Sol 1107143_Sections B and C - E.pdf

Section B, Price(s)

B-1

Item No. Description Price/Cost 0001 Independently and not as an agent of the Government, the Contractor shall furnish the necessary project management, supervision, personnel, materials, equipment, services, and otherwise do all things necessary for or incident to the renovations of existing space in the U.S. Food and Drug Administration (FDA), Jefferson Laboratories, Building 53A, Room 225 to convert space into a laboratory.

For the Firm Fixed-Price Lump Sum of

1 Job

Section C, Contract Clauses

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C-1 FAR Clause 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 addresses: https://www.acquisition.gov/far/ and http://www.hhs.gov/policies/hhsar/subpart352.html

FAR

Clause No. Title and Date 52.204-7 Central Contractor Registration (FEB 2012) 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011) 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

(FEB 2012)

52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (DEC

2010) 52.211-10 Commencement, Prosecution, and Completion of Work (APR 1984)

“… within 5 calendar days after the date the Contractor receives the notice to proceed...complete the entire work ready for use not later than 45 calendar days after receipt of the notice to proceed…”

52.219-27 Notice of Service-Disabled Veteran-Owned Small Business Set-Aside

(NOV 2011)

52.219-28 Post-Award Small Business Program Representation (APR 2012) 52.222-3 Convict Labor (JUN 2003) 52.222-6 Davis-Bacon Act (JUL 2005) 52.222-7 Withholding of Funds (FEB 1988) 52.222-8 Payrolls and Basic Records (JUN 2010) 52.222-9 Apprentices and Trainees (JUL 2005) 52.222-10 Compliance with Copeland Act Requirements (FEB 1988) 52.222-11 Subcontracts (Labor Standards) (JUL 2005) 52.222-12 Contract Termination - Debarment (FEB 1988) 52.222-13 Compliance with Davis-Bacon and Related Act Regulations (FEB 1988) 52.222-14 Disputes Concerning Labor Standards (FEB 1988) 52.222-15 Certification of Eligibility (FEB 1988) 52.222-21 Prohibition of Segregated Facilities (FEB 1999) 52.222-26 Equal Opportunity (MAR 2007) 52.222-27 Affirmative Action Compliance Requirements for Construction (FEB 1999) 52.222-35 Equal Opportunity for Veterans (SEP 2010) 52.222-36 Affirmative Action for Workers with Disabilities (OCT 2010) 52.222-37 Employment Reports Veterans (SEPT 2010) 52.222-50 Combating Trafficking in Persons (FEB 2009) 52.223-3 Hazardous Material Identification and Material Safety Data (JAN 1997) –

Alternate I (JUL 1995) 52.223-5 Pollution Prevention and Right-to-Know Information (AUG 2003) 52.223-6 Drug-Free Workplace (MAY 2001)

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52.223-11 Ozone-Depleting Substances (May 2001) 52.223-12 Refrigeration Equipment and Air Conditioners (May 1995) 52.223-14 Toxic Chemical Release Reporting (AUG 2003) 52.223-15 Energy Efficiency in Energy-Consuming Products (DEC 2007) 52.223-17 Affirmative Procurement of EPA-Designated Items in Service and

Construction Contracts. (MAY 2008) 52.223-18 Contractor Policy to Ban Text Messaging While Driving. (AUG 2011) 52.225-9 Buy American Act - Construction Materials (SEPT 2010) 52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008) 52.227-1 Authorization and Consent (DEC 2007) 52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement

(DEC 2007)

52.227-4 Patent Indemnity - Construction Contracts (DEC 2007) 52.228-2 Additional Bond Security (OCT 1997) 52.228-5 Insurance - Work on a Government Installation (JAN 1997) 52.228-11 Pledges of Assets (JAN 2012) 52.228-12 Prospective Subcontractor Requests for Bonds (OCT 1995) 52.228-13 Alternative Payment Protections (JUL 2000)

(a) “…Payment Bond, Irrevocable Letter of Credit, U.S. Bonds or Notes, Certified or Cashiers Checks, Bank Drafts, Money Orders, or Currency.”

(c) “…within 10 calendar days of contract award.”

52.228-14 Irrevocable Letter of Credit. (DEC 1999) 52.228-15 Performance and Payment Bonds—Construction (OCT 2010) 52.232-5 Payments under Fixed-Price Construction Contracts (SEP 2002) 52.232-23 Assignment of Claims (JAN 1986) 52.232-27 Prompt Payment for Construction Contracts (OCT 2008) 52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration

(OCT 2003)

52.233-1 Disputes (JUL 2002) - Alternate I (Dec 1991) 52.233-3 Protest after Award (AUG 1996) 52.233-4 Applicable Law for Breach of Contract Claim (OCT 2004) 52.236-2 Differing Site Conditions (APR 1984) 52.236-3 Site Investigation and Conditions Affecting the Work (APR 1984) 52.236-5 Material and Workmanship (APR 1984) 52.236-6 Superintendence by the Contractor (APR 1984) 52.236-7 Permits and Responsibilities (NOV 1991) 52.236-8 Other Contracts (APR 1984) 52.236-9 Protection of Existing Vegetation, Structures, Equipment, Utilities, and

Improvements (APR 1984) 52.236-10 Operations and Storage Areas (APR 1984) 52.236-11 Use and Possession Prior to Completion (APR 1984) 52.236-12 Cleaning Up (APR 1984) 52.236-13 Accident Prevention (NOV 1991) 52.236-14 Availability and Use of Utility Services (APR 1984) 52.236-15 Schedules for Construction Contracts (APR 1984) 52.236-17 Layout of Work (APR 1984)

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52.236-21 Specifications and Drawings for Construction (FEB 1997) - Alternate I

(APR 1984)

52.236-26 Preconstruction Conference (FEB 1995) 52.242-14 Suspension of Work (APR 1984) 52.243-4 Changes and Changed Conditions (APR 1984) 52.244-6 Subcontracts for Commercial Items (DEC 2010) 52.245-1 Government Property (AUG 2010) 52.245-9 Use and Charges (AUG 2010) 52.246-12 Inspection of Construction (AUG 1996) 52.246-21 Warranty of Construction (MAR 1994) 52.248-3 Value Engineering—Construction (OCT 2010) 52.249-2 Termination for Convenience of the Government (Fixed-Price) (APR 2012)

– Alternate I (SEPT 1996) 52.249-10 Default (Fixed-Price Construction) (APR 1984) 52.253-1 Computer Generated Forms (JAN 1991)

HHSAR

Clause No. Title and Date

352.201-70 Paperwork Reduction Act (January 2006) 352.202-1 Definitions (January 2006) 352.203-70 Anti-Lobbying (January 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (January 2010) 352.223-70 Safety and Health (January 2006) 352.224-70 Privacy Act (January 2006) 352.227-70 Publications and Publicity (January 2006) 352.231-71 Pricing of Adjustments (January 2001) 352.242-71 Tobacco-Free Facilities (January 2006) 352.242-73 Withholding of Contract Payments (January 2006)

C-2 Government Furnished Property and Services

Water and electricity may be used by the Contractor from existing outlets at no cost to the Contractor. The Contractor shall pay for all temporary connections. Additionally, the Government will disconnect all services to the walk-in cooler prior to Contractor demolition and disposal. No other property or services will be furnished by the Government.

C-3 Government Inspectors

The work shall be conducted under the general direction of the Contracting Officer and is subject to inspection by his/her designated inspectors, referred to herein as Contracting Officer’s Representative (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 Contracting Officer, nor shall the presence or

C-4 absence of an inspector relieve the Contractor from any requirements of the contract.

C-4 Reports/Deliverables

Unless otherwise noted, all reports/deliverables shall be delivered to the attention of the Contract Specialist.

At a minimum, the Contractor shall submit the following reports/deliverables:

Scheduled Items Qty Due Dates

1. FDA Form 3391 1 per person

Within 5 calendar days of clearance under preliminary security checks

2. Alternative Payment Protection 1 Within 10 calendar days of contract award

3. Listing of Contractor Employees 1 Within 10 calendar days of contract award

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

5. Construction Performance Schedule and Schedule of Values

Preliminary within 5 calendar days of receipt of notice to proceed with final not later than 5 calendar days of Government’s review

6. Invoice 3 Monthly

7. Submittals 5 Not later than 5 calendar days from receipt of notice to proceed

8. Updates to Construction Schedule 2 Monthly with Invoice

9. Certification Statement & Payrolls 1 Monthly with Invoice

10. Project Record Drawings 2 NLT 5 calendars days prior to submission of final invoice

11. O & M Manuals 4 NLT 5 calendars days prior to submission of final invoice

12. Warranties 2 NLT 5 calendars days prior to submission of final invoice

C-5 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

C-5 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.

C-6 Technical Guidance

a. Performance of the work under this contract shall be subject to the technical Guidance of the Contracting Officer’s Technical Representative (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

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;

Perform technical evaluation as required;

Perform technical inspections and acceptances required by this contract; and

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 and Changed Conditions," (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

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

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

E. If, in the opinion of the Contractor, any instruction or direction issued by the COR is within one of the categories as defined in b.1 through b.4 above, the Contractor shall not proceed but shall notify the 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

C-6 directions are within the scope of this clause and do not constitute a change under the "Changes and Changed Conditions" 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 COR prior to performance to arrange for the following:

Access to the Facility

C-7 Contract Administration

a. Contracting Officer Jerry, Martin 3900 NCTR Road Jefferson, AR 72079 Phone: 870-543-7370 Email: jerry.martin@fda.hhs.gov

b. Contract Specialist Sondea Blair 3900 NCTR Road Jefferson, AR 72079 Phone: 870-543-7370 Email: sondea.blair@fda.hhs.gov

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

Office:

Cell:

Email:

d. Contracting Officer’s Representative (COR) (To be completed at time of award) Name:

Office:

Email:

C-8 Alternative Payment Protection

Payment protection (FAR Clause 52.228-13) shall be furnished to the Contracting Officer within ten (10) days of contract award. Notice to Proceed will not be given until the payment protection requirements are satisfactorily met.

C-7

C-9 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

C-10 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) working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or leased space for less than thirty

(30) calendar days are exempted from the full background investigation requirement but will still be subjected to a background check. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. General

The contractor shall submit the following items to the Contracting Officer, within ten (10) calendar days of contract award, certification that all required security form packets and a list of contractor employees names for whom the requisite security information have been provided to the NCTR Office of Regulatory Compliance and Risk Management (RCRM) together with “Contractor’s Commitment to Protect Non-public Information Agreement” forms signed by each employee.

NCTR RCRM Staff will perform all fingerprinting and the Government will conduct all required background investigations at no cost to the contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned

C-8 or leased property without an escort. However, in the event that work must commence before security badges can be issued, contractor employees may be allowed onto DHHS-owned or leased property, following a preliminary background check performed by RCRM, provided they are 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 Questionnaires for Investigations 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-level for this contract are Level 5.

Public Trust Positions (Levels 5 or 6) (SEE CHART 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 CHART 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 RCRM 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. RCRM 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 COR will provide the name of the appropriate RCRM Specialist to the Contractor.

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

3. BADGING PROCESS

The COR 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. Fingerprinting shall be conducted by RCRM and shall be scheduled by the contractor such that all employees requiring access complete fingerprinting within 5 calendar days of contract award.

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://www.uscis.gov/files/form/i-9.pdf.

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An individual who receives an unfavorable report may appeal that finding by submitting a written request through the Contracting Officer to the NCTR Office of Regulatory Compliance and Risk Management.

4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those Risk- Level 5 individuals serving under this contract.

Additional 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 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 Office of Regulatory Compliance and Risk Management 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 shall be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

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

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Employees who have been previously granted a Government security clearance shall advise the RCRM 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 the RCRM Staff, in writing, with copies to the COR and Contracting Officer.

The OPM background investigation will take approximately 30 calendar days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared 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 COR.

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.

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

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CHART B

Public Trust Positions - Levels 5 or 6

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 and Public Trust Positions - Level 5 or 6 Clearance

Submit to OPM online via the e-QIP system

Within 5 calendar days of contract award

Fingerprinting Contracting Officer

Public Trust Positions - Level 5 or 6 Clearance

When requested by the government

NCTR RCRM Within 5 calendar days of contract award

FDA Form 3391 - FDA Security Card Access Request

COR.

Sponsorship must be provided by

FDA COR.

All positions on DHHS property or leased space

NCTR RCRM

Within 5 calendar days of contract award

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

Within 5 calendar days of contract award

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

Contractor generated

All Contractor Personnel

NCTR RCRM Within 5 calendar days of contract award

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CHART B

Public Trust Positions - Levels 5 or 6

FORM NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT

TO

DATE

REQUIRED

completed Fair Credit Reporting Act Release

C-11 Payments to Contractors

Progress payments will be made in accordance with the FAR Clause 52.232-5, 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. 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 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 and acceptance of the work, and prior to final payment, the Contractor, and each assignee under an assignment entered into under this contract and in effect at the time of final payment under this contract, shall execute and deliver, at the time of and as a condition precedent to final payment under this contract, a release discharging the Government, its officers, agents, and employees of and from all liabilities, obligations, and claims arising out of or under this contract.

C-12 Invoice Submission

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

A. An original and two (2) copies shall be submitted to the attention of the Contracting Officer.

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B. One copy to the COR clearly marked “courtesy copy only.”

C. Invoices must be submitted on company letterhead and shall strictly comply with FAR Clause 52.232-27. Improper invoice will be returned unpaid.

C-13 Contract Changes

FAR Clause 52.243-4 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), 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

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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.

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.

C-14 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 shall 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 FAR Clause 52.222- 26.

(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.)

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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 FAR Clause 52.249-10.

C-15 Required Insurance

FAR Clause 52.228-5 is supplemented as follows:

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.

C-16 General Conditions (Construction at NCTR)

A. General

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

Before work is started, the Contractor shall furnish to the Contracting Officer and COR, C-16 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

With the exception of the removal and disposal of the walk-in cooler which shall be coordinated with the COR and scheduled for after hours work so as not to disrupt normal building operations, the Contractor will be permitted to work on the job at the NCTR during the regular hours 7:30 a.m. to 4:30 p.m., Monday through Friday, except for the following holidays (observed on preceding Friday or following Monday when they occur on Saturday or Sunday):

New Years Day Martin Luther King's Birthday President's Day (Washington/Lincoln's Birthday) Memorial Day Independence Day Labor Day Columbus Day Veterans' Day Thanksgiving Day Christmas Day

Work at any other time including holidays requires the contractor to request in advance and submit a schedule, in writing, to the COR. The COR shall then either approve or disapprove of the request.

C. Non-Interruption of Government Activities

Interruption or interference with conduct of Government business in other building areas outside the contract area, or damage to existing equipment or property within the contract area, will not be permitted. To protect Government property and to isolate its work, the Contractor shall provide, at no additional expense to the Government, drop cloths, plastic film draping, taping, barriers, weatherproof closures and/or coverings, and temporary dust-proof enclosures and partitions, etc. Temporary dust-proof enclosures and partitions shall be provided whenever demolition or construction operations will produce dust or dirt, which would be spread by tracking or air currents beyond the immediate area of work. Such enclosures shall be erected structurally sound, and shall be maintained dust proof so as to keep surrounding areas clean and free of dust.

Where practical, dust-producing activities shall be kept dampened with water, so as to reduce the generation of dust.

Temporary dust-proof enclosures shall always be required to separate sterile or germ-free areas from the Contractor's work area. Materials shall be conveyed inside

C-17 buildings using Contractor-provided equipment, in a manner that prevents damage to floors (i.e., by hand, using rubber tired vehicles, etc.). Use of FDA equipment is prohibited. The use of equipment, which produces substantial noise or vibration in buildings, such as pneumatic hammers, etc., must be coordinated in advance with the

COR.

D. Utility Shutdowns

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

E. Material Delivery, Storage Areas and Debris Removal

1. Material Delivery. Contractors shall arrange for the deliveries of supplies or materials and equipment to the work site or designated storage areas via approved routes. Wherever practicable, deliveries shall be made during the regular FDA working hours (unless prior approval is obtained from the COR) and only when the Contractor's Authorized Representative is available to receive them.

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

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

F. Safety and Accident Prevention

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

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

3. Contractors shall provide illuminated barricades, flags, warning signs, and lighting at excavations, open manholes, damaged roads, or walks, and any interior danger areas, other open or broken surfaces, resulting from the Contractor's operations.

Similar barriers and warning devices shall be provided by the Contractor to limit access to hazardous work areas, such as pavement-breaking operations and overhead work that requires the use of cranes, ladders, or scaffolds.

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

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

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

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

G. Fire Prevention

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

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

3. Construction trailers, sheds or temporary storage buildings shall not be moved to, or erected on, FDA Property without written approval, including inspection by the COR and RCRM Staff, as to location of the structure and method of heating and lighting.

They must be located within the Contractor's assigned area and are generally restricted to Contractor's assigned area and are generally restricted to large projects.

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

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

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

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

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

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

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

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

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

H. Security

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

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

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

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

5. Conduct on Federal Property: Contractors are advised that operating a motor vehicle when entering upon or while on FDA property by a person under the influence of alcoholic beverages, narcotic drugs, including hallucinogens, marijuana, barbiturates or amphetamines, is prohibited. Entering upon the property, or while on the property, under the influence of, or using, or possessing any narcotic drug is prohibited. Such prohibition shall not apply in cases where the drug has been prescribed by a physician.

Entering upon the property, or being on the property, under the influence of alcoholic beverages is prohibited. All vehicles are subject to search.

I. Motor Vehicles and Parking Regulations

1. All persons driving motor vehicles on FDA Property in connection with Contractor business, including the driving of employees' personal vehicles, shall abide by the rules and regulations of this Clause and those of FMR 102-74.430, Vehicular and Pedestrian Traffic. Contractor vehicles shall be used for the conduct of business only. Vehicles shall remain parked at the job site, i.e., not be used to drive back and forth to the cafeteria.

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

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

4. Vehicles operated over station roads in connection with contract work shall be loaded so as to minimize spillage of dirt, gravel, and other debris. The Contractor shall remove inadvertent spillage of nails, construction materials, scrap, etc., immediately.

Dirt and gravel spillage or accumulations shall be removed as soon as practicable and as satisfactory to the COR, but in every case it shall be removed no later than the end of each workday.

5. The driver of any vehicle involved in an accident on the FDA Property shall stop and render aid as required. The accident shall be reported as soon as possible in person or by telephone to the COR. Drivers of the vehicles involved shall remain until released, and shall furnish such reports of the accident as required.

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6. When closing of roads or lots is necessary for a Contractor to perform work, notify the COR at least ten (10) working days in advance. Once approval is granted, Contractors shall provide their own barricades and cones and block off the area.

J. Grounds, Roads, and Walkways

1. Contractors shall perform their work in such a manner as to cause minimum damage to roads, walkways, and plantings, including lawns, shrubs, and trees. Any damaged items not specifically designated in the contract specifications for demolition, removal or alteration shall be restored to original condition or replaced, as satisfactory to the Contracting Officer. Ground areas disturbed during construction shall be landscaped and planted to original condition as promptly as possible. During the progress of the contract the Contractor shall, within the construction area, protect and maintain all plant material including lawns and temporary ground cover by mowing, spraying, watering, etc., sufficient to provide a level of maintenance conforming to that of other areas of the Property, and at no time shall weeds or undesirable grasses be allowed to seed.

2. Contractors shall not create obstruction to the flow of traffic, including temporary reductions in horizontal or vertical clearances, except in accordance with schedules and by such means satisfactory to the NCTR Building Manager.

K. Sanitation

1. Contractors shall maintain their working areas free from food debris and wrappers. Contractors shall provide covered trash containers in the number and type approved by the COR, and shall be responsible for the sanitary collection and prompt removal of trash in these containers from the FDA Property.

All temporary toilets used by the Contractor must be approved as to number, location, and construction by the COR. The Contractor will make arrangements to secure this approval.

L. Project Record Drawings

1. The Contractor shall set aside at the site one set of Contract Drawings to be used as Project Record Drawings (As-Builts). As-Builts shall be kept current.

2. The Contractor shall record on the Project Record Drawings all changes to accurately show as-built conditions.

3. The Contractor shall use colored pencils for the as-builts/record drawings, notes, sketches, cross references to drawing details, etc. Pasted-on data, sketches, etc., will be accepted provided they do not cover any of the drawing data, manufacturers' names, model numbers, size, rating, etc., of equipment. Submit redlined as-builts to the COR.

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4. Upon completion of the work and prior to the final payment, submit to COR a package labeled with the project name and containing one (1) copy of all final record drawings in AutoCAD, specifications, shop drawings and product data.

5. The COR must review and concur with all data placed on the drawings. The completed Project Record Drawings shall be given to the Contracting Officer at the conclusion of the job.

C-17 Specifications and Drawings for Construction

FAR Clause 52.236-21 is supplemented as follows:

Include any samples of material requests.

Submittal data shall be coordinated so that all interdependent component parts and systems of the installation are included in a single coordinated submittal.

Submittal data shall be reviewed by the Contractor for compliance with specification requirements, coordination, etc., prior to submittal and shall be so certified on the submittal by appropriate stamp and/or notation.

All submittal data shall be delivered at the Contractors expense. Submittal data shall include any additional copies which the Contractor wishes returned to them. A letter of transmittal setting forth the following, shall accompany the submittal:

The date;

The name of the project; and Appropriate description of submitted items, including reference to specification paragraph, submittal summary sheet, item number, etc.

The Contractor shall submit and have reviewed all data and samples required within 10 calendar days of the Notice to Proceed or at the earliest possible date available.

Approved samples not destroyed in testing shall be sent to the COR of the project.

Approved samples of hardware in good condition shall be marked for identification and may be used in the work. Materials and equipment incorporated in the work shall match the approved samples. Samples not destroyed testing or not approved will be returned to the Contractor at his expense, if requested at the time of submission.

Failure of any material to pass the specified test shall be sufficient cause for refusal to consider, under this contract, any further samples of the same brand or make of that material. The Government reserves the right to disapprove any material or equipment, which previously has proven unsatisfactory in service.

The COR may take samples of various materials or equipment delivered…