75N91019R00002_Attachments.pdf

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

75N91019R00002 Page 1 of 2

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with

FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel

Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of

Proposed Estimated Costs (plus Fee) with Excel Spreadsheet”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

75N91019R00002 Page 2 of 2

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf

Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 150 pages.

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not exceed 6 pages.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

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Proposal Intent Response Form Please review the attached request for proposal. Furnish the information requested below and return this page by the earliest practicable date. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

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75N91019R00002 Attachment 2 - Notice of Intent

75N91019R00002 Attachment 3 – Statement of Work (January 17, 2019) Page 1 of 10

Logistical and IT Support for the NCI CIRB:

Statement of Work (SOW)

Purpose

The purpose of this contract is to provide the Government with the expertise in Institutional Review Board (IRB) and other Federal regulations, IRB operations, ethics, quality, information technology, and program management necessary to manage the National Cancer Institute’s (NCI) Central Institutional Review Board (CIRB) and support the institutions that rely on it.

IT Accessibility Requirements

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-

220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

Applicable Functional Performance Criteria: All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

Applicable requirements for software features and components: All WCAG Level AA Success Criteria, 502 Interoperability with Assistive Technology, 503 Application

Applicable requirements for hardware features and components: All requirements apply

Applicable support services and documentation: All requirements apply

Transition-In (If applicable) This would only be required if the awardee is not the incumbent https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

Attachment 3 – Statement of Work (January 17, 2019) Page 2 of 10

The Contractor shall:

A. Present a Final Transition-In Plan to the Contracting Officer’s Representative (COR) for approval within 7 days of contract award. The Final Transition Plan shall describe the steps to ensure that:

a. Staff are oriented, trained, and available to assume all tasks described in this SOW.

b. The processes are in place to ensure compliance with IRB and other Federal regulations on protocols under the authority of the NCI CIRB.

c. Board meetings will continue their established schedules.

d. Worksheets and other submissions from enrolled institutions are reviewed according to established timelines.

e. The helpdesk is functional with staff responding to inquiries within the established timelines.

B. Conduct a transition-in from the incumbent contractor that ensures an orderly, secure, and efficient transition of all contract activities and materials within 90 days of contract award.

C. During the transition period, daily operations shall continue seamlessly and the CIRB will maintain continuous compliance with all applicable federal regulations, accreditation standards, and the most recent CIRB Standard Operating Procedure (SOPs).

D. In collaboration with the incumbent contractor, ensure that all tasks contained in the SOW are addressed during the 90-day transition period. It is the Contractor’s responsibility to ensure that all project tasks are addressed during the transition period.

TASK 1 CIRB Central Operations

The NCI uses the term ‘Central Operations’ to refer to those activities required to run the daily operations of the boards and the studies they review. The Contractor shall:

A. Manage and staff at least four (4) CIRBs (boards). The participating networks/consortia currently include, but are not limited to:

NCI Clinical Trials Network (NCTN) NCI Experimental Therapeutics Clinical Trials Network (ETCTN) Cancer Immunotherapy Trials Network (CITN) Adult Brain Tumor Consortium (ABTC) Pediatric Brain Tumor Consortium (PBTC) Children’s Oncology Group (COG) Phase I/Pilot Consortium NCI Community Oncology Research Program (NCORP) DCP Phase 0/I/II Cancer Prevention Clinical Trials Program (Consortia)

B. Implement processes that ensure that the structure, functionality, and decisions of NCI’s CIRBs (boards) are in continuous compliance with appropriate federal regulations, Association for Accreditation of Human Research Protection Programs (AAHRPP) standards, relevant NIH policies and the current CIRB SOPs.

https://www.cancer.gov/research/areas/clinical-trials/nctn https://ctep.cancer.gov/initiativesprograms/etctn.htm https://ctep.cancer.gov/MajorInitiatives/cancer_immunotherapy_trials_network.htm https://ctep.cancer.gov/MajorInitiatives/adult_brain_tumor_consortium.htm https://www.pbtc.org/ https://ctep.cancer.gov/investigatorResources/childhood_cancer_resources.htm#pbtc https://ncorp.cancer.gov/ https://prevention.cancer.gov/major-programs/phase-0iii-cancer-prevention

Attachment 3 – Statement of Work (January 17, 2019) Page 3 of 10

C. Annually assess the forms, tools, and procedures associated with the Central Operations to improve efficiency and effectiveness, comply with regulatory or policy changes, assure ease of use, and promote transparency.

D. Conduct the pre-board administrative review process that improves the Board’s efficiency. Proactively identify and resolve issues that would otherwise slow the work of the board. These activities include, at a minimum:

a. Assessing all CIRB application packages for completeness and readiness for CIRB review; return incomplete or inappropriate applications to the Study Chair/PI with guidance.

b. Conducting pre-board review of accepted applications, including but not limited to, type of review necessary (exempt, expedited, limited, full board review), regulatory compliance, and adherence to the required NCI Informed Consent (IC) template.

c. Drafting stipulations for board member consideration.

d. Conducting pre-board conference calls with the board Chair and/or Vice Chair prior to the meeting. Provide a summary of administrative review findings, reviewer comments, questions for discussion, and possible stipulations.

E. Conduct all CIRB meetings virtually using a web-based board management tool and provide board members with the necessary regulatory expertise, IRB knowledge, meeting facilitation, and procedural skills required for an effective meeting.

F. Compile and send board decision letters per the timeframe specified in the SOPs, unless a deviation is approved by the COR in writing. Letters reporting a board decision of ‘tabled’ shall be sent within a timeframe specified by the COR.

G. Complete minutes within 48 hours and distribute within 72 hours of the board meeting.

Board minutes shall adhere to the “Minutes of Institutional Review Board Meetings:

Guidance for Institutions and IRBs,” published by Office of Human Research Protections (OHRP), September 2017.

H. Upon receipt of COR approval, implement automated processes to improve the consistency and efficiency in the creation of meeting minutes and letters.

I. Receive, review and report to the Office of Human Research Protections (OHRP) and/or Food and Drug Administration (FDA) unanticipated problems and serious and continuing noncompliance.

J. Ensure NCI CIRB SOPs are current, complete and in compliance with all applicable regulations and AAHRPP standards.

a. Review and update current CIRB SOPs within 90 days of contract award and annually thereafter.

b. Identify SOP changes necessary to ensure regulatory compliance, minimize administrative burden on CIRB membership, and maximize efficiency of CIRB Operations.

c. Draft new SOPs within 10 days of identifying the need, unless a different timeline is approved by the COR.

Attachment 3 – Statement of Work (January 17, 2019) Page 4 of 10

K. Within 90 calendar days of the effective date of the contract, the Contractor shall provide the COR with documentation of all work processes (which include, but are not limited to how data is collected, received, and processed in the lifecycle; workflow processes for the help desk, specifically how inquiries are received, routed, reviewed, and responded to; and specific operational details of the central and local operations.)

used to conduct the activities described in this SOW. The document shall be updated as new procedures are developed and will be submitted to the COR for review and comment prior to implementation.

L. Management of CIRB Board Membership

a. Constitute each Board with qualified members who are well-trained, regularly evaluated, conflict-free, contribute effectively to the performance of the board, and fulfill their assigned role of their respective Board.

b. Develop, implement and evaluate a plan to identify, recruit, orient, train, and evaluate new CIRB members who are experienced, qualified, meet the regulatory requirements, and can fill the required roles for vacant positions on the Boards. This includes but is not limited to assuring that the membership of each board satisfies the requirements of 45 CFR 46 and 21 CFR 56 and provides special expertise as needed to adequately assess all aspects of cancer treatment, prevention, cancer control, and cancer care delivery clinical trials.

c. Conduct an annual solicitation process for the nomination and selection of new members to fill vacating positions.

d. Manage professional liability insurance for board members.

e. Ensure that board members receive honoraria according to the services rendered and in a timely fashion.

M. Plan, conduct, and evaluate a comprehensive education effort for new and established board members.

a. Board member continuing education

1. Submit a final draft of the Continuing Education Plan for COR approval within three (3) months of contract award.

The plan shall include goals, objectives, planned topics, delivery approaches, time frame and method of evaluation.

N. If the NCI decides that a new Board shall be established, the Contractor shall:

a. Develop a plan to establish a CIRB to review the specialized Board requirements to be determined. The CIRB shall follow the same CIRB SOPs as the existing CIRBs.

b. Nominate CIRB members qualified to support the new Board. Final membership list is due to COR 6 weeks prior to the first meeting of this CIRB.

c. Arrange for each CIRB member to be oriented to the CIRB processes and meeting management tool at least one week prior to the first CIRB meeting.

d. Modify existing CIRB SOPs and technology to support the CIRB.

Attachment 3 – Statement of Work (January 17, 2019) Page 5 of 10

TASK 2: CIRB Local Operations

The NCI uses the term ‘Local Operations’ to refer to those activities necessary to address local context considerations at individual institutions. This function includes enrolling organizations and reviewing local context information. The Contractor shall:

A. Within six (6) months of contract award, deliver a comprehensive evaluation of the current Local Operations process and functions. The evaluation shall include strengths and limitations of the current process and detail recommendations for improving efficiency, accuracy, consistency, and end user satisfaction. The report should include proposed timeframes for approval of local context worksheets and a mechanism for monitoring performance. Implement recommendations per direction of the COR.

B. Ensure that the capture and evaluation of local context information complies with applicable regulations, AAHRPP standards, and CIRB SOPs. Ensure that the CIRB SOPs are complete, correct, and compliant with relevant regulations and accreditation standards; and promote efficiency and effectiveness. Execute a plan to maintain SOP updates.

C. Develop, maintain and update as needed, local context worksheets to ensure continued regulatory compliance and minimize administrative burden to participating investigators and CIRB board members.

D. Provide administrative and regulatory support to institutions enrolled in or in the process of enrolling in the CIRB.

a. Enroll new institutions from the CIRB networks and consortia within 30 days of request. The COR should be notified of enrollments that take longer than 30 days so a support strategy can be developed.

b. For all local context submissions from signatory institutions and individuals ensure efficient, and accurate processes from administrative review, to CIRB review, and dissemination of approval letters.

c. Maintain an efficient system for annual verification of contact information for enrolled institutions.

E. Continuously analyze the local context experience and report patterns, trends, or issues to government staff that may reflect the need for SOP changes and stakeholder education to optimize efficiency, effectiveness and regulatory compliance.

F. Compile and send local operation letters within a timeframe specified by the COR.

G. Manage, store, and provide access to the official records of the CIRB in compliance with all applicable regulations suitable for presentation to potential auditors.

Attachment 3 – Statement of Work (January 17, 2019) Page 6 of 10

TASK 3: CIRB Helpdesk

The CIRB Operations Office helpdesk shall offer multiple channels of communication (e.g., telephone and email) with an average of 600 contacts/month. Most contacts are from enrolled institutions regarding local context issues. The Contractor shall:

A. Staff and operate a multi-channel helpdesk that conforms to industry best practices and standards for accuracy, timeliness, and satisfaction to ensure that CIRB stakeholders receive prompt, accurate, and courteous responses to questions or concerns.

B. Develop and implement processes, and staff training that ensures a consistent approach to managing questions and ensures reliability and consistency of responses across staff members.

C. Develop and implement metrics to track and assess help desk activities, workload and performance. This information shall be provided in the monthly help desk report.

Specifically, report volume per channel, volume per category, response time, and analysis of new observations or ongoing trends.

D. Design and implement, pending OMB clearance (if required), an annual survey for user satisfaction.

E. Supply and utilize an IT tool that facilitates achieving the tasks in this section of the SOW. If requested by the COR, adopt and implement NCI-provided helpdesk management software. The Contractor may either develop their own software or tailor the software to meet their needs within any best practices outlined by the NCI.

TASK 4: Communication and Education

The CIRB is a large, highly visible program that interacts with many individuals and organizations. Therefore, well planned, clear and consistent communication is essential to ensure smooth operations. The Contractor shall:

A. Plan, conduct and evaluate tools and mechanisms to ensure that government staff are apprised of operational or regulatory issues related to the conduct of the boards, support of institutions, or other issues necessary to ensure compliance with IRB regulations.

B. Serve as content experts for internal NCI meetings as requested.

C. Attend local, regional and national meetings (e.g. NCTN Group meetings, NIH conferences, PRIMR, AAHRPP) by delivering presentations or posters, serving as a panelist, and/or staffing a vendor booth as requested by the COR.

D. Provide management reports and review processes for process improvement of CIRB operations and workload.

Attachment 3 – Statement of Work (January 17, 2019) Page 7 of 10

E. CIRB Website

a. Maintain CIRB website

i. Ensure the URL remains compliant with current Federal regulations.

ii. Content is current and meets the objectives of the NCI CIRB.

iii. Update website content quarterly and refresh design/graphics/content every two years beginning at contract award.

b. Integrate the website into an overarching communications and education plan.

i. Use web site metrics to inform user engagement strategies.

ii. Implement strategies to effectively communicate new information and keep users engaged.

c. Provide an annual assessment of the CIRB website to determine if upgrades are required to meet evolving technical, regulatory, or business needs.

TASK 5: Maintain AAHRPP Accreditation

The Contractor shall:

A. Complete all requirements to maintain uninterrupted full accreditation status.

a. Ensure that CIRB operations, processes, education, and staffing are in continuous compliance with all existing or modified AAHRPP standards

b. Obtain the necessary data, prepare and submit all required reports, materials, information within the required timeline to ensure the continuous maintenance of accreditation.

B. Achieve the standards for AAHRPP recertification. This includes, but is not limited to, conducting meetings to acquire necessary information, preparing participants for interviews, and preparing documentation.

TASK 6: Quality Assurance (QA) and Quality Improvement

A. Conceptualize and implement a robust quality assurance and continuous quality improvement program that:

a. Ensures effective program operations by reporting Operations Office compliance with CIRB SOPs and Operational Efficiency Working Group (OEWG) timelines.

b. Promotes effective compliance with IRB regulations.

c. Meets or exceeds regulatory requirements and AAHRPP standards.

d. Reduces the administrative burden on CIRB Board members and individuals from CIRB participating institutions.

e. Minimizes timelines.

f. Minimizes contractor effort.

B. Mine data on processes and/or topics as requested by NCI and analyze the mined data, e.g., local context review or the helpdesk.

Attachment 3 – Statement of Work (January 17, 2019) Page 8 of 10

C. Deliver a quarterly QA report outlining current or potential risks and strategies for risk mitigation and other improvements to accuracy, efficiency, and efficacy for each of the CIRB Operations functional areas.

D. Conduct site visit and quality assurance activities per guidance from the COR.

E. Implement a Quality Control Plan which will cover the quality standards, metrics, and measurement processes that ensure the quality, timeliness, and integrity of all services provided in the contract. Submit a final draft of the Quality Control Plan for COR approval within three (3) months of contract award.

TASK 7: Provide IT software and support for all CIRB activities

A. Ensure all IT tools meet Federal IT requirements and are integrated with NCI Systems.

B. Utilize IRBManager as the repository for the CIRB regulatory documents. Within 90 days of contract award, acquire the license for IRBManager. IRBManager shall be maintained and tailored to meet the NCI CIRB’s requirements and the Contractor shall obtain and provide professional services support suitable to accomplish the needs of the contract, C. Utilize E-Panel as the web-based board management tool through November 10, 2019.

After expiration of the Government furnished license for E-Panel, provide and use a commercial-off-the-shelf (COTS) tool to support the Central Operations activities.

Requirements include, but are not limited to: collaboration, document management, resource repository, voting function, search capability, user-friendly interface, and role-based security that meets or exceeds Federal IT security requirements. If the Contractor proposes to a use a COTS tool other than E-Panel, the Contractor shall request approval from the NCI COR to use the alternative tool due to the amount of integration that would be needed with other systems within NCI.

D. Effectively manage IT and integrate it with NCI infrastructure with attention to ease of use for the end user.

TASK 8: Collaboration with other NCI contractors

A. As part of integrating with NCI processes, collaborate with other NCI contractors to achieve the requirements of the SOW while simultaneously promoting and supporting other NCI contractors to address their requirements by:

a. Participating in twice monthly cross-contractor meetings.

b. Participate in topic specific working groups as needed.

c. Tailor CIRB IT Systems to integrate with the NCI Systems.

Attachment 3 – Statement of Work (January 17, 2019) Page 9 of 10

d. Tailor CIRB SOPs to maximize benefit to other CTEP contractors while maintaining the CIRB specific requirements outlined in this SOW.

B. All proposed changes or modifications related to collaboration shall:

a. Be assessed for impact on CIRB requirements and cost to implement.

b. Be reviewed and approved by the CIRB COR prior to implementation.

TASK 9: Project Management

A. To maintain budget, scope, effectiveness and pace, a project shall have physical documents pertaining to each specific task. The Contractor shall follow the standards and best practices of the Project Management Institute (pmi.org) including, but not limited to:

a. Utilizing professionally recognized standard tools and processes to track the progress of all activities. This includes:

i. A final draft of the written CIRB Project Management plan to meet project requirements and ensure that project requirements are tracked and fulfilled. This should include how the Contractor will provide the COR with up-to-date financial, project status and staffing information.

ii. A visual representation of the plan.

iii. A method for evaluating and adjusting the plan.

iv. The plan, visual representation and evaluation mechanisms must be completed within 90 days of contract award. All three will be reviewed and modified on a quarterly basis.

B. Throughout the life of the contract, the project manager will focus on project documentation. The project manager shall ensure project requirements are met in accordance with the written plan and that the requirements are tracked and fulfilled, as well as to establish traceability regarding what has been completed, who has completed it, and when it has been completed.

C. Conduct weekly in person meetings and provide meeting materials that prioritize activities and demonstrate progress of ongoing tasks.

D. Ensure responsiveness to NCI CORs:

a. 1-hour response to urgent calls or emails

b. 4-hour response to routine calls or emails

c. Establish dedicated email for correspondence from NCI CORs.

E. Ensure Operational Efficiency Working Group (OEWG, https://ctep.cancer.gov/protocolDevelopment/OEWG.htm#oewg_timelines_sops ) deadlines are met.

https://ctep.cancer.gov/protocolDevelopment/OEWG.htm#oewg_timelines_sops

Attachment 3 – Statement of Work (January 17, 2019) Page 10 of 10

F. Collaborate as necessary with other components of the NCI Extramural Human Research Protections Program HRPP to ensure smooth and efficient operations.

Transition-Out

A. Transition-Out Plan

A. Develop and submit a draft phase-out transition plan 3 months prior to the expiration date of the contract, which shall describe the Contractor’s strategy for transferring work from this contract to a successor contract. The plan shall include a system for transfer of policies and procedures; transfer of relevant files, records, materials, and data; all source code and object code developed, modified, and/or enhanced under the contract; transition of all activities, and transition of all Cancer Trials Support Unit (CTSU)-Enterprise applications, as appropriate.

B. Upon receipt of COR feedback, submit the Final Transition Plan to the Government no later than one month prior to the expiration date of the contract.

C. Deliver all source code and object code on or before the contract expiration date.

If the Contractor is not awarded the follow-on award, the Contractor shall:

A. Perform transition-out activities in accordance with the approved final transition plan to ensure an orderly, secure, efficient, and expedient transition of all contract activities by the contract completion date.

B. The Contractor shall provide the successor Contractor with detailed briefings regarding the policies and procedures for managing all aspects of the project. As part of these detailed briefings, the Contractor shall provide the successor Contractor with all documentation of CIRB processes and products, which shall include, but not be limited to, SOPs, orientation materials, training materials, presentations on CIRB activities and samples of CIRB-generated reports.

Option B & C: Increased Capacity – Additional Level of Effort

The Contractor shall provide additional support to cover an expansion of work in the major task areas mentioned at all prior sections of this Statement of Work.

Attachment 4

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

Updated through FAC 2005-95 Last updated: 01/2017

This SECTION is made up of nine parts as follows:

1. Annual Representations and Certifications, FAR 52.204-8

2. Commercial and Government Entity Code Reporting, FAR 52.204-16

3. Predecessor of Offeror, FAR 52.204-20

4. Information Regarding Responsibility Matters, FAR 52.209-7

5. Cost Accounting Standards

6. Certification Regarding Trafficking in Persons Compliance Plan

7. Certification Regarding Environmental Tobacco Smoke

8. Certification of Institutional on Financial Conflicts of Interest

9. Disaster or Emergency Area Representation

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2017), FAR Provision 52.204-8

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is ____________ [insert NAICS code].

(2) The small business size standard is ____________ [insert size standard].

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in the System for Award Management (SAM), and has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certification in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

[_] (i) Paragraph (d) applies.

[_] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)(1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 4

SECTION K - Reps and Certs

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements—Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations—Representation.

(vii) 52.209-5; Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(viii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(ix) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(x) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xi) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(xii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xiv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xvi) 52.222-57, Representation Regarding Compliance with Labor Laws (Executive Order 13673).

This provision applies to solicitations expected to exceed $50 million which are issued from October 25, 2016 through April 24, 2017, and solicitations expected to exceed $500,000, which are issued after April 24, 2017.

Note to paragraph (c)(1)(xvi): By a court order issued on October 24, 2016, 52.222-57 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA- designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals— Representation. This provision applies to solicitations that include the clause at 52.204-7.

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $77,533, the provision with its Alternate II applies.

(D) If the acquisition value is $79,507 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan--Certification.

This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certification. This provision applies to all solicitations.

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.] ___ (i) 52.204-17, Ownership or Control of Offeror.

___ (ii) 52.204-20, Predecessor of Offeror.

___ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

___ (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Certification.

___ (v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

___ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only).

___ (vii) 52.227-6, Royalty Information.

___ (A) Basic.

___ (B) Alternate I.

___ (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the SAM Web site accessed through https://www.acquisition.gov . After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph

(c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of Provision)

2. COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING, (JUL 2016) FAR Provision 52.204-16

Note to Offeror: This provision is incorporated by reference and is applicable when the resultant contract will contain FAR Provision 52.204-6 and/or FAR Provision 52.204-7.

3. PREDECESSOR OF OFFEROR, (JULY 2016) FAR Provision 52.204-20

(a) Definitions. As used in this provision--

“Commercial and Government Entity (CAGE) code” means--

(1) An identifier assigned to entities located in the United States and its outlying areas by the Defense Logistics Agency (DLA) Contractor and Government Entity (CAGE) Branch to identify a commercial or government entity, or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Successor” means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company that only changes its name.

The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

(b) The Offeror represents that it [ ] is or [ ] is not a successor to a predecessor that held a Federal contract or grant within the last three years.

(c) If the Offeror has indicated “is” in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):

Predecessor CAGE code: ________ (or mark “Unknown”).

Predecessor legal name: ______________________________.

(Do not use a “doing business as” name).

(End of provision)

4. INFORMATION REGARDING RESPONSIBILITY MATTERS, (JUL 2013) FAR Provision 52.209-7

Note to Offeror: This provision is applicable when the resultant contract is expected to exceed $500,000.

(a) Definitions. As used in this provision—

“Administrative proceeding” means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceeding at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

“Federal contracts and grants with total value greater than $10,000,000” means—

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

“Principal” means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror [_] has [_] does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in—

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database via https://www.acquisition.gov (see 52.204-7).

(End of provision)

5.COST ACCOUNTING STANDARDS

(1) Cost Accounting Standards Notices and Certification (October 2015), FAR Provision 52.230-1

Note: This notice does not apply to small businesses or foreign governments. This notice is in three parts, identified by Roman numerals I through III.

Offerors shall examine each part and provide the requested information in order to determine Cost Accounting Standards (CAS) requirements applicable to any resultant contract.

If the offeror is an educational institution, Part II does not apply unless the contemplated contract will be subject to full or modified CAS-coverage pursuant to 48 CFR 9903.201- 2(C)(5) or 9903.201-2(c)(6), respectively.

I. Disclosure Statement -- Cost Accounting Practices and Certification

(a) Any contract in excess of $750,000 resulting from this solicitation will be subject to the requirements of the Cost Accounting Standards Board (48 CFR Chapter 99), except for those contracts which are exempt as specified in 9903.201-1.

(b) Any offeror submitting a proposal which, if accepted, will result in a contract subject to the requirements of 48 CFR Chapter 99 must, as a condition of contracting, submit a Disclosure Statement as required by 9903.202. When required, the Disclosure Statement must be submitted as a part of the offeror's proposal under this solicitation unless the offeror has already submitted a Disclosure Statement disclosing the practices used in connection with the pricing of this proposal. If an applicable Disclosure Statement has already been submitted, the offeror may satisfy the requirement for submission by providing the information requested in paragraph (c) of Part I of this provision.

CAUTION: In the absence of specific regulations or agreement, a practice disclosed in a Disclosure Statement shall not, by virtue of such disclosure, be deemed to be a proper, approved, or agreed-to practice for pricing proposals or accumulating and reporting contract performance cost data.

(c) Check the appropriate box below:

(1) Certificate of Concurrent Submission of Disclosure Statement.

The offeror hereby certifies that, as a part of the offer, copies of the Disclosure Statement have been submitted as follows:

(i) Original and one copy to the cognizant Administrative Contracting Officer (ACO) or cognizant Federal agency official authorized to act in that capacity (Federal official), as applicable; and

(ii) One copy to the cognizant Federal auditor.

(Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable. Forms may be obtained from the cognizant ACO or Federal official and/or from the loose-leaf version of the Federal Acquisition Regulation.)

Date of Disclosure Statement: __________________ Name and Address of Cognizant ACO or Federal Official Where Filed: _________________________

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the Disclosure Statement.

(2) Certificate of Previously Submitted Disclosure Statement.

The offeror hereby certifies that the required Disclosure Statement was filed as follows:

Date of Disclosure Statement: __________________ Name and Address of Cognizant ACO or Federal Official Where Filed: ________________________

The offeror further…