RFP N02-CM-01008-03.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

N02-CM-01008-03

3. Issue Date:

July 1, 2009

4. Set Aside:

[X] No

[ ] Yes Part IV Section L

5. Title : Clinical Trials Monitoring Service

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 pm local time on July 31, 2009. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. THIS SOLICITATION REQUIRES DELIVERY OF PROPOSALS TO THE OFFICIAL POINT OF RECEIPT FOR

THE PURPOSE OF DETERMINING TIMELY DELIVERY AS STATED IN ATTACHMENT 1, "PACKAGING

AND DELIVERY OF THE PROPOSAL." IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH SUBPARAGRAPH (c)(3) OF FAR CLAUSE 52.215-1, ENTITLED, "INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION" LOCATED IN SECTION L.1.

OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. http:// www.ccr.gov

11. FOR INFORMATION CALL: Erin Bain

PHONE: (301) 435-3814

e-MAIL: bainerin@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Richard L. Hartmann Contracting Officer Office of Acquisitions National Cancer Institute http://www.ccr.gov http://www.ccr.gov

RFP Number : N02CM01008-03

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. PERFORMANCE BASED ACQUISITION

e. ESTIMATE OF EFFORT

f. COMMITMENT OF PUBLIC FUNDS

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. REFERENCE MATERIALS

j. PREPARATION COSTS

k. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Specific Copyright Provisions Applicable to Software Development and/or Enhancement(s)

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10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Past Performance Information

13. Electronic and Information Technology Accessibility

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Cost and Pricing Data

3. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

4. Small Business Subcontracting Plan

5. HUBZone Small Business Concerns

6. Total Compensation Plan

7. Other Administrative Data

8. Qualifications of the Offeror

9. Subcontractors

10. Proposer's Annual Financial Report

11. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. EVALUATION OF OPTIONS

3. TECHNICAL EVALUATION CRITERIA

4. PAST PERFORMANCE FACTOR

5. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this project is to assist the Cancer Therapy Evaluation Program (CTEP), NCI in fulfilling its responsibilities in meeting the regulations set forth by the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) as an Independent New Drug (IND) sponsor and funding agency by monitoring NCI sponsored clinical trials.

ARTICLE B.2. ESTIMATED COST, FIXED FEE AND AWARD OPTION

a. Estimated Cost and Base Fee

1. The estimated cost of the Base Period of this contract is $ .

2. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.

3. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

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Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Base Period:

May 1, 2010 - April 30, 2011

Option Period:

May 1, 2011 - April 30, 2012

Optional Task A:

Implementation Year 1 Implementation Year 2 Maintenance Cost $ Per Year

(Note: up to 5 years)

Optional Task B:

FY 2011

(5 additional audits)

FY 2012

FY 2013

FY 2014

FY 2015

FY 2016

Total [Base Period and Option(s)]

b. Award Options

1. If the Award Option(s) are earned pursuant to the AWARD OPTION QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Base Period (FY10)

Award Option 1 (FY12)

Award Option 2 (FY13)

Award Option 3 (FY14)

Award Option 4 (FY15)

Award Option 5 (FY16)

Total [Base Period and Award Option(s)]

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c. Total Estimated Contract Amount

1. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee of the Base Period is $________.

2. If the Government exercises its options pursuant to the OPTION PROVISION Article in SECTION H of this contract, and if the Award Options are earned pursuant to the AWARD OPTION QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) Article in Section H of this contract, the Government's total estimated contract amount, represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Award Fee ($)

Base Period (FY10)

Option Period (FY11)

Optional Task A

Optional Task B

Award Options (FY12-

FY16)

Total Base Period plus Option Period plus Optional Work plus Award Options

3. Total funds currently available for payment and allotted to this contract are $_______ of which $________ represents the estimated costs, and of which $_______ represents the fixed fee. For further provisions on funding, see the LIMITATION of FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses.

4. It is estimated that the amount currently allotted will cover performance of the contract through______________.

5. The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated May 27, 2009, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 2 hard copies of these reports will be required as follows:

[ ] Monthly [ ] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

2. Task 1 Reports - Patient Registration, Protocol Patient Data Capture and Quality Control Reviews for Phase 0, Phase 1 and Selected Phase 2 Clinical Trials

a. Monitors Summary (MS) Report - a summary of the administrative conduct of studies, data submission status, protocol status, and patient accrual and basic performance indicators. The MS Report shall contain an administrative table listing for each study. The administrative table shall include institution; title of study; phase of study; protocol #; investigator; date of patient registrations; assigned dose levels; date of first course; and date of last course. The MS report shall also contain a status table listing for each study including, drug; regimen; dosing schedule;

# of registered patients; # of patients with toxicity; # of patients with response; highest toxicity grade; and, category of toxicity.

b. Clinical Studies Summary (CSS) - a summary of dose levels, adverse events, and incidence of toxicity. This report shall contain at least the following reports for each study: 1) Patient Summary - by study to include: patients registered; number of evaluable patients; current dose

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- all toxicities by dose, category and grade. The total number of patients, evaluable courses and summaries per dose level should be included in the toxicity summaries. Reports shall be available for all toxicities regardless of relatedness to investigational agent(s).

c. Monitors Detail (MD) Report - a detailed section display for each study to include: tabulation of registered patients on study including patient and course disposition; the date of last protocol patient test data on file for each treatment course; the percentage of missing items; and comments on investigator performance.

d. Clinical Studies Detail (CSD) Reports - shall include the following types of reports: 1) Patient Detail Report - by patient contains: demographics, eligibility, TAC, course information, physician notes, prior therapies, concomitant medications; 2) Patient Summary Report - by patient contains: demographics, TAC, dose, and disease description (e.g. lesion dimensions, quantitative bone marrow involvement); 3) Toxicity Detail Report - detail of toxicities by patient by Common Terminology Criteria for Adverse Events (CTCAE) category; 4) Study Synopsis Report - brief protocol patient study summary; 5) Toxicity Cross Tabulation - incidence of toxicity by category and dose level; and, 6) Response Summary - details of patients with significant responses.

e. Special Ad Hoc Reports - (approximately 35/year) shall be generated as requested by the Project Officer(s). These shall be submitted electronically with a rapid turnaround time of as little as 24 hours. All submitted data will be available via EXCEL spreadsheets or in a pre-determined format. The sample of the types of reports that may be generated are: 1) Compliance Indicators:

measures of eligibility, delinquency, and lab testing; 2) Lesion Responses: listing of lesion measurements; 3) Drug Administration: per protocol patient; 4) Escalation Highlight: tabulation of courses by dose level; 5) Lab Inquiry: details of specific lab test by day for all patients; 6) Response Evaluation: lesion measurements and investigator evaluations; 7) Summary of Eligibility; eligibility statistics; 8) Severe Toxicities: details of severe (Grade 4 and 5) adverse events; 9) Activity Indicators: status, registered patients, accrual, closure date, patients still on-study, etc; 10) Summary of AEs: incidence of AEs by category and grade; 11) Prior Therapies and Concomitant Meds: listings; 12) Categorized Toxicity Tabulation: listing of toxicities; 13) Physician Notes: listing of physician and data manager comments; 14) Inferred Toxicities:

adverse events inferred from lab data; and, 15) Endpoint Follow-up: occurrence of severe, related toxicities by dose level.

3. Final Report The Final Report shall be in sufficient detail to explain comprehensively the results achieved and shall contain a summary (not to exceed 200 words) of the salient results achieved during the performance of the contract. This report shall comprehensively summarize in tabular form the results achieved for all Tasks, for example, the number of audits performed, number of co-site visits and number of patient cases reviewed, etc. The final report shall be submitted on or before the expiration day of the contract performance period.

4. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

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1. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Technical Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute Executive Plaza North 6130 Executive Boulevard MSC 7436, Room 6108 Bethesda, MD 20892-7436

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from through .

b. If the Contractor earns any Options pursuant to the OPTION PROVISION Article in Section H of this contract and/or any Award Options pursuant to the AWARD OPTION QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) Article in Section H of this contract, the period of performance will be increased as listed below:

Option/Award Option Year Option/Award Option Period

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below:

Item Description SOW/ RFP Reference

Delivered To ( Copies) Due Date

A.15.a (SOW) Contracting Officer's Technical Representative (1), Contracting Officer (1), Senior Investigators in IDB (9), Project Manager of Drug Development Support Contract (1)

Monthly, on or before the 10th of each month

1. Monitor's Summary (MS)

(Task 1)

A.15.a (SOW) Senior Investigator in IDB (1), Project Manager of Drug Development Support Contract (1)

Two months prior to the due date of the Annual Report to the FDA

A.15.b (SOW) Contracting Officer's Technical Representative (1), Senior Investigators in IDB (9), Project Manager of Drug Development Support Contract (1)

Monthly, on or before the 10th of each month

A.15.b (SOW) Senior Investigator in IDB (1), Project Manager of Drug Development Support Contract (1)

Two months prior to the due date of the Annual Report to the FDA

2. Clinical Studies Summary

(CSS)

(Task 1)

A.15.b (SOW) Cross referenced IND sponsor drug companies

(3 copies)

Monthly, on or before the 10th of each month

3. Monitor's Detail (MD)

(Task 1)

A.15.c (SOW) Contracting Officer's Technical Representative (1)

Two months prior to the due date of the Annual Report to the FDA

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Item Description SOW/ RFP Reference

Delivered To ( Copies) Due Date

A.15.c (SOW) Senior Investigator in IDB (1), Project Manager of Drug Development Support Contractor (1)

Two months prior to the due date of the Annual Report to the FDA

A.15.c (SOW) Principal Investigator or institutional contact for specific protocols (3 copies)

Quarterly, first report due

August 10 th

A.15.c (SOW) Cross referenced IND sponsor drug companies (3 copies)

Quarterly, first report due

August 10 th

A.15.d (SOW) Contracting Officer's Technical Representative (1)

Two months prior to the due date of the Annual Report to the FDA

A.15.d (SOW) Senior Investigator in IDB (1), Drug Development Support Contractor (1)

Two months prior to the due date of the Annual Report to the FDA

A.15.d (SOW) Principal Investigator or institutional contact for specific protocols (3 copies)

Quarterly, first report due

August 10 th

4. Clinical Summary Detail

(CSD)

(Task 1)

A.15.d (SOW) Cross referenced IND sponsor drug companies (3 copies)

Quarterly, first report due

August 10 th

5. Special Ad Hoc Reports (Task 1)

A.15.e (SOW) Contracting Officer's Technical Representative (1)

Within 24 hours of Contracting Officer's Technical Representative request, as needed basis

6. Task 2 Audit Report C.3 (SOW) Contracting Officer's Technical Representative (1)

Within 10 working days of the last day of the audit

7. Task 3 Co-Site Preliminary Audit Report

D.4 (SOW) Contracting Officer's Technical Representative (1)

Within 24 hours of the end of the audit

8. Task 3 Co-Site Final Audit Report

D.5 (SOW) Contracting Officer's Technical Representative (1)

Within 15 working days after the site visit

9. Task 4 Cancer Center/Single Institution Site Visit Report (Draft)

E.5 (a-n)

(SOW)

Contracting Officer's Technical Representative (2)

Within 20 working days after the completion of the audit

10. Task 4 Cancer Center/Single Institution Site Visit Report (Final)

E.5/E.6 (SOW) Contracting Officer's Technical Representative (1)

Within 5 working days of receiving comments from the Contracting Officer's Technical Representatives

11. International Collaborator Reports

G.2 (SOW) Contracting Officer's Technical Representative (1)

Within 10 working days of the international collaborator meeting

12. Quarterly Financial Reports

For Tasks I-V

A.16; C.5;

D.7; E.9; G.4

(SOW)

Contracting Officer's Technical Representative (1)

Contracting Officer (1)

Quarterly or at any time upon request by the Contracting Officer's Technical Representative or Contracting Officer, first report due August 10 th

13. Final Report C.2 (RFP) Contracting Officer's Technical Representative (1);

Contracting Officer (1)

On or before the expiration date of the contract

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Item Description SOW/ RFP Reference

Delivered To ( Copies) Due Date

14. Individual Subcontracting Report (ISR)

H.8 (RFP) Contracting Officer (1) Annually on April 30 th, October 30 th and the expiration date of the contract

15. Summary Subcontract Report

(SSR)

H.8 (RFP) Contracting Officer (1) Annually on October 30th

16. Roster of Employees Requiring Suitability Investigations

H.9 (RFP) Contracting Officer's Technical Representative (1);

Contracting Officer (1)

Within 14 calendar days of the effective date of the contract

17. Information Security Training Report

H.9 (RFP) Contracting Officer's Technical Representative (1);

Contracting Officer (1)

Include with the first Monitor's Summary Report; April 10, 2010

18. Reporting of New and Departing Employees

H.9 (RFP) Contracting Officer's Technical Representative (1);

Contracting Officer (1)

Within 5 working days before a new employee assumes a position

19. Contractor - Employee Non- Disclosure Agreement(s)

H.9 (RFP) Contracting Officer's Technical Representative (1)

As deemed necessary

20. Self Assessment Reporting H.9 (RFP) Contracting Officer's Technical Representative (1);

Contracting Officer (1)

Annually, April 30th

21. Information System Security Plan Reporting

H.9 (RFP) Contracting Officer's Technical Representative (1)

August 1 , 2010

22. Section 508 Annual Report H.10 (RFP) Contracting Officer's Technical Representative (1);

Contracting Officer (1)

Annually, September 1 st

b. Copies of each report shall be sent to the Contracting Officer and Contracting Officer's Technical Representative via email. In addition a hard copy shall be sent to the following address:

U.S. Mail Hand Carry/Delivery Services Contracting Officer Contracting Officer Epidemiology, Therapeutics and Sciences Branch Epidemiology, Therapeutics and Sciences Branch Office of Acquisitions Office of Acquisitions National Cancer Institute National Cancer Institute Executive Plaza South, Room 6001 Executive Plaza South, Room 6001

6120 EXECUTIVE BLVD MSC 7193 6120 EXECUTIVE BLVD

BETHESDA, MD 20892-7220 ROCKVILLE, MD 20852

Email: bainerin@mail.nih.gov (Contract Specialist)

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

mailto:bainerin@mail.nih.gov http://www.acquisition.gov/comp/far/index.html

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. PROJECT OFFICER/CONTRACTING OFFICER'S TECHNICAL

REPRESENTATIVE

The following Project Officer(s) also known as the Contracting Officer's Technical Representative will represent the Government for the purpose of this contract:

To be specified prior to award.

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

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Contracting Officer hereby delegates the Project Officer as the Contracting Officer's authorized representative responsible for signing software license agreements issued as a result of this contract.

The Government may unilaterally change its Project Officer designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.270-5 (January 2006)

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

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

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1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions National Cancer Institute, NIH EPS, Room 6064

6120 EXECUTIVE BLVD MSC 7193

BETHESDA, MD 20892- 7193

E-Mail: Richard.Hartmann@nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is the National Cancer Institute .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCI OA Branch E - ncibrancheinvoices@mail.nih.gov.

c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

e. Invoice Matching Option. This contract requires a two-way match.

f. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

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b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

ARTICLE G.4. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health 6100 Building, Room 6B05

6100 EXECUTIVE BLVD MSC-7540

BETHESDA MD 20892-7540

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.5. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "Contractor's Guide for Control of Government Property," which can be found at:

http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR

42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf http://oamp.od.nih.gov/OD/CPS/cps.asp

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. NEEDLE EXCHANGE

Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.3. PRESS RELEASES

Pursuant to the current HHS annual appropriations act, the Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.4. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

"(3) Definition of unauthorized alien. - As used in this section, the term 'unauthorized alien' means, with respect to the employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General."

ARTICLE H.5. PRIVACY ACT, HHSAR 352.270-11 (January 2006)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term ''system of records'' means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C.

552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as HHS employees. These provisions also apply to all subcontracts awarded under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)).

The contract work statement: (a) Identifies the system(s) of records and the design, development, or operation work to be performed by the Contractor; and (b) specifies the disposition to be made of such records upon completion of contract performance.

(End of clause)

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html

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The Privacy Act System of Records applicable to this project is Number 09-25-0200. This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document is also available at: http:// oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm.

ARTICLE H.6. OPTION PROVISION

Unless the Government exercises its option(s) pursuant to the Option Clauses set forth in ARTICLE I.3., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract.

Option A: Pursuant to FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract.

Option A requires a two (2) year integration peiod and up to five (5) years of maintenance. Option A may be exercised anytime during the contract period of performance. If the option is not exercised on the anniversary date of the contract, the estimated cost plus fixed fee will be prorated. If the Government exercises this option, notice must be given at least 15 days prior to the exercise of the option, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST, FIXED FEE AND AWARD OPTION Article in SECTION B of this contract.

Option B: Pursuant to FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract.

This option may be exercised in increments of five (5) audits above a base of 30-35 audits per year as part of the contract with a maximum of one (1) increment (5 total additional audits) for years 2011-2014 and two (2) increments (10 total additional audits) exercised for years 2015-2016. Option B may be exercised anytime during the contract period of performance. If the Government exercises this option, notice must be given at least 15 days prior to the exercise of the option, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST, FIXED FEE AND AWARD OPTION Article in SECTION B of this contract.

Option to Extend the term of the contract (FY 11: May 1, 2011 April- 30, 2012): Pursuant to Far Clause 52.217-9, Option to Extend the Term of the Contract set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST, FIXED FEE AND AWARD OPTION Article in SECTION B of this contract.

ARTICLE H.7. AWARD OPTION QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

a. Award Option Contract

The Contractor may earn award options as described below. If the Contracting Officer determines that the Contractor's performance merits the award option, the estimated cost plus fixed fee will be increased as set forth in the ESTIMATED COST, FIXED FEE AND AWARD OPTION Article in SECTION B of this contract.

This Contract contains Award Option(s). The Contractor is not entitled to the exercise of any Award Options solely by meeting the criteria of the Quality Assurance Surveillance Plan (QASP). The Award Option evaluation serves as a precursor to the Government exercising its unilateral rights in accordance with FAR Part 17.2. A successful Award Option evaluation precedes the Government's review and determination to exercise or not to exercise the Award Option, in accordance with FAR Part 17.2

Award Option(s) that have not been exercised may be cancelled (rather than terminated), should the need for the items or services no longer exist. No equitable adjustments to the contract price will be applicable, as the determination not to exercise the Award Option is not considered a termination for convenience. There is no guarantee the Government will continue Performance beyond the base performance period.

Award Option(s) will be exercised based on the criteria set forth below, and the final decision whether to exercise the Award Option(s) will be made annually and is at the sole discretion of the Contracting Officer. If http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm

- 19 -the Contracting Officer determines that the Award Option has been earned, and the Government's need for the items or services still exists, the estimated cost plus fixed fee will be increased as set forth in the ESTIMATED COST, FIXED FEE AND AWARD OPTION Article in SECTION B of this contract.

b. Award Option Provisions

This contract has a base performance period of 1 year, May 1, 2010 - April 30, 2011 with a 1 year optional period from May 1, 2011 - April 30, 2012. The Contractor will have the opportunity to earn 5 additional years of work, May 1, 2012 - April 30, 2017 using the evaluation process described herein. These additional years of work are called Award Options. The total duration of this contract, including all options and Award Options, shall not exceed a period of 7 years, May 1, 2010 - April 30, 2017.

A unilateral contract modification to add the Award Option will be issued when scoring meets or exceeds that set forth in the contract. The Government shall issue this modification at least 60 days prior to contract expiration.

The Award Option determination and the methodology for determining the award option are unilateral decisions made solely by the Government and are not subject to dispute.

1. Quality Assurance Surveillance Plan

a. The Contractor's performance under this contract will be observed and evaluated continuously by the Government. The Contractor Assessment Report will be used to assess Contractor performance and determine whether the Contractor will receive Award Option(s). The Contractor Assessment Report includes Performance Indicators and Standards which identify the indicators to be evaluated and the associated standards for each indicator. A copy of the "Contractor Assessment Report/Performance Indicators and Standards," dated June 9, 2009 is included as an attachment in SECTION J of this contract.

b. The "Contractor Assessment Report/Performance Indicators and Standards" will be prepared by the Government, resulting in an overall rating which will be disseminated to the Contractor annually.

The Award Option(s) earned will be determined based upon review of the Contractor's performance against the performance indicators and standards as follows:

1. Using the 0-5 point score in the Plan, the Contractor must receive an average of 4.125 or better in the first two years of Contractor performance. In years three, four and five the Contractor must receive an average of 4.4375 or better in each year to earn the Award Options. These goals are intended to be a stretch for the Contractor, but achievable.

2. At the conclusion of year one, the Government will prepare a summary of the "Contractor Assessment Report/Performance Indicators and Standards" which will set forth the rating for the first year of performance. This report will be used to determine if the Award Option for year three has been earned. Likewise, at the conclusion of year two, three, four and five, the Government will prepare a "Contractor Assessment Report/Performance Indicators and Standards" and a summary report for each year to determine if the Award Option for years four, five, six and seven have been earned.

The advance evaluation of performance is required to allow adequate time for recompetition of the requirement in the event that Contractor performance does not meet the Award Option requirements. If the Contractor does not earn the first Award Option, there will be no opportunity to earn subsequent Award Option(s) and the contract expiration date will remain unchanged.

3. The "Contractor Assessment Report/Performance Indicators and Standards" described herein contains rating criteria used solely to assess whether the Contractor has earned the award option(s) specified in this contract. This report differs from the Contractor Performance Report described in the POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE Article in SECTION G of this contract, which uses a standard rating criteria established for the Federal Contractor Performance System to evaluate overall contract performance. For this reason, the Contractor's performance scores for determining authorization of the award option(s) may differ from the Contractor's performance scores for overall contract performance.

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2. Changes to the Contractor Assessment Report/Performance Indicators and Standards

Unilateral changes to the Contractor Assessment Report/Performance Indicators and Standards may be made if the Contractor is provided written notification by the Contracting Officer at least 30 days before the start of the upcoming evaluation period. Changes affecting the current evaluation period must be by mutual agreement of both parties.

3. Contractor Performance Assessment

The Project Officer, and other Government personnel as appropriate, will use the "Contractor Assessment Report/Performance Indicators and Standards" and the associated performance elements and standards to score contract performance for the Award Option determination. The Contracting Officer is responsible for making the final decision on the Contractor's score and for determining whether the Contractor has earned the Award Option.

4. Contractor Performance Evaluation

The Project Officer and Contracting Officer will prepare reports required by FAR 42.15 and described in the POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE Article in SECTION G of this contract to determine the Contractor's overall contract performance. Unless specifically identified as a rating criterion in the "Contractor Assessment Report/Performance Indicators and Standards," this evaluation report will not be used in the Award Option determination.

ARTICLE H.8. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith…