75N95020Q00151_SOW.pdf

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STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Reference clinical laboratory services for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study.

Statement of Need and Purpose:

The purpose of this requirement is to obtain reference clinical laboratory services as stated in the incumbent’s Directory of Services. The list of services may be modified. The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW).

Background Information and Objective:

The National Institute on Aging (NIA), one of the 27 Institutes and Centers of NIH, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The Intramural Research Program (IRP) of the National Institute on Aging (NIA) provides a stimulating setting for a comprehensive effort to understand aging through multidisciplinary investigator-initiated research, in this regard.

The Laboratory of Epidemiology and Population Sciences (LEPS), one of NIA IRP’s ten laboratories, plans, conducts, and directs epidemiology, demography, and biometry programs relevant to the mission of the NIA; collects and analyzes data regarding the distribution of the aged by such categories as sex, race, socioeconomic, and demographic characteristics and serves as a focal point for these data; and plans, initiates, coordinates, and analyzes national and international epidemiologic longitudinal studies and studies of special populations.

Within LEPS, the Health Disparities Research Section (HDRS) conducts interdisciplinary clinical and basic science research focused on examining the underlying cause of the disproportionate incidence, morbidity and mortality of age-related disease among minority and low socioeconomic status (SES) Americans. The approach provides a two-way bridge between basic science laboratory studies and clinical research that spans from the targeted epidemiologic population to the bench. Dissecting the interaction of race, socioeconomic status, culture, behavior, environmental exposure, biologic vulnerabilities, genetics, social environment, health care access, and quality of health care provides insight into how these interactions result in disproportionate rates of age-related disease and disability. The ultimate goal of this approach is to transform scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce incidence, morbidity, and mortality of age-associated diseases and health disparities. This is accomplished by the development and implementation of a clinical component (The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study) and a basic science laboratory component that are interdependent and pursuing related hypotheses.

HANDLS investigators conduct their research study on NIA’s mobile Medical Research Vehicles (MRVs) located throughout Baltimore City, MD. Participant samples and specimens are collected routinely during examinations performed daily. Additionally, and to avoid

ATTACHMENT – STATEMENT OF WORK, May 2020 Page 2 of 12 informative censoring (non-random missing data), NIA has also developed the HANDLS Home Visit Program (HHVP). This protocol is designed to allow participants who are home bound or disabled to continue to participate in the HANDLS study as scheduled. Providing an alternative to the examination visit on the MRVs allows NIA to continue to collect valuable data about the influences of race and socioeconomic status (SES) on the development of age-related health disparities and disability among socioeconomically diverse African Americans and whites in Baltimore.

Clinical lab testing and assay services are required for the participant visits at the MRVs as well as the HHVP. These assays are one basis for establishing participants’ health records. The data are used by investigators to assess change over time. These results are medico-legal documentation. They are retained in participants’ medical charts and participants are provided copies for their records and, if they choose, for their physicians’ records.

Period of Performance:

The period of performance is based upon the planned duration of the current Wave of the study, Wave 5. The base period of performance will be from July 1, 2020 through June 30, 2021, and three 12-month option periods.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the requirements below.

Specific Requirements:

The contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by the NIA HANDLS physicians. Services shall include the transportation of clinical laboratory specimens to the contractor’s laboratory(ies) (including providing the shipping/pickup containers), the performance of analytical testing as defined by the contractor’s reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility.

• Specimen Pick-up and Report Delivery: Laboratory will provide a reference specimen pick-up and report delivery service daily Monday-Saturday of each week except for holidays.

The specimens shall be picked-up between 1:00p-1:30pm daily and delivered to the contractor’s laboratory within 5 hours for processing. For the purposes of this SOW, holidays shall include: New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, and Christmas Day.

• Turnaround Time (TAT): Laboratory shall deliver or transmit results of a routine nature (general routine chemistries) to NIA within 24 hours from the time the specimen is received by the Laboratory’s testing facility. The Laboratory shall transmit or deliver results of tests performed on specimens of a special nature (special chemistries, tissues, etc.) to NIA within the times set forth in Laboratory’s then current turn-around-time schedule.

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• Specimen Collection and Handling Requirements – Price list must indicate whether test demographic information is available upon request in either hardcopy or electronic format, listing any e-mail addresses or web links necessary to obtain the Requirements.

• Sample Preparation: Each ordering activity will prepare (collect and handle) and package laboratory specimens in accordance with the requirements defined in the contractor's commercial specimen collection guide. The packaging and transportation procedures must be of a quality that ensures the integrity of the specimen throughout the shipment process.

• Supplies: Laboratory will provide, as part of its charges for the services, such items, devices or supplies that are used solely to collect, preserve, package, transport, process, or store specimens to be submitted to Laboratory for testing including, but not limited to:

o Forms o Specimen containers o Special media or culture tubes for samples o Specimen preservatives o Dry ice and appropriate container o Shipping and packaging containers o Specimen carriers o Labels and label printers as required by transportation guidelines o Centrifuge(s)

• Proper tracking of specimen: Tracking must be maintained from the initial pickup/shipping of the specimens from the ordering activity throughout the testing process at the contractor’s laboratory.

• Consultation: Laboratory staff shall be available to consult with NIA in person or by telephone during normal Laboratory working hours to discuss laboratory procedures and to provide the status of test results. The contractor shall provide telephone number(s) and contact personnel to be used by the ordering activity to address questions regarding their commercial services. The contractor shall include names and telephone numbers of technical directors and pathologists available for consultation.

• Testing: The testing methodology and reference ranges for a test must be defined in the laboratory user manual. The contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced no later than two weeks prior to test change implementation.

In the event that the contractor discontinues and/or substitutes a new test, the contractor shall notify the identified HANDLS stakeholders prior to the intended change.

Any changes to the tests may have a substantial impact on the program because study investigators make longitudinal comparisons which require stability in assay methods.

Consequrently changes may invalidate these assays for research purposes. Any such change may be sufficient cause for changing to an alternate contractor.

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All clinical reference laboratory testing shall be executed in accordance with standard industry practices. All test methods shall be FDA approved. Any non-FDA approved method being performed shall have a documented validation plan. Upon request the validation plan and validation results shall be made available. The contractor shall supply assay results comparable to assays results provided in HANDLS Wave 1, 3 & 4.

• Test Reporting:

o Participant formatted reports on website. The contractor shall provide access to a secure electronic health record website that provides formatted copies of laboratory reports including, but not limited to, test names, results, units, alert values, and reference ranges. Reports shall be available within 24 hours of specimen receipt. Contractor shall provide information on its website for partial or complete reports as assay results become available. Only final reports with all assay performed are considered completed deliverables. Any other reports are considered incomplete deliverables.

o Electronic results downloaded via HL7 protocol. The contractor shall provide the facility for downloading participant assay consistent with the HL7 protocol for laboratory information systems. The contractor shall provide access to their HL7 server and shall provide any necessary client software required for NIA to download and store these assay results in their database. The contractor shall provide all required hardware and software (including installation) and related consumable supplies to support the transmission of electronic data for each ordering activity at no additional charge. Any necessary “additional required connections” shall be the responsibility of the contractor. All equipment, software and hardware remain the property of the contractor.

• Critical Tests: The contractor shall immediately telephone the NIA physician or requesting Clinician to report Critical Value or test result that may indicate a life threatening condition.

Appropriate notification information will be provided at the time of award.

• Procedure Guidance: The contractor shall make available either through its electronic catalog or upon request the following information:

o Specimen collection and handling requirements o Test reference intervals adjusted for ages, sex, or race, when required o Test specific sensitivity, specificity, and interferences, when required o Result code (electronic transmissions only) o Test critical values, if any o Location of test performance by test name (i.e. name of primary laboratory, name of separate branch division of primary lab, name and address of secondary/subcontracted laboratory must be cited)

• Documentation: The contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and accuracy of all prepared and transcribed reports. The Contractor shall have a system in place to identify the personnel performing the test analysis.

• Retention of Specimens: Upon completion of the testing, the contractor shall retain all specimens as required by regulatory agencies.

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• Utilization Reports: The contractor, upon request, shall provide to each ordering activity at a minimum, the utilization reports customarily provided to commercial customers. The report shall at minimum identify the test code, test name, YTD volumes, unit cost, YTD expenditures, and turnaround times.

• Contract Quality Assurance/ Quality Control: The contractor facilities, test methodologies (defined as the principle of the method), validation studies, and quality control information may be examined by representatives of the Government at any time during the life of the contract. The contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required.

• HIPAA Compliance: Incumbent acknowledges it is a “covered entity” under the Health and

Portability and Accountability Act of 1996 (HIPAA) and agree to comply with the requirements thereof, as well as all other applicable laws and regulations pertaining to patient privacy.

• CLIA Compliance: The contractor must be licensed to perform laboratory testing under the Clinical Improvement Amendments (CLIA) of 1988, and perform testing in accordance with the CLIA regulations.

• Licensing and Accreditation: Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in the solicitation will be considered. The contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency with deemed status from the Centers for Medicare and Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as 02b - Statement of Work RFP-797-FSS-04- 0001-R23 mandated by federal and state statues. The Contractor must maintain valid certifications throughout the performance period of this contract.

The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award.

The contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, CLIA certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration. Immediate (within 24 hours) notification must be given to ordering activity upon adverse action by a regulatory agency.

• Malpractice Liability Insurance: Malpractice liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage of not less

ATTACHMENT – STATEMENT OF WORK, May 2020 Page 6 of 12 than $1,000,000.00 per occurrence. The contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract.

The contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension.

GOVERNMENT RESPONSIBILITIES

• NIA will grant the contractor access to the MRVs in Baltimore City, MD when specimens are picked up.

• NIA represents that it complies with all applicable federal, state, and local statues and regulations, government guidelines, any internal research policies (e.g. Institutional Review Board (IRB) or Privacy Board approval), and any consent, informed consent, or authorization requirements appropriate to the research effort its conducting relative to specimens tested under this Agreement.

DELIVERY OR DELIVERABLES

Description of Tasks and Associated Deliverables: Hard copies of test results are to be available from the electronic transfer within 24 hours from the time the specimen is received by the Laboratory’s testing facility (See above under “Contractor Requirements-Scope of Services”).

REPORTING REQUIREMENTS

See above guidelines under “Scope of Work, Specific Requirements”

OTHER CONSIDERATIONS

Travel:

Not Applicable Key Personnel:

Not Applicable

SECURITY REQUIREMENTS

Information System Security Plan:

ARTICLE H. NIH INFORMATION AND PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements

1. Applicability- The requirements herein apply whether the entire contract or order

(hereafter "contract"), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor)will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR)

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Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2. Safeguarding Information and Information Systems- In accordance with the Federal

Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality , which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity , which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability , which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov .

d. Comply with the Privacy Act requirements.

3. Information Security Categorization- In accordance with FIPS 199 and National

Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Contractor Non-Disclosure Agreement and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ X ] Low [ ] Moderate [ ] High Integrity: [ ] Low [ X ] Moderate [ ] High mailto:fisma@hhs.gov

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Availability: [ X ] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [ X ] Moderate [ ] High Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [X] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, "PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother's maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ ] Low [ ] Moderate [ X ] High

4. Controlled Unclassified Information (CUI)- CUI is defined as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323.

All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. Marked appropriately;

b. Disclosed to authorized personnel on a Need-To-Know basis;

c. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

5. Protection of Sensitive Information- For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

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6. Confidentiality and Nondisclosure of Information- Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non-Public Information - Contractor Employee Agreement" located at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

7. Internet Protocol Version 6 (IPv6)- All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

8. Government Websites- All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9. Contract Documentation- The Contractor shall use provided templates, policies, forms and other agency documents provided by the Contracting Officer and the Contracting Officer's Representative to comply with contract deliverables as appropriate.

10. Standard for Encryption- The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information

[PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf

ATTACHMENT – STATEMENT OF WORK, May 2020 Page 10 of 12 standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative within 15 days of the validation .

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

11. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

12. Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)- The Contractor shall assist the NIH Office of the Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed. The NIH PIA guide is located at https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide .pdf .

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the

OpDiv SOP or designee with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with HHS policy and OMB M-03- 22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

b. The Contractor shall assist the NIH Office of the SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

All contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation

(MBI).

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide.pdf

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[ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided, including clinical laboratory test results. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.”

FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

Not applicable

Publications and Publicity:

Not applicable

Confidentiality of Information:

See security plan above

Contracting Officer’s Representative:

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

Ms. Jennifer Norbeck HANDLS Clinical Study Manager NIH Biomedical Research Center 251 Bayview Blvd, Suite 100 Room 3A525 Baltimore, MD 21224 Email: norbeckje@grc.nia.nih.gov Phone: 410-558-8622

The COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

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The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract;

or (6) sign written licensing agreements.

The Government may unilaterally change the COR designation.