JOFOC_Redacted_1700078C.pdf

Attachment Performance Work Statement Revised on 12.15.2016 1

ATTACHMENT : PERFORMANCE WORK STATEMENT

(Revised 12.15.2016)

NIAID HIV AND OTHER INFECTIOUS DISEASES

CLINICAL RESEARCH SUPPORT SERVICES (CRSS)

NIAID-DAIDS-NIHAI2015050

1) BACKGROUND AND INTRODUCTION

The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to bring an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the advancement of therapies for HIV infection and its complications, and supporting the development of HIV/AIDS vaccines and other prevention measures. This mission is carried out through a variety of grants and contracts. DAIDS (herein after referred to as DAIDS) sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. DAIDS has designed, developed and sponsored extramural Clinical Trials Networks, supported investigator-initiated clinical trials, and partnered with other Government and private organizations to assist in carrying out the Division’s scientific objectives via various funding mechanisms.

In order to provide a wide variety of support services for the DAIDS clinical research portfolio, and to assist in the development and maintenance of a strong and responsive clinical infrastructure, a five-year contract was awarded to Pharmaceutical Product Development, Inc. (PPD) on July 15, 2005, under the project title “Clinical Research Support Contract” (CRS) (contract number HHSN266200500022C). A subsequent contract was awarded in 2011 to Westat, Inc. (hereinafter referred to as Westat) (contract number HHSN272201200009C) under the title “HIV Clinical Research Support Services” (CRSS) to continue the provision of services to DAIDS; the scope was broadened in 2011 to include additional diseases of relevance to HIV infection and at risk populations.

The purpose of this contract is to continue to provide a broad range of research support services to the current and evolving DAIDS supported research portfolio. The new contract will be a performance based acquisition. For the purposes of this contract, clinical research is defined as clinical studies, Phase I, II, III and IV clinical trials, laboratory projects and other related efforts required to support the DAIDS research portfolio. NIAID intends to award one contract to perform the research support functions specified in the Performance Work Statement (PWS). Although the use of subcontractors and consultants is permitted, the Contractor must possess the in-house capabilities, including qualified personnel, facilities, equipment and other resources, to perform at least some of the clinical and technical functions specified in the PWS.

2) SCOPE

The Contractor shall provide a broad range of clinical and other related research support services for DAIDS-supported clinical research programs and projects as well other infectious diseases that are of relevance to HIV infectious and at risk populations.

Options to increase level of effort, in order to support unanticipated increases in demand are also within the scope of the contract.

Revised on 12.15.2016 2

3) TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Performance Work Statement below. Specifically, the Contractor shall:

The Contractor shall use its best efforts to optimize achievement of the Performance Requirements and Performance Standards listed in the Attachment entitled “Quality Assurance Surveillance Plan (QASP)”.

A. CLINICAL RESEARCH SUPPORT

1. Conflict of Interest Policy

Establish and maintain a Conflict of Interest (COI) policy and Standard Operating Procedure (SOP) that addresses reporting chain independence of auditors from other contract related staff and independence from the sites to be evaluated. The Contracting Officer’s Representative (COR) will review the draft COI SOP and provide comments to the Contractor within ten (10) business days of receipt.

Provide the COI SOP within twenty (20) business days of contract award date and report any identified conflicts of interest fifteen (15) business days prior to any site assessment or audit.

2. Clinical Research Site Assessments

a. As directed by the COR, conduct and report the findings of assessments of DAIDS-sponsored or affiliated clinical research sites to evaluate overall capabilities for the conduct of human subjects research, and to evaluate site capabilities for the conduct of specific categories of clinical trials/studies (e.g., chemotherapeutics, leukepheresis, etc.). Such assessments shall include a detailed review and evaluation of all of the items identified in the Modules and Checklists to be provided by the Government (see the “DAIDS Site Assessment Tool” in the electronic reading room, referred to in Attachment 7:

Additional RFP-Specific Materials). This assessment visit shall include a detailed review and evaluation of the following:

i. the availability of appropriately trained clinical and technical personnel,

ii. outpatient and inpatient clinical research facilities, equipment and other resources for the screening, enrollment, treatment, safety monitoring, and follow-up of study subjects,

iii. research laboratory facilities and equipment,

iv. research pharmacy facilities and equipment,

v. standard operating procedures.

b. When a major deficiency (such as lack of a sink, no sharps container in phlebotomy room, etc.) is observed, provide a verbal debriefing and an email summary of the observation to the COR within three (3) business days of

Revised on 12.15.2016 3 return from the site visit. Provide the final report of findings (using the DAIDS provided checklist) within fifteen (15) business days after completion of each assessment visit.

3. Clinical Site Audits

a. At the direction of the COR, conduct routine or ad hoc Process Audits or “For Cause” Audits of clinical research sites and facilities to assess compliance with Federal regulatory requirements and guidance, including: (i) 21 CFR 312 – GCP; (ii) 45 CFR 46 –“Human Subjects Protection;” and (iii) International Conference on Harmonization (ICH) E6-GCP Guidelines (iv) country-specific regulatory requirements, (v) protocol- specific requirements, and (vi) DAIDS policies and procedures. In accordance with ICH E6 5.19, the Contractor shall provide qualified auditors and the COR will review curricula vitae (CVs) of auditors prior to performance of the audits.

NOTE: Because it is important for an audit to be an independent evaluation, personnel utilized for auditing must be independent from staff associated with the management or evaluation of the sites. For example, an auditor should have a separate reporting chain from personnel that serve in a leadership capacity for the site. Another example is that the auditor should have a separate reporting chain from monitoring personnel.

The two audits are defined briefly below:

Process Audit: This type of audit may focus on conformance to applicable requirements as well as the effectiveness of site standard operating procedures and site performance. Each process audit may be different in scope. A process audit may include a mock Food and Drug Administration (FDA) inspection.

“For Cause” Audit: A “For Cause” audit is similar to a process audit;

however, a “For Cause” audit may be initiated due to concerns of serious risks to participants, or by determination from DAIDS.

b. Provide to the COR an audit plan within ten (10) business days of request for audit. If during the conduct of the site visit, there is a condition at the site that meets the definition of a DAIDS critical event (using the definition of critical event as defined in the DAIDS Critical Event Policy (Policy with CE definition can be found at the link:

http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Docu ments/CESiteResp.pdf), then the Contractor must detect and notify the COR within twenty-four (24) hours of detection of the DAIDS defined Critical Event (via email). Provide the COR the final audit report of observations and findings within fifteen (15) business days after site visit completion. The Contractor shall receive additional information from DAIDS regarding areas to be audited and these areas may include, but are not limited to:

i. defined record review (agreed upon between the COR, his/her designees and the contractor)

ii. clinical research site internal quality assurance procedures

Revised on 12.15.2016 4

iii. review of specified site documents to include case report forms (CRFs) and informed consents

iv. documentation of adherence to GCP and GCLP

v. documentation of adherence to DAIDS policies and guidelines

vi. completeness of regulatory binders

vii. review of pharmacy operations

viii. review of clinical research facilities and equipment

ix. other documents/areas at discretion of COR/designee

4. Additional Support for Study-Specific Clinical Research Site Readiness

Under the direction of the COR, provide support services in advance of clinical trials/studies implementation:

a. Clinical Trial/Study-Specific Materials: Identify, prepare and distribute clinical trial/study-specific materials to the sites to facilitate site readiness.

b. Regulatory Files: assist site with organizing files for essential documents according to ICH E6 GCP and referencing the DAIDS Requirements for Essential Documents to be found in:

http://www.niaid.nih.gov/labsandresources/resources/daidsclinrsrch/Pages/Cl inicalSite.aspx

c. Review of Clinical Research Site Quality Management Plans: Review clinical research site Clinical Quality Management Plans (CQMPs) for compliance with DAIDS CQMP policy. Provide recommendations for improvement and increased compliance with policy to the COR designee within fifteen (15) business days of request. DAIDS will provide the established DAIDS CQMP template, and sample quality management (QM) tools – DAIDS Policy can be found at this link:

(http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Doc uments/qmppolicy.pdf

d. Provide site assistance – provide targeted evaluation of site operations and focused training (such as GCP training with an emphasis on any areas of site operations that can be “improved” after evaluation) to address potential performance concerns. Timelines and due dates will vary depending upon the request. Provide a summary of the visit to the COR within twenty (20) business days with prioritized observations and recommendations.

5. Clinical Trials and Other Related Support

At the request of the COR, provide additional support services to support the planning, development, implementation and coordination of DAIDS-supported clinical research trials/studies. This shall include the following:

a. Study-Specific Clinical and Technical Documents

Assist in the preparation of study-specific and related clinical and technical documents for clinical research trials/studies and other activities. These study-specific documents may include:

Revised on 12.15.2016 5

i. Draft and final clinical protocols, protocol amendments and clarification memos

ii. Investigator Brochures (IBs) and updates

iii. Manuals of Operational Procedures (MOPs)

iv. Standard Operating Procedures (SOPs)

v. Case Report Forms (CRFs)

vi. Integrated clinical/statistical reports

vii. Abstracts, manuscripts and journal articles

viii. Ancillary or related study documents

b. Translations and other document support services

i. Provide translations services of protocol and other clinical research-related materials. Provide back-translations and certifications of translation as requested. Provide a cost estimate and timeline to the COR within three

(3) business days of receipt of request for approval by the COR.

ii. Provide technical consultation with regards to communications with the press or other audiences in advance of clinical trial initiation or trial conclusions. The Contractor shall submit a cost estimate and timeline for delivery to the COR, within five (5) business days of receipt of request.

iii. Prepare other related documents upon request (e.g., clinic operation details, clinic listing of current clinical trials, and other media documents).

The Contractor shall submit a cost estimate and timeline for delivery to the COR, within five (5) business days of receipt of request for COR approval.

6. Data Management Support Services

As requested by the COR, provide support services for the management of clinical and laboratory data, including assessments of existing or planned data management services. Submit a summary of technical approach, cost estimate and timeline for delivery, within five (5) business days of receipt of request for COR approval. Specific data management support services may include:

a. Inventory, assess or audit existing data management tools, forms and practices for DAIDS-funded clinical trials/studies across DAIDS-funded clinical research sites.

b. Provide data management technical support, including validation of existing systems, and advice on data system improvements and implementation, and/or advice/facilitation regarding Consortium for Data Information Standards Compendium (CDISC) standards.

c. Provide data assistance and perform clinical data analyses for use in product licensure. In providing these services, the Contractor shall work with Network and non-Network Data Management Centers (DMCs) as well as the DAIDS Clinical Research Management System (NIAID CRMS).

7. Biostatistical Design and Analysis

Revised on 12.15.2016 6

As requested by the COR, provide ad hoc biostatistical assistance for DAIDS supported clinical trials/studies, biostatistical support or provide independent biostatistical support for individual clinical trials. Submit to the COR a summary of technical approach, cost estimate and timeline for delivery, within five (5) business days of receipt of request. Types of support that could be requested include:

a. Provide biostatistical input into protocol design.

b. Provide interim data analysis plans for ongoing trials.

c. Perform data analyses for interim review.

d. Perform data analyses for Data and Safety Monitoring Board (DSMB) report preparation.

e. Formulate detailed study monitoring plans in accordance with DAIDS guidelines

f. Prepare biostatistical sections of Clinical Study Reports.

g. Provide biostatistical data, plan and perform analyses of such data for ad hoc reports and publications.

8. Ad Hoc Clinical Trial/Study-Specific Support

As requested by the COR, provide a variety of support services to clinical research sites, including support during study initiation and/or to generate recommendations to assist in correcting deficiencies in site performance.

Submit for COR approval a summary of technical approach, cost estimate and timeline for delivery, within five (5) business days of receipt of request. Within twenty (20) business days of visit completion, prepare a report that summarizes the site services provided and any recommendations for actions to ensure resolution of any problems/deficiencies identified.

9. Clinical Research Project Management and Coordination

Provide project management and coordination support for DAIDS- sponsored clinical trials/studies and activities, particularly for non-network studies. Submit for COR approval, a summary of technical approach, cost estimate and timeline for delivery, within five (5) business days of receipt of request. Specific services that may be requested include:

a. Coordinating clinical research planning, initiation and conduct with multiple participating entities, such as pharmaceutical companies, data management centers and central laboratories

b. Providing expert consultative advice and guidance for data management, laboratory, and site operations

c. Scheduling and participating in meetings in connection with research planning and execution

d. Managing project timelines and reporting project progress to COR upon request

e. Providing consultative advice for data management, laboratory and site operations, and standardization of SOPs

f. Providing other types of support such as responding to informational requests or generating project summaries

Revised on 12.15.2016 7

B. LABORATORY SUPPORT

As directed by the COR, provide support services associated with the evaluation and performance of clinical research laboratory testing and sample storage for DAIDS-sponsored and/or supported clinical studies and Phase I-IV clinical trials. This shall include auditing of laboratories as well as specialized support services associated with the laboratories. Audits will be performed to assess compliance with Good Clinical Laboratory Practices (GCLP), Current Good Manufacturing Practices (cGMP) and/or Good Laboratory Practices (GLP) guidance in addition to other applicable Federal guidance as well as DAIDS policies.

During the performance of each task specified below, the Contractor shall coordinate planning and execution of laboratory audits with DAIDS personnel, central laboratories, audited laboratories and other contractors responsible for laboratory quality control/quality assurance. Specifically, perform the following tasks:

1. Audits of Clinical Research Laboratories

Conduct and report the findings of audits to assess the performance of laboratories in the processing and testing of biologic samples from participants enrolled in clinical trials supported and sponsored by DAIDS. Using DAIDS provided checklists (including but not limited to the GCLP Audit Module [see the “GCLP Audit Module” in the electronic reading room, referred to in Attachment 7:

Additional RFP-Specific Materials]) to assess compliance with GCLP; appropriate collection, labeling, storage and shipping of clinical specimens in accordance with protocol-specific requirements; and reporting of laboratory test results. Audits must address all of the items identified in the DAIDS Checklists. Within twenty-one (21) business days of completion of the audit visit, prepare and submit, for review by the COR and/or his/her designees, an audit report detailing/describing audit findings in compliance with the applicable DAIDS SOP and checklists. Areas that may be assessed include:

a. Laboratory Activities

b. External Quality Assurance

c. Organization and Personnel

d. Testing Facilities Operation

e. Verification of Performance Specifications

f. Laboratory Information System

g. Laboratory Data Management System

h. Quality Management

i. Physical Facilities

j. Equipment

k. Test and Control Articles

l. Records and Reports m.Specimen Transport and Management

n. Personnel Safety

o. Vertical Audit of SOP/Practice

2. cGMP audits

Upon request of the COR, perform cGMP audits of facilities. The Contractor shall report to the COR the findings of audits within twenty-

Revised on 12.15.2016 8 one (21) business days of audit completion and, when directed by the COR, provide prioritized recommendations to address observations and/or deficiencies identified in the report. The scope of the audit may include:

a. Organization and Personnel

b. Buildings and Facilities

c. Equipment

d. Control of Components and Drug Product Containers and Closures

e. Production and Process Controls

f. Packaging and Labeling Control

g. Holding and Distribution

h. Laboratory Controls

i. Returned and salvaged drug products.

3. GLP audits

Upon request of the COR, perform GLP audits of facilities. The Contractor shall report the findings of audits to the COR within twenty-one (21) business days of audit completion and provide prioritized recommendations to address observations and/or deficiencies identified in the report. Audits may include a review of the following areas:

a. Organization and Personnel

b. Facilities

c. Equipment

d. Testing Facilities Operation

e. Test and Control Articles

f. Protocol for and conduct of a non-clinical laboratory study

g. Records and Reports

h. Disqualification of testing facilities

4. Site-Specific Laboratory Assistance

Assist clinical research sites in the development of appropriate clinical research laboratory facilities, equipment and other resources (for example, assist laboratories in the standardization of SOPs for Mycobacterium tuberculosis (TB) related studies). Depending upon the complexity of the assistance requested, deliverables shall be submitted on a schedule negotiated between the COR and the Contractor.

C. TRAINING

As requested by the COR, provide training services for DAIDS funded site personnel involved in the conduct of DAIDS-sponsored clinical trials. Training services include the design, development and/or revision of, and delivery and management of training sessions (such as GCP training, DAIDS policy training or GCLP training).

Support services shall include:

1. Design, and Development of New Training Products

Revised on 12.15.2016 9

Design and develop new training products that address the areas of expertise identified by the COR. The Contractor shall submit to the COR a cost estimate and timeline due within five (5) business days of the request for a new training product. New training products will be due to COR sixty (60) days after request.

The Contractor may be requested to provide subject matter expertise on a variety of DAIDS clinical research topics. This may include coordinating with subject matter experts (SMEs) from DAIDS as well as other contractors.

2. Revision of Existing Training Products

Review and revise existing training products to ensure that they reflect current regulations, laws, policies and practices. The Contractor shall submit to the COR a cost estimate and timeline within five (5) business days of the request for a revised training product. Revised training products will be due to COR forty (40) business days after request. This may include coordinating with SMEs from DAIDS as well as other contractors.

3. Provide Training Sessions:

Within thirty (30) business days of notification by the COR, the Contractor shall deliver training sessions that address identified topics.

4. Training Archive

Within sixty (60) business days of receipt of requirement, inventory, transition, organize, manage and maintain a training archive (to include an online repository accessible to DAIDS) of all training products developed and delivered on behalf of DAIDS. This training archive shall include training products or materials developed by other DAIDS contractors and grantees.

D. OTHER RESEARCH AND RELATED SERVICES

1. Technical and Logistical Support for Meetings, Teleconferences and Videoconferences

As directed by the COR, provide technical logistical support services for in person meetings, teleconferences, and videoconferences related to work requests in this PWS. These meetings will involve DAIDS staff, clinical research site staff, and clinical research program/projects cosponsors and other DAIDS partners. Such meeting support activities include the following services:

a. Coordinate meetings, teleconferences and videoconferences, including, as necessary, teleconference/videoconference services, travel arrangements (transportation, lodging, Meals and Incidental Expenses (M&IE)), meeting room scheduling, and audiovisual facilities and equipment. DAIDS staff will make their own travel arrangements and be reimbursed by the Government.

Revised on 12.15.2016 10

b. Provide administrative support, including on-site, for meetings, teleconferences, and videoconferences, including:

moderators/timekeepers, the preparation of agendas, generating lists of participants and other related meeting materials and documents, and meeting/teleconference/videoconference summaries and/or minutes; and the distribution of all such materials to participants and others designated by the COR.

c. All meetings moderated by the Contractor must conclude with a verbal listing of action items/due dates and discussion of next steps. All meetings to be recorded and, at the discretion of the COR, recordings may be used in place of meeting minutes. If requested, action item listings shall be distributed within two (2) business days of the meeting. If requested, minutes shall be distributed within four (4) business days or less. Agendas are to be distributed no less than two (2) business days in advance of any meeting.

2. Subcontract Award and Management

Provide acquisition and management services related to the award and management of subcontracts and consultant agreements within each of the three functional areas: clinical research, laboratory and training. The Contractor shall:

a. Research and identify qualified consultants and contractors upon request of the COR, within ten (10) business days of request.

b. When required, develop solicitations to include a Performance Work Statement (PWS), milestones, deliverables and reporting requirements and evaluation criteria. A complete PWS with associated documents should be delivered to the COR within ten (10) business days of COR request.

c. Upon receipt of proposals, perform cost and technical analyses of proposals received. Provide all of the information to support selection for award to DAIDS within ten (10) business days of receipt of proposals for review, acceptance and consent to award.

d. Solicit, execute and manage subcontracts, including financial monitoring, tracking of deliverables and reporting requirements as well as subcontractor performance and achievement of milestones. Deliver monthly reports on progress and expenditures to the COR (see paragraph F.2. below).

e. The period of performance of each subcontract cannot exceed the period of performance of this contract.

E. COORDINATION AND COLLABORATION WITH OTHER DAIDS

COLLABORATORS AND CONTRACTORS

DAIDS supports clinical research through a large number of grants and contracts. As a gap-filling contact this contractor will be required to coordinate and collaborate with multiple other grantees and contractors, on all aspects of the work described in the PWS. Please see the “DAIDS Extramural Clinical Trial Portfolio” and “Other NIAID/DAIDS Clinical Research Support Contractors and Grantees” in the electronic reading room, referred to in “Attachments 7: Additional RFP-Specific Materials” for a listing of the contractors and grantee partners.

Revised on 12.15.2016 11

F. PROJECT MANAGEMENT

The Contractor shall use its best efforts to optimize achievement of the Performance Requirements and Performance Standards listed in the PWS and Quality Assurance Surveillance Plan (QASP), this will include a self-assessment report of Contractor performance and the quality of activities conducted. Emphasis should be placed on a proactive and customer oriented approach to performance.

The following meetings between the COR and senior contractor staff (PD, Assistant PD) will be required for the overall management and oversight of this contract.

1. COR Project Management Meetings and Teleconferences

a. Contract Initiation Meeting

Within five (5) business days of the effective date of the contract, participate in a one-day Contract Initiation Meeting with the COR, the Contracting Officer and other NIAID personnel designated by the COR, to be held at the offices of DAIDS in Rockville, MD. The purpose of the Contract Initiation Meeting will be to orient the Contractor to NIAID contract procedures, review contract requirements, and discuss upcoming support services to be provided.

Contractor attendees shall include technical leads in the PWS functional areas of clinical research support, laboratory and training.

b. Contract introduction to DAIDS

Within forty (40) business days of contract award, the Contractor shall prepare and present an “Introduction to the Contractor and CRSS” to DAIDS personnel. During this presentation, the Contractor shall present their staff and capabilities in a visual electronic slide format.

c. Routine Project Management with COR (Meetings/Teleconferences)

Plan and conduct weekly meetings at DAIDS and/or teleconferences attended by the Contractor’s Project Director, Contractor Senior personnel and the COR to review and discuss matters relevant to the technical administration and oversight of the contract. The schedule for these meetings will be established by the COR post-award. In advance of each weekly management meeting, distribute an agenda that contains the following:

i. Status of active projects with current monthly spend. percent complete, funds remaining and progress

ii. List of all open issues and COR requests with status update and due dates

iii. List of “self-reported” Quality Assurance issues and corrective action plans; risk assessment and risk mitigation activities

iv. All background and/or supporting materials related to agenda items to include all relevant emails

Prepare brief summaries of the major decisions and action items resulting from these meetings and submit to the COR within seven (7) business days

Revised on 12.15.2016 12 after meeting/teleconference completion. A summary of these meetings shall also be included in the Quarterly Technical Progress Reports.

2. Monthly Management Report

The Contractor shall provide a Monthly Management Report. This report, shall be in an electronic format and address, as applicable, the following:

a. the status of all on-going efforts (addressing hours worked, FTE, cost, schedule and performance);

b. identification of problems encountered and plan for resolution;

c. the activities and deliverables planned for the current month;

d. subcontract progress and expenditures;

e. any complaints received and resolution;

f. listing of all “open” COR requests and status/timeline for response.

3. Additional “ad hoc” Project Management Meetings and Teleconferences

a. At the request of the COR, plan and participate in additional teleconferences and/or meetings with the COR, his/her designee(s), and the Contracting Officer, to discuss contract activities.

b. Prepare and distribute agendas and other materials at least three (3) business days in advance of each meeting/teleconference. Prepare brief summaries of the major decisions and action items resulting from these meetings and teleconferences and submit to the COR within seven (7) business days after meeting/teleconference completion. A summary of all meetings and teleconferences shall also be included in the Quarterly Technical Progress Reports.

G. Initial Transition

In the event of transition to a new contractor, the Contractor shall ensure the orderly, efficient and secure transition of all contract activities and contract-related data, documents, and other materials from the previous contractor, as follows.

a. Within 20 calendar days of the contract effective date, develop and submit, for COR review and approval, a Draft Initial Transition Plan to ensure full assumption of all contract responsibilities and functions no later than 90 calendar days following the contract effective date. The Draft Initial Transition Plan shall include organization, project implementation, staffing, knowledge transfer, resources, risks and mitigation strategies, schedule, etc. as needed for contract start (initial) and contract end (final). The Plan shall also delineate the transition activities to be undertaken, timelines for the completion of each transition activity, and Contractor staff to be assigned and their roles and responsibilities. This plan shall include the transfer of all deliverables, acceptance and integration of all paper and electronic files and databases, the training and QA/QC plans, SOPs and all software and hardware used by the incumbent contractor. The Contractor shall transition existing website to Contractor’s server.

[END OF PERFORMANCE WORK STATEMENT FOR BASE PERIOD]

Revised on 12.15.2016 13

H. Option(s)

In addition to the services/quantities outlined above to be provided for the Base Period, the Government may exercise, at its discretion, Options(s) for additional services/quantities. These Options are defined as follows:

a. Option 1 - 6: Extend the Term of the Contract: The Government may exercise options to extend the period of the contract beyond the Base Period, annually for a total contract period of up to seven (7) years. If an Option is exercised, the services required shall be within the same scope as those provided during the Base Period.

b. Option 7 - 34: Increased Level of Effort: The Government may exercise options for increases in the level of effort that may result from unanticipated increases in demand during year 1 through 7 of contract performance. For each option quantity exercised, the Contractor shall provide one additional full time equivalent (FTE) for up to two (2) Options per year and shall provide two additional FTEs for up to twice per year. If an option quantity is exercised, the services required will be within the same scope as those provided for the base period. The period of performance of an Option for Increased Level of Effort will not exceed the term of the base period or Option year in which the Option is exercised.

[END OF PERFOMANCE WORK STATEMENT FOR OPTIONS]