1210198_Amendment_1_to_Solicitation_with_Attachments.pdf

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1210198 Amendment 1 to Solicitation with Attachments

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(See ).

SOLICITATION, OFFER,

AND AWARD

(Construction, Alteration, or Repair) IMPORTANT - The "offer" section on the reverse must be fully completed by offeror.

9. FOR INFORMATION

CALL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid and "bidder".

SOLICITATION

1. SOLICITATION NUMBER

CODE

6. PROJECT NUMBER

8. ADDRESS OFFER TO

4. CONTRACT NUMBER

11. The contractor shall begin performance within

12a. THE CONTRACTOR MUST FURNISH ANY REQUIRED PERFORMANCE AND PAYMENT BONDS?

(If "YES", indicate within how many calendar days after award in Item 12b.)

13. ADDITIONAL SOLICITATION REQUIREMENTS:

a. Sealed offers in original and

b. An offer guarantee

c. All offers are subject to the (1) work requirements, and (2) other provisions and clauses incorporated in the solicitation in full text or by reference.

d. Offers providing less than

STANDARD FORM 1442 (REV. 8/2014)

Prescribed by GSA - FAR (48 CFR) 53.236-1(d) calendar days for Government acceptance after the date offers are due will not be considered and will be rejected.

is, is not required.

containing offers shall be marked to show the offeror's name and address, the solicitation number, and the date and time offers are due.

(date). If this is a sealed bid solicitation, offers will be publicly opened at that time. Sealed envelopes copies to perform the work required are due at the place specified in Item 8 by (hour) award, YES NO notice to proceed. This performance period is mandatory negotiable.

calendar days and complete it within calendar days after receiving

a. NAME b. TELEPHONE NUMBER (Include area code) (NO COLLECT CALLS)

12b. CALENDAR DAYS

2. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

3. DATE ISSUED PAGE OF PAGES

1210198

7. ISSUED BY

FDA/00/0FBA/OAGS/DAP

Field Operations Branch Warren Dutter 3900 NCTR Road, Bldg 50, Rm, 417 Jefferson AR 72079 Warren.Dutter@fda.hhs.gov

Same as Block 7

5. REQUISITION/PURCHASE REQUEST NUMBER

1210198

HFA 323

Warren Dutter (870)543-7577

104/16/2019 local time 05/17/2019

FAR 52.211.10

X

10. THE GOVERNMENT REQUIRES PERFORMANCE OF THE WORK DESCRIBED IN THESE DOCUMENTS (Title, identifying number, date)

Project Title: Provide and install water treatment plant chemical feed upgrades in Building 11 to support the National Center for Toxicological Research (NCTR) campus potable water chemical treatment facility.

100% Small Business Set- aside; NAICS 236220 - Commercial and Institutional Building Construction; Small Business Size Standard is $36.5 Million.

The project magnitude is between $250,000 and $500,000.

A site visit is scheduled for 8:30 AM 1:00 PM (Central Time) on May 1, 2019. Offerors are highly encouraged to attend. Notification of intent to attend must be sent to Warren Dutter at warren.dutter@fda.hhs.gov no later than 4:30 PM (Central Time) on April 29, 2019.

Questions concerning the project are required in writing to warren.dutter@fda.hhs.gov by 4:30 PM (Central Time) on May 3, 2019.

Warren.Dutter Cross-Out

17. The offeror agrees to perform the work required at the prices specified below in strict accordance with the terms of this solicitation, if this offer is accepted calendar days after the date offers are due. (Insert any number equal to or greater than the minimum requirement by the Government in writing within stated in Item 13d. Failure to insert any number means the offeror accepts the minimum in Item 13d.)

OFFER (Must be fully completed by offeror)

AMOUNTS

18. The offeror agrees to furnish any required performance and payment bonds.

19. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the solicitation -- give number and date of each)

AMENDMENT

NUMBER

DATE.

AWARD (To be completed by Government)

CONTRACTING OFFICER WILL COMPLETE ITEM 28 OR 29 AS APPLICABLE

14. NAME AND ADDRESS OF OFFEROR (Include ZIP Code)

CODE FACILITY CODE

15. TELEPHONE NUMBER (Include area code)

16. REMITTANCE ADDRESS (Include only if different than Item 14.)

20a. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER (Type or print)

21. ITEMS ACCEPTED:

22. AMOUNT

26. ADMINISTERED BY

30a. NAME AND TITLE OF CONTRACTOR OR PERSON AUTHORIZED TO SIGN (Type or print)

31c. DATE

STANDARD FORM 1442 (REV. 8/2014) BACK

31b. UNITED STATES OF AMERICA

BY

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

29. AWARD (Contractor is not required to sign this document.) Your offer on this solicitation is hereby accepted as to the items listed. This award consummates the contract, which consists of (a) the Government solicitation and your offer, and (b) this contract award. No further contractual document is necessary.

30b. SIGNATURE 30c. DATE

28. NEGOTIATED AGREEMENT (Contractor is required to sign this document and return and deliver all items or perform all work requirements identified on this form and any continuation sheets for the consideration stated in this contract. The rights and obligations of the parties to this contract shall be governed by (a) this contract award, (b) the solicitation, and (c) the clauses, representations, certifications, and specifications incorporated by reference in or attached to this contract.

copies to issuing office.) Contractor agrees to furnish

24. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

23. ACCOUNTING AND APPROPRIATION DATA

ITEM 25. OTHER THAN FULL AND OPEN COMPETITION PURSUANT TO

27. PAYMENT WILL BE MADE BY

10 U.S.C. 2304(c) ( ) 41 U.S.C. 3304(a) ( )

20b. SIGNATURE 20c. OFFER DATE

H-3

FDA/OO/OFBA/OAGS/DAP Field Operations Branch Warren Dutter 3900 NCTR Rd, Bldg. 50, Rm 417, Jefferson, AR 72079

Table of Contents

PART I- THE SCHEDULE

SECTION B- SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C- DESCRIPTION/SPECIFICATONS/STATEMENT OF WORK

SECTION D- PACKAGING AND MARKING

SECTION E- INSPECTION AND ACCEPTANCE

SECTION F- DELIVERIES OR PERFORMANCE

SECTION G- CONTRACT ADMINISTRATION DATA

SECTION H- SPECIAL CONTRACT REQUIREMENT

SECTION I- CONTRACT CLAUSES

SECTION J- LIST OF ATTACHMENTS

SECTION K REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS OR RESPONDENTS

SECTION L- INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS OR RESPONDENTS

SECTION M- EVALUATION FACTORS FOR AWARD

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PART I- THE SCHEDULE

SECTION B- SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 Purpose

N.C.T.R. Building 11 Water Treatment Plant Upgrade at the U.S. Food and Drug Administration (FDA) Jefferson Laboratories Complex in Jefferson, AR as detailed herein.

B-2 Schedule of Items

Contract Line Item No.

Description Quantity Unit Price

The contractor shall provide and install water treatment plant chemical feed upgrades in N.C.T.R. Building 11 Water Treatment Plant to support the National Center for Toxicological Research (NCTR) campus potable water chemical treatment facility.

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth herein and in Section J, Attachment J-1 Specifications and Attachment J-2 Drawings.

Work shall be accomplished in accordance with Specifications and Drawings:

Attachment J-1: Specifications: N.C.T.R.

Building 11 Water Treatment Plant Upgrade Attachment J-2: Drawings: N.C.T.R. Building 11 Water Treatment Plant Upgrade

1 Job $

SECTION C- DESCRIPTION/SPECIFICATONS/STATEMENT OF WORK

C-1 Scope of Work

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This project consists of upgrading existing chemical feeders, pumps and improvements to the National Center for Toxicological Research (NCTR) Building 11 Water Treatment Plant.

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth herein and in Section J, Attachment J-1 Specifications and Attachment J-2 Drawings.

Government Furnished Property and Services:

Water and electricity may be used by the Contractor from existing outlets at no cost to the Contractor. 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.

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. Also, the full text of a clause may be accessed electronically at this/these address (es):

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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 insure 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.

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), OAGS, Building 50 Room 417, 3900 NCTR Road, Jefferson, AR 72079.

The Contractor shall submit the following reports/deliverables:

Scheduled Items Qty Due Dates

1. Submit Executed Bonds 1 Within 10 calendar days of contract award

2. Listing of Contractor Employees with Full Name, SSN, and DOB for Background Investigation.

1 Within 10 calendar days of contract award

3. Certificate of Insurance 1 Within 10 calendar days of contract award

4. Construction Performance Schedule and Schedule of Values 3

Preliminary within 10 calendar days of receipt of notice to proceed with final not later than 10 calendar days of Government’s review

Pre-construction Meeting Within 10 calendar days after contract award

5. Draft Invoice for Review 1 Monthly

6. Submittals of Product Data and Shop Drawings (Hard copy and Electronic) 3 Not later than 15 calendar days from contract award

7. Updates to Construction Schedule 2 Monthly with Invoice, if changes

8. Certification Statement & Payrolls 1 Monthly with Invoice

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9. Project Record Drawings 2 NLT 30 calendars days prior to submission of final invoice

10. O & M Manuals 4 NLT 30 calendars days prior to submission of final invoice

11. Warranties 2 NLT 30 calendars days prior to submission of final invoice

F-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 CO will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/?q=browsefar http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

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 September 29, 2019…”

Alternate I (Apr 1984) - The completion date is based on the assumption that the successful offeror will receive the notice to proceed by July 1, 2019.

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:

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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 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 within one of the categories as defined in B. (1) through B. (4) 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. Contract Specialist Warren Dutter 3900 NCTR Road

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HFT-320

Jefferson, AR 72079 Phone: 870-543-7577 Email: warren.dutter@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.

Name:

Office:

Email:

G-4 HHSAR 352.242-70 Key Personnel (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 calendar days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the CO and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the CO. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The individuals cited below are key personnel.

Name Title

____________________________ Project Manager ____________________________ On-Site Superintendent

(End of clause)

G-5 Bonding Requirement

Acceptable Performance and Payment Bonds shall be furnished to the Contract Specialist (CS) by the Contractor within ten (10) 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:

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Food and Drug Administration National Center for Toxicological Research Attention: Warren Dutter, Contract Specialist 3900 NCTR Road, HFT-320, Bldg. 50, Rm 417 Jefferson, AR 72079-9502

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.

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

The surety(ies) 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.

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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 https://www.cpars.gov/main/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 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 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 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. Evaluations will also be stored for a 3 year period (6 years for construction) in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

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 Personnel Security Clearance Requirements

1. Background

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) 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, 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 full background investigation requirement but will still be subjected to a background check. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. General

12 of 401210198 https://www.cpars.gov/main/cparsmain.htm https://www.cpars.gov/main/cparsmain.htm

The contractor shall submit the following items to the Contracting Officer, within ten (10) calendar days of contract award, a list of contractor employee’s names along with Social Security Number (SSN) and Date of Birth (DOB).

NCTR Office of Regulatory Compliance and Risk Management (RCRM) Staff will conduct all required background investigations at no cost to the contractor.

A Contractor’s failure to comply with the background investigation shall result in the Contractor’s employees being denied access to FDA property until all security processing has been completed.

In the event that a cleared individual is replaced, the contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

3. NON-PUBLIC DATA PROTECTION

The Contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure.

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 11, Section I, supplemented as follows:

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. No payment will be made for material delivered on or off site.

B. 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.

C. 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

A. The Contractor shall submit all Invoices to:

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Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is (insert name and email address.) To be completed at time of award.

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 award item number 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;

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(ix) Taxpayer Identification Number (TIN);

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

(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 Inspections, 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 Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

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

H-4 Contract Changes

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.

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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 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:

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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:

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.

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

New Year’s Day Martin Luther King's Birthday President's Day (Washington/Lincoln's Birthday) Memorial Day 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

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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 her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor will direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies.

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the contract.

C. Non-Interruption of Government Activities

Interruption or interference with conduct of Government business in other building areas outside the contract area, or damage to existing equipment or property within the contract area, will not be permitted. To protect Government property and to isolate its work, the Contractor shall provide, at no additional expense to the Government, drop cloths, plastic film draping, taping, barriers, weatherproof closures and/or coverings, and temporary dust-proof enclosures and partitions, etc.

Temporary dust-proof enclosures and partitions shall be provided whenever demolition or construction operations will produce dust or dirt, which would be spread by tracking or air currents beyond the immediate area of work. Such enclosures shall be erected structurally sound, and shall be maintained dust proof so as to keep surrounding areas clean and free of dust. Where practical, dust-producing activities shall be kept dampened with water, so as to reduce the generation of dust.

Temporary dust-proof enclosures shall always be required to separate sterile or germ-free areas from the Contractor's work area. Materials shall be conveyed inside buildings using Contractor-provided equipment, in a manner that prevents damage to floors (i.e., by hand, using rubber tired vehicles, etc.). Use of FDA equipment is prohibited. The use of equipment, which produces substantial noise or vibration in buildings, such as pneumatic hammers, etc., must be coordinated in advance with the COR.

D. Utility Shutdowns

Contractors shall not cut, disconnect, switch, open, or alter position of valves, or otherwise interrupt any utility systems, piping systems, electric services, etc. without prior written approval of the COR. Shutdown of any utility service, which will affect service to any areas other than those in the contract area, must be requested in writing a minimum of fourteen (14) working days in advance, and required written confirmation/approval prior to service interruption.

E. Material Delivery, Storage Areas and Debris Removal

1. Material Delivery. Contractors shall arrange for the deliveries of supplies or materials and equipment to the work site or designated storage areas via previously approved routes. Wherever practicable, deliveries shall be made during the regular FDA working hours (unless prior approval is

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2. Storage or Materials. The Government will make space available in FDA buildings or on FDA grounds for the storage of materials and equipment. The Contractor shall, as set forth in paragraph H.1 herein, be responsible for security of their property and material from theft and vandalism. Corridors and other public areas must be kept clear at all times.

3. Debris Removal. Removed materials, which are designated in the specifications or drawings as Contractor's property, or debris shall be promptly removed from the job site and the FDA facility.

Storage and/or collection of debris inside or outside buildings will not be permitted. Contractors shall remove all debris and other material with their own carts, containers, and/or refuse disposal facilities. Government facilities may not be used for this purpose. All interior areas of existing buildings shall be left clean on a daily basis. When debris must be removed from buildings outside normal FDA work hours, it must be scheduled for a designated time in advance (the same as for material deliveries). This shall be at the Contractor’s expense.

F. Safety and Accident Prevention

1. Contractors working at FDA facilities shall be responsible for compliance with all applicable safety regulations and standards issued under the provisions of the Williams/Steiger Occupational Safety and Health Act (OSHA) and other applicable regulations issued by state, county, or local authorities. Any deviations from the OSHA regulations will require a variance from the OSHA authorities prior to initiating the change.

2. Contractors shall safeguard the work site and perform all operations in such manner as to insure that their employees, Government personnel, and others who may gain access to the site will not be endangered.

3. Contractors shall provide illuminated barricades, flags, warning signs, and lighting at excavations, open manholes, damaged roads, or walks, and any interior danger areas, other open or broken surfaces, resulting from the Contractor's operations. Similar barriers and warning devices shall be provided by the Contractor to limit access to hazardous work areas, such as pavement-breaking operations and overhead work that requires the use of cranes, ladders, or scaffolds.

4. Explosives shall not be brought on FDA property without permission from the COR and local Fire Department Officials. Contractors shall obtain a written permit for the use of explosives at least five (5) calendar days prior to the actual date of use. For blasting operations, the Contractor shall provide personnel, flags, signs, barricades, and other appropriate means of adequate warning.

5. Where work requires entrance into a room posted as a "Restricted Area," which might present danger to Contractor's personnel in the form of pathogenic, radioactive, or chemical agents, the Contractor shall request instruction from the COR as to required protective measures, and shall abide by such instructions.

6. The Prime Contractor shall be responsible for the enforcement of these safety rules by its

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Subcontractors. Questions concerning safety shall be submitted to the COR for clarification by the Safety Office. The Safety Office has the authority at any time to enter a Contractor's construction site, in conjunction with the COR, after first contacting the Construction Foreman, for the purpose of conducting a safety survey.

7. A Contractor working on FDA Property is required to promptly report any accident suffered by its employees to the COR who will in turn notify the Safety Office.

G. Fire Prevention

1. Contractors shall instruct their employees to immediately report any fire to the COR, even if it has been extinguished.

2. Contractors are responsible for providing and maintaining fully functioning/charged fire extinguishers at work site at all times.

3. Construction trailers, sheds or temporary storage buildings shall not be moved to, or erected on, FDA Property without written approval, including inspection by the COR and Safety Officer, as to location of the structure and method of heating and lighting. They must be located within the Contractor's assigned area and are generally restricted to Contractor's assigned area and are generally restricted to large projects.

4. The installation of aboveground tanks for fueling the Contractor's equipment must be approved by the FDA COR and Safety Officer. Installation of underground tanks shall not be permitted.

5. Contractors shall not make connection to or use fire hydrants, standpipe risers, fire warning, or FDA fire alarm systems without prior approval of the COR. In the event of actual or anticipated emergencies, the Fire Department may discontinue the use by Contractors of water from fire hydrants or standpipe risers without advance notice.

6. Surges in water pressure frequently trip sprinkler alarm valves, and electric power switching surges affect the fire alarm system. Therefore, Contractors shall not open valves to new water lines or switch large electric loads on or off without prior notice to the FDA COR.

7. The Contractor shall obtain a Hazardous Work Permit from the FDA Safety Officer for any work involving heating, soldering, brazing, gas or electric welding, flame-cutting, tar kettles, salamanders, or other flame or heat-producing devices, both inside and outside buildings. The permit shall be conspicuously posted at the work site.

8. The Contractor shall provide fire extinguishers, fire blankets and fire watch personnel as required by the Hazardous Work Permit.

9. Accumulation of combustible waste materials and rubbish is prohibited. Such trash shall be removed promptly by the Contractor. Burning of waste material and rubbish is not permitted on the FDA Property.

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10. The bulk storage of combustible and flammable building materials in corridors, cross-corridor intersections, stairwells, lobbies, and mechanical rooms is prohibited.

11. The nightly storage of oil painting materials and supplies in corridors, cross-corridor intersections, stairwells, lobbies, and mechanical rooms is prohibited. Such materials shall be kept in locked and ventilated rooms or removed from the building each night.

12. The use of equipment fueled by petroleum products (propane, gasoline, fuel oil, etc.) is prohibited unless approved by the FDA Safety Officer. If approved, storage of flammable liquids in a building will be limited to the fuel tank capacity of such equipment.

H. Security

1. Contractors shall be responsible for security of their property and material from theft and vandalism.

2. The Government does not accept responsibility for loss or damage to any property or work it has not accepted.

3. Contractors shall be responsible for excluding all but authorized persons from their work sites.

4. Contractors and their employees shall immediately report any known violations of law or regulations, or the discovery of unaccountable property, either private or Government-owned, to the

COR.

5. Conduct on Federal Property: Contractors are advised that operating a motor vehicle when entering upon or while on FDA property by a person under the influence of alcoholic beverages, narcotic drugs, including hallucinogens, marijuana, barbiturates or amphetamines, is prohibited.

Entering upon the property, or while on the property, under the influence of, or using, or possessing any narcotic drug is prohibited. Such prohibition shall not apply in cases where the drug has been prescribed by a physician. Entering upon the property, or being on the property, under the influence of alcoholic beverages is prohibited. All vehicles are subject to search.

I. Motor Vehicles and Parking Regulations

1. All persons driving motor vehicles on FDA Property in connection with Contractor business, including the driving of employees' personal vehicles, shall abide by the rules and regulations of this Clause and those of FMR 102-74.430, Vehicular and Pedestrian Traffic.

Contractor vehicles shall be used for the conduct of business only. Vehicles shall remain parked at the job site, i.e., not be used to drive back and forth to the cafeteria.

2. Employees of Contractors shall park only in areas designated by the COR.

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3. Contractors and Subcontractors shall use only truck routes designated by the COR for deliveries of material and other contract operations. Designation of truck routes shall be requested and approved before the start of construction. Contractors shall be responsible for notifying all suppliers to make deliveries via the designated routes.

4. Vehicles operated over station roads in connection with contract work shall be loaded so as to minimize spillage of dirt, gravel, and other debris. The Contractor shall remove inadvertent spillage of nails, construction materials, scrap, etc., immediately. Dirt and gravel spillage or accumulations shall be removed as soon as practicable and as satisfactory to the COR, but in every case it shall be removed no later than the end of each workday.

5. The driver of any vehicle involved in an accident on the…

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