Final_RFP_CROMS_NIHAI2015043.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: FAR 1.602-1

2. Request for Proposal (RFP) Number:

RFP-NIAID-DMID-NIHAI2015043

3. Issue Date:

12/02/2015

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Clinical Research Operations and Management Support

6. ISSUED BY:

Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, Room 3B48, MSC 9821 Rockville, MD 20892-9821

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 12:00 noon eastern standard time (EST) on March 10, 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 Central Contractor Registry (CCR) 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: Erin Felent, Contracting Officer

PHONE: 240-669-5130

e-MAIL: Erin.Felent@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Deadline for receipt of Offerors' questions pertaining to this RFP:

February 2, 2016.

Note: The subject line of your email responses should include "RFP- NIAID-DMID-NIHAI2015043 questions".

Erin Felent Contracting Officer Office of Acquisitions, DEA

NIAID, NIH, DHHS

http://www.sam.gov

RFP Number : RFP-NIAID-DMID-NIHAI2015043

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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. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Certification of Filing and Payment of Taxes

13. Past Performance Information

14. Prohibition on Contractor Involvement with Terrorist Activities

15. Information and Physical Access Security

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. 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 National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID) Clinical Research Operations and Management Support (CROMS) program provides clinical trials management support services to DMID and DMID-supported investigators. Services shall include compliance with US and international regulations, clinical site management, information management, a document library, data analytics, safety monitoring and reporting, clinical site assessment and interim monitoring, site essential regulatory documentation, site quality management programs, training, medical writing, administrative support, and computerized activity tracking, monitoring and reporting systems.

ARTICLE B.2. ESTIMATED COST - OPTION

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

b. The fixed fee for the Base Period of this contract is $ . The fixed 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.

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 $ .

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:

BASE PERIOD AND TERM OPTIONS

Period Level of

Effort (FTEs) per Year

Contract Year Period of Performance

Estimated Cost ($)

Fixed Fee ($) Estimated Cost Plus

Fixed Fee ($) Base 101.60 Year 1 01/03/2017 -

01/02/2018

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BASE PERIOD AND TERM OPTIONS

TERM OPTIONS (FAR 52.217-9)

Option 1 101.60

Year 2 01/03/2018 - 01/02/2019

Option 2 101.60

Year 3 01/03/2019 - 01/02/2020

Option 3 101.60

Year 4 01/03/2020 - 01/02/2021

Option 4 101.60

Year 5 01/03/2021 - 01/02/2022

Option 5 101.60

Year 6 01/03/2022 - 01/02/2023

Option 6 101.60

Year 7 01/03/2023 - 01/02/2024

Subtotals - Term Options Years 2 -7 01/03/2017 -

QUANTITY OPTIONS to Increase Level of Effort (FAR 52.217-6) Option Level of

Effort (FTEs) per Year

Contract Year Period of Performance

Estimated Cost

Fixed Fee

Estimated Cost Plus

Fixed Fee ($) Option 7A 2 Year 1 01/03/2017 -

01/02/2018

Option 8A 5 Year 1 01/03/2017 - 01/02/2018

Option 9A 8 Year 1 01/03/2017 - 01/02/2018

Maximum Additional Allowed

26 Year 1 01/03/2017 - 01/02/2018

Option 7B 2 Year 2 01/03/2018 -

Option 8B 5 Year 2 01/03/2018 - 01/02/2019

Option 9B 8 Year 2 01/03/2018 - 01/02/2019

Maximum Additional Allowed

26 Year 2 01/03/2018 -

Option 7C 2 Year 3 01/03/2019 -

Option 8C 5 Year 3 01/03/2019 - 01/02/2020

Option 9C 8 Year 3 01/03/2019 - 01/02/2020

Maximum Additional Allowed

26 Year 3 01/03/2019 -

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QUANTITY OPTIONS to Increase Level of Effort (FAR 52.217-6) Option 7D 2 Year 4 01/03/2020 -

01/02/2021

Option 8D 5 Year 4 01/03/2020 - 01/02/2021

Option 9D 8 Year 4 01/03/2020 - 01/02/2021

Maximum Additional Allowed

26 Year 4 01/03/2020 - 01/02/2021

Option 7E 2 Year 5 01/03/2021 -

Option 8E 5 Year 5 01/03/2021 - 01/02/2022

Option 9E 8 Year 5 01/03/2021 - 01/02/2022

Maximum Additional Allowed

26 Year 5 01/03/2021 -

Option 7F 2 Year 6 01/03/2022 -

Option 8F 5 Year 6 01/03/2022 - 01/02/2023

Option 9F 8 Year 6 01/03/2022 - 01/02/2023

Maximum Additional Allowed

26 Year 6 01/03/2022 -

Option 7G 2 Year 7 01/03/2023 -

Option 8G 5 Year 7 01/03/2023 - 01/02/2024

Option 9G 8 Year 7 01/03/2023 - 01/02/2024

Maximum Additional Allowed

26 Year 7 01/03/2023 -

TRANSITION OPTIONS (FAR 52.217-7)

Option Contract Year Period of

Performance (Approx.)

Estimated Cost ($)

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

Option 10 Beginning Transition

Year 1 01/03/2017

- 05/03/2017

Option 11 Ending Transition

Year 7 09/02/2023

- 01/02/2024

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OPTION TO EXTEND SERVICES for no more than 6 additional months over life of the Contract (FAR 52.217-8) Option Level of

Effort (FTEs)

Contract Year(s)

Period of Performance

Estimated Cost

Fixed Fee

Estimated Cost Plus

Fixed Fee ($) Option 12 As necessary As necessary As necessary In accordance with period just ended.

In accordance with period just ended.

In accordance with period just ended.

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) 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.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 September 8, 2015, 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 hardcopy of each report shall be submitted to the Contracting Officer.

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."

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.

The Contractor shall submit to the Contracting Officer (CO) and to the Contracting Officer's Representative (COR) technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the CO and COR. These reports shall be brief, factual and prepared in accordance with the format described below.

All reports shall include a cover page prepared in accordance with the following format:

• Contract Number and Project Title

• Period of Performance Being Reported

• Contractor's Name and Address

• Author(s)

• Date of Submission

• Delivery Email Address

1) Monthly Progress Report

This report shall include a description of contractor, subcontractor and consultant activities during the reporting period, and the activities planned for the ensuing reporting period. Reporting period metrics shall also include cumulative totals for period specified by the COR. The first reporting period http://www.hhs.gov/web/508/index.html

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The first report shall be due on or before the 15th of the month after the first full calendar month of performance. Thereafter, reports shall be due on or before the 15th of the month following each reporting period.

The monthly report shall include information related to the following services and activities:

1. Clinical site essential regulatory documentation, including:

a. New requests for pre-study site essential regulatory document collection.

b. Internal procedural issues and critical site essential regulatory documentation issues or discrepancies.

c. Clinical sites pending DMID authorization for site activation.

d. Institutional Review Board approvals pending expiration within next 60 days and past expiration.

e. Clinical sites pending essential regulatory document file closeout.

2. Clinical site monitoring, including:

a. New requests for clinical site assessments, interim, closeout and ad hoc monitoring.

b. Clinical monitoring plan information including protocol, type, version and date.

c. Monitoring visits including type, date completed, scheduled and projected.

3. Clinical site quality management programs.

4. Clinical study protocol statuses.

5. Contractor, subcontractors and consultant staff list, including names, title, protocol/project assignments, and role/function in each of these projects.

6. Data management and analytics.

7. Information technology and data systems, including change requests, release dates, system availability metrics, and user access metrics.

8. Medical writing.

9. Quality Assurance/Quality Control (QA/QC) internal assessments once each quarter, including list of findings, actions taken and QA/QC Plan modifications

10. Safety Oversight structures, including safety committee metrics and a summary of committee recommendations.

11. Safety monitoring, including the number of Serious Adverse Event (SAE) reports:

a. Received and processed.

b. Reported to agencies.

c. Reported to stakeholders or partners.

12. Training plans, materials development, and Learning Management System metrics and user evaluation results.

13. Technical support services, e.g., preparation of IND reports, meeting support.

14. Expenditures by contract service area corresponding to SOW technical requirements sections to include direct costs for reporting period, cumulative contract Year-to-Date (YTD) overall costs and projected costs. Expenditures shall be broken down by protocol, including service area personnel labor hours expended, supplies and materials, travel (identify purpose of travel), and other direct costs. Report to include graphical displays of actual expenditures against projected expenditures.

15. Level-of-Effort (LOE) by contract service area corresponding to SOW technical requirements sections to include LOE for reporting period and cumulative contract Year-to-Date (YTD) FTEs/LOE expended sorted by personnel and by protocol. Report to include graphical displays of information against projections for LOE required.

2) Quarterly Progress Report

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(a) This report shall include a summation of the Monthly Progress Reports and the activities planned for the ensuing reporting period. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months.

(b) A Monthly Progress Report will not be submitted for the final month of a quarter.

3) Annual Progress Report

This report includes a summation of the results of the entire contract work for the period covered. An Annual Progress Report will not be required for the period when the Final Report is due. A Monthly and Quarterly Progress Report shall not be submitted when an Annual Progress Report is due.

4) Final Report

This report shall consist of the work performed and results obtained for the entire contract period of performance as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted on or before the last day of the contract performance period. An Annual, Quarterly, and Monthly Progress Report will not be required for the period when the Final Report is due.

5) 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

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. 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.

3. 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.

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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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. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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.)

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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.)

d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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.)

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

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In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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. 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.)

g. 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.)

h. 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.)

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4. 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."

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions 5601 Fishers Lane Rockville, Maryland 20852

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

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

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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.

Shipments will be time sensitive/time critical. International shipping will apply.

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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 Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

DHHS, National Institutes of Health National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases (DMID) Office of Clinical Research Affairs (OCRA) 5601 Fishers Lane Rockville, MD 20852

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 January 3, 2017 through January 2, 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 Term Option 1 1/03/18 - 1/02/19 Term Option 2 1/03/19 - 1/02/20 Term Option 3 1/03/20 - 1/02/21 Term Option 4 1/03/21 - 1/02/22 Term Option 5 1/03/22 - 1/02/23 Term Option 6 1/03/23 - 1/02/24 Option 10- Initial Transition To be decided Option 11- Final Transition To be decided Option 12- Option to Extend Services

To be decided

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. Technical Progress Reports

Item Reports Recipients Delivery Schedule

1. Monthly Progress Report 1 electronic copy to COR and CO As described in Article C.2.

2. Quarterly Progress Report 1 electronic copy to COR and CO

As described in Article C.2.

3. Annual Progress Report 1 electronic copy to COR and CO

As described in Article C.2.

4. Final Report 1 electronic copy to COR and CO

As described in Article C.2.

b. Other Reports and Deliverables (Delivery Schedule)

Item Other Reports SOW Reference Recipient Delivery Schedule

1. Service Area Design Input Documents

(DID)

A. 1 electronic copy to COR

Within 30 calendar days after the contract effective date.

2. Standard Operating Procedures (SOP)

A. 1 electronic copy to

COR

Within 30 calendar days after COR technical acceptance of DIDs.

3. DID Updates A. 1 electronic copy to

COR

Within 10 business days after receipt

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Item Other Reports SOW Reference Recipient Delivery Schedule of comments on DIDs and thereafter annually, as warranted by annual evaluation results.

4. SOP Updates A. 1 electronic copy to

COR

Within 30 calendar days after COR technical acceptance of DID(s) update, modify corresponding SOP(s) to conform to changes.

5. Protocol, protocol related document development or translation service request confirmation of receipt, requirements and estimated time to completion

B. 1 electronic copy to

COR

Within 1 business day after COR approval of the request.

6. Protocol, protocolrelated document development or translation services

B. 1 electronic copy to

COR

Within 15 business days after COR approval of the request.

7. Proposed Clinical Site Assessment Visit

C.1. 1 electronic copy to

COR

After COR approval of request within 5 business days schedule visit and within 30 days complete assessment visit.

8. Clinical Site Assessment Visit Reports

C.1. 1 electronic copy to

COR

Report critical findings within 24 hours.

Within 10 business days submit draft visit report. Within 5 business days after receipt of COR comments on draft report distribute final visit report.

9. Clinical Site Quality Management (QM) service request confirmation of requirements received and estimated time to completion

C.2. 1 electronic copy to

COR

Within 1 business day after COR approval of the request.

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Item Other Reports SOW Reference Recipient Delivery Schedule

10. Clinical Site Quality Management (QM) services

C.2. 1 electronic copy to

COR

Within 10 business days for QM document development or review, and 30 business days for QM consultation visit.

11. Site Essential Regulatory Documentation (SERD) services

C.3. 1 electronic copy to

COR

As directed by the COR, before, during and after study for closeout.

Critical SERD issues or discrepancies report within 1 business day.

12. Draft Clinical Monitoring Plans

(CMP)

D.3. 1 electronic copy to

COR

Within 15 business days of receipt of request from COR.

13. Final CMPs D.3. 1 electronic copy to

COR

Within 3 business days after receipt of COR comments on the draft CMP.

14. Draft CMP Updates D.3. 1 electronic copy to

COR

Evaluate need for CMP updates no less than quarterly and as warranted by protocol amendment or change in site status. Draft CMP Update within 15 business days of receipt of request from

COR.

15. Final CMP Updates D.3. 1 electronic copy to

COR

Within 10 business days after receipt of COR comments on the draft CMP Updates.

16. Clinical site pre-visit confirmation, visit agenda and site preparation instructions

C.1.

D.5.

D.6.

D.7.

1 electronic copy to COR and to the clinical site(s)

No less than 10 business days prior to all scheduled monitoring visits.

17. Draft Clinical Site Monitoring Visit Reports

D.8. 1 electronic copy to

COR

Within 10 business days following completion of each site visit. Critical findings report within 24 hours of discovery.

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Item Other Reports SOW Reference Recipient Delivery Schedule

18. Final Clinical Site Monitoring Visit Reports

D.8. 1 electronic copy to

COR

Within 3 business days after receipt of

COR

comments on draft report.

19. Ad hoc clinical site monitoring visits

D.9. 1 electronic copy to

COR

Within 15 business days after receiving visit requirements and COR technical acceptance.

20. Ad hoc site visit agenda and site preparation instructions

D.9. 1 electronic copy to COR and to the clinical site(s)

No less than 5 business days prior to the visit.

21. Draft summary of Ad Hoc Clinical Site Monitoring Visits

D.9. 1 electronic copy to

COR

Within 5 business days of visit completion.

Critical findings report on the same business day of discovery.

22. Final summary of Ad Hoc Clinical site Monitoring Visits

D.9. 1 electronic copy to

COR

Within 3 business days of receipt of COR comments on the draft.

23. Training materials E.1.

E.2.

1 electronic copy to

COR

At least 10 business days prior to planned release or scheduled training session.

24. Training session attendance and participant feedback

E.5. 1 electronic copy to

COR

Within 3 weeks of training session completion.

25. Expedited Safety Reports for DMID-held IND studies

F.1.e. 1 electronic copy to DMID Office of Regulatory Affairs Representative 1 electronic copy to

COR

As needed.

26. Draft written summaries of recommendations of NIAID Safety Oversight structures

F.2.b.1. 1 electronic copy to

COR, DMID CPM,

DMID MM, and safety committee chairperson

Within 1 business day of meeting/ teleconference

27. Final written summaries of recommendations of NIAID Safety Oversight structures

F.2.b.2. 1 electronic copy to

COR, DMID CPM,

DMID MM

Within 3 business days of comments received

28. Draft written minutes of open and closed Safety Oversight structure deliberations

F.2.c.1. 1 electronic copy to

COR, DMID CPM,

DMID MM

Within 1 week of meeting/ teleconference completion

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Item Other Reports SOW Reference Recipient Delivery Schedule

29. Final written minutes of open and closed Safety Oversight structure deliberations

F.2.c.2. 1 electronic copy to

COR, DMID CPM,

DMID MM

Within 1 week of meeting/ teleconference completion

30. Protocol reports, including: descriptors, current status, projected and actual milestones met, accrual and other metrics

G.1. 1 electronic copy to

COR

Monthly on the 15th of the month.

31. Technical writing, editing, and/or formatting assistance

G.2. 1 electronic copy to COR, DMID supported clinical investigators

Within 10 business days after receipt of COR request and requirements.

32. Draft Quality Assurance/Quality Control (QA/QC) Plan

K. 1 electronic copy to

COR

Within 6 weeks after the effective date of the contract.

33. Final Quality Assurance/Quality Control (QA/QC) Plan

K. 1 electronic copy to

COR

Within 1 month of receipt of COR comments on draft QA/QC Plan.

34. Internal QA/QC Results and Internal QA/QC plan changes

K.1. 1 electronic copy to

COR

Quarterly and as warranted in the QA/ QC Plan.

35. Plan for resolution of major QA/QC deviation(s)

K.2. 1 electronic copy to

COR

Within 24 hours of any major QA/QC deviation.

36. QA/QC Plan Analysis K.6. 1 electronic copy to

COR

Twice per year, occurring during the 1st and the 3rd Quarter.

37. Annual Site Visit agenda and reports

M.4.d.2)a)

M.4.d.2)c)

1 electronic copy to

COR

Provide agenda 1 month prior to visit;

provide visit report within 1 month of completion of visit.

c. Other Reports and Deliverables (Delivery Schedule) -Options 10 and 11

Item Deliverables SOW Reference Recipient Delivery Schedule

1. Draft Initial Transition Plan

N. Options 10.a.

1 electronic copy to

COR

Within 14 calendar days after the effective date of the contract.

2. Final Initial Transition Plan

N. Options 10.a.

1 electronic copy to

COR

Within 4 weeks of COR comments on Draft Initial Transition Plan.

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Item Deliverables SOW Reference Recipient Delivery Schedule

3. IT data systems source code and object code

N. Options 10.b.

1 electronic copy to COR or to a successor contractor

Within 14 calendar days after the effective date of the contract.

4. Initial Transition Orientation materials and briefings

N. Options 10.c.

1 electronic copy to

COR

Within 6 weeks after effective date of the contract.

5. Draft Final Transition Plan

N. Options 11.a.

1 electronic copy to

COR

6 months prior to the expiration date of the contract.

6. Final Transition Plan N. Options 11.a.

1 electronic copy to

COR

No later than 4 months prior to the expiration date of the contract.

7. Contract-generated materials and products including all IT data systems source code and object code

N. Options 11.b.

1 electronic copy to COR or to a successor contractor

30 Days prior to the expiration date of the contract.

The above items shall be addressed and delivered to:

Contracting Officer's Representative (COR) Name (To be decided) Email Address (To be decided)

Contracting Officer (CO) Name (To be decided) Email Address (To be decided)

ARTICLE F.3. LEVEL OF EFFORT

a. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor FTEs specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

b. In the event fewer FTEs than the minimum specified number of direct labor FTEs in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of FTEs by which the number of direct labor FTEs furnished is less than the number of direct labor FTEs specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.4. 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 352.242-70 (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

To be specified prior to award

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

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4for 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 copy of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Rockville, Maryland 20852 Through secure email

E-mail: NIAIDOAINVOICES@NIAID.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."

Central Point of Distribution: NIAID MIDBRCB Invoices

The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox. 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 Institute of Allergy and Infectious Diseases .

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 Research Operations and Management Support

g. Contract Line Items as follows:

Line Item # Line Item Description

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

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…