11-223-SOL-00030.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)

1082555

Food and Drug Administration

OAGS - ACQUISITIONS

Nick Sartain

3900 NCTR ROAD

HFA-323

AR

JEFFERSON 72079

Same as block 7

NICHOLAS SARTAIN

1x 03/17/2011

11-223-SOL-00030

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

The Contractor shall furnish the required labor, material, equipment and supervision to accomplish the work called for by this contract in accordance with the Scope of

Work in Part I, Section C and the specifications and drawings found in Part II, Section J-List of Attachments, Attachment J-1.

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.)

10 180 calendar days and complete it within ________________ ________________ calendar days after receiving

F-2 FAR 52.211-10

04/19/2011

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

Food and Drug Administration

OAGS - ACQUISITIONS

Attn: Nick Sartain

3900 NCTR ROAD

HFT-323

AR

JEFFERSON 72079

JERRY W. MARTIN

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

Continued...

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

NAME OF OFFEROR OR CONTRACTOR

3 70

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

11-223-SOL-00030

Delivery: 180 Days After Notice to Proceed

Delivery Location Code: NCTR

3900 NCTR ROAD

3900 NCTR ROAD

JEFFERSON AR 72079 US

FOB: Destination

1 Install elevator in Bldg 50, see section B for pricing details.

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

PART I – THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 Purpose B-2 Schedule of Items

SECTION C - DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK

C-1 – Scope of Work

SECTION D-PACKAGING AND MARKING

D-1 Marking Instructions for Reports D-2 Payment of Postage and Fees

SECTION E - INSPECTION AND ACCEPTANCE

E-1 - Inspection and Acceptance E-2 - 52.252-2 Clauses Incorporated by Reference. (FEB 1998) E-3 Government Inspectors

SECTION F - DELIVERIES OR PERFORMANCE

F-1 - Reports/Deliverables F-2 52.211-10 Commencement, Prosecution, and Completion of Work (APR 1984) F-3 - 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

SECTION G - CONTRACT ADMINISTRATION DATA

G-1 Contracting Officer’s Technical Representative (COTR) G-2 Technical Guidance G-3 Contract Administration G-4 HHSAR 352.242-70 Key Personnel (January 2006) G-5 Bonding Requirement G-6 Reporting Matters Involving Fraud, Waste, and Abuse

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H-1 FDA 1335 Personnel Security Clearance Requirements H-2 HHSAR 352.242-71 Tobacco-Free Facilities (January 2006) H-3 Payments to Contractors H-4 Invoice Submission H-5 FDA 1405 Contract Changes H-6 FDA 1409 Subcontracting and Subcontractors H-7 Required Insurance H-8 FDA 1418 General Conditions (Construction at NCTR) H-9 Specifications and Drawings for Construction H-10 Construction Schedule H-11 Pre-Construction/Installation Conference H-12 FAR 52.222-23 Notice of Requirement for Affirmative Action to Ensure Equal Employment Opportunity for Construction. (FEB 1999) H-13 Applicable Wage Rate Decision

PART II CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

I-1 FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998) I-2 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters.

(JAN 2011) Alternate I (Jan 2011)

I-3 FAR 52.215-19 NOTIFICATION OF OWNERSHIP CHANGES (OCT 1997)

I-4 FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (MAR 1989). 41

I-5 FAR 52.222-8 Payrolls and Basic Records (FEB 1988) DEVIATION I-6 FAR 52.223-11 Ozone-Depleting Substances (May 2001) I-7 FAR 52.225-9 Buy American Act - Construction Materials (SEPT 2010) I-8 52.228-1 Bid Guarantee (SEPT 1996) I-9 FAR 52.252-9 Authorized Deviations in Clauses (APR 1984)

PART III LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

Attachment J-1 -Specifications and Drawings Attachment J-2 -U.S. Department of Labor General Decision Number: AR100168

01/21/2011 AR168

Attachment J-3 - Standard Form 24, “Bid Bond” Attachment J-4 -Standard Form 25, “Performance Bond” Attachment J-5 -Standard Form 25A, “Payment Bond” Attachment J-6 -Standard Form 25B, “Continuation Sheet” (for SF’s 24, 25, and 25-A) Attachment J-7 -FDA Form 3391, “Security Card Access Request” Attachment J-8 -FDA Form 3398 “Contractor commitment to protect non-public information”

PART IV RESPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS OR RESPONDENTS

K-1 FAR 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998) K-2 FAR 52.204-8 Annual Representations and Certifications (JAN 2011)

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

RESPONDENTS

L-1 FAR 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998) L-2 52.215-1 Instructions to Offerors—Competitive Acquisition (JAN 2004)-

DEVIATION 53

L-3 FAR 52.215-20 REQUIREMENTS FOR COST OR PRICING DATA OR

INFORMATION OTHER THAN COST OR PRICING DATA (OCT 1997) Alternate IV (Oct 1997) L-4 FAR 52.216-1 Type of Contract (APR 1984)

L-5 FAR 52.222-5 DAVIS-BACON ACT—SECONDARY SITE OF THE WORK

(JULY 2005)

L-6 FAR 52.225-10 Notice of Buy American Act Requirement-Construction Materials (FEB 2009) L-7 FAR 52.233-2 Service of Protest (SEPT 2006) L.8 Bid Guarantee Requirements L-9 General Proposal Instructions L-10 Submission of Offers L-11 Cost of Proposal Preparation L-12 Reference Materials L-13 Magnitude of Construction L-14 Telegraphic and Facsimile Proposals L-15 FAR 52.236-27 Site Visit (Construction). (FEB 1995) Alt I (FEB 1995) L-16 FAR 52.252-5 Authorized Deviations in Provisions (APR 1984)

SECTION M - EVALUATION FACTORS FOR AWARD

M-1 General M-2 Evaluation Criteria M-3 52.217-5 Evaluation of Options (JULY 1990) M-4 Basis for Award

PART I – THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 Purpose

The Food and Drug Administration, Jefferson Lab Complex in Jefferson, Arkansas, is seeking firms interested in performing the installation of a 2,100 lb. capacity passenger elevator system in building 50.

Pursuant to the terms, conditions, specifications and drawings contained herein (See Scope of Work in Section C-1 and Attachment J-1 in Part II, Section J); the contractor shall furnish the necessary labor, materials, equipment and supervision to complete this project.

B-2 Schedule of Items

Item No. Description Price/Cost

01-

The scope of work consists of installing a fully operational 2100 lb elevator system in building 50 at the JLC. The new system will be installed per the construction drawings and manufacturer’s specifications and it shall meet all federal and state safety code requirements. The Firm shall provide all materials, labor and equipment necessary to prepare the existing shaft to receive the new system and then install the new system in its entirety. The Firm is responsible for the testing of all system parts and components. The work will be completed as indicated on the contract drawings and specifications.

For the Fixed Price Lump Sum of …… 1 job $___________

Notice to Offerors: Line items 02 through 05 are optional items. Options may be exercised within 180 calendar days after contract award, see FAR clause 52.217-7 in section I-4.

02- Optional item: Extended three (3) year warranty for the elevator system in item 01 above.

For the Fixed Price Lump Sum of …………. 1 job $___________

03- Optional item: Extended five (5) year warranty for the elevator system in item 01 above.

For the additional Fixed Price Lump Sum of …1 job $___________

04- Optional item: Replacement of existing passenger elevator in building 50 with a new fully functional elevator system.

05- Optional item: Extended (3) year warranty for the elevator system in item 04 above.

SECTION C - DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK

C-1 – Scope of Work

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth herein and in Attachment No. J-1, Contract Drawings and Specifications in Part II to this contract Section J- List of Attachments. The attachments listed in Section J are hereby made part of this solicitation and any resultant contract.

Scope of Work (See drawings and specifications Section J, attachment J-1, for Complete Scope of Work)

The scope of work consists of installing a complete and fully operational 2100 lb. Capacity Seven Floor Passenger Elevator System in Building 50. The new system will be installed per existing construction drawings and manufacturer’s specifications and it shall meet all federal and state safety code requirements. It is a stand-alone system. The Firm shall provide all materials, labor and equipment necessary to prepare the existing shaft to receive the new system and then install the new system in its entirety. The Firm is responsible for the testing of all system parts and components to verify that they are in working order prior to installation, and if there is any part or component failure after installation the Firm will replace the parts or components at no cost to the government. The contractor is responsible for the installation of all architectural, electrical (including a 480 volt grounded transformer), mechanical, and any other requirements associated with the new system at each floor. The Firm is also responsible for all testing requirements. Upon completion of construction, the Firm shall provide operational testing to demonstrate 100% successful performance prior to commissioning of system. The Firm shall also provide as-built drawings, four (4) sets of O & M manuals and four (4) hours of training.

Government Furnished Property and Services

NOTE: The Jefferson Laboratories will not furnish any materials/property, except as noted below.

Utilities

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. The Contractor must provide telephone services at the contractor’s cost.

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 appropriate inspection clause as provided 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 CO or his/her designated inspector (COTR). The Contractor shall be responsible for any countermeasures or corrective action, within the scope of this contract, which may be required by the Contracting Officer 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):

[Internet addresses: http://www.acqnet.gov/FAR ]

FAR

Clause No. Title and Date

52.246-12 Inspection of Construction (AUG 1996)

E-3 Government Inspectors

The work will be conducted under the general direction of the Contracting Officer and is subject to inspection by his/her designated inspectors (COTR) 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 Contracting Officer, nor shall the presence or absence of an inspector relieve the Contractor from any requirements of the contract.

http://www.acqnet.gov/FAR

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,OAGS, Building 50 Room 422, 3900 NCTR Road, Jefferson, AR 72079.

The Contractor shall submit the following reports/deliverables:

Scheduled Items Qty Due Dates

1. Key Personnel Information As specified Submit with proposal. See section L-9.

2. Bid Bond 1 Submit with proposal. See section L-8

3. FDA Form 3391 1/person Upon notice of clearance under Preliminary security checks as requested.

4. Performance and Payment Bonds 1 Within 20 calendar days after contract award

5. Pre-construction conference 1 Within 20 calendar days after contract award

6. Listing of Contractor Employees 1 10 calendar days prior to commencement of work.

7. Certificate of insurance 1 Prior to commencement of work.

8. Preliminary Construction Performance Schedule 3

NLT 20 calendar days after receipt of notice to proceed submit preliminary schedule. Submit complete schedule as outlined in section H-10. Submit to

COTR.

9. Subcontracting Information 3 Within 14 calendar days after contract award. Updated as needed

10. Schedule of Values 3 Within 30 calendar days of date established for commencement of work

11. Invoice 3 Monthly.

12. Submittals 5

Far enough in advance of scheduled dates of installation to provide 30 calendar days for reviews, approvals, possible revisions and resubmittals and for placing orders and securing delivery.

13. Updates to construction schedule 2 Monthly to COTR.

14. Certification Statement & Payrolls 1 Monthly with Invoice

15. Progress Meetings As needed – Date to be Determined

16. Project Record Drawings 2 NLT 30 days Prior to submission of final invoice

17. O & M Manuals 4 With submission of final invoice

17. Warranties 2 NLT 30 days Prior to submission of final invoice

F-2 52.211-10 Commencement, Prosecution, and Completion of Work (APR 1984)

The Contractor shall be required to (a) commence work under this contract within 10 calendar days after the date the Contractor receives the notice to proceed, (b) prosecute the work diligently, and (c) complete the entire work ready for use not later than _180 calendar days after receipt of the notice to proceed. The time stated for completion shall include final cleanup of the premises.

(End of clause)

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

[Internet addresses: http://www.acqnet.gov/FAR ]

FAR

Clause No. Title and Date 52.211-13 Time Extensions. (SEPT 2000) 52.242-14 Suspension of Work (APR 1984)

SECTION G - CONTRACT ADMINISTRATION DATA

G-1 Contracting Officer’s Technical Representative (COTR)

The COTR responsible for the acceptance of work provided hereunder will be designated by separate correspondence. The term ‘‘COTR’’ means the person who monitors the technical aspects of contract performance. The COTR 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 COTR 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 Contracting Officer’s Technical Representative (COTR). 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 COTR 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 COTR 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 COTR 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 COTR is within one of the categories as defined in B.(1) through B.(4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. 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 COTR prior to performance to arrange for the following:

Access to the Facility

G-3 Contract Administration

a. Administrative Contracting Officer Nick Sartain, Contract Specialist 3900 NCTR Road

HFT-320

Jefferson, AR 72079 Phone: 870-543-7370 Email: Nick.sartain@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 Technical Representative (COTR)

Name: To be completed at time of award 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 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 mailto:Nick.sartain@fda.hhs.gov employ of the Contractor), the Contractor shall notify the Contracting Officer 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 Contracting Officer. 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 Job Superintendent (on-Site)

(End of clause)

G-5 Bonding Requirement

Acceptable Performance and Payment Bonds shall be furnished to the Contracting Officer by the Contractor within twenty (20) 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: Nick Sartain, Contract Specialist

OAGS, HFT-320

3900 NCTR Road 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 will 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” are attached. 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 Generals 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/hotline.html mailto:HHStips@oig.hhs.gov http://oig.hhs.gov/hotline.html

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H-1 FDA 1335 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) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or leased space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b. “Contractor’s Commitment to Protect Non-public Information Agreement” forms signed by each employee named in paragraph a. above.

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.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process). However, in the event that work must commence before security badges can be issued, contractor employees will be 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 (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk levels for this contract are Level 5.

There are two (2) potential position risk levels, which are:

a. Non-Sensitive Positions (Level 1) (SEE CHART A) – Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The impact involving the duties are of limited effect. The forms set forth by CHART A are required for Non- Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a favorable preliminary check will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHARTS B) – Positions in which the incumbent’s actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHARTS B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive a preliminary check as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate 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. The Personnel Security Specialist will use this information to initiate 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 suitability background investigation. The COTR for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in the Contractor’s employees being denied access to FDA property until all security processing has been completed.

3. BADGING PROCESS

The FDA COTR will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Officer at least ten (10) days prior to the commencement of work. Fingerprints will be submitted in one of two ways, depending on where the contract will be performed.

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

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

Food and Drug Administration National Center for Toxicological Research Safety Office, Building 50, Room 304 3900 NCTR Road

Jefferson, AR 72079 Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk levels 1, 5, and 6 serving under this contract.

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

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquires covering the subject’s background.

Background investigations will be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor’s name, the contract number, the name of the Contracting Officer administering the Contract, the names of all Contractor employees’ for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, “TO BE OPENED BY ADDRESSEE ONLY,” to:

Food and Drug Administration National Center for Toxicological Research Safety Office, Building 50, Room 304 3900 NCTR Road Jefferson, AR 72079

The Contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The Contractor shall advise its prospective employees that all standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

Personnel Security Staff will resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract.

Those who are not cleared must cease work on the contract immediately.

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

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.

The Contractor shall be responsible for the return of any Government issued security badges to the COTR.

5. 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

Charts A & B attached.

For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided:

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE POSITIONS

- LEVEL 1

FORM NAME

OBTAIN

FROM

WHEN REQUIRED SUBMIT

TO

DATE REQUIRED

FDA Form 3391 - FDA Security Card Access Request

COTR. Sponsorship must be provided by

FDA COTR.

All positions on DHHS property or leased space

Food and Drug Administration Office of Security Operations, Policy & Planning Attn: Food and Drug Administration

National Center for Toxicological Research

Safety Office, Building 50, Room 304

Form must be received prior to making fingerprint appointment.

**Form must be submitted by Security

Rep.

Contractor’s Commitment to

Protect Non-Public Information (NPI) Agreement form

Contracting Officer All positions with access to non-public privileged, proprietary, or trade secret information

If requested by the government

Contracting Officer for retention in contract file

Ten (10) calendar days prior to commencement of work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act Release

Contractor generated All positions, including intermittent, per diem or

Temporary

When Requested by

* Food and Drug Administration Attn: Food and Drug Administration

National Center for Toxicological Research

Safety Office, Building 50, Room 304 3900 NCTR Road

Jefferson, AR 72079 870-543-7193, -7941

Ten (10) calendar days prior to commencement of work

SF 85 - Questionnaire for Non- Sensitive Positions

Online via OPM’s e- QIP system

For Non U.S. Citizens only

Non-Sensitive Positions - Level 1 Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days upon request of the Contracting Officer

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (870) 543-7193

Contracting Officer Non-Sensitive Positions - Level 1 Clearance

When Requested by government

* Food and Drug Administration Attn: Food and Drug Administration

National Center for Toxicological Research

Safety Office, Building 50, Room 304 3900 NCTR Road

Jefferson, AR 72079 870-543-7193, -7941

Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of

Contracting Officer.

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

Food and Drug Administration

Attn: Food and Drug Administration National Center for Toxicological Research

Safety Office, Building 50, Room 304 3900 NCTR Road

870-543-7193, -7941

CHART B

Public Trust

Positions - Levels 5 or

FORM NAME

OBTAIN

FROM

WHEN REQUIRED SUBMIT

TO

DATE

REQUIRED

SF 85P - Questionnaire for Public Trust Positions

Online via OPM’s e-QIP system

For non U.S. Citizens only

Public Trust Positions - Level 5 or 6 Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days prior to commencement of work

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 827-9527

Contracting Officer Public Trust Positions - Level 5 or 6 Clearance

When requested by the

* Food and Drug Administration Attn: Food and Drug Administration

National Center for Toxicological Research Safety Office, Building 50, Room 304

3900 NCTR Road

Ten (10) calendar days prior to

870-543-7193, -7941

FDA Form 3391 - FDA Security Card Access Request

COTR.

Sponsorship must be provided by FDA

COTR.

All positions on DHHS property or leased space

Food and Drug Administration Office of Security Operations, Policy & Planning Attn: Food and Drug Administration

National Center for Toxicological Research Safety Office, Building 50, Room 304

**Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.

Contractor’s Commitment to Protect Non-Public Information

(NPI) Agreement form

Contracting Officer All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to commencement of work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting

Act Release

Contractor generated All positions, including intermittent, per diem or temporary

* Food and Drug Administration Attn: Food and Drug Administration

National Center for Toxicological Research Safety Office, Building 50, Room 304

3900 NCTR Road Jefferson, AR 72079 870-543-7193, -7941

Ten (10) calendar days prior to

H-2 HHSAR 352.242-71 Tobacco-Free Facilities (January 2006)

In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understand, and comply with this policy.

(End of clause)

H-3 Payments to Contractors

Progress payments will be made in accordance with the clause 52.232-5 entitled "Payments Under Fixed-Price Construction Contracts (SEP 2002)" 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 Contracting Officer, 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 Contracting Officer.

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. Partial payments containing requests for materials on site shall be accompanied by itemized inventory lists with unit prices and supporting invoices showing unit costs of materials on site.

C. The Contractor, prior to receiving a progress or final payment under this contract, shall submit to the Contracting Officer 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 Contracting Officer 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-4 Invoice Submission

The Contractor shall submit vouchers or invoices in accordance with the following instructions:

A. In accordance with FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003); all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration, OAGS, HFT-320, 3900 NCTR Road, Jefferson, AR 72079-9502 on each invoice submission:

B. An original and two (2) copies shall be submitted to the attention of the designated Contract Specialist at the following address:

Department of Health and Human Services Food and Drug Administration National Center for Toxicological Research Attention: Nick Sartain, Contract Specialist Office of Acquisitions & Grants Services, HFT-320 3900 NCTR Road Jefferson, AR 72079-9502

C. To constitute a proper invoice, the Contractor must submit the invoice on company letterhead and include:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract number;

(iv) 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;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the Contract or in a proper notice of assignment);

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

(ix) Taxpayer identification number (TIN).

(x) Electronic funds transfer (EFT) banking information.

(xi) Name and telephone number of the FDA Contracting Officer’s Technical Representative referenced on the contract; and

(xii) Any other information or documentation required by the Contract.

H-5 FDA 1405 Contract Changes

The provisions of clauses 52.243-4, Changes, and 52.243-5, Changes and Changed Conditions, in Part II, Section I, are supplemented as follows:

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

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

1. Material quantities and unit prices;

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

3. Construction equipment costs;

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

5. Overhead costs;

6. Profit;

7. Employment Taxes, and those resulting from the Federal Insurance Contribution Act (FICA) and Federal Unemployment Tax Act (FUTA), and State Unemployment Act (SUTA);

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

9. Any increase or decrease in bond coverage.

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

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

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

F. Not more than three (3) percentages, none of which shall exceed ten percent (10%) will be allowed regardless of the number of Subcontractors, i.e., the mark-up on work subcontracted by a Subcontractor will be limited to one overhead percentage and one profit percentage in addition to the general Contractor's commission percentage.

G. 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-6 FDA 1409 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.

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 Contracting Officer, 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 will be allowed to perform any work on the project site until the following condition, 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 Contracting Officer; 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-7 Required Insurance

The clause 52.228-5,…