FDA Solicitation 75F40120R00010.pdf

SOLICITATION, OFFER,

AND AWARD

2. TYPE OF SOLICITATION

6. PROJECT NO. 4. CONTRACT NO. 5. REQUISITION/PURCHASE REQUEST NO.

PAGE OF PAGES

7. ISSUED BY CODE 8. ADDRESS OFFER TO

SOLICITATION

(Construction, Alteration, or Repair)

1. SOLICITATION NO. 3. DATE ISSUED

IMPORTANT -- The "offer" section on the reverse must be fully completed by offeror.

9.

INFORMATION

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

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

CALL:

FOR

SEALED BID (IFB)

NEGOTIATED (RFP)

FDA/OO/OFBA/OAGS/DAP

OAGS - Field Operations Branch

ATTN: Tim Walbert 3900 NCTR ROAD, Bldg 50 Rm 426

HFT-323

JEFFERSON AR 72079

Same as Block 7

TIMOTHY WALBERT 870-543-7267

1x 03/09/2020

75F40120R00010

10. THE GOVERNMENT REQUIRES PERFORMANCE OF THE WORK DESCRIBED IN THESE DOCUMENTS (Title, identifying no., date)

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires complete roof and deck structure tear-down and replacement of Bldg. 5(D), to include interior area demolition and renovation, and re-location of FDA scientific and animal-care personnel.

The Government intends to award a Firm Fixed-Price contract. This acquisition is 100% set-aside for HUBZone concerns. The applicable North American Industry Classification System (NAICS) code for this acquisition is 238160 (Roofing Contractors) with a Small Business Size Standard is $16.5 million dollars. The project magnitude is between $1,000,000 and $5,000,000.

A site visit is scheduled for 9:00 AM Central Time on Monday, March 16, 2020.

Offerors are strongly encouraged to attend. Notification of intent to attend must be sent to Tim Walbert at timothy.walbert@fda.hhs.gov no later than 2:00 PM Central

Time on Friday, March 13, 2020.

11. The Contractor shall begin performance

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

award, notice to proceed. The performance period is mandatory negotiable. (See ________________________________________________.)

13. ADDITIONAL SOLICITATION REQUIREMENTS:

a. Sealed offers in original and is not required.is, 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.

(date). If this is a sealed bid solicitation, offers will be publicly opened at that time. Sealed envelopes containing offers shall be marked to show the offeror's name and address, the solicitation number, and the date and time offers are due.

d. Offers providing less than

12b. CALENDAR DAYSYES NO

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

10 540 calendar days and complete it within ________________ ________________ calendar days after receiving

FAR 52.211-10

________________________ 04/09/2020

NSN 7540-01-155-3212

x x x x copies to perform the work required are due at the place specified in Item 8 by _____________ ___________________ (hour) local time calendar days for Government acceptance after the date offers are due will not be considered and will be rejected . _________________

STANDARD FORM 1442 (Rev. 4-85)

Prescribed by GSA

FAR(48 CFR) 53.236-1(d)

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 by the Government in writing within ____________________ calendar days after the date offers are due. (Insert any number equal to or greater than the minimum requirement stated in item 13d. Failure to insert any number means the offeror accepts the minimum in item 13d.)

14. NAME AND ADDRESS OF OFFEROR (Include ZIP Code) 15. TELEPHONE NO. (Include area code)

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

CODE FACILITY CODE

AMOUNTS

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

19. ACKNOWLEDGEMENT OF AMENDMENTS

OFFER (Must be fully completed by offeror)

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

AMENDMENT NO.

DATE.

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

AWARD (To be completed by Government)

21. ITEMS ACCEPTED:

22. AMOUNT 23. ACCOUNTING AND APPROPRIATION DATA

24. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM 25. OTHER THAN FULL AND OPEN COMPETITION PURSUANT TO

26. ADMINISTERED BY CODE 27. PAYMENT WILL BE MADE BY

CONTRACTING OFFICER WILL COMPLETE ITEM 28 OR 29 AS APPLICABLE

(Contractor is required to sign this document and return (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.

30a. NAME AND TITLE OF CONTRACTOR OR PERSON AUTHORIZED TO SIGN (Type or print) 31a. NAME OF CONTRACTING OFFICER (Type or print)

30b. SIGNATURE 30c. DATE 31b. UNITED STATES OF AMERICA 31c. DATE

BY

2PAGE OF

FDA/OO/OFBA/OAGS/DAP

OAGS - Field Operations Branch

ATTN: Tim Walbert 3900 NCTR ROAD, Bldg 50 Rm 426

HFT-323

JEFFERSON AR 72079

REGINA R. WILLIAMS

28. NEGOTIATED AGREEMENT 29. AWARD

Contractor agrees to furnish 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, copies to issuing office.)

10 U.S.C. 2304(c) 41 U.S.C. 253(c)

STANDARD FORM 1442 (REV. 4-85) BACK

See SECTION B, paragraph B-2, Compensation - Fixed Price Schedule

FDA Solicitation No.: 75F40120R00010

Page | 3

Table of Contents

PART I- THE SCHEDULE 3

SECTION B- SUPPLIES OR SERVICES AND PRICES/COSTS 4

SECTION C- DESCRIPTION/SPECIFICATONS/STATEMENT OF WORK 4

SECTION D- PACKAGING AND MARKING 5

SECTION E- INSPECTION AND ACCEPTANCE 5

SECTION F- DELIVERIES OR PERFORMANCE 6

SECTION G- CONTRACT ADMINISTRATION DATA 7

SECTION H- SPECIAL CONTRACT REQUIREMENT 11

PART II- CONTRACT CLAUSES 32

SECTION I- CONTRACT CLAUSES 32

PART III- LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS 36

SECTION J- LIST OF ATTACHMENTS 36

PART IV- REPRESENTATION AND INSTRUCTIONS 37

SECTION K- REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS OR RESPONDENTS 37

SECTION L- INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

OR RESPONDENTS 40

SECTION M- EVALUATION FACTORS FOR AWARD 46

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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 complete roof and deck structure tear-down and replacement of Bldg. 5(D), to include interior area demolition and renovation, and re-location of FDA scientific and animal-care personnel.

B-2 Compensation – Fixed Price Schedule

Contract Line Item

No.

Description Quantity Unit Price

Phase 1 - Relocation of Bldg. 5(D) diet prep personnel and equipment, to include demolition and renovation of interior spaces and existing mechanical, electrical and plumbing systems;

Phase 2 – tear-down and replacement of entire Bldg. 5(D) roof area to include demolition and construction of existing roof and decking structure;

Phase 1 and Phase 2 shall be completed in accordance with the following attachments:

• ATTACHMENT J-1: Project Manual

• ATTACHMENT J-2: Drawings

1 Job $

Total Price CLIN 0001 $

SECTION C- DESCRIPTION/SPECIFICATONS/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 and in Section J, ATTACHMENT J-1: Project Manual, and ATTACHMENT J-2: Drawings.

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C-2 Government Furnished Property and Services

Water and electricity may be used by the Contractor form 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. 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) https://www.acquisition.gov/?q=browsefar

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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. 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), OAGS, Building 50, Room 426, 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 10 calendar days after contract award

2. Pre-construction conference 1 Within 7 calendar days after contract award

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

Within 10 calendar days of contract award. Submit to NCTR Safety Office, Building 50, Room 304.

4. Certificate of Insurance (See Section H-6) 1 Within 10 calendar days after contract award. .

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

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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

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

The FDA does not accept documents which contain the use of macros. 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)

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 365 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

Page | 8 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

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."

Page | 9

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. Tim Walbert, Contract Specialist (CS) 3900 NCTR Road HFT-320, Rm 426 Jefferson, AR 72079 Phone: 870-543-7267 Email: timothy.walbert@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 352.237-75 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.

mailto:timothy.walbert@fda.hhs.gov

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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 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:

Food and Drug Administration National Center for Toxicological Research Attention: Tim Walbert, Contract Specialist 3900 NCTR Road, HFT-320, Bldg. 50, Rm 426 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 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:

http://www.gsa.gov/portal/forms/type/SF

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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 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.

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.

http://oig.hhs.gov/fraud/ http://www.cpars.gov/ https://www.cpars.gov/main/cparsmain.htm

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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 time while in DHHS- owned or leased space.

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

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

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

and

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

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

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

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

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

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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.

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

Page | 14 in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

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

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

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

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

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

6. PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, 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.

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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 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

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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

Appendix A

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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:

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 not 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:

A. Contractor Shall Submit All Invoices To:

U.S. FOOD AND DRUG ADMINISTRATION

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

MAIL HUB 2145

Silver Spring, MD 20993-0002

Phone: 301-827-3742 Email: FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

Provide a copy of Invoice(s) marked “courtesy” to the COR:

mailto:FDAVendorPaymentsTeam@fda.hhs.gov

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

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

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

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

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

(ix) Taxpayer Identification Number (TIN);

(x) 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;

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(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.

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.

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.

mailto:ERIC@fda.hhs.gov

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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:

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.

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(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.

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

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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 Presidents’ Day 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 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.

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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.