RFPAttachment1IDIQTermandConditions_AmendmentNo.0001.pdf

FDA-SOL-18-1192468 / Amendment No. 0001 Page 1 of 79 RFP Attachment 1: IDIQ Terms and Conditions

Food and Drug Administration

RFP Attachment 1

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) & CENTER FOR BIOLOGICS EVALUATION AND

RESEARCH (CBER)

Pharmacovigilance System Implementation and Support for Product Safety and Quality

FDA Adverse Event Reporting System (FAERS) II

Indefinite Delivery/Indefinite Quantity (IDIQ) Terms and Conditions

FDA-SOL-18-1192468 / Amendment No. 0001 Page 2 of 79

SECTION 1: PRICING SCHEDULE

1.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

1.2 CONTRACT TYPE: INDEFINITE DELIVERY / INDEFINITE QUANTITY (ID/IQ) CONTRACT

1.3 MINIMUM AND MAXIMUM CONTRACT VALUE

1.4 PRICING TERMS

1.5 DISCOUNTS

1.6 MATERIAL HANDLING

SECTION 2: DELIVERIES OR PERFORMANCE

2.1 ORDERING PERIOD

2.2 PERIOD OF PERFORMANCE FOR TASK ORDERS

2.3 NOTICE TO THE GOVERNMENT OF DELAYS

2.4 DELIVERABLES

2.5 PERSONNEL

2.6 PLACE OF PERFORMANCE

2.7 OBSERVANCE OF LEGAL HOLIDAYS & OTHER GOVERNMENT CLOSINGS

2.8 CONTRACT MANAGEMENT

2.8.1 Government Points of Contact

2.8.2 IDIQ Contracting Officer’s Representative (COR)

2.8.3 Task Order and Delivery Order COR

2.8.4 Contractor’s Contract Administration Information

2.9 ORDERING

2.9.1 Delivery Orders –

2.9.2 Task Orders -

2.10 TRAVEL

2.11 OTHER DIRECT COSTS

2.12 GOVERNMENT FURNISHED EQUIPMENT/GOVERNMENT FURNISHED INFORMATION

2.13 FDA SECURITY REQUIREMENTS

2.14 IT CONSTRAINTS

2.15 SECTION 508 COMPLIANCE

2.16 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

2.17 ORGANIZATIONAL CONFLICT OF INTEREST (SIMPLIFIED)

2.18 CONTRACTOR CLOSEOUT RESPONSIBILITIES

2.19 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

2.20 DO NOT COMPETE

2.21 NON-PERSONAL SERVICES

2.22 NONCOMMERCIAL COMPUTER SOFTWARE RIGHTS DEFINITIONS

2.23 CERTIFICATE OF MAINTAINABILITY

2.24 SPECIAL NOTICE AND AGREEMENT REGARDING SOFTWARE EULA/TOS

2.25 TECHNOLOGY UPGRADES/REFRESHMENT/INSERTION

PROVISIONS AND CONTRACT CLAUSES

3.1 FAR PROVISIONS INCORPORATED BY REFERENCE

3.2 PROVISIONS INCORPORATED BY FULL TEXT

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) PROVISIONS

2.7 HHSAR CLAUSES INCORPORATED BY REFERENCE

SUBMISSION INSTRUCTIONS AND DEADLINES

4.1 GENERAL INSTRUCTIONS FOR THE PREPARATION OF THE TECHNICAL PROPOSAL AND BUSINESS

PROPOSAL

4.2 INSTRUCTIONS FOR TECHNICAL PROPOSAL (VOLUME I)

FACTOR 1 – FAERS II REQUIREMENTS (Go / No Go) ( RFP Attachment No. 4) FACTOR 2 - Technical Approach to FAERS II DME FACTOR 3: Product Accessibility Templates, Configuration Approach, and 508 Risk Mitigation strategy

FDA-SOL-18-1192468 / Amendment No. 0001 Page 3 of 79

VOLUME 3: PAST PERFORMANCE AND SMALL BUSINESS SUBCONTRACT REQUIREMENTS

SECTION A: PAST PERFORMANCE

4.3 GENERAL INSTRUCTIONS FOR BUSINESS PROPOSAL (VOLUME II)

4.3.1 BUSINESS PROPOSAL ELEMENTS

4.4 SPECIFIC BUSINESS PROPOSAL INSTRUCTIONS (VOLUME II)

4.4.1 BUSINESS PROPOSAL COVERSHEET:

4.4.2 CAPABILITY MATURITY MODEL

4.4.3 EVIDENCE OF RESPONSIBILITY

4.4.4 SIGNED AGREEMENT FROM ORIGINAL EQUIPMENT MANUFACTURER (OEM) OR AUTHORIZED

RESELLER

4.4.5 ASSUMPTIONS

4.4.6 ATTACHMENT NO. 6: PRICING SHEET INSTRUCTIONS

SUMMARY TAB (Tab 1) IDIQ GOVERNMENT-SITE TAB (Tab 2) IDIQ CONTRACTOR-SITE TAB (Tab 3)

IDIQ LICENSES AND MAINTENANCE (TABS 4-8)

FAERS DME (TAB 9)

ASSUMPTIONS: TAB

BASIS FOR AWARD AND EVALUATION CRITERIA

5.1 AWARD BASIS

5.2 FACTOR 1: FAERS II REQUIREMENTS (Go / No Go)

5.3 EVALUATION APPROACH OF TRADE-OFF FACTORS

FACTOR 3 / TECHNICAL APPROACH TO FAERS II DME

FACTOR 3: PRODUCT ACCESSIBILITY TEMPLATES, CONFIGURATION APPROACH, AND 508 RISK MITIGATION

STRATEGY

VOLUME 3: PAST PERFORMANCE AND SMALL BUSINESS SUBCONTRACT REQUIREMENTS

5.4 PAST PERFORMANCE AS A CONFIDENCE ASSESSMENT

5.5 SMALL BUSINESS SUBCONTRACTING MANAGEMENT PLAN

PRICE EVALUATION

FDA-SOL-18-1192468 / Amendment No. 0001 Page 4 of 79

SECTION 1: PRICING SCHEDULE

1.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The U.S. Food and drug Administration (FDA) is establishing an Indefinite Delivery / Indefinite Quantity (IDIQ) contract to purchase a pharmacovigilance Commercial-Off-the-Shelf (COTS) suite of products to replace FDA’s Adverse Event Reporting system (FAERS), obtain continued operations and maintenance support of the legacy FAERS system currently running on Oracle AERs, obtain transition services from Legacy FAERS to the new pharmacovigiliance COTs tool, and obtain full IT Lifecycle support service of FAERS II and supporting applications.

1.2 CONTRACT TYPE: INDEFINITE DELIVERY / INDEFINITE QUANTITY (ID/IQ) CONTRACT

This is an Indefinite Delivery/Indefinite Quantity (IDIQ) contract per FAR parts 12, 15, and 16.5.

At the discretion of the Contracting Officer, the Government may use a variety of contract types under this contract for each task order including: Firm Fixed Price (FFP), Time and Materials (T&M), Labor Hour, or a combination thereof.

Each Request For Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of task order type.

Specific requirements tailored to meet a particular center program needs will be included in each RFTOP, including specific deliverables and schedules for the deliverables. Each RFTOP shall include the specific Center requirements, performance standards, and a quality assurance plan. The period of performance of each task order will be established upon the issuance the order. Deliverables are to be determined upon the issuance of each task order.

1.3 MINIMUM AND MAXIMUM CONTRACT VALUE

(a) The concurrent award of Task Order One will fulfill the minimum order guarantee.

(b) Estimated maximum aggregate dollar value of the task orders awarded over the 5.5-year IDIQ ordering period shall not exceed $36 million.

1.4 PRICING TERMS

The labor rates and unit prices shall be fixed for the duration of this contract and shall be derived from the IDIQ pricing schedule and effective for the task order period of performance. The unit prices specified in the Task Order shall be fixed for the Task Order Period of Performance and shall not be subject to adjustment, even when the Task Order Period of Performance overlaps the IDIQ Period of Performance. If a task order’s stated period of performance must be extended as a result of delays, the Contractor shall continue to perform at the established labor rates of the Order for the work effort during the extended period. The Pricing Schedule will be developed based on pricing proposed on RFP Attachment 6: FAERS Pricing Sheet. The labor rates in the pricing schedule are fully burdened, inclusive of all direct costs, indirect costs, and profit.

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable unit price for a task order shall be the unit price for the time period in which the services are estimated to be performed, as

FDA-SOL-18-1192468 / Amendment No. 0001 Page 5 of 79 agreed to by the Government and the Contractor at the time the task order is issued. The price (s) specified in the FFP task orders issued under this contract is/are fixed.

Each Time and Material or Labor Hour task order shall contain a ceiling price. The Contractor shall comply with FAR 52.212-4(ALT I) in regards to the ceiling price for the individual task order(s).

1.5 DISCOUNTS

The contractor is encouraged to offer any and all discounts for goods and services provided under future task orders. The type or amount of discount may vary based on the circumstances of each particular task order and should be proposed in accordance with the Contractor’s pricing policies.

1.6 MATERIAL HANDLING

Payment for material handling for ODCs shall be at a fixed percent of __%. Any material handling proposed must be exclusive of any profit and of any costs that would normally be covered by the indirect rates applied to the direct labor rate.

SECTION 2: DELIVERIES OR PERFORMANCE

2.1 ORDERING PERIOD

The ordering period is five years from the effective date of award. In accordance with 52.217-8 Option to Extend Services (1999) the Government reserves the right to extend services 6-months beyond the ordering period.

2.2 PERIOD OF PERFORMANCE FOR TASK ORDERS

Period of Performance for task orders will be as specified in individual task orders. Two constraints apply to the period of performance for task orders. First, individual task orders may not exceed 5 years (inclusive of option periods). Second, individual task orders may not extend one year beyond the end date of the IDIQ Ordering Period.

2.3 NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

2.4 DELIVERABLES

Deliverables shall be specified in the task orders released under this contract. Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

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2.5 PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to task orders awarded.

2.6 PLACE OF PERFORMANCE

The contractor may be required to work on site at the government or at the contractor’s location as required in individual task order. Specific location information will be specified in each task order. Per individual task order telework may be authorized, please note authorized telework shall be charged at the Government site rate or Contractor’s site rate (whichever is less). In general, most FDA Centers and Offices operate predominantly in the Washington, DC Metropolitan area with concentrations in the FDA's Maryland locations of Bethesda, College Park, Laurel, Rockville, and White Oak. NCTR operates from its headquarters in Jefferson, Arkansas.

2.7 OBSERVANCE OF LEGAL HOLIDAYS & OTHER GOVERNMENT CLOSINGS

Coverage is expected during all Federal work days. Services will not be performed at the Federal site when the Federal Government is closed for reasons such as inclement weather or executive order. No services or deliveries shall be performed at the Federal sites on Federal legal holidays as shown below unless specifically requested by the COR (in the best interest of industry coverage).

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

2.8 CONTRACT MANAGEMENT

Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor.

Communications pertaining to the contract administration will be addressed to the Contracting Officer.

No changes to the statement of work are authorized without a written modification to the contract executed by the Contracting Officer.

The Contractor is advised that only the Contracting Officer can change or modify the contract terms or take any other action, which obligates the Government. Then, such action must be set forth in a formal written modification to the contract.

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Contractors who reply on direction from other than the Contracting Officer do so at their own risk and expense. Such actions do not bind the Government contractually. Any contractual questions shall be directed to the Contracting Officer, or Contract Specialist.

2.8.1 Government Points of Contact

Address and phone number of the Contracting Staff:

Contract Specialist:

Jody O’Kash Contract Specialist – Systems Technology Acquisitions Branch Office of Acquisition and Grants Services U.S. Food & Drug Administration 5630 Fishers Lane, Room 2084, HFA-500, Rockville MD 20857 240-402-4996 Jody.OKash@fda.hhs.gov

Contracting Officer (Alternate POC):

Tzeleong Chang Chief – System Technology Acquisitions Branch Office of Acquisition and Grants Services U.S. Food & Drug Administration 5630 Fishers Lane, Room 2102, HFA-500, Rockville MD 20857 240-402-7527 Tzeleong.Chang@fda.hhs.gov

2.8.2 IDIQ Contracting Officer’s Representative (COR)

The Contracting Officer may designate other Government personnel (known as the Contracting Officer’s Representative) to act as her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the contract.

The Contractor shall immediately contact the Contracting Officer if there is any question regarding the authority of an individual to act on behalf of the Contracting Officer under this contract.

IDIQ Contracting Officer Representative (COR): TBD

2.8.3 Task Order and Delivery Order COR

For each Order, a COR will be assigned. The COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (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; (5) assisting in the resolution of technical problems encountered during mailto:Jody.OKash@fda.hhs.gov mailto:Tzeleong.Chang@fda.hhs.gov

FDA-SOL-18-1192468 / Amendment No. 0001 Page 8 of 79 performance; and (6) providing technical direction in accordance with Technical Direction section below;

and, (7) reviewing of invoices/vouchers.

The Government may unilaterally change its COR designation.

Technical Leads may assist the COR. The Technical Leads will not have the authority to provide technical direction; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances as required by this performance; and (5) reviewing of invoices/vouchers.

Technical Direction Performance of the work under task order shall be subject to the technical direction of the Task Order COR. The term “technical direction” is defined to include, without limitation, the following:

Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work descriptions.

Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general scope of work stated in the contract. The COR does not have the authority to and may not issue any technical direction which:

Constitutes an assignment of additional work outside the general scope of work of the contract.

Constitutes a change as defined in the applicable contract clause entitled FAR 52.212-4(c)

Contract Terms and Conditions – Commercial Items.

In any manner cause an increase or decrease in the total estimated contract cost, fixed-fee, or the time required for contract performance.

Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction shall be issued in writing by the IDIQ or Task Order COR or shall be confirmed by him/her in writing within 5 working days after issuance.

The Contractor shall proceed promptly with the performance of technical direction duly issued by the COR in the manner prescribed by this article and within his/her authority under the provisions of this article.

If, in the opinion of the Contractor, any instructions or direction issued by the COR is within one of the out of scope categories described above, the Contractor shall not proceed, but shall notify the Contracting Officer in writing within 1 working day after the receipt of any such instructions or direction.

Upon receiving such notification from the Contractor, the Contracting Officer will advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract.

The Government is not required to reimburse any out of scope work performed by the Contractor.

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2.8.4 Contractor’s Contract Administration Information

The Contractor’s contract administration functions will be performed at the following address:

Name and Title:

Responsible Office:

Address:

Telephone Number:

Fax Number:

E-mail Address:

DUNS#:

TIN:

Notification Regarding Administrative Problems If at any time during the performance of this contract, administrative problems should arise which will have an adverse impact on the timely performance by the Contractor or affect the contract costs or funding, the Contractor is required to immediately notify the Contracting Officer.

2.9 ORDERING

2.9.1 Delivery Orders –

Ordering supplies, such as software licenses, shall be accomplished by the issuance of a written delivery order specifying the type and quantity of supplies. All delivery orders issued under this contract shall conform to provisions of clause FAR 52.216-18 “Ordering” in this contract. The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer (CO).

Delivery orders will include the following

a. Delivery Order Number

b. Date

c. Accounting Information

d. Quantity

e. Type

f. Cost

g. Any terms, conditions, or instructions unique to the order.

2.9.2 Task Orders -

Ordering services shall be accomplished by the issuance of written task orders specifying the types of services or goods being ordered.

Ordering Procedures – When a need for services/goods within scope of this contract arises, the FDA will issue a Request for Task Order Proposal (RFTOP). The process for awarding orders will be as follows:

1. FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue an RFTOP via email. The RFTOP will include at a minimum a SOW, the period of performance, the anticipated order type (LH, T&M or FFP), reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

FDA-SOL-18-1192468 / Amendment No. 0001 Page 10 of 79

2. Within ten (10) business days (unless another time frame is specified in writing) the contractor will provide a proposal to the Contracting Officer. The proposal will include a brief description of the technical approach and a price build up. The price build up should include the labor categories to be utilized, the number of hours within each labor category, extended pricing for each labor category and a bottom line price/ceiling. Labor category rates shall not change for the entire period of performance in a twelve-month task order.

3. Generally, FDA will evaluate the task order proposal for technical acceptability and price reasonableness. If the FDA has questions or concerns, the Contracting Officer will contact the Offeror, and may ask for a revised proposal.

4. Once FDA has reached an award determination, the Contracting Office will issue the task order.

5. Orders will include the following:

a. Task Order Number

b. Date

c. Accounting Information

d. SOW

e. Price/Ceiling

f. Period of Performance

g. Any terms, conditions, or instructions unique to the order.

Any work that the Contractor undertakes prior to receiving a fully executed task order signed by the Contracting Officer is undertaken at their own risk. The Government will not reimburse the Contractor.

2.10 TRAVEL

Any required travel by the Contractor will be at the direction of the Government and will be reimbursed at cost (except Firm Fixed Price task orders) in accordance with the Federal Travel Regulations (FTR).

Local travel will not be reimbursed.

Travel Arrangements for Contractor Personnel Performance under this contract may require travel by Contractor personnel. If travel, domestic or overseas, is required, the Contractor is responsible for making all needed arrangements for Contractor’s personnel. This includes but is not limited to the following:

Medical Examinations

Immunizations

Passports

Visas, etc

Security Clearances

Travel Policy

FDA-SOL-18-1192468 / Amendment No. 0001 Page 11 of 79

The Government will reimburse the Contractor for allowable travel costs incurred by the Contractor in performance of the contract and determined to be in accordance with FAR subpart 31.2, subject to the following provisions: Travel required for tasks assigned under this contract shall be governed in accordance with rules set forth for temporary duty travel in FAR 31.205-46.

Travel – Travel, subsistence, and other associated labor charges for travel time are authorized, whenever a task assignment requires work to be accomplished at a temporary alternate worksite.

Travel performed for personal convenience and daily travel to and from work at Contractor’s facility will not be reimbursed.

Per Diem – Per Diem for travel on work assigned under this contract will be reimbursed to employees consistent with company policy, but not exceed the amount authorized in the Federal Travel Regulations.

Air/Rail Travel – In rendering services, the Contractor shall be reimbursed for the actual costs of transportation incurred by its personnel not to exceed the cost of tourist class rail, or plane fare, to the extent that such transportation is necessary for the performance of the services hereunder and is authorized by the Contracting Officer. Such authorization by the Contracting Officer shall be indicated in the order or in some other suitable written form.

Note: To the maximum extent practicable without the impairment of the effectiveness of the mission, transportation shall be tourist class. In the event that only first class travel is available, it will be allowed, provided justification therefore is fully documented and warranted.

Private Automobile – The use of privately owned conveyance within the continental United States by the traveler will be reimbursed to the Contractor at the mileage rate allowed by Federal Travel Regulations. Authorization for the use of privately owned conveyance shall be indicated on the order. Distances traveled between points shall be shown in standard highway mileage guides. Any deviations from distance shown in such standard mileage guides shall be explained by the traveler on the expense sheet.

Car Rental – The Contractor shall be entitled to reimbursement for car rental, exclusive of mileage charges, as authorized by each order, when the services are required to be performed outside the normal commuting distance from the Contractor’s facilities. Car rental for TDY teams will be limited to a rate of one car for every four (4) persons on TDY at one site.

2.11 OTHER DIRECT COSTS

All Other Direct Costs (ODC) should be submitted through the invoice. All OCDs over $3,500, other than those ODCs acquired under the firm fixed price line items, must be pre-approved by the Contracting Officer, if not already approved through the issuance of a task order or modification.

To be eligible to receive reimbursement for ODC the Contractor must obtain at least three quotes for each transaction in excess of $3,500.00 to ensure that adequate price competition was sought or the Contractor must provide an acceptable justification as to why it was impracticable to do so. For purchases of ODC, the Contractor shall provide the aforementioned documentation with every ODC purchase request to the Contracting Officer.

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The Contractor shall maintain documentation of all reimbursable purchase until three years after the contract is completed and shall provide access to and copies of such documentation when requested by the Contracting Officer.

The Contracting Officer may deny any reimbursement request by any amount above that which the Contracting Officer has approved. It shall be the Contractor’s burden to demonstrate that the price it paid for the reimbursable items was fair and reasonable.

2.12 GOVERNMENT FURNISHED EQUIPMENT/GOVERNMENT FURNISHED INFORMATION

Each task order will identify Government Furnished Equipment and Government Furnished Information.

The Contractor will be provided with documented standards, policies, and FDA EPLC templates.

Additionally, FDA will provide updates to artifacts (standards, document templates, and processes) as they become available. As the FDA EPLC artifacts are modified, the contractor shall use the most current artifacts in all subsequent development activities.

2.13 FDA SECURITY REQUIREMENTS

Procurements Requiring Information Security and/or Physical Access Security

A. Baseline Security Requirements

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

2) 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.

a. 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.

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

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

FDA-SOL-18-1192468 / Amendment No. 0001 Page 13 of 79

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

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

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

b. Provide security for any Contractor systems, and information contained therein, connected to an 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.

c. 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.

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

4) 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:

Confidentiality: [ ] Low [ X] Moderate [ ] High

Integrity: [ ] Low [ ] Moderate [X ] High

Availability: [ ] Low [ ] Moderate [ X ] High

Overall Risk Level: [ ] Low [ ] Moderate [ X] High

Based on information provided by the Privacy Office, system/data owner, or other privacy http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

FDA-SOL-18-1192468 / Amendment No. 0001 Page 14 of 79 representative, it has been determined that this solicitation/contract involves:

[ ] No PII [ X] Yes PII

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: [ ] Low [ X] Moderate [ ] High

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

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

a. marked appropriately;

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

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

d. returned to 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.

6) Protection of Sensitive Information. For security purposes, information is or may be

FDA-SOL-18-1192468 / Amendment No. 0001 Page 15 of 79 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:

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

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

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

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

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

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

Document Section Deliverable Title/Description Due Date Applicable (y/n)

F- Roster Roster Within 60 days of the Y

FDA-SOL-18-1192468 / Amendment No. 0001 Page 16 of 79 effective date of this contract, updated quarterly

A – Contractor Employee Non- Disclosure Agreement (NDA)

Contractor Employee Non- Disclosure Agreement (NDA)

Prior to performing any work on behalf of

HHS/FDA

Y

A – Privacy Threshold Analysis(PTA)/Privacy Impact Assessment (PIA)

Assist in the completion of a PTA/PIA form

Per timeline as specified by the FDA Privacy POCs after contract award. As needed for each release (per PPA).

Y

B – Training Records Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Y

C – Rules of Behavior Signed ROB for all employees Initiation of contract and at least annually thereafter

Y

D – Incident Response Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Y

D – Incident Response Incident and Breach Response Plan

Upon request from Government

Y

2 – Personnel Security Responsibilities

List of Personnel with defined roles and responsibilities

Within a time directed by the COR that is before an employee begins working on this contract.

N (Roster is sufficient)

G – Personnel Security Responsibilities

Off-boarding documentation, equipment and badge when leaving contract

The last day that work is being performed after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Y

E – Background Investigation

Onboarding documentation when beginning contract.

Prior to performing any work on behalf of

HHS/FDA

Y

G - Certification of Sanitization of Government and Government Activity- Related Files, Information and Devices.

Form or deliverables required by

FDA.

At contract expiration.

Y

G – Contract Initiation and Expiration

If the procurement involves a system or cloud service, additional documentation will be required, such as Disposition/Decommission Plan

At contract initiation and expiration, or as directed by COR.

A – Security Assessment and Authorization

(SA&A)

SA&A Package

SSP

SCF

SAR

POA&M

Authorization Letter

Due for each system as requested by the COR and/or identified in the PPA after contract award.

FDA-SOL-18-1192468 / Amendment No. 0001 Page 17 of 79

ISCP and ISCPT Report E-Auth (if applicable) PTA/PIA/SPP (if applicable) Interconnection/Data Use

Agreements (if applicable) Authorization Letter Configuration Management

Plan (if applicable) Configuration Baseline documents

A – Reporting and Continuous Monitoring

POA&M updates; Revised security documentation/Agreements

As requested by COR

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

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

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

c. 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).

d. 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.

e. Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (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.

11) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the 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.

http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf

FDA-SOL-18-1192468 / Amendment No. 0001 Page 18 of 79

12) 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.

a. 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).

b. 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.

B. Training

1) 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.

2) 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).

3) 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.

FDA-SOL-18-1192468 / Amendment No. 0001 Page 19 of 79

C. Rules of Behavior

1) 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.

2) 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.

D. 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:

1) 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.

2) 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.

3) Report all suspected and confirmed information security and privacy incidents and breaches

FDA-SOL-18-1192468 / Amendment No. 0001 Page 20 of 79 to the FDA Systems Management Center, COR, CO, and 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:

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

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

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

4) 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.

5) 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.

E. 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:

F. 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

FDA-SOL-18-1192468 / Amendment No. 0001 Page 21 of 79

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. 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.

G. Contract Initiation and Expiration

1) 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 HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here:

https://www.hhs.gov/ocio/ea/documents/proplans.html

2) 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…