N02CM71001-75_CTMS.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92.218 as amended

2. Request for Proposal (RFP) Number:

N02CM71001-75

3. Issue Date:

October 19, 2016

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Clinical Trials Monitoring Service (CTMS)

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E580 MSC 9705 Bethesda, MD 20892-9705

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 E.S.T. on November 18, 2016. 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 as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Catherine Kennedy

PHONE: 301-825-8699

e-MAIL: catherine.kennedy3@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cut-off date for questions is November 2, 2016 3:00 PM E.S.T.

Rukshani Levy Contracting Officer Office of Aquisitions http://www.sam.gov

RFP Number : N02CM71001-75

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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. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. 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. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

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11. ROTC Access and Federal Military Recruiting on Campus

12. Certification of Filing and Payment of Taxes

13. Past Performance Information

14. Information and Physical Access Security

15. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Instructions to Offerors-Sustainable Acquisition, HHSAR Provision 352.223-71 (December 2015). . . 70

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Cost and Pricing Data

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

6. Salary Rate Limitation

7. Small Business Subcontracting Plan

8. Mentor Protege Program, HHSAR 352.219-70

9. HUBZone Small Business Concerns

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION FACTORS

6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. PAST PERFORMANCE FACTOR

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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 contract is to provide data management, quality assurance, clinical trial monitoring and auditing capability, for NCI sponsored clinical trials at participating sites both within and outside of the U.S and monitoring for current Good Manufacturing Practices (cGMP) for biopharmaceutical manufacturing facilities and Good Laboratory Practices for Core Laboratories performing investigational integral and integrated biomarker assays.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is To Be Negotiated.

b. The fixed fee for the Base Period of this contract is To Be Negotiated. 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.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is To Be Negotiated.

d. 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:

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

Option A: Phase-In Transition Option A: Phase-In Transition (3 months) TBD TBD TBD Base Work Base Period (12 months) TBD TBD TBD Option Period 1 (12 months) TBD TBD TBD

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

Option Period 2 (12 months) TBD TBD TBD Option Period 3 (12 months) TBD TBD TBD Option Period 4 (12 months) TBD TBD TBD Option B GMP Audits Option B1 GMP Audits (12 months) TBD TBD TBD Option B2 GMP Audits (12 months) TBD TBD TBD Option B3 GMP Audits (12 months) TBD TBD TBD Option B4 GMP Audits (12 months) TBD TBD TBD Option B5 GMP Audits (12 months) TBD TBD TBD Option C I Increased Capacity Option C I.1 Increased Capacity (12 months) TBD TBD TBD Option C I.2 Increased Capacity (12 months) TBD TBD TBD Option C I.3 Increased Capacity (12 months) TBD TBD TBD Option C I.4 Increased Capacity (12 months) TBD TBD TBD Option C I.5 Increased Capacity (12 months) TBD TBD TBD Option C II Increased Capacity Option C II.1 Increased Capacity (12 months)

TBD TBD TBD

Option C II.2 Increased Capacity (12 months)

TBD TBD TBD

Option C II.3 Increased Capacity (12 months)

TBD TBD TBD

Option C II.4 Increased Capacity (12 months)

TBD TBD TBD

Option C II.5 Increased Capacity (12 months)

TBD TBD TBD

Option D GLP Audit Option D1 GLP Audit (12 months) TBD TBD TBD Option D2 GLP Audit (12 months) TBD TBD TBD Option D3 GLP Audit (12 months) TBD TBD TBD Option D4 GLP Audit (12 months) TBD TBD TBD Option D5 GLP Audit (12 months) TBD TBD TBD Option E Phase-Out Transition Option E Phase-Out Transition (3 months) TBD TBD TBD Total (Base Period and Options) TBD TBD TBD

ARTICLE B.4. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT

a. The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs, is $TBD.

b. The following represents the schedule* by which the Government expects to allot funds to this contract:

CLIN, Task, Number, or Description

Start Date of Period or Increment of

Performance

End Date of

Period or Increment of Performance

Estimated Cost ($)

Fee ($) (as appropriate)

Estimated Cost Plus Fee ($) (as appropriate)

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CLIN, Task, Number, or Description

Start Date of Period or Increment of

Performance

End Date of

Period or Increment of Performance

Estimated Cost ($)

Fee ($) (as appropriate)

Estimated Cost Plus Fee ($) (as appropriate)

[Total] [Total] [Total]

*To be inserted after negotiation

c. Total funds currently obligated and available for payment under this contract are $TBD .

d. The Contracting Officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs b. and/or c., above.

e. Until this contract is fully funded, the requirements of the clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232-20, Limitation of Cost, shall govern.

f. Payment of fee 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.

The fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

ARTICLE B.5. 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) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.6. 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 October 19, 2016, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format via email as attachments to the following designated NCI Branch Distribution Mailbox: ncibrancheinvoices@mail.nih.gov.

Note: Hard copies of reports are no longer required and shall no longer be mailed to NCI, OA. Each email submission shall contain only one deliverable. If the attached files for the deliverables exceed 50 MB, the contractor shall divide the deliverables into files 50 MB each. All deliverables should be limited to five file attachments or less. We understand that in some cases more than five attachments will be necessary.

The subject line of the email should read as follows:

Deliverable_Contract Number_Vendor's name_Deliverable Description_Due Date

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

Data transfer of PII or sensitive information to the NCI is to be encrypted.

a. Technical Progress Reports

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.]

1. Special Ad Hoc Reports

Special Ad Hoc Reports(approximately 35/year) shall be generated as requested by the Contracting Officer's Technical Representative(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 http://www.hhs.gov/web/508/index.html

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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.

2. 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.

3. Final Study Report

The Final Study 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. Task II Audit Report

The Contractor shall prepare a report of the findings of the audit that will be submitted within 15 working days (for audit reports for studies assigned as either CTMS Comprehensive and CTMS Routine-separate reports are to be submitted for CTMS Comprehensive and CTMS Routine using the same timeline for submission). The report is to be transmitted electronically utilizing the Clinical Trials Monitoring Branch Audit Information System (CTMB-AIS). The audit report shall contain a narrative description of the interaction between the Contractor auditor and the investigator. The audit report shall summarize the findings and be submitted via the CTMB-AIS in the AIS format. The Contractor's report of the audit findings shall follow the parameter fields contained the CTMB-AIS.

5. Task III Co-Site Preliminary Audit Report

The Contractor shall submit a Preliminary Report of audit findings within 24 hours of the end of the audit. The Preliminary Report will include a brief description of any Major/Critical finding identified during the audit. The Preliminary Report will be faxed or submitted electronically to CTMB. The COR and Contracting Officer must be notified by telephone with a follow-up email of any findings suspicious and/or suggestive of intentional misrepresentation of data and/or disregard for regulatory safeguards for any of the three (regulatory, pharmacy and patient case) components of an audit.

Similarly, any data irregularities identified through other quality control procedures suspicious and/ or suggestive of intentional misrepresentation of data must be reported to COR and Contracting Officer within 1 working day.

6. Task III Co-Site Final Audit Report

The Contractor shall submit to the COR a co-site audit report in an electronic format to the CTMB-AIS within fifteen working days after a site visit. The report shall not only summarize the audit findings, but shall also describe if the auditors conducted the audit in accordance with CTMB Guidelines. Any major deficiency will also be briefly described in the report.

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7. Task IV Auditing of Institutions/Investigators That Do Not Have Data Management Performed by CTMS Draft Report

Within twenty (20) working days after an audit the Contractor shall electronically submit via the CTMB-AIS, a draft audit report to the COR. The audit report shall be formatted according to the CTMB Audit Information System specifications.

8. Task IV Auditing of Institutions/Investigators That Do Not Have Data Management Performed by CTMS Final Report

Within 5 business day after receiving comments on the draft report from the COR, the comments from the COR will be incorporated and the Final Audit Report submitted electronically via the CTMB Audit Information System.

9. International Collaborator Reports

The Contractor shall submit a written report within ten (10) working days of the meeting with an international collaborator, explaining the reason for the meeting and a summary of the meeting and the outcome(s). Also, included are actions that are expected of the collaborator or the DCTD/NCI.

10. cGMP Audit Reports

Within 30 days following the cGMP audit, the Contractor shall provide a written report of observations and recommendations. The final report shall include an Executive Summary, a listing of all auditors and attendees, a summary of observations, and findings, and recommendations. All findings/ deficiencies shall be classified as Critical, Major, or Minor.

11. GLP Audit Reports

Within 30 days following the GLP audit, the Contractor shall provide a written report of observations and recommendations. The final report shall include an Executive Summary, a listing of all auditors and attendees, a summary of observations, and findings, and recommendations. All findings/ deficiencies shall be classified as Critical, Major, or Minor.

b. Other Reports/Deliverables

1. Semi- Annual Financial Reports - For Task I-V, Option B, Option C

Financial reports shall be submitted to the COR for all activities under the contract. For data management cost information should be kept for institution, treatment, and phase of study. Cost information should also be included for: study build and data management, per patient cost for study build and data management, and IT support and maintenance.

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2. Semi - Annual Report

The Contractor shall submit to the COR a semiannual report summarizing accomplishments and identifying any difficulties or problematic areas encountered during the reporting period. The Semi-annual report should include a log of down time for the web based patient registration system as mentioned in Section I, item 2 of the Statement of Work.

3. Monitoring Plan

The Contractor shall submit on an annual by January 15 of each year the monitoring plan for CTMS studies so that it can be included as part of the annual update to the CTEP Drug Master File submitted to the FDA. The monitoring plan shall include procedures for the standard operating procedures of the Clinical Data Management System and quality assurance review process, staff training, bio-sketches for staff involved in the project. The monitoring plan should include an updated version of the monitoring physician's handbook (educational tool that serves to prepare outside physicians on their role as auditors).

4. Phase-in Transition Plan

The Contractor shall develop and submit a draft initial phase-in plan at the time of proposal, which will describe the Contractor's strategy for taking over work from the incumbent Contractor, if required, to ensure continuity of CTMS services. The plan must include provision of key personnel, transfer of relevant files, records, materials, data and transition of all activities, and IT applications and programs from the incumbent Contractor to a secure server space. Within 15 calendar days of the award, the draft initial transition plan will be revised, if necessary, and the draft initial transition plan will become the final initial transition plan upon approval of the Contracting Officer's Representative (COR).

5. Phase-out Transition Plan

The Contractor shall prepare and submit a draft Phase-out Transition Plan to the Contracting Officer and the Contracting Officer's Representative 90 days prior to the completion date of the contract. The draft Phase-Out Transition plan shall describe the Contractor's strategy for transferring work from this contract to a successor contract, in the event a final transition would be required. The phase-out plan must include plans for transfer of policies and procedures; transfer of relevant files, records, materials, and data; electronic data, database(s), and software applications transition of all activities, and transition of all applications, as appropriate. The Contractor shall ensure that Procedures Manuals are accurate and up-to-date.

6. Final Report

A Final Report shall be submitted on or before the expiration date of the contract and include a summary of the results of the work performed over the entire contract.

7. Individual Subcontracting Report (ISR)

Individual Subcontracting Report shall be submitted electronically annually.

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8. Summary Subcontractor Report

A Summary Subcontractor Report shall be submitted electronically annually on October 30th.

9. 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.

10. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. Annual Privacy Impact Assessment

An Annual Privacy Impact Assessment must be submitted electronically by July 10 each year of the contract performance. See: https://oma.od.nih.gov/DMS/Pages/Privacy- Program-Privacy-Impact-Assessments.aspx

c. IT Security Plan (IT-SP)

The contractor shall submit the IT-SP within thirty (30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

https://oma.od.nih.gov/DMS/Pages/Privacy-Program-Privacy-Impact-Assessments.aspx https://oma.od.nih.gov/DMS/Pages/Privacy-Program-Privacy-Impact-Assessments.aspx

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d. IT Risk Assessment (IT-RA)

The contractor shall submit the IT-RA within thirty (30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

e. IT Security Certification and Accreditation (IT-SC&A)

The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. FIPS 199 Assessment

The Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

g. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

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h. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

i. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

11. Self Assessment Report

The Contractor shall submit a Self Assessment Report annually.

12. Information Security Plan Report

The Contractor shall submit the Information Security Plan Report within twenty-one (21) calendar days following each reporting period

13. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

http://www.hhs.gov/web/508/contracting/technology/vendors.html

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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, Contracting Officer Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive, Room TBD Rockville, MD 20850

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 May 1, 2017 through April 30, 2018.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option Period 1 12 months Option Period 2 12 months Option Period 3 12 months Option Period 4 12 months Optional Task A: Phase-In Transition 3 months Optional Task B1: GMP Audits 12 months Optional Task B2: GMP Audits 12 months Optional Task B3: GMP Audits 12 months Optional Task B4: GMP Audits 12 months Optional Task B5: GMP Audits 12 months Optional Task C I.1: Increased Capacity (20%) 12 months Optional Task C I.2: Increased Capacity (20%) 12 months Optional Task C I.3: Increased Capacity (20%) 12 months Optional Task C I.4: Increased Capacity (20%) 12 months Optional Task C I.5: Increased Capacity (20%) 12 months Optional Task C II.1: Increased Capacity (20%) 12 months Optional Task C II.2: Increased Capacity (20%) 12 months Optional Task C II.3: Increased Capacity (20%) 12 months Optional Task C II.4: Increased Capacity (20%) 12 months Optional Task C II.5: Increased Capacity (20%) 12 months Optional Task D1- GLP Audit 12 months Optional Task D2- GLP Audit 12 months Optional Task D3- GLP Audit 12 months Optional Task D4- GLP Audit 12 months Optional Task D5- GLP Audit 12 months Option E: Phase-Out Transition 3 months

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 date(s) specified below:

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Item Description Delivered To ( Copies) Due Date

1. Special Ad Hoc Reports

(Task I) COR email Within 24 hours of Contracting

Officer's Representative request or as otherwise directed by the

COR.

2. Summary of Salient Results ncibrancheinvoices@mail.nih.gov and

COR

On or before the expiration date of the contract

3. Final Study Report COR email, IDB Monitor(s) Within 30 days of the study being closed and database for the study has been locked. Submit electronically via the Web Reporting Module.

4. Task II Audit Report

(CTMS Comprehensive and CTMS Routine)

COR email Within 15 business days from the last day of the audit by electronic submission via CTMB-Audit Information System.

5. Task III Co-Site Preliminary Audit Report

COR email Within 24 hours from the end of the audit by electronic submission via CTMB-Audit Information System.

6. Task III Co-Site Final Audit Report COR email Within 15 business days from the last day of the audit by electronic submission via CTMB-Audit Information System.

7. Task IV Auditing of Institutions/ Investigators That Do Not Have Data Management Performed by CTMS (Draft Report Submission to

CTMB)

COR email Within 20 business days from the last day of the audit by electronic submission via CTMB-Audit Information System.

8. Task IV Auditing of Institutions/ Investigators That Do Not Have Data Management Performed by CTMS (Final Report Submission to

CTMB)

COR email Return Final Report with revisions as required by CTMB within 5 business days of receiving comments from the Contracting Officer's Representatives/designee by electronic submission via CTMB-Audit Information System.

9. International Collaborator Reports COR email Within 10 business days of the international collaborator meeting

10. cGMP Audit Report ncibrancheinvoices@mail.nih.gov and

COR

Within 30 days of the last day of the cGMP audit.

11. GLP Audit Report ncibrancheinvoices@mail.nih.gov and

COR

Within 30 days of the last day of the GLP audit.

12. Semi-Annual Financial Reports - For Tasks I-V, Option B, Option C ncibrancheinvoices@mail.nih.gov and

COR

Semi-Annually on November 30th and May 31st

13. Semi-Annual Report ncibrancheinvoices@mail.nih.gov and

Update on Status of Projects, Problems Encountered and Actions Taken. Include log of down-time for IWRS and web reporting systems.

mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

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Item Description Delivered To ( Copies) Due Date Semi-Annually on November 30th and May 31st

14. Monitoring Plan with SOPs for data handling, staff training, C.V.s and monitoring physicians' Handbook ncibrancheinvoices@mail.nih.gov and

COR

Annually by January 15 of each Contract year.

15. Phase-in Transition Plan (Option A) ncibrancheinvoices@mail.nih.gov and

COR

Within 15 calendar days of the award

16. Phase-out Transition Plan ncibrancheinvoices@mail.nih.gov and

COR

Within 90 days prior to the completion of the contract.

17. Final Report ncibrancheinvoices@mail.nih.gov and

COR

On or before the expiration date of the contract

18. Individual Subcontracting Report

(ISR)

ncibrancheinvoices@mail.nih.gov and

Annually

19. Summary Subcontract Report

(SSR)

ncibrancheinvoices@mail.nih.gov and

COR

Annually on October 30th

20. Source Code and Object Code ncibrancheinvoices@mail.nih.gov and

COR

On or before the expiration date of the contract

21. Roster of Employees Requiring Suitability Investigations ncibrancheinvoices@mail.nih.gov and

COR

Within 14 calendar days of the effective date of the contract

22. Annual Privacy Impact Assessment COR email Annually by July 10 of each calendar year via electronic submission

23. IT Security Plan (IT-SP) ncibrancheinvoices@mail.nih.gov and

COR

Within 30 calendar days of the effective date of the contract

24. IT Risk Assessment (IT-RA) ncibrancheinvoices@mail.nih.gov and

COR

Within 30 calendar days of the effective date of the contract

25. IT Security Certification and Accreditation (IT-SC&A) ncibrancheinvoices@mail.nih.gov and

COR

Within 90 calendar days of the effective date of the contract

26. FIPS 199 Assessment ncibrancheinvoices@mail.nih.gov and

COR

Within 30 calendar days of the effective date of the contract

27. Reporting of New and Departing Employees ncibrancheinvoices@mail.nih.gov and

COR

Within 5 working days of a new employee being hired and within 5 days after an employee departs a position

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

COR email As deemed necessary

29. Vulnerability Scanning Reports ncibrancheinvoices@mail.nih.gov and

COR

Within ten (10) calendar days following each reporting period

30. Self Assessment Reporting ncibrancheinvoices@mail.nih.gov and

COR

Annually

31. Information System Security Plan Reporting

COR email Within 90 calendar days of the effective date of the contract

32. Section 508 Annual Report ncibrancheinvoices@mail.nih.gov and

COR

Within twenty-one (21) calendar days following each reporting period mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

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b. The above items shall be addressed and delivered to:

Addresses Deliverable Item No.

Contracting Officer's Representative (COR)

[To be named]

1 - 32

Contracting Officer (CO)

[To be named]

Office of Acquisitions (OA)

National Cancer Institute

10 - 21

23 - 27

29, 30 and 32

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/far .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

http://www.acquisition.gov/far

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

To be specified prior to award

The COR 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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

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; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

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

Name Title

TBD TBD

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

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1for NIH Cost-Reimbursement Type Contracts 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 courtesy copy of the original invoice shall be submitted electronically as follows:

1. The Contractor shall scan the original payment request (invoice) in Adobe Portable Document Format (PDF) along with the necessary supporting documentation as one single attachment.

2. Save the single attachment (scanned invoice along with any supporting documentation) in the following format: YourVendorName_Invoice number (e.g., if you are submitting Invoice 123456, save the single attachment as "ABCCompany_Invoice 123456") [Note: Please do not use special characters such as (#, $, %,*, &, !) when saving your attachment. Only the underscore symbol (_) is permitted.]

3. Transmit the saved single attachment via e-mail to the appropriate branch's Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCI OA Branch E - ncibrancheinvoices@mail.nih.gov . Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contract Number_ Contract Title_ Contractor's Name_ unique Invoice number

(e.g, HHSN2612XXXXXC_Clinical Genetics Support_ABCCompany_Invoice 12345) [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office listed in subparagraph a, above, to meet the requirements of a "proper invoice." Also, The Contractor must certify on the payment request that the electronic courtesy copy is a duplicate of the original invoice mailed to NIH's Office of Financial Management.]

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 National Cancer Institute .

b. 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. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

c. 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

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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. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

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

e. 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.

f. The Contract Title is:

Clinical Trials Monitoring Service

g. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

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

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

ARTICLE G.5. 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

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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

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ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance…