Solicitation NIHOF2008062 - Pharmacy Commissioning.doc

Validation Services for the NIH cGMP Pharmacy Production Facility Solicitation/Contract No NIHOF2008062:

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Services

National Institutes Health

Bethesda, Maryland 20892 September 10, 2008

Instructions to all Prospective Offerors:

Solicitation packages should be read thoroughly.

Proposal is due September 19, 2008 by 3:00 PM, EDT

SUBMITTALS:

· Your offer should be submitted on the SF 1449 in triplicate with an original signature on all copies to Mary Grasson, Contract Specialist, Email: grassonm@mail.nih.gov. (Rubber stamp or carbon signatures cannot be accepted.) Please complete Blocks 17a, 30a and Section B as appropriate. DUNS number must be included in 17a to verify registration in Central Contractor Registration.

· One copy of the completed Section E - Representations and Certifications should also be returned along with the SF 1449. Enclose any other additional submittals required in contract specs or special conditions.

· “Technical capability” is comprised of the technical evaluation factors listed below, each of which is of equal importance. The Office of

Research Facilities (ORF) will conduct an assessment of technical merit based on information provided with the vendor’s proposal and as may be augmented by information gathered. For each factor, ORF will identify strengths and weaknesses/risks and determine the overall technical merit of the proposal.

· “Past performance” is an evaluation factor. A list of three references, minimum, is required (government contracts are preferred). References should be for similar or same type of work and recent, within the past three years. References should be legible and include business name, address, point of contact name, phone number, dates of service, type of work and dollar amount. If a point of contact cannot be reached within 48 hours of initial contact by phone, the reference may not be considered. NIH is not limited to using only the references provided by the offeror.

· Enclose any other additional submittals required in contract specs or special conditions.

Questions may be E-mailed to Mary Grasson, Contract Specialist by September 15, 2008.

Email: grassonm@mail.nih.gov

COMMERCIAL ITEMS – SERVICES

Simplified Acquisition FAR 12 and 13

TABLE OF CONTENTS

Section A - Standard Form 1449 Solicitation and

Pages 1-2

Award Document

Section B - Schedule of Commercial Services and

Pages 3-11

Prices

B.1 Schedule of Prices

B.2 Statement of Work

B.3 Contract Administration Section C - Contract Clauses – Full Text

Pages 12-23

C.1 - 52.214-4 Contract Terms and Conditions

Commercial Items

C.2 - 52.212-5 Contract Terms and Conditions

Required to Implement Statutes or Executive

Orders – Commercial Items

C.3 - 52/216-1 Type of Contract

C.4 - HHSAR 352.270-05 Key Personnel

C.5 - 52.252-1 and 52.252-2, Solicitation, Provisions

And Contract Clauses Incorporated by Reference

Section D - Attachments

Pages 24-26

D.1 – Table Validation Services Required

D.2 - Invoice Instructions

Section E - Solicitation Provisions

Pages 27-47

E.1 – Solicitation Instructions

E.2 - 52.212-1, Instructions to Offerors –

E.3 - 52.212-2, Evaluation – Commercial Items

E.4 - 52.212-3, Offeror Representations and Certifications –

E.5 - Technical Evaluation Selection Factors

SECTION B

SCHEDULE OF COMMERCIAL SERVICES AND PRICES

B.1.

Schedule of Prices

Total Estimated Costs for Phase 1 and Phase 2

SECTION B.2

WORK STATEMENT

VALIDATION SERVICES FOR THE NIH cGMP

PHARMACY PRODUCTION FACILITY

1. INTRODUCTION

National Institutes of Health Pharmacy Department (NIH/PHAR) requires validation services, in accordance with the Federal Food, Drug and Cosmetic Act Section 501(a)(2)(B), current good manufacturing practice (cGMP) regulations Section 21 C.F.R. Part 210 (General) and Part 211 (Finished pharmaceuticals) for human drugs and current FDA guidelines (all referred to hereafter as “Federal Regulations”, to audit the formal architectural design and physical plant operational specifications of a small to medium scale monoclonal antibody/recombinant protein parenteral biologic drug production facility, hereafter referred to as “the facility”. These services shall be performed in two phases.

1.1 Phase 1: Prepare Validation and Certification (activation) study and plan

(a) Analyze, review, verify and vet pharmaceutical manufacturing facility design specifications, equipment lists, construction activity, plant conditions, mechanical, electrical and scientific equipment conditions and prepare plan for validation and certifications. Prepare and submit, for approval, a plan for activation , validation and certification.

1.2 Phase 2 Validation and Certification services

(a) Perform work in accordance with the approved plan for activation, validation and certification. Review construction, equipment installation and commissioning (actual commissioning will be performed by others) according to USFDA cGMP standards with preparation of turn-over packages for facility operation. Provide formal validation documentation of the physical plant operation of the facility with preparation of FDA presentation package and critique of the proposed processes of pharmaceutical production.

2. BACKGROUND

The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs.

2.1 The NIH Clinical Center Pharmacy Department provides pharmaceutical care and dispenses medications to inpatient and outpatients. Clinical Center pharmacists provide research support to health care providers and investigators. Pharmacy staff members conduct and participate in research programs that enhance knowledge regarding optimal dosing and appropriate use of investigational and commercially available agents. The Pharmacy Department’s Pharmaceutical Development Section manages investigational drug inventories through a computerized information system, prepares customized investigational drug products, and assists investigators in filing Investigational New Drug (IND) applications with the FDA. To provide these services, the accepted standard of practice is to conduct all such operations in an area certified as compliant with current Good Manufacturing Practices (cGMP).

3. DESCRIPTION OF SERVICES REQUIRED

Validation services, in accordance with Federal Regulations, to audit the formal architectural design and physical plant operation specifications of the facility. These services shall include four major tasks. One, the validation audit of the facility design according to Federal Regulations; two, consultation with NIH on facility validation; three, review of construction and equipment installation and documentation in formal turn-over packages according to the deliverables and Federal Regulation; and four, formal validation documentation of the physical plant operation of the facility and preparation of the formal FDA presentation package and critique of the proposed processes of the facility. In addition to these services, the following may be required: confirm with the architect and engineer all equipment specification, compile and assemble all information for FDA documentation submission and operating procedures; technical reports, review of shop drawings, construction inspection, ongoing review and inspection of physical plant installation and operation ensuring compliance with Federal Regulations and contract objectives are met or exceeded. Close coordination with the architectural engineering and construction contractors on the facility will be essential as well as providing the primary consultation to NIH in all phases of validation of the facility including critique and consultation on process validation. Recommendations, guidance, and audit will be the primary services expected in process validation.

4. SCOPE OF WORK

This contract will be performed in two phases. These phases are identified as:

Phase 1 – Prepare a Validation and Certification (activation) study and plan.

Phase 2 – Validation and Certification services Initial Operation; Validation and Certification and Pharmaceutical Production

The description of each phase is:

4.1 PHASE 1

Prepare a validation and Certification (activation) study and plan. Work shall require:

4.1.1 Analyze, review, verify and vet pharmaceutical manufacturing, facility design specifications, equipment lists, construction activity, plant conditions, mechanical , electrical and scientific equipment conditions and prepare plan for validation and certifications. Prepare and submit, for approval a plan for activation, validation and certification.

4.2 PHASE 2

This phase shall be issued as a Notice To Proceed (NTP) in an amount not to exceed $400,000.00 to support oversight of commissioning, validation and certification of the pharmacy. Actual commissioning shall be performed by the NIH Facility Dynamics contractor under a separate award not associated with this contract award.

The NTP shall be authorized after the CO reviews the proposed cost to complete this phase of the requirement.

4.2.1 Validation and Certification services.

4.2.1.1 Perform work in accordance with the approved plan for activation, validation and certification. Review construction, equipment installation and commissioning (actual commissioning will be performed by others) according to USFDA cGMP standards with preparation of turn-over packages for facility operation. Prepare formal validation documentation of the physical plant operation of the facility with preparation of FDA presentation package and critique of the proposed processes of pharmaceutical production.

4.2.1.2 Operation. Validation Testing shall confirm the design criteria and operating principles in compliance with Federal Regulations and contract objectives; establish preventative maintenance and maintenance procedures for all physical plant and equipment; Review NIH recommended scientific equipment preventive maintenance, maintenance, and calibration protocols for compliance with Federal regulations.

4.2.1.3 Pharmaceutical Production. The validation contractor shall analyze the operating conditions during actual drug production and guide in finalizing validation documentation; complete final documentation recommendations for facility validation and certification according to Federal Regulations requirements and contract objectives.

4.3 PHASE 1 AND PHASE 2 PRICE

· Provide a price in dollars for activities required in Phase 1

· Provide a price in dollars for activities required in Phase 2. Phase 2 work shall not exceed $400,000

· Provide a detailed cost break-out for each price.

SECTION B.3

CONTRACT ADMINISTRATION

5.

The following named Contracting Officer’s Technical Representative/Project Officer (COTR/PO) will represent the National Institutes of Health for the purpose of this contract:

Jeffrey Boarman

Tel No. 301-402-8683

Email:

boarmanj@mail.nih.gov

5.1 The Project Officer is responsible for: (1) monitoring the contractor’s progress, including surveillance and assessment of performance and recommending the Contracting Officer changes in requirements; (2) interpreting scope of work; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting the contractor in resolution of technical problems encountered during performance.

For guidance from the Project Officer to be valid, it shall: (1) be consistent with the description of work set forth in this contract; (2) not constitute new assignment of work or changes to the expressed terms, conditions, or specifications incorporated into this contract; (3) not constitute a basis for an extension to the period of performance or contract completion schedule; and (4) not constitute a basis for any increase in the contract price.

5.2 The Contracting Officer for this contract is:

Mary Grasson

Tel. No. 301-435-4558

Email: grassonm@mail.nih.gov Only the Contracting Officer has authority to: (1) increase or decrease the contract amount; (2) direct or negotiate any changes; (3) modify or extend the period of performance; (4) change the schedule of completion; (5) authorize payment under this contract; (6) otherwise modify any terms or conditions of this contract.

5.3

Monthly billings for progress in accordance with FAR clause 52.232-1. Payments shall be fully documented to show that the amount and value of the work billed is justified. Each monthly billing shall establish that the progress in completing each phase including preliminary and other concurrently required effort is proportional to the amount of the progress billing for the phase.

5.4

DELIVERABLES

5.4.1 Contract deliverables shall consist of the following:

5.4.1.1 Monthly reports detailing work performed.

5.4.1.2

Completed documents and packages shall include:

5.4.1.2.1 Facility Installation Specifications and

Procedures, Facility Copy and enhanced FDA

Presentation Copy.

5.4.1.2.2 Facility operations validation documentation turnover package including; operator’s manuals, instrument and operational specifications, calibration specifications, procedures and schedules, preventive maintenance and maintenance procedures, schedules, and specifications. Facility copy and FDA enhanced Presentation copy.

5.4.1.2.3 Process documentation review and recommendation for establishment certification covering all operations in the facility. Facility Copy and recommended detailed FDA presentation format.

5.4.1.2.4 All documentation and turn-over packages to include materials and procedures required by the Federal Regulations and the objectives of the contract.

5.4.1.3

Phone contact reports shall be followed up by written documentation of the contact supplied to the Project Officer in triplicate.

5.4.1.4

Reports shall be provided on the monthly progress within five (5) days following the last day of each calendar month in triplicate.

5.4.1.5

All turnover packages documenting completion of validation services shall be in accordance withFederal

Regulations and the objectives of the contract, and include one unbound original and four bound copies with MS Word CD for each.

5.5 The Contractor shal1 within five (5) days after award of the contract submit a schedule showing the order in which it proposes to carry on the work with dates on which effort of the various services listed below will be started and the dates for completion of the same, along with a progress chart showing percentages of completion of the various services at stated time intervals. The contractor shall submit a report within five (5) days after the end of each month providing information of progress and any necessary revisions to the schedule.

5.6 The services on which proposed progress schedules are required as follows:

Provide:

· Design Audit Report

· Construction Installation Audit Report

· Physical Plant Operation Validation Audit Report

· Process Review Validation Report

· Final Documentation Turnover Packages meeting Federal Regulations and the objectives of the contractor and including: equipment operation, calibration, maintenance and preventive maintenance procedures, training procedures for maintenance personnel.

5.6.1 The contractor shall attend a progress meeting with the Project Officer (i.e. Project Manage) within two (2) weeks after submission of the initial of the initial schedule as required above, and shall attend other progress meetings as arranged by the Project Officer.

5.6.2 Following each on-site visit, meeting with NIH, or upon request of the Project Officer, a written report by the contractor documenting tasks accomplished shall be submitted to the Project Officer (2 copies) and the Contracting Officer (1 copy).

5.7 Key Personnel

The personnel specified in this contract shall be considered to be essential to the work being performed hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer required by this clause. The contract may be amended from time to time during the course of the contract to either add or delete personnel, as appropriate.

SECTION C

CONTRACT CLAUSES – FULL TEXT

C.1 52.212-4 Contract Terms and Conditions—Commercial Items.

As prescribed in 12.301(b)(3), insert the following clause:

Contract Terms and Conditions—Commercial Items (Feb 2007)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to the Contract Disputes Act of 1978, as amended (41 U.S.C. 601-613). Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(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;

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

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

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

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration, or 52.232-34, Payment by Electronic Funds Transfer—Other Than Central Contractor Registration), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall immediately notify the Contracting Officer and request instructions for disposition of the overpayment.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. 3701, et seq., Contract Work Hours and Safety Standards Act; 41 U.S.C. 51-58, Anti-Kickback Act of 1986; 41 U.S.C. 265 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. 423 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, and Compliance with Laws Unique to Government Contracts paragraphs of this clause.

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(t) Central Contractor Registration (CCR).

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the CCR database, and for any liability resulting from the Government’s reliance on inaccurate or incomplete data. To remain registered in the CCR database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the CCR database to ensure it is current, accurate and complete. Updating information in the CCR does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(2)(i) If a Contractor has legally changed its business name, “doing business as” name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in FAR Subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day’s written notification of its intention to (A) change the name in the CCR database; (B) comply with the requirements of Subpart 42.12; and (C) agree in writing to the timeline and procedures specified by the responsible Contracting Officer. The Contractor must provide with the notification sufficient documentation to support the legally changed name.

(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the CCR information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the “Suspension of Payment” paragraph of the electronic funds transfer (EFT) clause of this contract.

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the CCR record to reflect an assignee for the purpose of assignment of claims (see Subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the CCR database. Information provided to the Contractor’s CCR record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the “Suspension of payment” paragraph of the EFT clause of this contract.

(4) Offerors and Contractors may obtain information on registration and annual confirmation requirements via the internet at http://www.ccr.gov or by calling 1-888-227-2423 or 269-961-5757.

(End of clause)

Alternate I (Feb 2007). When a time-and-materials or labor-hour contract C.2 – 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items

As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (June 2008)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(2) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78)

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

__ (2) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a).

__ (3) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (July 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (4) [Reserved]

__ (5)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-6.

__ (iii) Alternate II (Mar 2004) of 52.219-6.

__ (6)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (7) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)).

__ (8)(i) 52.219-9, Small Business Subcontracting Plan (Apr 2008) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (9) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)).

__ (10) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (11)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Sept 2005) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__ (12) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (13) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (14) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f).

__ (15) 52.219-28, Post Award Small Business Program Rerepresentation (June 2007) (15 U.S.C. 632(a)(2)).

__ (16) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__ (17) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2008) (E.O. 13126).

__ (18) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

__ (19) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

__ (20) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

__ (21) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793).

__ (22) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

__ (23) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201).

__ (24)(i) 52.222-50, Combating Trafficking in Persons (Aug 2007) (Applies to all contracts).

__ (ii) Alternate I (Aug 2007) of 52.222-50.

__ (25)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)).

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)).

__ (26) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (27)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

__ (ii) Alternate I (Dec 2007) of 52.223-16.

__ (28) 52.225-1, Buy American Act—Supplies (June 2003) (41 U.S.C. 10a-10d).

__ (29)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (Aug 2007) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, Pub. L 108-77, 108-78, 108-286, 109-53 and 109-169).

__ (ii) Alternate I (Jan 2004) of 52.225-3.

__ (iii) Alternate II (Jan 2004) of 52.225-3.

__ (30) 52.225-5, Trade Agreements (Nov 2007) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (31) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (32) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (33) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (34) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (35) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (36) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

__ (37) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

__ (38) 52.232-36, Payment by Third Party (May 1999) (31 U.S.C. 3332).

__ (39) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (40)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and Option Contracts) (Nov 2006) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Feb 2002) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

__ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

__ (7) 52.237-11, Accepting and Dispensing of $1 Coin (Aug 2007) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settelement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in paragraphs (i) through (vii) of this paragraph in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(ii) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

(iv) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793).

(v) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201).

(vi) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

(vii) 52.222-50, Combating Trafficking in Persons (Aug 2007) (22 U.S.C. 7104(g)). Flow down required in accordance with paragraph (f) of FAR clause 52.222-50.

(viii) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

(ix) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

(x) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)Type of Contract C.3 - 52.216-1 Type of Contract

As prescribed in 16.105, complete and insert the following provision:

TYPE OF CONTRACT (APR 1984)

The Government contemplates award of a firm-fixed price contract resulting from this solicitation.

(End of provision)

Firm-fixed-prices include all overhead, G&A, profit, and anything else that applies to delivering the services listed in Section I. Firm-fixed-price work in the contract includes all work identified in the Statement of Work.

C.4 - HHSAR 352.270-5 KEY PERSONNEL (APR 1984)

The personnel specified in this contract are considered to be essential to the work being performed hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer required by this clause. The contract may be amended from time to time during the course of the contract to either add or delete personnel as appropriate.

C.6 - INSURANCE REQUIREMENTS Evidence of insurance is to be provided to the address below before notice to proceed on contract can be issued:

National Institute of Health, ORF

Office of Acquisitions (OA), Bldg. 13, Room 2E43

Facilities Services Support Branch

9000 Rockville Pike

Bethesda, MD 20892 a.

Worker's Compensation and Employer's Liability:

The Contractor is required to comply with applicable Federal and State Worker's compensation and occupational disease statutes; however, notwithstanding the permissibility of deductibles under those statutes, occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy. Employer's liability coverage of at least $100,000 for each accident shall be required except in states with exclusive or monopolistic funds that do not permit worker's compensation to be written by private carriers.

Even though the laws of a State might allow a Contractor to be a non‑subscriber to worker's compensation, the Contractor is required to carry and maintain worker's compensation insurance (without any deductibles) and employer's liability insurance. If occupational diseases are not covered under the worker's compensation policy, it shall be covered under the employer's liability section of the insurance policy.

Employer's liability insurance coverage shall be as specified in paragraph A above.

b.

General Liability Insurance:

General Liability insurance coverage written on the comprehensive form of policy is required in the amount of $500,000 per occurrence for bodily injury, $50,000 per occurrence for property damage.

CANCELLATION:

Either the Government or the contractor may terminate this contract without cause. The termination date will be effective 60 calendar days from the date on which the written termination notice is received. Notice to terminate must be made by certified mail, return receipt requested, or by overnight delivery service provided that the service records the signature of the party to whom the notice was delivered. The contractor is responsible for full performance of the contract until the effective termination date. Cancellation of the contract shall be regarded as neither termination for cause nor termination for convenience. Cancellation will be at no cost to the Government and not subject to appeal either administratively or in any legal form.

FAR 52.252-1 & FAR 52.252-2 SOLICITATION PROVISIONS AND CONTRACT CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provision or contract clause by reference, with the same force and effect as if they were given in full text. Upon request, the contracting officer will make their full text available. The offeror is cautioned that the listed provisions and clauses may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions and clauses, the offeror may identify the provision or clause by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision or clause may be accessed electronically at this address: http://www.arnet.gov/far/ FAR Clause

Number

Title Date Reference 52.203-5 Covenant Against Contingent Fees Apr 1984 3.404

52.217-5 Evaluation of Options Jul 1990 17.208(c) (1)

52.217-8 Option to Extend Services Nov 1999 17.208(f)

52.217-9 Option to Extend the Term of the Contract Mar 2000 17.208(g)

"(a)...30 calendar days of the contract expiration date..."

"(c)..six (6) months.

52.219-6 Notice of Total Small Business Set-Aside Jun 2003 19.508(c)

52.219-9 Small Business Subcontracting Plan Apr 2008 19.708(b)

52.222-1 Notice to the Government of Labor Disputes Feb 1997 22.103-5(a)

52.223-3 Hazardous Material Identification & Material

Safety Data Jan 1997 23.303

52.228-5 Insurance -- Work on a Government Installation Jan 1997 28.310

52.232-1 Payments Apr 1984 32.111(a) (1) 52.232-8 Discounts for Prompt Payment Feb 2002 32.111(c) (1)

52.232-11 Extras Apr 1984 32.111(d) (2)

52.232-17 Interest Jun 1996 32.617(a) (b)

52.232-18 Availability of Funds Apr 1984 32.705-1(a)

52.232-24 Prohibition of Assignment of Claims Jan 1986 32.806(b)

52.232-25 Prompt Payment Oct 2003 32.908(c)

52.233-1 Disputes Jul 2002 33.215

Alternate I Dec 1991 33.215

52.237-2 Protection of Government Buildings, Equipment, and Vegetation Apr 1984 37.110(b)

52.237-3 Continuity of Services Jan 1991 37.110(c)

52.242-15 Stop-Work Order Aug 1989 42.1305(b)

52.243-1 Changes -- Fixed-Price Aug 1987 43.205(a) (1)

Alternate I

43.205(a) (2)

52.246-4 Inspection of Services -- Fixed-Price Aug 1996 46.304

52.246-25 Limitation of Liability -- Services Feb 1997 46.805(a) (4)

52.249-1 Termination for Convenience of the

Government (Fixed-Price) (Short Form)

49.502(a) (1)

52.249-4 Termination for Convenience of the

Government (Services) (Short Form)

49.502(c)

52.253-1 Computer Generated Forms Jan 1991 53.111

SECTION D

CONTRACT DOCUMENTS, EXHIBITS, ATTACHMENTS

ATTACHMENT D.1

TABLE 1. VALIDATION SERVICES REQUIRED

VALIDATION SERVICES

Prepare Enhanced Turn-Over Package (for Presentation)

D.2 – INVOICE INSTRUCTIONS

The Contractor will be paid within 30 days on the submission of proper invoices for the services performed during the preceding month. To ensure and expedite your payment, invoices must contain the following information on each invoice, otherwise it may be returned due to non compliance and treated as an improper invoice:

(1) NIH contract award number,

(2) NIH task order number or purchase order number or modification number

(3) Requisition Number

(4) DUNS number

(5) VIN number

(6) 3-way match

(7) Contracting Officer's Name: (Mary…