A2 - S4 SoW 2020-02-13.pdf

SOW: Specialized and Strategic Services to Support the NIH Intramural Research Program

STATEMENT OF WORK – Technical Specifications

Specialized and Strategic Services to Support The National Institutes of Health Intramural Research Program

(“The NIH IRP S4 Contract”)

(02-13-20)

1.0 PURPOSE

The purpose of this requirement is to acquire complex, specialized and strategic services to support the activities of the National Institutes of Health (NIH) Intramural Research Program (IRP) across all NIH Institutes, Centers, and Offices (ICOs). It is trans-NIH, intramurally focused, and requires highly qualified and experienced personnel capable of providing a full range of specialized, strategic, technical and operational services. This requirement provides support that is critical to the broad range of NIH intramural biomedical and clinical research activities in-process, planned and unanticipated (due to new or re-emerging health threats and science advances).

This Statement of Work (SOW) includes support services in the following Task Areas:

• Program Management Office Support

• Basic, Translational and Preclinical Research

• Clinical Research Studies and Trials

• Bioinformatics, Biostatistical and Technical

• Operational and Management

• Regulatory and Compliance

• Other Specialized Support Services

The Office of Intramural Research (OIR), located within the Office of the Director (OD), of the National Institutes of Health (NIH), is acquiring and administering this requirement.

2.0 BACKGROUND

The NIH Intramural Research Program (IRP) is known for its synergistic approach to biomedical science and distinctive ability to leverage extensive resources and expertise to perform truly interdisciplinary research, from the bench to the bedside. With approximately 1,200 Principal Investigators (PIs) and more than 6,000 postdoctoral fellows conducting basic, translational, preclinical and clinical research, including 1,900 clinical research protocols, the NIH IRP is the largest biomedical research program in the United States.

The NIH IRP accelerates scientific progress by advancing basic, translational, and clinical research across all fields of biomedical study. Since its inception, the NIH IRP has led some of the most significant scientific breakthroughs of the modern age and continues to operate at the forefront of scientific discovery. To remain a leading academic center of excellence, and to take advantage of the diversity and scope of the NIH IRP’s cross-disciplinary resources, infrastructure, and scientific expertise, NIH IRP is pursuing research activities in the core scientific areas listed below.

• Investing in Cutting-Edge Animal Models - Organisms with human-like diseases and symptoms are critical to finding cures.

• Creating Cell-Based Therapies - Before reaching patients, new treatments must first be tested in the body’s building blocks.

• Advancing Computational and Structural Biology - Ambitious scientific undertakings require massive computing power.

• Combating Drug Resistance - As dangerous microbes grow more resilient, new approaches are needed to thwart life-threatening infections.

• Developing Novel Imaging Techniques - The mysteries of biology are becoming clearer thanks to major advances in technology.

• Charting the Pathways of Inflammation - A common thread connecting many diseases holds promise as a therapeutic target.

• Zooming in on the Microbiome -Tiny passengers inside the human body may hold the key to improving human health.

• Uncovering New Opportunities for Natural Products - The world around us is filled with myriad potential therapies.

• Stimulating Neuroscience Research - Scientists are applying their brainpower to study the most complex human organ.

• Pursuing Precision Medicine - The great variation among patients requires treatments that are tailored to the individual.

• Unlocking the Potential of RNA Biology and Therapeutics -DNA’s second-in-command could help treat a variety of diseases.

• Producing Novel Vaccines - Methods of enhancing disease immunity could prevent and alleviate global epidemics.

https://irp.nih.gov/about-us

The intramural facilities are located on the NIH Main Campus in Bethesda, Maryland, as well as NIH facilities located in Research Triangle Park, North Carolina; Baltimore, Maryland; Frederick, Maryland; Hamilton, Montana; and Phoenix, Arizona. More than 50 buildings on NIH campuses are devoted to the research enterprise, from state-of-the-art animal care facilities to homes for 7-Tesla MRIs and confocal microscopes, to a neurosciences cluster designed to foster collaborations across disciplines. The NIH IRP includes a 240-bed research hospital dedicated entirely to clinical research protocols.

Although each NIH Principal Investigator (PI) is organizationally aligned with a particular ICO, collaborations are not limited to the NIH campus, and many PIs work extensively with scientific colleagues both nationally and internationally. Working in scientific laboratories, hospital clinics, and fieldwork stations around the world, NIH PIs are constantly advancing the state of biomedical science with the goal of changing lives for the better.

The NIH is composed of 27 separate Institutes and Centers (ICs) that conduct and coordinate research across different disciplines of biomedical science, such as:

• Biomedical Engineering and Biophysics

• Cancer Biology

• Cell Biology

• Chemical Biology

• Chromosome Biology

• Clinical Research

• Computational Biology

• Developmental Biology

• Epidemiology

• Genetics and Genomics

• Health Disparities

• Immunology

• Microbiology and Infectious Diseases

• Molecular Biology and Biochemistry

• Molecular Pharmacology

• Neuroscience

• RNA Biology

• Social and Behavioral Sciences

• Stem Cell Biology

• Structural Biology

• Systems Biology

• Virology

The Office of Intramural Research (OIR), located within the Office of the Director (OD), of the National Institutes of Health (NIH), is responsible for the oversight and coordination of the Intramural Research Program (IRP). This includes research, training and technology transfer conducted within the intramural laboratories and clinics of the NIH; human subject protections, animal welfare, research integrity and reproducibility, policy development and laboratory safety. OIR is led by the NIH Deputy Director for Intramural Research (DDIR) and the IRP within each Institute and Center (IC) is led by a Scientific Director.

3.0 OBJECTIVE

The objective of this requirement is to fulfill the complex, specialized and strategic services needed to support the entire NIH Intramural Research Program (IRP), across all Institutes, Centers and Offices (ICOs). This acquisition delivers the complex and broad range of specialized and strategic services critical to the biomedical and clinical research activities of the NIH IRP.

4.0 SCOPE

This requirement includes a full range of trans-NIH, intramurally-focused, specialized, strategic, technical and operational services to support the NIH IRP. New and expanding Congressional mandates, rapid evolution of research tools and technical capabilities, changing policies and information technologies, expanding research programs, and the NIH OIR’s leadership role in supporting the NIH IRP have resulted in a critical requirement to acquire a contractor with the demonstrated experience and expertise capable of successfully providing all of the complex, specialized, technical and operational support services specified below.

5.0 SOW TASK AREAS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, transportation, tools, supervision, facilities, and other items; and non-personal services, not otherwise provided by the Government, necessary to perform Task Orders issued under this SOW at the direction of the Contracting Officer’s Representative (COR).

5.1 TASK AREA 1 – Program Management Office (PMO) Support

The Program Management Office (PMO) responsible for the inherently governmental functions relative to this contract shall reside within the NIH OIR. The Contracting Officer’s Representative (COR) responsibilities for this contract shall also reside within the

PMO.

In support of the PMO, the Contractor shall effectively and efficiently manage cost, schedule, and performance under this contract by using integrated program management processes across all aspects of performance and in a manner that yields cost savings and/or performance efficiencies throughout the execution of all Task Orders (TOs) issued under this SOW.

The Contractor shall provide PMO support for the overall administration of the contract;

and development, tracking and management of all TOs issued under this contract. The Contractor’s PMO support staff shall work in coordination with designated federal staff;

and be responsible for performing all the non-inherently governmental activities associated with administration of this contract.

The Contractor shall serve as the primary liaison to government stakeholders and designated federal staff such as the Contracting Officer (CO), the designated COR, task order managers/points of contact (POCs), administrative officers, etc.

The Contractor’s PMO support duties shall also include, but not be limited to, the following client services support activities:

• Performing liaison responsibilities that include, but not be limited to, gathering initial project requirements; developing Task Order Request Packages (TORPs); providing ongoing technical and administrative support of active TOs, such as budget, travel approvals, ad hoc reporting, etc.; communicating and reporting.

• Assisting government stakeholders in defining their need.

• Delineating schedules.

• Facilitating submission of TOs and tracking the TO progress.

• Developing and maintaining standard TO templates, processes and workflows; all elements of which shall be consistent with industry best practices and contract requirements.

• Documenting all management processes as well as recommending and implementing technologies/systems to ensure and support their execution.

• Obtaining the necessary approval prior to the adoption of any standard process or template.

Note that proprietary and sensitive information is required by the Contractor’s PMO support staff to accomplish its responsibilities. As such, the Contractor shall employ appropriate measures and safeguards.

Upon request, the Contractor shall perform project evaluation to ensure that activities are on track, within budget, and above all, meet requirements.

Contract Management Plan: The Contractor shall prepare a Contract Management Plan to ensure that the Contractor’s staff (including any subcontractor’s staff) follow individual Project Plans established in support of the work performed under this SOW. The COR will closely monitor the cost and schedule of the work to minimize the potential for cost and/or schedule variance.

The Contractor shall follow the work process flow, methodology, procedures, deliverables and best practices that conform to the standards dictated by the Project Management Body of Knowledge (PMBOK) Guide, and Project Management Life Cycle defined and published by the Project Management Institute (PMI).

The Contract Management Plan shall include: 1) detailing the understanding and approach that will be used to keep the project on track; 2) ensuring risks are understood and managed; 3) handling changes to scope, and 4) communicating with stakeholders. The Contract Management Plan shall be kept current and updated throughout the period of performance; and shall address, but is not limited to, the following:

• Team organization and responsibilities

• Project execution

• Project constraints and assumptions

• Project schedule and milestones

• Project risks identification and management

• Budgeted costs

• Project monitoring

The Contractor shall submit a draft of the Contract Management Plan to the COR no later than five (5) calendar days after the award of the contract. Following the timely receipt of comments from the COR, the Contractor shall submit a final version of the Contract Management Plan to the COR no later than 15 calendar days after award of the contract.

Monthly Activity and Financial Status Reports: The Contractor shall provide separate written Monthly Activity and Financial Status Reports that monitor the progress, cost, schedule, quality assurance, configuration management, and security management as applicable to the TOs issued under this SOW. The reports shall include, but are not limited to, progress updates on recruiting, outstanding administrative or technical issues, and cost projections. The Contractor shall provide other reports as requested by the COR.

Although the activity and financial status reports are due monthly, this shall not relieve the Contractor of the responsibility to pro-actively keep the Government informed of issues or problems as they occur (including technical, cost, or schedule issues).

Reports in a computer-readable format of the Contractor’s staff leave schedules are required to enable the Government to be notified of anticipated absences and vacation schedules.

5.2 TASK AREA 2 – Specialized and Strategic Services to Support Basic, Translational and Preclinical Research

The Contractor shall provide specialized and strategic services to support the basic, translational and preclinical research consistent with the research mission and priorities of the NIH IRP. The specialized and strategic support services shall include, but are not limited to, the following:

• Provide expertise in all pertinent scientific disciplines, to include highly qualified senior scientific subject matter experts (SMEs), who will provide specialized and strategic support to a variety of research efforts, such as viral pathogens requiring high (BSL 3) and maximum (BSL 4) containment and development of new assays and vaccines.

• Provide complex services and products that support planning and conducting a wide array of research experiments. The services and products which shall be subject to established procedures and processes shall include assay development, selection and execution; complex tests, analyses, procedures and techniques, which may include, and are not limited to: cell culture, clinical/diagnostic microbiology, DNA isolation, DNA purification, gene cloning, immunoprecipitation, immunochemistry, peptide synthesis, protein analysis, protein purification, SDS- PAGE, western blot, purification of viruses, tissue culture, RNA isolation, serological assays such as ELISA, column chromatography, thin-layer chromatography, and microarray design and printing.

• Assist with a broad range of animal studies to support preclinical research involving species such as non-human primate, rodent and other small mammals. Support may include acquisition, housing and care of animals; health monitoring and surveillance;

procedures in high containment areas; imaging; laboratory animal medicine; sample collection; model development; immunogenicity, safety and efficacy testing.

• Present findings at meetings, both inside and outside of the government; all information must be cleared by the task leader before being disseminated outside of the NIH.

• Assist in the scientific and professional development of a large and diverse biomedical research workforce (i.e., trainees, employees, special volunteers, guest researchers). Trainees include high school and college students, recent college graduates, graduate students, professional students, and postdoctoral and clinical fellows. This includes develop and provide a wide variety of courses, seminars and workshops; and providing career resources and guidance.

5.3 TASK AREA 3 – Clinical Research Studies and Trials Support Services

The Contractor shall provide clinical research studies and trails support services consistent with the research mission and priorities of the NIH IRP. Support services shall include, but are not limited to, the following:

• Assist with and participate in clinical protocol design, development, implementation and coordination; provide protocol templates; conduct protocol reviews and facilitate submission to various review committees, boards and panels.

• Provide direct and indirect patient care activities. Contractor must have appropriate medical liability coverage.

• Provide, monitor and manage all aspects of clinical research studies and trials, to include, but not limited to the following: recruit, educate, advise, assist and consent study participants; collect, analyze, maintain and report study data; manage patient records.

• Develop Standard Operating Procedures (SOPs), guidelines, manuals, pamphlets, checklists, sample packages, templates, and other similar documents and communications.

• Conduct site visits, develop study forums and clinical trial implementation; perform clinical protocol audits; conduct quality improvement assessments.

• Provide support, accommodate and quickly onboard subject matter experts (SMEs) with competence in special areas beyond, or in addition to, the existing NIH IRB members, i.e., unaffiliated NIH IRB members; provide liability coverage at $2M per event/occurrence and $2M in aggregate for the unaffiliated IRB members.

5.4 TASK AREA 4 – Bioinformatics, Biostatistical and Technical Support Services

The Contractor shall provide bioinformatics, biostatistical and technical support services consistent with the research mission and priorities of the NIH IRP. Support services shall include, but are not limited to, the following:

• Perform scientific data management tasks, including data collection, entry, verification and maintenance; provide administrative and management support for scientific projects and initiatives.; develop scientific communications, which may include and is not limited to scientific/technical writing and editing, graphic design, and outreach activities.

• Provide bioinformatics, computational biology, and data analysis for basic, translational, preclinical and clinical research projects.

• Provide system(s) support for the collection, storage, import, integration, management, tracking, updating, and exchange of a variety of data types, sources and formats from all research activities conducted within the NIH IRP.

• Provide statistically sound preclinical and clinical study design enabling data analyses and data sharing.

• Provide software tools and computational algorithms to analyze, visualize, and interpret all supported data types.

• Serve as advisers/experts to end users on bioinformatics approaches for data collection/dissemination, management, integration, and data analysis.

• Provide support for NIH enterprise activities, such as biospecimen collection, storage, tracking and reporting; the Intramural Review Board (IRB) system, to optimize workflow; centralize oversight; enhance data quality, collection, accessibility and reporting; conduct safety evaluations, monitoring and reporting;

provide notifications, progress reports, updates and other communications.

• Develop, test, maintain and support various software applications, such as the NIH IRB system; includes providing system updates and user training.

• Consolidate different applications to increase efficiency.

5.5 TASK AREA 5 – Operational and Management Support Services

The Contractor shall provide operational and management support services that include, but are not limited to, the following:

• Perform strategic and tactical assessments, forecasts and plans.

• Provide business process management, reengineering and data modeling.

• Document current processes; develop benchmarks; identify best practices and recommend changes to improve operations and efficiencies.

• Lead focused groups and conduct stakeholder meetings, often including scientists and other subject matter experts, to define and prioritize project system requirements.

• Prepare and document all functional, technical, and security requirements in enough detail to develop and test recommendations for change.

• Define, develop and test strategies for target applications.

5.6 TASK AREA 6 – Regulatory and Compliance Support Services

The Contractor shall provide regulatory and compliance support services that include, but are not limited to, the following:

• Participate in and support research misconduct inquiries and investigations;

perform digital examination of computer directories; forensic analysis, collection and imaging; recover deleted files; prepare findings and reports. All information recovered belongs to the U.S. government and may not be shared with anyone unless first approved by the COR.

• Provide support for facilitating the transfer of NIH inventions to the commercial sector for further research and development into products that benefit public health; activities may include, and are not limited to, preparing, evaluating and submitting patent applications and licenses.

• Provide Investigational New Drug (IND)/Investigational Device Exemption (IDE) regulatory support such as initial and continuing applications to the U.S. Food & Drug Administration (FDA); support FDA meetings and participate in FDA inspections.

• Provide support for the entire NIH Human Research Protection Program (HRRP), coordinated and managed through the NIH Office of Human Subjects Research Protections (OHSRP). This includes formulation and implementation of policies, operation of Institutional Review Board(s) (IRBs) and the conduct of compliance and training programs.

• Provide contracted services for outside, commercial IRBs for multi-site, collaborative, non-exempt, human research protocols (when initiated by an NIH IRP investigator and approved by OHSRP).

• Provide support for specialized research facilities, such as Current Good Manufacturing Practice (cGMP) production of clinical products and compounding facilities on campus; facility design and operations to meet regulatory requirements;

centralized resource for microbial decontamination; assist with FDA inspection of facilities; develop quality systems; conduct routine audits; develop SOPs.

5.7 TASK AREA 7 – Other Specialized Support Services

The Contractor shall provide other specialized support services that include, but are not limited to, the following:

• Bio-manufacturing support, such as growing vast quantities of human cells, including genetically engineered ones and those produced from stem cells; strands of genetic material that can be used to treat diseases; harmless viruses that are manipulated to carry genes into cells; and other biological molecules.

• Production of viral-based platforms for gene delivery, including lentiviral vectors and adeno-associated vectors (AAV), to design, clone and produce vectors suitable for in-vitro and in-vivo studies.

• Providing FDA approved and commercially manufactured drug products for use in clinical trials, to include, pharmaceutical compounding to fit unique patient needs and protocol requirements; preparation of individual unit (patient) doses; and performance of sterility and endotoxin testing of a finished product to ensure safety.

All such activities shall be performed in accordance with proper regulatory control and monitoring, including Current Good Manufacturing Practice (cGMP) requirements of the FDA.

• Development and manufacture of dosage forms of small molecule and other drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. Work shall be conducted in accordance with Current Good Manufacturing Practices (cGMP) regulations. Data and documentation shall be prepared in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA).

• Unless waived by the COR, the following conditions must be satisfied:

o Ensure a robust and comprehensive quality control, to include only using QA approved reagents; guarantee of purity and safety; development of batch production records; and performance of release testing.

o Produce material using SOPs compliant with U.S. FDA regulations and certification testing performance that meets current FDA requirements.

o Perform clinical research quality management activities, to include independent audits, to evaluate prospective outside vendors for approval as a qualified supplier for the NIH.

• At the direction of the COR, the Contractor shall perform other Task Orders directly relating to the scope of this requirement, but which might not be otherwise be specified in the previous Task Areas.

5.8 TASK AREA 8 – Transition Plan (Optional)

In the event the Government re-competes the requirements of this SOW, and prior to completion of the contract period of performance, the Contractor shall, at the Government’s option, provide the Government with a Transition Plan that shall ensure an orderly and successful transition of the remaining contract to a successor contractor should the incumbent Contractor not be selected during the re-competition. As part of the Transition Plan, the Contractor shall adequately train the successor contractor’s employees following any re-competition of the requirements specified in this SOW.

6.0 LABOR CATEGORIES

The labor categories required to successfully perform the work requirements under Task Orders issued under this SOW are specified in the attached Labor Categories - Descriptions.

The Contractor shall ensure the prime contractor and subcontractor personnel providing the labor hours possess the knowledge, skills, and ability necessary to address the applicable Revised 508 Standards defined in this SOW; and shall provide supporting documentation upon request.

Due to the broad range of NIH biomedical and clinical research activities in-process, planned and unanticipated, and new or re-emerging health threats and science advances; it is understood that additional labor categories may need to be incorporated into this SOW to accomplish the work requirements specified herein. Additional labor categories may be incorporated into this SOW at the direction of the Government or by suggestion from the Contractor. Any labor category added to this SOW shall be approved in advance by the COR and incorporated by modification into this SOW.

7.0 DELIVERABLES/DELIVERY SCHEDULE

The Contractor shall provide the following deliverables for review and acceptance by the

COR:

SOW

Provision

Deliverable Title

Deliverable Due Date

5.1 Contract Management Plan (written

draft)

Within 5 calendar days after award

5.1 Contract Management Plan (written

final)

Within 15 calendar days following receipt of comments from the COR

5.1 Monthly Activity Reports By the 10th calendar day of

each month

5.1 Financial Status Reports By the 10th calendar day of

each month

5.2 Deliverables specified in each Task

Order issued by the COR As required by the COR

5.3 Deliverables specified in each Task

Order issued by the COR As required by the COR

5.4 Deliverables specified in each Task

Order issued by the COR As required by the COR

5.5 Deliverables specified in each Task

Order issued by the COR As required by the COR

5,6 Deliverables specified in each Task Order issued by the COR As required by the COR

5.7 Deliverables specified in each Task

Order issued by the COR As required by the COR

5,8 Deliverables specified in each Task Order issued by the COR As required by the COR

5.8 Transition Plan (Optional)

Within 20 calendar days following instructions from the

COR

11.0 Continuity of Operations During a

Government Closure Plan

Within 20 calendar days following instructions from the

COR

Contract Articles

All other reports specified in the Contract Articles

As specified in the Contract Articles

All documents required herein shall be submitted in electronic format. In addition, one hardcopy of each document shall be submitted when directed by the COR.

Requirements for accessibility based on the Revised Section 508 Standards of the Rehabilitation Act of 1973 (29 U.S.C. 794d) are determined to be relevant under this SOW for the Section 508 Criteria specified in the attached Accessibility Requirements Tool (ART).

Before acceptance, when the Contractor is required to perform testing to validate conformance to the Revised Section 508 accessibility requirements as specified in a Task Order issued under this SOW, the Contractor shall provide a Supplemental Accessibility Conformance Report (SAR) that contains the following information:

• Accessibility test results based on the required test methods.

• Documentation of features provided to help achieve accessibility and usability for people with disabilities.

• Documentation of core functions that cannot be accessed by persons with disabilities.

• Documentation on how to configure and install the Information and Communication

Technology (ICT) item to support accessibility.

• When an ICT item is an authoring tool that generates content (including documents, reports, videos, multimedia productions, web content, etc.)., provide information on how the ICT item enables the creation of accessible electronic content that conforms to the Revised 508 Standards, including the range of accessible user interface elements the tool can create.

• Before final acceptance, the contractor shall provide a fully working demonstration of the completed ICT Item to demonstrate conformance to the agency's accessibility requirements.

The demonstration shall expose where such conformance is and is not achieved.

Before acceptance under a Task Order issued under this SOW, the Government reserves the right to perform independent testing to validate that the ICT solution provided by the Contractor conforms to the applicable Revised 508 Standards.

Before final acceptance of any ICT item, including updates and replacements, if the Contractor claims its products or services satisfy the applicable Revised 508 Standards specified in the SOW, and the Contracting Officer determines that any furnished ICT item is not in compliance with such requirements, the Contracting Officer will promptly inform the Contractor in writing of the noncompliance. The Contractor shall, at no cost to the agency, repair or replace the non-compliant products or services within the period specified by the Contracting Officer.

Electronic documents delivered must be made available in alternate formats when requested by the designated COR, including formats compatible with assistive technology, at no additional charge.

All paper/hardcopy documents (including reports) submitted under Task Orders issued under this SOW shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

At the request of the COR, the Contractor shall provide deliverables, including written reports, presentations to federal staff, and other materials, in draft form for Government review and comment and in final form, conforming to schedule, format, and other requirements as specified by the COR. In addition to monthly activity and financial status reports, deliverables may include project plans, management briefings, other financial reports, analyses, evaluations, reviews, and other reports as required. Additional reports may be requested by the COR at any time during the period of performance.

8.0 INDEFINITE-DELIVERY, INDEFINITE-QUANTITY (ESTIMATED, NOT TO EXCEED)

The Contractor shall provide the resources in the performance of this SOW as specified in the attached Labor Hours Table.

9.0 TIME AND ATTENDANCE POLICY

Each Contractor employee working under this SOW at a “Federally-controlled facility” shall comply with the following Time and Attendance procedures. [Reference: Definition of “Federally-controlled facility” at Federal Acquisition Regulation (FAR) Subpart 2.1, Definitions – http://www.arnet.gov/far/current/html/Subpart%202_1.html#wp1145507]

For purposes of this SOW, the term “Contractor employee” shall include any subcontractor employee.

The Contractor shall only invoice the Government for “Productive Direct Labor Hours” which are hereby defined as those hours directly expended by Contractor employees in performing work under this SOW.

Each Contractor employee, whether part-time or full-time, who is assigned to work under this SOW is required to establish a daily work schedule to be approved in advance by the Contractor’s Employee Project Manager, who will take into consideration the schedules of others on the project (especially the project leaders) when making the decision of whether or not to approve a particular schedule. Each full-time Contractor employee shall establish a daily work schedule which shall include the core hours of 9:30 am to 2:30 pm. Within the work hours, ½ hour is provided as a non-billable lunch break. Generally, a Contractor employee’s daily work schedule shall be the same set of hours each weekday. As appropriate, the Contractor’s Employee Project Manager may approve a work schedule for a Contractor employee that includes varying start and end times for different days of the week. A Contractor employee may charge more than 8 hours of work on any given day provided that special prior permission was received from the Contractor’s Employee Project Manager.

http://www.arnet.gov/far/current/html/Subpart%202_1.html#wp1145507

A Contractor employee shall give reasonable prior notice and obtain advance permission from the Contractor’s Employee Project Manager in order to be absent from his/her daily work schedule.

Government staff shall not participate in any time and attendance activities involving the Contractor employees assigned to work under this SOW.

Contractor employees assigned to work on a Government site shall not be scheduled to work when the Government offices are officially closed; e.g., Federal holidays, emergency closure, inclement weather. The following holidays are normally observed by the Federal Government: New Year’s Day, Martin Luther King’s Birthday, Presidential Inauguration Day (metropolitan DC area only), President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, Christmas Day, and any other day designated by Federal Statute, Executive Order, and/or Presidential Proclamation; or any other kind of administrative leave such as acts of God (i.e. hurricanes, snow storms, tornadoes, etc.), Presidential funerals, or any other unexpected Government closures.

The Contractor shall only invoice the Government for “productive direct labor hours” which are hereby defined as those hours directly expended by Contractor employees in performing work under this SOW.

10.0 TELEWORK

As directed by the COR or the Contractor’s Employee Project Manager, a Contractor employee with a Government-furnished (i.e., Government-issued) or approved laptop may be allowed and/or required to telework from home or some other alternate work location (including the Contractor’s facility) that is not a “Federally-controlled facility”

Each Contractor employee authorized to telework shall comply with all of the following conditions:

• Use either (1) only a Government-furnished laptop with all necessary software and hardware when teleworking from home or some other alternate work location, or (2) an approved computer by either the designated COR or the Contractor’s Employee Project Manager satisfying the most recent contract computer security requirements.

• Perform services under this SOW as a teleworker and understand that the teleworking arrangement is a work alternative that must be requested and approved by the designated COR and the Contractor’s Employee Project Manager prior to beginning a telework assignment.

• Retain the same duties, obligations, and responsibilities assigned under this SOW without change throughout the telework schedule.

• Maintain the teleworker’s work schedule and meet the terms agreed upon with the Contractor’s Employee Project Manager.

• Develop an effective communications strategy with the Contractor’s Employee Project Manager and work group, such that, for example, meetings can be attended using teleconferencing technology.

• Designate the Contractor employee’s home or some other alternate work location as the Contractor employee’s official telework location, subject to approval by the Contractor’s Employee Project Manager.

• Protect the Contractor employee’s approved telework location from hazards and danger that could affect the Government-furnished equipment and the teleworker.

• Acknowledge that teleworking is not an entitlement and may be terminated by the designated COR or the Contractor’s Employee Project Manager at any time.

• Restrict the use of any Government-furnished equipment, software, data, and supplies located at the Contractor employee’s approved telework location to the sole use of conducting Government business.

• Return any Government-furnished telework equipment, software, data, and supplies upon termination of the telework assignment or upon separation from this SOW for any reason.

• Immediately notify the Contractor’s Employee Project Manager of any equipment malfunction and the impact of the malfunction upon the teleworker’s ability to continue the telework assignment; and obtain instructions from the Contractor’s Employee Project Manager about working at another alternate work location.

• Be responsible for the maintenance and repair of all the teleworker’s personal property, and for maintaining appropriate insurance coverage against loss or theft for all Government-furnished equipment/supplies in the possession of the teleworker.

• Acknowledge that all work products, including documents, reports, and data created as a result of the teleworker’s work-related activities are owned by the Government and shall be properly secured and returned to the Government as instructed by the Contractor’s Employee Project Manager.

• Acknowledge receipt and compliance with the NIH Telework Policy (NIH Policy Manual Chapter 2300-600-1, http://www1.od.nih.gov/oma/manualchapters/person/2300-600- 1/).

• Acknowledge receipt and compliance with the NIH technology guidelines on use of Government-furnished equipment for telework assignments.

• Acknowledge receipt and compliance with NIH Information, Physical Access, and Personal Identity Information (PII) Security provisions applicable to the SOW.

• Acknowledge that the Contractor employee’s approved telework location is considered an extension of the Contractor’s worksite.

• Acknowledge that attending to personal comfort needs is not considered official duties.

• Report as soon as possible to the Contractor’s Employee Project Manager any job-related accident during the Contractor employee’s telework schedule. If injured in the course of performing official duties at the approved telework location during the approved telework schedule, the teleworker shall be governed by Workman’s Compensation through the Contractor.

During a period of Government closure, a Contractor employee with a Government approved secure laptop may telework from home or report an alternate work site (including the Contractor’s facility,) provided that approval has been received from the COR or the Contractor’s Employee Project Manager.

http://www1.od.nih.gov/oma/manualchapters/person/2300-600-1/ http://www1.od.nih.gov/oma/manualchapters/person/2300-600-1/

11.0 CONTINUITY OF OPERATIONS DURING A GOVERNMENT CLOSURE

The Contractor shall submit a plan entitled Continuity of Operations During a Government Closure to the COR for approval within 20 calendar days following an instruction from the COR to do so. The plan shall sufficiently specify what work tasks would be performed at non-Government location(s) (i.e., not a “Federally-controlled facility”) during a closure and which Contractor employees would be authorized to telework under the TELEWORK DURING A GOVERNMENT CLOSURE provision of this acquisition.

The Contractor shall implement its approved Continuity of Operations During a Government Closure plan when directed by the COR.

12.0 USE OF CONTRACT WORKERS TO SUPPOR SCIENTIFIE FUNCTIONS IN NIH

INTRAMURAL RESEARCH PROGRAMS

Work performed under this SOW directly supports the intramural research activities of the NIH IRP, and is therefore subject to the requirements set forth in the National Institutes of Health Policy for Use of Contract Workers to Support Scientific Functions in the Intramural Research Programs [see: http://www1.od.nih.gov/oir/sourcebook/irp-policy/contractproposal.htm]. Consistent with that Policy, the Contractor agrees to require its employees to assign to it their entire right, title and interest in all work made by its employees as a result of their assignments at NIH; furthermore the Contractor agrees to assign to the Government its entire right, title and interest in and to all work made by its employees as a result of their assignments at NIH (including, but not limited to, inventions, patent applications, patents, copyrights, and know-how). This shall be accomplished through the attached document entitled Assignment of Contractor Employee Work Products.

For purposes of work performed under this SOW, the FAR Clause 52.227-17, Rights in Data

– Special Works (December 2007) supersedes the FAR Clause 52.227- 14, Rights in Data – General (May 2014). The previously mentioned Assignment by the Contractor to the Government of its entire right, title and interest in and to all work made by its employees as a result of their assignments at NIH (including, but not limited to, inventions, patent applications, patents, copyrights, and know-how) shall take precedence over FAR Clause 52.227-17, should an inconsistency arise.

http://www1.od.nih.gov/oir/sourcebook/irp-policy/contractproposal.htm http://www1.od.nih.gov/oir/sourcebook/irp-policy/contractproposal.htm

13.0 SOW ATTACHMENTS

This SOW includes the following attachments:

• Labor Categories - Descriptions

• Labor Hours Tables

• Accessibility Requirements Tool (ART)

• Assignment of Contractor Employee Work Products