OER_SP_Support_PWS_Final.pdf

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Performance Work Statement (PWS)

Office of Extramural Research Scientific and Program Support Services

National Institutes of Health / Office of Extramural Research

December 7, 2018

1. Introduction

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), through this acquisition, intends to award a contract to procure a wide range of program support services for the Office of Extramural Research (OER) of the NIH.

2. Background

The NIH mission is to uncover new knowledge that shall lead to better health for everyone. NIH accomplishes that mission by: conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators;

and fostering communication of biomedical information.

OER supports the NIH extramural research by providing policy and guidance to the 24 NIH

Institutes and Centers (IC) that award grants. OER serves as a vital interface for the biomedical research community by guiding investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER’s mission is to provide the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio.

Through interactions with major stakeholders, OER supports the research enterprise by ensuring appropriate policies, procedures and systems for oversight are in place while, at the same time, considering the impact on our research partners. Our responsibilities span a wide breadth of support systems including developing policies and procedures and providing electronic systems for extramural staff and more than 100,000 investigators worldwide. For many of these activities we provide support to other agency partners as well.

3. OER Organizational Structure and Functions:

Immediate Office of the Director (IMOD): Acts on behalf of the NIH Director to provide guidance to the research institutes on the development and management of extramural (grant, cooperative agreement, and contract) research and training programs; advises the NIH Director and staff on issues relating to extramural research activities; and oversees the protection of human subjects and

2 | P a g e the proper care and use of laboratory animals on behalf of the entire U.S. Public Health Service.

Division of Communications and Outreach (DCO): Provides a coordinated effort to disseminate OER and NIH information to external and internal customers and to reach out to those same groups to assure OER is meeting their expectations and hearing their concerns; manages major OER communication and information dissemination activities including GrantsInfo Service desk, eRA activities and OER informational websites; coordinates internal OER communications to assure that requests for information and for work product are coordinated centrally; and tracks the status of projects ongoing in OER and, when necessary, to establish temporary teams of OER and NIH employees to address efforts in specified areas that need attention.

Division of Special Programs (DSP): Provides scientific program management and oversight of the Small Business Innovation Research (SBIR) program, the Small Business Technology Transfer (STTR) Program; documents and provides guidance regarding policy development and interpretation pertaining to these programs; coordinates SBIR/STTR eligibility reviews; provides training and technical assistance for SBIR/STTR, applicants and awardees; develops and implements extramural staff training and cross training to increase staff efficiency and effectiveness; and performs science program outreach and education.

Extramural Staff Training: Provides training for extramural staff who are responsible for the administration and oversight of NIH extramural grants, contracts, and cooperative agreements. The office advises on training activities for extramural staff with OER staff, NIH Institutes and Centers, and other NIH training offices and departments. In addition, the office develops learning opportunities and training programs designed to increase awareness and knowledge of NIH policies, procedures, and practices related to the administration of grants and contracts; reduce agency risk, build skills and competencies; and improve organizational effectiveness.

Division of Biomedical Research Workforce (DBRW): Provides ongoing analysis of the biomedical research workforce and evaluation of NIH policies to enable NIH to sustain and grow the biomedical research workforce at all levels to assure the most productive biomedical research endeavor and most effective use of taxpayer dollars; provides leadership and expertise on program and policy aspects of research training and research career development; oversees the implementation of and adherence to the NIH diversity policy for extramural programs.

Office of Extramural Programs (OEP): Advises the Deputy Director for Extramural Research, NIH, on matters pertaining to the development, implementation, promulgation, and management of policies and operations related to extramural research programs; provides leadership and expertise in science and special program management, including program and policy development, interpretation, coordination, oversight, evaluation, training and outreach, for the extramural research community and NIH extramural staff; conducts evaluations of programs, policies, and procedures; provides leadership and expertise on human subjects’ research issues; provides leadership in NIH Loan Repayment Program (LRP) management; implements NIH-wide service requirements and administers the National Research Service Awards (NRSA) Payback Service Center (PSC); represents the OER on numerous permanent and ad hoc NIH, Departmental, interagency, and non-governmental committees concerned with extramural program activities.

Division of Loan Repayment (DLR): Advises the Director, Office of Extramural Programs on matters pertaining to the development, implementation, promulgation, and management of the NIH extramural loan repayment programs (LRPs); handles the application process, participant

3 | P a g e servicing, and IT support activities for the Intramural LRPs; manages outreach and information dissemination activities; provides centralized system for online application and applicant databases; verifies basic eligibility (non-Scientific) and application completeness; manages LRP contracts counsels participants regarding their repayment schedule and participant obligations;

reconciles CANs by IC and LRP; obligates and manages funds with the IC Budget Offices; makes quarterly payments (approximately 12,000) directly to the loan servicers for each LRP awardee;

conducts evaluations of programs, policies, and procedures; and represents the OER on numerous permanent and ad hoc NIH, Departmental, interagency, and non-governmental committees concerned with extramural program activities.

NRSA PSC: Implements NIH-wide service agreements and administers payback requirements for National Research Service Awards.

Division of Human Subjects Research (DHSR): Provides leadership, expertise, coordination, and oversight for NIH policies related to the protection of human research participants in NIH supported grants and contracts, and extramural program management; develops and provides training for extramural staff and the public on research involving human subjects; coordinates the issuances of Certificates of Confidentiality for NIH and non-federally funded research; leads and coordinates the review of NIH grant appeals.

Office of Policy for Extramural Research Administration (OPERA): Assures effective grants administration policies and procedures for the NIH extramural programs and stewardship of Federal funds; maximizes research productivity, increases public accountability, enhances administrative integrity, and monitors fiscal stewardship in research administration systems; ensures proper management of extramural resources at both the portfolio level (allocation issues), program level (strategic planning), and project level (cost analysis); promotes the proper selection and effective use of assistance mechanisms by both NIH staff and the extramural community; initiates new procedures for research administration; provides assistance to NIH extramural staff and grantee organizations regarding policies and procedures pertinent to the administration of NIH grants; as well as providing central coordination and support for grants closeout and public access reporting compliance receives and maintains all documentation relating to extramural inventions made with assistance of research grants or research and development contracts from NIH; establishes and maintains communication between NIH and awardee and applicant institutions and investigators with respect to extramural policies and procedures; conducts studies, develops plans and manages projects that extend, improve and/or maintain system capabilities to satisfy the information requirements associated with NIH extramural research; reviews for OMB clearance all application forms, proposed surveys, and questionnaires for information gathering activities conducted under research contracts to meet the requirements of the Federal Paperwork Reduction Act; and participates in Departmental and Federal-wide efforts involving grant administration policies and procedures; coordinates NIH implementation;

provides extensive policy support to eRA to automate all grants management and policy processes across the NIH enterprise.

Division of Grants Policy (DGP): Initiates new and modifies existing NIH grants administration policies and procedures; provides assistance to NIH extramural staff and grantee organizations regarding policies and procedures pertinent to the administration of NIH grants to ensure stewardship of Federal funds; provides guidance to and articulates grants management policy for NIH extramural staff on the effective utilization of extramural assistance mechanisms (grants

4 | P a g e and cooperative agreements); reviews for OMB clearance all application forms, proposed surveys, and questionnaires for information gathering activities conducted under research contracts to meet the requirements of the Federal Paperwork Reduction Act; and develops the business process and functionality for pertinent Electronic Research Administration components.

Division of Extramural Inventions and Technology Resources (DEITR): Ensures proper and complete compliance with mandated patent policies and procedures; informs grantees, contractors, and NIH staff of their responsibilities through various policy and administration manual issuances, and instructions and commentary in the NIH Guide for Grants and Contracts;

receives and maintains all documentation relating to extramural inventions made with the assistance of research grants or research and development contracts from NIH; promotes the proper utilization of patents and inventions in extramural programs through guidance or referral on licensing agreements and distribution of shared resources; and develops the business process and functionality for progress reporting, abstracting, research resources and other pertinent Electronic Research Administration components.

Division of Grants Compliance and Oversight (DGCO): Advises the NIH Deputy Director for Extramural Research and the Director, OPERA, on the direction and management of extramural research compliance activities; develops and implements the NIH extramural research oversight program to promote grantee compliance with legislative and policy requirements; develops initiatives to encourage grantees to strengthen their stewardship of Federal funds and enhance local compliance oversight; manages internal control program to ensure that NIH grant awards are issued in compliance with applicable regulations and policies; develops, implements, and participates in educational, instructional, and outreach programs on grants compliance for grantees and NIH extramural staff; works closely with grantee institutions to address compliance issues and ensure that appropriate corrective actions are implemented; and provides guidance and consultation to grantees on and NIH extramural staff on a wide range of compliance issues.

Office of Research Information Systems (ORIS): Provides strategic, tactical oversight direction to OER, NIH, HHS and OMB; monitors all ORIS programs for cost, schedule and performance and demonstrates Earned Value Analysis; oversees ORIS internal and external communications and the coordination of internal websites; designs, develops, and maintains NIH-wide databases and enterprise applications to facilitate the reporting and analysis of information on NIH extramural programs for both internal NIH use by staff and public use; aggregates administrative records from NIH enterprise systems, integrates this information with data from other sources; provides the reporting and analysis tools to facilitate program management, portfolio analysis, decision-making, policy development, program evaluation, and public communication; automates the development of summary reports and provides search tools to facilitate access to information on NIH programs; develops, supports, and maintains scientifically defensible trans-NIH definitions; produces annual categorical spending data required by the National Institutes of Health Reform Act of 2006; prepares ad hoc reports that define NIH-funded projects within requested areas of science; ensures NIH transparency and accountability through data and reports to audiences within and beyond the NIH; provides data, analyses and reports to diverse stakeholder groups on NIH-supported research projects and scientific workforce to demonstrate NIH's great contributions to improving human health, and supporting a world-class, national biomedical research workforce;

ensures the quality and accuracy of NIH extramural data; and provides expert advice on minimizing data errors in IT systems.

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Division of Data Quality (DDQ): Performs data monitoring and data updating to ensure that data collected on NIH activities are accurate and reliable; executes software testing and monitoring services to ensure that the systems accessing NIH project data are operating as designed; supports grant-related activities and decision making within the NIH and other federal agencies; provides accountability and transparency of NIH and other federal agencies’ data to the public.

Division of Scientific Categorization and Analysis (DSCA): Develops, supports, and maintains scientifically defensible trans-NIH definitions; produces annual categorical spending data required by the National Institutes of Health Reform Act of 2006; prepares ad hoc reports that define NIH-funded projects within requested areas of science; ensures consistency and transparency of scientific NIH reporting.

Division of Statistical Analysis and Reporting (DSAR): Ensures NIH transparency and accountability through data and reports to audiences within and beyond the NIH; provides data, analyses and reports to diverse stakeholder groups on NIH-supported research projects and scientific workforce to demonstrate NIH's great contributions to improving human health, and supporting a world-class, national biomedical research workforce.

Division of Data Systems (DDS): Designs, develops, and maintains NIH-wide databases and enterprise applications to facilitate the reporting and analysis of information on NIH extramural programs for both internal NIH use by staff and public use; aggregates administrative records from NIH enterprise systems, integrates this information with data from other sources. and provide the reporting and analysis tools to facilitate program management, portfolio analysis, decision-making, policy development, program evaluation, and public communication; automates the development of summary reports and provides search tools to facilitate access to information on NIH programs; and

(4) coordinates with other federal agencies and non-federal funders of biomedical research to develop trans-agency and international reporting and analysis systems.

Office of Laboratory Animal Welfare (OLAW): Develops and monitors, as well as exercises compliance oversight relative to PHS policy on Humane Care and Use of Laboratory Animals involved in research conducted or supported by any component of the Public Health Service; coordinates appropriate PHS regulations, policies, and procedures both within PHS and in coordination with other Departments and Agencies in the Federal Government; and establishes criteria for and negotiation of Assurances of Compliance with institutions engaged in PHS-conducted or supported research using animals; conducts programs of clarification and guidance for both the Federal and non-Federal sectors with respect to the use of animals in research; and directs the development and implementation of educational and instructional programs and generating educational resource materials; evaluates the effectiveness of PHS policies and programs for the humane care and use of laboratory animals; and serves as liaison to Presidential, Departmental, Congressional, interagency, and non-governmental Commissions and Boards established to examine issues pertaining to laboratory animal welfare in research and exercises leadership in identifying and addressing such issues.

Division of Assurances: Negotiates animal welfare Assurances of Compliance with research entities;

provides liaison, guidance, and PHS policy interpretation to research entities, investigators, Federal officials and the public; maintains existing animal welfare assurance mechanisms; and develops and implements new procedures to ensure that the PHS policy is appropriately and effectively implemented to meet the changing needs of the biomedical research community.

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Division of Compliance Oversight: Conducts inquiries and investigations into alleged noncompliance with PHS animal welfare policy; prepares inquiry and investigative reports;

recommends remedial or corrective actions necessary to agency or PHS officials as appropriate; and conducts a program of oversight of awardee institution implementation of PHS animal welfare policy.

Division of Policy and Education: Develops policy clarification and guidance, coordinates development of such clarification and guidance with other agencies based on MOUs, and disseminates this information to the research community; produces and coordinates conferences focusing on animal welfare issues in PHS-funded research; promotes cooperative education and development efforts with external groups to increase training opportunities for IACUCs, research administrators, investigators, veterinarians, and other involved in research with animals; develops and implements training programs for NIH grants managements, review and program staff develops, maintains, updates and distributes educational resources; and provides assistance and guidance to institutions engaged in PHS-supported activities involving animals.

Office of Administrative Operations (OAO): Directs, coordinates, and conducts administrative management activities of the OER by providing assistance in the areas of financial management, procurement, quality assurance, and management and program analysis; advises the Deputy Director for Extramural Research on developments in administrative management and their implications and effects on program management; develops policies on administrative management and prepares and issues procedures and guidelines for implementation of administrative policies, delegations, and requirements; formulates and executes action plans in response to business and management problems or initiatives, directives, regulations, legislation or anything else that might require administrative action or have administrative implications.

Division of Administrative Services (DAS): Plans and directs administrative management functions of the Office of Administrative Operations including general administrative support, procurement, property management, office services, travel, facility management, and data calls relating to the Offices' administrative activities; advises the Deputy Director for Extramural Research and senior staff on the administrative management of OER and its offices; and develops and promulgates policies, guidelines, and procedures on matters relating to the administrative management of OER.

Division of Financial Analysis and Oversight (DFAO): Performs financial management in accordance with NIH and OD guidance and any applicable rules and regulations; formulates cost projections for all funding sources and aspects of the budget including contracts; develops detailed financial analyses and reports for OER senior management and OD; and provides administrative oversight of OER contracts.

Division of Workforce Management (DWM): Acts as liaison between OER offices and the Office of Human Resources and OD for all issues, concerns, and data calls related to OER employees and recruitment; conducts workforce analysis and succession planning; coordinates performance plans and awards and ensures compliance with rules and regulations; develops and coordinates position description development and organizational changes; and supports the Extramural Title 42(f) Committee led by the Principal Deputy Director and Deputy Director of Extramural Research by handling all communications and requests from ICs, advising on policy, and managing the data repository.

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Office of electronic Research Administration (OeRA) - Provides strategic, tactical and oversight direction for the NIH extramural systems ensuring alignment to OER, NIH, HHS and OMB; provides solutions to manage the receipt, processing, review, award reporting and monitoring of funding for research and non-research grants awarded annually by NIH and other grantor agencies in support of the collective mission of improving human health; designs, develops, maintains, updates, and supports NIH's customized enterprise-wide grants management system used by the grantee community and federal staff to apply for, evaluate, award, manage and track, and close out grants for NIH as well as for other federal partners; serves as HHS Grants Management Center of Excellence providing services for multiple HHS Operational Divisions (OpDivs) and other federal agencies;

ensures strong system and data security; provides a dependable, scalable and responsive system using sound management and secure controls; promotes effective and efficient end-to-end grants management while reducing the administrative burden on the user community as well as agency staff; oversees eRA internal and external communications and the coordination of internal websites; provides technical and analytic leadership for reengineering the end-to-end activities of NIH extramural grants programs; provides support and training to staff who use central information systems to transact extramural business.

Division of Information Technology (DIT): Interprets policies, defines objectives and sets customer-driven performance standards for system implementations; provides technical oversight of day-to-day operations and coordination of activities with other areas; plans, designs, develops, and maintains overall software architecture for NIH's eRA system initiatives, specifically IMPAC II and the Commons; analyzes the compatibility of the eRA architectures with other architectures in NIH and coordinates with technical staff in other technical groups to work toward assuring NIH hardware, network, and software infrastructures are synchronized; defines major software issues and provides direction and oversight in those areas; and develops strategies for implementation of high priority initiatives designed to improve program performance; and provides technical expertise and guidance in the investigation, testing and adoption of new technologies to enhance system performance and the user experience.

Division of Customer Support Services (DCSS): Directs the development of technology strategies for communication with customers and their requirements; distributes proactive notification to customers and prepares business cases and feasibility studies to foster a commitment to a team approach to work; applies state-of-the-art technologies to generate new ideas and solve problems;

serves as the principal point of contact with stakeholders to provide technical program support for projects; develops business process modeling and maintains the business architecture layer of the eRA Enterprise; and manages functional requirements using customer-focused prioritization and identifies inconsistencies, redundant and duplicate requirements.

Division of Technical and Strategic Coordination (DTSC): Develops the eRA Strategic Plan; sets business management policies; conducts complex management studies and reviews of the fiscal controls of IT services; develops IT management plans for projects, including milestones and standards for performance measurement; directs and is responsible for risk management assessments and directs improvements in the software development life cycle including enterprise quality assurance; provides strategic program planning for projects while ensuring appropriate focus on IT management practices; responsible for overall quality of eRA systems and services, and maintains metrics on eRA system and program performance; serves as the principal point of contact with stakeholders to provide technical support for use of the systems.

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4. Definitions

Contracting Officer (CO): The person authorized to act on behalf of the Government to negotiate and award contracts and modifications thereto, and to administer contracts through completion or termination. Except for certain limited authority delegated by the CO to a technical representative, the CO is the only individual with the authority to direct the work of the Contractor.

Contracting Officer Representative (COR): The authorized Government representative(s) acting within the limits of written delegated authority for management of specific projects or functional activities. Copies of COR delegations shall be provided to the Contractor.

Defective Service: A service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable: Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Physical Security: Actions that prevent the loss or damage of Government property.

Quality Assurance (QA): Those actions taken by the Government to assure services meet the requirements of the PWS.

Quality Control Plan: An organized written document provided by the Contractor to ensure the requirements of this contract are provided as specified.

Quality Assurance Surveillance Plan (QASP): An organized written document provided by the Government specifying the surveillance methodology to be used for surveillance of contractor performance.

Quality Control (QC): Those actions taken by the Contractor to control the performance of services so that they meet the requirements of this contract.

Subcontractor: One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

Technical Monitor (TM): The authorized Government representative(s) who shall examine the Contractor’s services and determine whether they are accomplishing program objectives; prepare and present correspondence and/or reports on Contractor performance to the COR; make recommendations to the COR as needed.

Work Day: The number of hours per day the Contractor provides services in accordance with the contract.

Work Week: Monday through Friday, unless specified otherwise.

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5. General Requirements

This is a non-personal services contract to provide to provide scientific and program support services to the OER organization to include professional, scientific, analytical, consultative, and subject matter expertise. The Government shall not exercise any supervisory control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

Nonpersonal Services and Inherently Governmental Functions:

a. Pursuant to FAR 37.1, no personal services shall be performed under this contract. A personal services contract is defined as a contract that makes the Contractor personnel appear to be, in effect, government employees. Government agencies may not award personal services contracts unless authorized by statute to do so. No Contractor employee will be directly supervised by the Government. All individual Contractor employee assignments, and daily work direction, shall be given by the applicable Contractor employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

b. Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract / task order, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work.

In all communications with other Government Contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the Contractor believes this communication to be a direction to change their contract/task order, they should notify the Contracting Officer for that contract/task order and not carry out the direction until a clarification has been issued by the Contracting Officer.

c. The Contractor shall ensure that all its employees working on this contract / task order are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

Organizational Conflict of Interest: The Contractor acknowledges that it is familiar with FAR Subpart 9.5, Organizational and Consultant Conflicts of Interest, and agrees to avoid, neutralize or mitigate such conflicts of interest in accordance with the principles set forth in the FAR. If the performance requires the Contractor (to include subcontractors) to supply technical support related to systems or projects with which the Contractor is already directly concerned, either by prime or subcontract, the Contractor shall immediately inform the Contracting Officer. The PWS may be withdrawn if a conflict is found. The Contractor shall not undertake performance of any PWS requirements which requires it to supply technical support regarding such systems until the notice is given, and written consent to proceed is issued by the Contracting Officer.

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It is imperative that the Contractor be proactive in order to avoid organizational conflicts of interest.

The Contractor shall take all reasonable measures to assure that organizational conflicts of interest do not occur. As part of the Contractor's efforts to avoid organizational conflict of interest situations, the Contractor shall inform the Government of any actual, potential, or apparent conflicts of interest. The Contractor is responsible for providing a detailed written report of actual, potential, or apparent organizational conflicts of interest to the Contracting Officer as soon as the circumstance is known, describing the conflict and how the Contractor plans to resolve the problem.

Subcontracts: The Contractor shall include an article, substantially similar to this article, in subcontracts involving the performance of advisory and assistance services as that term is defined at FAR 37.201. The terms "contract," "contractor," and "contracting officer" shall be appropriately modified to preserve the Government's rights.

Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

Key Control: The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the Contracting Officer.

The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

Government Furnished Equipment (GFE) / Government Furnished Information (GFI):

The Government shall provide the Contractor with IT equipment, software, and access to information required to successfully perform the work requirements.

All Government-furnished property and Contractor-acquired Property shall be subject to the following Federal Acquisition Regulation (FAR) clauses, as applicable:

• FAR 52.245-1, Government Property (JAN 2017); with Alternate I (APR 2012)

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Government property provided under this clause shall include any items acquired by the Contractor or furnished by the Government under this contract which are subject to being inventoried in the NIH Property Management System.

(End of clause)

• FAR 52.245-9, Use and Charges (APR 2012)

In addition to the requirements of the FAR clauses above, the Contractor shall comply with the provisions of HHS Publication entitled HHS Contracting Guide for Contract of Government Property which is incorporated into this contract by reference. This document can be accessed at:

http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf This publication provides a summary of the Contractor's responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract. A copy of this publication is available upon request from the Contracting Officer.

The Government will provide the Contractor with appropriate access to all information required to successfully perform the work requirements specified in this PWS. The Government will allow the Contractor's employees free access to the premises and facilities at all reasonable hours within prescribed NIH Security procedures and guidelines.

Personnel: Contractor shall provide a mix of personnel experienced and qualified to perform the required tasks under the direction of the contractor’s Program Manager in consultation with the Contracting Officer’s Representative (COR) and Technical Monitor(s) (TM). Contractor personnel shall be capable of providing services as outlined in this PWS. Contractor personnel shall possess the experience, knowledge, and skills to successfully perform each function that is identified.

The Contractor shall be responsible for providing trained, experienced staff for performing the work ordered under this contract, and for continuously monitoring, managing and controlling the work.

The Contractor shall make its best efforts to retain staff members who have gained experience on this contract, and to minimize staff turnover.

The Contractor shall train its own staff to ensure that all personnel are able to perform their duties under each task satisfactorily. This may require staff training in the specific technology area. The Contractor will furnish the COR with formal documentation of the training provided to each labor category under the contract as requested by the COR, including testing tools for determining if individual employees have achieved competence in their labor categories. Except where specifically approved by the COR, training of Contractor staff is not separately billable. Specialized training requested by the COR beyond that which would normally be required to perform under the contract may be billable with advance approval by the COR.

In addition to job-specific or professional training, the Contractor shall ensure its employees on this contract are trained on "contract-specific" issues such as HHS ethics, standards of conduct, individual conflicts of interest, confidentiality requirements, HHS security requirements, the function of reporting, and the importance of quality control and quality assurance. In addition, Contractor managers shall be educated regarding the terms and conditions of the contract.

The Government reserves the right to verify resumes of staff proposed to support the contract to verify they have the skills, experience, and knowledge required for their proposed labor category.

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All Contractor staff that have access to and use of NIH electronic mail (e-mail) must identify themselves as contractors on all outgoing e-mail messages, including those that are sent in reply or are forwarded to another user. To best comply with this requirement, the Contractor staff shall set up an e-mail signature (“AutoSignature”) or an electronic business card (“V-card”) on each contractor employee’s computer system and/or Personal Digital Assistant (PDA) that will automatically display “Contractor” in the signature area of all e-mails sent.

Program Management: The Contractor shall provide program management, project control, and contract administration necessary to manage the contract process so that cost, schedule and quality requirements are tracked, communicated to the COR and TM. The TMs are government staff assigned to specific program areas. The Contractor shall establish and maintain program management practices throughout the period of performance. The Government will have visibility into the Contractor’s organization and techniques used in managing the program.

Key Personnel: Key Personnel must be an employee of the prime Contractor. Subcontractor employees shall not be proposed as Key Personnel. Key personnel shall not be substituted by the Contractor during the execution of this contract without prior permission from the COR. The Government reserves the right to verify the qualifications of all staff proposed and to approve assignment of proposed Key personnel.

The Government reserves the right to require the Contractor to remove or reassign from this Contract any “Key Personnel” Contractor employee(s) who is/are deemed incompetent, careless, unsuitable, or whose continued employment under the contract is deemed contrary to the best interests of the Government. Failure of “Key Personnel” Contractor employee(s) to comply with the Government’s standards of conduct may also be grounds for the Government or the client agency (thru the Government) to require corrective action by the contractor to include possible removal or reassignment of offending Contractor employee(s).

The Contractor shall propose Key personnel. Key personnel shall only be substituted by the Contractor during the course of the execution of this contract in accordance with the Key Personnel clause which requires concurrence from the COR. The Government reserves the right to review and verify the individuals proposed for Key personnel positions.

Supervision of Contractor Employees: The Contractor shall provide sufficient day-to-day Contractor supervision of each employee to ensure successful performance. Each employee shall be aware of his/her contract Supervisor. At no time shall Contractor personnel be supervised by any Government employee. The Contractor shall submit a Supervisory Plan with their proposal with an update thirty (30) days after contract award and as necessary based on staffing levels for approved positions.

The Contractor is solely responsible for hiring, selecting/non-selecting, upgrading/promoting, work assignment, work related awards or discipline, approving work schedules/absences, labor-management issues, career planning, or compensation for all employees working or with potential to work under this PWS. Any suspected or actual incident of an OER personnel being involved in these processes must be reported to the Contracting Officer.

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Confirmation of Credentials The Government may confirm the credentials of any proposed contractor or subcontractor employee before allowing access to the systems. The proposed employee must be able to demonstrate the expertise specified in the assigned labor category.

Changes to Staffing Levels: The Government may at any time request the Contractor to either increase or decrease the numbers of assigned Contractor employees in any particular contract labor category, or assigned to the contract as a whole due to changes in schedule or workload. The Contractor shall obtain prior approval from the COR before onboarding to fill vacant positions.

Use of Federal Employees: The Contractor shall not employ any person who is an employee of the United States Government.

Quality Control Plan: The Contractor shall establish and maintain a Quality Control Plan to ensure the requirements of this contract are provided as specified. The Contractor shall provide a Quality Control Plan describing the inspection system for the requested services listed in the PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The written Quality Control Plan shall be required when proposals are submitted. The CO will notify the Contractor of acceptance or required modifications to the Plan.

The Contractor shall make appropriate modifications (at no additional cost to the Government) and obtain acceptance of the Plan by the CO before the start of the performance period. The Plan shall be updated as changes occur and shall be submitted for review and acceptance by the Government.

Quality Assurance: The Government will monitor and evaluate the Contractor’s performance under this contract. (attached Quality Assurance Surveillance Plan) When poor or defective performance is observed, the COR will notify the CO and the Contractor. Any action taken by the CO as a result of surveillance will be according to the terms of this contract. Any matter concerning a change to the scope, prices, terms or conditions of this contract shall be referred to the CO. The services to be performed by the Contractor during the period of this contract will at all times and places be subject to review by the CO or authorized representative(s). Other Government personnel may from time-to-time observe Contractor operations. These personnel will not interfere with Contractor performance.

Collaboration: It is expected that all Contractor staff that work under this PWS shall work collaboratively with designated federal staff and other contractors. This collaboration includes day-to-day activities, planning, development, knowledge transfer and creating and sharing documentation.

Performance Evaluation Meetings: The Contractor shall be required to meet with the COR and the CO during the performance of this contract. Quarterly meetings shall be scheduled, or as often as necessary as determined by the COR and the CO, to discuss performance. An evaluation survey shall be provided to the Contractor on a monthly basis. Written minutes may be taken by the Government and signed by the COR, CO; if written minutes are taken and the Contractor non-concurs with the minutes, they shall so state any areas of non-concurrence in writing to the CO within 10 calendar days of receipt of the signed minutes. The minutes shall be included in the contract file.

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Travel: Travel may be required of the Contractor under this contract. Any and all travel shall be coordinated and approved by the COR and the CO and performed in accordance with GSA Federal Travel Regulations and applicable contract clauses. Itineraries and estimated costs are required and submitted to the COR for approval prior to travel. Reimbursement for travel shall not exceed the rates and expense types allowed by the GSA Travel Regulations to a government employee traveling under similar circumstances. Work-time in travel status—In keeping with Department of Labor regulations [39 CFR 785.39] “will consider as work-time that time spent in travel away from home outside of regular working hours (Monday through Friday 0600-1800), as a passenger on an airplane, train, boat, bus or automobile” under this PWS. Approved travel shall be invoiced as Other Direct Costs (ODC).

Physical Security: Most work shall be performed within secure Government facilities. Contract employees shall be issued Government Personal Identity Verification (PIV) cards. The Contractor shall be responsible for safeguarding all Government property provided for Contractor use or under Contractor control. Whenever a work area is to be unattended for a period of time, Government facilities, equipment, and materials shall be secured.

Government property totally under the Contractor’s control (in-possession, in-travel, etc.) will be totally the Contractor’s responsibility. The Contractor shall establish and implement methods of ensuring that all Government property issued to the Contractor by the Government are not lost or misplaced and not used by unauthorized persons.

Security and Privacy Requirements: The Contractor shall comply with all HHS and NIH security and privacy protection requirements.

Hours of Operations: During all applicable Periods of Performance, the Contractor shall provide services Monday through Friday, during the operating hours of 0600-1800. The Contractor shall observe the same Federal holidays and mandatory time-off periods as the NIH Government Personnel. Organizational hours of support may change over the course of the contract and the Contractor shall support this dynamic environment.

The Contractor shall support PWS requirements upon directive by the Government. In doing so, this may include work to be performed weekends and evenings in order to accommodate “scheduled” activities of the Government. The Contractor shall provide for work performed over and above the normal hours of operation, as required and authorized by the COR and CO to cover unforeseen workload increases or unanticipated workload surges. Contractor employees may be authorized to makeup missed work hours at the discretion of the Government with COR and CO approval.

Observance of Legal Holidays and Facility Closures: Contractor shall normally not be required or allowed to work when their assigned facility is on holiday or closed. During such periods, the Contractor shall not be compensated for labor hours without 1) advanced direction by the CO or COR or 2) the work being a response to a Government emergency.

Following is a list of U.S. Federal holidays and reasons for facility closures:

a. New Year’s Day, January 1

b. Martin Luther King’s birthday, the third Monday in January

c. President’s Day, the last Monday in February

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d. Memorial Day, the last Monday in May

e. Independence Day, July 4

f. Labor Day, the first Monday in September

g. Columbus Day, the second Monday in October

h. Veteran’s Day, November 11

i. Thanksgiving Day, the fourth Thursday in November

j. Christmas Day, December 25

k. Any other day/time designated by Federal statute, executive order, or Presidential Proclamation

l. Adverse weather conditions or national emergencies may require the Government facility to close

Standard Work Week for Individual Contractors: Each Contractor support staff shall be expected to work a standard (40) forty-hour work week outside of Federal Legal Holidays, facility closure or approved personal time off, unless otherwise directed either by the Government or Contractor.

Over and Above the Standard Work Week for Individual Contractors: Either directed by the Government or requested by the Contractor, over and above a (40) forty-hour work week may be necessary on occasion for an individual. These types of requests shall be made to the CO and COR only when absolutely necessary to meet work requirements, not as a result of a failure to meet schedules or availability of Contractor personnel.