N6264518R0008_NSMRL_Solicitation.pdf

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until 10:00 AM local time 05 Feb 2018

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72 - 83 X H 84 - 90 jennifer.m.reed20.civ@mail.mil

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 90

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

N62645 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and 0 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and

No Hand Carry/ See Section L conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

JENNIFER M. REED 301-619-1200

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 3

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

4 - 14 J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 17 - 19 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 20 - 37 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIONS AND INSTRUCTIONS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

38 - 48

PART II - CONTRACT CLAUSES

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

(301) 619-9180

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

49 - 63

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

05 Jan 2018

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

N6264518R0008

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Lot NSMRL R&D Support Services IDIQ

CPFF

Base Period - NSMRL R&D Support Services

This contract is for non personal services.

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

0002 1 Lot OPTION NSMRL R&D Support Services IDIQ

CPFF

Option Period 1- NSMRL R&D Support Services

0003 1 Lot OPTION NSMRL R&D Support Services IDIQ

CPFF

Option Period 2- NSMRL R&D Support Services

0004 1 Lot OPTION NSMRL R&D Support Services IDIQ

CPFF

Option Period 3- NSMRL R&D Support Services

0005 1 Lot OPTION NSMRL R&D Support Services IDIQ

CPFF

Option Period 4- NSMRL R&D Support Services

Section C - Descriptions and Specifications

PWS

PERFORMANCE WORK STATEMENT (PWS)

NAVAL SUBMARINE MEDICAL RESEARCH LABORATORY

R&D SUPPORT SERVICES

1. BACKGROUND

1.1. The Naval Submarine Medical Research Laboratory (NSMRL) is a Navy Medicine Research and Development Command charged with providing innovative human-centric research solutions, aligned with the Submarine Force strategic direction, to sustain superiority in the undersea domain. The Navy’s unique human performance research area is Undersea Medicine, A National Naval Responsibility. NSMRL is the only Department of Defense laboratory dedicated to research in Submarine Medicine.

2. SCOPE OF WORK

2.1. The purpose of this contract is to provide support to Naval Submarine Medical Research Laboratory (NSMRL) research and development (R&D) investigations of medical, psychological, physiological, and other issues associated with the health and performance of Naval personnel in operational and non-operational settings. Research and testing conducted under this contract will be broad in scope, and encompass a wide range of disciplines, covering all aspects of Submariner Wellness, Submariner Psychological Factors, Shipboard and Diving Force Health Protection, Human Factors, and Undersea Warfighter Health and Performance. This includes Submarine Medicine, Operational and Ship Safety, Hearing Conservation and Force Health Protection, Underwater Bio-Effects, Epidemiological Studies, Informational Display and Processing, Submarine Escape and Rescue, Submarine Atmosphere Health Assessment, Physiology, Psychological Selection and Resilience, and other Biomedical Research. The Government shall augment (within scope) the technical requirements of the PWS through the issuance of task orders.

3. CONTRACT REQUIREMENTS

3.1. Assumptions and Constraints

3.1.1. The expectation is that the task orders issued under this base IDIQ contract will be incrementally-funded Cost Plus Fixed-Fee (CPFF) task orders because the services are directed toward objectives for which the work cannot be precisely described in advance. A CPFF arrangement addresses research and development because of the unpredictability of the level of support.

3.1.2. The Offeror shall already be approved for performance on a Cost-Plus-Fixed-Fee contract and a security clearance level of Top Secret/ Sensitive Compartmented Information (TS/SCI).

3.1.3. This effort is not considered a new requirement (legacy contract N62645-17-C-4023) and therefore the right of first refusal concerning incumbent employees with the successful offeror is relevant.

3.1.4 Human use research is expected under the task orders that will be issued under this base IDIQ contract.

Research with human subjects may not begin until the contractor (and all subcontractors) obtains a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A Human Research Protection Officer (HRPO) review must be in place before any human use research can be supported.

3.1.5. Travel is expected in support of the research efforts at NSMRL. Travel approval must be processed in accordance with NSMRL procedures, in accordance with Joint Travel Regulations, documented and submitted with the Quarterly Status Report, and correlated with a corresponding line item in the invoice for payment. The number of Contractor personnel required will be determined at the discretion of COR. All travel must be approved by the COR in writing via e-mail prior to incurring costs.

An estimated travel amount will be delineated at the task order level. The estimated travel amount (provided at the task order level) is an estimated amount and is before contractor burdens. Contractor burdens must be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

3.1.6. Other Direct Costs (ODC) are expected in support of the research efforts at NSMRL. All ODC costs must be approved by the COR in writing via e-mail prior to incurring costs.

An estimated ODC amount will be delineated at the task order level. The estimated ODC amount (provided at the task order level) is an estimated amount and is before contractor burdens. Contractor burdens must be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

3.1.7. Task orders issued under this base IDIQ contract require indemnification and medical liability insurance. The Federal Tort Claims act does not apply.

3.1.8. All services provided under this base IDIQ contract are non- personal in nature and are considered severable.

3.1.9. There are no known Organizational Conflicts of Interest (OCI) within this effort.

4. TECHNICAL REQUIREMENTS

4.1. For Warfighter Capabilities

4.1.1. The contractor shall support research studies and analyses to determine the biomedical and cognitive response of humans to stressors identified in the special warfare, surface, undersea, diving, and submarine environments. The contractor shall provide services in support of the design, development, testing and evaluation of procedures, guidance, equipment, and systems to enhance human performance in these environments. R&D areas will include submariner cognitive performance and psychological selection, resilience and attrition, submariner work, rest, and watch-standing schedules, attentional and perceptual processes as they relate to submariners’ performance, recognition of constituents of breathing gas, accelerated decompression states associated with hypo- and hyperbaric exposure, methods to preserve and enhance individual physical and cognitive performance in temperature, pressure, and fatigue extremes. The contractor shall also support epidemiological studies to determine how the health and rate of illness and death of the submariner population differs from that of the non-submariner naval population. Some aspects will require personnel with security clearance of TS/SCI.

4.1.2. The contractor shall support research to develop guidelines for underwater noise/blast exposure, measurement techniques to assess noise hazards, epidemiological studies of diver hearing, evaluation of underwater auditory capabilities and whole-body sound exposure, to include effects on cardiopulmonary function, on central nervous system, vestibular function and other medical hazards as identified. The contractor shall provide technical support of the accumulation and analysis of data on noise/blast exposed subjects to determine the physiological response of human and non-human organisms, including, but not limited to, the amount of auditory threshold shift and psychological stress due to noise. The contractor shall support investigation of means for prevention or mitigation of diving-related stressors and injuries.

4.1.3. The contractor shall also support new initiatives in the area of Undersea Warfighter Capabilities, including, but not limited to, development of hyperbaric fMRI devices, devices for sound source localization using Ultra High Frequency (UHF) characteristics.

4.2. For Shipboard Health Protection and Submariner Wellness

4.2.1. The contractor shall support research to determine and monitor the composition of the atmosphere of operational U.S. Navy nuclear submarines. The contractor shall support studies and research on problems associated with a disabled submarine (DISSUB), including the assessment of procedures and strategies. The studies shall evaluate new biomedical technologies and search and rescue devices to enhance Navy operational decisions and capability in disabled submarine survival, escape and rescue, and thermal protection and regulation in cold and warm water.

4.2.2. The contractor shall also perform work in support of epidemiologic studies examining whether any health outcomes are associated with submarine or diving service, including, but not limited to, supporting the creation and maintenance of a relational database for use in epidemiologic research.

4.2.3. The contractor shall support research to determine whether otoacoustic emissions: 1) can be used to predict and accurately measure changes in behavioral auditory thresholds; 2) are a more sensitive measure of auditory damage from noise exposure than current pure-tone audiograms; 3) can predict an individual's susceptibility to hearing loss; 4) and to determine which aspects of Evoked Oto-Acoustic Emissions (EOAEs) are related to threshold and supra-threshold auditory abilities in noise-exposed ears. The contractor shall support studies on the application of database analyses to audiograms from hearing conservation programs including software development, and value-added implementation of the necessary hardware in addition to statistical analyses using the database.

4.2.4. The contractor shall support hearing conservation research studies to evaluate the effectiveness of hearing protection for reducing noise-induced hearing loss (NIHL); examine the life cycle costs of hearing loss to the US Navy; develop, build, and test hearing-loss simulation as a means of training active-duty military members on the effects and impact of hearing loss, and good hearing conservation practices. This research may include providing active support to hearing conservation programs and equipment testing/evaluation held in operational environments.

This research effort will require the accumulation and analysis of data, computer programming, and statistical analysis. Preparation of survey and assessment materials, conducting literature reviews and preparation of Institutional Review Board (IRB) materials shall also be required in support of these programs.

4.2.5. The contractor shall support research to determine the impact of submarine deployments on the gut microbiome and metabolome and determine its significance for the host metabolome and submariner health.

4.2.6. The contractor shall also support new initiatives in the area of Shipboard Force Health Protection and Submariner Wellness.

4.3. For Submariner Psychological Factors

4.3.1. The contractor shall support studies to evaluate multiple medical conditions affecting submarine qualifications as well as the effectiveness of resiliency training. The studies shall assess and enhance the psychological screening of prospective warfighters and test and evaluation of attrition risk. This includes various data entry and database management services and statistical analyses and coordination of such with other Navy commands when necessary.

Work also includes assisting in the preparation of grant applications for other psychological, medical, and performance studies. Contractor shall support studies on the psychological health, including prevention and recovery of psychological trauma and/or illness.

4.3.2. The contractor shall also support new initiatives in the area of Submariner Psychological factors.

4.4. For Human Factors

4.4.1. The contractor shall support studies that assess and enhance human systems integration to ensure that the design and implementation of submarine systems, training programs, and culture combine to increase the effectiveness of operator performance. Some examples of studies that may be included in this research area are the examination of the current human-machine, human-automated interfaces, examination of methods for enhanced communications, development of auditory and visual process models and cueing strategies, investigation of improvements to training methods, and examination of changes in the culture that may improve team performance under extreme operational conditions.

4.5. For General project support

4.5.1. The contractor shall provide requisite administrative, graphic, logistic and technical support to research and development, test and evaluation activities. The contractor shall provide technical support such as responses to workshops, coordination of technical review meetings and the preparation and presentation of point papers and other briefings, and will prepare fact sheets and newsletters related to the technical research. The contractor shall write and adapt text for IRB protocols, presentation of work at scientific meetings, writing peer-reviewed articles, and technical reports. The contractor shall support the development of research proposals or grant applications to fund research efforts. The contractor shall also draft and prepare survey and psychological assessment materials, provide data entry and database management services, and coordinate these with other Navy commands when necessary for all supported research. As directed, contractor shall act as scientific liaison and engineering point of contact to facilitate business, technical and research relationships, and delivery of new technologies to the fleet.

4.5.2. Contractor shall provide information services including research, planning, scheduling, and overseeing the operations of the library information center, creating and maintaining various project databases including a database for library information management, as well as designing, managing, and maintaining internal and external websites.

4.6. Qualifications of the Contractor-The contractor must have in-depth knowledge of Department of Defense and Federal research and administrative policy as outlined below:

4.6.1. Access to fully qualified individuals who have an understanding of the Navy Medicine Research vision, mission, programs, personnel, and facilities.

4.6.2. Knowledge and experience working within the Department of Defense requirement processes, including detailed knowledge of BUMED R&D policies and procedures.

4.6.3. Technical writing expertise and expertise in development of briefings and briefing materials.

4.6.4. Expert ability to evaluate the latest applicable reports from the worldwide medical community.

4.6.5. Personnel fluent in the English language as exemplified by their written and verbal skills.

4.7. Reporting Requirements

4.7.1. Progress updates will be required in the form of monthly reporting. These reports shall contain, at a minimum, the status of any actions resulting from technical direction given during the reporting period, discussion of any significant issues, and a short report/status of each task. A final report will also be required at the end of each 12 month period of performance and shall contain significant accomplishments for the 12 month period highlighting research project progress on data collections, data analysis, summary reports, briefing, presentations, and publications.

5. WORK LOCATION

5.1. A portion of the effort under this contract shall be performed on a Government installation. The normal work week for Government employees at the Naval Submarine Medical Research Laboratory (NSMRL) Groton, CT is Monday through Friday with flexible working hours from 0600 to 1800. NSMRL core hours, during which all personnel must be at work or on approved leave, are 0930 to 1430.

6. GOVERNMENT-FURNISHED PROPERTY/MATERIAL

6.1. Naval Submarine Medical Research Laboratory (NSMRL) shall provide offices, computers, paper, and necessary supplies and materials to perform tasks on a daily basis.

Additional Government Furnished Property (GFP) will be delineated at the task order level.

7. PERFORMANCE STANDARDS

7.1. Tasks will be evaluated for completeness, timeliness, utility, and accuracy. Positive and negative performance will be documented in the Contractor Performance Assessment Report System (CPARS).

7.2. Performance. The Contracting Officer’s Representative (COR) will measure the contractor’s performance by assessing the quality of the services delivered by the contractor as evaluated by the NSMRL staff. Examples of services to be provided include research, studies, and reports provided in accordance with the tasks in the performance work statement. The quality standards are defined as follows:

7.2.1. Successful services are defined as those that conform to the task description provided in the Performance Work Statement (PWS), with little or no rework required of the contractor by the Government.

7.2.2. Unsuccessful services are defined as those that do not conform to the task description provided in the PWS, thereby requiring significant rework by the contractor at the direction of the Government.

7.3. Schedule. The Contracting Officer’s Representative (COR) will determine whether the contractor has met the schedule using the due dates for receipt of deliverables. The quality standards are defined as follows:

7.3.1. Successful delivery is defined as delivery of data and accomplishment of the metrics at least 95% of the time.

7.3.2. Unsuccessful delivery is defined as delivery of data and accomplishment of the metrics less than 95% of the time.

7.4. Cost-the COR will review monthly cost vouchers to monitor the contractor’s expenditures in comparison to the contractor’s proposed budget (submitted under the Monthly Progress Reports) throughout the contract performance.

The quality standards are defined as follows:

7.4.1. Successful cost control is defined as performance of the tasks within the amount of funds allotted. If the contractor’s actual expenditures on a monthly basis exceed the budgeted amount for expenditures, the contractor must provide an explanation as to why this occurred and what changes have been made to ensure completion of the work within the ceiling in order to still receive a successful assessment of performance.

7.4.2. Unsuccessful cost control is defined as exceeding the funding allotted for the tasks or exceeding the original ceiling of the contract for reasons not attributable to the Government. Furthermore, if the Government is not notified of why budgetary overruns have occurred on a monthly basis and what steps the contractor is taking to ensure completion of the work within the ceiling, the contractor will receive an unsuccessful assessment of performance.

8. QASP

8.1. Objective: This Quality Assurance Surveillance Plan (QASP) serves as the principal basis for assessing overall performance quality by the contractor. This document will be used by the Government to assess the effectiveness of the Contractor's performance. This QASP provides the methodology by which the Contractor's performance will be monitored to determine compliance with established performance objectives and to establish performance benchmarks that ensure a quantifiable basis for measuring effectiveness. The plan is designed so that surveillance is limited to that which is necessary to verify the Contractor is performing satisfactorily and relates directly to performance objectives of the performance objectives delineated in the PWS.

8.2. Performance Objectives Summary Matrix:

TASK/

DELIVERABLE

PERFOMANCE

STANDARD

PERFORMANCE

INDICATOR/

ACCEPTABLE

LEVEL OF

PERFORMANCE

METHOD OF

SURVEILLANCE

PERFORMANCE RATING

Compliance of products, services, documents.

Related deliverables and overall quality of work performance.

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

Does not cause a delay in schedule;

Does not cause costs to increase Involves minimal effort to fix;

and

Does not affect overall contractor performance.

All matters shall be resolved in a satisfactory and timely manner.

Random inspection (by reviewing monthly report).

Are study reports complete and are they compliant with various government regulations?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework;

problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework;

problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements require re-performance/rework.

Substantial problems were encountered and were resolved in a less than satisfactory manner.

Timeliness of Performance and Services and Product Deliverables , including Administrative aspects of Performance

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional r e q u i r e m e n t s in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

• does not cause a delay in schedule;

• does not cause costs to increase;

• involves minimal effort to fix; and does not affect overall contractor performance

Random Inspection (by reviewing monthly report).

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework;

problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework;

problems that are encountered satisfactory and timely manner.

are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements require re-performance/rework.

Substantial problems were encountered and were resolved in a less than satisfactory manner.

Commitment to Customer Satisfaction and Business- like concern for its Customers' interest including responsiveness to internal and external clients.

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

• does not cause a delay in schedule;

• does not cause costs to increase;

• involves minimal effort to fix; and

• does not affect overall contractor performance satisfactory and timely manner.

Random Sampling (by reviewing monthly report).

Is the contractor committed to high customer satisfaction?

How contractor proactive is to contractor? Is the contractor providing positive value to the government?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework;

problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework;

problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements required re-performance/rework.

Substantial problems were encountered and were resolved in a less than satisfactory manner.

Overall Satisfaction

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

• does not cause a delay in schedule;

• does not cause costs to increase;

Random Sampling (by reviewing monthly report).

What is the governments overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework;

problems that are encountered are minor and resolved in a highly effective manner.

Acceptable

204-9400(1-17) Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information

Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 – “DoD Implementation of Homeland Security Presidential Directive – 12 (HSPD- 12)” dated November 26, 2008 (or its subsequent DoD instruction) directs implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives.

APPLICABILITY

This text applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a DoN or DoD computer/network/system to perform certain unclassified sensitive duties. This clause also applies to contractor employees who access Privacy Act and Protected Health Information, provide support associated with fiduciary duties, or perform duties that have been identified as National Security Position, as advised by the command security manager. It is the responsibility of the responsible security officer of the command/facility where the work is performed to ensure compliance.

Each contractor employee providing services at a Navy Command under this contract is required to obtain a Department of Defense Common Access Card (DoD CAC). Additionally, depending on the level of computer/network access, the contract employee will require a successful investigation as detailed below.

ACCESS TO FEDERAL FACILITIES

Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Command’s Security Manager upon arrival to the Command and shall out-process prior to their departure at the completion of the individual’s performance under the contract.

ACCESS TO DOD IT SYSTEMS

In accordance with SECNAV M-5510.30, contractor employees who require access to DoN or DoD networks are categorized as IT-I, IT-II, or IT-III. The IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI).

All contractor employees under this contract who require access to Privacy Act protected information are therefore and informative data and information.

• involves minimal effort to fix; and

• does not affect overall contractor performance satisfactory and timely manner.

Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework;

problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements require re-performance/rework.

Substantial problems were encountered and were resolved in a less than satisfactory manner.

categorized no lower than IT-II. IT Levels are determined by the requiring activity’s Command Information Assurance Manager.

Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) or T5 or T5R equivalent investigation , which is a higher level investigation than the National Agency Check with Law and Credit (NACLC)/T3/T3R described below. Due to the privileged system access, an investigation suitable for High Risk national security positions is required. Individuals who have access to system control, monitoring, or administration functions (e.g. system administrator, database administrator) require training and certification to Information Assurance Technical Level 1, and must be trained and certified on the Operating System or Computing Environment they are required to maintain.

Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee’s duties, such employees shall in-process with the Navy Command’s Security Manager and Information Assurance Manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual’s performance under the contract.

Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The decision to authorize access to a government IT system/network is inherently governmental. The contractor supervisor is not authorized to sign the SAAR-N;

therefore, the government employee with knowledge of the system/network access required or the COR shall sign the SAAR-N as the “supervisor”.

The SAAR-N shall be forwarded to the Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date may result in delaying the individual’s start date.

When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

INTERIM ACCESS

The Command's Security Manager may authorize issuance of a DoD CAC and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the investigative questionnaire and advance favorable fingerprint results. When the results of the investigation are received and a favorable determination is not made, the contractor employee working on the contract under interim access will be denied access to the computer network and this denial will not relieve the contractor of his/her responsibility to perform.

DENIAL OR TERMINATION OF ACCESS

The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.

CONTRACTOR’S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the Contractor’s Security Representative. Within three work days after contract award, the contractor shall provide to the requiring activity’s Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor’s Security Representative. The Contractor’s Security Representative shall be the primary point of contact on any security matter. The Contractor’s Security Representative shall not be replaced or removed without prior notice to the Contracting Officer and Command Security Manager.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR

CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE

DUTIES

Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied. Contractor employees under this contract are recognized as Non- Critical Sensitive [ADP/IT-II] positions when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. This designation is also applied to contractor employees who access Privacy Act and Protected Health Information (PHI), provide support associated with fiduciary duties, or perform duties that have been identified as National Security Positions. At a minimum, each contractor employee must be a US citizen and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive or IT-II position. The investigation consists of a standard NAC and a FBI fingerprint check plus law enforcement checks and credit check. Each contractor employee filling a non-critical sensitive or IT-II position is required to complete:

SF-86 Questionnaire for National Security Positions (or equivalent OPM investigative product) Two FD-258 Applicant Fingerprint Cards (or an electronic fingerprint submission) Original Signed Release Statements

Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date. Background investigations shall be reinitiated as required to ensure investigations remain current (not older than 10 years) throughout the contract performance period. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

Regardless of their duties or IT access requirements ALL contractor employees shall in-process with the Command’s Security Manager upon arrival to the command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Employees requiring IT access shall also check-in and check-out with the Navy Command’s Information Assurance Manager. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The SAAR-N shall be forwarded to the Navy Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date.

The contractor shall ensure that each contract employee requiring access to IT systems or networks complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the Command Security Manager. The Command’s Security Manager will review the submitted documentation for completeness prior to submitting it to the Office of Personnel Management (OPM); Potential suitability or security issues identified may render the contractor employee ineligible for the assignment. An unfavorable determination is final (subject to SF- 86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. The Command’s Security Manager will forward the required forms to OPM for processing. Once the investigation is complete, the results will be forwarded by OPM to the DoD Central Adjudication Facility (CAF) for a determination.

If the contractor employee already possesses a current favorably adjudicated investigation, the contractor shall submit a Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS) or a hard copy VAR directly from the contractor’s Security Representative. Although the contractor will take JPAS “Owning” role over the contractor employee, the Command will take JPAS "Servicing" role over the contractor employee during the hiring process and for the duration of assignment under that contract. The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee’s performance under the contract.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR

CONTRACTORS ASSIGNED TO OR PERFORMING NON-SENSITIVE DUTIES

Contractor employee whose work is unclassified and non-sensitive (e.g., performing certain duties such as lawn maintenance, vendor services, etc. ...) and who require physical access to publicly accessible areas to perform those duties shall meet the following minimum requirements:

Must be either a US citizen or a US permanent resident with a minimum of 3 years legal residency in the United States (as required by The Deputy Secretary of Defense DTM 08-006 or its subsequent DoD instruction) and

Must have a favorably completed National Agency Check with Written Inquiries (NACI) or T1 investigation equivalent including a FBI fingerprint check prior to installation access.

To be considered for a favorable trustworthiness determination, the Contractor’s Security Representative must submit for all employees each of the following:

SF-85 Questionnaire for Non-Sensitive Positions Two FD-258 Applicant Fingerprint Cards (or an electronic fingerprint submission) Original Signed Release Statements

The contractor shall ensure each individual employee has a current favorably completed National Agency Check with Written Inquiries (NACI) or T1 equivalent investigation, or ensure successful FBI fingerprint results have been gained and investigation has been processed with OPM

Failure to provide the required documentation at least 30 days prior to the individual’s start date may result in delaying the individual’s start date.

* Consult with your Command Security Manager and Information Assurance Manager for local policy when IT-III (non-sensitive) access is required for non-US citizens outside the United States.

Section E - Inspection and Acceptance

COR

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(a) For the purpose of this clause, the Contracting Officer’s Representative (COR) is the duly authorized representative of the Contracting Officer.

(b) The COR for this contract will be appointed at time of award.

(c) The COR will perform inspection and acceptance of services to be provided. Inspection and acceptance will be performed at the locations listed in the contract or task orders.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government 0005 Destination Government Destination Government

CLAUSES INCORPORATED BY REFERENCE

52.246-5 Inspection Of Services Cost-Reimbursement APR 1984 52.246-8 Inspection Of Research And Development Cost

Reimbursement

MAY 2001

252.246-7000 Material Inspection And Receiving Report MAR 2008

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 08-MAY-2018 TO

07-MAY-2019

N/A NAVAL SUBMARINE MEDICAL

RESEARCH LAB

BOX 900 TROUT AVENUE

GROTON CT 06349

N66596

0002 POP 08-MAY-2019 TO

07-MAY-2020

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 08-MAY-2020 TO

07-MAY-2021

N/A (SAME AS PREVIOUS LOCATION)

0004 POP 08-MAY-2021 TO

07-MAY-2022

N/A (SAME AS PREVIOUS LOCATION)

0005 POP 08-MAY-2022 TO

07-MAY-2023

N/A (SAME AS PREVIOUS LOCATION)

52.242-15 Alt I Stop-Work Order (Aug 1989) - Alternate I APR 1984

Section G - Contract Administration Data

ADMINISTRATION CONTACTS

Contract Specialist: Ms. Jennifer M. Reed Phone Number: 1-301-619-1200 Email: jennifer.m.reed20.civ@mail.mil

Contracting Officer’s Representative: To Be Determined Phone Number:

Email:

252.204-7006 Billing Instructions OCT 2005 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF.

Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

COST VOUCHER

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

N/A

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table* Field Name in WAWF Data to be entered in WAWF Pay Official DoDAAC HQ0248 Issue By DoDAAC N62645 Admin DoDAAC N62645 Inspect By DoDAAC N/A Ship To Code N66596 Ship From Code N/A Mark For Code N/A Service Approver (DoDAAC) N/A Service Acceptor (DoDAAC) N66596 Accept at Other DoDAAC N/A LPO DoDAAC N66596 DCAA Auditor DoDAAC TBD Other DoDAAC(s) N/A

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

WAWF Acceptor/COR Email Address: TBD

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section H - Special Contract Requirements

SPECIAL CONTRACT REQUIREMENTS

INVENTION DISCLOSURES AND REPORTS

(a) In accordance with the requirements of the Patent Rights clause (FAR 52.227-13) of this contract, the contractor shall submit “Report of Inventions and Subcontracts” (DD Form 882) along with written disclosure of inventions to the designated Contract Administrator.

(b) The Contract Administrator will forward such reports and disclosures directly to the appropriate Patent Counsel, designated below, for review and recommendations, after which the reports will be returned to the Contract Administrator.

Address of Patent Counsel:

Office of Legal and Technology Services Naval Medical Research Center (Code 1URO) 503 Robert Grant Avenue, Suite 1W/15 Silver Spring, MD 20910

(c) The above designated Patent Counsel will represent the Procurement Contracting Officer with regard to invention reporting matters arising under this contract.

(d) A copy of each report and disclosure shall be forwarded to the Procuring Contracting Officer.

(e) The contractor shall furnish the Contracting Officer a final report within three (3) months after completion of the contracted work listing all subject inventions or certifying that there were no such inventions, and listing all subcontracts at any tier containing a patent rights clause or certifying that there were no such subcontracts.

PATIENT CARE AND MEDICAL LIABILITY INSURANCE

The character of services for health care workers that are providing patient care in clinical or administrative tasks under this contract will be categorized as non-personal services as provided for by Federal Acquisition Regulation (FAR) Subpart 37.4. Patient care will be incidental to research activities or projects supported under this contract.

Alleged acts of medical malpractice by non-personal health care workers are not covered under the Federal Tort Claims Act and the contractor shall indemnify the Government against legal action alleging malpractice by such workers by way of indemnification and medical liability insurance provided by the contractor. Insurance as prescribed by FAR clause 52.237-7 shall be required for those medical personnel such as physicians or nurses providing patient care in clinical or administrative tasks consistent with standard coverage prevailing within the local community as to the specific medical specialty.

NOTICE REGARDING THE DISSEMINATION OF…