Amendment_1_Section_B-M_Sentinel_Base_IDIQ.docx

SENTINEL INITIATIVE

SENTINEL INITIATIVE

IDIQ BASE CONTRACT

Contents

G6 Contractor Representative for Task Order Contract Adminstration…………………………….12

H9 Disable Macros in Microsoft Office Documents from Outside Sources……………………….32

SECTION K: Representations, Certifications and Other Statements or Offerors…………………………41 K.1 Representatons, Certifications and Other Statements or Offerors…………………………….41 K.2 FAR CLAUSES in FULL TEXT………………………………………………………………………………………41

L15. Cost of Proposal Preparation… …………………………………………………………………………………..60 L16. Service of Protest……………………………………………………………………………………………………….60 L17. Disable Macros in Microsoft Office Documents from Outside Sources……………….………60

M4 Subcontracting Plan……………………………………………………………………………………………………….61

Attachment 12-HHS FDA FAR Class Deviation 18-01……………………………………………… ……………..76

SECTION B: SUPPLIES OR SERVICES AND PRICES/COSTS

B1 Description of Services The Food and Drug Administration (FDA) has a requirement to strengthen the core capabilities of Sentinel and direct the Sentinel program to meet the challenges during the period of performance.

B2 Type of Contract The government intends to award a multiple award Indefinite Delivery Indefinite Quantity (IDIQ) contract for the services specified and effective for the stated period of performance. Task order will then be competed amongst the multiple IDIQ awardees. The quantities of services ordered under this contract shall be accomplished by the issuance of task orders that will describe the contract type, objectives, scope, period of performance, and deliverables. All task orders are subject to the terms and conditions in the IDIQ base contract. At its discretion, the government may use any combination of contract types when issuing task orders under this IDIQ contract to meet its needs, including Firm-Fixed Price (FFP), Time and Materials (TM), or Labor Hour (LH). For each Request for Task Order Proposal (RTOP), the Contractor shall prepare and submit a task order proposal addressing all the areas in the requirement.

The Contractor shall develop the administrative processes and appropriate governance system to issue scientific Workgroup Opportunities (Work Orders) for investigators inside and outside of the Sentinel network. These Work Orders shall be vehicles to procure the expertise necessary for methods development, infrastructure development, or to meet other Sentinel System or FDA-Catalyst needs.

· In-Network: Sentinel Data Partners and other scientific collaborators

· Outside Network: Organizations include academic institutions, industry, contract research organizations, technology companies, or other organizational entities whose expertise or partnership is desirable to achieve a project goal but have not previously signed on with the prime contractor.

B3 Minimum and Maximum Ordering Amounts The guaranteed contract minimum will be 10K.

B4 Maximum Total Contract Amount The contract maximum amount for the IDIQ is estimated at $220 million over five years. The $220 million dollar ceiling applies to all contracts and task orders combined.

B5 Prices/Costs The Contractor shall propose fully burdened fixed hourly rates for services expected to be required to meet all current and future requirements under this contract. Contractor shall provide off-site rates with each task order. These rates shall apply to all task orders awarded under this contract. Labor categories and skill levels shall reflect a broad range of technical and business disciplines and experience levels that may be needed to support both small and large developmental efforts. The labor category rates specified shall be fixed hourly rates which include, as a minimum, the following: wages, indirect costs (including overhead, local taxes, fringe benefits and general and administrative expenses), and profit. All travel costs estimates shall be consistent with General Service Administration (GSA) rates. The pricing matrix is located in Attachment 9.

IDIQ BASE CONTRACT

SECTION C: DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

PROJECT TITLE: Sentinel Initiative [Separate Document for Section C Sentinel Base IDIQ]

C1 Introduction

SECTION D: PACKAGING AND MARKING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. As appropriate, note on the face page of the report and when feasible on the binding: (1) “one volume only” or (2) “volume 1 of 2.

SECTION E: INSPECTION AND ACCEPTANCE

E1 Inspection And Acceptance Of Deliverables

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of all the services. Inspection and acceptance will be performed at the location identified in individual task orders. Acceptance shall be communicated within 30 days of receipt in writing.

SECTION F: DELIVERIES OR PERFORMANCE

F.1 Period of Performance

The period of performance shall be five years, starting from the actual date of award. Task orders may be issued up to the final day of this IDIQ contract, inclusive of any contract extensions and shall remain in force to allow the completion of all issued task orders.

During the performance period, all Federal Holidays will be observed by government personnel, including New Year’s Day, Martin Luther King Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day.

F.2 Place of Performance

The place of performance will be at the contractor’s facility, except for any meetings, presentations, training and events deemed necessary by the government. This includes required periodic travel to the FDA White Oak Campus or other location. Contractors listed in the Key Personnel section of this contract are required to be located in the United States and able to attend in person to program meetings held at the FDA White Oak campus in Silver Spring, MD as specified in the SOW.

Contractor employees shall be required to always wear the required identification badges when working in government facilities.

F.3 CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15 Stop Work Order AUG 1989

The general process for task orders is as follows:

· The FDA will prepare a statement of work in accordance with the base scope of work.

· RTOP shall only be issued by the Contracting Officer.

· The Contractor shall prepare and submit a task order proposal addressing all the areas of the requirement. The Contractor shall submit the task proposal within the time period as specified in the RTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit, and/or negotiate a task order proposal.

· It is the task order Contractor’s responsibility to maintain an ‘Invoice Log’ which captures each activity in the Item Number.

A. Authorized Ordering Activities and Requesting Task Order Proposals: The Contracting Officer of the FDA may place orders under this contract. Except as may be otherwise specifically stated therein, whenever the words, “Contracting Officer” are used in the schedule of this contract, they shall be deemed to mean the Contracting Officer of the ordering activity, or which the Contracting Officer has full responsibility for administering all contractual actions arising from any task order issued by the ordering activity.

The Contracting Officer, or his/her representative, whose signature appears on this contract, has the sole responsibility and authority to make any changes to the provisions of this contract.

The Contracting Officer may solicit responses to requirements from Offerors within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (RTOP) will be prepared and issued for each task order requirement. All contract clauses contained the resultant contract shall be incorporated in the RTOP and the resultant task order. If conflicts exist between the contract clauses and the information outlined in the task order, the resultant contract language takes precedence over the information in the task order.

B. Content of Order: Each task order place under this contract shall include the following information:

1. The contract number, task order number, and date of order.

2. Applicable accounting and appropriation data, and special invoicing instructions where applicable.

Additional information can include in, accordance of FAR 16.505(a) (7):

1. Item number and description, quantity and unit price.

2. Cost and hours (as negotiated), extended amounts, fee (if applicable), total estimated.

3. Delivery or performance date.

4. Place of delivery or performance (including consignee).

5. Packaging, packing, and shipping instructions, if any.

6. Such other terms and conditions as may be pertinent and peculiar to the particular tasks thereby ordered.

7. Individual orders will reflect the requirement of particular circumstances as applicable. Urgent orders will cite peculiar terms and requirements.

C. Processing of Orders by the Contractor: The Task Order Proposal and all supporting information shall be delivered to the Government (TBD By the Program Leads) calendar days after the Government issues the initial Task Order Request.

D. Competitive Ordering Process

1. All Offerors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of the resultant contract unless otherwise specified in the proposed task order.

2. Offerors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in FAR Part 15. However, the Offeror shall provide information sufficient for consideration in accordance with FAR Part 16. Each RTOP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

· Understanding of the requirements;

· Experience and capability on similar tasks;

· Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies.

· Procedures for assuring quality of work, products, and deliverables;

· Plan for managing the task order, including meeting requirements and schedules, and performance measures (if applicable);

· Staffing plan with skill levels and level of effort for each individual proposed. Generally, resumes will be required for proposed personnel (if not previously submitted);

· References to evaluate past performance; and

· Cost/Price to perform the task order.

E. General Process for Individual Work Group Opportunities (Work Orders) The general process for work orders is as follows:

· FDA defines the objectives and requirements for each Work Order.

· The Contractor will prepare a Work Order (Workgroup Opportunity) in accordance with FDA’s stated objectives. Work Orders shall contain the project’s objectives, background, motivation, deliverables, contractual needs, project risks, and constraints, the key selection criteria in conjunction with FDA, and allow for a pricing schedule in the Work Order proposal.

· The Contractor shall issue Work Orders to organizations in/out of the network to meet the project objectives.

· The organizations either in/out of network shall prepare and submit a Work Order proposal addressing all the areas of the requirement within the time period as specified in the Work Order request. No separate payment will be made for the cost to prepare, submit, and/or negotiate a Work Order proposal.

· The Contractor and FDA shall evaluate the Work Order proposals for technical acceptability and price reasonableness, and FDA will select the investigation team.

· The Contractor shall work with the FDA to ensure that timelines and deliverables are met within the agreed upon scope of work and budget.

· FDA inspects and approves all Work Order deliverables.

· During the course of the project, the Contractor shall make any necessary changes to the timeline, budget or scope of work using Work Order Change Request Forms, in conjunction with FDA. FDA approves all Work Order changes.

· It is the Contractor’s responsibility to maintain a ‘Work Order Tracker’ and ‘Summary Log of All Work Orders’ to capture Work Order activities in the task order CLIN. The Contractor shall provide templates for ‘Work Order Tracker’ and ‘Summary Log of All Work Orders’.

· ‘Work Order Tracker’ shall include at a minimum the following information:

· contract number,

· Item Number

· task order award number,

· project name,

· work order number,

· project description,

· estimated total cost (mapped to the task order CLIN),

· labor categories,

· number of hours,

· total amount,

· associated invoice number,

· project start date, and

· project end date.

See Attachment 11 for a ‘Work Order Tracker’ example.

· ‘Summary Log of All Work Orders’ shall include at a minimum the following information:

· contract number,

· total task order award value,

· CLIN,

· task order award number,

· project name,

· work order number,

· invoice number,

· invoice date See Attachment 10 for a ‘Summary Log of All Work Orders’ example.

G2 Contracting Officer

Name: Matthew Bucher Organization: FDA Office of Acquisitions and Grants Services Email: Matthew.Bucher@fda.hhs.gov Telephone: 240-402-7570

G3 Contract Specialist

Name: Tara Hobson Organization: FDA Office of Acquisitions and Grants Services Email: Tara.Hobson@fda.hhs.gov Telephone: 240-402-7586

G4 IDIQ Contracting Officer’s Representative (COR):

Name: TBD Organization: TBD Email: TBD Telephone: TBD

G5 Task Order Contracting Officer’s Representative (TOCOR):

Name: TBD Organization: TBD Email: TBD Telephone: TBD

G6 Contractor Representative For Task Order Contract Administration

The Contractor shall designate an IDIQ Contractor's Representative. The Contractor's representative shall be responsible for all task order administration issues and shall act as the central point of contact with the FDA for all such issues. The representative shall have full authority to act for the Contractor in all contractual matters. The Contractor's representative to be contacted for all task order contract administration matters is as follows:

Name:

Organization:

Email:

Telephone:

G7 Key Personnel Per HHSAR 352.237-75, the key personnel specified in this IDIQ are considered essential to the work performance of this IDIQ and key personnel will be specified for each task order. Contractors shall notify the Contracting Officer’s Representative, Contracting Officer, and the Sentinel Program Lead at least 30 days prior to the contractor voluntarily diverting these individuals with a justification and proposed plan for replacement of the individual. If the employee of the contractor is terminated for cause or separates from the Contractor voluntarily, the Contractor shall provide the government notice as soon as possible. Key personnel changes can be modified with the agreement of both the Contractor and government.

The contractor shall provide the names and qualifications of the key personnel assigned to this contract. The individuals cited below are key personnel.

G8 Invoice Submission

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A. THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer / System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) The contractor shall include the Contract Line Item/Funding line item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment

(xi) Name and telephone number of the FDA Contracting Officer (CO) and the Contracting Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

(xii) Any other information or documentation required by the purchase order/award.

C. An electronic invoice shall be in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742) (Amend as necessary) INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE REQUIREMENTS SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND 52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER. SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

SECTION H: SPECIAL CONTRACT REQUIREMENTS

H1 Conformance With Applicable Laws, Regulations, Policies, And Standard

Contractor Compliance The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accountability Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/

The computer programs, data management systems, databases, and other resources used or developed through this contract shall comply with data standards and procedures established by DHHS and FDA (per http://www.fda.gov/ForIndustry/DataStandards/default.htm).

H2 FDA IT Requirements

H2.1 Section 508 Compliance The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that the deliverables generated as part of this contract shall be compliant with Section 508.

· The Offeror shall demonstrate their ability to adhere to and comply with the applicable Section 508 standards identified below:

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements).

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements).

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements).

· E205 Electronic Content (Appendix A, Application and Scoping).

· 302 Functional Performance Criteria (Appendix C, Application and Scoping Requirements).

· E207 Software (Appendix A, Application and Scoping Requirements).

· Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements).

· E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements).

· Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements).

· 602 Support Documentation.

· 603 Support Services.

· All applicable WCAG 2.0 A and AA requirements.

· The Offeror shall submit a written Accessibility Conformance Report (ACR) for this DME Technical Scenario which is complete and includes a detailed explanation of the Offeror’s capabilities and understanding of accessibility testing and customization to conform with the above Section 508 standards. The ACR shall be based on the Voluntary Product Accessibility Template Version 2.1 (VPAT link: http://www.itic.org/policy/accessibility/vpat) (MS Word) provided by the Industry Technology Industry Council (ITIC).

H.2.2 Security and Privacy NOTE: Completion of the FDA Security and Privacy Language for IT Procurements (October 2017), Appendix A entitled, “Information Security & Privacy Certification Checklists” to determine applicable of security and privacy requirements is on hold due to the Government Shutdown and availability of the FDA Senior Privacy Officer or Representative.

H3 Security and Privacy

· Baseline Security Requirements

· Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

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

· Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

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

· Protect government information and information systems in order to ensure:

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

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

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

· Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

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

· Comply with the Privacy Act requirements and tailor FAR clauses as needed.

· Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[ X ] No PII [ ] Yes PII

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

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

PII Confidentiality Impact Level has been determined to be:

[ X ] Not Applicable [ ] Low [ ] Moderate [ ] High

· Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

· marked appropriately;

· disclosed to authorized personnel on a Need-To-Know basis;

· protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

· returned to FDA control, destroyed when no longer needed, or held until otherwise directed.

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media.

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

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

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

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

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

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

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

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

· Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

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

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

· Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

· All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

· Verify that the encryption solutions in use are compliant with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

· Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

· Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the FDA non-disclosure agreement (3398 Form), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

· Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

· If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

· The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

· Training

· Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

· Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

· Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

· Rules of Behavior

· The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

· All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual FDA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

· Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA SMC /Incident Response Team (IRT) teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

· Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

· NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send FDA approved notifications to affected individuals as directed by FDA’s SOP.

· Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “other stakeholders.”) including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour of discovery/detection, and consistent with the applicable FDA and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

· cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

· not include any sensitive information in the subject or body of any reporting e-mail; and

· encrypt sensitive information in attachments to email, media, etc.

· Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information and HHS and FDA incident response policies when handling PII breaches.

· Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation demand.

· Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4) that apply to this award.]

· Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes shall be submitted within a timeline as directed by the COR and/or CO. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

· Contract Initiation and Expiration

· General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here: http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.aspx HHS EA requirements may be located here: https://www.hhs.gov/about/agencies/asa/ocio/index.html

· System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

· Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with FDA OAGS SMGs to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media

· Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR as soon as it is known that an employee will stop working under this contract.

· Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or FDA policies.

· The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm as soon as it is known that an employee will terminate work under this contract within days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

· Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

H4 Organizational Conflict Of Interest

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract; and,

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors.