Redacted_JOFOC_for_Contract_No._HHSN272201700014C.pdf

ATTACHMENT : PERFORMANCE WORK STATEMENT NIAID/

DIVISION OF AIDS: REGULATORY SUPPORT CENTER

1) BACKGROUND AND INTRODUCTION

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The mission of the Division of AIDS (DAIDS), NIAID, 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. NIAID/DAIDS, henceforth referred to as DAIDS, supports extramural Clinical Trials Networks, investigator-initiated clinical trials, and partners with other Government and private organizations to accomplish the Division’s scientific objectives. Through grants and contracts, DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines, and other preventive modalities. This contract will be used primarily to support DAIDS activities. However, this contract may be used to support other NIAID programs as necessary to help accomplish our mission.

DAIDS acts as study sponsor for clinical trials that meet the requirements to be conducted under Health Authority (HA) oversight (U.S. Food and Drug Administration [FDA] and others as appropriate), of Investigational New Drug (IND) studies, as well as those studies that do not meet these requirements (non-IND). As of May 2015, there are 61 active INDs containing 117 protocols (86 active), and 1342 clinical research sites (718 domestic, 624 international) with trials being conducted in 64 (22 active) different countries. As the IND sponsor for a large number of DAIDS-supported clinical trials, there is an established requirement for DAIDS to provide regulatory support for these clinical trials to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Parts 11, 50, 54, 56, 312, and 314 and Title 45 CFR Part 46.

Clinical trials must also be conducted in accordance with the International Conference on Harmonisation (ICH) Guidelines: E2A Clinical Safety Data Management and E6 Good Clinical Practices (GCP), and country-specific regulatory requirements. In order to provide regulatory support services for DAIDS clinical research and clinical trials, on April 15, 2010, a seven-year contract [Contract No.: HHSN272201000013C] was awarded to Technical Resources International, Inc. to operate the Regulatory Support Center (RSC).

The purpose of this solicitation is to continue clinical regulatory and technical support services for DAIDS-supported clinical trials and clinical research and to meet evolving regulatory and scientific needs.

DAIDS has several systems and processes that provide resources for regulatory support:

The NIAID-Clinical Research Management System (N-CRMS) is a comprehensive information system that supports many of the clinical research management and oversight responsibilities of DAIDS.

Data Management Center (DMC): Each of the DAIDS Clinical Trial Networks have associated DMCs. The DMC collects, manages, and analyzes data from clinical trials and epidemiological studies. The HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the Microbicide Trials Network (MTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) are supported by the Statistical Center for HIV/AIDS Research & Prevention (SCHARP). The AIDS Clinical Trials Group (ACTG) is supported by Frontier Science & Technology Research Foundation, Inc. (FSTRF).

The DAIDS protocol registration process verifies that sites have received the necessary Institutional Review Board (IRB)/ Ethics Committee (EC) and other applicable Regulatory Entity (RE)/Approving Entity (for example, ministry of health, national regulatory agency, in-country drug control council, national IRB/EC, or other government agency) approvals and have provided to DAIDS all documentation pertaining to investigator qualifications and responsibilities that are required by U.S. Federal regulations and NIH. The DAIDS protocol registration process also verifies that site-specific informed consent (IC) forms contain the necessary information to comply with U.S. Federal regulations.

DAIDS RSC public website http://rsc.tech-res.com/default.aspx

2) SCOPE

The Contractor shall operate and manage the NIAID/DAIDS Regulatory Support Center (RSC) to provide comprehensive clinical regulatory and administrative support services for NIAID-supported clinical trials and clinical research, both domestic and international.

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 (PWS) as stated herein. Specifically, the Contractor shall:

A. General Requirements Optimize efficient achievement of the Performance Requirements and Performance Standards listed in the PWS. The requirements below affect all other task areas of the PWS.

1. Develop, maintain, and implement DAIDS RSC Standard Operating Procedures (SOPs) used by DAIDS and Contractor personnel to carry out all RSC regulatory support responsibilities. SOPs shall be reviewed, and modified by the Contractor, and approved by the Contracting Officer’s Representative (COR). Within 14 business days of receipt of comments from the COR and other designated DAIDS staff, electronic versions of the SOPs shall be made available by the Contractor to appropriate DAIDS staff. Electronic SOP versions shall be posted by the Contractor on the secure password protected/limited access RSC website.

2. Use various information systems:

a. NIAID-Clinical Research Management System (N-CRMS): The N-CRMS is a comprehensive information system that supports many of the clinical research management and oversight responsibilities of DAIDS. The Contractor shall use the following N-CRMS components: Master Contact, Protocol Management, Protocol Registration, Protocol Development Tracking, Investigational New Drug Application Management, Clinical Site Monitoring, Adverse Experience Reporting System, Adverse Experience Processing System, and others as designated by the COR.

b. FDA Electronic Submissions Gateway (ESG): For electronic submission of documents to the FDA http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.ht m

c. NIAID interface for electronic Common Technical Document (eCTD) publishing

d. ClinicalTrials.gov website: (http://clinicaltrials.gov)

e. NIAID clinical trial networks’ Data Management Centers (DMCs)

3. Complete all tasks in compliance with all applicable U.S. and in-country regulations as well as NIH, NIAID, and DAIDS policies and procedures.

4. Interface with the appropriate entities, and comply with the format of the deliverable output(s) and timelines, which include review and approval by DAIDS staff.

5. Provide support for operational meetings and teleconferences with HA and DAIDS collaborators: Prepare draft formal meeting request and briefing packets as well as meeting minutes, final documents should incorporate all DAIDS’ comments;

and track action items as directed by the COR and per DAIDS-provided timelines.

For meetings with HA, follow all applicable rules, regulations and guidances as well as DAIDS SOPs.

6. Provide support for training related to tasks under this contract, such as safety reporting and protocol registration.

a. The Contractor shall provide any or all of the following support as directed by the COR: administrative and logistical support, develop, conduct, and assess effectiveness of the training and develop and administer tests approved by the COR.

b. Training may be conducted in a variety of ways, for example, in-person, web-based or pre-recorded.

c. Training may be provided to a variety of NIH, contractor and collaborator staff at a variety of venues or at a location provided by Contractor.

d. Training may also be targeted to address recurring problems at certain clinical research sites and across sites.

7. Other Support:

a. Provide other administrative support such as development of technical templates, copying, posting, tracking, delivery (paper copy and electronic) and distribution of documents (using various mechanisms), tracking status of projects, and providing reports such as Monthly highlights within 10 business days following each monthly reporting period, as directed by the

COR.

b. Provide Help Desk/customer service support for tasks under this contract during normal business hours (Monday through Friday, 8:00 am-5:00 pm Local Time).

c. Provide pertinent information to other DAIDS contractors and collaborators (such as information related to safety report identification).

B. IND and other Regulatory Support Provide technical and administrative support, in compliance with HA and DAIDS timelines, to DAIDS staff for the processing and maintenance of a variety of U.S. and non-U.S. DAIDS-held regulatory filings and related regulatory activities. Support shall include the following and other related tasks as directed by the COR. For clinical trials involving non-DAIDS sponsorship, the Contractor may be responsible for carrying out a subset of the following functions.

1. Preparation of Regulatory Filings Draft, prepare, publish, distribute and track complete and accurate documents for DAIDS-sponsored regulatory filings in accordance with all applicable U.S. and in-country regulations, and NIH and DAIDS templates and relevant SOPs (see https://ecollab.niaid.nih.gov/readingroom/DAIDSRSC) and DAIDS-determined timelines. Publish eCTD-compliant documents and convert non-compliant documents to a compliant format using NIAID-provided eCTD software for submission to DAIDS-held INDs through the U.S. FDA ESG as directed by DAIDS.

2. Regulatory Submissions Submit DAIDS-approved documents to national HA (such as U.S. FDA). Prepare and deliver Submission Status Summary Reports, Status Summary Reports of IND Annual Reports, and other regulatory documents and reports as directed by the COR.

3. Additional Support Services

a. Obtain, duplicate, and distribute Investigators’ Brochures (IBs), IB updates, package inserts, and updates to HA and to relevant organizations and relevant personnel per DAIDS-approved SOPs.

b. Distribute DAIDS documents to relevant organizations and personnel per DAIDS-approved timelines.

c. Maintain paper copy and electronic files of all HA (e.g., FDA) correspondence and submissions for DAIDS-sponsored clinical trials.

d. Provide technical assistance in the development and implementation of regulatory strategies and approaches for design and submissions to the FDA and other regulatory health authorities.

e. Maintain and update data in relevant N-CRMS components. Ensure that systems are in alignment with and support current DAIDS business processes, and conform to DAIDS business rules and data standards, and are fully integrated within the N-CRMS architecture.

f. Provide, use, support and maintain desktop configurations that satisfy NIAID security requirements to access the NIAID eCTD system.

C. Safety and Pharmacovigilance Assist DAIDS staff with safety and pharmacovigilance activities within timeframes that meet all applicable requirements and conform to DAIDS SOPs, such as:

1. Safety Reporting and Safety Information Distribution Prepare and distribute safety-related information:

a. Receive, process, evaluate, triage, prepare and distribute Adverse Experience Safety Reports (i.e., Serious Adverse Events [SAEs] and/or Expedited Adverse Events [EAEs]) reported by sites participating in DAIDS-supported clinical activities. Use the N-CRMS DAIDS Adverse Experience Reporting System (DAERS). Include review by the DAIDS Medical Officer.

b. Prepare interim and final Adverse Experience Safety Reports with a Compliance Statement in appropriate formats to meet applicable timelines and that include all information required by all applicable regulations and DAIDS SOPs.

c. Generate and maintain periodic (daily, weekly, monthly and ad hoc) status reports for compliance with Adverse Experience Safety Reporting requirements, contractor performance, etc.

d. Distribute Safety Information such as Safety Memoranda, Safety Reports, Safety Notices, Package Inserts, IBs with a summary of changes (if available), Data and Safety Monitoring Board (DSMB) reports, other serious safety information (e.g., DAIDS Safety Alerts, information from company collaborators) and DAIDS policy notices. Provide instructions to clinical research sites on site responsibilities related to the disseminated safety information.

2. Pharmacovigilance and Safety Data Code, reconcile and analyze safety data:

a. Provide Medical Dictionary for Regulatory Activities (MedDRA) coding of safety data as specified by the COR;

b. Participate in the cross-center consistency check activity (to ensure that adverse experience data are coded consistently and uniformly) and in relevant Working Groups as directed by the COR;

c. Conduct two-way reconciliation of Safety Data with DMCs per DAIDS-approved timelines;

d. Implement ICH E2B Compliance of Safety reports and other safety data outputs;

e. Assist DAIDS in performing ongoing analyses of safety data (to include AE data from DMCs);

f. Support weekly and ad hoc electronic data interchange of safety data reported to the RSC, to the central database of each DAIDS HIV/AIDS Clinical Trials Network (such as Network DMCs);and

g. Collaborate with DAIDS to implement weekly and ad hoc electronic data interchange of AE data reported on case report forms (CRFs) received by DAIDS-supported DMCs to DAIDS.

3. Other RSC Safety Office Support Services Provide other support as directed by the COR (generate status reports, respond to requests for information, assist in other projects, etc.) per DAIDS-approved timelines. The Contractor shall:

a. Prepare and submit to the COR and other DAIDS staff a daily report on status of 7-day and 15-day IND Safety Reports as well as Adverse Experience/Safety reports to other HA;

b. For IND annual reports and other periodic reports, compile accurate, complete data, reconciled with DMC data;

c. Generate SAE/EAE summary reports for specific studies, study agents, and by type of SAE/EAE;

d. Prepare and provide monthly and quarterly safety summary reports to each HIV/AIDS Clinical Trials Network by study and study agent;

e. Respond to queries on pharmacovigilance and the safety databases;

f. Provide support for DAIDS projects such as performing literature searches, summarizing literature reviews, gathering country-specific safety reporting requirements, and developing country-specific safety data reporting process documents.

g. Develop, implement and maintain quality assurance/ quality control (QA/QC) procedures.

D. RSC Website and Information Systems Maintain, and update an N-CRMS-independent RSC government-labeled website and other RSC-related databases/applications that will interact with the DAIDS clinical research system, with Network DMCs and the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB). All infrastructure and software lifecycle activities associated with the N-CRMS will be performed by the N-CRMS contractor.

Specifically, the Contractor shall:

1. RSC Databases/Information Systems Maintain the RSC related databases/applications to Government requirements for scheduling, tracking, reporting, storage, modification, transmission, and disposition of all work and work products generated under this contract. These databases/applications shall provide for the following features and capabilities:

a. Generation of customized reports on a broad range of RSC functions and the status of specific regulatory activities.

b. Analysis of and reporting on the use of RSC resources and time required to complete regulatory requirements, etc., as directed by the COR.

c. Appropriate backup systems to restore the data and functionality.

2. RSC Website Maintain and update a reliable, secure and user friendly RSC Government-labeled website that serves as an information source for DAIDS staff, DAIDS-supported clinical investigators and other clinical, operations and data management staff.

The website shall be independent of the N-CRMS and house and provide easy access to all required documents as directed by the COR.

E. Coordinate and Collaborate with NIAID Clinical Research Management System (N-CRMS) or Alternative Information Technology System Contractor:

1. Coordinate and collaborate with the N-CRMS contractor staff in order to assure efficient systems and data integration in support of DAIDS. Enter, update and facilitate interchange of RSC information with the relevant N-CRMS systems, or if necessary into an alternative DAIDS clinical research system as directed by the COR and in compliance with all applicable standards, regulations and policies.

2. As needed, adapt local/internal Contractor data management systems and develop/deploy data interchange mechanisms required to receive, store and exchange data with and from the N-CRMS, or alternative, in accordance with specifications provided by the COR (e.g., N-CRMS specified software Application Programming Interfaces (APIs), eXtensible Markup Language (XML)-based web services, XML Schema Definitions (XSD), RDBMS, .NET Framework, UDDI, IIS, Internet Explorer, Service Oriented Architecture (SOA), Design Patterns, Frameworks and Templates, Microsoft Office, web browsers, etc., including specific versions thereof). The Contractor shall adhere to these guidelines and standards on a continuous basis.

3. Provide input in identifying requirements and specifications for new functionality within the N-CRMS system, or alternative, and adapt to new system features implemented by DAIDS.

F. Protocol Registration

1. Receive, process, and track all protocol registration materials supporting DAIDS

IND and non-IND studies in compliance with DAIDS SOPs and DAIDS-approved timelines.

2. Provide support to DAIDS staff for protocol registration by maintaining electronic registration records in N-CRMS Protocol Registration to ensure that all clinical research sites conducting DAIDS–supported and/or-sponsored clinical research do so in compliance with all applicable regulations governing human subjects protection and the use of investigational drugs, biologics and/or devices as well as NIH, NIAID, and DAIDS SOPs and policies and in compliance with DAIDS SOPs and DAIDS-approved timelines. Support includes but is not limited to the following:

a. Receive, process, review and track all protocol registration documentation (i.e., IRB/EC documents, site IC forms);

b. Prepare and distribute protocol registration reports to DAIDS staff and collaborators;

c. Provide instructions to DAIDS clinical research sites on site responsibilities related to protocol registration requirements;

d. Notify appropriate DAIDS staff and collaborators of protocol registration approvals; and

e. Provide other support as directed by the COR (generate status reports, respond to requests for information, assist in other projects, etc.).

G. Clinical Study Information

1. Receive, post, distribute, and track draft and final versions of protocols, protocol amendments, and related information submitted to DAIDS using the N-CRMS Protocol Management (PM) module to DAIDS staff and collaborators to meet DAIDS-approved timelines.

2. Track and enter protocol statuses, milestones, and event changes during the lifecycle of DAIDS-supported clinical trials/studies into N-CRMS.

3. Maintain an up-to-date electronic document library with copies of study-related documents per DAIDS SOPs.

4. Abstract data elements from the clinical documents and enter into the N-CRMS per DAIDS-approved timelines.

5. Enter and update information in N-CRMS Master Contact (MC) module per DAIDS-approved timelines. This includes contact information for DAIDS staff and collaborators, such as pharmacies, laboratories, pharmaceutical companies and other personnel.

6. Detect and resolve discrepancies in data entered into N-CRMS.

H. Clinical Trial Agreements (CTAs) and Other Research Agreements

1. Provide support to DAIDS, in compliance with limitations imposed by the Federal

Guidelines on Inherently Governmental Functions and NIH Policy on Relations with the Office of General Counsel, for the preparation, negotiation, finalization, distribution and tracking of CTAs and other research agreements (e.g., Confidential Disclosure Agreements) using DAIDS-approved templates.

2. Maintain records of CTAs and other agreements, track the documents and negotiation milestones in the N-CRMS Protocol Development Tracking module, and provide status reports as directed by the COR.

I. Human Subjects Protection (HSP) Provide assistance to the DAIDS staff in the review of sample informed consent (SIC) documents and their translations, and maintenance and distribution of informed consent (IC) templates.

1. Review SIC documents at various stages of protocol development as well as site-specific IC forms, for the following:

a. compliance with all applicable international, Federal regulations, NIH, and DAIDS policies and all in-country requirements for studies outside of the U.S.,

b. consistency with IBs and/or package inserts

c. consistency with the protocol

2. Translate SIC documents to other languages as directed by the COR.

3. Maintain and distribute to applicable parties all DAIDS IC templates used to prepare the SICs for all protocols sponsored by DAIDS. Maintain the templates on the RSC website.

J. DAIDS Scientific Review Committees (SRCs) Provide administrative, technical and scientific support for the SRCs used by DAIDS for programmatic and regulatory review of clinical documents (such as protocols and SIC documents) from DAIDS collaborators and track status per DAIDS-approved timelines and SOPs. Prepare a summary of Committee comments and decisions to the protocol teams.

Note: DAIDS currently has two in-house SRCs to review and approve clinical trial protocols on a Divisional level: the Clinical Scientific Review Committee (CSRC) for therapeutic studies, and the Prevention Scientific Review Committee (PSRC) for prevention and vaccine studies.

K. ClinicalTrials.gov Provide support and assistance to DAIDS for cross-program issues related to ClinicalTrials.gov:

1. Receive, process, review, document and maintain relevant records as well as perform other related tasks.

2. Determine if a trial meets ClinicalTrials.gov criteria for an “Applicable Clinical Trial” per all applicable rules and regulations and NIH policies.

3. Track registration of “Applicable Clinical Trials” as well as deadlines for the reporting of summary results information (including adverse events) to ClinicalTrials.gov.

4. Respond to queries regarding compliance with the ClinicalTrials.gov requirements.

L. Quality Assurance/Quality Control (QA/QC)

1. Develop and implement a COR-approved QA/QC Plan. The first draft is to be provided to the COR within three months of contract effective date, to be finalized within 4 weeks of receipt of COR comments. The plan should be designed to standardize processes; ensure that the conduct of all contract activities complies with all applicable regulations (for example, FDA and Office for Human Research Protections (OHRP) regulations governing human subjects research, ICH/GCP guidelines) as well as NIH, NIAID and DAIDS policies and procedures; and provide for the self-assessment of Contractor performance and the quality of activities conducted.

2. The COR may authorize, at any time during the contract period of performance, independent audits of the Contractor with one (1) week advance notice of the scheduled audit. For cause audits or IND file audits may be performed at any time and without advance notice to the Contractor. Comply with audits authorized by the COR.

M. Other Regulatory Support Services Provide other types of regulatory support services in order to respond to various requests under routine and expedited timelines, as directed by the COR, such as archiving documents, retrieving archived documents, drafting and distributing documents, complying with FDA and other audits, or responding to requests for information [such as Freedom of Information Act (FOIA) requests] in compliance with instructions, timeframes and DAIDS-approved SOPs.

N. Facilities, Equipment and Other Resources Provide all required facilities, equipment and other resources necessary to carry out the requirements of the contract.

This includes:

1. Locked, secure, and fireproof storage of IND files and other regulatory files with controlled access for appropriate RSC and NIAID staff.

2. Long-term storage facilities for documents such as regulatory files, CRFs and pharmacy records.

3. DAIDS RSC Document Collaboration Website that includes:

a. Secure password-protected document storage and collaborative tools

b. Customizable user permissions for different levels of access

4. DAIDS RSC public website http://rsc.tech-res.com/default.aspx

O. Project Management

1. Provide for overall management, integration and coordination of all contract and subcontract activities, project management and communications, tracking, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines; per a COR-approved Project Management Plan which should be implemented within 7 calendar days of receipt of COR comments, but no later than 60 calendar days of contract effective date.

2. Provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation and timely completion of all projects carried out under this contract and effective communications with the COR and the Contracting Officer.

3. Provide support for meetings and teleconferences. Meetings include:

a. Contract Initiation Meeting

Within five (5) business days after the effective date of the contract, participate in a Contract Initiation Meeting with NIH and NIAID personnel as designated by the COR.

b. Contract introduction to DAIDS Within forty (40) business days of contract effective date, prepare and present an “Introduction to the Contractor and RSC” to DAIDS personnel.

During this presentation, the Contractor shall present their staff and capabilities in a visual electronic slide format.

c. Routine and Ad Hoc Meetings Organize and participate in monthly project and contract management meetings with the Government at which the Contractor shall provide and discuss the Monthly Progress Report. This report, at a minimum, shall be in a visual electronic slide format.

P. Subcontract Management and Reporting Solicit, evaluate, award and manage international and domestic subcontracts, as needed. Ensure the complete and effective transfer of technology by the subcontractors to the Contractor, the Government, or a third party designated by the COR, as needed. Perform all necessary transition and closeout functions on each subcontract.

Q. Initial and Final Transition

1. Initial Transition In the event of a transition to a new Contractor, the Contractor shall work with the COR to ensure an orderly, secure, and efficient transition of contract activities and contract-related data, documents, and other materials from the previous contractor as follows:

a. Within three (3) business days of the award date of the contract, the COR will provide the Contractor with a copy of the incumbent contractor’s Final Transition Plan specifying transition requirements and processes. The Initial Transition shall require the transfer of contract-related materials and data from the incumbent Contractor to the successor Contractor, which includes the following:

1. All paper and electronic files and databases;

2. Training and QA/QC plans;

3. SOPs;

4. Government-Owned Property

b. Within ten (10) business days of the award date of the contract, the Contractor shall develop and submit to the COR and Contracting Officer for review and approval, a Draft Initial Transition Plan to ensure full assumption of all contract responsibilities and functions no later than sixty

(60) calendar days of the contract effective date. The Draft Initial Transition Plan shall include 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 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.

c. Implement and complete the transition, per the COR and Contracting Officer approved Initial Transition Plan, no later than sixty (60) calendar days following the effective date of the contract.

2. Final Transition

a. The Contractor shall provide a Final Transition Plan for the orderly, secure, and efficient transition of contract-related materials and activities to the successor contractor or to the Government. A description of transition activities, timelines, and assigned staff shall be provided in a Draft and Final Transition Plan, which will be reviewed and approved by the COR.

b. The Draft Transition Plan shall be submitted to the COR and Contracting Officer no later than six (6) months prior to the completion date of the contract for review and comment. Upon receipt of comments, the Contractor shall revise the Draft Final Transition Plan as necessary.

c. The Final Transition Plan shall be submitted for written approval to the COR and the Contracting Officer no later than four (4) months prior to the completion date of the contract.

[END OF PERFORMANCE WORK STATMENT FOR THE BASE PERIOD]

R. Options

In addition to the services/quantities outlined above to be provided for the Base Period, the Government may exercise, at its discretion, Options for additional level of effort as follows: 1) Options to extend the term of the contract; and 2) Options for Increased Level of Effort to accommodate significant increases in demand for the activities supported by the base requirements of the contract. These Options are defined as follows:

Option 1-6: Extend the Term of the Contract: The Government may exercise options to extend the term of the contract in one-year increments beyond the base period. The total period of performance resulting from the base period plus all potential options is seven years. If an option is exercised, the services required will be within the same scope as those provided during the base year.

Option 7-20: Increased Level of Effort: The Government may exercise options for incremental increases in the level of effort to accommodate significant increases in demand. For each option exercised, the Contractor shall provide an additional 1.0 full time equivalent (FTE) inclusive of subcontractor and consultant effort. Up to two (2) Options per year may be exercised during years 1 through 7 of contract performance.

If an option of this type is exercised, the services required shall be within the same scope as those provided for the base requirement. The period of performance of an Option for Increased Level of Effort will not exceed the term of the base year or Option year in which the Option is exercised.

Option 21-34: Increased Level of Effort: The Government may exercise options for incremental increases in the level of effort to accommodate significant increases in demand. For each option exercised, the Contractor shall provide an additional 2.0 FTEs, inclusive of subcontractor and consultant effort. Up to two (2) Options per year may be exercised during years 1 through 7 of contract performance. If an option of this type is exercised, the services required will be within the same scope as those provided for the base requirement. The period of performance of an Option for Increased Level of Effort will not exceed the term of the base year or Option year in which the Option is exercised.