B.

• Demolition of entire solar system in Bldg.

5B including foundations (approx. 12 ft deep) for solar panels.

• Demolition of two chillers in Bldg. 53A and associated cooling tower on south side of Bldg. 53A.

• Demolition of three chillers in Bldg. 26 and associated cooling tower on south side of Bldg. 14.

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No.

Description Quantity Unit Price

Option 6 –

• Installation of chilled water lines over roof of Bldg. 5B and 5C.

• Installation of new roofing membranes over

Bldg. 5B and 5C.

• Cost proposal shall include cost of replacing

200 Sq. Ft deteriorated portion of lightweight concrete roof deck.

• Cost proposal shall include cost of replacing 200 Sq. ft deteriorated portion of metal roof deck.

• Cost proposal shall include cost of replacing 150 linear feet wooden blocking at edge of roof, expansion joint and roof curb in base bid.

1 Job $_______

Option 7 –

• Replace deteriorated portion of lightweight concrete roof deck (In accordance with FAR Clause 52.217-7)

Shall be exercised any time within the contract period of performance when exact quantity is known.

Work shall be completed if/when the option is exercised within the same period of performance of the contract.

SF

Option 8 –

• Replace deteriorated portion of metal roof deck known.

Work shall be completed if/when the option is

SF

Option 9 –

• Replace wooden blocking at edge of roof, expansion joint and roof curb in base bid.

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No.

Description Quantity Unit Price

Shall be exercised any time within the contract period of performance when exact quantity is known.

Work shall be completed if/when the option is exercised within the same period of performance of the contract.

10 LF $_______

Option 10 –

• Removal of undergrade concrete foundation.

known.

Work shall be completed if/when the option is

CF

For base bid and all options, cost proposal shall include cost for asbestos sampling (within work limits) performed as per provided attachments, cost for abatement of asbestos containing material so mentioned in attachment. Additional discovery of asbestos containing material during asbestos sampling performed by contractor shall be address by change order.

Work shall be completed in accordance with Attachments:

• Folder J-1: Bldg. 2_Chiller Plant o J-1a: Bldg. 2_Design Analysis o J-1b: Bldg. 2_Drawing o J-1c: Bldg. 2_Specification_Vol 1 o J-1d: Bldg. 2_Specification_Vol 2

• Folder J-2: Bldg. 6_Demo o J-2a: Bldg. 6_ Demo_Project Manual o J-2b: Bldg. 6_Demo_Drawing o J-2c: Bldg. 6_Old Drawings o J-2d: Bldg. 6_Overhead Lines_Asbestos Report

• Folder J-3: Bldg. 53A_MCC o J-3a: Bldg. 53A_MCC_Drawing o J-3b: Bldg. 53A_MCC_Project Manual

• J-4: Big Tanks and Overhead Lines Foundation

• J-5: Bldg. 5B_ Cooling Tower Drawing

• J-6: Bldg. 13 Old Drawing

• J-7: Bldg. 26_Cooling Tower Drawing

• J-8: Bldg. 53A_Cooling Tower Drawing

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No.

Description Quantity Unit Price

Total Price (CLIN 0001 – CLIN 0011) $_____________

SECTION C- DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C-1 Scope of Work

Independently and not as an agent of the Government, the Contractor shall furnish the necessary management, supervision, personnel, materials, equipment, services, facilities, and otherwise do or provide all things necessary for or incident to the performance of the work set forth herein as in Section J, Attachment Folder J-1, J-2, J-3 & Files J-4, J-5, J-6, J-7, & J-8.

C-2 Government Furnished Property and Services

The Government will provide sufficient utilities, space on the campus to accommodate on-site portable construction office, supply storage, and access to secured facilities as needed. The Contractor shall pay for all temporary connections. No other property or services will be furnished by the Government.

SECTION D- PACKAGING AND MARKING

D-1 Marking Instructions for Reports

The contractor shall mark each shipment with its organization name, contract number, item number, and quantity (indicate partial or final shipment). As appropriate note on the face page of the report and when feasible on the binding (1) “one volume only” or (2) “volume 1 of 2, volume 2 of 2” etc.

D-2 Payment of Postage and Fees

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

SECTION E- INSPECTION AND ACCEPTANCE

E-1 Inspection and Acceptance

Pursuant to the FAR 52.246-12, Inspection of Construction clause below, and upon notice by the Contractor that the work is substantially complete, final inspection and acceptance of all items called for by this contract shall be made by the Contracting Officer (CO) or his/her designated Contracting Officer’s Representative (COR). The Contractor shall be responsible for any countermeasures or corrective action, within the scope of this contract, which may be required by the CO as a result of such inspection.

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E-2 - 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. The full text of a clause may also be accessed electronically at this address:

https://www.acquisition.gov/?q=browsefar

FAR

Clause No. Title and Date

52.246-12 Inspection of Construction (AUG 1996)

E-3 Government Inspectors

The work shall be conducted under the general direction of the CO and is subject to inspection by his/her COR to ensure compliance with the terms of the contract. No inspector is authorized to change any provision of the specifications without written authorization of the CO, nor shall the presence or absence of an inspector relieve the Contractor from any requirements of the contract. Contractor shall be required to work under the supervision of Government onsite construction administration personnel. Contractor shall comply with requirements, inspections and requests made by construction administration personnel with prior approval of COR.

SECTION F- DELIVERIES OR PERFORMANCE

F-1 Reports/Deliverables

Unless otherwise noted, all reports/deliverables shall be delivered to the attention of the Contract Specialist (CS), via email Howard.Nesmith@fda.hhs.gov, delivered or mailed to NCTR/OAGS, Building 50, Room 424, 3900 NCTR Road, Jefferson, AR 72079.

The Contractor shall submit the following reports/deliverables:

Scheduled Items Qty Due Dates

1. Performance and Payment Bonds (See Section G-5) 1 Within 20 calendar days after contract award

2. Pre-construction conference 1 Within 25 calendar days after contract award

3. Listing of Contractor Employees (See Section H-1) 1

Within 25 calendar days of contract award. Submit to NCTR Safety Office, Building 50, Room 304.

Provide updates as needed.

4. Certificate of Insurance (See Section H-6) 1 Within 25 calendar days after contract award. .

https://www.acquisition.gov/?q=browsefar mailto:Howard.Nesmith@fda.hhs.gov

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5. Preliminary Construction Performance Schedule (See Section H- 9)

Not later than 10 calendar days after receipt of notice to proceed.

Submit to COR.

6. Schedule of Values 3 Within 30 calendar days after receipt of notice to proceed

7. Invoice 1 Monthly

8. Submittals 3 hard copies /1 electronic

Not later than 30 calendar days after receipt of notice to proceed.

9. Updates to construction schedule 2 Monthly with Invoice.

10. Certification Statement & Payrolls 1 Monthly with Invoice

11. Project Record Drawings/”as-builts” (See Section H-7 (L))

3 hard copies & 1 electronic copy in

AutoCAD

Not later than 30 calendar days prior to submission of final invoice

12. O & M Manuals 4 Not later than 30 calendar days prior to submission of final invoice

13. Warranties 4 Not later than 30 calendar days prior to submission of final invoice

14. Estimate of Percentage of Recovered Material Content for EPA-Designated Items (FAR 52.223-9)

1 Prior to submission of final invoice

15. Release of Claims 1 Submitted with final invoice.

16. COVID Attestation Form 1 per person

First day of arrival onto FDA property and kept on person and available upon request thereafter.

F-2 Notice Regarding the Use of Macros in Submitted Documents

The 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 enabled macro functionality.

Any document(s) delivered having macro functionality will be deemed delinquent, if not corrected prior to the due date.

F-3 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

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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 CO will make their full text available. The full text of a clause may also be accessed electronically at this address:

https://www.acquisition.gov/?q=browsefar

FAR

Clause No. Title and Date 52.211-10 Commencement, Prosecution, and Completion of Work (APR 1984) “…within 10 calendar days after the date the Contractor receives the notice to proceed…complete the entire work ready for use not later than 1,095 calendar days after receipt of the notice to proceed…” 52.242-14 Suspension of Work (APR 1984)

SECTION G- CONTRACT ADMINISTRATION DATA

G-1 Contracting Officer’s Representative (COR)

The COR responsible for the acceptance of work provided hereunder will be designated by separate correspondence. The term ‘‘COR’’ means the person who monitors the technical aspects of contract performance. The COR is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the COR is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds Clauses of this contract.

G-2 Technical Guidance

A. Performance of the work under this contract shall be subject to the technical guidance of the COR. The term "technical guidance" is defined to include the following:

1. Providing information to the Contractor for assistance in the interpretation of drawings, specifications, or technical portions of the work description, other technical performance requirements; and

2. Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract;

3. Perform technical evaluation as required;

4. Perform technical inspections and acceptances required by this contract; and

5. Assisting in the resolution of technical problems encountered during performance.

B. Technical guidance must be within the general scope of work stated in the contract. The

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COR does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (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 (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical guidance shall be issued in writing by the COR or shall be confirmed by him/her in writing within five (5) working days.

D. The Contractor shall proceed promptly with the performance of technical guidance duly issued by the COR in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

E. If, in the opinion of the Contractor, any instruction or direction issued by the COR is not within one of the categories as defined in B. (1) through B. (2) above, the Contractor shall not proceed but shall notify the CO, in writing, within five (5) working days after the receipt of any such instruction or direction. Upon receiving such notification from the Contractor, the CO shall determine whether or not a modification is necessary, take appropriate action and advise the Contractor accordingly. The Contractor shall thereupon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract Clause entitled "Disputes."

The Contractor shall contact the FDA's COR prior to performance to arrange for the following:

Access to the Facility

G-3 Contract Administration

a. Howard Nesmith, Contract Specialist (CS) 3900 NCTR Road HFT-320, Rm 424 Jefferson, AR 72079 Phone: 870-543-7459 Email: Howard.Nesmith@fda.hhs.gov

b. Contractor’s Point of Contact (To be completed at time of award) Name:

Office:

Cell:

Email:

c. Technical Point of Contact-Contracting Officer’s Representative (COR) (To be completed at time of award) mailto:Howard.Nesmith@fda.hhs.gov

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Name:

Office:

Email:

G-4 HHSAR 352.237-75 Key Personnel (December 2015)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances.

The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The positions cited below are key personnel.

Title

Project Manager

On-Site Superintendent

(End of clause)

G-5 Bonding Requirement

Acceptable Performance and Payment Bonds shall be furnished to the CS by the Contractor within twenty (20) calendar days after date of contract award. Notice to Proceed will not be given until all bond requirements are satisfactorily met. Bonds shall be delivered to:

howard.nesmith@fda.hhs.gov.

The penal amount of the performance bond shall be 100% of the original contract price.

The penal amount of the payment bond shall equal:

1. 100% of the original contract price; and

2. If the contract price increases, an additional amount equal to 100% of the increase; and

3. The amount of the Payment Bond must be no less than the amount of the Performance

Bond.

mailto:howard.nesmith@fda.hhs.gov

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Any increase in the contract price shall require an increase in performance and payment bond.

The surety or sureties shall be acceptable to the Government and a “Power of Attorney” of the agent authorized to certify under the surety’s seal shall be furnished with the bond. Standard Form 25 “Performance Bond” and 25A “Payment Bond” can be obtained electronically at http://www.gsa.gov/portal/forms/type/SF. Contractors and sureties shall follow the instructions on the back of the form. See FAR Clause 52.228-15 included in Section I.

G-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 on 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 330 Independence Avenue, S.W.

Washington, D.C. 20201

Information regarding procedural matters is contained on the HHS/OIG website at:

http://oig.hhs.gov/fraud/

G-7 Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at the CO’s 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 www.cpars.gov. 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 14 calendar 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 disagree http://www.gsa.gov/portal/forms/type/SF mailto:HHStips@oig.hhs.gov http://oig.hhs.gov/fraud/ http://www.cpars.gov/

Page | 15 with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by FDA. Any disagreement between the CO and the Contractor will be referred to a contracting official one level above the CO, 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.

Note: Effective January 15, 2019, the Past Performance Information Retrieval System (PPIRS) has been merged into CPARS. CPARS.gov is now the official source for past performance information. The PPIRS name will no longer be used except in the Federal Acquisition Regulation (FAR). Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/main/cparsmain.htm. There is no fee for registration or use of the CPARS system.

SECTION H- SPECIAL CONTRACT REQUIREMENT

H-1 Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017)

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

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

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

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

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

and

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

https://www.cpars.gov/main/cparsmain.htm

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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.

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.

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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): ___1___

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

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

• Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust Positions

- Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

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

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

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

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

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

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

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

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

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquiries covering the subject's background.

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

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

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

*Food and Drug Administration Badging and Credentialing Office 8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time 10903 New Hampshire Avenue

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Building 32, Room 1205 Silver Spring, MD 20993 No appointment necessary Telephone: (301) 796-4000

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

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

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

Food and Drug Administration National Center for Toxicological Research Office of Regulatory Compliance and Risk Management 3900 NCTR Road Bldg. 50, Room 304 Jefferson, AR 72079

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Appendix A

H-2 Payments to Contractors

Progress payments will be made in accordance with the Clause 52.232-5 entitled "Payments Under Fixed-Price Construction Contracts (MAY 2014)" in Part II, Section I, supplemented as follows:

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A. Before the first progress payment under the contract becomes due, the Contractor shall prepare a schedule, acceptable to the CO, of the estimated values of each principal category of the work which, when added together, will be used for determining progress payments and shall be in such detail as may be required by the CO. The cost of preparatory work, overhead, profit, bonds and insurance, taxes, warranties, as-built drawings, etc., shall be prorated into items of work throughout the contract.

B. Separate payments for materials delivered on-site or to locations other than on-site as contemplated by FAR Clause 52.232-5(b)(2) will be made under this contract.

C. The Contractor, prior to receiving a progress or final payment under this contract, shall submit to the CO a certification that the Contractor has made payment from the proceeds of prior payments, or that it will make timely payment then due, to its Subcontractor and suppliers in accordance with contractual arrangements with them.

D. After completion of the work, and prior to final payment, the Contractor shall furnish to the CO a release of claims against the United States arising out of the Contractor, other than claims specifically excepted from the operation of the release.

H-3 Invoice Submission

Before formal invoice submission, the Contractor shall submit draft invoice to COR for review.

Upon approval from COR, contractor shall submit invoices in accordance with the following instructions:

CONTRACTOR SHALL SUBMIT ALL INVOICES AS FOLLOWS:

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

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

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

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

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

Page | 22 within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

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

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

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

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

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

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

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

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

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

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

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

- Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and mailto:IPPCustomerSupport@fiscal.treasury.gov

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

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

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

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

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

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827- ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

H-4 Contract Changes mailto:ERIC@fda.hhs.gov

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The provisions of Clauses 52.243-4, Changes, in Part II, Section I, is supplemented as follows:

A. All proposals for equitable adjustments due to changes in the work shall be submitted in a lump-sum amount.

B. With each lump-sum proposal for a change involving either an increase or decrease in the amount of the contract, or an extension or an acceleration of the period of performance, the Contractor shall promptly submit, by separate trades, an itemized breakdown that will include the following:

1. Material quantities and unit prices;

2. Labor costs (broken down by contractor and each subsequent subcontractor by trades, hours worked, and hourly rates;

3. Construction equipment costs;

4. Workmen's Compensation and Public Liability Insurance costs;

5. Overhead costs;

6. Profit;

7. Employment Taxes, and those resulting from the Federal Insurance Contribution

Act (FICA) and Federal Unemployment Tax Act (FUTA), and State Unemployment Act (SUTA);

8. Any effect of the change on the time required to complete the job, increase or decrease; and

9. Any increase or decrease in bond coverage.

C. When, either because of insufficient time to review and negotiate a proposed change or through failure of the parties to reach an agreement, the Government may order the Contractor to proceed, on the basis of a price to be determined later (at the earliest practicable date) which will not be more than the increase or less than the decrease stated in the proceed order.

D. Allowable overhead, profit, and commission percentages shall be considered to include, but not be limited to, insurance other than mentioned herein, field and office supervisors and assistants, use of small tools, incidental job burdens, and general office expense. No percentage for overhead, profit or commission will be allowed on employment taxes under FICA, FUTA and SUTA.

E. The percentages for overhead, profit, and commission to be allowed by the Government may vary according to the nature, extent, and complexity of the work involved, and will be negotiated under each individual change order.

F. On proposals involving a combination of increases and decreases in the amount of the contract, the overhead, profit, and commission will be allowed on the net difference between the direct costs of the increases and decreases only.

H-5 Subcontracting and Subcontractors

A. Selection of Subcontractors. Unless otherwise specified, the Contractor and each

Page | 25 subcontractor shall be free to select their subcontractors. Each Subcontractor must be capable of satisfactorily performing all work Subcontracted to it or of Subcontracting, in turn, those portion(s) of the work which it cannot perform to someone who is capable of performing the work.

When there is Subcontracting, the Contractor must submit, or require the submission of, the following to the Contract Specialist:

1. The name and address of each subcontractor;

2. A detailed description of the work covered by each Subcontractor; and

3. A statement that the subcontractor has adequate resources and is capable of performing the work.

When required by the CO, the Contractor shall submit for approval the names and addresses of any firms to be employed as subcontractors by the prime Contractor or any subcontractors.

B. Copies of subcontracts. No Subcontractor shall be allowed to perform any work on the project site until the following conditions, in addition to those in Paragraph A. above, have been met by the Contractor:

1. A copy of the subcontract entered into on SF-1413 (Statement and Acknowledge), describing the work to be performed on the project site, has been furnished to the CO; and

2. The subcontract contains Paragraphs (b)(i) through (b)(ii) of Clause 52.222-26, Equal Opportunity.

(These requirements pertain to all subcontracts, no matter what tier of relationship they have to the prime Contractor, except that the Equal Opportunity Clause is not required to be included in subcontracts of $10,000 or less.)

C. Contractor's responsibility for a Subcontractor. The Contractor shall be responsible for the acts of all Subcontractors and their employees while performing work at the project site, regardless of the subcontractor’s contractual relationship to the Contractor. Failure of any Subcontractor to compete the work described in its subcontract in a satisfactory manner, or without delay, will not excuse the Contractor from any delay in the completion of the entire contract, except as provided under Clause 52.249-10, Default (Fixed-Price Construction) in Section I of this contract.

H-6 Required Insurance

The Clause 52.228-5, Insurance-Work on a Government Installation, in Part II, Section I, is supplemented to require the following minimum amount of insurance:

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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.

H-7 General Conditions (Construction at Jefferson Labs Campus)

A. General

Contractors (including Subcontractors), their officials, employees, and all other persons visiting or conducting business at any Food and Drug Administration facility or construction site in connection with contract work shall conform to these requirements and those of Federal Management Regulation (FMR) 41 CFR 102-74.365-455, Conduct on Federal Property, as a condition of being permitted to enter on the property and as part of the contract. The Prime Contractor shall be responsible for the enforcement of these requirements by its Subcontractors.

Before work is started, the Contractor shall furnish to the CO and COR, the name of the principal responsible official for the contract plus at least one alternate, with their home addresses and phone numbers, who may be contacted in case of emergencies occurring outside the regular hours of work. Similar information shall be furnished concerning all Subcontractors.

B. Hours to Work

The Contractor will be permitted to work on the job at the NCTR during the regular hours 6:00 a.m. to 5:00 p.m., Monday through Friday, except for the following holidays (some are

Page | 27 observed on preceding Friday or following Monday when they occur on Saturday or Sunday):

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

Work at any other time including holidays requires the contractor to request in advance and submit a schedule, in writing, to the COR. The COR shall then either approve or disapprove of the request. In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed.

However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or…