FBODaily.com | FedBizOpps: PRESOL | B | Evaluation of Intimal Medical Thickness Measurement in the Healthy Aging Neighborhoods of Diversity Across the Life Span (HANDLS) Study - Statement of Work (SOW)

FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 12, 2016 FBO #5194
SOLICITATION NOTICE

B -- Evaluation of Intimal Medical Thickness Measurement in the Healthy Aging Neighborhoods of Diversity Across the Life Span (HANDLS) Study - Statement of Work (SOW)

Notice Date: 2/10/2016
Notice Type: Combined Synopsis/Solicitation
NAICS: 541690 — Other Scientific and Technical Consulting Services
Contracting Office: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
ZIP Code: 20892
Solicitation Number: HHS-NIH-NIDA-SSSA-2016-158
Archive Date: 3/5/2016
Point of Contact: Samantha A. Kelly, Phone: 3014028855
E-Mail Address: samantha.kelly2@nih.gov
(samantha.kelly2@nih.gov)
Small Business Set-Aside: N/A
Description: Copy of Solicitation SF 18 Request for Quotation Terms and Conditions Invoicing Instructions Evaluation Criteria Statement of Work (SOW) REQUEST FOR QUOTATION WORK FORM TABLE OF CONTENT Standard Form 18, Request for Quotation 1 PART I - INSTRUCTIONS Article 1 - General Article 2 - Quote Submission Article 3 - Requests for Clarification Article 4 - Socio-economic Set-Aside Article 5 - Price Reductions Article 6 - Evaluation of Quotes and Award Determination Article 7 - Physical, Functional, or Performance Specifications Article 8 - Delivery Period / Period of Performance Article 9 - Price Quote Article 10 - Technical Approach / Plan Article 11 - Past Performance Article 12 - Quote Packaging and Delivery Instructions PART II - PURCHASE DESCRIPTION / SPECIFICATIONS / SCOPE OR WORK / STATEMENT OF WORK Brief Description of Supplies or Services Purchase Description or Scope of Work - Statement of Work Other Considerations Advance Understandings Inspection and Acceptance Packaging, Marking, and Shipping Instructions Deliveries or Performance PART III - CONTRACT ADMINISTRATION Contract Administration Contracting Officer's Technical Representative Key Personnel Invoice Submission Instructions Option Provisions PART IV - ADDITIONAL PROVISIONS AND REPRESENTATIONS Information and Physical Access Security Electronic and Information Technology Accessibility, HHSAR 352.239-73(b) Access to National Institutes of Health (NIH) Electronic Mail ATTACHMENTS: Attachment 1: Statement of Work Attachment 2: Evaluation Criteria Attachment 3: Invoice Instructions Attachment 4: Terms and Conditions PART I - INSTRUCTIONS ARTICLE 1 - General This request for quote is issued in accordance with the Federal Acquisition Regulations (FAR) Part 13 - Simplified Acquisition Procedures. This request for quote does not commit the Government to pay any cost incurred in the submission of quotes or make necessary studies or designs for the preparation thereof, nor to procure or contract for the articles or services. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. Any other commitment, either explicit or implied, is invalid. In addition to the clauses/provision of this request for quote, the resultant purchase order shall include any clauses/provisions required by Public Law, Executive Order, or acquisition regulations, in effect at the time of execution of the award. Responses' to this RFQ are not to be considered an offer that can be accepted by the Government to form a binding contract. The actual purchase order award is considered the offer by the Government to the contractor and the contractor's written acceptance of the purchase order, or the commencement of performance under the purchase order, is the contractor's indication of their acceptance of the offer. THE GOVERNMENT RESERVES THE RIGHT TO MAKE AN AWARD WITHOUT FURTHER DISCUSSIONS OF THE QUOTES RECEIVED. THEREFORE, IT IS IMPORTANT THAT THE QUOTE IS INITIALLY SUBMITTED ON THE MOST FAVORABLE TERMS FROM BOTH THE TECHNICAL AND COST STANDPOINTS. All communications must be directed to the attention of the Contract Specialist / Contracting Officer. All documents and deliverables described in this RFQ and amendments or modifications, shall be submitted in a professional manner and on the prime contractor's letterhead. ARTICLE 2 - Quote Submission 1.Responses to this RFQ are due on February 19, 2016 at 8:00AM Eastern Standard Time (EST), under solicitation number HHS-NIH-NIDA-SSSA-2016-158. 2.The email subject line must include the RFQ Number, the Title and the Offerors's name. 3.The proposal must be in submitted in the format as described in Part II - Proposal Submission Instructions, Paragraph B - Proposal Format. 4.The proposals must be signed by an authorized signatory authority of the offeror. 5.The Contractor must submit with their quote the following: Cost-Price Quote, inclusive of all costs, which shall include but is not limited to, unit price, list price, shipping and handling costs for deliverables. Any other information or factors that provide clear and convincing evidence of the interested parties' bona-fide capabilities of providing the service, meeting EACH of the requirements set forth in this solicitation or factors that may be considered in the award decision. Technical Specifications or Technical Plan that illustrates how the work will be completed and how the quotation meets each of the requirements of this solicitation. Redacted Invoice (which is an edited version of an invoice issued within 12 months of this solicitation, that shows the details of similar or identical services/items) and/or Published Price Listing or other information to determine price reasonableness Dun and Bradstreet Number (DUNS); and Verification of System for Award Management (SAM) Registration www.sam.gov. 6.Late Proposal Provisions a.Any proposal, modification, or revision that is received at the designated Government office after the exact date and time specified for receipt of proposals is "late" and will not be considered. Proposals received "late" will not be evaluated or considered for award and will be returned to the offeror. b.Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel. c.If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the Government office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation closing date, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. ARTICLE 3 - Requests for Clarification 1.Requests for clarification may be submitted electronically to the Contract Specialist, no later than February 15, 2016 at 8:00AM EST. 2.When submitting requests for clarification, contractors must cite the relevant section, paragraph, and page number. Questions should be written in a way that enables clear understanding of the contractors' issues or concerns. Statements expressing opinions, sentiments, or conjectures are not considered valid inquiries and will not be provided a response. Further, contractors are reminded that the Contract Specialist will not address hypothetical questions aimed at receiving a potential "evaluation decision." 3.Offerors may submit no more than 5 questions for clarification. 4.Responses will not disclose proprietary information to the offeror. 5.Requests to extend the proposal due date will not be granted. ARTICLE 4 - Socio-Economic Small Business Set-Aside Program 1.The North American Industry Classification System (NAICS) code for this requirement is 541690 and the size standard is $15 Million. 2.This requirement not a socio-economic business set-aside. ARTICLE 5 - Price Reductions Vendors are expected to propose pricing that is fair and reasonable and should consider offering price reductions which are guided by the complexity, scope and estimated value of the requirement. ARTICLE 7 - Evaluation of Quotes and Award Determination 1.The Government will evaluate all responses received using the evaluation criteria set forth in Article 8, titled: "Evaluation Criteria." Also, refer to Attachment 2 Titled "Evaluation Criteria". 2.Each quote will be evaluated in strict conformity with the evaluation factors, utilizing point scores and written critiques. The evaluation will be based upon the demonstrated capabilities of the prospective contractor in relation to the needs of the project as set forth in the RFQ. 3.The price quoted will also be evaluated taking into consideration any price reductions, the level of effort and the mix of labor proposed to perform the task(s) being ordered. A price reasonable determination will be made and a best value analysis will be performed. The best value analysis will take into consideration the results of the technical evaluation, price evaluation, and the ability to complete the work within the Government's required schedule. The analysis will document that the award represents the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to meet the Government's needs. The Government reserves the right to issue an order to the best advantage of the Government, technical merit, price, and other factors considered. 4.All aspects of a quote are subject to discussion, including price, technical approach and terms and conditions. At the completion of discussions, the contractor will ensure his technical plan and price quote reflects the mutual understandings of the requirement and if requested, submit a revised technical plan and price quote to the Contracting Officer. The technical plan should consist of the contractor's intent and approach to this particular effort, any considerations that should be made by the government, as well as any additional information that expresses the Contractor's position above others for this effort. 5.The Government may request clarifying information from the schedule contractor, as it relates to its quote. 6.If an award will be made without conducting discussions, schedule contractors may be given the opportunity to clarify certain aspects of their quote (e.g., the relevance of the schedule contract, the contractor's past performance information, and adverse past performance information to which the schedule contractor has not previously had an opportunity to respond) or to resolve minor or clerical errors. 7.The Government reserves the right to make a single award, multiple awards, or no award at all as a result of the RFQ. In addition, the RFQ may be amended or canceled as necessary to meet the Government's requirements. ARTICLE 8 - Evaluation Criteria 1.Mandatory Criteria: The mandatory requirements will be evaluated on a pass/fail basis. •Doctorate of Medicine and Board Certified for Vascular Surgery and/or Cardiology •Licensed in the State of Maryland 2.Technical Evaluation Criteria Item No. Evaluation Criteria Rating StandardTotal Possible Points 1. Technical Capability The proposal should address each of the "Contractor Requirements" of the Statement of Work (in Part II of this RFQ. Also, refer to Attachment 1 titled "Statement of Work"), in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. The Offeror should provide evidence of sufficient planning to show that work will be accomplished and how it will be accomplished as required and on schedule, utilizing all available resources as well as controlling the execution of assigned activities, tasks, sub-tasks, monitoring progress, status reporting, resolving critical issues and mitigating risks. The proposal should demonstrate a firm understanding of the requirements and goals set forth in the scope of work. 45 2. The qualifications of all proposed key personnel. Proposed key personnel are identified, and each meets or exceeds the training and experience requirements for the positions for which each is proposed. The proposal shall be evaluated to ensure that all key personnel qualifications identified in this statement of work are met, to include, but not limited to the following: •Documented evidence of the offeror's successful performance at a minimum five (5) years of experience evaluating the quality and accuracy of intimal-medial thickness (IMT) measurements and performing clinical evaluation for the presence of atherosclerosis and risk for stenosis and; •Documented evidence of five (5) years' experience collaborating on IMT data resulting in published manuscripts. 40 3. Prior experience and past performance. Documented evidence of the Offerors successful performance of the same or substantially similar services as those required in the RFP. Documented evidence of the Offeror's successful performance for a minimum of three (3) recent contracts should be provided. 40 Total Possible Points 125 ARTICLE 9 - Delivery Period / Period of Performance 1.Period of performance for services is: Base Year: 04/01/2016 - 03/31/2017 Optional Renewal Years: Option Year One (1): 04/01/2017 - 03/31/2018 2.Location where the work is to be performed is at the Contractor's location. ARTICLE 10 - Price Quote The cost-price proposal is submitted separately from the technical proposal (described in Article 11) and shall be submitted as specified in the ‘Cost-price Proposal' format as specified in the statement of work for each year / partial year of the period of performance, including a summary of the costs for the entire period of performance. The cost-price proposal should contain all information necessary to allow for a comprehensive evaluation of the prices including an accompanying narrative that fully describes all assumptions made by the contractor. The cost-price proposal should contain sufficient information to determine the reasonableness of services proposed and to evaluate whether the proposed costs-prices are consistent with the technical proposal. No property or equipment shall be purchased under this work order. Requests for purchasing of property or equipment must be submitted to the COR, for their review and, if approved, the items may be purchased through CONTRACTING OFFICE established purchasing mechanisms. The requirement contains option provisions and period(s) pursuant to FAR Clause 52.217-5, Evaluation of Options (July 1990). The Government will evaluate offers, for award purposes, by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s). The price quote proposal must be in Microsoft Excel, Microsoft Word or PDF format. There are no pages limits for the cost-price proposal. The pages must be sequentially numbered (e.g., 1 of 10, 2 of 10, 3 of 10, etc.,) and must contain a header or footer to include the name of the Offeror and the work order number. The cost-price proposal must be submitted for each year / partial year of the period of performance, including a summary of the costs for the entire period of performance. The Vendor shall submit a price quote with the following: 1.Product / Catalog number(s) 2.Product Description 3.Quantity 4.Fixed Unit Price 5.Discounted Price 6.All relevant information and documentation that the item(s) quoted meets the performance characteristics as specified in the statement of work. ARTICLE 11 - Technical Approach / Plan 1.Instructions The Contractor must submit a technical plan and price quote for this requirement to the Contract Specialist cited herein. The total number of pages, (combination of technical plan and price quote) is not expected to exceed 25 pages in length, excluding resumes. The Contractor shall submit its quote electronically in a "read only" format. A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical plan should reflect a clear understanding of the nature of the work being undertaken. The technical plan must include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks. Plans which merely state that the tasks will be conducted in accordance with the requirements of the Government's scope of work will not be eligible for further consideration. The schedule contractor must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. The technical plan shall include: Resumes of all professional individuals proposed for the contract. Resumes should be no longer than 3 pages in length Project Management Summary. Technical Approach of how the work will be performed. An outline of quality control procedures A milestones and time lines for the project, indicating the estimated period of performance for each task. Facilities and /or resources used. 2.Technical Plan Format The suggested outline for the technical plan is as follows: a.Work Scope b.Objectives. State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relationship to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it. c.Approach. Discuss the possible or probable outcome of approaches proposed. d.Methods. Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate. e.Schedule. Provide a schedule for completion of the work and delivery of items specified in the statement of work. Performance or delivery schedules shall be indicated for phases or segments, as applicable, as well as for the overall program. Schedules shall be shown in terms of calendar months from the date of authorization to proceed or, where applicable, from the date of a stated event, as for example, receipt of a required approval by the Contracting Officer. Unless the request for quotes indicates that the stipulated schedules are mandatory, they shall be treated as desired or recommended schedules. In this event, Plans based upon the schedule contractor's best alternative schedule, involving no overtime, extra shift or other premium, will be accepted for consideration. f.Personnel. Describe the experience and qualifications of personnel who will be assigned for direct work on this project. Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. g.The Offeror must submit its technical proposal in Microsoft Word or PDF format in a font size of 11 or 12 point and font type of Arial or Times Romans. Margins must be 1-inch wide (top, bottom, left, and right). The technical proposal must not exceed 25 pages in length and the pages must be sequentially numbered regardless of the section or part (e.g., 1 of 25, 2 of 25, 3 of 25, etc.,) and must contain a header or footer to include the name of the Offeror and the work order number. Pages in excess of the specified page limit will not be considered or evaluated. Resumes must not exceed 3 pages in length and are not counted in the page limit. h.In accordance with FAR Part 52.204-4: Printed or Copied Double-Sided on Postconsumer Fiber Content Paper, the originals and copies of the proposal must be produced double-sided and on at least 30% postconsumer fiber papers. In accordance with Section 101 of Executive Order 13101 dated September 14, 1998, Greening the Government through Waste Prevention, Recycling, and Federal Acquisition, the Contractor is encouraged to submit paper documents, such as offers, letters, or reports, that are printed or copied double-sided on recycled paper that meet minimum content standards specified in Section 505 of Executive Order 13101, when not using electronic commerce methods to submit information or data to the Government. i.The proposal must include a statement to the effect that the offer is firm for a period of at least thirty (30) days from the date of receipt by the Government. ARTICLE 12 - Past Performance An evaluation of schedule contractors' past performance information will be documented prior to any communications with the schedule contractor. However, a past performance evaluation will not be conducted on any schedule contractor whose quote is not eligible for further consideration. The evaluation will be based on information obtained from references provided by the schedule contractor, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the schedule contractor concerning problems encountered on the identified contracts and corrective action taken. The government will assess the relative risks associated with each schedule contractor. Performance risks are those associated with a schedule contractor's likelihood of success in performing the acquisition requirements as indicated by that schedule contractor's record of past performance. The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of a schedule contractor's performance on a list of contracts but rather the product of a subjective judgment by the Government after it considers relevant information. When assessing performance risks, the Government will focus on the past performance of the schedule contractor as it relates to all acquisition requirements, such as the schedule contractor's record of performing according to specifications, including standards of good workmanship; the schedule contractor's record of controlling and forecasting costs; the schedule contractor's adherence to contract schedules, including the administrative aspects of performance; the schedule contractor's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the schedule contractor's business-like concern for the interest of the customer. The Government will consider the currency and relevance of the information, sources of the information, context of the data, and general trends in the schedule contractor's performance. The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the schedule contractor. The schedule contractors shall submit the following information as part of their technical plan. A list of the last three (3) delivery or task orders and / or contracts completed during the past three (3), years and the last three (3) delivery or task orders and / or contracts awarded currently in process that are similar in nature to the RFQ's work scope. Delivery or task orders and / or contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Schedule contractors that are newly formed entities without prior delivery or task orders and / or contracts should list contracts and subcontracts as required above for all key personnel. Include the following information for each delivery or task orders and / or contracts or subcontracts: 1.Name of Contracting Organization; 2.Contract Number (for subcontracts, provide the prime contract number and the subcontract number); 3.Contract Type; 4.Total Contract Value; 5.Description of Requirement; 6.Contracting Officer's Name and Telephone Number; 7.Program Manager's Name and Telephone Number; and 8.North American Industry Classification System(NAICS) Code The schedule contractor may provide information on problems encountered on the identified contracts and the schedule contractor's corrective actions. Each schedule contractor will be evaluated on its performance under existing and prior contracts for similar products or services. The Government is not required to contact all references provided by the schedule contractor. Also, references other than those identified by the schedule contractor may be contacted by the Government to obtain additional information that will be used in the evaluation of the schedule contractor's past performance. ARTICLE 13 - Quote Packaging and Delivery Instructions The quote must be submitted in accordance with Part I - "Instructions." The delivery and markings of the quote shall be as follows. PLEASE READ THE FOLLOWING INFORMATION CAREFULLY Responses to the Request for Quote are due on February 19, 2016 by 8:00AM EST. Response must be submitted in a "read-only" electronic format via e-mail to the Contract Specialist citing the RFQ number and the name of firm in the subject line. In the event that an electronic copy cannot be submitted, a print copy must be received by the due date and addressed in accordance with the instructions below. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." Questions/clarifications regarding this solicitation must be received in this office, to the email address supplied below, by 8:00AM (EST) on February 15, 2016. All offers must be received by 8:00AM (EST) on February 19, 2016 and must reference number HHS-NIH-NIDA-SSSA-2016-158. Responses must be submitted electronically to Samantha Kelly, Contract Specialist at Samantha.Kelly2@nih.gov. PART II - STATEMENT OF WORK BACKGROUND: The National Institute on Aging (NIA) Intramural Research Program is embarking on a longitudinal study of the effects of race and socioeconomic status on healthy aging in a representative sample of community dwelling residents from the Baltimore metropolitan region. The study is called Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS). The HANDLS study requires a detailed knowledge of the public health characteristics of this region and the ways in which racial and socioeconomic data must be collected to assess their influence on a variety of health outcomes such as cardiovascular and cerebrovascular functioning, psychophysiological and cognitive performance, and muscular strength and conditioning. Carotid Doppler ultrasonography is the method of choice for noninvasive, in vivo examination of the structure and function of the carotid arteries. In this study, a high resolution B-mode ultrasonography on the left carotid artery for evaluating systolic and diastolic common carotid arterial diameters, carotid arterial flow, intimal-medial thickness, and plaques is performed. This test is done to demonstrate blocked or reduced blood flow in the arteries of the neck, which could predispose to cerebrovascular events. Upon delivery and acceptance of the item(s) described in the Statement of Work (SOW), the Government shall pay to the contractor the estimated not to exceed amounts as negotiated. PURPOSE AND OBJECTIVES: The purpose of this requirement is to procure the services of a vascular surgeon who has the expertise to read, analyze and interpret carotid Doppler studies collected as part of the HANDLS wave 4 examinations to evaluate the quality and accuracy of Intimal Medial Thickness (IMT) measurement in the HANDLS study and perform clinical evaluation for the presence of atherosclerosis and risk for stenosis. PROJECT DESCRIPTION: Project Description: The contractor shall provide a Cardiologist or Vascular Surgeon who will provide the following services: 1.Review and advise sonographer's acquisition of Images including feedback on the quality of the tests and quality control of the images obtained as part of the HANDLS study; 2.Evaluate the quality and accuracy of intimal-medial thickness (IMT) measurements and perform clinical evaluation for the presence of atherosclerosis and risk for stenosis; 3.Provide technical supervision for the sonographer when required, including feedback on the quality of the tests, and quality control of the images; 4.Review, on a yearly basis, the measurements that are acquired to determine whether any modifications or changes to the protocol are needed. 5.Provide on-call services as needed to review clinical status of participants presenting with plaques, stenosis, or any other relevant vascular condition conferring urgent health risk Although the government will own the data, the Contractor will be encouraged to participate and collaborate in analyses that involve the carotid Doppler studies. Other Important Considerations: Deliverables include the following: 1.No more than 30 evaluated Carotid Doppler studies per week with minimal errors in data processing 2.Participation in manuscript development and reports on quality control of data collected and coded, data and manuscript proposals 3.Reports on quality control of data collected and coded data as well as manuscript proposals shall be delivered to the Contracting Officer's Representative electronically on these respective dates, subject to change: July 30th, November 30th and March 31st of each year. Key Personnel: The proposed key personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.242-70 KEY PERSONNEL, HHSAR 352.242-70 (January 2006). a.The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government. b.The cardiologist or vascular surgeon is considered key personnel and will provide the services and will be responsible for the deliverables. The education requirements include a Doctorate of Medicine and Board Certified & Licensed in the State of Maryland. Finally, experience requirements include five years of experience evaluating the quality and accuracy of intimal-medial thickness (IMT) measurements and performing clinical evaluation for the presence of atherosclerosis and risk for stenosis and collaborating on IMT data resulting in published manuscripts The cardiologist or vascular surgeon is considered key personnel and will provide the services and will be responsible for the deliverables. The education requirements include a Doctorate of Medicine and Board Certified & Licensed in the State of Maryland. Finally, experience requirements include five years of experience evaluating the quality and accuracy of intimal-medial thickness (IMT) measurements and performing clinical evaluation for the presence of atherosclerosis and risk for stenosis and collaborating on IMT data resulting in published manuscripts. NameTitle To be determined in the contract awardCardiologist or Vascular Surgeon Government Responsibilities: The Government will perform monitoring activities of the data received, for completeness, accuracy, consistency and minimal errors of the data. Government monitoring will be performed at random intervals no less than three times per year. The Government will provide the website upon award, where the data shall be uploaded and analyzed. 1.Advance Understandings Other provisions of this order notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer. 2.Inspection and Acceptance a.The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided. b.Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt. 3.Packaging, Marking and Shipping Instructions All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and vendor name. The Vendor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. 4.Deliveries or Performance a.Period of Performance The period of performance of this contract shall be from April 1, 2016 through March 31, 2017. b.Option Years 1)The period of performance of the base contract shall be from April 1, 2016 through March 31, 2017. 2)If the Government exercises its option(s) pursuant to the OPTION PROVISION, the period of performance will be increased as listed below: Option YearOption Period One (1) April 1, 2017 through March 31, 2018 PART III CONTRACT ADMINISTRATION 1. CONTRACT ADMINISTRATION The Vendor's primary contact after award will be with the Contracting Officer's Representative (COR)/ Project Officer (PO) (who will be appointed at the time of award), who will provide information, clarifications to the requirement, and answer questions. All correspondence, letters, reports, and other deliverables will be submitted to the COR/PO for acceptance. The Contracting Officer (CO) is the only person with authority to act as agent of the Government. Only the CO has authority to: (1) direct or negotiate any changes; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance; or (5) otherwise change any terms and conditions of the award. The Contact Specialist (CS) acts as a representative of the Contracting Officer. 2.Contracting Officer's Representative (COR) The Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract and will be appointed at the time of award. 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. 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; or (5) otherwise change any terms and conditions of this contract. The Government may unilaterally change the COR designation. 3.Key Personnel, HHSAR 352.242-70 (January 2006) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government. (End of Clause) The following individual(s) is/are considered to be essential to the work being performed hereunder: Name Title To be determined in the contract award Cardiologist or Vascular Surgeon 4.Invoice Instructions Invoice instructions are attached to this solicitation, in Attachment 3, for NIH Fixed-Price Type Contracts. The invoice instructions and the following directions for the submission of invoices must be followed to meet the requirement of a "proper" invoice, pursuant to FAR 32.9 5.Option Provisions Unless the Government exercises its option pursuant to the Option Clause set forth herein, the contract will consist only of the Base Period of the Statement of Work as defined herein. Pursuant to clause 52.217-8 set forth below of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined herein. If the Government exercises this option, notice must be given at least 30 days prior to the expiration date of this contract, and the price of the contract will be increased as set forth in the OPTION PRICES Article in PRICE AND COST SECTION of this contract. 1.52.217-3 Evaluation Exclusive of Options (Apr 1984) The Government will evaluate quotes for award purposes by including only the price for the basic requirement; i.e., options will not be included in the evaluation for award purposes. (End of provision) 2.52.217-4 Evaluation of Options Exercised at Time of Contract Award (June 1988) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate the total price for the basic requirement together with any option(s) exercised at the time of award. (End of provision) 3.52.217-5 Evaluation of Options (July 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate quotes for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). (End of provision) 4.52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within the effective period of performance of this contract. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. (End of clause) 5.52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the effective period of performance of this contract. (End of clause) 6.52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a)The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b)If the Government exercises this option, the extended contract shall be considered to include this option clause. (c)The total duration of this contract, including the exercise of any options under this clause, shall not exceed three years. (End of clause) PART IV - ADDITIONAL PROVISIONS AND REPRESENTATIONS NIH Information and Physical Access Security and Applicable Information Security Clauses 1.Security Requirements: Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility as specified in the solicitation, in dealing with access to sensitive information and information systems belonging to or being used on behalf of the NIA. To satisfy those requirements, a level 5 Risk Background Investigation shall be conducted prior to performing work under this contract. Appropriate background investigation forms will be provided upon contract award and are to be completed and returned to NIA within 30 days for processing. Contractors will be notified when the investigation has been completed and adjudicated. All costs associated with obtaining clearances for contractor-provided personnel will be the responsibility of the contractor. Further, the contractor will be responsible for the actions of all individuals provided to work under this contract. If damages arise from work performed by contractor-provided personnel under the auspices of this contract, the contractor will be responsible for all resources necessary to remedy the incident. This acquisition requires the Contractor to; •develop, have the ability to access, or host and/or maintain Federal information and/or Federal information system(s). •access, or use, Personally Identifiable Information (PII), including instances of remote access to or physical removal of such information beyond agency premises or control. The Contractor and all subcontractors performing under this acquisition shall comply with the following requirements: HHS-Controlled Facilities and Information Systems Security Standard for Security Configurations, HHSAR 352.239-70 Standard for Encryption language, HHSAR 352.239-71 Security Requirements for Federal Information Technology Resources, HHSAR 352.239-72 Security Categorization of Federal Information and Information Systems (FIPS 199 Assessment) Information Security Training Personnel Security Responsibilities A.INFORMATION TYPE [ ]Administrative, Management and Support Information [ x ]Mission Based Information: Research and Development Information Scientific and Technological Research and Innovation B.SECURITY CATEGORIES AND LEVELS (SCL): Confidentiality:[x] Low[ ] Moderate[ ] High Integrity:[ ] Low[x] Moderate[ ] High Availability:[x] Low[ ] Moderate[ ] High Overall:[ ] Low[x] Moderate[ ] High The Contractor shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. The Contracting Officer will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed. C.POSITION SENSITIVITY DESIGNATIONS (PSD): The following position sensitivity designations and associated clearance and investigation requirements apply under this contract: [ ]Level 6: Public Trust - High Risk (Requires Suitability Determination with a BI). Contractor employees assigned to a Level 6 position are subject to a Background Investigation (BI). [ x ]Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with MBI or LBI). Contractor employees assigned to a Level 5 position with no previous investigation and approval shall undergo a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI). [ ]Level 1: Non Sensitive (Requires Suitability Determination with an NACI). Contractor employees assigned to a Level 1 position are subject to a National Agency Check and Inquiry Investigation (NACI). D.PROSPECTIVE OFFEROR NON-DISCLOSURE AGREEMENT [x]Offerors WILL NOT require access to sensitive information in order to prepare an offer. [ ]Offerors WILL require access to sensitive information in order to prepare an offer. INFORMATION SECURITY AND PHYSICAL ACCESS REPORTING REQUIREMENTS: The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article. 2.Reporting of New and Departing Employees The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows: a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level. b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request. 2.Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf. Clauses and Provisions: [ x ]Standard for Security Configurations, HHSAR 352.239-70, (January 2010) a.The Contractor shall configure its computers that contain HHS data with the applicable Federal Desktop Core Configuration (FDCC) (see http://nvd.nist.gov/fdcc/index.cfm ) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level. Note: FDCC is applicable to all computing systems using Windows XPTM and Windows VistaTM, including desktops and laptops - regardless of function - but not including servers. b.The Contractor shall apply approved security configurations to information technology (IT) that is used to process information on behalf of HHS. The following security configuration requirements apply: c.The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security Content Automation Protocol (SCAP)-validated tools with FDCC Scanner capability to ensure its products operate correctly with FDCC configurations and do not alter FDCC settings - see http://scap.nist.gov/validation. The Contractor shall test applicable product versions with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products met the latest FDCC major version and subsequent major versions. d.The Contractor shall ensure IT applications designed for end users run in the standard user context without requiring elevated administrative privileges. e.The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above. f.The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant ( http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf ), Homeland Security Presidential Directive 12 (HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart 4.13, Personal Identity Verification. g.The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause. [ x ]Standard for Encryption language, HHSAR 352.239-71, (January 2010) a.The Contractor shall use Federal Information processing Standard (FIPS) 140-2-compliant encryption (Security) Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004). b.The Contractor shall verify that the selected encryption product has been validated under the Cryptographic Module Validation Program (see http://csrc.nist.gov/cryptval/ ) to confirm compliance with FIPS 140-2 (as amended). The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative. c.The Contractor shall use the Key Management Key (see FIPS 201, Chapter 4, as amended) on the HHS personal identification verification (PIV) card; or alternatively, the Contractor shall establish and use a key recovery mechanism to ensure the ability for authorized personnel to decrypt and recover all encrypted information (see http://csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf ). The Contractor shall notify the Contracting Officer and the Contracting Officer's Technical Representative of personnel authorized to decrypt and recover all encrypted information. d.The Contractor shall securely generate and manage encryption keys to prevent unauthorized decryption of information in accordance with FIPS 140-2 (as amended). e.The Contractor shall ensure that this standard is incorporated into the Contractor's property management/control system or establish a separate procedure to account for all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive HHS information. f.The Contractor shall ensure that its subcontractors (all tiers) which perform work under this contract comply with the requirements contained in this clause. [ x ]Security Requirements For Federal Information Technology Resources, HHSAR 352.239-72, (January 2010) a. Applicability. This clause applies whether the entire contract or order (hereafter "contract"), or portion thereof, includes information technology resources or services in which the Contractor has physical or logical (electronic) access to, or operates a Department of Health and Human Services (HHS) system containing, information that directly supports HHS' mission. The term "information technology (IT)", as used in this clause, 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. This clause does not apply to national security systems as defined in FISMA. b. Contractor responsibilities. The Contractor is responsible for the following: 1.Protecting Federal information and Federal information systems in order to ensure their - a.Integrity, which means guarding against improper information modification or destruction, and includes ensuring information non-repudiation and authenticity; b.Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; and c.Availability, which means ensuring timely and reliable access to and use of information. 2.Providing security of any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor, regardless of location, on behalf of HHS. 3.Adopting, and implementing, at a minimum, the policies, procedures, controls and standards of the HHS Information Security Program to ensure the integrity, confidentiality, and availability of Federal information and Federal information systems for which the Contractor is responsible under this contract or to which it may otherwise have access under this contract. The HHS Information Security Program is outlined in the HHS Information Security Program Policy, which is available on the HHS Office of the Chief Information Officer's (OCIO) Web site. c. Contractor security deliverables. In accordance with the timeframes specified, the Contractor shall prepare and submit the following security documents to the Contracting Officer for review, comment, and acceptance: 1. IT Security Plan (IT-SP) - due within 30 days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies. a.The Contractor's IT-SP shall comply with applicable Federal laws that include, but are not limited to, the Federal Information Security Management Act (FISMA) of 2002 (Title III of the E-Government Act of 2002, Public Law 107-347), and the following Federal and HHS policies and procedures: i.Office of Management and Budget (OMB) Circular A-130, Management of Federal Information Resources, Appendix III, Security of Federal Automation Information Resources. ii.National Institutes of Standards and Technology (NIST) Special Publication (SP) 800-18, Guide for Developing Security Plans for Information Systems, in form and content, and with any pertinent contract Statement of Work/Performance Work Statement (SOW/PWS) requirements. The IT-SP shall identify and document appropriate IT security controls consistent with the sensitivity of the information and the requirements of Federal Information Processing Standard (FIPS) 200, Recommend Security Controls for Federal Information Systems. The Contractor shall review and update the IT-SP in accordance with NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems and FIPS 200, on an annual basis. iii.HHS-OCIO Information Systems Security and Privacy Policy. 2. IT Risk Assessment (IT-RA) - due within 30 days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy. After resolution of any comments provided by the Government on the draft IT-RA, the Contracting Officer shall accept the IT-RA and incorporate the Contractor's final version into the contract for Contractor implementation and maintenance. The Contractor shall update the IT-RA on an annual basis. 3. FIPS 199 Standards for Security Categorization of Federal Information and Information Systems Assessment (FIPS 199 Assessment) - due within 30 days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard. After resolution of any comments by the Government on the draft FIPS 199 Assessment, the Contracting Officer shall accept the FIPS 199 Assessment and incorporate the Contractor's final version into the contract. 4. IT Security Certification and Accreditation (IT-SC&A) - due within 3 months after contract award. The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed for applicable information systems - see paragraph (a) of this clause. The Contractor shall perform the IT-SC&A in accordance with the HHS Chief Information Security Officer's Certification and Accreditation Checklist; NIST SP 800-37, Guide for the Security, Certification and Accreditation of Federal Information Systems; and NIST 800-53, Recommended Security Controls for Federal Information Systems. An authorized senior management official shall sign the draft IT-SC&A and provided it to the Contracting Officer for review, comment, and acceptance. a.After resolution of any comments provided by the Government on the draft IT SC&A, the Contracting Officer shall accept the IT-SC&A and incorporate the Contractor's final version into the contract as a compliance requirement. b.The Contractor shall also perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid. Evidence of a valid system accreditation includes written results of: i.Annual testing of the system contingency plan; and ii.The performance of security control testing and evaluation. d. Personal identity verification. The Contractor shall identify its employees with access to systems operated by the Contractor for HHS or connected to HHS systems and networks. The Contracting Officer's Representative (COR) shall identify, for those identified employees, position sensitivity levels that are commensurate with the responsibilities and risks associated with their assigned positions. The Contractor shall comply with the HSPD-12 requirements contained in "HHS-Controlled Facilities and Information Systems Security" requirements specified in the SOW/PWS of this contract. e. Contractor and subcontractor employee training. The Contractor shall ensure that its employees, and those of its subcontractors, performing under this contract complete HHS-furnished initial and refresher security and privacy education and awareness training before being granted access to systems operated by the Contractor on behalf of HHS or access to HHS systems and networks. The Contractor shall provide documentation to the COR evidencing that Contractor employees have completed the required training. f. Government access for IT inspection. The Contractor shall afford the Government access to the Contractor's and subcontractors' facilities, installations, operations, documentation, databases, and personnel used in performance of this contract to the extent required to carry out a program of IT inspection (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the integrity, confidentiality, and availability, of HHS data or to the protection of information systems operated on behalf of HHS. g. Subcontracts. The Contractor shall incorporate the substance of this clause in all subcontracts that require protection of Federal information and Federal information systems as described in paragraph (a) of this clause, including those subcontracts that - a.Have physical or electronic access to HHS' computer systems, networks, or IT infrastructure; or b.Use information systems to generate, store, process, or exchange data with HHS or on behalf of HHS, regardless of whether the data resides on a HHS or the Contractor's information system. h. Contractor employment notice. The Contractor shall immediately notify the Contracting Officer when an employee either begins or terminates employment (or is no longer assigned to the HHS project under this contract), if that employee has, or had, access to HHS information systems or data. i. Document information. The Contractor shall contact the Contracting Officer for any documents, information, or forms necessary to comply with the requirements of this clause. j. Contractor responsibilities upon physical completion of the contract. The Contractor shall return all HHS information and IT resources provided to the Contractor during contract performance and certify that all HHS information has been purged from Contractor-owned systems used in contract performance. k. Failure to comply. Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause shall be grounds for the Contracting Officer to terminate this contract. (End of Clause) [ x ]PERSONNEL SECURITY RESPONSIBILITIES In addition to any personnel security responsibilities covered under HHSAR 352.239-72, the contractor shall comply with the below personnel security responsibilities: a.In accordance with Paragraph (h) of HHSAR 352.239-72, the Contractor shall notify the Contracting officer and the COR within five working days before a new employee assumes a position that requires access to HHS information systems or data, or when an employee with such access stops working on this contract. The Government will initiate a background investigation on new employees assuming a position that requires access to HHS information systems or data, and will stop pending background investigations for employees that no longer work under the contract or no longer have such access. b.New contractor employees who have or will have access to HHS information systems or data: The Contractor shall provide the COR with the name, position title, e-mail address, and phone number of all new contract employees working under the contract and provide the name, position title and position sensitivity level held by the former incumbent. If an employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate position sensitivity level. c. Departing contractor employees: The Contractor shall provide the COR with the name, position title, and position sensitivity level held by or pending for departing employees. The Contractor shall perform and document the actions identified in the Contractor Employee Separation Checklist (https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf ) when a Contractor/subcontractor employee terminates work under this contract. All documentation shall be made available to the COR upon request. d. Commitment to Protect Non-Public Departmental Information and Data: The Contractor, and any subcontractors performing under this contract, shall not release, publish, or disclose non-public Departmental information to unauthorized personnel, and shall protect such information in accordance with provisions of the following laws and any other pertinent laws and regulations governing the confidentiality of such information: - 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records) - 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information) - Public Law 96-511 (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. [ x ]Loss and/or Disclosure of Personally Identifiable Information (PII) - Notification of Data Breach The Contractor shall report all suspected or confirmed incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH Incident Response Team (IRT) via email ( IRT@mail.nih.gov ) within one hour of discovering the incident. The Contractor shall follow up with IRT by completing and submitting one of the applicable two forms below within three (3) work days of incident discovery: NIH PII Spillage Report at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/NIH_PII_Spillage_Proced.doc NIH Lost or Stolen Assets Report at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/ISSO_Stolen_Device-Media_Handling_Procedures.doc In addition to any training covered under paragraph (e) of HHSAR 352.239-72, the contractor shall comply with the below training: a.Mandatory Training i.All Contractor employees having access to (1) Federal information or a Federal information system or (2) sensitive data/information as defined at HHSAR 304.1300(a)(4), shall complete the NIH Computer Security Awareness Training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, Contractor employees having access to the information identified above shall complete an annual NIH-specified refresher course during the life of this contract. The Contractor shall also ensure subcontractor compliance with this training requirement. ii.The Contractor shall maintain a listing by name and title of each Contractor/Subcontractor employee working on this contract and having access of the kind in paragraph 1.a(1) above, who has completed the NIH required training. Any additional security training completed by the Contractor/Subcontractor staff shall be included on this listing. The list shall be provided to the COR and/or Contracting Officer upon request. b.Role-based Training HHS requires role-based training when responsibilities associated with a given role or position, could, upon execution, have the potential to adversely impact the security posture of one or more HHS systems. Read further guidance about "NIH Information Security Awareness and Training Policy," at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/Final-InfoSecAwarenessTrainPol.doc. The Contractor shall maintain a list of all information security training completed by each contractor/subcontractor employee working under this contract. The list shall be provided to the COR and/or Contracting Officer upon request. c.Rules of Behavior The Contractor shall ensure that all employees, including subcontractor employees, comply with the NIH Information Technology General Rules of Behavior ( https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx ), which are contained in the NIH Information Security Awareness Training Course http://irtsectraining.nih.gov. Section 508-Electronic and Information Technology Standards: The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998. Electronic and Information Technology Accessibility, HHSAR 352.239-73(b) Access to National Institutes of Health (NIH) Electronic Mail 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. Other Clauses and Provisions: 1.Confidentiality of Information a.Confidential information, as used in this article, means information or data of a personal nature about individual, or proprietary information or data submitted by or pertaining to an institution or organization. b.The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause. c.If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. d.Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization. e.Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. f.Contracting Officer's determination will reflect the result of internal coordination with appropriate program and legal officials. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws. 2. The provision at FAR clause at FAR 52.213-4 (Feb 2016), Terms and Conditions-Simplified Acquisitions (Other Than Commercial Items), applies to this acquisition. 3. The provision at FAR clause at FAR 52.227-14 (Dec 2007) Rights in Data-General applies to this acquisition. The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract, including collected data, reports, recommendations, briefings, work plans and all other deliverables. 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.
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